Notices. Notice of Availability (NOA)
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BILLING CODE 6050-$$-P DEPARTMENT OF DEFENSE Department of the Army, Corps of Engineers Notice of Availability for the Draft Environmental Impact Statement/Environmental Impact Report for the Middle Harbor Redevelopment Project of the Port of Long Beach, Los Angeles County, CA AGENCY: U.S. Army Corps of Engineers, Los Angeles District, DoD. ACTION: Notice of Availability (NOA). SUMMARY: The U.S. Army Corps of Engineers, Los Angeles District (Corps) in coordination with the Port of Long Beach has completed a Draft Environmental Impact Statement/ Environmental Impact Report (EIS/EIR) for the Middle Harbor Redevelopment project in the Port of Long Beach.
The Corps is considering an application for Section 404 and Section 10 permits to conduct dredge and fill activities associated with the proposed consolidation of Piers D, E and F into a single 345-acre marine terminal with a 4,250-foot-long wharf at build-out. This would include redevelopment of 294 acres of existing land, creation of 10.7 acres of new open water and the placement of dredged material in 65.3 acres open water for a net gain of approximately 54.6 acres of new land in the consolidated terminal.
The new terminal, which would be constructed over a 10-year time period, is intended to accommodate increasing cargo volumes being produced by the new generation of larger container vessels, and would include four deep-water berths, a container terminal yard, and an intermodal rail yard. FOR FURTHER INFORMATION CONTACT: Comments and questions regarding scoping of the Draft EIS/EIR may be addressed to: U.S. Army Corps of Engineers, Los Angeles District, Regulatory Branch, ATTN:
File Number 2004-01053-AOA, P.O. Box 532711, Los Angeles, California 90053-2325. Comments or questions can also be sent to Stacey Crouch, Port of Long Beach, P.O. Box 570, Long Beach, CA 90801-0570. Phone messages or questions should be directed to Antal Szijj at 805-585-2147. Dated: April 29, 2008. Mark Durham, Acting Chief, Regulatory Division, Los Angeles District, Corps of Engineers. [FR Doc. E8-10908 Filed 5-15-08; 8:45 am] BILLING CODE 3710-KF-P DEPARTMENT OF ENERGY Notice of Intent To Prepare an Environmental Impact Statement for Remediation of Area IV of the Santa Susana Field Laboratory and Conduct Public Scoping Meetings AGENCY:
Office of Environmental Management, Department of Energy. ACTION: Notice of Intent To Prepare an Environmental Impact Statement and Conduct Public Scoping Meetings. SUMMARY: The Department of Energy
(DOE)announces its intent to prepare an Environmental Impact Statement
(EIS)and conduct public scoping meetings under the National Environmental Policy Act
(NEPA)for remediation of Area IV of the Santa Susana Field Laboratory (SSFL Area IV). The SSFL, approximately 2,852 acres in the hills between Chatsworth and Simi Valley, CA, was developed as a remote site to test rocket engines and conduct nuclear research. Area IV was established at the SSFL in 1953 and occupies 290 acres of the SSFL. The DOE Energy Technology Engineering Center
(ETEC)is located on 90 acres within SSFL Area IV. DOE is preparing the EIS in part as a response to a May 2, 2007, decision by the U.S. District Court of Northern California that DOE was in violation of NEPA for its 2003 decision to issue a Finding of No Significant Impact (FONSI), and to conduct remediation of the ETEC site, on the basis of an environmental assessment
(EA)rather than an EIS. DOE recognizes the need to follow the NEPA process and will evaluate the range of reasonable alternatives for remediation of SSFL Area IV. DOE will evaluate alternatives for disposition of radiological facilities and support buildings, remediation of the affected environment, and disposal of all resulting waste at existing, approved sites. DOE will consider the cumulative impacts from exposure to chemical and radiological constituents in SSFL Area IV from future land uses. DOE invites public comment on the scope of this EIS during a scoping period that will end August 14, 2008. During this period, DOE officials will conduct public scoping meetings in the region surrounding the SSFL and in Sacramento, California, to provide the public and other stakeholders with an opportunity to comment on the scope of the EIS. DOE recognizes the value of the public's perspectives, and will inform, involve, and interact with the public during all phases of the EIS process. DOE is issuing this Notice of Intent
(NOI)in order to inform and request comments and assistance from Federal and state agencies, state and local governments, Tribal Nations, natural resource trustees, the general public, and other interested parties on the appropriate scope of the EIS, alternatives, environmental issues, and the environmental impacts related to DOE's remediation activities for SSFL Area IV. DOE invites those agencies with jurisdiction by law or special expertise to be cooperating agencies. DATES: The public scoping period starts May 16, 2008 and will continue until August 14, 2008. DOE will consider all comments received or postmarked by August 14, 2008, in defining the scope of this EIS. Comments received or postmarked after that date will be considered to the extent practicable. ADDRESSES: Public scoping meetings will be held to provide the public with an opportunity to present comments on the scope of the EIS and to learn more about the proposed action from DOE officials. *Public scoping meetings will be held at the following locations on the following days and times:* • *Simi Valley, California:* Grand Vista Hotel, 999 Enchanted Way, July 22, 2008, 2 p.m. to 4 p.m. and 6:30 p.m. to 9:30 p.m.; • *Northridge, California:* World Vision Church, 19514 Rinaldi Street, July 23, 2008, 2 p.m. to 4 p.m. and 6:30 p.m. to 9:30 p.m.; and • *Sacramento, California:* Sacramento Central Library, 828 I Street, July 24, 2008, 2 p.m. to 4 p.m. and 6:30 p.m. to 9:30 p.m. *Written comments on the scope of the EIS should be sent to:* Ms. Stephanie Jennings, NEPA Document Manager, U.S. Department of Energy, P.O. Box 10300, Canoga Park, CA 91309, Express Mail Delivery Address: 5800 Woolsey Canyon Road, Canoga Park, CA 91304, telephone number: 818-466-8162, fax: 818-466-8730, or e-mail to *stephanie.jennings@emcbc.doe.gov* (use “Scoping comments” for the subject). All comments whether offered in person at the scoping meeting, or in writing as described above will be considered. FOR FURTHER INFORMATION CONTACT: To request further information about this EIS or about the public scoping activities, or to be placed on the EIS distribution list, use any of the methods (mail, express mail, fax, telephone, or e-mail) listed under ADDRESSES above. For general information concerning the DOE NEPA process, contact Carol Borgstrom, Director, Office of NEPA Policy and Compliance (GC-20), U.S. Department of Energy, 1000 Independence Avenue, SW., Washington, DC 20585-0119, e-mail to: *AskNEPA@hq.doe.gov,* telephone: 202-586-4600, leave a message at 1-800-472-2756, or fax: 202-586-7031. This NOI will be available on the internet at: *http://www.eh.doe.gov/NEPA* and at *http://www.etec.energy.gov,* click on the Area IV EIS link on the toolbar. Further information about SSFL Area IV can be found at *http://www.etec.energy.gov* and click on the SSFL Area IV EIS link in the toolbar. *Reading rooms with information about the SSFL Area IV are available to the public and are located in:* • *Simi Valley, California:* Simi Valley Library, 2969 Tapo Canyon Road,
(805)526-1735; • *Woodland Hills, California:* Platt Branch Library, 23600 Victory Blvd.,
(818)340-9386; and • *Northridge, California:* California State University Northridge Oviatt Library, 2nd Floor, Room 265,
(818)677-2285. SUPPLEMENTARY INFORMATION: Background SSFL, located on approximately 2,852 acres in the hills between Chatsworth and Simi Valley, CA, was developed as a remote site to test rocket engines and conduct nuclear research. The Atomics International Unit of Rockwell International's Canoga Park-based Rocketdyne Division began testing in 1947. An estimated 17,000 open-air rocket tests that supported the space program were conducted at the site. In 1996, Rockwell International sold its aerospace and defense business, including the SSFL, to The Boeing Company (Boeing). SSFL is divided into four administrative areas, Areas I, II, III, and IV, and two undeveloped land areas. Area I consists of about 713 acres, including 671 acres that are owned and operated by Boeing and 42 acres that are owned by the National Aeronautics and Space Administration
(NASA)and operated for it by Boeing. Area II consists of about 410 acres that are owned by NASA and operated for it by Boeing. Area III consists of about 114 acres that are owned and operated by Boeing. Area IV consists of about 290 acres that are owned by Boeing, a portion of which it operated for the DOE. Boeing also owns a contiguous undeveloped land area of 1,143 acres to the south and a contiguous undeveloped land area of 182 acres to the north. Starting in the mid-1950s, the Atomic Energy Commission (AEC), a predecessor agency of DOE, funded nuclear energy research on a 90-acre parcel of SSFL Area IV leased from Rocketdyne. ETEC was established by the AEC on this parcel in the early 1960s as a “center of excellence” for liquid metals technology. A total of 10 small reactors were built for various research activities over the years of operation. The most notable of the reactors was the Sodium Reactor Experiment (SRE). SRE was an experimental development-stage sodium-cooled nuclear reactor that operated from April 1957 to February 1964 at the SSFL. SRE was the first commercial nuclear power plant to provide electricity to the public (powering the City of Moorpark in 1957). An accident occurred at the SRE in July 1959 when there was an accidental blockage of sodium coolant in some of the reactor coolant channels resulting in the partial melting of the fuel cladding in 13 of the 43 reactor fuel assemblies. Radioactive gases from the accident were contained within the facility. Over a period of two months, the gases were vented and released to the atmosphere. The controlled releases were always below those levels allowed by requirements in existence both then and today. Following cleanup, the facility was refueled, brought back online, and operated until February 1964. All SSFL reactor operations ended in 1980 and nuclear research work was completed in 1988. Cleanup of ETEC began in the 1960s and was performed in an ongoing manner as unnecessary facilities were decommissioned. In March 2003, DOE issued an *Environmental Assessment for Cleanup and Closure of the Energy Technology Engineering Center,* DOE/EA-1345. Based on the results of the EA, DOE determined that an EIS was not required and issued a FONSI in March 2003. Comments on the Environmental Assessment were received by DOE from Federal and State agencies, elected officials, and from local community members. The comments addressed the following concerns: U.S. Environmental Protection Agency, Region 9
(EPA)said that the EA did not clearly identify the decisions that were to be made, how those decisions related to each other, or how or when the decisions would be made. EPA also expressed concern that the conclusions reached by DOE in the EA were based upon inadequate standards and information. *EPA stated:* “* * * that the [Comprehensive Environmental Response, Compensation and Liability Act (CERCLA)] process should be used to evaluate and select a cleanup alternative.” EPA and the State of California Department of Toxic Substances Control
(DTSC)criticized the Rocketdyne survey of radiological contamination, which the EA relied upon, as being insufficient for not addressing multiple exposures to radiological contamination, contamination through combinations of radiological and chemical contamination, and contamination from different radionuclides. They also expressed concern that there was no plan to examine SSFL Area IV beyond the 90 acres of ETEC, that groundwater contamination was not addressed, and that there was a failure to address past releases of contamination. The City of Los Angeles and local community members expressed concern that DOE did not adequately consider the effects of releases and remediation on the surrounding communities. Senator Barbara Boxer expressed concern with proposed waste disposal methods and with the intention to leave a substantial amount of radioactive soil in place. The Committee to Bridge the Gap criticized DOE for assuming the site would be suitable in the future for residential development. Local community members were concerned with what DOE proposed as an acceptable rate of increased cancer risk. DOE is now preparing an SSFL Area IV EIS in response to the U.S. District Court of Northern California's May 2, 2007, ruling in the case *Natural Resources Defense Council* v. *Department of Energy* Slip Op. 2007 WL 2349288 (N.D. Cal. Aug. 15, 2007), which held that DOE's decision to issue a FONSI and conduct cleanup and closure on the basis of DOE/EA-1345 was in violation of NEPA. The Court ordered DOE to prepare an EIS for SSFL Area IV in accordance with NEPA. The Court further prevented the DOE from transferring ownership or possession, or otherwise relinquishing control over any portion of SSFL Area IV, until DOE completes the EIS and issues a Record of Decision pursuant to NEPA. In response to requests from DTSC and the California Congressional delegation, DOE suspended the physical demolition and removal activities for the remaining facilities at ETEC, except for those activities necessary to maintain the site in a safe and stable configuration. DOE will continue surveillance, maintenance, and environmental monitoring, including soil and groundwater characterization required under the Resource Conservation and Recovery Act (RCRA), the California Health and Safety Code section 25187, and DOE Orders, while it prepares the EIS. In addition to the investigation and evaluation of individual soils contamination areas under the requirements of RCRA, DOE, Boeing and NASA also are required to investigate and evaluate the groundwater for development of potential cleanup or interim actions. The EIS will address groundwater contamination and contributors to the contamination related to Area IV. All prior and currently planned interim corrective action activities under the DTSC administered Consent Order are located outside of Area IV and will be evaluated to determine if any impact on the groundwater plumes within Area IV exist. In August 2007, DTSC issued a RCRA Consent Order to DOE, NASA, and Boeing (as respondents) pursuant to its authority over hazardous waste under the California Health and Safety Code section 25187. This Order requires the respondents to clean up all chemically-contaminated soils at SSFL by 2017 or earlier, provides the option for DTSC to require additional work to be conducted offsite of SSFL Area IV to assess air, soil, and water contamination and requires the preparation of an Environmental Impact Report (EIR), pursuant to the California Environmental Quality Act (CEQA). DTSC may use information in the EIS in its preparation of the EIR. DOE issued an Advance Notice of Intent (ANOI), 72 FR 58834 (October 17, 2007), to prepare an EIS for SSFL Area IV and to conduct Public Involvement Activities in order to inform and request early comments and assistance. Informal discussions resulting from publication of the ANOI with both members of the public and other stakeholders aided in the development of this NOI. DOE has conducted interviews with interested parties. The purpose of these interviews was to learn about concerns with the proposed remediation of SSFL Area IV as well as the public's preferences for being involved during the development of the EIS. This broad cross section of individuals includes neighbors of the SSFL, individuals who have been active in previous SSFL actions, former employees, elected and appointed local, state, and Federal officials, representatives of local and national environmental groups, members of local neighborhood associations, organizations, and the business community. This sampling of a wide range of perspectives is enhancing the development of future public involvement activities. The report of these interviews and associated recommendations for improvements in public involvement activities will be posted on the Web site listed in the FOR FURTHER INFORMATION SECTION of this NOI. In October 2007, California Senate Bill 990 (SB 990) was signed into law. SB 990 requires the DTSC to certify that the SSFL has been completely remediated so that the cumulative risk of exposure from residual chemical and radiological contamination does not exceed a risk range premised on future land use of either suburban or rural residential. Until this certification is completed, the land at SSFL cannot be transferred or sold. In December 2007, the EPA announced the results of a Hazard Ranking Survey it had conducted at SSFL beginning in Spring 2007. Although EPA could not reveal the final score, EPA indicated that the score exceeded the threshold for listing SSFL on the National Priority List for cleanup under CERCLA. Consequently, EPA sent a letter dated December 6, 2007, to the Governor of California requesting his concurrence in the listing. In response, the California Environmental Protection Agency, in a letter dated January 15, 2008, asked that EPA defer for six months the decision regarding whether to propose listing for this site. EPA Region 9 agreed to defer listing SSFL until July 2008. As part of the FY 2008 appropriations, Congress mandated that DOE shall use a portion of the funding for ETEC to enter into an interagency agreement
(IAG)with EPA to conduct a joint comprehensive radioactive site characterization of Area IV and ensure that all aspects of the cleanup of the radioactive contamination comply fully with CERCLA. DOE and EPA are negotiating the terms of the IAG, and the associated scope of the site characterization. DOE is collecting updated information that it will incorporate into the EIS analysis. A data gap analysis was conducted to evaluate the usability and acceptability of existing data, and to identify any additional data that may be needed to support the EIS. Results of the data gaps analysis will be shared with interested parties in June 2008, and will also be made available on the Web site ( *http://www.etec.energy.gov,* click on Area IV EIS in the toolbar) . A follow-on field analysis and sampling plan will be developed and will also be shared with interested parties in August 2008. Dates, locations and times for these workshops on the draft gap analysis and availability of the subsequent draft sampling and analysis plans will be announced through the site mailing list, the local media, and on the Web site. The draft gap analysis, field analysis, and sampling plans will all be available in the public reading rooms listed above. Printed copies of documents may be obtained from Ms. Jennings at the location listed in the above ADDRESSES section. Purpose and Need for Agency Action DOE needs to complete remediation of SSFL Area IV to comply with applicable requirements and for radiological and hazardous contaminants. Alternatives In the EIS, DOE will describe the statutory and regulatory requirements for each remediation alternative and whether legislation or regulatory modifications may be needed to implement the alternative under consideration. The EIS will present the health and environmental consequences of the alternatives in comparative form to provide a clear basis for informed decision making. In summary, DOE proposes to evaluate the alternatives listed below: • *Alternative 1:* No Action—This alternative involves the cessation of all DOE management and oversight of SSFL Area IV. The buildings would remain and would not be monitored or maintained. Unmitigated natural processes, including erosion, groundwater transport of contamination and concrete degradation, would be assumed to occur. The purposes of evaluating this alternative are to establish the baseline against which the environmental impacts from all other alternatives are compared and to justify the proposed action. NEPA regulations require analysis of a no action alternative. • *Alternative 2:* No further cleanup or disposition of buildings and no remediation of contaminated media at SSFL Area IV—DOE would continue environmental monitoring and maintain security of SSFL Area IV. • *Alternative 3:* Onsite Containment at SSFL Area IV—Containment onsite of buildings, wastes, radiological and chemical contaminants, aligned with potential future land use scenarios including, but not limited to, agricultural, residential, and open space. • *Alternative 4:* Offsite Disposal of SSFL Area IV Materials—Demolition of buildings, removal of contaminated media aligned with potential future land use scenarios including, but not limited to, agricultural, residential, and open space. Transportation of non-radiological wastes to approved disposal or treatment facilities and radiological wastes to an approved out-of-state disposal facility. • *Alternative 5:* Combination On-Site/Off-Site Disposal Alternative for SSFL Area IV—Demolition of buildings, on-site containment of contaminated media aligned with potential future land use scenarios including, but not limited to, agricultural, residential, and open space. Transportation of non-radiological wastes from building demolition to approved disposal or treatment facilities and radiological waste from building demolition to an approved, out-of-state disposal facility. These preliminary alternatives will be refined and further developed as part of the scoping process through public and other stakeholder input. Preliminary Environmental Impacts for Analysis DOE has tentatively identified the following environmental impacts for analysis in the SSFL Area IV EIS. This list is presented to facilitate comment during the public involvement activities on the scope of the EIS. *These impacts include:* • Potential health and safety impacts to the general population, and to workers, and to the environment from radiological and non-radiological releases; • Potential transportation impacts from the shipment of radiological and non-radiological wastes to disposal sites; • Potential impacts from accidents that might occur ( *e.g.* , accidents associated with removal and transportation of contaminated media); • Potential impacts from intentional destructive acts; • Land use impacts; • Socioeconomic impacts; • Impacts to ecological resources (endangered and protected species [Braunton's milk-vetch, Santa Susana tarplant, Southern California black walnut, Mariposa lily, Coast Horned Lizard], floodplain and wetlands); • Cultural, historical and paleontological resources impacts; • Irretrievable and irreversible commitment of resources; • Potential disproportionately high and adverse effects on low-income and minority populations (environmental justice); and • Cumulative impacts from radiological and non-radiological contamination both onsite and offsite of SSFL Area IV, and from both radiological and non-radiological contaminants. Preliminary Identification of Issues The following issues have been tentatively identified for consideration in the EIS. This list is not intended to be all-inclusive, but is presented to facilitate public comment during the public scoping period: • Best methods to obtain accurate information on radiological and hazardous contamination; • Compliance with applicable Federal, state and local requirements; • Long-term stewardship and institutional controls; and • Mitigation measures to avoid or mitigate potentially significant environmental impacts. Scoping Process DOE issued an Advance Notice of Intent (ANOI), 72 FR 58834 (October 17, 2007), to prepare an EIS for SSFL Area IV and to conduct public involvement activities in order to inform and request early comments and assistance. Informal discussions resulting from publication of the ANOI with both members of the public and other stakeholders aided in the development of this NOI. DOE is issuing the NOI, pursuant to 40 CFR 1501.7 and 10 CFR 1021.311, in order to inform and request comments and assistance from Federal and state agencies, state and local governments, natural resource trustees, the general public, and other interested parties on the scope of the EIS, environmental issues, alternatives to be analyzed, and the potential environmental impacts related to DOE's potential activities at this site. The NOI is also being issued to notify the public and other stakeholders of the scoping meetings to be held as described. In addition, DOE will provide progress updates to the public and other stakeholders throughout all phases of the EIS process. DOE will consult with appropriate Federal and state agencies regarding the environmental and regulatory issues germane to the proposed remediation alternatives for analysis in the EIS and the environmental issues to be analyzed. DOE invites those agencies with jurisdiction by law or special expertise to be cooperating agencies. Public scoping meetings will be held at the locations and times listed in the ADDRESSES section of this Notice. DOE will designate a presiding officer for the scoping meetings. At the opening of each meeting, the presiding officer will announce procedures necessary for the conduct of the meeting. At the beginning of the scoping meetings, a brief presentation by DOE officials will be given explaining DOE's proposed approach to alternatives, issues to be addressed, and impacts that will be analyzed in the EIS. This presentation will be followed by a question and answer session. Following the question and answer session, the public will be given the opportunity to provide comments orally. This part of the scoping meetings will not be conducted as an evidentiary hearing, and there will be no questioning or cross-examination of the speakers. DOE personnel, however, may ask for clarifications to ensure that they fully understand the comments and suggestions. The presiding officer will establish the order of the speakers, and will ensure that everyone who wishes to speak has a chance to do so. Oral comments will be limited in duration at the discretion of the presiding officer based on the number of commenters and the time available. DOE is especially interested in learning from the public any additional issues or alternatives that should be considered. Comment cards will also be available for those who would prefer to submit written comments. Persons who wish to speak may sign up to speak before each meeting at the reception desk. Oral and written comments will be considered equally in the preparation of the EIS. See the ADDRESSES section of this Notice for the times and locations of these meetings. DOE will make transcripts of the scoping meetings and other environmental and SSFL Area IV related materials available for public review in the reading rooms listed in the FOR FURTHER INFORMATION CONTACT [section of this Notice]. This information will also be available through the project web site at *http://www.etec.energy.gov,* click on Area IV EIS in the toolbar. Draft EIS Schedule and Availability DOE will provide a public comment period of at least 45 days from the publication of the EPA's Notice of Availability
(NOA)of the Draft EIS in the **Federal Register** and will hold at least one public hearing. DOE will separately announce in the **Federal Register** and local media information on the public hearings schedule and location. DOE expects to issue the Draft EIS in early 2009. Comments on the Draft EIS will be considered and addressed in the Final EIS, which DOE anticipates issuing in the fall 2010. DOE will issue a Record of Decision no sooner than 30 days from EPA's NOA of the Final EIS. Issued in Washington, DC, on May 13, 2008. Ines R. Triay, Acting Assistant Secretary for Environmental Management. [FR Doc. E8-11033 Filed 5-15-08; 8:45 am] BILLING CODE 6450-01-P DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Idaho National Laboratory AGENCY: Department of Energy. ACTION: Notice of open meeting. SUMMARY: This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Idaho National Laboratory. The Federal Advisory Committee Act (Pub. L. 92-463, as amended) requires that public notice of this meeting be announced in the **Federal Register** . DATES: Thursday, May 29, 2008—8 a.m.-5 p.m. Opportunities for public participation will be held Thursday, May 29, from 11:45 a.m. to 12 p.m. and from 3 p.m. to 3:15 p.m. These times are subject to change; please contact the Federal Coordinator (below) for confirmation of times prior to the meeting. ADDRESSES: AmeriTel Inn, 645 Lindsay Boulevard, Idaho Falls, Idaho 83402. FOR FURTHER INFORMATION CONTACT: Robert L. Pence, Federal Coordinator, Department of Energy, Idaho Operations Office, 1955 Fremont Avenue, MS-1203, Idaho Falls, ID 83415. Phone
(208)526-6518; Fax
(208)526-8789 or e-mail: *pencerl@id.doe.gov* or visit the Board's Internet home page at: *http://www.inlemcab.org* . SUPPLEMENTARY INFORMATION: *Purpose of the Board:* The purpose of the Board is to make recommendations to DOE in the areas of environmental restoration, waste management, and related activities. Tentative Topics (agenda topics may change up to the day of the meeting; please contact Robert L. Pence for the most current agenda): • Tour Cleanup Areas/Projects on the Idaho National Laboratory (INL); • Progress to Cleanup; • Accelerated Decontaminating and Decommissioning Plan; • Calcine—Nuclear Regulatory Commission Licensing Update; • Integrated Waste Treatment Unit Project; • Savannah River/INL Spent Fuel Transfer. *Public Participation:* The meeting is open to the public. Written statements may be filed with the Board either before or after the meeting. Individuals who wish to make oral presentations pertaining to agenda items should contact Robert L. Pence at the address or telephone number listed above. The request must be received five days prior to the meeting and reasonable provision will be made to include the presentation in the agenda. The Deputy Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Individuals wishing to make public comment will be provided a maximum of five minutes to present their comments. *Minutes:* Minutes will be available by writing or calling Robert L. Pence, Federal Coordinator, at the address and phone number listed above. Minutes will also be available at the following Web site: *http://www.inlemcab.org/meetings.html* . Issued at Washington, DC on May 12, 2008. Rachel Samuel, Deputy Committee Management Officer. [FR Doc. E8-11006 Filed 5-15-08; 8:45 am] BILLING CODE 6450-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 12551-001] Salvatore and Michelle Shifrin; Notice of Application Accepted for Filing and Soliciting Motions To Intervene and Protests May 9, 2008. Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection. a. *Type of Application:* Exemption From Licensing. b. *Project No.:* P-12551-001. c. *Date Filed:* January 25, 2008. d. *Applicant:* Salvatore and Michelle Shifrin. e. *Name of Project:* Mansfield Hollow Hydro Power Project. f. *Location:* On the Natchaug River in Tolland County, Connecticut. The project would occupy United States land managed by the U.S. Army Corps of Engineers. g. *Filed Pursuant to:* Public Utilities Regulatory Policies Act of 1978, 16 U.S.C. 2705, 2708. h. *Applicant Contact:* Salvatore or Michelle Shifrin, 78 Bricktop Road, Windham, CT 06280,
(860)423-7709. i. *FERC Contact:* Tom Dean,
(202)502-6041. j. *Deadline for filing motions to intervene and protests:* 60 days from the issuance date of this notice. All documents (original and eight copies) should be filed with: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. The Commission's Rules of Practice require all intervenors filing documents with the Commission to serve a copy of that document on each person on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency. Motions to intervene and protests may be filed electronically via the Internet in lieu of paper. The Commission strongly encourages electronic filings. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site ( *http://www.ferc.gov* ) under the “eFiling” link. k. This application has been accepted for filing, but is not ready for environmental analysis at this time. l. Description of Project: The Mansfield Hollow Hydro Power Project would consist of:
(1)The existing 80-foot-long, 10-foot-high Kirby Mill Dam;
(2)the existing 1.6-acre reservoir;
(3)the existing headgate structure;
(4)the existing 12-foot-wide, 8-foot-high, 330-foot-long head race channel;
(5)a new powerhouse containing five generating units with a total installed capacity of 500 kilowatts;
(6)the existing 5-foot-wide, 7-foot-high, 100-foot-long conduit and 75-foot-long open tailrace; and
(7)appurtenant facilities. The project would have an average annual generation of about 2,500 megawatt-hours. In addition to a new powerhouse, project reconstruction would consist of:
(1)A new 12-foot-wide, 8-foot-high, 330-foot-long head race channel;
(2)a new 20-foot-wide, 8-foot-high, 20-foot-long box culvert connected to a new 25-foot-wide, 4-foot-high, 153-foot-long open channel tail race; and
(3)a new 275-foot-long transmission line. m. A copy of the application is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at *http://www.ferc.gov* using the “eLibrary” link. Enter the docket number excluding the three digits in the docket number field to access the document. For assistance, please contact FERC Online Support at *FERCOnlineSupport@ferc.gov* or toll free at
(866)208-3676, or for TTY, contact
(202)502-8659. A copy is also available for inspection and reproduction at the address in item h above. You may also register online at *http://www.ferc.gov/docs-filing/esubscription.asp* to be notified via e-mail of new filings and issuances related to this or other pending projects. For assistance, contact FERC Online Support. n. Anyone may submit a protest or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, 385.211, and 385.214. In determining the appropriate action to take, the Commission will consider all protests filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any protests or motions to intervene must be received on or before the specified deadline date for the particular application. All filings must:
(1)Bear in all capital letters the title “PROTEST” or “MOTION TO INTERVENE;”
(2)set forth in the heading the name of the applicant and the project number of the application to which the filing responds;
(3)furnish the name, address, and telephone number of the person protesting or intervening; and
(4)otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. Agencies may obtain copies of the application directly from the applicant. A copy of any protest or motion to intervene must be served upon each representative of the applicant specified in the particular application. o. *Procedural schedule and final amendments:* The application will be processed according to the following Hydro Licensing Schedule. Revisions to the schedule will be made as appropriate. The Commission staff proposes to issue one environmental assessment rather than issue a draft and final EA. Comments, terms and conditions, recommendations, prescriptions, and reply comments, if any, will be addressed in an EA. Staff intents to give at least 30 days for entities to comment on the EA, and will take into consideration all comments received on the EA before final action is taken on the license application. Notice of application ready for environmental analysis: September 2008. Notice of availability of the EA: March 2009. Kimberly D. Bose, Secretary. [FR Doc. E8-11026 Filed 5-15-08; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 2669-061] Bear Swamp Power Company LLC; Notice of Application for Amendment of License and Soliciting Comments, Motions To Intervene, and Protests May 7, 2008. Take notice that the following application has been filed with the Commission and is available for public inspection: a. *Application Type:* Amendment of License to Revise the Installed Capacity of the Project. b. *Project No.:* 2669-061. c. *Date Filed:* March 31, 2008. d. *Applicant:* Bear Swamp Power Company LLC. e. *Name of Project:* Bear Swamp Hydroelectric Project. f. *Location:* On the Deerfield River, in Franklin and Berkshire counties, Massachusetts. g. *Filed Pursuant to:* Federal Power Act, 16 U.S.C. 791a-825r. h. *Applicant Contact:* Mr. Paul Bernhardt, P.E., Brookfield Power Company, 225 Greenfield Parkway, Suite 201, Liverpool, NY 13088, *paul.bernhardt@brookfieldpower.com* , telephone:
(315)413-2750. i. *FERC Contact:* Mrs. Anumzziatta Purchiaroni, Telephone
(202)502-6191, and e-mail address: *anumzziatta.purchiaroni@ferc.gov* . j. *Deadline for filing comments, motions to intervene, and protest:* June 9, 2008. All documents (original and eight copies) should be filed with: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. The Commission's Rules of Practice and Procedure require all intervenors filing documents with the Commission to serve a copy of that document on each person whose name appears on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency. A copy of any motion to intervene must also be served upon each representative of the Applicant specified in the particular application. k. *Description of Request:* The licensee is proposing non-capacity upgrades for two existing units at the project. The licensee plans to replace the pump turbine runners and rewind both generators. Consequently, the project's total authorized installed capacity would increase from 610 MW to 676 MW, and hydraulic capacity will increase from 5,430 cfs to 6,200 cfs. The licensee explains that all the work will be done within the existing powerhouse, and there are no planned modifications to the upper or lower reservoirs. l. *Locations of the Application:* A copy of the application is available for inspection and reproduction at the Commission's Public Reference Room, located at 888 First Street, NE., Room 2A, Washington, DC 20426, or by calling
(202)502-8371. Information about this filing may also be viewed on the Commission's Web site at *http://www.ferc.gov* using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document. You may also register online at *http://www.ferc.gov/docs-filing/esubscription.asp* to be notified via e-mail of new filings and issuances related to this or other pending projects. For assistance, call 1-866-208-3676 or e-mail *FERCOnlineSupport@ferc.gov* , for TTY, call
(202)502-8659. A copy is also available for inspection and reproduction at the address in item
(h)above. m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission. n. *Comments, Protests, or Motions to Intervene* —Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, .214. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application. o. Any filings must bear in all capital letters the title “COMMENTS”, “PROTEST”, or “MOTION TO INTERVENE”, as applicable, and the Project Number of the particular application to which the filing refers. p. *Agency Comments:* Federal, State, and local agencies are invited to file comments on the described application. A copy of the application may be obtained by agencies directly from the Applicant. If an agency does not file comments within the time specified for filing comments, it will be presumed to have no comments. One copy of an agency's comments must also be sent to the Applicant's representatives. q. Comments, protests and interventions may be filed electronically via the Internet in lieu of paper. See, 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site at *http://www.ferc.gov* under the “e-Filing” link. Kimberly D. Bose, Secretary. [FR Doc. E8-10954 Filed 5-15-08; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 1992-003] Fire Mountain Lodge; Notice of Application Tendered for Filing With the Commission, Soliciting Additional Study Requests, and Establishing Procedural Schedule for Relicensing and a Deadline for Submission of Final Amendments May 7, 2008. Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection. a. *Type of Application:* Existing Minor License. b. *Project No.:* 1992-003. c. *Date Filed:* April 25, 2008. d. *Applicant:* Ken Willis. e. *Name of Project:* Fire Mountain Lodge. f. *Location:* On Fern Spring in Tehama County, California. The project is located primarily on privately owned land except for a small portion of the dam and reservoir which is located on U.S. Forest Service land. g. *Filed Pursuant to:* Federal Power Act 16 U.S.C. 791 (a)-825(r). h. *Applicant Contact:* Ken Willis, Fire Mountain Lodge, 43500 Highway 36, Mill Creek, CA 96060,
(530)258-1952. i. *FERC Contact:* Matt Buhyoff,
(202)502-6824 or *matt.buhyoff@ferc.gov* j. *Cooperating agencies:* We are asking Federal, State, local, and tribal agencies with jurisdiction and/or special expertise with respect to environmental issues to cooperate with us in the preparation of the environmental document. Agencies who would like to request cooperating status should follow the instructions for filing such requests described in item l below. Cooperating agencies should note the Commission's policy that agencies that cooperate in the preparation of the environmental document cannot also intervene. *See* , 94 FERC ¶ 61,076 (2001). k. Pursuant to Section 4.32(b)(7) of 18 CFR of the Commission's regulations, if any resource agency, Indian Tribe, or person believes that an additional scientific study should be conducted in order to form an adequate factual basis for a complete analysis of the application on its merit, the resource agency, Indian Tribe, or person must file a request for a study with the Commission not later than 60 days from the date of filing of the application, and serve a copy of the request on the applicant. l. *Deadline for filing additional study requests and requests for cooperating agency status:* June 24, 2008. All documents (original and eight copies) should be filed with: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. Additional study requests and requests for cooperating agency status may be filed electronically via the Internet in lieu of paper. The Commission strongly encourages electronic filings. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site ( *http://www.ferc.gov* ) under the “e-Filing” link. m. This application is not ready for environmental analysis at this time. n. The existing Fire Mountain Lodge project consists of:
(1)A 265-foot-long earth and concrete filled dam;
(2)a 0.24-acre reservoir;
(3)a 38 inch intake tower;
(4)a 1540-foot-long penstock;
(7)a powerhouse with an installed capacity of 60-kilowatts; a
(8)a 4000 foot-long transmission line and;
(9)appurtenant facilities. The power generated by the project is utilized for commercial and residential purposes, solely for the owners of Fire Mountain Lodge, a self-provider of electricity. o. A copy of the application is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at *http://www.ferc.gov* using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, contact FERC Online Support at *FERCOnlineSupport@ferc.gov* or toll-free at 1-866-208-3676, or for TTY,
(202)502-8659. A copy is also available for inspection and reproduction at the address in item h above. You may also register online at *http://www.ferc.gov/docs-filing/esubscription.asp* to be notified via e-mail of new filings and issuances related to this or other pending projects. For assistance, contact FERC Online Support. p. With this notice, we are initiating consultation with the California State Historic Preservation Officer (SHPO), as required by § 106, National Historic Preservation Act, and the regulations of the Advisory Council on Historic Preservation, 36, CFR, at § 800.4. q. *Procedural schedule and final amendments:* The application will be processed according to the following Hydro Licensing Schedule. Revisions to the schedule will be made as appropriate. Issue Deficiency Letter—June 2008. Issue Acceptance letter—June 2008. Issue Scoping Document 1 for comments—June 2008. Request Additional Information—July 2008. Issue Scoping Document 2—August 2008. Notice of application is ready for environmental analysis—October 2008. Notice of the availability of the draft EA—April 2009. Final amendments to the application must be filed with the Commission no later than 30 days from the issuance date of the notice of ready for environmental analysis. Kimberly D. Bose, Secretary. [FR Doc. E8-10957 Filed 5-15-08; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP06-9-001] Florida Gas Transmission Company, LLC; Notice of Application To Amend Authorization May 8, 2008. Take notice that on May 2, 2008, Florida Gas Transmission Company, LLC (FGT), 5444 Westheimer Road, Houston, Texas 77056, filed in Docket No. CP06-9-001, an application, pursuant to section 7 of the Natural Gas Act (NGA), for an order amending its authorization granted by the Commission in Docket No. CP06-9-000 on May 30, 2006 in order to continue the existing certificate authority for its 18-inch and 24-inch pipelines located in Broward County, Florida and hold in abeyance the abandonment authority for these facilities until newly identified conflicts with planned construction by the Florida Department of Transportation/Florida Turnpike Enterprise are resolved, or for a period not to exceed 36 months, all as more fully set forth in the application which is on file with the Commission and open to public inspection. This filing is accessible on-line at *http://www.ferc.gov* , using the “eLibrary” link and is available for review in the Commission's Public Reference Room in Washington, DC. There is an “eSubscription” link on the Web site that enables subscribers to receive e-mail notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please e-mail *FERCOnlineSupport@ferc.gov* , or call
(866)208-3676 (toll free). For TTY, call
(202)502-8659. Any questions regarding this application should be directed to Michael T. Langston, Senior Vice President of Government and Regulatory Affairs, Florida Gas Transmission Company, LLC, 5444 Westheimer Road, Houston, Texas 77056 at
(713)989-7610. Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9, within 90 days of this Notice the Commission staff will either: Complete its environmental assessment
(EA)and place it into the Commission's public record (eLibrary) for this proceeding; or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the final environmental impact statement
(FEIS)or EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule for Environmental Review will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's FEIS or EA. There are two ways to become involved in the Commission's review of this project. First, any person wishing to obtain legal status by becoming a party to the proceedings for this project should, on or before the comment date stated below, file with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a motion to intervene in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the NGA (18 CFR 157.10). A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies of all documents filed by the applicant and by all other parties. A party must submit 14 copies of filings made with the Commission and must mail a copy to the applicant and to every other party in the proceeding. Only parties to the proceeding can ask for court review of Commission orders in the proceeding. However, a person does not have to intervene in order to have comments considered. The second way to participate is by filing with the Secretary of the Commission, as soon as possible, an original and two copies of comments in support of or in opposition to this project. The Commission will consider these comments in determining the appropriate action to be taken, but the filing of a comment alone will not serve to make the filer a party to the proceeding. The Commission's rules require that persons filing comments in opposition to the project provide copies of their protests only to the party or parties directly involved in the protest. The Commission strongly encourages electronic filings of comments, protests and interventions in lieu of paper using the “eFiling” link at *http://www.ferc.gov* . Persons unable to file electronically should submit an original and 14 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. This filing is accessible on-line at *http://www.ferc.gov* , using the “eLibrary” link and is available for review in the Commission's Public Reference Room in Washington, DC. There is an “eSubscription” link on the Web site that enables subscribers to receive e-mail notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please e-mail *FERCOnlineSupport@ferc.gov* , or call
(866)208-3676 (toll free). For TTY, call
(202)502-8659. *Comment Date:* May 29, 2008. Kimberly D. Bose, Secretary. [FR Doc. E8-10965 Filed 5-15-08; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #1 May 1, 2008. Take notice that the Commission received the following electric corporate filings: *Docket Numbers:* EC08-83-000. *Applicants:* Iberdrola Renewables, Inc., PPM Wind Energy LLC, Aeolus Wind Power IV LLC, Klondike Wind Power III LLC. *Description:* Application for Order Under Section 203 of the FPA Authorizing Disposition of Jurisdictional Facilities, and Request for Waivers, Confidential Treatment of Transaction Document and 21-Day Comment Period. *Filed Date:* 04/30/2008. *Accession Number:* 20080430-5245. *Comment Date:* 5 p.m. Eastern Time on Wednesday, May 21, 2008. Take notice that the Commission received the following electric rate filings: *Docket Numbers:* ER98-1466-005; ER00-814-006; ER00-2924-006; ER02-1638-005. *Applicants:* Allegheny Power; Allegheny Energy Supply Company; Green Valley Hydro, LLC; Buchanan Generation, LLC. *Description:* Allegheny Power submits a Supplemental Affidavit of Julie R Solomon re their combined triennial market power analysis submitted on 1/14/08. *Filed Date:* 04/21/2008. *Accession Number:* 20080430-0200. *Comment Date:* 5 p.m. Eastern Time on Tuesday, May 6, 2008. *Docket Numbers:* ER98-4421-008; ER98-4421-009; ER04-543-004; ER04-543-005; ER99-791-006; ER99-791-005; ER99-3677-007; ER99-3677-008; ER01-570-008; ER01-570-009; ER00-2187-003; ER99-806-005; ER99-806-006; ER00-2187-004. *Applicants:* Consumers Energy Company; CMS Energy Resource Management Company; Grayling Generating Station L.P.; CMS Generation Michigan Power, L.L.C.; Dearborn Industrial Generation, L.L.C.; CMS Distributed Power, L.L.C.; Genesee Power Station, LP. Description: Consumers Energy Company et al submit a notice of non-material change in status and Original Sheet 1 *et al* to FERC Electric Tariff, Third Revised Volume 8. *Filed Date:* 04/23/2008. *Accession Number:* 20080429-0073. *Comment Date:* 5 p.m. Eastern Time on Wednesday, May 14, 2008. *Docket Numbers:* ER05-1089-004; ER06-1027-001; EL05-136-002. *Applicants:* Wisconsin Public Service Corporation. *Description:* Algoma Group *et al* submits an amended Stipulation to the Stipulation filed on 9/20/07. *Filed Date:* 04/24/2008. *Accession Number:* 20080430-0164. *Comment Date:* 5 p.m. Eastern Time on Thursday, May 8, 2008. *Docket Numbers:* ER08-676-000. *Applicants:* Winnebago Windpower LLC. *Description:* Winnebago Windpower LLC requests to withdraw their application for order accepting initial tariff, providing for shortened comment period, waiving regulations, and granting blanket approvals which was filed on 3/17/08. *Filed Date:* 04/28/2008. *Accession Number:* 20080429-0207. *Comment Date:* 5 p.m. Eastern Time on Monday, May 19, 2008. *Docket Numbers:* ER08-765-001. *Applicants:* KD Power Marketing Services, LLC. *Description:* KD Power Marketing Services LLC submits an amended application for market-based rate authority. *Filed Date:* 04/28/2008. *Accession Number:* 20080430-0035. *Comment Date:* 5 p.m. Eastern Time on Monday, May 19, 2008. *Docket Numbers:* ER08-867-000. *Applicants:* New York Independent System Operator, Inc. *Description:* New York Independent System Operator, Inc submits an Agreement to Amend Joint Operating Agreement Among with PJM Interconnection, LLC etc. *Filed Date:* 04/23/2008. *Accession Number:* 20080428-0114. *Comment Date:* 5 p.m. Eastern Time on Wednesday, May 14, 2008. *Docket Numbers:* ER08-876-000. *Applicants:* Wisconsin Public Service Corporation. *Description:* Wisconsin Public Service Corporation submits an executed Back-Up Service Agreement with Eagle River Light and Water Commission designated as Rate Schedule FERC 82, effective 4/22/08. *Filed Date:* 04/28/2008. *Accession Number:* 20080430-0037. *Comment Date:* 5 p.m. Eastern Time on Monday, May 19, 2008. *Docket Numbers:* ER08-877-000. *Applicants:* Southern California Edison Company. *Description:* Southern California Edison Company submits a Notice of Cancellation of the Firm Transmission Service Agreement with the City of Vernon. *Filed Date:* 04/28/2008. *Accession Number:* 20080430-0038. *Comment Date:* 5 p.m. Eastern Time on Monday, May 19, 2008. *Docket Numbers:* ER08-878-000. *Applicants:* Wisconsin Power and Light Company. *Description:* Wisconsin Power and Light Power Company *et al* submits the proposed Balancing Area Operations Coordination Agreement designated as Rate Schedule FERC 500 etc, effective 6/27/08. *Filed Date:* 04/28/2008. *Accession Number:* 20080430-0036. *Comment Date:* 5 p.m. Eastern Time on Monday, May 19, 2008. Take notice that the Commission received the following open access transmission tariff filings: *Docket Numbers:* OA08-112-000. *Applicants:* Idaho Power Company. *Description:* Idaho Power Co submits compliance filing proposing to amend its Open Access Transmission Tariff to include a methodology for distributing penalty revenues associated with Imbalance Penalties, Late Study Penalties etc. *Filed Date:* 04/21/2008. *Accession Number:* 20080424-0125. *Comment Date:* 5 p.m. Eastern Time on Monday, May 12, 2008. Any person desiring to intervene or to protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214) on or before 5 p.m. Eastern time on the specified comment date. It is not necessary to separately intervene again in a subdocket related to a compliance filing if you have previously intervened in the same docket. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant. In reference to filings initiating a new proceeding, interventions or protests submitted on or before the comment deadline need not be served on persons other than the Applicant. The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at *http://www.ferc.gov.* To facilitate electronic service, persons with Internet access who will eFile a document and/or be listed as a contact for an intervenor must create and validate an eRegistration account using the eRegistration link. Select the eFiling link to log on and submit the intervention or protests. Persons unable to file electronically should submit an original and 14 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First St. NE., Washington, DC 20426. The filings in the above proceedings are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive e-mail notification when a document is added to a subscribed dockets(s). For assistance with any FERC Online service, please e-mail *FERCOnlineSupport@ferc.gov* or call
(866)208-3676 (toll free). For TTY, call
(202)502-8659. Nathaniel J. Davis, Sr., Deputy Secretary. [FR Doc. E8-10999 Filed 5-15-08; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 4656-020] Boise-Kuna Irrigation District, Nampa & Meridian Irrigation District, New York; Irrigation District, Wilder Irrigation District, and Big Bend Irrigation District; Notice of Availability of Environmental Assessment May 9, 2008. An environmental assessment
(EA)is available for public review. The EA was prepared for an application filed by Boise-Kuna Irrigation District, *et al.* (licensee) on August 1, 2007, requesting Commission approval of:
(1)An extension of time for the commencement of project construction to December 13, 2009, pursuant to Public Law 109-383;
(2)changes to dates or time periods specified in license articles relating to actions that would be affected by an amendment; and
(3)amendments to project design. The licensee proposes to install two 7.5-megawatt
(MW)generating units with a total installed capacity of 15 MW, instead of two, 30-MW generating units with a total installed capacity of 60 MW, as authorized in the March 27, 1989 Order Issuing License. The licensee also proposes to decrease the length of the licensed project's transmission line. Finally, the licensee requests deletion or revision of certain license articles that are related to the proposed design changes. The project would be located at the U.S. Bureau of Reclamation's (Reclamation) existing Arrowrock Dam on the Boise River, in Elmore and Ada Counties, Idaho. Parts of the project would occupy lands managed by Reclamation, the U.S. Corps of Engineers, and the U.S. Forest Service within Boise National Forest. The EA concludes that the proposed amendment, with staff-recommended mitigation measures, would not constitute a major federal action significantly affecting the quality of the human environment. Any comments should be filed within 30 days from the date of this notice and should be addressed to Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. A copy of the EA is available for review at the Commission in the Public Reference Room, or it may be viewed on the Commission's Web site at *http://www.ferc.gov* using the e-Library link. Enter the docket number “P-4656” in the docket number field to access the document. For assistance, call
(202)502-8222 or
(202)502-8659 (for TTY). For further information regarding this notice, please contact B. Peter Yarrington at
(202)502-6129. Kimberly D. Bose, Secretary. [FR Doc. E8-11027 Filed 5-15-08; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP08-32-000] Natural Gas Pipeline Company of America; Notice of Availability of the Environmental Assessment for the Proposed Herscher-Galesville Expansion Project May 9, 2008. The staff of the Federal Energy Regulatory Commission (FERC or Commission) has prepared an environmental assessment
(EA)for the natural gas pipeline facilities proposed by Natural Gas Pipeline Company of America (Natural) in the above-referenced docket. The EA was prepared to satisfy the requirements of the National Environmental Policy Act
(NEPA)of 1969. The staff concludes that approval of the proposed project, with appropriate mitigating measures, would not constitute a major Federal action significantly affecting the quality of the human environment. The EA assesses the potential environmental effects of the construction and operation of the proposed project. Natural proposes to add new and modify existing natural gas storage field facilities, and add compression to Compressor Station 201, at its existing Herscher-Galesville Gas Storage Field in Kankakee County, just south of the Town of Herscher, Illinois. Specifically, the project would include: • Construction of 15 new water withdrawal wells with pumps; • Construction of 11 new water disposal wells; • Construction of three booster pumps at existing water disposal wells; • Up to four lateral recompletions at existing water disposal wells; • Construction of workover/extensions on five existing gas withdrawal/injection wells; • Construction of a new 8,180 horsepower
(hp)gas-fired engine compressor unit within Compressor Station 201; and • Replacement, looping or extension of 12 waterlines with 8- to 13-inch-diameter plastic pipelines. The purpose of this project is to increase the Herscher-Galesville Gas Storage Field's working gas capacity by 10 billion cubic feet and increase the peak day withdrawal capacity. Natural would achieve this increased capacity by constructing facilities to remove water from the field. Reworking of five existing gas withdrawal/injection wells, and construction of the new compressor unit within its existing adjacent Compressor Station 201, would enable Natural to increase peak day withdrawal capacity. The EA has been placed in the public files of the FERC. A limited number of copies of the EA are available for distribution and public inspection at: Federal Energy Regulatory Commission, Public Reference Room, 888 First Street, NE., Room 2A, Washington, DC 20426,
(202)502-8371. Copies of the EA have been mailed to Federal, state and local agencies, public interest groups, interested individuals, newspapers, and parties to this proceeding. Any person wishing to comment on the EA may do so. To ensure consideration prior to a Commission decision on the proposal, it is important that we receive your comments before the date specified below. Please note that the Commission strongly encourages electronic filing of any comments or interventions or protests to this proceeding. See 18 Code of Federal Regulations 385.2001(a)(1)(iii) and the instructions on the Commission's Internet Web site at *http://www.ferc.gov* under the link to “Documents and Filings” and “eFiling.” eFiling is a file attachment process and requires that you prepare your submission in the same manner as you would if filing on paper, and save it to a file on your hard drive. New eFiling users must first create an account by clicking on “Sign up” or “eRegister.” You will be asked to select the type of filing you are making. This filing is considered a “Comment on Filing.” In addition, there is a *“Quick Comment”* option available, which is an easy method for interested persons to submit text only comments on a project. The Quick-Comment User Guide can be viewed at *http://www.ferc.gov/docs-filing/efiling/quick-comment-guide.pdf* . Quick Comment does not require a FERC eRegistration account; however, you will be asked to provide a valid e-mail address. All comments submitted under either eFiling or the Quick Comment option are placed in the public record for the specified docket or project number(s). If you are filing written comments, please carefully follow these instructions to ensure that your comments are received in time and properly recorded: • Send an original and two copies of your comments to: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First St., NE., Room 1A, Washington, DC 20426; • Label one copy of the comments for the attention of the Gas Branch 2, PJ11.2; • Reference Docket No. CP08-032-000; and • Mail your comments so that they will be received in Washington, DC on or before June 11, 2008. Comments will be considered by the Commission but will not serve to make the commentor a party to the proceeding. Any person seeking to become a party to the proceeding must file a motion to intervene pursuant to Rule 214 of the Commission's Rules of Practice and Procedures (18 CFR 385.214). 1 Only intervenors have the right to seek rehearing of the Commission's decision. 1 Interventions may also be filed electronically via the Internet in lieu of paper. See the previous discussion on filing comments electronically. Affected landowners and parties with environmental concerns may be granted intervenor status upon showing good cause by stating that they have a clear and direct interest in this proceeding which would not be adequately represented by any other parties. You do not need intervenor status to have your comments considered. Additional information about the project is available from the Commission's Office of External Affairs, at 1-866-208-FERC or on the FERC Internet Web site ( *http://www.ferc.gov* ) using the eLibrary link. Click on the eLibrary link, click on “General Search” and enter the docket number excluding the last three digits in the Docket Number field. Be sure you have selected an appropriate date range. For assistance, please contact FERC Online Support at *FercOnlineSupport@ferc.gov* or toll free at 1-866-208-3676, or for TTY, contact
(202)502-8659. The eLibrary link also provides access to the texts of formal documents issued by the Commission, such as orders, notices, and rulemakings. In addition, the Commission now offers a free service called eSubscription which allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries and direct links to the documents. Go to *http://www.ferc.gov/esubscribenow.htm* . Kimberly D. Bose, Secretary. [FR Doc. E8-11028 Filed 5-15-08; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [ Project No. 906-006 (VA)] Virginia Electric & Power Company; Notice of Availability of Final Environmental Assessment May 8, 2008. In accordance with the National Environmental Policy Act of 1969 and the Federal Energy Regulatory Commission's regulations, 18 CFR Part 380 (Order No. 486, 52 FR 47879), the Office of Energy Projects has reviewed the application for a new license for the Cushaw Hydroelectric Project, located on the James River, near the Town of Glasgow, Virginia, and has prepared a Final Environmental Assessment (FEA). In the FEA, Commission staff analyze potential environmental effects of relicensing the project and conclude that issuing a new license for the project, with appropriate environmental measures, would not constitute a major federal action significantly affecting the quality of the human environment. A copy of the FEA is on file with the Commission and is available for public inspection. The FEA may also be viewed on the Commission's Web site at *http://www.ferc.gov* using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, contact FERC Online Support at *FERCOnlineSupport@ferc.gov* or toll-free at 1-866-208-3676, or for TTY,
(202)502-8659. For further information, contact Kristen Murphy at
(202)502-6236. Kimberly D. Bose, Secretary. [FR Doc. E8-10959 Filed 5-15-08; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Effectiveness of Exempt Wholesale Generator Status May 8, 2008. Docket Nos. Wheatfield Wind Power Project LLC EG08-10-000 Capricorn Ridge Wind II, LLC EG08-34-000 Texas Gulf Wind LLC EG08-35-000 Providence Heights Wind, LLC EG08-39-000 Ocotillo Windpower, LP EG08-40-000 Goat Wind, LP EG08-41-000 Starwood Power-Midway, LLC EG08-44-000 Take notice that during the month of April 2008, the status of the above-captioned entities as Exempt Wholesale Generators became effective by operation of the Commission's regulations, with the exception of the entity described in Docket No. EG08-10-000, whose Exempt Wholesale Generator status became effective in January 2008. 18 CFR 366.7(a). Kimberly D. Bose, Secretary. [FR Doc. E8-10961 Filed 5-15-08; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket Nos. ER08-370-003; EL08-22-000] Midwest Independent Transmission System Operator, Inc.; Missouri River Energy Services; Western Minnesota Municipal Power Agency; Notice of Filing May 9, 2008. Take notice that on May 5, 2008, Missouri River Energy River Services filed a supplement to its April 14, 2008 filing. Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant and all the parties in this proceeding. The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at *http://www.ferc.gov.* Persons unable to file electronically should submit an original and 14 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. This filing is accessible on-line at *http://www.ferc.gov,* using the “eLibrary” link and is available for review in the Commission's Public Reference Room in Washington, DC. There is an “eSubscription” link on the Web site that enables subscribers to receive e-mail notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please e-mail *FERCOnlineSupport@ferc.gov,* or call
(866)208-3676 (toll free). For TTY, call
(202)502-8659. *Comment Date:* 5 p.m. Eastern Time on May 27, 2008. Kimberly D. Bose, Secretary. [FR Doc. E8-11022 Filed 5-15-08; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER08-695-001] New York Independent System Operator, Inc.; Notice of Filing May 9, 2008. Take notice that on May 6, 2008, New York Independent system Operator, Inc. filed revisions to it Market Administration and Control Area Services Tariff, pursuant to the Commission's March 7, 2008 Order. Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant and all the parties in this proceeding. The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at *http://www.ferc.gov.* Persons unable to file electronically should submit an original and 14 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. This filing is accessible on-line at *http://www.ferc.gov,* using the “eLibrary” link and is available for review in the Commission's Public Reference Room in Washington, DC. There is an “eSubscription” link on the Web site that enables subscribers to receive e-mail notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please e-mail *FERCOnlineSupport@ferc.gov,* or call
(866)208-3676 (toll free). For TTY, call
(202)502-8659. *Comment Date:* 5 p.m. Eastern Time on May 27, 2008. Kimberly D. Bose, Secretary. [FR Doc. E8-11025 Filed 5-15-08; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket Nos. ER08-527-000; ER08-527-001] Public Service Company of Colorado Notice of Filing May 7, 2008. Take notice that on April 17, 2008, Public Service Company of Colorado
(PSCo)filed an Offer of Settlement and Settlement Agreement resolving all issues between PSCo and Holy Cross Electric Association, Inc., Grand Valley Rural Power Lines, Inc., and Yampa Valley Electric Association, Inc., with respect to PSCo's February 1 and February 14 filings in the above-captioned proceeding. On April 25, 2008, PSCo filed an Offer of Settlement and Settlement Agreement resolving all issues between PSCo and the City of Burlington, Colorado, and the Town of Center, Colorado, with respect to PSCo's February 1 and February 14 filings in the above-captioned proceeding. Also on April 25, 2008, PSCo filed an Offer of Settlement and Settlement Agreement resolving all issues between PSCo and Aquila, Inc., with respect to PSCo's February 1 and February 14 filings in the above-captioned proceeding. Any person desiring to intervene or to protest these filings must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. On or before the comment date, it is not necessary to serve motions to intervene or protests on persons other than the Applicant. The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at *http://www.ferc.gov* . Persons unable to file electronically should submit an original and 14 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. This filing is accessible on-line at *http://www.ferc.gov* , using the “eLibrary” link and is available for review in the Commission's Public Reference Room in Washington, DC. There is an “eSubscription” link on the Web site that enables subscribers to receive e-mail notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please e-mail *FERCOnlineSupport@ferc.gov* , or call
(866)208-3676 (toll free). For TTY, call
(202)502-8659. *Comment Date:* 5 p.m. Eastern Time on May 16, 2008. Kimberly D. Bose, Secretary. [FR Doc. E8-10956 Filed 5-15-08; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket Nos. EL05-25-006; EL05-26-006; EL05-27-006] Southern Company Services, Inc.; Notice of Filing May 9, 2008. Take notice that on May 5, 2008, Southern Company Services, Inc., acting as agent for Alabama Power Company, Georgia Power Company, Gulf Power Company, and Mississippi Power Company filed an update on the O&M refund payment to Tenaska and three revised interconnection agreements. Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant and all the parties in this proceeding. The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at *http://www.ferc.gov.* Persons unable to file electronically should submit an original and 14 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. This filing is accessible on-line at *http://www.ferc.gov,* using the “eLibrary” link and is available for review in the Commission's Public Reference Room in Washington, DC. There is an “eSubscription” link on the Web site that enables subscribers to receive e-mail notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please e-mail *FERCOnlineSupport@ferc.gov,* or call
(866)208-3676 (toll free). For TTY, call
(202)502-8659. *Comment Date:* 5 p.m. Eastern Time on May 27, 2008. Kimberly D. Bose, Secretary. [FR Doc. E8-11021 Filed 5-15-08; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ID-5705-000] Taylor, G. Tom; Notice of Filing May 8, 2008. Take notice that on May 1, 2008, G. Tom Taylor filed an application to hold an interlocking positions pursuant to section 305(b) of the Federal Power Act, 16 U.S.C. 825d(b) (2000), Part 45 of the Commission's Regulations, 18 CFR Part 45
(2005)and the Commission's Order No. 664, 112 FERC ¶ 61,298 (2005). Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. On or before the comment date, it is not necessary to serve motions to intervene or protests on persons other than the Applicant. The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at *http://www.ferc.gov* . Persons unable to file electronically should submit an original and 14 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. This filing is accessible on-line at *http://www.ferc.gov* , using the “eLibrary” link and is available for review in the Commission's Public Reference Room in Washington, DC. There is an “eSubscription” link on the Web site that enables subscribers to receive e-mail notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please e-mail *FERCOnlineSupport@ferc.gov* , or call
(866)208-3676 (toll free). For TTY, call
(202)502-8659. *Comment Date:* 5 p.m. Eastern Time on May 22, 2008. Kimberly D. Bose, Secretary. [FR Doc. E8-10963 Filed 5-15-08; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ID-5703-000] Wagoner, Gregory E.; Notice of Filing May 8, 2008. Take notice that on April 30, 2008, Gregory E. Wagoner filed an application to hold an interlocking positions pursuant to section 305(b) of the Federal Power Act, 16 U.S.C. 825d(b) (2000), Part 45 of the Commission's Regulations, 18 CFR Part 45
(2005)and the Commission's Order No. 664, 112 FERC ¶ 61,298 (2005). Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. On or before the comment date, it is not necessary to serve motions to intervene or protests on persons other than the Applicant. The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at *http://www.ferc.gov* . Persons unable to file electronically should submit an original and 14 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. This filing is accessible on-line at *http://www.ferc.gov* , using the “eLibrary” link and is available for review in the Commission's Public Reference Room in Washington, DC. There is an “eSubscription” link on the Web site that enables subscribers to receive e-mail notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please e-mail *FERCOnlineSupport@ferc.gov* , or call
(866)208-3676 (toll free). For TTY, call
(202)502-8659. *Comment Date:* 5 p.m. Eastern Time on May 21, 2008. Kimberly D. Bose, Secretary. [FR Doc. E8-10962 Filed 5-15-08; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER08-656-000] Shell Energy North America (U.S.), L.P.; Notice of Issuance of Order May 9, 2008. Shell Energy North America (U.S.), L.P. (Shell) filed an application for market-based rate authority, with an accompanying rate schedule. The proposed market-based rate schedule provides for the sale of energy, capacity and ancillary services at market-based rates. Shell also requested waivers of various Commission regulations. In particular, Shell requested that the Commission grant blanket approval under 18 CFR Part 34 of all future issuances of securities and assumptions of liability by Shell. On May 8, 2008, pursuant to delegated authority, the Director, Division of Tariffs and Market Development-West, granted the requests for blanket approval under Part 34 (Director's Order). The Director's Order also stated that the Commission would publish a separate notice in the **Federal Register** establishing a period of time for the filing of protests. Accordingly, any person desiring to be heard concerning the blanket approvals of issuances of securities or assumptions of liability by Shell, should file a protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure. 18 CFR 385.211, 385.214 (2004). The Commission encourages the electronic submission of protests using the FERC Online link at *http://www.ferc.gov.* Notice is hereby given that the deadline for filing protests is June 9, 2008. Absent a request to be heard in opposition to such blanket approvals by the deadline above, Shell is authorized to issue securities and assume obligations or liabilities as a guarantor, indorser, surety, or otherwise in respect of any security of another person; provided that such issuance or assumption is for some lawful object within the corporate purposes of Shell, compatible with the public interest, and is reasonably necessary or appropriate for such purposes. The Commission reserves the right to require a further showing that neither public nor private interests will be adversely affected by continued approvals of Shell's issuance of securities or assumptions of liability. Copies of the full text of the Director's Order are available from the Commission's Public Reference Room, 888 First Street, NE., Washington, DC 20426. The Order may also be viewed on the Commission's Web site at *http://www.ferc.gov,* using the eLibrary link. Enter the docket number excluding the last three digits in the docket number filed to access the document. Comments, protests, and interventions may be filed electronically via the internet in lieu of paper. See, 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site under the “e-Filing” link. The Commission strongly encourages electronic filings. Kimberly D. Bose, Secretary. [FR Doc. E8-11024 Filed 5-15-08; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket Nos. ER08-636-000; ER08-636-001] Standard Binghamton LLC; Notice of Issuance of Order May 9, 2008. Standard Binghamton LLC (Standard Binghamton) filed an application for market-based rate authority, with an accompanying rate schedule. The proposed market-based rate schedule provides for the sale of energy, capacity and ancillary services at market-based rates. Standard Binghamton also requested waivers of various Commission regulations. In particular, Standard Binghamton requested that the Commission grant blanket approval under 18 CFR Part 34 of all future issuances of securities and assumptions of liability by Standard Binghamton. On May 9, 2008, pursuant to delegated authority, the Director, Division of Tariffs and Market Development-West, granted the requests for blanket approval under Part 34 (Director's Order). The Director's Order also stated that the Commission would publish a separate notice in the **Federal Register** establishing a period of time for the filing of protests. Accordingly, any person desiring to be heard concerning the blanket approvals of issuances of securities or assumptions of liability by Standard Binghamton, should file a protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure. 18 CFR 385.211, 385.214 (2004). The Commission encourages the electronic submission of protests using the FERC Online link at *http://www.ferc.gov.* Notice is hereby given that the deadline for filing protests is June 10, 2008. Absent a request to be heard in opposition to such blanket approvals by the deadline above, Standard Binghamton is authorized to issue securities and assume obligations or liabilities as a guarantor, indorser, surety, or otherwise in respect of any security of another person; provided that such issuance or assumption is for some lawful object within the corporate purposes of Standard Binghamton, compatible with the public interest, and is reasonably necessary or appropriate for such purposes. The Commission reserves the right to require a further showing that neither public nor private interests will be adversely affected by continued approvals of Standard Binghamton's issuance of securities or assumptions of liability. Copies of the full text of the Director's Order are available from the Commission's Public Reference Room, 888 First Street, NE., Washington, DC 20426. The Order may also be viewed on the Commission's Web site at *http://www.ferc.gov,* using the eLibrary link. Enter the docket number excluding the last three digits in the docket number filed to access the document. Comments, protests, and interventions may be filed electronically via the internet in lieu of paper. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site under the “e-Filing” link. The Commission strongly encourages electronic filings. Kimberly D. Bose, Secretary. [FR Doc. E8-11023 Filed 5-15-08; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [ Docket No. PF08-6-000] Columbia Gas Transmission Corporation; Notice of Limited Scoping for the Ohio Storage Expansion Project May 9, 2008. The staff of the Federal Energy Regulatory Commission (FERC or Commission) will prepare an environmental assessment
(EA)that will discuss the potential environmental impacts of the Ohio Storage Expansion Project, involving construction and operation of natural gas facilities by Columbia Gas Transmission Corporation (Columbia) in Ashland, Fairfield, Hocking, and Holmes Counties, Ohio. The EA will be used by the Commission in its decision-making process to determine whether the project is in the public convenience and necessity. On May 1, 2008, Columbia filed a revision to its project that would remove two wells from consideration, thus not affecting two landowners. Further, Columbia would add four additional wells (Well 12491, Well 12492, Well 12578, and Well 12496) affecting two additional landowners. This filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at *http://www.ferc.gov* using the “eLibrary” link. Enter the docket number excluding the last three digits (i.e., PF08-6) in the docket number field to access the document. For assistance, please contact FERC Online Support at *FERCOnlineSupport@ferc.gov* or call toll free at
(866)208-3676, or for TTY, contact
(202)502-8659. Because the two additional landowners were recently added to our environmental mailing list (after the April 7, 2008 close of scoping), they have not had an opportunity to comment on Columbia's planned project. Therefore, we are opening a limited scoping period directed at these landowners to comment on the project and attaching the original *Notice of Intent to Prepare an Environmental Assessment and Request for Comments on Environmental Issues* to this letter. Please note that this limited scoping period will close on June 1, 2008. Kimberly D. Bose, Secretary. [FR Doc. E8-11019 Filed 5-15-08; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP08-187-000] Equitrans, L.P.; Notice of Request Under Blanket Authorization May 7, 2008. Take notice that on April 24, 2008, Equitrans, L.P. (Equitrans), 225 North Shore Drive, Pittsburgh, Pennsylvania 15212, filed in Docket No. CP08-187-000, a prior notice request pursuant to sections 157.205 and 157.210 of the Federal Energy Regulatory Commission's regulations under the Natural Gas Act for authorization to replace approximately 9.71 miles of Line No. H-152, located in Allegheny and Washington Counties, Pennsylvania, all as more fully set forth in the application, which is on file with the Commission and open to public inspection. The filing may also be viewed on the Web at *http://www.ferc.gov* using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, contact FERC at *FERCOnlineSupport@ferc.gov* or call toll-free,
(866)208-3676 or TTY,
(202)502-8659. Specifically, Equitrans proposes to replace approximately 9.71 noncontiguous miles of 16-inch diameter bare steel pipeline, located in Allegheny and Washington Counties, Pennsylvania, with 16-inch diameter coated steel pipeline. Equitrans estimates the cost of construction to be $22,362,143. Equitrans states that the replacement project is necessitated by the age and condition of the existing bare steel pipeline. Equitrans asserts that there are nine segments planned for replacement. Any questions regarding the application should be directed to David K. Dewey, Vice President & General Counsel, Equitrans, L.P., 225 North Shore Drive, Pittsburgh, Pennsylvania 15212, at
(412)395-2566 or facsimile at
(412)395-3347. Any person or the Commission's Staff may, within 60 days after the issuance of the instant notice by the Commission, file pursuant to Rule 214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to intervene or notice of intervention and, pursuant to section 157.205 of the Commission's Regulations under the Natural Gas Act
(NGA)(18 CFR 157.205) a protest to the request. If no protest is filed within the time allowed therefore, the proposed activity shall be deemed to be authorized effective the day after the time allowed for protest. If a protest is filed and not withdrawn within 30 days after the time allowed for filing a protest, the instant request shall be treated as an application for authorization pursuant to Section 7 of the NGA. The Commission strongly encourages electronic filings of comments, protests, and interventions via the internet in lieu of paper. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site ( *http://www.ferc.gov* ) under the “e-Filing” link. Kimberly D. Bose, Secretary. [FR Doc. E8-10955 Filed 5-15-08; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP08-188-000] Northern Natural Gas Company; Notice of Request Under Blanket Authorization May 8, 2008. Take notice that on April 25, 2008, Northern Natural Gas Company (Northern), 1111 South 103rd Street, Omaha, Nebraska 68124, filed in Docket No. CP08-188-000, a prior notice request pursuant to sections 157.205 and 157.211 of the Federal Energy Regulatory Commission's regulations under the Natural Gas Act for authorization to install and operate a new meter station, located in Pine County, Minnesota, all as more fully set forth in the application, which is on file with the Commission and open to public inspection. The filing may also be viewed on the Web at *http://www.ferc.gov* using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, contact FERC at *FERCOnlineSupport@ferc.gov* or call toll-free,
(866)208-3676 or TTY,
(202)502-8659. Specifically, Northern proposes to install and operate a new meter station to accommodate natural gas deliveries to the Corporate Commission of the Mille Lacs Band of Ojibwe Indians d/b/a Grand Casino Hinckley under a throughput service agreement. Northern proposes to install a skid-mounted station, which will include buildings, a heater, regulators, a meter, and associated piping, fittings, and valves. Northern estimates the cost of construction to be $276,558. Northern states that the new meter station will have the capability of delivering up to 980 MMcf per day. Any questions regarding the application should be directed to Michael T. Loeffler, Senior Director, Certificates and External Affairs, or Donna Martens, Senior Regulatory Analyst, Northern Natural Gas Company, 1111 South 103rd Street, Omaha, Nebraska 68124, at
(402)398-7103 or at
(402)398-7138, respectively. Any person or the Commission's Staff may, within 60 days after the issuance of the instant notice by the Commission, file pursuant to Rule 214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to intervene or notice of intervention and, pursuant to section 157.205 of the Commission's Regulations under the Natural Gas Act
(NGA)(18 CFR 157.205) a protest to the request. If no protest is filed within the time allowed therefore, the proposed activity shall be deemed to be authorized effective the day after the time allowed for protest. If a protest is filed and not withdrawn within 30 days after the time allowed for filing a protest, the instant request shall be treated as an application for authorization pursuant to Section 7 of the NGA. The Commission strongly encourages electronic filings of comments, protests, and interventions via the internet in lieu of paper. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site ( *http://www.ferc.gov* ) under the “e-Filing” link. Kimberly D. Bose, Secretary. [FR Doc. E8-10960 Filed 5-15-08; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP08-164-000] Tennessee Gas Pipeline Company; Notice of Request Under Blanket Authorization May 7, 2008. Take notice that on April 21, 2008, Tennessee Gas Pipeline Company (Tennessee), 1001 Louisiana, Houston, Texas 77002, filed in Docket No. CP08-164-000, a prior notice request pursuant to sections 157.205 and 157.216 of the Federal Energy Regulatory Commission's regulations under the Natural Gas Act for authorization to abandon by sale to Sea Robin Pipeline Company (Sea Robin), offshore pipelines designated as Line Nos. 524X-100 and 524X-200 and Tennessee's ownership interest in Line No. 524X-1600, located in offshore Louisiana, all as more fully set forth in the application, which is on file with the Commission and open to public inspection. The filing may also be viewed on the Web at *http://www.ferc.gov* using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, contact FERC at *FERCOnlineSupport@ferc.gov* or call toll-free,
(866)208-3676 or TTY,
(202)502-8659. Specifically, Tennessee proposes to abandon by sale to Sea Robin, Tennessee's remaining portion of Line No. 524X-100, consisting of a sub-sea tap assembly on a Sea Robin pipeline and approximately 120 feet of twelve-inch diameter pipeline; Line No. 524X-200, consisting of approximately 7.3 miles of twelve-inch diameter lateral pipeline with associated appurtenances; and Tennessee's ownership interest, 8.17%, in Line No. 524X-1600. Tennessee states that Sea Robin cooperated in a plan to return Line Nos. 524X-200 and 524X-1600 to service by allowing a new interconnection to its system. Tennessee asserts that because Tennessee provides comprehensive receipt and delivery points for interruptible shippers, contracts between Tennessee and its customers will not be impacted by the sale. Any questions regarding the application should be directed to Jay V. Allen, Senior Counsel, Tennessee Gas Pipeline Company, 1001 Louisiana, Houston, Texas 77002, at
(713)420-5589 or fax
(713)420-1601 or Juan Eligio, Analyst, Certificates & Regulatory Compliance, at
(713)420-3294 or fax
(713)420-1605. Any person or the Commission's Staff may, within 60 days after the issuance of the instant notice by the Commission, file pursuant to Rule 214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to intervene or notice of intervention and, pursuant to section 157.205 of the Commission's Regulations under the Natural Gas Act
(NGA)(18 CFR 157.205) a protest to the request. If no protest is filed within the time allowed therefore, the proposed activity shall be deemed to be authorized effective the day after the time allowed for protest. If a protest is filed and not withdrawn within 30 days after the time allowed for filing a protest, the instant request shall be treated as an application for authorization pursuant to section 7 of the NGA. The Commission strongly encourages electronic filings of comments, protests, and interventions via the Internet in lieu of paper. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site ( *www.ferc.gov* ) under the “e-Filing” link. Kimberly D. Bose, Secretary. [FR Doc. E8-10958 Filed 5-15-08; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP08-343-000] Transcontinental Gas Pipe Line Corporation; Notice of Request Under Blanket Authorization May 9, 2008. Take notice that on April 30, 2008, Transcontinental Gas Pipe Line Corporation (Transco), Post Office Box 1396, Houston, Texas 77251, filed in Docket No. CP08-343-000, a prior notice request pursuant to sections 157.205, 157.208, and 157.212 of the Federal Energy Regulatory Commission's regulations under the Natural Gas Act for authorization to construct and operate a new receipt point to receive revaporized liquefied natural gas (LNG), located in Evangeline Parish, Louisiana, all as more fully set forth in the application, which is on file with the Commission and open to public inspection. The filing may also be viewed on the Web at *http://www.ferc.gov* using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, contact FERC at *FERCOnlineSupport@ferc.gov* or call toll-free,
(866)208-3676 or TTY,
(202)502-8659. Specifically, Transco proposes to construct and operate a new receipt point on Transco's mainline in Evangeline Parish, Louisiana to receive revaporized LNG from the Cheniere Pass LNG terminal in Cameron Parish, Louisiana by way of the Kinder Morgan Louisiana Pipeline, LLC (KMLP). The facilities Transco proposes to construct will include a 24-inch tap assembly on Transco's 36-inch Mainline B and a 24-inch tap assembly on Transco's 36-inch Mainline C, flow computer, gas chromatograph with building enclosure, flow/pressure control and overpressure protection facilities, valves, and radio communication facilities at the mainline B and C. Transco estimates the cost of construction to be approximately $1.7 million. Transco states that KMLP will reimburse Transco for all costs associated with such facilities. Transco asserts that the new receipt point will provide Transco with the ability to receive up to 600 MMcf/d of revaporized LNG from KMLP. Any questions regarding the application should be directed to Marg Camardello, Transcontinental Gas Pipe Line Corporation, P. O. Box 1396, Houston, Texas 77251, at
(713)215-3380. Any person or the Commission's Staff may, within 60 days after the issuance of the instant notice by the Commission, file pursuant to Rule 214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to intervene or notice of intervention and, pursuant to section 157.205 of the Commission's Regulations under the Natural Gas Act
(NGA)(18 CFR 157.205) a protest to the request. If no protest is filed within the time allowed therefor, the proposed activity shall be deemed to be authorized effective the day after the time allowed for protest. If a protest is filed and not withdrawn within 30 days after the time allowed for filing a protest, the instant request shall be treated as an application for authorization pursuant to Section 7 of the NGA. The Commission strongly encourages electronic filings of comments, protests, and interventions via the Internet in lieu of paper. See 18 C. 385.2001(a)(1)(iii) and the instructions on the Commission's Web site ( *http://www.ferc.gov* ) under the “e-Filing” link. Kimberly D. Bose, Secretary. [FR Doc. E8-11020 Filed 5-15-08; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Supplemental Notice Announcing Revised Treatment of Initial Electric Market-Based Rate Authorization Filings That Also Request Blanket Section 204 Authorization May 8, 2008. On April 3, 2008, the Commission issued a notice stating that, effective April 3, 2008, it would issue a separate combined notice of filing for initial electric market-based rate authorization filings. Upon further consideration, and effective upon the date of issuance of this supplemental notice, the Commission instead will include initial electric market-based rate authorization filings along with other filings in a combined notice of filing. However, once it is determined that an initial electric market-based rate authorization filing includes a request for blanket authorization, pursuant 18 CFR Part 34, of future issuances of securities and assumptions of liability, it will issue a separate supplemental notice. By this initiative, the Commission seeks to expedite the process for noticing initial electric market-based rate authorization filings, while also providing notice of requests for blanket authorizations for future issuances of securities and assumptions of liabilities. Kimberly D. Bose, Secretary. [FR Doc. E8-10964 Filed 5-15-08; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY National Nuclear Security Administration Notice of Availability of the Final Site-Wide Environmental Impact Statement for Continued Operation of Los Alamos National Laboratory, Los Alamos, NM AGENCY: U.S. Department of Energy (DOE), National Nuclear Security Administration (NNSA). ACTION: Notice of Availability. SUMMARY: NNSA announces the availability of the *Final Site-Wide Environmental Impact Statement for Continued Operation of Los Alamos National Laboratory, Los Alamos, New Mexico* (Final SWEIS) (DOE/EIS-0380). The Final SWEIS analyzes the potential environmental impacts of continuing to operate Los Alamos National Laboratory
(LANL)and addresses public comments received on the Draft SWEIS. NNSA's Preferred Alternative for LANL, as identified in the Draft and Final SWEIS, is the Expanded Operations Alternative. The Final SWEIS also evaluates a No Action Alternative and a Reduced Operations Alternative. DATES: NNSA will not issue Records of Decision based on the SWEIS before 30 days have passed from the publication of this notice of availability. ADDRESSES: A copy of the Final SWEIS may be obtained by writing to: U.S. Department of Energy, National Nuclear Security Administration, Los Alamos Site Office, Attn: NEPA Compliance Officer, Environmental Operations, 528 35th Street, Los Alamos, New Mexico 87544. Requests for copies of the document may also be sent by facsimile ((505) 845-4239); or by E-mail ( *LANL_SWEIS@doeal.gov* ) or *LASO.SWEIS@doeal.gov.* The Final SWEIS will also be available on the NNSA Los Alamos Site Office's NEPA Web site at: *http://www.doeal.gov/laso/NEPASWEIS.aspx.* Copies of the Final SWEIS are also available for review at the following locations: The Los Alamos Research Library, West Jemez Road, Los Alamos National Laboratory, Los Alamos, New Mexico; the Office of the Northern New Mexico Citizens Advisory Board, 1660 Old Pecos Trail, Suite B, Santa Fe, New Mexico; and, the Zimmerman Library, Central Avenue, University of New Mexico, Albuquerque, New Mexico. FOR FURTHER INFORMATION CONTACT: For general information on NNSA's NEPA process, please contact: Ms. Alice C. Williams, NA-50, NEPA Compliance Officer, U.S. Department of Energy, National Nuclear Security Administration, 1000 Independence Avenue, SW., Washington, DC 20585, or telephone 1-202-586-6847. For general information about the DOE NEPA process, please contact: Ms. Carol Borgstrom, Director, Office of NEPA Policy and Compliance (GC-20), U.S. Department of Energy, 1000 Independence Avenue SW., Washington, DC 20585,
(202)586-4600, or leave a message at 1-800-472-2756. SUPPLEMENTARY INFORMATION: The primary purpose and need for continued operation of LANL is to provide support for DOE and NNSA core missions as directed by Congress and the President. NNSA's need to continue operating LANL arises from its obligation to ensure a safe and reliable nuclear weapons stockpile. LANL is also needed to support other Federal agencies, including the Department of Homeland Security. The Final SWEIS analyzed the environmental impacts of operating LANL at different levels. LANL is located in north-central New Mexico and covers an area of about 40 square miles (104 square kilometers). It was established in 1943 as “Project Y” of the Manhattan Project with a single mission—to build the world's first nuclear weapons. After World War II ended, Project Y was designated a permanent research and development laboratory and its work was expanded to incorporate a wide variety of assignments in support of other government and civilian programs. LANL is now a multi-disciplinary, multipurpose institution engaged in theoretical and experimental research and development. DOE issued a Final SWEIS and Record of Decision in 1999 for the continued operation of the laboratory. DOE regulations implementing NEPA require the evaluation of site-wide NEPA analyses every five years to determine their continued applicability; such a five-year evaluation was initiated for the 1999 SWEIS in 2004, and NNSA subsequently decided to prepare a new SWEIS. A new Draft SWEIS was issued in July 2006 for public review and comment over a 75-day period. NNSA considered the comments received on the Draft SWEIS in preparing the Final SWEIS. The alternatives evaluated in the Final SWEIS represent a range of operational levels from the minimal reasonable activity levels (Reduced Operations Alternative) to the highest reasonable activity levels that could be supported by current facilities combined with expansion and construction of new facilities (Expanded Operations Alternative). The No Action Alternative would continue current mission support work at LANL and includes actions, facility construction, and other activities for which NEPA analyses have already been completed. All alternatives assumed that NNSA will continue to operate LANL as a national security laboratory for the foreseeable future. *Subsequent Document Preparation:* NNSA will consider the environmental impact analysis presented in the Final LANL SWEIS, along with other information, in making decisions regarding the continued operation of LANL. NNSA will wait to issue a ROD for at least 30 days following publication in the **Federal Register** of this notice of availability. It is anticipated that several RODs may be issued based on the Final SWEIS over the next several years. NNSA will publish all RODs in the **Federal Register** . Signed in Washington, DC, this 4th day of April, 2008. Thomas P. D'Agostino, Administrator, National Nuclear Security Administration. [FR Doc. E8-11007 Filed 5-15-08; 8:45 am] BILLING CODE 6450-01-P ENVIRONMENTAL PROTECTION AGENCY [FRL-8567-1, EPA-HQ-OW-2008-0238] Draft National Pollutant Discharge Elimination System (NPDES) General Permit for Stormwater Discharges From Construction Activities AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of proposed permit issuance. SUMMARY: EPA Regions 1, 2, 3, 5, 6, 7, 8, 9, and 10 today are proposing for public comment the issuance of their 2008 National Pollutant Discharge Elimination System general permits for stormwater discharges from new dischargers engaged in large and small construction activities. Hereinafter, these NPDES general permits will be referred to as “permit” or “2008 construction general permit” or “2008 CGP.” “New dischargers” are those who did not file a notice of intent (“NOI”) to be covered under the 2003 construction general permit (“2003 CGP”) before it expired. Existing dischargers who properly filed an NOI to be covered under the 2003 CGP continue to be authorized to discharge under that permit according to its terms. This draft 2008 CGP contains the same limits and conditions as the Agency's 2003 CGP with the exception of a few minor modifications which are detailed below. As proposed, EPA is issuing this CGP for a period not to exceed two
(2)years and will make the permit available to new construction activities and unpermitted ongoing activities only. In addition to proposing this draft CGP, EPA is also requesting comments on the criteria to be used by the Agency to incorporate, by reference, “qualifying local program requirements” for erosion and sediment control as provided for in EPA's regulations. Approved qualifying local program requirements can then be incorporated by reference into the Agency's construction general permit. A construction site operator with construction activities within the jurisdiction of the qualifying local program can follow local erosion and sediment control requirements in lieu of complying with comparable erosion and sediment control requirements in EPA's CGP. DATES: Comments on EPA's proposal, including the draft permit, must be postmarked by June 16, 2008. ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-OW-2008-0238, by one of the following methods: • *www.regulations.gov:* Follow the on-line instructions for submitting comments. • *E-mail:* *ow-docket@epa.gov* . • *Mail:* Water Docket, Environmental Protection Agency, Mailcode: 2822T, 1200 Pennsylvania Ave., NW., Washington, DC 20460. • *Hand Delivery:* EPA Docket Center, Public Reading Room, EPA Headquarters West Building, Room 3334, 1301 Constitution Ave., NW., Washington, DC 20460. Such deliveries are only accepted during the Docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information. *Instructions:* A copy of the draft 2008 CGP and its accompanying fact sheet is available at *www.epa.gov/npdes/stormwater/cgp* . Direct your comments to Docket ID No. EPA-HQ-OW-2008-0238. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at *www.regulations.gov* , including any personal information provided, unless the comment includes information claimed to be Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through *www.regulations.gov* or e-mail. The *www.regulations.gov* Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through *www.regulations.gov* your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. *Docket:* All documents in the docket are listed in the *www.regulations.gov* index. Although listed in the index, some information is not publicly available, *e.g.* , CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in *www.regulations.gov* or in hard copy at the Water Docket, EPA/DC, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is
(202)566-1744, and the telephone number for the Water Docket is
(202)566-2426. FOR FURTHER INFORMATION CONTACT: Greg Schaner, Water Permits Division, Office of Wastewater Management (Mail Code: 4203M), Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., EPA East, Washington, DC 20460; telephone number:
(202)564-0721; fax number:
(202)564-6431; e-mail address: *schaner.greg@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does This Action Apply to Me? *The 2008 construction general permit (“2008 CGP”) would potentially apply to the following construction activities:* Category Examples of affected entities North American industry classification system (NAICS) code Industry Construction site operators disturbing 1 or more acres of land, or less than 1 acre but part of a larger common plan of development or sale if the larger common plan will ultimately disturb 1 acre or more, and performing the following activities: Building, Developing and General Contracting 233 Heavy Construction 234 EPA does not intend the preceding table to be exhaustive, but provides it as a guide for readers regarding entities likely to be regulated by this action. This table lists the types of activities that EPA is now aware of that could potentially be affected by this action. Other types of entities not listed in the table could also be affected. To determine whether your facility is affected by this action, you should carefully examine the definition of “construction activity” and “small construction activity” in existing EPA regulations at 40 CFR 122.26(b)(14)(x) and 122.26(b)(15), respectively. If you have questions regarding the applicability of this action to a particular entity, consult the person listed for technical information in the preceding FOR FURTHER INFORMATION CONTACT section. Eligibility for coverage under the 2008 CGP would be limited to operators of “new projects” or “unpermitted ongoing projects.” A “new project” is one that commences after the effective date of the 2008 CGP. An “unpermitted ongoing project” is one that commenced prior to the effective date of the 2008 CGP, yet never received authorization to discharge under the 2003 CGP or any other NPDES permit covering its construction-related stormwater discharges. This proposal is limited to those areas where EPA is the permitting authority. A list of eligible areas is included in Appendix B of the draft 2008 CGP. B. What Should I Consider as I Prepare My Comments for EPA? 1. *Submitting CBI.* Do not submit this information to EPA through *www.regulations.gov* or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 2. *Tips for Preparing Your Comments.* When submitting comments, remember to: • Identify the rulemaking by docket number and other identifying information (subject heading, **Federal Register** date, and page number). • Follow directions—The agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations
(CFR)part or section number. • Explain why you agree or disagree, suggest alternatives, and substitute language for your requested changes. • Describe any assumptions and provide any technical information and/or data that you used. • If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced. • Provide specific examples to illustrate your concerns, and suggest alternatives. • Explain your views as clearly as possible, avoiding the use of profanity or personal threats. • Make sure to submit your comments by the comment period deadline identified. C. Public Hearings EPA has not scheduled any public hearings to receive public comment concerning the proposed permit. All persons will continue to have the right to provide written comments during the public comment period. However, interested persons may request a public hearing pursuant to 40 CFR 124.12 concerning the proposed permit. Requests for a public hearing must be sent or delivered in writing to the same address as provided above for public comments prior to the close of the comment period. Requests for a public hearing must state the nature of the issues proposed to be raised in the hearing. Pursuant to 40 CFR 124.12, EPA shall hold a public hearing if it finds, on the basis of requests, a significant degree of public interest in a public hearing on the proposed permit. If EPA decides to hold a public hearing, a public notice of the date, time and place of the hearing will be made at least 30 days prior to the hearing. Any person may provide written or oral statements and data pertaining to the proposed permit at the public hearing. D. Finalizing the Permit After the close of the public comment period, EPA will issue a final permit. This permit will not be issued until after all public comments have been considered and appropriate changes made to the permit. EPA's response to public comments received will be included in the docket as part of the final permit decisions. Once the final permit becomes effective, operators of new and unpermitted ongoing construction projects may seek authorization to discharge by filing a NOI to be covered under the new 2008 CGP. Under EPA's regulations at 40 CFR 122.6, any construction site operator obtaining permit coverage prior to the July 1, 2008 expiration date of the 2003 CGP, automatically remains covered under that permit until the earliest of: • The operator submits a Notice of Termination, or; • EPA issues an individual permit or denies coverage under an individual permit for the site's stormwater discharges, or; • EPA issues a new general permit that establishes procedures for covering these existing dischargers to obtain coverage under the new general permit and the operator obtains coverage consistent with the procedures detailed in that new general permit. E. Who Are the EPA Regional Contacts for This Proposed Permit? For EPA Region 1, contact Thelma Murphy at tel.:
(617)918-1615 or e-mail at *murphy.thelma@epa.gov.* For EPA Region 2, contact Stephen Venezia at tel.:
(212)637-3856 or e-mail at *venezia.stephen@epa.gov,* or for Puerto Rico, contact Sergio Bosques at tel.:
(787)977-5838 or e-mail at *bosques.sergio@epa.gov.* For EPA Region 3, contact Garrison Miller at tel.:
(215)814-5745 or e-mail at *miller.garrison@epa.gov.* For EPA Region 5, contact Brian Bell at tel.:
(312)886-0981 or e-mail at *bell.brianc@epa.gov.* For EPA Region 6, contact Brent Larsen at tel.:
(214)665-7523 or e-mail at: *larsen.brent@epa.gov.* For EPA Region 7, contact Mark Matthews at tel.:
(913)551-7635 or e-mail at: *matthews.mark@epa.gov.* For EPA Region 8, contact Greg Davis at tel.:
(303)312-6314 or e-mail at: *davis.gregory@epa.gov.* For EPA Region 9, contact Eugene Bromley at tel.:
(415)972-3510 or e-mail at *bromley.eugene@epa.gov.* For EPA Region 10, contact Misha Vakoc at tel.:
(206)553-6650 or e-mail at *vakoc.misha@epa.gov.* II. Background of Permit Proposal A. Statutory and Regulatory History The Clean Water Act (“CWA”) establishes a comprehensive program “to restore and maintain the chemical, physical, and biological integrity of the Nation's waters.” 33 U.S.C. 1251(a). The CWA also includes the objective of attaining “water quality which provides for the protection and propagation of fish, shellfish and wildlife.” 33 U.S.C. 1251(a)(2). To achieve these goals, the CWA requires EPA to control the discharges through the issuance of National Pollutant Discharge Elimination System (“NPDES”) permits. Section 405 of the Water Quality Act of 1987
(WQA)added section 402(p) of the Clean Water Act (CWA), which directed EPA to develop a phased approach to regulate stormwater discharges under the NPDES program. EPA published a final regulation in the **Federal Register** on the first phase of this program on November 16, 1990, establishing permit application requirements for “storm water discharges associated with industrial activity.” See 55 FR 47990. EPA defined the term “storm water discharge associated with industrial activity” in a comprehensive manner to cover a wide variety of facilities. Construction activities, including activities that are part of a larger common plan of development or sale, that ultimately disturb at least five acres of land and have point source discharges to waters of the U.S. were included in the definition of “industrial activity” pursuant to 40 CFR 122.26(b)(14)(x). Phase II of the stormwater program was published in the **Federal Register** on December 8, 1999, and required NPDES permits for discharges from construction sites disturbing at least one acre, but less than five acres, including sites that are part of a larger common plan of development or sale that will ultimately disturb at least one acre but less than five acres, pursuant to 40 CFR 122.26(b)(15)(i). See 64 FR 68722. NPDES permits issued for construction stormwater discharges are required under Section 402(a)(1) of the CWA to include conditions for meeting technology-based effluent limits established under Section 301 and, where applicable, Section 306. Once an effluent limitations guideline or new source performance standard is promulgated in accordance with these sections, NPDES permits are required to incorporate limits based on such limitations and standards. See 40 CFR 122.44(a)(1). Prior to the promulgation of national effluent limitations and standards, permitting authorities incorporate technology-based effluent limitations on a best professional judgment basis. CWA section 402(a)(1)(B); 40 CFR 125.3(a)(2)(ii)(B). The NPDES regulations, at 40 CFR 122.44(s), authorize EPA to recognize local erosion and sediment control requirements that meet or exceed the requirements in that section as a “qualifying local program” (“QLP”). EPA can incorporate any such QLP requirements meeting or exceeding regulatory criteria into the CGP consistent with procedures for permit modifications established at 40 CFR 124.5. Following final incorporation of any QLP into the CGP, construction site operators that are subject to the requirements of the CGP and who are operating within the jurisdiction of a QLP, would then be directed (in the CGP) to follow those qualified local erosion and sediment control requirements in lieu of otherwise applicable erosion and sediment control requirements detailed in the CGP. Other CGP requirements, such as meeting eligibility criteria and standard NPDES permit conditions would still apply to that construction site operator. EPA has not incorporated QLPs into any of its previously issued construction general permits. However, in the interest of implementing this regulation, consistent with the Office of Water's May 8, 2006 memorandum entitled “Qualifying Local Programs for Construction Site Stormwater Runoff” (available at *www.epa.gov/npdes/stormwater* ), EPA is today proposing draft criteria for incorporating QLPs into this or any future CGPs. B. Summary of Permit Proposal EPA proposes to issue the 2008 CGP for a period of not to exceed two years. As proposed, the 2008 CGP will include conditions and limits that would be identical to the 2003 CGP, with the exception that the 2008 CGP only applies to new and unpermitted ongoing construction projects. Discharges from ongoing projects (or “existing dischargers”) would continue to be covered under the existing 2003 CGP. (However, EPA clarifies that if an operator of a permitted ongoing project transfers ownership of the project, or a portion thereof, to a different operator, that subsequent operator will be required to submit a complete and accurate NOI for a new project under the 2008 CGP.) Although the existing permit expires on July 1, 2008, dischargers who filed notices of intent
(NOIs)to be authorized under that permit prior to the expiration date will continue to be authorized to discharge in accordance with EPA's regulations at 40 CFR 122.6. The draft permit proposed here will only apply to dischargers who were not authorized under the 2003 CGP, which includes both “new projects” and “unpermitted ongoing projects.” Operators of new projects or unpermitted ongoing projects seeking coverage under the 2008 CGP would be expected to use the same electronic Notice of Intent
(eNOI)system that is currently in place for the 2003 CGP. As stated, EPA proposes to issue the 2008 CGP for a period not to exceed two years. As a result of recent litigation brought against EPA concerning the promulgation of effluent limitations guidelines and standards for the construction and development (“C&D”) industry, EPA is required by court order to propose effluent limitations guidelines and new source performance standards (hereinafter, “effluent guidelines”) for the C&D industry by December 2008, and promulgate those effluent guidelines by December 2009. See *Natural Resources Defense Council, et al.* v. *U.S. Environmental Protection Agency,* No CV—0408307-GH (C.D. Cal.)(Permanent Injunction and Judgment, December 5, 2006). EPA projects that the Agency may publish a proposed rule ahead of the court-ordered deadlines. If EPA publishes the proposed rule ahead of schedule, this may allow the Agency to promulgate a final rule ahead of schedule as well. The Agency currently hopes to promulgate a final rule as early as the end of this calendar year. However, completion of the tasks necessary to do so is dependent on the timing of numerous future activities and factors associated with the effluent guidelines rulemaking process. EPA believes it is appropriate to propose a revised CGP once EPA has issued C&D effluent guidelines, and therefore proposes a maximum two-year duration for this permit to coincide with the court-ordered deadlines for the C&D rule. EPA intends to propose and finalize a new, revised CGP sooner, if the C&D rule is promulgated earlier than the date directed by the court. EPA solicits comments on the proposed 2-year duration of this permit. C. What Is EPA's Rationale for This Permit Proposal? Since the 2003 CGP expires on July 1, 2008, it is incumbent upon EPA to make available a similar general permit that provides coverage for the estimated 4,000 new dischargers per year commencing construction in the areas where EPA is the permitting authority. Without such a permit vehicle, the only other available option for construction site operators is to obtain coverage under an individual permit. As has been described in the past, issuance of individual permits for every construction activity disturbing one acre or more is infeasible given the resources required for the Agency to issue individual permits. EPA is proposing to issue a CGP that adopts the same limits and conditions of the previous permit (the 2003 CGP) for a limited period of time. This action is appropriate for several reasons. First, as discussed above, EPA is working on the development of a new effluent guideline that will address stormwater discharges from the same industrial activities ( *i.e.* , construction activities disturbing one or more acres) as the CGP. Because the development of the C&D rule and the issuance of the CGP are on relatively similar schedules, and the C&D rule will establish national technology-based effluent limitations and standards for construction activities, EPA believes that it is more appropriate to proceed along two tracks to permit construction discharges. The first track entails issuing a CGP for a limited period of time, not to exceed 2 years, that contains the 2003 CGP limits and conditions, but for only operators of new and unpermitted ongoing projects, so that such entities can obtain valid permit coverage for their discharges. The second track involves proposing and issuing a revised 5-year CGP that incorporates the requirements of the new C&D rule shortly after the rule is promulgated. Second, EPA believes that issuing a substantially revised CGP by July 1, 2008, would be impracticable given the number of unknowns concerning the outcome of the C&D rule. EPA does not believe that it would be appropriate to issue a permit containing technology-based limitations that would be outdated so quickly, given the fact that the C&D rule may be promulgated only a few months after permit issuance. For similar reasons, if EPA had attempted to approximate the requirements of the new C&D rule and incorporate such limits into a new CGP, such a permit would presuppose the outcome of the C&D rule and potentially conflict with the scope and content of the effluent limitation guideline prior to full consideration of public comments. Instead, the Agency believes it is a much better use of Agency resources to wait the short time until after the C&D rule promulgation to issue a revised CGP that is fully reflective of the new effluent limitation guideline. In the meantime, during this relatively short period of time prior to the C&D rule's promulgation and prior to the issuance of the revised CGP that incorporates those standards, EPA is proposing to use the permit limits and conditions in the 2003 CGP as an effective vehicle to control new discharges. EPA notes that it has minimized the amount of time during which the 2008 CGP will remain effective in order to underscore the Agency's intention to issue a revised CGP once the C&D rule is finalized. Third, EPA found the alternative of allowing the 2003 CGP to expire without a replacement, relying instead on an enforcement discretion approach prior to the issuance of the next permit (similar to the practice used for the NPDES Multi-Sector General Permit
(MSGP)for stormwater discharges from industrial activities), to be an unacceptable option for stormwater discharges from construction activities. The CGP potentially has an estimated 4,000 new dischargers per year that seek coverage. EPA has made progress with the regulated community in terms of compliance assistance that would be compromised if a permit is not in place during the interim period prior to the promulgation of the C&D rule. For instance, EPA Regional offices have led substantial efforts to boost compliance with the CGP, resulting in an increased rate of compliance among construction operators. If no permit is made available by July 1, 2008, EPA anticipates that such efforts will be undermined, and the compliance rate may decline. Additionally, the enforcement discretion approach would leave construction operators without a reasonable way to obtain authorization to discharge and would expose them to liability from third party lawsuits for violating the Clean Water Act for unpermitted discharges. A short-term permit that mirrors the existing 2003 CGP addresses these concerns by providing a Federal permit with provisions that have already been reviewed in the previous permit issuance process, and by avoiding any period of time during which dischargers are not able to obtain permit coverage. D. Significant Changes From 2003 CGP As discussed above, EPA is proposing to issue the 2008 CGP for a period not to exceed two years. This permit would include the same limits and conditions as the 2003 CGP with the following noteworthy differences: 1. Clarification that eligibility for coverage under the 2008 CGP is limited to operators of new and unpermitted ongoing construction projects. 2. Clarification that operators of ongoing permitted construction projects are not eligible for coverage under the 2008 CGP. 3. Removal of eligibility for operators in Tribal Lands in Maine from the list of areas in Appendix B where this permit is effective. E. Geographic Coverage EPA is only authorized to provide permit coverage for classes of discharges that are outside the scope of a State's NPDES program authorization. EPA Regions 1, 2, 3, 5, 6, 7, 8, 9, and 10 are proposing to issue the 2008 CGP to replace the expiring 2003 CGP for operators of new and unpermitted ongoing construction projects. The geographic coverage and scope of the 2008 CGP are listed in Appendix B of the draft permit. The only change from the scope of coverage in the 2003 CGP is that the State of Maine is now the permitting authority for all discharges in the State, including operators in Tribal Lands, and as such, discharges in the State of Maine are no longer eligible for coverage under EPA's CGP. III. Proposed QLP Approval Criteria EPA is requesting public comment on a set of criteria for use in approving QLPs. EPA developed the criteria based on the QLP regulatory elements identified in 40 CFR 122.44(s). *These regulatory elements include the following:*
(i)Requirements for construction site operators to implement appropriate erosion and sediment control best management practices;
(ii)Requirements for construction site operators to control waste such as discarded building materials, concrete truck washout, chemicals, litter, and sanitary waste at the construction site that may cause adverse impacts to water quality;
(iii)Requirements for construction site operators to develop and implement a stormwater pollution prevention plan. (A stormwater pollution prevention plan includes site descriptions, descriptions of appropriate control measures, copies of approved State, Tribal or local requirements, maintenance procedures, inspection procedures, and identification of non-stormwater discharges);
(iv)Requirements to submit a site plan for review that incorporates consideration of potential water quality impacts; and
(v)For large construction activities only, any additional requirements necessary to achieve the applicable technology-based standards of “best available technology” and “best conventional technology” based on the best professional judgment of the permit writer. Using these regulatory elements, EPA has developed a draft set of criteria to review local erosion and sediment control requirements in an objective and systematic manner. EPA is proposing to use the following list of criteria to determine whether local programs meet the basic elements in 122.44(s). EPA notes that these criteria are presented in a summary format. During the actual evaluation of candidate local programs, EPA will need to assess in greater detail whether the local requirements meet or exceed the requirements in the applicable section of the CGP that is in effect at the time of the evaluation. I. *Erosion and Sediment Control* a. Sediment controls ( *e.g.* , perimeter controls, protection of storm drain inlets, location of stockpiles away from storm drainage conveyance), collection of sediment on paved areas to prevent it from entering storm drains. b. Off-site, vehicle tracking of sediments ( *e.g.* , establish site entrances and exits). c. Sediment pond, or similar level of control, for sites greater than 10 acres. d. Erosion controls ( *e.g.* , minimize disturbed areas, phase construction activity, blankets, mulches, divert stormwater flowing onto and through property away from disturbed areas). e. Temporary stabilization ( *e.g.* , stabilize areas of exposed soil where construction activity has temporarily ceased). f. Final stabilization. II. *Control of Other Wastes* —To prevent contamination of construction stormwater, the following wastes must be controlled: g. Solid waste management ( *e.g.* , trash cans, dumpsters, material handling. and storage areas). h. Concrete truck washout ( *e.g.* , designate concrete controlled washout areas). i. Sanitary waste ( *e.g.* , portable toilets). j. Spill prevention and response procedures ( *e.g.* , for petroleum products, chemicals, etc.). III. *Develop a Stormwater Pollution Prevention Plan* k. Project description ( *e.g.* , nature of construction, dates and sequence of construction, site operator information, identification of potential pollutant sources). l. Site map(s). m. Description of all erosion, sediment, other waste controls. n. Operation and maintenance procedures for erosion and sediment controls. o. Routine self-inspections. p. Train employees and subcontractors on the implementation of controls. *IV. Submit Site Plan for Review* q. Submit site plan or entire SWPPP to the qualified local program for review. EPA anticipates that although a program may not meet all of the criteria listed above, it still may be approved as a QLP for those parts of the program that do meet the criteria. In such a situation, the CGP would specify which requirements would be included in the QLP requirements and which ones would be subject to the CGP requirements. EPA invites comments on the draft criteria for approving QLPs. EPA specifically encourages commenters to suggest modifications to the wording of the criteria, where necessary, and/or to recommend other criteria that EPA should use. In addition, EPA invites the public to suggest candidate local programs that could be considered as a QLP. EPA also asks for recommendations on how the process for identifying, approving, and implementing QLPs can work effectively. IV. Compliance With the Regulatory Flexibility Act A. EPA's Approach to Compliance With the Regulatory Flexibility Act for General Permits The Regulatory Flexibility Act
(RFA)generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions. The legal question of whether a general permit (as opposed to an individual permit) qualifies as a “rule” or as an “adjudication” under the Administrative Procedure Act
(APA)has been the subject of periodic litigation. In a recent case, the court held that the CWA Section 404 Nationwide general permit before the court did qualify as a “rule” and therefore that the issuance of that general permit needed to comply with the applicable legal requirements for the issuance of a “rule.” *National Ass'n of Home Builders* v. *U.S. Army Corps of Engineers* , 417 F.3d 1272, 1284-85 (DC Cir. 2005) (Army Corps general permits under Section 404 of the Clean Water Act are rules under the APA and the Regulatory Flexibility Act; “Each NWP [nationwide permit] easily fits within the APA's definition “rule.* * * As such, each NWP constitutes a rule * * *”). As EPA stated in 1998, “the Agency recognizes that the question of the applicability of the APA, and thus the RFA, to the issuance of a general permit is a difficult one, given the fact that a large number of dischargers may choose to use the general permit.” 63 FR 36489, 36497 (July 6, 1998). At that time, EPA “reviewed its previous NPDES general permitting actions and related statements in the **Federal Register** or elsewhere,” and stated that “[t]his review suggests that the Agency has generally treated NPDES general permits effectively as rules, though at times it has given contrary indications as to whether these actions are rules or permits.” *Id.* at 36496. Based on EPA's further legal analysis of the issue, the Agency “concluded, as set forth in the proposal, that NPDES general permits are permits [ *i.e.* , adjudications] under the APA and thus not subject to APA rulemaking requirements or the RFA.” *Id.* Accordingly, the Agency stated that “the APA's rulemaking requirements are inapplicable to issuance of such permits,” and thus “NPDES permitting is not subject to the requirement to publish a general notice of proposed rulemaking under the APA or any other law * * * [and] it is not subject to the RFA.” *Id.* at 36497. However, the Agency went on to explain that, even though EPA had concluded that it was not legally required to do so, the Agency would voluntarily perform the RFA's small-entity impact analysis. *Id.* EPA explained the strong public interest in the Agency following the RFA's requirements on a voluntary basis: “[The notice and comment] process also provides an opportunity for EPA to consider the potential impact of general permit terms on small entities and how to craft the permit to avoid any undue burden on small entities.” *Id.* Accordingly, with respect to the NPDES permit that EPA was addressing in that **Federal Register** notice, EPA stated that “the Agency has considered and addressed the potential impact of the general permit on small entities in a manner that would meet the requirements of the RFA if it applied.” *Id.* Subsequent to EPA's conclusion in 1998 that general permits are adjudications rather than rules, as noted above, the DC Circuit recently held that Nationwide general permits under section 404 are “rules” rather than “adjudications.” Thus, this legal question remains “a difficult one” ( *supra* ). However, EPA continues to believe that there is a strong public policy interest in EPA applying the RFA's framework and requirements to the Agency's evaluation and consideration of the nature and extent of any economic impacts that a CWA general permit could have on small entities ( *e.g.,* small businesses). In this regard, EPA believes that the Agency's evaluation of the potential economic impact that a general permit would have on small entities, consistent with the RFA framework discussed below, is relevant to, and an essential component of, the Agency's assessment of whether a CWA general permit would place requirements on dischargers that are appropriate and reasonable. Furthermore, EPA believes that the RFA's framework and requirements provide the Agency with the best approach for the Agency's evaluation of the economic impact of general permits on small entities. While using the RFA framework to inform its assessment of whether permit requirements are appropriate and reasonable, EPA will also continue to ensure that all permits satisfy the requirements of the Clean Water Act. Accordingly, EPA has committed to operating in accordance with the RFA's framework and requirements during the Agency's issuance of CWA general permits (in other words, the Agency has committed that it will apply the RFA in its issuance of general permits as if those permits do qualify as “rules” that are subject to the RFA). B. Application of RFA Framework to Proposed Issuance of CGP EPA has concluded, consistent with the discussion in Section IV.A above, that the proposed issuance of the 2008 CGP could affect a substantial number of small entities. In the areas where the CGP is effective (see Section II.E), (those areas where EPA is the permit authority), an estimated 4,000 construction projects per year were authorized under the 2003 CGP, a substantial number of which could be operated by small entities. However, EPA has concluded that the proposed issuance of the 2008 CGP is unlikely to have an adverse economic impact on small entities. The draft 2008 CGP includes the same requirements as those of the 2003 CGP. Additionally, an operator's use of the CGP is volitional ( *i.e.* , a discharger could apply for an individual permit rather than for coverage under this general permit) and is less burdensome than an individual NPDES permit. EPA intends to include an updated economic screening analysis with the issuance of the next CGP. Authority: Clean Water Act, 33 U.S.C. 1251 *et seq.* Dated: May 7, 2008. Ira Leighton, Acting Regional Administrator, EPA Region 1. Dated: May 8, 2008. Walter Mugden, Director, Division of Environmental Planning & Protection, EPA Region 2. Dated: May 6, 2008. Carl-Axel P. Soderberg, Division Director, Caribbean Environmental Protection Division, EPA Region 2. Dated: May 7, 2008. Jon M. Capacasa, Director, Water Protection Division, EPA Region 3. Dated: May 7, 2008. Tinka Hyde, Acting Director, Water Division, EPA Region 5. Dated: May 8, 2008. William H. Honker, Acting Director, Water Quality Protection Division, EPA Region 6. Dated: May 8, 2008. William A. Spratlin, Director, Water, Wetlands and Pesticides Division, EPA Region 7. Dated: May 8, 2008. Debra H. Thomas, Deputy Assistant Regional Administrator, Office of Partnerships & Regulatory Assistance, EPA Region 8. Dated: May 6, 2008. Alexis Strauss, Director, Water Division, EPA Region 9. Dated: May 7, 2008. Michael Gearheard, Director, Office of Water and Watersheds, EPA Region 10. [FR Doc. E8-10997 Filed 5-15-08; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY [ER-FRL-6698-9] Environmental Impact Statements and Regulations; Availability of EPA Comments Availability of EPA comments prepared pursuant to the Environmental Review Process (ERP), under section 309 of the Clean Air Act and Section 102(2)
(c)of the National Environmental Policy Act as amended. Requests for copies of EPA comments can be directed to the Office of Federal Activities at 202-564-7167. An explanation of the ratings assigned to draft environmental impact statements
(EISs)was published in FR dated April 11, 2008 (73 FR 19833). Draft EISs *EIS No. 20070344, ERP No. D-FHW-B40172-VT,* Circ-Williston Transportation Project, Improvements between I-89 and the Towns Williston and Essex and the Village of Essex Junction, City of Burlington, Chittenden County, VT. *Summary:* EPA has environmental objections to the proposed Circ A-B alternatives based on environmental impacts to wetlands, water resources and storm water, air quality, indirect and cumulative impacts and hydrologic impacts. EPA also noted that the VT 2A alternatives appear to include the least environmentally damaging practicable alternative. Rating EO2. *EIS No. 20080010, ERP No. D-FHW-E40819-00,* US-231/I-10 Connector Project HPP-1602-(507), Proposal to Build Limited Access Facility from US 231 North of Dothan to the Alabama/Florida State Line, Dale, Houston, Geneva Counties, AL. *Summary:* EPA expressed environmental concerns about impacts related to noise, aquatic resources and community impacts, as well as to the 100-year floodplains. Rating EC2. *EIS No. 20080038, ERP No. D-BLM-J65507-WY,* West Antelope Coal Lease Application (Federal Coal Lease Application WYW163340), Implementation, Converse and Campbell Counties, WY. *Summary:* EPA expressed environmental concerns about impacts to air quality based on monitored data, wildlife habitat and wetlands. The final EIS should address these issues, and include mitigation for air quality and wetlands where applicable. Rating EC2. *EIS No. 20080043, ERP No. D-FTA-K39111-HI,* Lahaina Small Boat Harbor Ferry Pier Project, To Build a New Inter-island Ferry Pier, Maui, Hawaii. *Summary:* EPA expressed environmental concerns about the proposed project related to dredging, water quality, habitat, and cumulative impacts. In particular, EPA is concerned that the document does not discuss how the dredging and construction associated with the project will be performed and the impacts of those methods. Rating EC2. *EIS No. 20080091, ERP No. D-AFS-J65513-WY,* Winter Elk Management Programs, Long-Term Special Use Authorization for Wyoming Game and Fish Commission to use National Forest System Land within the Bridger-Teton National Forest at Alkali Creek, Dog Creek, Fall Creek, Fish Creek, Muddy Creek, Patrol Cabin, and Upper Green River, Jackson and Sublette, WY. *Summary:* EPA expressed environmental concerns about potential impacts to water quality resulting from stream bank damage, erosion, and sedimentation. EPA requested that the Final EIS provide additional information on existing water quality conditions and consider additional mitigation to reduce potential impacts. Rating EC2. *EIS No. 20080111, ERP No. D-COE-E09811-00,* WITHDRAWN-PROGRAMMATIC—Hydropower Rehabilitations, Dissolved Oxygen and Minimum Flow Regimes at Wolf Creek Dam, Kentucky and Center Hill and Dale Hollow Dams, Tennessee, Implementation. *Summary:* Officially withdrawn by the preparing agency. Rating NW. *EIS No. 20080129, ERP No. D-FHW-J40182-UT,* Layton Interchange Project, Improvements on I-15 (Exit-330) to Provide Unrestricted Access Across the Unicon Pacific Railroad and to Address Traffic Congestion on Gentile St. in West Layton, Layton City, UT. *Summary:* While EPA has no objections to the proposed action, EPA did request clarification of the air quality analysis. Rating LO. Final EISs *EIS No. 20070458, ERP No. F-FHW-B40086-CT,* CT 82/85/11 Corridor Transportation Improvements, Selected Preferred Alternative, is a Modification of Alternative 4(E), Funding and COE Section 404 Permit, In the Towns of Salem, Montville, East Lyme and Waterford, CT. *Summary:* EPA has environmental objections to the proposed project about the evaluation of alternatives, the significance of impacts on the aquatic ecosystem, and compensatory mitigation issues. *EIS No. 20080099, ERP No. F-FHW-E40778-NC* , US 74 Shelby Bypass Transportation Improvements, Preferred Alternative is 21, Construction, Funding and COE Section 404 Permit, Cleveland County, NC. *Summary:* EPA expressed environmental concerns about the impacts to streams, potential prime farmland impacts, potential impacts to the protection of surface water quality within a protected water supply watershed and indirect and cumulative impacts. EPA is also concerned that impacts from mobile source air toxics were not addressed. *EIS No. 20080102, ERP No. F-BLM-K65323-00* , Yuma Field Office
(YFO)Resource Management Plan, Provide Direction Managing Public Lands, Implementation, Yuma, La Paz and Maricopa Counties, AZ and Imperial and Riverside Counties, CA. *Summary:* The final EIS addressed EPA's comments; therefore, EPA does not object to the project. *EIS No. 20080131, ERP No. F-AFS-K65332-CA* , Eldorado National Forest Public Wheeled Motorized Travel Management Project, Proposes to Regulate Unmanaged Public Wheeled Motor Vehicle, Implementation, Alphine, Amador, El Dorado, and Placer Counties, CA. *Summary:* EPA continues to have environmental concerns about the potential adverse impacts on water quality and sensitive resources. As the plan is implemented we continue to recommend eliminating routes in sensitive and easily damaged, high elevation habitat. *EIS No. 20080094, ERP No. FS-AFS-L65453-ID* , North Sheep Allotments—Sheep and Goat Allotment Management Plans, Additional Information on Analyses Concerning Management Indicator Species, Capable and Suitable Grazing Lands, and Adaptive Management Strategies, Authorization of Continued Sheep Grazing for Fisher Creek, Smiley Creek, North Fork-Boulder and Baker Creek Sheep and Goat Grazing Allotments, Sawtooth National Forest, Ketchum Ranger District, Sawtooth National Recreation Area, Blaine and Custer Counties, ID. *Summary:* While EPA supports adaptive management we have concerns that the monitoring necessary to implement adaptive management may not be implemented. Providing an indication that funding will be available for the adaptive management is recommended. *EIS No. 20080127, ERP No. FS-FHW-J40135-MT* , US 93 Highway Ninepipe/Ronan Improvement Project, from Dublin Gulch Road/Red Horn Road, Funding, Special-Use Permit, NPDES Permit and U.S. Army COE Section 404 Permit, Lake County, MT. *Summary:* EPA has environmental concerns with the proposed project regarding impacts to wetlands and aquatic habitat, as well as impacts to wildlife and wildlife movement. Additional information is needed to fully assess and mitigate all potential impacts of the management actions. Dated: May 13, 2008. Ken Mittelholtz, Environmental Protection Specialist, Office of Federal Activities. [FR Doc. E8-11069 Filed 5-15-08; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY [ER-FRL-6698-8] Environmental Impacts Statements; Notice of Availability Responsible Agency: Office of Federal Activities, General Information
(202)564-7167 or *http://www.epa.gov/compliance/nepa/* . Weekly Receipt of Environmental Impact Statements Filed May 5, 2008 Through May 9, 2008 Pursuant to 40 CFR 1506.9. *EIS No. 20080181, Draft EIS, FAA, OH,* Port Columbus International Airport
(CMH)Project, Replacement of Runway 10R/28L, Development of a New Passenger Terminal and other Associated Airport Projects, Funding, City of Columbus, OH, Comment Period Ends: 07/11/2008, Contact: Katherine Jones 734-229-2958. *EIS No. 20080182, Final EIS, AFS, NM* Perk-Grindstone Fuel Reduction Project, To Protect Life, Property, and Natural Resources, Village of Ruidoso, Lincoln National Forest, Lincoln County, New Mexico, Wait Period Ends: 06/16/2008, Contact: Ron Hannan 575-434-7245. *EIS No. 20080183, Final EIS, FHW, 00,* US-131 Improvement Study, from the Indiana Toll Road (I-80/90) to a Point One Mile North of Cowling Road, U.S. Army COE Section 404 Permit, St. Joseph County, MI and Elkhart County, IN, Wait Period Ends: 06/16/2008, Contact: David T. Williams 517-702-1820. *EIS No. 20080184, Draft EIS, FHW, IA,* I-29 Improvements in Sioux City, Construction from Burlington Northern Santa Fe Rail Road
(BNSF)Bridge over the Missouri River to Existing Hamilton Boulevard Interchange, Woodbury County, IA, Comment Period Ends: 06/30/2008, Contact: Philip Barnes 515-233-7300. *EIS No. 20080185, Draft Supplement, FSA, 00,* Programmatic—Expansion of the Emergency Conservation Program, To Restore Farmland (Cropland, Hayland and Pastureland) to a Normal Productive State after a Natural Disaster, Comment Period Ends: 06/30/2008, Contact: Matthew Ponish 202-720-6853. *EIS No. 20080186, Draft EIS, FAA, NV,* City of Mesquite, Proposed Replacement General Aviation Airport, Implementation, Clark County, NV, Comment Period Ends: 07/03/2008, Contact: Barry Franklin 650-876-2778. *EIS No. 20080187, Final EIS, AFS, MT,* Marten Creek Project, Proposed Timber Harvest, Prescribed Fire Burning, Watershed Restoration, and Associated Activities, Cabinet Ranger District, Kootenai National Forest, Sanders County, MT, Wait Period Ends: 06/16/2008, Contact: John Head 406-827-3533. *EIS No. 20080188, Final EIS, IBW, CA,* Programmatic—Tijuana River Flood Control Project, Proposing a Range of Alternatives for Maintenance Activities and Future Improvements, San Diego County, CA, Wait Period Ends: 06/16/2008, Contact: Daniel Borunda 915-832-4767. *EIS No. 20080189, Final EIS, NSA, NM,* Continued Operations of Los Alamos National Laboratory, Proposal to Expand Overall Operational Levels, (DOE/EIS-0380), Site Wide, Los Alamos County, NM, Wait Period Ends: 06/16/2008, Contact: Elizabeth Withers 505-665-0308. *EIS No. 20080190, Draft Supplement, USA, 00,* Programmatic—Army Growth and Force Structure Realignment, Evaluation of Alternatives for Supporting the Growth, Realignment, and Transformation of the Army to Support Operations in the Pacific Theater, Implementation, Nationwide and the Pacific Region of AK, HI, Comment Period Ends: 06/30/2008, Contact: Mike Ackerman 410-436-2522. *EIS No. 20080191, Final Supplement, AFS, MT,* Fishtrap Project, Updated Information on Past Maintenance/Restorative Treatments within Old Growth Stands, Timber Harvest, Prescribed Burning, Road Construction and Other Restoration Activities, Lolo National Forest, Plains/Thompson Falls Ranger District, Sanders County, MT, Wait Period Ends: 06/30/2008, Contact: Randy Hojem 406-826-4308. *EIS No. 20080192, Draft EIS, AFS, MT,* Sheppard Creek Post-Fire Project, Timber Salvage, Implementation, Flathead National Forest, Flathead and Lincoln Counties, MT, Comment Period Ends: 07/01/2008, Contact: Bryan Donner 406-758-3508. Amended Notices EIS No. 20080106, *Draft EIS, AFS, CO,* Long Draw Reservoir Project, Re-Issue a Special-Use-Authorization to Water Supply and Storage to Allow the Continued Use of Long Draw Reservoir and Dam, Arapaho and Roosevelt National Forests and Pawnee National Grassland, Grand and Larimer Counties, CO, Comment Period Ends: 06/11/2008, Contact: Ken Tu 970-295-6623. Revision of FR Notice Published 03/28/2008: Extending Comment Period from 05/12/2008 to 06/11/2008. *EIS No. 20080163, Draft EIS, AFS, AK,* Withdrawn—Spencer Mineral Materials Project, Proposal to Develop and Extract Quarry Rock and Gravel from a Site near Spencer Glacier, Chugach National Forest, Kenal Borough, AK, Comment Period Ends: 06/16/2008, Contact: Alice Allen 605-673-4853. Revision to FR Notice Published 05/02/2008: Officially Withdrawn by the Preparing Agency. *EIS No. 20080171, Draft EIS, NOA, WA,* Proposed Authorization of the Makah Indian Tribe's Request to Hunt Gray Whales in the Tribe's Usual and Accustomed Fishing Grounds off the Coast of Washington, Comment Period Ends: 07/08/2008, Contact: Donna Darm 206-526-6150. Revision to FR Notice Published 05/09/2008: Correction to Title and Comment Period from 07/07/2008 to 07/08/2008. Dated: May 13, 2008. Ken Mittelholtz, Environmental Protection Specialist, Office of Federal Activities. [FR Doc. E8-11009 Filed 5-15-08; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2008-0046; FRL-8361-6] Notice of Filing of Pesticide Petitions for Residues of Pesticide Chemicals in or on Various Commodities AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: This notice announces the initial filing of pesticide petitions proposing the establishment or modification of regulations for residues of pesticide chemicals in or on various commodities. DATES: Comments must be received on or before June 16, 2008. ADDRESSES: Submit your comments, identified by docket identification
(ID)number EPA-HQ-OPP-2008-0046 and the pesticide petition number
(PP)of interest, by one of the following methods: • *Federal eRulemaking Portal* : * http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs
(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is
(703)305-5805. *Instructions* : Direct your comments to EPA-HQ-OPP-2008-0046 the assigned docket ID number and the pesticide petition number of interest. EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at *http://www.regulations.gov* , including any personal information provided, unless the comment includes information claimed to be Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or e-mail. The regulations.gov website is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. *Docket* : All documents in the docket are listed in the docket index available in regulations.gov. To access the electronic docket, go to *http://www.regulations.gov* , select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy. Publicly available docket materials are available electronically at *http://www.regulations.gov* , or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is
(703)305-5805. FOR FURTHER INFORMATION CONTACT: The person listed at the end of the pesticide petition summary of interest. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed at the end of the pesticide petition summary of interest. B. What Should I Consider as I Prepare My Comments for EPA? 1. *Submitting CBI* . Do not submit this information to EPA through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 2. *Tips for preparing your comments* . When submitting comments, remember to: i. Identify the document by docket ID number and other identifying information (subject heading, **Federal Register** date and page number). ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations
(CFR)part or section number. iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes. iv. Describe any assumptions and provide any technical information and/or data that you used. v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced. vi. Provide specific examples to illustrate your concerns and suggest alternatives. vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats. viii. Make sure to submit your comments by the comment period deadline identified. II. Docket ID Numbers When submitting comments, please use the docket ID number and the pesticide petition number of interest, as shown in the table. PP Number Docket ID Number PP 7E7258 EPA-HQ-OPP-2008-0049 PP 7E7337 EPA-HQ-OPP-2008-0270 PP 8E7314 EPA-HQ-OPP-2008-0258 PP 8E7324 EPA-HQ-OPP-2008-0271 PP 8E7340 EPA-HQ-OPP-2008-0272 PP 1F6299 EPA-HQ-OPP-2008-0276 PP 7F7200 EPA-HQ-OPP-2007-0337 PP 7F7263 EPA-HQ-OPP-2008-0261 PP 7F7274 EPA-HQ-OPP-2008-0262 PP 8E7340 EPA-HQ-OPP-2008-0272 PP 8E7315 EPA-HQ-OPP-2008-0254 PP 5F6945 EPA-HQ-OPP-2008-0275 III. What Action is the Agency Taking? EPA is printing notice of the filing of pesticide petitions received under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, proposing the establishment or modification of regulations in 40 CFR part 180 for residues of pesticide chemicals in or on various food commodities. EPA has determined that the pesticide petitions described in this notice contain data or information regarding the elements set forth in FFDCA section 408(d)(2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the pesticide petitions. Additional data may be needed before EPA rules on these pesticide petitions. Pursuant to 40 CFR 180.7(f), a summary of each of the petitions included in this notice, prepared by the petitioner, is included in a docket EPA has created for each rulemaking. The docket for each of the petitions is available on-line at *http://www.regulations.gov* . New Tolerance 1. *PP 7E7258* . (EPA-HQ-OPP-2008-0049). Interregional Research Project Number 4 (IR-4), 500 College Rd., East, Suite 201W, Princeton, NJ 08540, proposes to establish a tolerance for residues of the fungicide triflumizole, 1-[1-((4-chloro-2-(trifluoromethyl) phenyl)imino)-2 propoxyethyl]-1H-imidazole, and its metabolites containing the 4-chloro-2-trifluoromethylaniline moiety in or on the food commodities leafy greens subgroup 4A, except spinach and cilantro at 35 parts per million (ppm); turnip, greens at 40 ppm; swiss chard at 18 ppm; pineapple at 4.0 ppm; papaya; sapote, black; canistel; sapote, mamey; mango; sapodilla; star apple at 2.5 ppm; and hop, dried cones at 50.0 ppm. The analytical method is suitable for analyzing crops for residues of triflumizole and its aniline containing metabolites at the proposed tolerance levels and has been independently validated. Residue levels of triflumizole are converted to FA-1-1 by acidic and alkaline reflux, followed by distillation. Residues are then extracted and subjected to SPE purification. Detection and quantitation are conducted by gas chromatograph equipped with nitrogen phosphorus detector, electron capture detector or mass spectrometry detection. The limit of quantitation of the method has been determined in the range of 0.01 ppm to 0.05 ppm for the combined residues of triflumizole and FA-1-1. The enforcement methodology has been submitted to the Food and Drug Administration for publication in the Pesticide Analytical Manual, Vol. II (PAM II). Contact: Susan Stanton,
(703)305-5218, *stanton.susan@epa.gov* . 2. *PP 7E7337* . (EPA-HQ-OPP-2008-0270). Interregional Research Project No. 4 (IR-4), 500 College Road East, Suite 201W, Princeton, NJ 08540, proposes to establish a tolerance for residues of the fungicide (plant activator), acibenzolar S-methyl in or on the food commodity onion, bulb, subgroup 3-07A at 0.07 ppm. Syngenta Analytical Method AG-671A is a practical and valid method for the determination and confirmation of acibenzolar S-methyl (CGA245704) in raw agricultural commodities
(RAC)and processing substrates from the tobacco, leafy (including brassica) and fruiting vegetable crop groups at a limit of quantitation
(LOQ)of 0.02 ppm. Based on recoveries of dry bulb onion samples fortified at the lower limit of method validation, the limit of detection and LOQ were calculated as 0.013 and 0.040 ppm, respectively. The method involves extraction, solid phase cleanup of samples with analysis by high performance liquid chromatography
(HPLC)with ultraviolet
(UV)detection or confirmatory liquid chromatography/mass spectrometry (LC/MS). The validity is demonstrated by the acceptable accuracy and precision obtained on numerous procedural recovery samples (radiovalidation and field trial sample sets), and by the extractability and accountability obtained by the analysis of weathered radioactive substrates using Analytical Method AG-671A. Contact: Susan Stanton,
(703)305-5218, *stanton.susan@epa.gov* . 3. *PP 8E7324* . (EPA-HQ-OPP-2008-0271). Interregional Research Project No. 4 (IR-4), 500 College Road East, Suite 201W, Princeton, NJ 08540, proposes to establish a tolerance for residues of the insecticide indoxacarb, (S)-methyl 7-chloro- 2,5-dihydro-2-[[(methoxycarbonyl)[4-(trifluoromethoxy)phenyl] amino]carbonyl] indeno[1,2e] [1,3,4]oxadiazine-4a(3H)-carboxylate, and its R-enantiomer [(R)-methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-(trifluoromethoxy) phenyl]amino]carbonyl]indeno [1,2-e] [1,3,4] oxadiazine-4a(3H)- carboxylate in a 75:25 mixture (DPX-MP062), respectively, in or on the food commodities Bushberry subgroup 13-07B at 1.5 ppm; beet, garden, roots at 0.3 ppm; and beet, garden, tops at 6.0 ppm. The plant residue enforcement method detects and quantitates indoxacarb in various matrices including sweet corn, lettuce, tomato, broccoli, apple, grape, cottonseed, peanut, and soybean commodity samples by HPLC with UV detection. The limit of quantitation in the method allows monitoring of crops with indoxacarb residues at or above the levels proposed in these tolerances. Contact: Susan Stanton,
(703)305-5218, *stanton.susan@epa.gov* . 4. *PP 8E7314* . (EPA-HQ-OPP-2008-0258). Interregional Research Project No. 4 (IR-4), 500 College Road East, Suite 201 W, Princeton, NJ 08540, proposes to establish a tolerance for residues of the fungicide dimethomorph, (E,Z)4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-oxo-2-propenyl]-morpholine in or on the food commodities bean, lima at 0.6 ppm; ginseng at 0.85 ppm; grape at 3.5 ppm; grape, raisin at 6.0 ppm; and turnip, greens at 20 ppm. A reliable method for the determination of dimethomorph residues in bean, lima; ginseng; grape; grape, raisin; and turnip, greens exists; this method is the FDA Multi-Residue Method, Protocol D, as published in the Pesticide Analytical Manual I. Contact: Sidney Jackson,
(703)305-7610, *jackson.sidney@epa.gov* . 5. *PP 8E7340* . (EPA-HQ-OPP-2008-0272). Interregional Research Project No. 4 (IR-4), 500 College Road East, Suite 201 W, Princeton, NJ 08540, proposes to establish a tolerance for the combined residues of the insecticide spiromesifen, 2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl 3, 3-dimethylbutanoate and its enol metabolite 4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one, calculated as the parent compound equivalents in or on the food commodities: Corn, sweet, kernel plus cob with husks removed at 0.02 ppm; corn, sweet, forage at 6.0 ppm; corn, sweet, stover at 7.0 ppm; and berry and small fruit, low growing berry, subgroup 13-07G at 2.0 ppm. Adequate analytical methodology using liquid chromatography/mass spectrometry detection is available for enforcement purposes. Contact: Sidney Jackson,
(703)305-7610, *jackson.sidney@epa.gov* . 6. *PP 1F6299* . (EPA-HQ-OPP-2008-0276). Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box 12014, Research Triangle Park, NC 27709, proposes to establish a tolerance for residues of the herbicide iodosulfuron-methyl-sodium, methyl 4-iodo-2-[3-(4-methoxy-6-methyl-1,3,5-triazin-2-yl)-ureidosulfonyl]benzoate, sodium salt in or on the food commodities wheat, grain at 0.02 ppm; wheat, forage at 0.06 ppm; wheat, straw at 0.05 ppm; and wheat, hay at 0.05 ppm. An enforcement procedure is available whereby extractable residues of iodosulfuron-methyl-sodium and AE F075736 are removed from crops by blending with acetonitrile. After blending, the extract is filtered, reduced in volume and partitioned with hexane to remove oils. The partially cleaned up extract is evaporated to dryness under reduced pressure; dissolved in dichloromethane and further cleaned-up on a series of solid phase extraction columns, first, silica gel, then Bond Elut(tm) ENV, and finally on polyamide 6S. The extract is again concentrated to dryness and reconstituted in either 70/30 deionized water/acetonitrile for analysis by high performance liquid chromatography/mass spectrometry (HPLC-MS/MS), or in 50/50 deionized water/acetonitrile for analysis by HPLC/Ultraviolet (HPLC/UV). Contact: Hope Johnson,
(703)305-5410, *johnson.hope@epa.gov* . 7. *PP 7F7200* . (EPA-HQ-OPP-2007-0337). Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box 12014, Research Triangle Park, NC 27709, proposes to revise tolerances for residues of the insecticide cyfluthrin; cyano(4-fluoro-3-phenoxyphenyl)methyl-3-(2,2-dichloroethenyl)-2,2-dimethyl-cyclopropanecarboxylate in or on the food commodities barley, grain; buckwheat, grain; millet, grain; oats, grain; rye, grain; triticale, grain; and wheat, grain at 0.15 ppm; corn, field, grain; corn, pop, grain; teosinte, grain; and corn, sweet, kernel plus cob with husks removed at 0.05 ppm; sorghum, grain at 3.5 ppm; grain, cereal, forage, group 16 (except rice) at 25.0 ppm; grain, cereal, stover, group 16 (except rice) at 30.0 ppm; grain, cereal, hay, group 16 (except rice) at 6.0 ppm; and grain, cereal, straw, group 16 (except rice) at 7.0 ppm; and beta-cyfluthrin; cyano(4-fluoro-3-phenoxyphenyl)methyl-3-(2,2-dichloroethenyl)-2,2-dimethyl-cyclopropanecarboxylate [mixture comprising the enantiomeric pair (R)-α-cyano-4-fluoro-3-phenoxybenzyl (1S,3S)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate and (S)-α-cyano-4-fluoro-3-phenoxybenzyl (1R,3R)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate with the enantiomeric pair (R)-α-cyano-4-fluoro-3-phenoxybenzyl (1S,3R)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate and (S)-α-cyano-4-fluoro-3-phenoxybenzyl (1R,3S)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate] in or on the food commodities: Alfalfa, forage at 5.0 ppm; alfalfa, hay at 13 ppm; barley, bran at 0.5 ppm; barley, grain at 0.15 ppm; beet, sugar, dried pulp at 1.0 ppm; beet, sugar, roots at 0.10 ppm; brassica, head and stem, subgroup 5A at 2 5 ppm; buckwheat, grain at 0.15 ppm; carrot, roots at 0.20 ppm; cattle, fat at 2.0 ppm; cattle, meat at 0.10 ppm; cattle, meat byproducts at 0.10 ppm; citrus, dried pulp at 0.3 ppm; citrus, oil at 0.3 ppm; corn, field, grain at 0.05 ppm; corn, sweet, kernel plus cob with husks removed at 0.05 ppm; cotton, hulls at 2.0 parts ppm; cotton, refined oil at 2.0 ppm; cotton, seed at 1.0 ppm; egg at 0.01 ppm; fruit, citrus, group 10 at 0.2 ppm; goat, fat at 2.0 ppm; goat, meat at 0.05 ppm; goat, meat byproducts at 0.05 ppm; grain, cereal, forage, fodder and hay, group 16, forage, except rice at 25 ppm; grain, cereal, forage, fodder and hay, group 16, hay except rice at 6.0 ppm; grain, cereal, forage, fodder and hay, group 16, stover, except rice at 30 ppm; grain, cereal, forage, fodder and hay, group 16, straw, except rice at 7.0 ppm; grass, forage, fodder and hay, group 17, forage at 12 ppm; grass, forage, fodder and hay, group 17, hay at 50 ppm; hog, fat at 0.5 ppm; hog, meat at 0.01 ppm; hog, meat byproducts at 0.01 ppm; hop, dried cones at 20.0 ppm; hop, vine at 4.0 ppm; horse, fat at 2.0 ppm; horse, meat at 0.05 ppm; horse, meat byproducts at 0.05 ppm; lettuce, head at 2.0 ppm; lettuce, leaf at 3.0 ppm; milk at 0.2 ppm; milk, fat at 5.0 ppm; millet, grain at 0.15 ppm; mustard greens at 7.0 ppm; oat, bran at 0.5 ppm; oat, grain at 0.15 ppm; pea, dry, seed at 0.15 ppm; pea, southern, succulent at 0.25 ppm; pepper at 0.50 ppm; potato at 0.01 ppm; poultry, fat at 0.01 ppm; poultry, meat at 0.01 ppm; poultry, meat byproducts at 0.01 ppm; radish, roots at 1.0 ppm; rye, bran at 0.5 ppm; rye, grain at 0.15 ppm; sheep, fat at 2.0 ppm; sheep, meat at 0.05 ppm; sheep, meat byproducts at 0.05 ppm; sorghum, grain, at 3.5 ppm; soybean, forage at 8.0 ppm; soybean, hay at 4.0 ppm; soybean, seed at 0.03 ppm; sugarcane, cane at 0.05 ppm; sugarcane, molasses at 0.20 ppm; sunflower, forage at 5.0 ppm; sunflower, seed at 0.02 ppm; teosinte, grain at 0.05 ppm; tomato at 0.20 ppm; tomato, paste at 0.5 ppm; tomato, pomace at 5.0 ppm; triticale, grain at 0.15 ppm; wheat, bran at 0.5 ppm; wheat milled by product, except flour at 5.0 ppm; and wheat, grain at 0.15 ppm. Adequate analytical methodology using gas chromatography/electron capture (GC/EC) detection is available for enforcement purposes. Contact: Olga Odiott,
(703)308-9369, *odiott.olga@epa.gov* . 8. *PP 7F7263* . (EPA-HQ-OPP-2008-0261). Syngenta Crop Protection, Inc. P.O. Box 18300; Greensboro, NC 27419-8300, proposes to establish a tolerance for residues of the insecticide emamectin benzoate, 4'-epi-methylamino- 4'-deoxyavermectin B <sup>1</sup> benzoate (a mixture of a minimum of 90% 4'-epi-methylamino-4'- deoxyavermectin B <sup>1a</sup> and a maximum of 10% 4'-epi-methlyamino-4'deoxyavermectin B <sup>1b</sup> benzoate), and its metabolites 8,9 isomer of the B <sup>1a</sup> and B <sup>1b</sup> component of the parent insecticide in or on the food commodities tree nuts (Crop Group 14) and pistachios at 0.02 ppm; and almond hulls at 0.25 ppm. Adequate analytical methods (HPLC-fluorescence methods) are available for enforcement purposes. Contact: Thomas Harris,
(703)308-9423, *harris.thomas@epa.gov* . 9. *PP 7F7274* . (EPA-HQ-OPP-2008-0262). Bayer CropScience, P. O. Box 12014, 2 T. W. Alexander Drive, Research Triangle Park, NC 27709, proposes to establish a tolerance for residues of the insecticide spiromesifen, (2-oxo-3-2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate and its enol metabolite 4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one, calculated as parent compound in or on the food commodity corn, field forage at 6.0 ppm. Adequate analytical methodology using LC/MS/MS detection is available for enforcement purposes. Contact: Amer Al-Mudallal,
(703)605-0566, *al-mudallal.amer@epa.gov* . Amendment to Existing Tolerance *PP 8E7340* . (EPA-HQ-OPP-2008-0272). Interregional Research Project No. 4 (IR-4), 500 College Road East, Suite 201W, Princeton, NJ 08540, proposes to delete the existing tolerance in 40 CFR 180.607 for the combined residues of the insecticide spiromesifen, 2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl 3, 3-dimethylbutanoate and its enol metabolite; 4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one, calculated as the parent compound equivalents in or on the food commodity strawberry at 2.0 ppm since residues of spiromesifen on strawberry will be covered by the new tolerance proposed for berry and small fruit, low growing berry, subgroup 13-07G elsewhere in this document. Contact: Sidney Jackson,
(703)305-7610, *jackson.sidney@epa.gov* . New Exemption from Tolerance 1. *PP 8E7315* . (EPA-HQ-OPP-2008-0254). Rhodia, Inc. c/o SciReg, Inc., 12733 Director's Loop, Woodbridge, VA 22192, proposes to establish an exemption from the requirement of a tolerance for residues of the oxirane, 2-methyl-, polymer with oxirane, mono [2-[2-(2-butoxymethylethoxy)methylethoxy] methylethyl] ether (CAS Reg. No. 926031-36-9), under 40 CFR 180.960 when used as an inert ingredient in pesticide formulations. Because this petition is a request for an exemption from the requirement of a tolerance, no analytical method is required. Contact: Karen Samek, 703-347-8825, *samek.karen@epa.gov* 2. *PP 5F6945* . (EPA-HQ-OPP-2008-0275). Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box 12014, Research Triangle Park, NC 27709, proposes to establish an exemption from the requirement of a tolerance for residues of the herbicide iodosulfuron-methyl-sodium methyl 4-iodo-2-[3-(4-methoxy-6-methyl-1,3,5-triazin-2-yl)-ureidosulfonyl]benzoate, sodium salt, in or on the food commodity soybean. As shown in the confined rotational crop study, no residues of iodosulfuron-methyl-sodium or its degradates are taken up by soybeans planted 7 days after application; thus no residues would be expected in soybeans planted several months after application. As this petition is a request for an exemption from the requirement of a tolerance analytical methods are not required. Contact: Hope Johnson,
(703)305-5410, *johnson.hope@epa.gov* . List of Subjects Environmental protection, Agricultural commodities, Feed additives, Food additives, Pesticides and pests, Reporting and recordkeeping requirements. Dated: April 16, 2008. Daniel Kenny, Acting Director, Registration Division, Office of Pesticide Programs. [FR Doc. E8-10915 Filed 5-15-08; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY [EPA—New England Region I—EPA-R01-OW-2008-20215; FRL-8566-8] Massachusetts Marine Sanitation Device Standard—Receipt of Petition AGENCY: Environmental Protection Agency (EPA). ACTION: Notice—receipt of petition. SUMMARY: Notice is hereby given that a petition has been received from the state of Massachusetts requesting a determination by the Regional Administrator, U.S. Environmental Protection Agency, that adequate facilities for the safe and sanitary removal and treatment of sewage from all vessels are reasonably available for the waters of Salem Sound in the towns of Manchester-by-the-Sea, Beverly, Danvers, Salem, and Marblehead. DATES: May 16, 2008. ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R01-OW-2008-0215 by one of the following methods: *http://www.regulations.gov:* Follow the on-line instructions for submitting comments. • *E-mail:* *rodney.ann@epa.gov.* • *Fax:*
(617)918-0538. *Mail and hand delivery:* U.S. Environmental Protection Agency—New England Region, One Congress Street, Suite 1100, COP, Boston, MA 02114-2023. Deliveries are only accepted during the Regional Office's normal hours of operation (8 a.m.-5 p.m., Monday through Friday, excluding legal holidays), and special arrangements should be made for deliveries of boxed information. *Instructions:* Direct your comments to Docket ID No. EPA-R01-OW-2008-0212. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at *http://www.regulations.gov,* including any personal information provided, unless the comment includes information claimed to be Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through *http://www.regulations.gov,* or e-mail. The *http://www.regulations.gov* Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through *http://www.regulations.gov* your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. *Docket:* All documents in the docket are listed in the *http://www.regulations.gov* index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in *http://www.regulations.gov* or in hard copy at the U.S. Environmental Protection Agency—New England Region, One Congress Street, Suite 1100, COP, Boston, MA 02114-2023. Such deliveries are only accepted during the Regional Office's normal hours of operation, and special arrangements should be made for deliveries of boxed information. The Regional Office is open from 8 a.m.-5 p.m., Monday through Friday, excluding legal holidays. The telephone number is
(617)918-1538. FOR FURTHER INFORMATION CONTACT: Ann Rodney, U.S. Environmental Protection Agency—New England Region, One Congress Street, Suite 1100, COP, Boston, MA 02114-2023. Telephone:
(617)918-1538, Fax number:
(617)918-0538; e-mail address: *rodney.ann@epa.gov.* SUPPLEMENTARY INFORMATION: Notice is hereby given that a petition has been received from the state of Massachusetts requesting a determination by the Regional Administrator, U.S. Environmental Protection Agency, pursuant to Section 312(f)(3) of Public Law 92-500 as amended by Public Law 95-217 and Public Law 100-4, that adequate facilities for the safe and sanitary removal and treatment of sewage from all vessels are reasonably available for the area within the following boundaries: Waterbody/General area Latitude Longitude Southern Landward boundary—Marblehead town line 42°28′43″ N 70°52′45″ W Southern Seaward boundary 42°26′33″ N 70°49′05″ W Eastern boundary—Halfway Rock 42°30′10″ N 70°46′30″ W Northern Seaward boundary—3 miles off Eastern Point 42°33′03″ N 70°36′06″ W Northern Landward boundary—Manchester town line 42°34′20″ N 70°42′52″ W The proposed NDA boundary includes the municipal waters of Manchester-by-the-Sea, Beverly, Danvers, Salem, and Marblehead and extends to the boundary between state and federal waters. This area includes the islands of Bakers Island, Crowninshield Island, Cat Island, Children's Island, Great and Little Misery Islands, and House Island. There are approximately 19 marinas, 14 yacht clubs and five public landings/piers in the proposed area. Massachusetts has certified that there are eight pumpout facilities within the proposed area available to the boating public and two additional facilities pending. In addition, there will be a pumpout facility on the Beverly Pier once the area has been redeveloped. The majority of facilities are connected directly into the local wastewater treatment system. A list of the facilities, phone numbers, locations, and hours of operation is provided at the end of this petition. Massachusetts has provided documentation indicating that the total vessel population is estimated to be 7,000 in the proposed area. It is estimated that 3,590 of the total vessel population may have a Marine Sanitation Device
(MSD)of some type. The Trustees of Reservations manages three conservation properties within the area, Crowninshield Island, Misery Islands, and the Coolidge Reservation. The Salem Maritime National Historical Site is located within the area. There are forty-two beaches located within the proposed No Discharge Area. The proposed area has a variety of rich natural habitats, and supports a wide diversity of species. Both recreational and commercial fishermen use the area for fisheries for mackerel, striped bass, blue fish and flounder. Pumpout Facilities Within Proposed No Discharge Area Name Location Contact Info. Hours Mean low water depth Manchester Marine Manchester
(978)526-7911 VHF 72 Mon-Thurs—7 a.m.-6 p.m. Fri-Sun (+holidays) 7 a.m.-8 p.m 6 ft Manchester Marine Manchester
(978)526-7911 VHF 72 Mon-Thurs—7 a.m.-6 p.m. Fri-Sun (+holidays) 7 a.m.-8 p.m N/A Boat service Ferry Way Public Landing Beverly
(978)921-6059 VHF 9 Fri-Sun (+holidays) 8 a.m.-4 p.m 10 ft Danversport Yacht Club Danvers (2 facilities)
(978)774-8644 Mon-Thurs—8 a.m.-5 p.m. Fri-Sat—8 a.m.-6 p.m. Sun—8 a.m.-4 p.m 6 ft Salem Waterfront (Winter Island) Salem
(978)741-0098 VHF 9 Sat-Sun (+holidays) 9 a.m.-5 p.m N/A Boat service Congress St. Landing Salem
(978)741-0098 VHF 9 24 hours/7 days a week 3 ft Ferry Lane—Harbormaster's office Marblehead
(781)631-2386 VHF 16 Mon-Fri—9 a.m.-3 p.m. N/A Boat service Cliff Street Boatyard Marblehead
(781)631-2386 VHF 16 24 hours/7 days a week 9 ft Pending ** Danvers Danvers TBD TBD N/A Boat service ** Salem Salem TBD TBD N/A Boat service ** Beverly Pier Beverly TBD TBD TBD ** = Pending facilities. Dated: May 9, 2008. Robert W. Varney, Regional Administrator, New England Region. [FR Doc. E8-10998 Filed 5-15-08; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2008-0344; FRL-8363-1] Pesticide Products; Registration Applications AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: This notice announces receipt of applications to register pesticide products containing new active ingredients not included in any currently registered products pursuant to the provisions of section 3(c)(4) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended. DATES: Comments must be received on or before June 16, 2008. ADDRESSES: Submit your comments, identified by docket identification
(ID)number EPA-HQ-OPP-2008-0344, by one of the following methods: • *Federal eRulemaking Portal* : *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs
(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is
(703)305-5805. *Instructions* : Direct your comments to docket ID number EPA-HQ-OPP-2008-0344. EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at *http://www.regulations.gov* , including any personal information provided, unless the comment includes information claimed to be Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or e-mail. The regulations.gov website is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. *Docket* : All documents in the docket are listed in the docket index available in regulations.gov. To access the electronic docket, go to *http://www.regulations.gov* , select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is
(703)305-5805. FOR FURTHER INFORMATION CONTACT: Chris Pfeifer, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703)308-0031; e-mail address: *pfeifer.chris@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. What Should I Consider as I Prepare My Comments for EPA? 1. *Submitting CBI* . Do not submit this information to EPA through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 2. *Tips for Preparing Your Comments* . When submitting comments, remember to: i. Identify the document by docket ID number and other identifying information (subject heading, **Federal Register** date and page number). ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations
(CFR)part or section number. iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes. iv. Describe any assumptions and provide any technical information and/or data that you used. v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced. vi. Provide specific examples to illustrate your concerns and suggest alternatives. vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats. viii. Make sure to submit your comments by the comment period deadline identified. II. Registration Applications EPA received applications as follows to register pesticide products containing active ingredients not included in any previously registered products pursuant to the provision of section 3(c)(4) of FIFRA. Notice of receipt of these applications does not imply a decision by the Agency on the applications. Application Form *File Symbol* : 52991-EE. *Applicant* : Bedoukian Research, Inc.; 21 Finance Drive, Danbury, CT 06810-4192. *Product name* : Bedoukian e,e-9,11-Tetradecadienyl Acetate Technical Pheromone. Pheromone / attractant. *Active ingredient* : (E9,E11) 9,11-Tetradecadien-1-OL Acetate at 94%. *Proposal classification/Use* : Manufacturing Use. List of Subjects Environmental protection, Pesticides and pest. Dated: May 6, 2008. W. Michael McDavit, Acting Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs. [FR Doc. E8-11001 Filed 5-15-08; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2007-1082; FRL-8364-2] Sulfluramid; Product Cancellation Order AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: This notice announces EPA's order for the cancellation, voluntarily requested by the registrant and accepted by the Agency, of products containing the pesticide sulfluramid, pursuant to section 6(f)(1) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended. This cancellation order follows a December 19, 2007 **Federal Register** Notice of Receipt of Request from the sulfluramid registrant to voluntarily cancel the last remaning sulfluramid manufacturing-use product
(MUP)registration. In the December 19, 2007 notice, EPA indicated that it would issue an order implementing the cancellation, unless the Agency received substantive comments within the 30-day comment period that would merit its further review of these requests, or unless the registrant withdrew their request within this period. The Agency did not receive any comments on the notice. Further, the registrant did not withdraw their request. Accordingly, EPA hereby issues in this notice a cancellation order granting the requested cancellation. This cancellation order does not cancel the remaining end-use sulfluramid products currently registered for use in the United States. Any distribution, sale, or use of the sulfluramid products subject to this cancellation order is permitted only in accordance with the terms of this order, including any existing stocks provisions. DATES: The cancellations are effective May 16, 2008. FOR FURTHER INFORMATION CONTACT: Rosanna Louie, Special Review and Reregistration Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703)308-0037; fax number:
(703)308-8005; e-mail address: *louie.rosanna@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? This action is directed to the public in general, and may be of interest to a wide range of stakeholders including environmental, human health, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Copies of this Document and Other Related Information? 1. *Docket* . EPA has established a docket for this action under docket identification
(ID)number EPA-HQ-OPP-2007-1082. Publicly available docket materials are available either in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the Office of Pesticide Programs
(OPP)Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is
(703)305-5805. 2. *Electronic access* . You may access this **Federal Register** document electronically through the EPA Internet under the **Federal Register** listings at *http://www.epa.gov/fedrgstr* . II. What Action is the Agency Taking? This notice announces the cancellation, as requested by the sole technical registrant, of the last registered sulfluramid manufacturing-use product
(MUP)registered under section 3 of FIFRA. Table 1 in this unit describes the registration information of the affected product. **Table 1.—Sulfluramid Product Cancellation** EPA Registration Number Product Name 352-710 Finitron Brand Sulfluramid Termite MUP Table 2 of this unit includes the name and address of record for the registrant of the product in Table 1 of this unit by EPA company number. **Table 2.—Registrant of the Canceled Sulfluramid Product** EPA Company Number Company Name and Address 352 DuPont Crop Protection, P.O. Box 30, Newark, DE 19714-0030 III. Summary of Public Comments Received and Agency Response to Comments During the public comment period provided, EPA received no comments in response to the December 19, 2007 **Federal Register** notice announcing the Agency's receipt of the request for voluntary cancellation of sulfluramid. IV. Cancellation Order Pursuant to FIFRA section 6(f), EPA hereby approves the requested cancellation of sulfluramid registration identified in Table 1 of Unit II. Accordingly, the Agency orders that the sulfluramid product registration identified in Table 1 of Unit II. is hereby canceled. Any distribution, sale, or use of existing stocks of the products identified in Table 1 of Unit II. in a manner inconsistent with any of the Provisions for Disposition of Existing Stocks set forth in Unit VI. will be considered a violation of FIFRA. V. What is the Agency's Authority for Taking this Action? Section 6(f)(1) of FIFRA provides that a registrant of a pesticide product may at any time request that any of its pesticide registrations be canceled or amended to terminate one or more uses. FIFRA further provides that, before acting on the request, EPA must publish a notice of receipt of any such request in the **Federal Register** . Thereafter, following the public comment period, the Administrator may approve such a request. VI. Provisions for Disposition of Existing Stocks Existing stocks are those stocks of registered pesticide products which are currently in the United States and which were packaged, labeled, and released for shipment prior to the effective date of the cancellation action. The cancellation order issued in this notice includes the following existing stocks provisions. This notice announces EPA's order to cancel the final sulfluramid MUP registration, which is identified in Table 1 of this notice. Since DuPont (the only seller) has no existing stocks, EPA is not allowing any further sale or distribution of the MUP. However, this request does not cancel the remaining end-use sulfluramid products (the remaining registered use is for termite control) currently registered in the U.S. End-use registrants may continue to reformulate any existing stocks of the MUP currently in their possession until December 31, 2012. List of Subjects Environmental protection, Pesticides and pests. Dated: May 7, 2008. Steven Bradbury, Director, Special Review and Reregistration Division, Office of Pesticide Programs. [FR Doc. E8-10919 Filed 5-15-08; 8:45 am] BILLING CODE 6560-50-S DEPARTMENT OF HEALTH AND HUMAN SERVICES [Document Identifier: OS-0990-New; 30-day notice] Agency Information Collection Request. 30-Day Public Comment Request AGENCY: Office of the Secretary, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects:
(1)The necessity and utility of the proposed information collection for the proper performance of the agency's functions;
(2)the accuracy of the estimated burden;
(3)ways to enhance the quality, utility, and clarity of the information to be collected; and
(4)the use of automated collection techniques or other forms of information technology to minimize the information collection burden. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, e-mail your request, including your address, phone number, OMB number, and OS document identifier, to *Sherette.funncoleman@hhs.gov* , or call the Reports Clearance Office on
(202)690-5683. Written comments and recommendations for the proposed information collections must be received within 30 days of this notice directly to the OS OMB Desk Officer all comments must be faxed to OMB at 202-395-6974. *Proposed Project:* Evaluation of Healthy People 2010 Users—New—Office of the Assistant Secretary for Planning and Evaluation (ASPE)). *Abstract:* Office of the Assistant Secretary for Planning and Evaluation (ASPE), Office of Disease Prevention and Health Promotion (ODPHP) is seeking OMB approval to conduct a short survey using a self-administered questionnaire of state, local, and tribal health organizations. The survey will be administered through mail and respondents will have the option to complete the survey as a web-based electronic survey. *Healthy People 2010 (HP2010)* is an important Federal initiative that establishes national health promotion and disease prevention goals. *HP2010* represents the third of a series of publications by HHS that specifies ten-year health objectives for the nation. Its overarching goals are to increase the quality and years of healthy life and eliminate health disparities. *HP2010* consists of 28 primary focus areas and 467 measurable health objectives designed to identify the most significant preventable threats to health and to establish public health priorities. The central theme of *HP2010* focuses on the role of communities and community partnerships in promoting healthy living in the U.S. *HP2010* is a powerful force in the effort to promote health and prevent disease in the U.S. The agenda reflects extensive consultation with over 350 national organizations, 250 state agencies, health experts, and the public. HHS is eager to document the utilization of *HP2010* , and to seek input from key users on how the next iteration of the initiative, *Healthy People 2020* , could be improved to encourage greater involvement. This study will identify examples of effective strategies and approaches to using *HP2010* , and, where possible, the short-term results of those efforts. Estimated Annualized Burden Table Type of respondent Number of respondents Number of responses per respondent Average burden per response (in hrs) Total burden hours State Healthy People Coordinators (Frame A) 51 1 15/60 13 State Chronic Disease Program Directors (Frame A) 51 1 15/60 13 Local Health Organizations (Frame B) 300 1 15/60 75 Tribal Health Organizations (Frame C) 100 1 15/60 25 Total 126 Terry Nicolosi, Office of the Secretary, Paperwork Reduction Act Reports Clearance Officer. [FR Doc. E8-11031 Filed 5-15-08; 8:45 am] BILLING CODE 4150-32-P DEPARTMENT OF HEALTH AND HUMAN SERVICES [Document Identifier: OS-0990-0281] Agency Information Collection Request; 60-Day Public Comment Request AGENCY: Office of the Secretary, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed information collection request for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects:
(1)The necessity and utility of the proposed information collection for the proper performance of the agency's functions;
(2)the accuracy of the estimated burden;
(3)ways to enhance the quality, utility, and clarity of the information to be collected; and
(4)the use of automated collection techniques or other forms of information technology to minimize the information collection burden. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, e-mail your request, including your address, phone number, OMB number, and OS document identifier, to *Sherette.funncoleman@hhs.gov* , or call the Reports Clearance Office on
(202)690-6162. Written comments and recommendations for the proposed information collections must be directed to the OS Paperwork Clearance Officer at the above e-mail address within 60 days. *Proposed Project:* Prevention Communication Formative Research—Revision—OMB No. 0990-0281—Office of Disease Prevention and Health Promotion. *Abstract:* The information collected will be used as formative research to develop messages and materials, in support of development of disease prevention and health promotion information, including the Physical Activity and Dietary Guidelines for Americans. It is necessary to obtain consumer input to better understand the informative needs, attitudes, and beliefs of the audience in order to tailor messages, as well as to assist with clarity, understandability, and acceptance of prototyped messages, materials, and online tools. This generic clearance request describes data collection activities involving a limited set of consumer interviews, focus groups, Web concept testing, message testing, and usability testing. Frequency, reporting and on occasion. The program is requesting a three year clearance. Estimated Annualized Burden Table Data collection task Instrument/form name Number of respondents Number of responses per respondent Average burden per response (in hours) Total response burden In depth interviews (Limited Literacy Consumers) Screener 133 1 10/60 22 Interview 33 1 1.5 50 Confidentiality Agreement 33 1 5/60 3 In depth Interviews (Health Intermediaries) Screener 75 1 10/60 13 Interview 25 1 1.5 38 Confidentiality Agreement 25 1 5/60 2 In depth Interviews (Public Health Professionals) Screener 50 1 10/60 8 Interview 25 1 1.5 38 Confidentiality Agreement 25 1 5/60 2 In person Focus Groups (35)—Limited Literacy Consumers Screener 372 1 10/60 62 Focus Group 93 1 2 186 Confidentiality Agreement 93 1 5/60 8 In Person Focus Groups (20)— Health Intermediaries Screener 159 1 10/60 27 Focus Group 53 1 2 106 Confidentiality Agreement 53 1 5/60 4 In person Focus Groups (15)—Public Health Professionals Screener 80 1 10/60 13 Focus Group 40 1 2 80 Confidentiality Agreement 40 1 5/60 3 Usability and other testing of prototype materials (print and Web) Screener 400 1 10/60 68 Usability Test 100 1 1.5 150 Confidentiality Agreement 100 1 5/60 8 Web-based concept and prototype testing Screener 0 1 0 0 Web-test 167 1 1 167 Confidentiality Agreement 167 1 5/60 14 In person message testing Screener 200 1 10/60 33 Message Test 50 1 1 50 Confidentiality Agreement 50 1 5/60 4 Telephone-based message testing Screener 268 1 10/60 45 Telephone Test 67 1 1 67 Confidentiality Agreement 67 1 5/60 6 Web-based message testing Screener 0 1 10/60 0 Web-test 115 1 1 115 Confidentiality Agreement 115 1 5/60 10 TOTAL 1,402 Terry Nicolosi, Office of the Secretary, Paperwork Reduction Act Reports Clearance Officer. [FR Doc. E8-11032 Filed 5-15-08; 8:45 am] BILLING CODE 4150-32-P DEPARTMENT OF HEALTH AND HUMAN SERVICES [Document Identifier: OS-0990-New; 30-day notice] Agency Information Collection Request. 30-Day Public Comment Request AGENCY: Office of the Secretary, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects:
(1)The necessity and utility of the proposed information collection for the proper performance of the agency's functions;
(2)the accuracy of the estimated burden;
(3)ways to enhance the quality, utility, and clarity of the information to be collected; and
(4)the use of automated collection techniques or other forms of information technology to minimize the information collection burden. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, e-mail your request, including your address, phone number, OMB number, and OS document identifier, to *Sherette.funncoleman@hhs.gov,* or call the Reports Clearance Office on
(202)690-5683. Written comments and recommendations for the proposed information collections must be received within 30 days of this notice directly to the OS OMB Desk Officer all comments must be faxed to OMB at 202-395-6974. *Proposed Project:* Evaluation of the “I Can Do It, You Can Do It” Health Promotion Program for Children and Youth with Disabilities—New—Office on Disability (OD). *Abstract:* The Department of Health and Human Services' Office on Disability
(OD)oversees the implementation and coordination of disability programs, policies, and special initiatives pertaining to the over 54 million persons with disabilities in the United States. As part of these efforts, the OD encourages youth with physical and cognitive disabilities to adopt a healthier life style that includes good nutrition and increased physical activity. “I Can Do it, You Can Do It” is a health promotion intervention program for children and youth between the ages of 10 and 21 with disabilities that employs a one-on-one mentoring approach to change health behaviors. The program is implemented by sponsoring organizations who work with children and youth with disabilities. The OD will evaluate the effectiveness of the program. The evaluation will be completed over a two-year period. Respondents will be children and youth with disabilities who are participating in the program. Mentors who work with the participants/mentees will complete a post-program survey. Coordinators from the sponsoring organizations will complete a process evaluation survey. Results will be used to determine if the program has been successful, to report progress, and to make revisions for future administration of the program. There are no costs to respondents except their time to participate in the surveys. Estimated Annualized Burden Table Forms Type of respondent Number of respondents Number of responses per respondent Average burden hours per response (in hours) Total burden hours Registration Form Program Participant/Mentee 660 1 8/60 88 Goal Setting Worksheet Program Participant/Mentee 610 1 7/60 71 Mentor Registration Form Mentor 450 1 10/60 75 Pre-Test Survey Program Participant/Mentee 560 1 19/60 177 Weekly Check-In Form Program Participant/Mentee 560 8 7/60 522 First Post-Test Survey Program Participant/Mentee 510 1 18/60 153 Second Post-Test Survey Program Participant/Mentee 460 1 18/60 138 Mentor Post Assessment Mentor 450 1 15/60 112 Agency Coordinator Survey Agency Coordinators 6 1 45/60 4.5 Total 1340.5 Terry Nicolosi, Office of the Secretary, Director, Office of Resources Management . [FR Doc. E8-11045 Filed 5-15-08; 8:45 am] BILLING CODE 4150-39-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Hospital Preparedness Program
(HPP)AGENCY: Office of the Assistant Secretary for Preparedness and Response, ASPR (HHS). ACTION: Notice. SUMMARY: This notice sets forth the Secretary's proposal to require Hospital Preparedness Program
(HPP)cooperative agreement recipients to contribute non-federal matching funds starting with the FY 2009 funding cycle and each year thereafter. The amount of the cost sharing requirement in FY 2009 will be five percent of the award amount and in FY 2010 and each year thereafter the amount of match will be ten percent of the award amount. DATES: To be considered, comments on this notice must be submitted by June 16, 2008. Subject to consideration of the comments submitted, the Department intends to publish a final notice of any cost sharing requirement. ADDRESSES: See Supplementary Information, Request for Comments section for addresses for submitting all comments concerning this proposal. FOR FURTHER INFORMATION CONTACT: CDR Melissa Sanders, Team Leader, Healthcare Systems Preparedness Program, 202-245-0763 SUPPLEMENTARY INFORMATION: Authorized by section 319C-2 of the Public Health Service
(PHS)Act, as amended by the Pandemic and All-Hazards Preparedness Act (PAHPA) (Pub. L. 109-417), the HPP is a cooperative agreement program funded and administered by the Assistant Secretary for Preparedness and Response (ASPR). Its purpose is to improve surge capacity and enhance community and hospital preparedness for public health emergencies. Currently there are 62 awardees comprised of the 50 States; the District of Columbia; the three metropolitan areas of New York City, Los Angeles County and Chicago; the Commonwealths of Puerto Rico and the Northern Mariana Islands; the territories of American Samoa, Guam and the U.S. Virgin Islands; the Federated States of Micronesia; and the Republics of Palau and the Marshall Islands. Since the inception of the program in 2002 awardees have received funding through a statutory formula that employs a base allocation with an adjustment for population. PAHPA amended section 319C-1 and 319C-2 of the PHS Act to add certain accountability provisions. Consistent with those accountability provisions, this notice proposes to introduce a cost sharing requirement for the HPP program as a concrete way of solidifying collaboration between States and the Federal government in assuring this program will achieve enhanced sustainability in healthcare system preparedness during and after the project period has ended. ASPR proposes that awardees will make available, either directly or through donations from public or private entities non-Federal contributions in an amount equal to five percent of the award amount in FY 2009 and ten percent of the award amount in FY 2010 and each successive year for the duration of the program. Non-Federal contributions would be provided directly or through donations from public or private entities and may be in cash or in kind, fairly evaluated, including plant, equipment or services. Amounts provided by the Federal government, or services assisted or subsidized to any significant extent by the Federal government, would not be included in determining the amount of such non-Federal contributions. The cost sharing requirement would apply to the entire award amount received by the State from the U.S. Department of Health and Human Services through the HPP. The cost sharing requirement would be implemented as a term and condition of the HPP award. *Request for Comments:* The ASPR invites public comment on this notice to add a cost sharing requirement to the HPP. You may submit comments in one of three ways (please choose only one of the ways listed): • *E-mail* : CDR Melissa Sanders, *melissa.sanders@hhs.gov.* • *Mail* : CDR Melissa Sanders, Team Leader, Healthcare Systems Preparedness Programs, HSS/OS/ASPR, 395 E Street, SW., 10th Floor, Suite 1075, Washington, DC 20201 • *Hand Delivery/Courier* : CDR Melissa Sanders, Team Leader, Healthcare Systems Preparedness Programs, HSS/OS/ASPR, 395 E Street., SW., 10th Floor, Suite 1075, Washington, DC 20201 Dated: May 9, 2008. RADM W. Craig Vanderwagon, Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services. [FR Doc. E8-10970 Filed 5-15-08; 8:45 am] BILLING CODE 4150-45-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Program Reporting and Accountability Changes to the Hospital Preparedness Program
(HPP)AGENCY: Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, ASPR (HHS). ACTION: Notification of intent to fund and information on:
(1)Maintenance of Funding (MOF);
(2)Evidenced-Based Benchmarks and Objective Standards;
(3)Reporting;
(4)Funding Formula;
(5)Withholding; and
(6)Maximum Carryover Amount. The final FY 2008 Funding Opportunity Announcement
(FOA)for the Hospital Preparedness Program
(HPP)will be available in the coming weeks at *http://www.grants.gov* . SUMMARY: The Department of Health and Human Services (HHS or the Department) is issuing in the third quarter of FY 2008 a Funding Opportunity Announcement
(FOA)for the HPP, authorized under section 319C-2 of the Public Health Service
(PHS)Act, as amended by the Pandemic and All-Hazards Preparedness Act (PAHPA) (Pub. L. 109-417). The Consolidated Appropriations Act, 2008, provides funding for these awards (Pub. L. 110-161). This **Federal Register** notice provides information concerning critical aspects of this program including: • Program Background; • Program Requirements: ○ Maintenance of Funding; ○ Evidenced Based Benchmarks and Objective Standards; ○ Reporting; ○ Funding Formula; ○ Withholding; ○ Maximum Carryover Amount; • Important Dates. FOR FURTHER INFORMATION CONTACT: CDR Melissa Sanders at
(202)245-0763, or *melissa.sanders@hhs.gov* . SUPPLEMENTARY INFORMATION: Program Background Building on the lessons learned from the attacks of September 11th, 2001, and Hurricanes Katrina and Rita, PAHPA was enacted in December 2006 to improve the Nation's public health and medical preparedness and response capabilities for emergencies, whether deliberate, accidental, or natural. PAHPA amended and added new sections to the PHS Act. Examples of these changes include: identifying the Secretary of Health and Human Services as the lead official for all Federal public health and medical responses to public health emergencies and other incidents covered by the National Response Framework; establishing the position of the Assistant Secretary for Preparedness and Response (ASPR), who will lead and coordinate HHS preparedness and response activities, advise the Secretary of HHS during an emergency, and lead the coordination of emergency preparedness and response efforts between HHS and other Federal agencies; consolidating Federal public health and medical response programs under the Assistant Secretary for Preparedness and Response (ASPR); requiring the development and implementation of the National Health Security Strategy; and reauthorizing the Public Health and Emergency Preparedness
(PHEP)cooperative agreements administered by the CDC and the HPP grants administered by the ASPR. In addition to reauthorizing these two cooperative agreement programs, PAHPA amended these grant programs to add certain new requirements that awardees must meet. The purpose of this notice is to notify HPP awardees about critical aspects and requirements of the HPP as amended by PAHPA. *Purpose:* The purpose of the Hospital Preparedness Program
(HPP)is to provide funding to improve surge capacity and realize the following preparedness goals: • Integration: Ensuring the integration of public and private medical capabilities with public health and other first responder systems, including— 1. Periodically evaluating preparedness and response capabilities through drills and exercises; and 2. Integrating public and private sector public health and medical donations and volunteers. • Medical: Increasing the preparedness, response capabilities, and surge capacity of hospitals, other health care facilities (including mental health facilities), and trauma care and emergency medical service systems, with respect to public health emergencies. This shall include developing plans for the following: 1. Strengthening public health emergency medical management and treatment capabilities. 2. Improving medical evacuation and fatality management capabilities. 3. Rapidly distributing and administering medical countermeasures, specifically to hospital based health care workers and their family members or partnership entities. 4. Utilizing effectively any available public and private mobile medical assets and integration of other Federal assets. 5. Protecting health care workers and health care first responders from workplace exposures during a public health emergency. • At-Risk Individuals: Preparing for the medical needs of at-risk individuals in their community in the event of a public health emergency. Medical needs include behavioral health consisting of both mental health and substance abuse considerations. The term “at-risk individuals” means children, pregnant women, senior citizens and other individuals who have special needs in the event of a public health emergency. Before, during and after an incident, members of at-risk populations may have additional needs in one or more of the following functional areas: maintaining independence, communications, transportation, supervision and medical care. In addition to those individuals specifically identified as at-risk in the above definition, individuals who may need additional response assistance should include those who: 1. Have disabilities; 2. Live in institutionalized settings; 3. Are from diverse cultures; 4. Have limited English proficiency or are non-English speaking; 5. Are transportation disadvantaged; 6. Have chronic medical disorders; and 7. Have pharmacologic dependency. • Coordination: Minimizing duplication of, and ensuring coordination between, Federal, State, local, and tribal planning, preparedness, response and recovery activities (including the State Emergency Management Assistance Compact). • Continuity of Operations: Maintaining vital public health and medical services to allow for optimal Federal, State, local, and tribal operations in the event of a public health emergency. *Eligibility:* The following are eligible entities: • A State; • A political subdivision determined to be eligible for an award under section 319C-1 of the PHS Act; or • A consortium of States. Program Requirements 1. Maintenance of Funding
(MOF)Award recipients must maintain their health care preparedness expenditures at a level that is not less than the average of expenditures made during the preceding two year period (i.e., federal FY 2006 and FY 2007). The MOF requirement refers to the awardee's expenditures (i.e., state (or political subdivision) contributions for health care preparedness, not Federal dollars) and may include expenditures for surge capacity investments such as: a. Beds; b. Isolation; c. Decontamination; d. Personal Protective Equipment; e. Pharmaceuticals; f. Mobile Medical Assets; g. Interoperable communications equipment; h. Laboratory equipment and trainings. 2. Evidence-Based Benchmarks and Objective Standards In accordance with section 319C-1(g) of the PHS Act, ASPR has established evidence-based benchmarks and targets to be achieved at the mid-year and end-of-year reporting times. Please see the FY08 HPP FOA for the specific benchmarks that awardees must achieve. As noted in more detail below, HPP awardees will have funds withheld from their FY 2009 awards if, when expending their FY 2008 HPP awards, they fail substantially to meet the benchmarks described in the FY 2008 HPP FOA. 3. Reporting In order to ensure all awardees are able to demonstrate compliance with newly established benchmarks and other reporting requirements, HHS will require semi-annual reporting information. Please see the FY08 HPP FOA for actual reporting targets to be met. 4. Funding Formula Per section 319C-2(j) of the PHS Act, funding for this mandatory cooperative agreement is determined in the same manner as amounts are determined for PHEP awardees under section 319C-1(i) of the PHS Act, via a statutory formula that employs a base allocation with an adjustment for population. 5. Withholding The Secretary of HHS is required under section 319C-1(g) of the PHS Act to develop and require application of measurable benchmarks and objective standards that measure levels of preparedness with respect to HPP activities. The Secretary shall withhold funds beginning in FY 2009 from HPP awardees who fail substantially to meet the applicable benchmarks for the immediate preceding fiscal year and/or who fail to submit a Pandemic Influenza Plan. Thus, HPP awardees will have funds withheld from their FY 2009 awards if, when expending their FY 2008 HPP awards, they fail substantially to meet the benchmarks described in the FY 2008 FOA or to submit a Pandemic Influenza Plan. The amounts to be withheld are as follows:
(i)For the fiscal year immediately following a fiscal year in which an entity experienced a failure, an amount equal to 10 percent of the amount the entity was eligible to receive;
(ii)For the fiscal year immediately following two consecutive fiscal years in which an entity experienced a failure, an amount equal to 15 percent of the amount the entity was eligible to receive, taking into account the withholding of funds for the immediately preceding fiscal year;
(iii)For the fiscal year immediately following three consecutive fiscal years in which an entity experienced such a failure, an amount equal to 20 percent of the amount the entity was eligible to receive, taking into account the withholding of funds for the immediately preceding two fiscal years;
(iv)For the fiscal year immediately following four consecutive fiscal years in which an entity experienced such a failure, an amount equal to 25 percent of the amount the entity was eligible to receive, taking into account the withholding of funds for the three preceding fiscal years. Each failure to meet the benchmarks for the immediately preceding fiscal year or to submit a Pandemic Influenza Plan will be treated as a separate failure for purposes of calculating amounts withheld. The Secretary is required to develop and implement a process to notify entities who have failed substantially to meet the evidence-based benchmarks or who have failed to submit a Pandemic Influenza Plan. HHS will notify awardees during the mid- year reporting period that are determined to have failed to meet the benchmark targets that are described in the FOA. Awardees will have the opportunity to seek intensive technical assistance from project officers and be involved in the development of such technical assistance. Should awardees fail to correct their failures, they shall be subject to the withholding amounts described previously. 6. Maximum Carryover Amount Per section 319C-1(j)(3) of the PHS Act the Secretary shall determine, for each fiscal year, the maximum percentage of unobligated funds that may be carried over to the succeeding fiscal year. If the percentage of unobligated funds exceeds the maximum percentage permitted, the awardee shall return that portion of the unobligated funds that exceeds the maximum amount permitted. Awardees may apply to the Secretary for a waiver of the maximum percentage amount by including an explanation why the requirement should not apply to the awardee and the steps the awardee will take to ensure that all funds will be expended appropriately. Further, the Secretary may waive or reduce the amount of carryover determined for a single entity or for all entities in a fiscal year, if the Secretary determines that mitigating conditions exist that justify the waiver or reduction. An awardee may not have more than 15% of the award available as unobligated funds at the time a carryover request is made, approximately 10 months into the budget cycle. Amounts in excess of 15% may result in repayment. 7. Important Dates Anticipated Application Due Date: June 11, 2008. Anticipated Award Date: August 1, 2008 Dated: May 9, 2008. RADM W. Craig Vanderwagon, Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services. ASPR Hospital Preparedness Program
(HPP)Cooperative Agreement Enforcement Actions and Disputes I. Purpose Sections 319C-1 and C-2 of the Public Health Service (PHS), as amended by the Pandemic and All-Hazards Preparedness Act (PAHPA), include certain accountability and compliance requirements that grantees must meet, including achievement of evidence-based benchmarks, audit requirements, and maximum carryover amounts. This document provides information about enforcement actions associated with these requirements, and appeal processes in the event there is a dispute. This document addresses requirements and enforcement actions specifically outlined in section 319C-1 and C-2 of the PHS. It is not intended to cover all requirements that grantees must meet pursuant to grant laws, regulations, Departmental grants policy, and terms and conditions of the award. Grant laws, regulations, and Departmental grants policies apply to these grants to the extent they are consistent with section 319C-1 and C-2 of the PHS Act. II. Abbreviations, Acronyms and Definitions A. For the purpose of this document, the following abbreviations and acronyms apply: 1. ARC—Agency Review Committee. 2. ASPR—Assistant Secretary for Preparedness and Response. 3. CGMO—Chief Grants Management Officer. 4. DAB—Departmental Appeals Board. 5. GMO—Grants Management Officer. 6. GMS—Grants Management Specialist. 7. HHS—Department of Health and Human Services. 8. HPP—Hospital Preparedness Program. 9. IDDA—Intra-Departmental Delegation of Authority (IDDA). 10. NoA—Notice of Award. 11. OPHS—Office of Public Health and Science. 12. PHEP—Public Health Emergency Preparedness. 13. PO—Project Officer. B. For the purpose of this document, the following definitions apply: 1. HHS Department Appeals Board (DAB)—The administrative board responsible for resolving certain disputes arising under HHS assistance programs. The DAB provides an impartial adjudicatory hearing process for appealing certain final written decisions by GMOs. The DAB's jurisdiction is specified in 45 CFR Part 16, “Procedures for HHS Grant Appeals Board.” 2. Agency Review Committee (ARC)—Committee comprised of awarding agency members who review awardee appeals to adverse determinations made by grant officials. A minimum of three appointed core members, one of whom will be designated a chairperson by the ASPR. Others may be designated as determined by the chairperson. Members of the ARC may not be from the branch or program whose adverse determination is being appealed. 3. Recipient—The organization that receives a grant or cooperative agreement award from an awarding agency, and is responsible and accountable for using the funds provided, and for the performance of the grant-supported project or activity. The recipient is the entire legal entity, even if a particular component is designated in the NoA. The term includes “awardee/grantee.” 4. Corrective action—Action taken by the awardee that corrects identified deficiencies or produces recommended improvements. 5. Enforcement—Actions taken to compel the observance of policies, regulations, and laws governing the administration of an assistance program. Such actions are generally the result of a recipient's failure to comply with the terms and conditions of an award. These failures may cause an awarding agency to take one or more actions, depending on the severity and duration of the non-compliance. The awarding agency generally will afford the recipient an opportunity to correct the deficiencies before taking enforcement action, unless public health or welfare concerns require immediate action. However, even if an awardee is taking corrective action, the awarding agency may take proactive steps to protect the Federal government's interests, including placing special conditions on awards, or may take action designed to prevent future non-compliance, such as closer monitoring. 6. Termination—The permanent withdrawal by the awarding agency of an awardee's authority to obligate previously awarded grant funds before that authority would otherwise expire, including the voluntary relinquishment of that authority by the recipient. 7. Disallowance—A determination denying payment of an amount claimed under an award, or requiring return of funds or off-set of funds already received. 8. Void—A determination that an award is invalid because the award was not authorized by statute or regulation, or because it was fraudulently obtained. 9. Withholding of funds—An action taken by an awarding agency to withhold or reduce support within a previously approved or subsequent budget period. Withholding may occur for the following justifiable reasons:
(1)An awardee is delinquent in submitting required reports;
(2)adequate Federal funds are not available to support the project;
(3)an awardee fails to show satisfactory progress in achieving the objectives of the project, e.g., performance measures/benchmarks and/or excessive carryover;
(4)an awardee fails to meet the terms of a previous award;
(5)an awardee's management practices fail to provide adequate stewardship of Federal funds;
(6)any reason which would indicate that continued funding would not be in the best interests of the Government. 10. Offset—The withholding of funds from an award recipient in order to compensate for costs owed the awarding agency. 11. Repayment of funds—Funds for payment of a debt determined to be owed to the Federal Government. Repayment of funds cannot come from other Federally-sponsored programs. 12. Terms and conditions of award—All requirements imposed on a recipient by the Federal awarding agency, whether by statute, regulation, or within the grant award document itself. The terms of award may include both standard and special provisions, appearing on each NoA that are considered necessary to attain the objectives of the grant; facilitate post award administration of the grant, conserve grant funds, or otherwise protect the Federal government's interests. 13. Performance measures/benchmarks—The use of statistical evidence to determine progress toward specific defined objectives. These are leading indicators that will allow a national “snapshot” to show how preparedness and response activities, and the associated resources, aid in improving the public health system. 14. Excessive Carryover—Unobligated funds of a recipient that exceed the established maximum percentage of 15% of the award, as reported on a Financial Status Report (SF-269) at the time a carryover request is made, approximately 10 months into the 12 month budget cycle. The threshold amount includes direct and indirect costs. 15. Outlays or Expenditures—The charges made to the Federally-sponsored project or program. They may be reported on a cash or accrual basis. For reports prepared on a cash basis, outlays are the sum of cash disbursements for direct charges for goods and services, the amount of indirect expense charged, the value of third party in-kind contributions applied and the amount of cash advances and payments made to sub-awardees. For reports prepared on an accrual basis, outlays are the sum of cash reimbursements for direct charges for goods and services, the amount of indirect expense incurred, the value of in-kind contributions applied, and the net increase (or decrease) in the amounts owed by the recipient for goods and other property received, for services performed by employees, contractors, sub-awardees and other payees and other amounts becoming owed under programs for which no current services or performance are required. 16. Audits—A systematic review or appraisal made to determine whether internal accounting and other control systems provide reasonable assurance of financial operations are properly conducted; financial reports are timely, fair, and accurate; the entity has complied with applicable laws, regulations, and terms and conditions of award; resources are managed and used economically and efficiently; desired results and objectives are being achieved effectively. 17. Failure—Noncompliance with any or all of the provisions of the NoA which include but not limited to various laws, regulations, assurances, terms, or conditions applicable to the grant or cooperative agreement. 18. Matching or Cost Sharing—The value of third-party in-kind contributions and the portion of the costs of a federally assisted project or program not borne by the Federal Government. Costs used to satisfy matching or cost-sharing requirements are subject to the same policies governing allowability as other costs under the approved budget. III. Background PAHPA amended section 319C-2 of the PHS Act, and authorizes the Assistant Secretary for Preparedness and Response
(ASPR)to award cooperative agreements to eligible entities to enable such entities to improve surge capacity and enhance community and hospital preparedness for public health emergencies. Funding for these awards is provided by the Consolidated Appropriations Act of 2008 (Public Law 110-161). Grantees must meet certain statutory accountability and compliance requirements. Sections 319C-1 and C-2 of the PHS Act require the Department to take certain enforcement actions if grantees fail to meet these requirements. More specifically, this document addresses the following enforcement actions required by the statute:
(1)Beginning in fiscal year 2009, withholding a statutorily-mandated percentage of the award if an awardee fails substantially to meet established benchmarks and performance measures for the immediately preceeding fiscal year or fails to submit a satisfactory pandemic flu plan to the Department;
(2)repayment of any funds that exceed the maximum percentage of an award that an entity may carryover to the succeeding fiscal year; and
(3)repayment or future withholding or offset as a result of a disallowance decision if an audit shows that funds have not been spent in accordance with section 319C-2 of the PHS Act . IV. Enforcement Actions and Disputes A. Withholding for Failure To Meet Established Benchmarks and Performance Measures or To Submit a Satisfactory Pandemic Influenza Plan 1. Beginning with the distribution of FY 2009 funding, awardees that fail substantially to meet performance measures/benchmarks for the immediately preceding fiscal year and/or who fail to submit a pandemic influenza plan to CDC as part of their application for PHEP funds, may have funds withheld from their FY 2009 and subsequent award amounts. An awardee that fails to correct such noncompliance shall be subject to withholding in the following amounts: • For the fiscal year immediately following a fiscal year in which the awardee has failed substantially to meet performance measures/benchmarks or who has failed to submit a satisfactory pandemic influenza plan; an amount equal to 10 percent of funding the awardee was eligible to receive. • For the fiscal year immediately following two consecutive fiscal years in which an awardee experienced such a failure, an amount equal to 15 percent of funding the awardee was eligible to receive, taking into account the withholding of funds for the immediately preceding fiscal year. • For the fiscal year immediately following three consecutive fiscal years in which an awardee experienced such a failure, an amount equal to 20 percent of funding the awardee was eligible to receive, taking into account the withholding of funds for the immediately preceding fiscal years. • For the fiscal year immediately following four consecutive fiscal years in which an entity experienced such a failure, an amount equal to 25 percent of funding the awardee was eligible to receive for such a fiscal year, taking into account the withholding of funds for the immediately preceding fiscal year. Please note that HHS is required to treat each failure to substantially meet all the benchmarks and each failure to submit a satisfactory pandemic influenza plan as a separate withholding action. For example, an awardee failing substantially to meet benchmarks/performance measures and who fails to submit a satisfactory pandemic influenza plan could have 10% withheld for each failure for a total of 20% for the first year this happens. If this situation remained unchanged, HHS would then be required to assess 15% for each failure for a total of 30% for the second year this happens. Alternatively, if one of the two failures are corrected in the second year but one remained, HHS is required to withhold 15% of the second year funding. 2. Technical Assistance and Notification of Failures ASPR may, in coordination with the CGMO and in accordance with established Departmental grants policy, provide to an awardee, upon request, technical assistance in meeting benchmarks/performance measures and submitting a satisfactory pandemic influenza plan. In addition, as described below, ASPR will notify awardees that are determined to have failed substantially to meet benchmarks/performance measures and/or who have failed to submit a satisfactory pandemic influenza plan and give them an opportunity to correct such noncompliance. Entities who fail to correct such noncompliance will be subject to withholding as described in the paragraph above. The awardee shall submit the required progress report on or before the specified due date according to the terms and conditions of the NoA. The Project Officer shall, within 15 days of receipt of the required progress report, assess performance, provide technical assistance to the awardee as required, and issue a written letter acknowledging completion of assessment and that the assessment has been forwarded to the GMO. Upon determination that the awardee has failed to comply with the terms and conditions of a grant or cooperative agreement, the Project Officer
(PO)shall issue a written recommendation and provide a complete documentation package to the Grants Management Officer
(GMO)based on the review and monitoring of the awardee. Within 15 days of receipt of the recommendation from the PO, the GMO shall issue an initial failure notification to the awardee in writing. This document will provide compliance requirements as submitted by the PO and will include the total amount of Federal funds which will be withheld or reduced in the subsequent fiscal year due to noncompliance, absent corrective action by the awardee that is satisfactory to the GMO. The document will specify that the GMO will take such other remedies as may be legally available and appropriate in the circumstances, such as withholding of Federal funds. The awardee must provide a proposed Corrective Action Plan
(CAP)in writing to the GMO, within 15 days of receipt of the initial failure notification.. The GMO will forward a copy to the PO. The awardee may request technical assistance at this time. Within 15 days of receipt of the proposed CAP, the PO will assess the remedies and provide a recommendation to the GMO. If the GMO finds the corrective action measures satisfactory, the GMO shall, within 15 days of receipt of the PO's assessment, provide notification to the awardee of the awarding agency's intent to rescind the initial failure notification. If in the GMO's judgment the awardee has still failed to comply with the terms and conditions of a grant or cooperative agreement, the GMO shall issue a final failure notification and provide information about the appeal process to include applicable timelines in writing. The GMO will concurrently issue his/her decision to the awardee and the Agency Review Committee (ARC). 3. Dispute Process The ASPR has established an ARC for the purpose of providing awardees a fair and flexible process to appeal certain enforcement actions such as a final decision to withhold funds due to a failure to meet benchmarks/performance measures and/or to submit a satisfactory pandemic influenza plan. The ARC consists of three regular members: ASPR Principal Deputy (Director); OPEO (Director); and Resource Planning and Evaluation (Director). The ASPR Principal Deputy, Director, or designee, shall be the chairperson for the ARC. The ARC may consult with subject matter experts within the Department as necessary (i.e., attorneys, Branch Chiefs, Team Leaders, Project Officer/Public Health Advisors, etc.) Members of the ARC may not be from the branch or program whose adverse determination is being appealed. If the awardee chooses to appeal the GMO decision, the awardee must do so directly to the ARC within ten days of receipt of the GMO's final failure notification. The Notice of Appeal shall include:
(1)a detailed description of the reason for appeal including supporting documentation and
(2)a description of how the enforcement action impacts the affected organization. The awardee should be aware that they bear the burden of proof to the extent of the type of modification or reversal of the GMO's decision they seek and the necessity for modification or reversal. Within ten days of receipt of the awardee's notice of appeal, the GMO will
(1)Brief the ARC on the issues of the case,
(2)submit any relevant documentation supporting the decision, and
(3)provide a written statement responding to the notice of appeal. Within ten days of receipt of the brief and documentation submitted by the GMO, the ARC will acknowledge, in writing, the notice of appeal to the awardee and the GMO. The ARC will review the relevant information, within seven days of providing written notification to awardee and GMO, and use one or a combination of the following methods for dispute resolution:
(a)Documentation Review—an independent evaluation of documents to verify compliance with laws, regulations, or policies;
(b)Conference—allow parties an opportunity to make an oral presentation to clarify issues, question both parties to obtain a clear understanding of the facts, and provide recommendations for resolution. Telephone conferences are acceptable. Based on the outcome of the review or conference, the ARC will decide on the resolution of an issue within seven days. The ARC may decide that the Department should waive or reduce the withholding as described above for a single entity or for all entities in a fiscal year, if the ARC reviews and determines that mitigating conditions exist that justify the waiver or reduction. The ARC will notify the GMO, PO, and the awardee, in writing, of their final decision that the Department should waive or withhold federal funds. If the ARC's final decision is to for the Department to waive the federal funds to be withheld or withhold Federal funds for the subsequent fiscal year, the GMO shall issue, in writing, a final decision to the awardee within ten days from the receipt of the ARC's final decision. Funds that are withheld for failure to substantially meet benchmarks/performance measures and/or to submit a satisfactory pandemic influenza plan will be reallocated so that the Secretary may make awards under section 319C-2 to entities described in subsection (b)(1) of that section (i.e., Healthcare Facility Partnership grants). 4. Responsibilities A. PO/Public Health Advisor shall: 1. During the corrective action phase, provide technical assistance to the awardee to meet the requirement. 2. If determined the awardee will not meet the requirement, the PO shall issue a written recommendation to the GMO based on the review and monitoring of awardee progress. 3. Provide a timely documentation package to the GMO regarding a decision to withhold or reduce cooperative agreement funds. B. GMO shall: 1. Rescind initial failure notification or issue a final failure notification and provide the awarding agency's process for appeal to include applicable timelines, in writing, to the awardee and provide a copy to ARC. 2. Brief ARC on issues pertaining to disputes. 3. Prepare and submit a complete documentation package to the ARC regarding a decision to withhold or reduce cooperative agreement funds. C. ARC shall: 1. Establish regular committee members and consult with subject matter experts in the Department as necessary. 2. Receive initial Notice of Appeal. 3. Send acknowledgements to the awardee and GMO. 4. Review disputes by documentation or conference. 5. Provide recommendations and facilitate disputes to preclude further action. 6. Provide the ARC decisions on appeals. D. Awardee or Complainant shall: 1. Remedy non-compliance issues during the corrective action phase. If the GMO determines that corrective actions have not been adequate, the awardee may submit a written request for review. 2. If awardee disputes the GMO's final decision, submit dispute to ARC after Failure Notification is received from the agency awarding office. The dispute must contain the following: A. A detailed description of the reason for dispute including supporting documentation and B. A description of how the enforcement action impacts the affected organization. B. Repayment of Any Funds That Exceed the Maximum Percentage of an Award That an Entity May Carry Over to the Succeeding Fiscal Year 1. For each fiscal year, ASPR, in consultation with the States and political subdivisions, will determine the maximum percentage amount of an award that an awardee may carry over to the succeeding fiscal year. This percentage amount will be listed in the funding opportunity announcement (FOA). For fiscal year 2008 awards, this maximum percentage amount that an awardee may carry over is 15%. For each fiscal year, if the percentage amount of an award unobligated by an awardee exceeds the maximum percentage permitted (i.e., 15% for FY 2008 awards), the awardee shall repay the portion of the unobligated amount that exceeds the maximum amount permitted to be carried over to the succeeding fiscal year. 2. Notification of Failure Upon determination that the awardee has exceeded the maximum percentage permitted, the GMO shall issue an initial failure notification to the awardee in writing. Such documentation will specify that the GMO will take such remedies as may be legally available and appropriate in the circumstances, such as requiring repayment of the portion of the unobligated amount that exceeds the maximum amount permitted to be carried over to the succeeding fiscal year. The awardee must provide a proposed Corrective Action Plan
(CAP)in writing to the GMO, within 15 days of receipt of the initial failure notification.. The GMO will provide a copy to the PO. The awardee may request technical assistance at this time. Within 15 days of receipt of the proposed CAP, the PO will assess the remedies and provide a recommendation to the GMO. The GMO shall, within 15 days of receipt of the PO's assessment, provide notification to the awardee of the awarding agency's intent to rescind the initial failure notification. If the awardee has still failed to comply with the terms and conditions of a grant or cooperative agreement, the GMO shall issue a final failure notification in writing and provide information about the appeal process and application for waiver of repayment to include applicable timelines. The GMO will concurrently issue his/her decision to the awardee and the Agency Review Committee (ARC). 3. Dispute Process If the awardee chooses to appeal the GMO decision, the awardee must do so directly to the ARC within ten days of receipt of the GMO's final failure notification. The Notice of Appeal shall include:
(1)A detailed description of the reason for appeal including supporting documentation;
(2)a description of how the enforcement action impacts the affected organization; and
(3)request for a waiver of repayment that includes an explanation why such requirement (for maximum percentage of carryover amount) should not apply to the awardee and the steps taken by the awardee to ensure that all HPP funds will be expended appropriately. The awardee should be aware that they bear the burden of proof to the extent of the type of modification or reversal of the GMO's decision they seek and the modification or reversal. Within ten days of receipt of the awardee's notice of appeal, the GMO will
(1)Brief the ARC on the issues of the case,
(2)submit any relevant documentation supporting the decision, and
(3)provide a written statement responding to the notice of appeal. Within ten days of receipt of the brief and documentation submitted by the GMO, the ARC will acknowledge, in writing, the notice of appeal to the awardee and the GMO. The ARC will review the relevant information, within seven days, and use one or a combination of the following methods for dispute resolution:
(a)Documentation Review—an independent evaluation of documents to verify compliance with laws, regulations, or policies;
(b)Conference—allow parties an opportunity to make an oral presentation to clarify issues, question both parties to obtain a clear understanding of the facts, and provide recommendations for resolution. Telephone conferences are acceptable. The ARC may decide that the Department should waive or reduce the amount to be repaid for a single entity or for all entities in a fiscal year, if the ARC reviews and determines that mitigating conditions exist that justify the waiver or reduction. The ARC will notify the GMO, PO, and the awardee, in writing, of their final decision that the Department should waive or require repayment of the portion of the unobligated amount of HPP funds that exceeds the maximum amount permitted to be carried over to the succeeding fiscal year. If the ARC's final decision is to waive or to require repayment of the portion of the unobligated amount of HPP funds that exceeds the maximum amount permitted to be carried over to the succeeding fiscal year, the GMO shall issue a final decision in writing to the awardee within ten days from the receipt of the ARC's final decision. Funds that are repaid to ASPR will be reallocated so that the Secretary may make awards under section 319C-2 to entities described in subsection (b)(1) of that section (i.e., Healthcare Facility Partnership grants). 4. Responsibilities A. PO/Public Health Advisor shall: 1. If determined the awardee has exceeded the maximum carryover percentage, the PO shall issue a written recommendation to the GMO based on the review and monitoring of awardee progress. 2. Provide a timely documentation package to the GMO regarding a decision to repay unobligated HPP funds that exceed the maximum carryover percentage. B. GMO shall: 1. Rescind initial failure notification or issue a final failure notification and provide the awarding agency's process for appeal to include applicable timelines, in writing, to the awardee and provide a copy to ARC. 2. Brief ARC on issues pertaining to disputes. 3. Prepare and submit a complete documentation package to the ARC regarding a decision to repay. C. ARC shall: 1. Establish regular committee members and consult with subject matter experts in the Department, as necessary. 2. Receive initial Notice of Appeals. 3. Send acknowledgements to the awardee and GMO. 4. Review disputes by documentation or conference. 5. Provide recommendations and facilitate disputes to preclude further action. 6. Provide the ARC decisions on appeals. D. Awardee or Complainant shall: 1. Remedy non-compliance issues during the corrective action phase. If the GMO determines that corrective actions have not been adequate, the awardee may submit a written request for review. 2. If awardee disputes the GMO's final decisions, submit dispute to ARC after Failure Notification is received from the agency awarding office as described in the NoA. The dispute must contain the following: A. A detailed description of the reason for dispute including supporting documentation; B. A description of how the enforcement action impacts the affected organization; and C. Request for a waiver of repayment that includes an explanation why such requirement (for maximum percentage of carryover amount) should not apply to the awardee and the steps taken by the awardee to ensure that all HPP funds will be expended appropriately. C. Repayment or Future Withholding or Offset as a Result of a Disallowance Decision if an Audit Shows That Funds Have Not Been Spent in Accordance With Section 319C-2 of the PHS Act 1. Awardees shall, not less often than once every 2 years, audit their expenditures from HPP funds received. Such audits shall be conducted by an entity independent of the agency administering the HPP program in accordance with the Comptroller General's standards for auditing governmental organizations, programs, activities, and functions and generally accepted auditing standards. Within 30 days following completion of each audit report, awardees should submit a copy of that audit report to ASPR. Awardees shall repay to the United States amounts found not to have been expended in accordance with section 319C-2 of the PHS Act. If such repayment is not made, ASPR may offset such amounts against the amount of any allotment to which the awardee is or may become entitled under section 319C-2 or may otherwise recover such amount. ASPR may withhold payment of funds to any awardee which is not using its allotment under section 319C-2 in accordance with such section. ASPR may withhold such funds until it finds that the reason for the withholding has been removed and there is reasonable assurance that it will not recur. 2. Disallowance notification Upon determination as a result of audit findings that the awardee has not expended funds in accordance with section 319C-2, the GMO shall issue a disallowance notification to the awardee for the portion of funds not expended in accordance with section 319C-2 and require repayment of those funds to the United States. 3. Dispute process HHS has established a DAB for the purpose of providing awardees a fair and flexible process to appeal certain written final decisions involving grant and cooperative agreement programs administered by agencies of HHS. This document notifies HPP awardees that an opportunity exists to appeal a disallowance enforcement action to the DAB. If the awardee chooses to appeal a final disallowance decision by the GMO, the awardee must do so directly to the DAB within thirty days of receipt of the GMO's final disallowance notification. The Notice of Appeal shall include:
(1)A copy of the final decision,
(2)a statement of the amount in dispute in the appeal, and
(3)a brief statement of why the decision is wrong. More details about the DAB's procedures may be found at 45 CFR part 16. V. References A. Code of Federal Regulations
(CFR)• 45 CFR Part 16 and Appendix A, Procedures of the Departmental Grants Appeal Board. • 45 CFR Part 74 and Appendix E, Uniform Administrative Requirements for Awards and Sub-awards to Institutions of Higher Education, Hospitals, Other Nonprofit organizations, and commercial organizations. • 45 CFR Part 92, Uniform Administrative Requirements for Grants and Cooperative Agreements to State, Local, and Tribal Governments. B. OMB Circulars • A-87, Cost Principles for State, Local and Indian Tribal Governments. • A-102, Grants and Cooperative Agreements with State and Local Governments. • A-110, Uniform Administrative Requirements for Grants and Other Agreements with Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations. • A-133, Audits of States, Local Governments, and Non-Profit Organizations Requirements. C. HHS Grants Policy Statement, January 1, 2007 [FR Doc. E8-11015 Filed 5-15-08; 8:45 am] BILLING CODE 4150-37-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60 Day-08-08BD] Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention
(CDC)will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-639-5960 and send comments to Maryam I. Daneshvar, CDC Acting Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to *omb@cdc.gov* . Comments are invited on:
(a)Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;
(b)the accuracy of the agency's estimate of the burden of the proposed collection of information;
(c)ways to enhance the quality, utility, and clarity of the information to be collected; and
(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice. Proposed Project National Survey of HIV Testing in Hospitals—New—National Center for HIV, Viral Hepatitis, STD and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC). Background and Brief Description Early identification of HIV infection has significant benefits to the infected individual and society. In light of recent advancements in HIV testing and treatment, the Centers for Disease Control and Prevention
(CDC)released its prevention initiative, Advancing HIV Prevention: New Strategies for a Changing Epidemic. A key component of this strategy focuses upon increased HIV testing in healthcare settings to increase the number of persons with HIV who are aware of their infection and are successfully referred to treatment and prevention services. In September 2006, CDC released revised recommendations for routine HIV testing of adults, adolescents, and pregnant women in healthcare settings as a measure to address the high number of individuals who are unaware of their HIV infection. Routine HIV testing programs in hospital settings, including emergency departments
(EDs)and urgent care centers (UCCs), have great potential to identify a large number of previously undiagnosed individuals. Prior to the release of the revised recommendations, few such hospital-based testing programs had existed in the United States. CDC is committed to increasing the number of such programs in the U.S., and is currently working with partners to achieve these goals. This project proposes a survey to assess HIV testing policies and practices in hospitals nationwide and to describe the up-take of the revised HIV testing recommendations for hospital settings. The objectives of this project are:
(1)To determine the extent to which HIV testing is being conducted in U.S. hospitals;
(2)to describe the characteristics of hospitals with and without HIV testing programs; and
(3)to identify barriers to and facilitators of implementing HIV testing programs in these settings. This data will assist CDC in monitoring the uptake of recommendations for HIV testing in healthcare settings. CDC is requesting approval for a 2-year clearance for data collection. This project will collect data from hospitals on a one-time voluntary basis using a brief survey. Surveys will be completed by the hospital administrators at each site who are most knowledgeable on HIV testing practices, infection control, and laboratory procedures for their site, in consultation with other hospital staff, as necessary. Collection of data will provide information on current HIV testing practices and policies for the hospital; use of point-of-care and conventional HIV tests; and barriers and facilitators of hospital-based HIV testing. Data will be requested from a representative sample of 4,927 U.S. community hospitals. Surveys will be sent to approximately 1,000 hospital sites with an estimated 70% response rate, based upon estimates from response rates from prior similar surveys among U.S. hospitals. This will result in approximately 700 participating hospital sites, representing approximately 15% of U.S. community hospitals. The average duration of the survey, including time required to collect the requested data, is estimated to be 4 hours per hospital site. There is no cost to the participating hospitals other than their time. Estimated Annualized Burden Hours Type of form Number of respondents Number of responses per respondent Average burden per response in hours Total burden in hours Hospital Survey 700 1 4 2,800 Total 2,800 Dated: May 8, 2008. Maryam I. Daneshvar, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E8-10935 Filed 5-15-08; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Advisory Council for the Elimination of Tuberculosis In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention
(CDC)announces the following council meeting. *Name:* Advisory Council for the Elimination of Tuberculosis *Times and Dates:* 8:30 a.m.-5 p.m., June 17, 2008. 8:30 a.m.-2 p.m., June 18, 2008. *Place:* Corporate Square, Building 8, 1st Floor Conference Room, Atlanta, Georgia 30333, telephone
(404)639-8317. *Status:* Open to the public, limited only by the space available. The meeting room accommodates approximately 100 people. *Purpose:* This council advises and makes recommendations to the Secretary of Health and Human Services, the Assistant Secretary for Health, and the Director, CDC, regarding the elimination of tuberculosis. Specifically, the Council makes recommendations regarding policies, strategies, objectives, and priorities; addresses the development and application of new technologies; and reviews the extent to which progress has been made toward eliminating tuberculosis. *Matters to be Discussed:* Agenda items include issues pertaining to the Findings from the Philippine Technical Instruction Program Review; Division of Tuberculosis Training, Informatics, Surveillance and Research Issues; and Discussion on the Office of Management and Budget
(OMB)and Genomics, and other related Tuberculosis Issues. Agenda items are subject to change as priorities dictate. *Contact Person for More Information:* Margie Scott-Cseh, Coordinating Center for Infectious Diseases, Strategic Business Unit, 1600 Clifton Road, NE., M/S E-07, Atlanta, Georgia 30333, telephone
(404)639-8317. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** Notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Dated: May 9, 2008. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E8-10993 Filed 5-15-08; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Preparedness and Emergency Response Research Centers: A Public Health System Approach, Program Announcement Number
(PA)TP 08-001 In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention
(CDC)announces the aforementioned meeting. *Times and Dates:* 7 p.m.-9:30 p.m., July 7, 2008 (Closed). 8:30 a.m.-5:30 p.m., July 8, 2008 (Closed). 8:30 a.m.-5:30 p.m., July 9, 2008 (Closed). 7 p.m.-9:30 p.m., July 9, 2008 (Closed). 8:30 a.m.-5:30 p.m., July 10, 2008 (Closed). 8:30 a.m.-5:30 p.m., July 11, 2008 (Closed). *Place:* Spring Hill Suites Marriott, 3459 Buckhead Loop, Atlanta, GA 30326, Telephone
(404)844-4800. *Status:* The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c)
(4)and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463. *Matters to be Discussed:* The meeting will include the review, discussion, and evaluation of applications received in response to “Preparedness and Emergency Response Research Centers: A Public Health System Approach,” PA TP 08-001. *Contact Person for More Information:* Charles Rafferty, Ph.D., Senior Scientific Review Officer, Office of Science and Public Health Practice, Coordinating Office for Terrorism Preparedness and Emergency Response, CDC, 1600 Clifton Road NE., Mailstop D44, Atlanta, GA 30333, Telephone
(404)639-7495. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: May 9, 2008. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E8-10974 Filed 5-15-08; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Healthcare Infection Control Practices Advisory Committee In accordance with section 10(a)
(2)of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention
(CDC)announces the following meeting for the aforementioned committee: *Name:* Healthcare Infection Control Practices Advisory Committee (HICPAC). *Times and Dates:* 9 a.m.-5 p.m., June 12, 2008. 9 a.m.-1 p.m., June 13, 2008. *Place:* Centers for Disease Control and Prevention, 1600 Clifton Road, Global Communications Center, Building 19, Auditorium B3, Atlanta, Georgia 30333. *Status:* Open to the public, limited only by the space available. *Purpose:* The Committee is charged with providing advice and guidance to the Secretary, the Assistant Secretary for Health, the Director, CDC, and the Director, National Center for Preparedness, Detection, and Control of Infectious Diseases (NCPDCID), regarding
(1)the practice of hospital infection control;
(2)strategies for surveillance, prevention, and control of infections (e.g., nosocomial infections), antimicrobial resistance, and related events in settings where healthcare is provided; and
(3)periodic updating of guidelines and other policy statements regarding prevention of healthcare-associated infections and healthcare-related conditions. *Matters to be Discussed:* Guidelines and progress including prevention of UTI and Norovirus transmission, HICPAC prioritization of recommendations for implementation. Agenda items are subject to change as priorities dictate. *Contact Person for More Information:* Wendy Vance, HICPAC, Division of Healthcare Quality Promotion, NCPDCID, CDC, l600 Clifton Road, NE., Mailstop D-10, Atlanta, Georgia 30333. Telephone
(404)639-2891. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: May 9, 2008. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E8-10991 Filed 5-15-08; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Statement of Organization, Functions, and Delegations of Authority Part C (Centers for Disease Control and Prevention) of the Statement of Organization, Functions, and Delegations of Authority of the Department of Health and Human Services (45 FR 67772-76, dated October 14, 1980, and corrected at 45 FR 69296, October 20, 1980, as amended most recently at 73 FR 20297-304, dated April 15, 2008) is amended to reflect the reorganization of the Financial Management Office within the Office of the Chief Operating Officer, Centers for Disease Control and Prevention. Section C-B, Organization and Functions, is hereby amended as follows: Delete in their entirety the titles and functional statements for the Financial Management Office (CAJE), and insert the following: *Financial Management Office (CAJE).*
(1)Provides leadership and coordination in the development and administration of the Centers for Disease Control and Prevention's
(CDC)financial management policies;
(2)develops budget submissions for the CDC;
(3)collaborates with the CDC Office of the Director
(OD)in the development and implementation of long-range program and financial plans;
(4)participates in budget reviews and hearings;
(5)manages CDC's system of internal budgetary planning and control of funds;
(6)develops and implements CDC-wide budgetary, accounting, and fiscal systems and procedures;
(7)conducts CDC-wide manpower management (including productivity measurement) activities;
(8)prepares financial reports;
(9)serves as the focal point for domestic and international travel policy, procedures and interpretation;
(10)provides legislation reference services;
(11)plans, directs and conducts internal quality assurance reviews;
(12)analyzes data and makes recommendations to assure effective safeguards are in place to prevent fraud, waste and abuse;
(13)assists in identifying or conducting special financial management training programs; and
(14)maintains liaison with the Department of Health and Human Services (DHHS), Office of Management and Budget (0MB), Congress, and other government organizations on financial management matters. *Office of the Director (CAJE1).*
(1)Provides leadership, guidance, direction, and oversight necessary to fully manage the performance of CDC's Financial Management Office (FMO);
(2)establishes FMO's vision and long-term strategy;
(3)leads the overall budgetary and human resource management strategy for FMO;
(4)develops customer service strategy and actively engages the Agency around financial management effectiveness and improvement;
(5)provides financial guidance and strategic support for the Agency and the Chief Operating Officer;
(6)advocates and supports policy and appropriations law compliance;
(7)serves as CDC witness in budget hearings before Committees of Congress, OMB, and DHHS;
(8)participates with senior program and Agency management in program planning and policy determinations, evaluations, conferences, and decisions concerning financial resources;
(9)provides a centralized source for current information on financial management legal and regulatory requirements governing the prevention and control of diseases; and
(10)provides consultation and assistance in financial management to state and local health departments when requested by CDC officials. *Travel Management Activity (CAJE12).*
(1)Provides expertise, guidance, oversight, and interpretation of policies, laws, rules and regulations for all aspects of travel procedures and policies at CDC, including the use of the automated travel system, local travel, domestic and foreign temporary duty travel, and change of station travel for civil service employees, foreign service employees, commissioned officers, CDC fellows, etc.;
(2)communicates and implements Departmental travel policies;
(3)manages the administrative aspects of travel for the agency, including enforcement of travel card policy, delegation of authority, distribution of cash purchase memos, and approval of First-Class memos;
(4)serves as liaison with travel provider for travel contract matters;
(5)provides the Director's Emergency Operations Center travel support; and
(6)develops CDC Conference Travel planning and reporting for DHHS and Congress. *Office of Organizational Excellence (CAJE13).*
(1)Provides direction, strategy, and advice necessary to support the management and continuous improvement of FMO and financial processes;
(2)coordinates creation and implementation of operating standards/procedures and processes, and monitors compliance;
(3)provides leading practices in government financial management practices to FMO;
(4)coordinates continuous improvement and special project initiatives and advises on performance improvement opportunities;
(5)manages FMO Service Desk;
(6)develops, implements, and manages recruiting, hiring, retention, and succession strategies;
(7)manages all aspects of human resources for FMO, including application of Federal programs and staffing administration;
(8)develops, implements, and manages professional development strategy and plan for FMO;
(9)develops and implements FMO's communication strategy and plan; and
(10)manages the development and communication of financial management policies. *Office of Formulation, Evaluation, and Analysis (CAJE14).*
(1)Develops CDC's budget in accordance with DHHS, OMB, and Congressional requirements, policies, procedures, and regulations;
(2)provides leadership and advice on matters of budget formulation, public health policy development, budget and performance integration, and Congressional appropriations for CDC/ATSDR;
(3)participates in budget reviews and hearings before DHHS, OMB, and Congress;
(4)provides direction and guidance for appropriations strategy and program support;
(5)manages budget submissions and OMB Performance Assessment and Rating Tool
(PART)content;
(6)provides leadership and advice in implementing performance systems, including the PART assessments, key performance indicators, and CDC's Government Performance Results Act
(GPRA)program;
(7)serves as a liaison with the Office of the Secretary, OMB, Government Accountability Office, other government organizations, and Congress on financial management matters;
(8)manages appropriations analysis and reporting process, submissions, and summary information; and
(9)manages appropriations communication and issues management both internally and externally, and interacts with BBS, OMB, Congress, and partners. *Accounting Branch (CAJEB).*
(1)Oversees and provides approach to accounting for the Agency;
(2)manages accounting treatment for CDC on all business systems implementations and upgrades to current business systems;
(3)manages all financial audit reviews for FMO and conducts risk assessment on internal controls;
(4)prepares SF 133 Report on Budget Execution for CDC Appropriation and IDDAs, FACTS I and II Report and Year-End Closing Statement (2108 Report), and SF 224;
(5)prepares, analyzes fluctuations, and coordinates explanation on differences for financial statements and notes, including Statement of Changes in Net Position, Statement of Budgetary Resources, Balance Sheet, Statement of Net Cost, and Statement of Financing;
(6)performs GPRA reporting analysis for compliance;
(7)ensures compliance of Federal and Department reporting requirements;
(8)coordinates accounting policy issues with the DHHS Office of Financial Policy and FMO's Office of Organization Excellence;
(9)manages Fund Balance with Treasury, including authority, disbursements (payroll and non-payroll), collections, deposit funds and budget clearing accounts;
(10)prepares manual and ADI journal vouchers for corrections to the general ledger; and
(11)performs monthly, quarterly, and year-end closeout process of the general ledger. *Financial Systems Branch (CAJED).*
(1)Provides management and coordination necessary for FMO to have access to systems, data, and reporting capability;
(2)develops, implements, and manages long-term systems strategy for FMO;
(3)provides systems analysis, design, programming, implementation, enhancement and documentation of FMO related systems;
(4)provides technical support and assistance for data error analysis and resolution, coordination of system initiatives, management of IT resources, and the access and interpretation of financial system data;
(5)serves as a liaison to UFMS Operations and Maintenance and other internal and external groups as needed;
(6)manages all aspects of FMO's systems security and administration;
(7)performs certification and accreditation of FMO systems;
(8)performs CAN realignment coordination; and
(9)manages FMO hardware and equipment, and serves as the custodial officer. *Financial Services Branch (CAJEE).*
(1)Manages all activities, policies, quality control, and audit support for accounts payable and disbursement functions for the Agency;
(2)serves as the CDC subject matter expert on all financial matters dealing with all travel, assignments and payments;
(3)ensures all payments are made in accordance with applicable Federal and international laws and standards, such as Appropriations Law;
(4)serves as liaison with the Department of Treasury (DOT), the CC/COs, NCs, Divisions, and/or Offices, as well as outside customers, to provide financial information and reconcile payment issues;
(5)compiles and submits a variety of cash management and travel reports required by the DOT and various other outside agencies;
(6)provides training and advice on payment, travel and disbursement issues;
(7)manages the transactions related to accounts payable, such as processing cables, reimbursements, IPAC disbursements, and payments for Foreign internationals and Visiting Fellows;
(8)completes all reconciliations of sub-legers to General Ledger;
(9)responds to traveler inquiries for vouchers and certifies funds availability; and
(10)manages change of station payment processing. *Budget Operations Branch (CAJEH).*
(1)Provides agency-level budget execution functions, financial data analysis, and reporting;
(2)provides budgetary information for business decision making support surrounding public health;
(3)develops high-level plans to execute Agency level budget;
(4)ensures changes and plans are in compliance with decisions and Agency direction;
(5)reports compliance of laws, regulations, and decisions to FMO Deputy Director for Budget;
(6)provides agency-wide budget planning, analysis, and reporting for agency budget execution and public health goals strategy;
(7)provides Agency spend plan validation, remediation, and analysis;
(8)provides funds control management for the Agency level budget;
(9)assists in the review of Congressional bill language to identify and properly account for earmarks and other directed programs;
(10)provides Departmental and OMB reporting; and
(11)provides budget execution for Centralized Mandatory Services. *Debt Management Branch (CAJEJ).*
(1)Oversees and provides approach to invoicing, billing, collections, reconciliations and reporting for the Agency;
(2)serves as the central point of contact for the Agency on all debt management issues, including training and issue resolution;
(3)develops strategy and analysis for reimbursable agreements in accordance with the CC/CO, NC, Division, and/or Office;
(4)manages all aspects of accounts receivable transactions in UFMS, prepares invoices, and processes billing;
(5)works with programs, the Chief Financial Officer, and FMO to resolve all posting errors, such as the resolution for over-obligated and unsigned agreements, DC calculations, and uncollectible debt;
(6)analyzes the intra- and inter-governmental eliminations process for compliance with financial statements;
(7)prepares and submits Agency level fmancial reports to HHS/OS; and
(8)prepares and submits the year end certification and verification of the Treasury Report on receivables. *Grants and Asset Management Branch (CAJEK).*
(1)Oversees and provides approach to grants management;
(2)serves as liaison with the Procurements and Grants Office, Buildings and Facilities Offices, Program offices, and Budget Execution Services on capital asset procedures;
(3)manages financial accounting for all assets for CDC, including real and personal property, equipment, land, leases, software, personal property, and stockpiles;
(4)conducts financial and inventory reconciliations for all applicable assets, including inventory such as Vaccine for Children and Strategic National Stockpile, real and personal property, equipment, leases, leasehold improvements, land, and others as needed;
(5)provides training and assistance to CDC project officers and grants management officials around financial grants management;
(6)serves as liaison with grantees and other operating divisions for financial questions/inquiries related to grants;
(7)manages the process to perform grant processing for commitments, obligations, advances, disbursements, and accruals;
(8)manages grants transactions, such as vendor set-up, establishing sub-accounts, CAN set-up within PMS, reconciling sycnfile to PMS, and posting files from PMS; and
(9)conducts grant reviews, monitors burn rates, and supports Program in grant execution. *Budget Execution Services Branch 1 (CAJEL).* This branch supports the National Center for Zoonotic, Vector-Borne, and Enteric Diseases and the National Center for Preparedness, Detection, and Control of Infectious Diseases by performing the following:
(1)Provides the legal and regulatory expertise and support to execute CDC's budget within the framework of DHHS, OMB, and Congressional regulations, and policies of CDC OD;
(2)manages to the expectations agreed upon in the Budget Execution Services Service Level Agreement;
(3)promotes structured, ongoing partnerships with the Coordinating Centers/Coordinating Offices (CC/CO), National Centers (NC), Divisions, and Offices;
(4)manages and supports Program in all aspects of funds management;
(5)provides the leadership and guidance for spend plan creation and administration, in compliance with all Federal guidelines and policies, such as the Anti-Deficiency Act;
(6)provides the overall analysis and reconciliation of spend plans to advise Program on future spending decisions;
(7)assists Program Officials in developing sub-allocation of CC/CO, NC, and Division ceilings;
(8)communicates and shares knowledge with Program, FMO Central, and CDC's FMO Budget Analyst Community; and
(9)performs cost-benefit analysis to review financial requests and makes recommendations for future year budget. *Budget Execution Services Branch 2 (CAJEM).* This branch supports the National Center for Immunization and Respiratory Diseases, the National Center for HP//AIDS, Viral Hepatitis, STD, and TB Prevention, and the Office of the Director for Coordinating Center for Infectious Diseases by performing the following:
(1)Provides the legal and regulatory expertise and support to execute CDC's budget within the framework of DHHS, OMB, and Congressional regulations, and policies of CDC OD;
(2)manages to the expectations agreed upon in the Budget Execution Services Service Level Agreement;
(3)promotes structured, ongoing partnerships with the CC/COs, NCs, Divisions, and Offices;
(4)manages and supports Program in all aspects of funds management;
(5)provides the leadership and guidance for spend plan creation and administration, in compliance with all Federal guidelines and policies, such as the Anti Deficiency Act;
(6)provides the overall analysis and reconciliation of spend plans to advise Program on future spending decisions;
(7)assists Program Officials in developing sub-allocation of CCICO, NC, and Division ceilings;
(8)communicates and shares knowledge with Program, FMO Central, and CDC's FMO Budget Analyst Community; and
(9)performs cost-benefit analysis to review financial requests and makes recommendations for future-year budget. *Budget Execution Services Branch 3 (CAJEN).* This branch supports the Coordinating Center for Environmental Health and Injury Prevention and the National Institute for Occupational Safety and Health by performing the following:
(1)Provides the legal and regulatory expertise and support to execute CDC's budget within the framework of DHHS, OMB, and Congressional regulations, and policies of CDC OD;
(2)manages to the expectations agreed upon in the Budget Execution Services Service Level Agreement;
(3)promotes structured, ongoing partnerships with the CC/COs, NCs, Divisions, and Offices;
(4)manages and supports Program in all aspects of funds management;
(5)provides the leadership and guidance for spend plan creation and administration, in compliance with all Federal guidelines and policies, such as the Anti Deficiency Act;
(6)provides the overall analysis and reconciliation of spend plans to advise Program on future spending decisions;
(7)assists Program Officials in developing sub-allocation of CC/CO, NC, and Division ceilings;
(8)communicates and shares knowledge with Program, FMO Central, and CDC's FMO Budget Analyst Community; and
(9)performs cost-benefit analysis to review financial requests and makes recommendations for future-year budget. *Budget Execution Services Branch 4 (CAJEP).* This branch supports the Coordinating Center for Health Promotion and the Office of Workforce and Career Development by performing the following:
(1)Provides the legal and regulatory expertise and support to execute CDC's budget within the framework of DHHS, OMB, and Congressional regulations, and policies of CDC OD;
(2)manages to the expectations agreed upon in the Budget Execution Services Service Level Agreement;
(3)promotes structured, ongoing partnerships with the CC/COs, NCs, Divisions, and Offices;
(4)manages and supports Program in all aspects of funds management;
(5)provides the leadership and guidance for spend plan creation and administration, in compliance with all Federal guidelines and policies, such as the Anti-Deficiency Act;
(6)provides the overall analysis and reconciliation of spend plans to advise Program on future spending decisions;
(7)assists Program Officials in developing sub-allocation of CC/CO, NC, and Division ceilings;
(8)communicates and shares knowledge with Program, FMO Central, and CDC's FMO Budget Analyst Community; and
(9)performs cost-benefit analysis to review financial requests and makes recommendations for future-year budget. *Budget Execution Services Branch 5 (CAJER).* This branch supports the Coordinating Office for Global Health, the Office of the Chief Operating Officers, and the Office of the Director, CDC, by performing the following:
(1)Provides the legal and regulatory expertise and support to execute CDC's budget within the framework of DUBS, OMB, and Congressional regulations, and policies of CDC OD;
(2)manages to the expectations agreed upon in the Budget Execution Services Service Level Agreement;
(3)promotes structured, ongoing partnerships with the CC/COs, NCs, Divisions, and Offices;
(4)manages and supports Program in all aspects of funds management;
(5)provides the leadership and guidance for spend plan creation and administration, in compliance with all Federal guidelines and policies, such as the Anti-Deficiency Act;
(6)provides the overall analysis and reconciliation of spend plans to advise Program on future spending decisions;
(7)assists Program Officials in developing sub-allocation of CC/CO, NC, and Division ceilings;
(8)communicates and shares knowledge with Program, FMO Central, and CDC's FMO Budget Analyst Community; and
(9)performs cost-benefit analysis to review financial requests and makes recommendations for future year budget. *Budget Execution Services Branch 6 (CAJES).* This branch supports the Coordinating Center for Health Information and Service and the Coordinating Office for Terrorism Preparedness and Emergency Response by performing the following:
(1)Provides the legal and regulatory expertise and support to execute CDC's budget within the framework of DHHS, OMB, and Congressional regulations, and policies of CDC OD;
(2)manages to the expectations agreed upon in the Budget Execution Services Service Level Agreement;
(3)promotes structured, ongoing partnerships with the CC/COs, NCs, Divisions, and Offices;
(4)manages and supports Program in all aspects of funds management;
(5)provides the leadership and guidance for spend plan creation and administration, in compliance with all Federal guidelines and policies, such as the Anti-Deficiency Act;
(6)provides the overall analysis and reconciliation of spend plans to advise Program on future spending decisions;
(7)assists Program Officials in developing sub-allocation of CC/CO, NC, and Division ceilings;
(8)communicates and shares knowledge with Program, FMO Central, and CDC's FMO Budget Analyst Community; and
(9)performs cost-benefit analysis to review financial requests and makes recommendations for future-year budget. Dated: May 8, 2008. Joseph Henderson, Acting Chief Operating Officer, Centers for Disease Control and Prevention. [FR Doc. E8-10982 Filed 5-15-08; 8:45 am] BILLING CODE 4160-18-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Statement of Organization, Functions, and Delegations of Authority Part C (Centers for Disease Control and Prevention) of the Statement of Organization, Functions, and Delegations of Authority of the Department of Health and Human Services (45 FR 67772-76, dated October 14, 1980, and corrected at 45 FR 69296, October 20, 1980, as amended most recently at 73 FR 20297-3 04, dated April 15, 2008) is amended to reflect the establishment of the Office of Critical Information Integration and Exchange within the National Center for Zoonotic, Vector Borne, and Enteric Diseases, Coordinating Center for Infectious Diseases, Centers for Disease Control and Prevention. Section C-B, Organization and Functions, is hereby amended as follows: After the functional statements for the *Mycotic Diseases Branch (CVHEG), Division of Foodborne, Bacterial and Mycotic Diseases (CVHE), National Center for Zoonotic, Vector-Borne, and Enteric Diseases (CVH),* insert the following: *Office of Critical Information Integration and Exchange (CVHG).* The mission of the Office of Critical Information Integration and Exchange (OCIIX) is to provide a CDC-wide resource that facilitates the exchange, integration, and visualization of relevant information from a variety of sources to enhance Agency and programmatic situational awareness for decision making and early event detection. To carry out its mission, OCIIX:
(1)Develops tools that enable social networking and the creation of communities of practice to facilitate the exchange of information essential to developing an accurate and complete picture of developments that could threaten health worldwide;
(2)identifies and/or develops information technologies to improve access to the integrated information;
(3)detects, analyzes and communicates relevant information from a variety of sources to provide situational awareness services that reduce emergency response times for the CDC Office of the Director and Agency programs; and
(4)analyzes, integrates and provides information to key stakeholders to widen their understanding of emerging threats and to enhance the effectiveness of subsequent response strategies. Dated: May 8, 2008. Joseph Henderson, Acting Chief Operating Officer, Centers for Disease Control and Prevention. [FR Doc. E8-10986 Filed 5-15-08; 8:45 am] BILLING CODE 4160-18-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-R-267] Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY: Centers for Medicare & Medicaid Services, Department of Health and Human Services. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services, is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects:
(1)The necessity and utility of the proposed information collection for the proper performance of the Agency's function;
(2)the accuracy of the estimated burden;
(3)ways to enhance the quality, utility, and clarity of the information to be collected; and
(4)the use of automated collection techniques or other forms of information technology to minimize the information collection burden. 1. *Type of Information Collection Request:* Revision of a currently approved collection; *Title of Information Collection:* Medicare Advantage Program: Application and Contract Requirements; *Use:* The information collection requirements are mandated by 42 CFR 422. Section 4001 of the Balanced Budget Act of 1997 added sections 1851 through 1859 to the Social Security Act to establish this new program. The Medicare, Medicaid, and SCHIP Benefits Improvement Act and Protection Act of 2000 and sections 201-204 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003
(MMA)added new requirements. Medicare Advantage
(MA)organizations (formerly M+C organizations) and potential MA organizations (applicants) use the information to comply with the application requirements and the MA contract requirements. CMS will use this information to approve contract applications, monitor compliance with contract requirements, make proper payment to MA organizations, determine compliance with the new prescription drug benefit requirements established by the MMA, and to ensure that correct information is disclosed to Medicare beneficiaries, both potential enrollees and enrollees. The reported change in burden is due to program growth and revisions to the Medicare Advantage and Prescription Drug Benefit. *Form Number:* CMS-R-267 (OMB# 0938-0753); *Frequency:* Yearly; *Affected Public:* Business or other for-profit and Not-for-profit institutions, and Individuals or households; *Number of Respondents:* 9,000,670; *Total Annual Responses:* 9,000,670; *Total Annual Hours:* 8,529,541. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS Web Site address at *http://www.cms.hhs.gov/PaperworkReductionActof1995* , or E-mail your request, including your address, phone number, OMB number, and CMS document identifier, to *Paperwork@cms.hhs.gov* , or call the Reports Clearance Office on
(410)786-1326. To be assured consideration, comments and recommendations for the proposed information collections must be received by the OMB desk officer at the address below, no later than 5 p.m. on *June 16, 2008* . OMB Human Resources and Housing Branch, Attention: Carolyn Raffaelli, New Executive Office Building, Room 10235, Washington, DC 20503, Fax Number:
(202)395-6974. Dated: May 7, 2008. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E8-10664 Filed 5-15-08; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0094] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing that a proposed collection of information has been submitted to the Office of Management and Budget
(OMB)for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by June 16, 2008. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974, or e-mailed to *baguilar@omb.eop.gov* . All comments should be identified with the OMB control number 0910-0562. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations—(OMB Control Number 0910-0562)—Extension The Food Quality Protection Act of 1996 (FQPA), which amended the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (the act), established a new safety standard for pesticide residues in food, with an emphasis on protecting the health of infants and children. The Environmental Protection Agency
(EPA)is responsible for regulating the use of pesticides (under FIFRA) and for establishing tolerances or exemptions from the requirement for tolerances for residues of pesticide chemicals in food commodities (under the act). EPA, in accordance with the FQPA, is in the process of reassessing the pesticide tolerances and exemptions which were in effect when the FQPA was signed into law. When EPA determines that a pesticide's tolerance level does not meet the safety standard under section 408 of the act (21 U.S.C. 346a), the registration for the pesticide may be canceled under FIFRA for all or certain uses. In addition, the tolerances for that pesticide may be lowered or revoked for the corresponding food commodities. Under section 408(l)(2) of the act, when the registration for a pesticide is canceled or modified due to, in whole or in part, dietary risks to humans posed by residues of that pesticide chemical on food, the effective date for the revocation of such tolerance (or exemption in some cases) must be no later than 180 days after the date such cancellation becomes effective or 180 days after the date on which the use of the canceled pesticide becomes unlawful under the terms of the cancellation, whichever is later. When EPA takes such actions, food derived from a commodity that was lawfully treated with the pesticide may not have cleared the channels of trade by the time the revocation or new tolerance level takes effect. The food could be found by FDA, the agency that is responsible for monitoring pesticide residue levels and enforcing the pesticide tolerances in most foods (the U.S. Department of Agriculture
(USDA)has responsibility for monitoring residue levels and enforcing pesticide tolerances in egg products and most meat and poultry products), to contain a residue of that pesticide that does not comply with the revoked or lowered tolerance. FDA would normally deem such food to be in violation of the law by virtue of it bearing an illegal pesticide residue. The food would be subject to FDA enforcement action as an “adulterated” food. However, the channels of trade provision of the act (section 408(l)(5) of the act) addresses the circumstances under which a food is not unsafe solely due to the presence of a residue from a pesticide chemical for which the tolerance has been revoked, suspended, or modified by EPA. The channels of trade provision states that food containing a residue of such a pesticide shall not be deemed “adulterated” by virtue of the residue, if the residue is within the former tolerance, and the responsible party can demonstrate to FDA's satisfaction that the residue is present as the result of an application of the pesticide at a time and in a manner which were lawful under FIFRA. In the **Federal Register** of May 18, 2005 (70 FR 28544), FDA announced the availability of a guidance document entitled, “Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations.” The guidance represents the agency's current thinking on its planned enforcement approach to the channels of trade provision of the act and how that provision relates to FDA-regulated products with residues of pesticide chemicals for which tolerances have been revoked, suspended, or modified by EPA under dietary risk considerations. The guidance can be found at *http://www.cfsan.fda.gov/guidance.html* . FDA anticipates that food bearing lawfully applied residues of pesticide chemicals that are the subject of future EPA action to revoke, suspend, or modify their tolerances, will remain in the channels of trade after the applicable tolerance is revoked, suspended, or modified. If FDA encounters food bearing a residue of a pesticide chemical for which the tolerance has been revoked, suspended, or modified, it intends to address the situation in accordance with provisions of the guidance. In general, FDA anticipates that the party responsible for food found to contain pesticide chemical residues (within the former tolerance) after the tolerance for the pesticide chemical has been revoked, suspended, or modified will be able to demonstrate that such food was handled, e.g., packed or processed, during the acceptable timeframes cited in the guidance by providing appropriate documentation to the agency as discussed in the guidance document. FDA is not suggesting that firms maintain an inflexible set of documents where anything less or different would likely be considered unacceptable. Rather, the agency is leaving it to each firm's discretion to maintain appropriate documentation to demonstrate that the food was so handled during the acceptable timeframes. Examples of documentation which FDA anticipates will serve this purpose consist of documentation associated with packing codes, batch records, and inventory records. These are types of documents that many food processors routinely generate as part of their basic food-production operations. FDA is requesting the extension of OMB approval for the information collection provisions in the guidance. *Description of Respondents* : The likely respondents to this collection of information are firms in the produce and food-processing industries that handle food products that may contain residues of pesticide chemicals after the tolerances for the pesticide chemicals have been revoked, suspended, or modified. In the **Federal Register** of February 25, 2008 (73 FR 10033), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. **Table 1.—Estimated Annual Reporting Burden** 1 Activity No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours Submission of documentation 1 1 1 3 3 1 There are no capital costs or operating and maintenance costs associated with this collection of information. FDA expects the total number of pesticide tolerances that are revoked, suspended, or modified by EPA in the next 3 years to significantly decrease, as EPA concludes its review activity. Thus, the previous estimates for respondents and numbers of responses in table 1 of this document are based on the submissions that the agency has received in the past 3 years and the expectation that the number of submissions will significantly decrease in the next 3 years. However, to avoid counting this burden as zero, FDA has estimated the burden at one respondent making one submission a year for a total of one annual submission. The hours per response values were estimated as follows: First, we assumed that the information requested in the guidance is readily available to the submitter. We expect that the submitter will need to gather information from appropriate persons in the submitter's company and to prepare this information for submission to FDA. The submitter will almost always merely need to copy existing documentation. We believe that this effort should take no longer than 3 hours per submission. **Table 2.—Estimated Annual Recordkeeping Burden** 1 Activity No. of Recordkeepers Annual Frequency per Recordkeeping Total Annual Records Hours per Record Total Hours Develop documentation process 1 1 1 16 16 1 There are no capital costs or operating and maintenance costs associated with this collection of information. In determining the estimated annual recordkeeping burden, FDA estimated that at least 90 percent of firms maintain documentation, such as packing codes, batch records, and inventory records, as part of their basic food production or import operations. Therefore, the recordkeeping burden was calculated as the time required for the 10 percent of firms that may not be currently maintaining this documentation to develop and maintain documentation, such as batch records and inventory records. In previous information collection requests, this recordkeeping burden was estimated to be 16 hours per record. FDA has retrained its prior estimate of 16 hours per record for the recordkeeping burden. As shown in table 1 of this document, FDA estimates that one respondent will make one submission per year. Although FDA estimates that only 1 out of 10 firms will not be currently maintaining the necessary documentation, to avoid counting the recordkeeping burden for the 1 submission per year as 1/10 of a recordkeeper, FDA estimates that 1 recordkeeper will take 16 hours to develop and maintain documentation recommended by the guidance. Dated: May 8, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8-10985 Filed 5-15-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0073] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Experience Reporting for Licensed Biological Products; and General Records AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing that a proposed collection of information has been submitted to the Office of Management and Budget
(OMB)for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by June 16, 2008. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974, or e-mailed to *baguilar@omb.eop.gov* . All comments should be identified with the OMB control number 0910-0308. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Adverse Experience Reporting for Licensed Biological Products; and General Records—(OMB Control Number 0910-0308)—Extension Under the Public Health Service Act (42 U.S.C. 262), FDA is required to ensure the marketing of only those biological products which are safe and effective. FDA must, therefore, be informed of all adverse experiences occasioned by the use of licensed biological products. FDA issued the adverse experience reporting
(AER)requirements in part 600 (21 CFR part 600) to enable FDA to take actions necessary for the protection of the public health in response to reports of adverse experiences related to licensed biological products. The primary purpose of FDA's AER system is to flag potentially serious safety problems with licensed biological products, focusing especially on newly licensed products. Although premarket testing discloses a general safety profile of a biological product's comparatively common adverse effects, the larger and more diverse patient populations exposed to the licensed biological product provides the opportunity to collect information on rare, latent, and long-term effects. Reports are obtained from a variety of sources, including patients, physicians, foreign regulatory agencies, and clinical investigators. Information derived from the AER system contributes directly to increased public health protection because such information enables FDA to recommend important changes to the product's labeling (such as adding a new warning), to initiate removal of a biological product from the market when necessary, and to assure the manufacturer has taken adequate corrective action if necessary. The regulation in § 600.80(c)(1) requires licensed manufacturers to report each adverse experience that is both serious and unexpected, whether foreign or domestic, as soon as possible but in no case later than 15-calendar days of initial receipt of the information by the licensed manufacturer. These are known as postmarketing 15-day Alert reports. Section 600.80(c)(1) also requires licensed manufacturers to submit any followup reports within 15-calendar days of receipt of new information or as requested by FDA. Section 600.80(e) requires licensed manufacturers to submit a 15-day Alert report for an adverse experience obtained from a postmarketing clinical study only if there is a reasonable possibility that the product caused the adverse experience. Section 600.80(c)(2) requires licensed manufacturers to report each adverse experience not reported in a postmarketing 15-day Alert report at quarterly intervals, for 3 years from the date of issuance of the biologics license, and then at annual intervals. The majority of these periodic reports will be submitted annually because a large percentage of currently licensed biological products have been licensed longer than 3 years. Section 600.80(i) requires licensed manufacturers to maintain for a period of 10 years records of all adverse experiences known to the licensed manufacturer, including raw data and any correspondence relating to the adverse experiences. Section 600.81 requires licensed manufacturers to submit, at an interval of every 6 months, information about the quantity of the product distributed under the biologics license, including the quantity distributed to distributors. These semiannual distribution reports provide FDA with important information about products distributed under biologics licenses, including the quantity, certain lot numbers, labeled date of expiration, number of dosage units, and date of release. Under § 600.90, a licensed manufacturer may submit a waiver request for any requirements that applies to the licensed manufacturer under § 600.80 and 600.81. A waiver request submitted under § 600.90 must include supporting documentation. Manufacturers of biological products for human use must keep records of each step in the manufacture and distribution of a product including any recalls. These recordkeeping requirements serve preventative and remedial purposes by establishing accountability and traceability in the manufacture and distribution of products. These requirements also enable FDA to perform meaningful inspections. Section 600.12 requires, among other things, concurrently with the performance of each step that all records of each step in the manufacture and distribution of a product be made and retained for no less than 5 years after the records of manufacture have been completed or 6 months after the latest expiration date for the individual product, whichever represents a later date. In addition, manufacturers must maintain records of sterilization of equipment and supplies, animal necropsy records, and records in cases of divided manufacturing of a product. Section 600.12(b)(2) requires manufacturers to maintain complete records pertaining to the recall from distribution of any product. Respondents to this collection of information are manufacturers of biological products. Under table 1 of this document, the number of respondents is based on the estimated number of manufacturers that submitted the required information to the Center for Biologics Evaluation and Research and Center for Drug Evaluation and Research, FDA, in fiscal year
(FY)2006. Based on information obtained from FDA's database system, there were 88 licensed biologics manufacturers. This number excludes those manufacturers who produce blood and blood components and in-vitro diagnostic licensed products, because § 600.80(k) specifically exempts manufacturers of these products from adverse experience reporting requirements. The total annual responses are based on the estimated number of submissions received annually by FDA in FY 2006. However, not all manufacturers have submissions in a given year and some may have multiple submissions. There were an estimated 23,835 15-day Alert reports, 21,872 periodic reports, and 179 lot distribution reports submitted to FDA. The number of 15-day Alert reports for postmarketing studies under § 600.80(e) is included in the total number of 15-day Alert reports. FDA received 6 requests for waiver under § 600.90, all of which were granted. The hours per response are based on FDA experience. The burden hours required to complete the MedWatch Form for § 600.80(c)(1), (e), and
(f)are reported under OMB control no. 0910-0291. In the **Federal Register** of February 15, 2008 (73 FR 8881), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. **Table 1.—Estimated Annual Reporting Burden** 1 21 CFR Section No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 600.80(c)(1) and 600.80(e) 88 270.85 23,835 1 23,835 600.80(c)(2) 88 248.55 21,872 28 612,416 600.81 88 2.03 179 1 179 600.90 6 1 6 1 6 Total 636,436 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Under table 2 of this document, the number of respondents is based on the number of manufacturers subject to those regulations. Based on information obtained from FDA's database system, there were 303 licensed manufacturers of biological products in FY 2006. However, the number of recordkeepers listed for § 600.12(a) through
(e)excluding (b)(2) is estimated to be 112. This number excludes manufacturers of blood and blood components because their burden hours for recordkeeping have been reported under 21 CFR 606.160 in OMB control no. 0910-0116. The total annual records is based on the annual average of lots released (5,291), number of recalls made (1,841), and total number of adverse experience reports received (45,707) in FY 2006. The hours per record are based on FDA experience. FDA estimates the burden of this recordkeeping as follows: **Table 2.—Estimated Annual Recordkeeping Burden** 1 21 CFR Section No. Of Recordkeepers Annual Frequency per Recordkeeping Total Annual Records Hours per Record Total Hours 600.12 112 47.24 5,291 32 169,312 600.12(b)(2) 303 6.08 1,841 24 44,184 600.80(i) 88 519.40 45,707 1 45,707 Total 259,203 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: May 13, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8-11057 Filed 5-15-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Dental & Craniofacial Research; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the Board of Scientific Counselors, National Institute of Dental and Craniofacial Research. The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the National Institute of Dental & Craniofacial Research, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. *Name of Committee:* Board of Scientific Counselors, National Institute of Dental and Craniofacial Research. *Date:* June 9-11, 2008. *Time:* June 9, 2008, 7 p.m. to 9 p.m. *Agenda:* To review and evaluate personal qualifications and performance, and competence of individual investigators. *Place:* National Institutes of Health, Building 30, 30 Convent Drive, Room 117, Bethesda, MD 20892. *Time:* June 10, 2008, 8 a.m. to 8 p.m. *Agenda:* To review and evaluate personal qualifications and performance, and competence of individual investigators. *Place:* National Institutes of Health, Building 30, 30 Convent Drive, Room 117, Bethesda, MD 20892. *Time:* June 11, 2008, 8 a.m. to 12:30 p.m. *Agenda:* To review and evaluate personal qualifications and performance, and competence of individual investigators. *Place:* National Institutes of Health, Building 30, 30 Convent Drive, Room 117, Bethesda, MD 20892. *Contact Person:* Norman S Braveman, Assistant to the Director, NIH—NIDCR, 31 Center Drive, Bldg. 31, Room 5B55, Bethesda, MD 20892, 301 594-2089, *norman.braveman@nih.gov* . Information is also available on the Institute's/Center's home page: *http://www.nidcr.nih.gov/about/CouncilCommittees.asp* , where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.121, Oral Diseases and Disorders Research, National Institutes of Health, HHS) Dated: May 8, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E8-10836 Filed 5-15-08; 8:45 am] BILLING CODE 4140-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. *Name of Committee:* Center for Scientific Review Special Emphasis Panel; Member Conflict: Inner Ear Hair Cells. *Date:* May 22, 2008. *Time:* 1 p.m. to 5 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). *Contact Person:* Daniel R. Kenshalo, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5176, MSC 7844, Bethesda, MD 20892, 301-435-1255, *kenshalod@csr.nih.gov* . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: May 8, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E8-10837 Filed 5-15-08; 8:45 am] BILLING CODE 4140-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the Pathobiology of Kidney Disease Study Section, June 12, 2008, 8 a.m. to June 13, 2008, 5 p.m., Hotel Deca, 4507 Brooklyn Avenue, NE., Seattle, WA 98105 which was published in the **Federal Register** on May 2, 2008, 73 FR 24296-24298. The meeting will be held one day only June 12, 2008. The meeting time and location remain the same. The meeting is closed to the public. Dated: May 8, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E8-10840 Filed 5-15-08; 8:45 am] BILLING CODE 4140-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. *Name of Committee:* Center for Scientific Review Special Emphasis Panel Member Conflict: Inner Ear and Cochlea. *Date:* May 28, 2008. *Time:* 1 p.m. to 5 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). *Contact Person:* Daniel R. Kenshalo, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5176, MSC 7844,Bethesda, MD 20892, 301-435-1255, *kenshalod@csr.nih.gov.* This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. *Name of Committee:* Brain Disorders and Clinical Neuroscience Integrated Review Group Clinical Neuroscience and Disease Study Section. *Date:* June 9-10, 2008. *Time:* 8 a.m. to 5 p.m. *Agenda:* To review and evaluate grant applications. *Place:* Latham Hotel, 3000 M Street, NW., Washington, DC 20007. *Contact Person:* Seetha Bhagavan, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5194, MSC 7846,Bethesda, MD 20892,
(301)435-1121, *bhagavas@csr.nih.gov.* *Name of Committee:* Center for Scientific Review Special Emphasis Panel Clinical Neuroscience and Disease. *Date:* June 9-10, 2008. *Time:* 8 a.m. to 5 p.m. *Agenda:* To review and evaluate grant applications. *Place:* Latham Hotel, 3000 M Street, NW., Washington, DC 20007. *Contact Person:* Seetha Bhagavan, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3022D, MSC 7846,Bethesda, MD 20892,
(301)435-1121, *bhagavas@csr.nih.gov.* *Name of Committee:* Integrative, Functional and Cognitive Neuroscience Integrated Review Group Central Visual Processing Study Section. *Date:* June 10, 2008. *Time:* 8 a.m. to 5 p.m. *Agenda:* To review and evaluate grant applications. *Place:* Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. *Contact Person:* Judith A. Finkelstein, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5178, MSC 7844,Bethesda, MD 20892, 301-435-1249, *finkelsj@csr.nih.gov.* *Name of Committee:* Center for Scientific Review Special Emphasis Panel Molecular Neurogenetics. *Date:* June 12, 2008. *Time:* 8 a.m. to 6 p.m. *Agenda:* To review and evaluate grant applications. *Place:* One Washington Circle Hotel, One Washington Circle, Washington, DC 20037. *Contact Person:* Robert C. Elliott, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5190, MSC 7846, Bethesda, MD 20892, 301-435-3009, *elliotro@csr.nih.gov.* *Name of Committee:* Center for Scientific Review Special Emphasis Panel ITT Member Conflict Application Review. *Date:* June 17, 2008. *Time:* 1 p.m. to 4 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). *Contact Person:* Jin Huang, Ph.D., Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4095G, MSC 7812, Bethesda, MD 20892, 301-435-1230, *jh377p@nih.gov.* *Name of Committee:* Center for Scientific Review Special Emphasis Panel Cardiovascular Devices. *Date:* June 23, 2008. *Time:* 8 a.m. to 5 p.m. *Agenda:* To review and evaluate grant applications. *Place:* Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. *Contact Person:* Roberto J. Matus, MD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5108, MSC, 7854 Bethesda, MD 20892, 301-435-2204, *matusr@csr.nih.gov.* *Name of Committee:* Center for Scientific Review Special Emphasis Panel Small Business: Radiation Therapy and Biology. *Date:* June 23, 2008. *Time:* 8 a.m. to 5 p.m. *Agenda:* To review and evaluate grant applications. *Place:* Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. *Contact Person:* Bo Hong, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6194, MSC 7804, Bethesda, MD 20892, 301-435-5879, *hongb@csr.nih.gov.* *Name of Committee:* Center for Scientific Review Special Emphasis Panel Non-HIV Microbial Vaccine Development. *Date:* June 23, 2008. *Time:* 8 a.m. to 5 p.m. *Agenda:* To review and evaluate grant applications. *Place:* George Washington University Inn, 824 New Hampshire Avenue, NW., Washington, DC 20037 *Contact Person:* Jin Huang, Ph.D., Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4095G, MSC 7812, Bethesda, MD 20892, 301-435-1230, *jh377p@nih.gov.* *Name of Committee:* Center for Scientific Review Special Emphasis Panel Oncology Fellowship. *Date:* June 23-24, 2008. *Time:* 8 a.m. to 5 p.m. *Agenda:* To review and evaluate grant applications. *Place:* Sir Francis Drake Hotel, 450 Powell Street, San Francisco, CA 94102. *Contact Person:* Eun Ah Cho, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6202, MSC 7804, Bethesda, MD 20892,
(301)451-4467, *choe@csr.nih.gov.* *Name of Committee:* Center for Scientific Review Special Emphasis Panel Cancer Chemoprevention. *Date:* June 23, 2008. *Time:* 1 p.m. to 2:30 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). *Contact Person:* Zhiqiang Zou, MD, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6190, MSC 7804, Bethesda, MD 20892, 301-451-0132, *zouzhiq@csr.nih.gov.* *Name of Committee:* Center for Scientific Review Special Emphasis Panel Cancer Clinical Trials. *Date:* June 24, 2008. *Time:* 1 p.m. to 3 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). *Contact Person:* Denise R. Shaw, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6158, MSC 7804, Bethesda, MD 20892, 301-435-0198, *shawkath@mail.nih.gov.* *Name of Committee:* Center for Scientific Review Special Emphasis Panel Member Conflict: Sleep and Memory. *Date:* June 25, 2008. *Time:* 1 p.m. to 5 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). *Contact Person:* Edwin C. Clayton, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5095C, MSC 7844, Bethesda, MD 20892,
(301)402-1304, *claytone@csr.nih.gov.* *Name of Committee:* Center for Scientific Review Special Emphasis Panel Molecular Biophysics of Voltage-Gated Channels. *Date:* June 26-28, 2008. *Time:* 7 a.m. to 2 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). *Contact Person:* James W. Mack, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4154, MSC 7806, Bethesda, MD 20892,
(301)435-2037, *mackj2@csr.nih.gov.* *Name of Committee:* Center for Scientific Review Special Emphasis Panel Small Business: Respiratory Sciences. *Date:* June 26, 2008. *Time:* 11 a.m. to 4 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). *Contact Person:* Bonnie L. Burgess-Beusse, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2191C, MSC 7818, Bethesda, MD 20892, 301-435-1783, *beusseb@mail.nih.gov* . *Name of Committee:* Center for Scientific Review Special Emphasis Panel Molecular Pathways in Cancer. *Date:* June 26, 2008. Time: 1 p.m. to 3 p.m., Agenda: To review and evaluate grant applications. *Place:* National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). *Contact Person:* Denise R. Shaw, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6158, MSC 7804, Bethesda, MD 20892, 301-435-0198, *shawkath@mail.nih.gov* . *Name of Committee:* Center for Scientific Review Special Emphasis Panel Cancer Drug Discovery and Therapeutics SBIR/STTR. *Date:* June 30, 2008. *Time:* 8 a.m. to 5 p.m. *Agenda:* To review and evaluate grant applications. *Place:* Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. *Contact Person:* Hungyi Shau, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6214, MSC 7804, Bethesda, MD 20892, 301-435-1720, *shauhung@csr.nih.gov* . (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: May 9, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E8-10948 Filed 5-15-08; 8:45 am] BILLING CODE 4140-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Dental & Craniofacial Research; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. *Name of Committee:* National Institute of Dental and Craniofacial Research Special Emphasis Panel; Review Small Research Grants for Data Analysis and Statistical Methodology. *Date:* June 17, 2008. *Time:* 1 p.m. to 3 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, One Democracy Plaza, 6701 Democracy Boulevard, Bethesda, MD 20892, (Telephone Conference Call). *Contact Person:* Mary Kelly, Scientific Review Officer, Scientific Review Branch, National Inst of Dental & Craniofacial Research, NIH 6701 Democracy Blvd, room 672, MSC 4878, Bethesda, Md 20892-4878, 301-594-4809, *mary_kelly@nih.gov* . (Catalogue of Federal Domestic Assistance Program Nos. 93.121, Oral Diseases and Disorders Research, National Institutes of Health, HHS) Dated: May 8, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E8-10835 Filed 5-15-08; 8:45 am] BILLING CODE 4140-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Child Health and Human Development; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. *Name of Committee:* National Institute of Child Health and Human Development Special Emphasis Panel; National Child Study. *Date:* June 8-10, 2008. *Time:* 2 p.m. to 5 p.m. *Agenda:* To review and evaluate contract proposals. *Place:* Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road, NW., Washington, DC 20015. *Contact Person:* Sathasiva B. Kandasamy, PhD, Scientific Review Administrator, Division of Scientific Review, National Institute of Child Health and Human Development, 6100 Executive Boulevard, Room 5b01, Bethesda, MD 20892-9304,
(301)435-6680, *skandasa@mail.nih.gov* . (Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS) Dated: May 8, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E8-10838 Filed 5-15-08; 8:45 am] BILLING CODE 4140-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Child Health and Human Development; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. *Name of Committee:* National Institute of Child Health and Human Development, Special Emphasis Panel Hormonal Signals that regulate Ovarian Differentiation. *Date:* June 10, 2008. *Time:* 1 p.m.to 3:30 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, 6100 Executive Boulevard, Room 5B01, Rockville, MD 20852. (Telephone Conference Call) *Contact Person:* Dennis E. Leszczynski, PhD, Scientific Review Administrator, Division Of Scientific Review, National Institute of Child Health, and Human Development, NIH, 6100 Exeuctive Blvd., Rm. 5B01, Bethesda, MD 20892,
(301)435-6884, *leszczyd@mail.nih.gov* . *Name of Committee:* National Institute of Child Health and Human Development, Special Emphasis Panel IEARDA. *Date:* June 10, 2008. *Time:* 2 p.m. to 4 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, 6100 Executive Boulevard, Room 5B01, Rockville, MD 20852. (Telephone Conference Call) *Contact Person:* Michele C. Hindi-Alexander, PhD, Division of Scientific Review, National Institutes of Health, Eunice Kennedy Shriver, National Institute for Child Health & Development, 1600 Executive Boulevard, R. 5B01, Bethesda, MD 20812-7510,
(301)435-8382, *hindialmmailnih.gov* . (Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS) Dated: May 8, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E8-10839 Filed 5-15-08; 8:45 am] BILLING CODE 4140-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Mental Health; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. *Name of Committee:* National Institute of Mental Health Special Emphasis Panel, National Cooperative Drug Discovery Groups. *Date:* June 4-5, 2008. *Time:* 8:30 a.m. to 1:30 p.m. *Agenda:* To review and evaluate grant applications. *Place:* Hotel Lombardy, 2019 Pennsylvania Ave., NW., Washington, DC 20006. *Contact Person:* Peter J. Sheridan, PhD, Scientific Review Administrator, Division of Extramural Activities, National Institute of Mental Health, NIH Neuroscience Center, 6001 Executive Blvd., Room 6142, MSC 9606, Bethesda, MD 20892, 301-443-1513, *psherida@mail.nih.gov* . *Name of Committee:* National Institute of Mental Health Special Emphasis Panel, Child Conflicts 2. *Date:* June 10, 2008. *Time:* 8 a.m. to 5 p.m. *Agenda:* To review and evaluate grant applications. *Place:* Crystal City Marriott, 1999 Jefferson Davis Highway, Arlington, VA 22202. *Contact Person:* Marina Broitman, Ph.D., Scientific Review Administrator, Division of Extramural Activities, National Institute of Mental Health, NIH Neuroscience Center, 6001 Executive Blvd., Room 6153, MSC 9608, Bethesda, MD 20892-9608, 301-402-8152, *mbroitma@mail.nih.gov* . *Name of Committee:* National Institute of Mental Health Special Emphasis Panel, Cognition and Schizophrenia Panel. *Date:* June 11, 2008. *Time:* 9 a.m. to 1 p.m. *Agenda:* To review and evaluate grant applications. *Place:* Crystal City Marriott, 1999 Jefferson Davis Highway, Arlington, VA 22202. *Contact Person:* Allan F. Mirsky, PhD, Scientific Review Administrator, Division of Extramural Activities, National Institute of Mental Health, NIH Neuroscience Center, 6001 Executive Boulevard, Rm. 6157, MSC 9609, Bethesda, MD 20892-9609, 301-496-2551, *afmirsky@mail.nih.gov* . (Catalogue of Federal Domestic Assistance Program Nos. 93.242, Mental Health Research Grants; 93.281, Scientist Development Award, Scientist Development Award for Clinicians, and Research Scientist Award; 93.282, Mental Health National Research Service Awards for Research Training, National Institutes of Health, HHS) Dated: May 8, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E8-10841 Filed 5-15-08; 8:45 am] BILLING CODE 4140-01-M DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency Use of Digital Flood Data AGENCY: Federal Emergency Management Agency, DHS. ACTION: Notice of availability. SUMMARY: Section 107 of the Bunning-Bereuter-Blumenauer Flood Insurance Reform Act of 2004 requires that geospatial digital flood hazard data distributed by the Federal Emergency Management Agency (FEMA), or its designee, or the printed products derived from that data, be interchangeable and legally equivalent for the determination of the location of 1-in-100-year and 1-in-500-year floodplains, provided that all other geospatial data shown on the printed product meets or exceeds any accuracy standard promulgated by FEMA. This is required for the purposes of flood insurance and floodplain management activities conducted pursuant to the National Flood Insurance Program under the National Flood Insurance Act of 1968. The FEMA Mitigation Directorate has developed a policy to implement this requirement. The policy states: To which FEMA products it applies; that “printed products” refers to both printed paper products produced by FEMA and by others; and that the horizontal location of the special flood hazard area on new products is defined by geographic coordinates. DATES: This notice is effective as of November 29, 2007. ADDRESSES: The policy is available online at *http://www.fema.gov/library/viewRecord.do?id=3235* . You may also view a hard copy of the policy at the Office of Chief Counsel, Federal Emergency Management Agency, Room 835, 500 C Street, SW., Washington, DC 20472. FOR FURTHER INFORMATION CONTACT: Paul Rooney, Data and Dissemination Branch, Mitigation Directorate, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, e-mail: *paul.rooney@dhs.gov* . SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA)publishes new Flood Insurance Rate Maps (FIRMs) in the form of paper maps, digital map images (the full-size FIRM Scans and letter-size FIRMettes) and digital geospatial flood hazard data (the Digital Flood Insurance Rate Map (DFIRM) Database product). The previously published maps are available only as paper maps or FIRM Scans/FIRMettes. As required by 42 U.S.C. 4101 note, FIRM Scans/FIRMettes, published paper FIRMs, DFIRM Database products and printed versions produced from the official digital products are all equivalent to each other and represent official FEMA designations of the areas of special flood hazard, base flood elevations, insurance risk zones and other regulatory information, provided that all other geospatial data shown on the printed product meets or exceeds any accuracy standard promulgated by FEMA. Beginning in 2001, most new FIRMs began showing a coordinate grid on the printed effective FIRM and are available as a DFIRM Database product. When a coordinate grid is shown on the printed FIRM or when the DFIRM Database version is available, the horizontal location of the flood hazard information is defined with respect to the primary coordinate system shown on the printed FIRM or stored in the DFIRM Database product. The horizontal location of the flood hazard information is not defined by its relationship to the base map features such as streets. If there are conflicting interpretations of the precise horizontal location of the areas of special flood hazard, the conflict shall be resolved using the grid coordinates shown on the printed FIRM or stored in the DFIRM Database product rather than the base map features. *Base map* is defined as the set of physical and cultural features shown on a flood map to provide a geographic and visual context to the flood hazard information. Features depicted by the base map include roads, railroads, buildings, lakes, streams, shorelines, jurisdiction boundaries, public land survey system information, land parcel, and orthoimagery. The policy is available online located at *http://www.fema.gov/library/viewRecord.do?id=3235* . You may also view a hard copy of the policy at the Office of Chief Counsel, Federal Emergency Management Agency, Room 835, 500 C Street, SW., Washington, DC 20472. Authority: 42 U.S.C. 4101 note. Dated: May 7, 2008. David I. Maurstad, Federal Insurance Administrator of the National Flood Insurance Program, Federal Emergency Management Agency, Department of Homeland Security. [FR Doc. E8-10932 Filed 5-15-08; 8:45 am] BILLING CODE 9110-12-P DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services Agency Information Collection Activities: Form G-845 and G-845S, and Supplement, Revision of a Currently Approved Information Collection; Comment Request ACTION: 30-Day Notice of Information Collection Under Review: Form G-845 and G-845S, Document Verification Request, and Document Verification Request Supplement; OMB Control No. 1615-0101. The Department of Homeland Security, U.S. Citizenship and Immigration Services (USCIS) has submitted the following information collection request to the Office of Management and Budget
(OMB)for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection was previously published in the **Federal Register** on March 4, 2008, at 73 FR 11654, allowing for a 60-day public comment period. USCIS did not receive any comments for this information collection. The purpose of this notice is to allow an additional 30 days for public comments. Comments are encouraged and will be accepted until June 16, 2008. This process is conducted in accordance with 5 CFR 1320.10. Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the Department of Homeland Security (DHS), and to the Office of Management and Budget
(OMB)USCIS Desk Officer. Comments may be submitted to: USCIS, Chief, Regulatory Management Division, Clearance Office, 111 Massachusetts Avenue, Suite 3008, Washington, DC 20529. Comments may also be submitted to DHS via facsimile to 202-272-8352 or via e-mail at *rfs.regs@dhs.gov,* and to the OMB USCIS Desk Officer via facsimile at 202-395-6974 or via e-mail at *kastrich@omb.eop.gov.* When submitting comments by e-mail please make sure to add OMB Control Number 1615-0101. Written comments and suggestions from the public and affected agencies should address one or more of the following four points:
(1)Evaluate whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2)Evaluate the accuracy of the agency's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;
(3)Enhance the quality, utility, and clarity of the information to be collected; and
(4)Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. Overview of This Information Collection
(1)*Type of Information Collection:* Revision of a currently approved information collection.
(2)*Title of the Form/Collection:* Document Verification Request and Document Verification Request Supplement.
(3)*Agency form number, if any, and the applicable component of the Department of Homeland Security sponsoring the collection:* Form G-845, Form G-845S, and Supplement. U.S. Citizenship and Immigration Services.
(4)*Affected public who will be asked or required to respond, as well as a brief abstract: Primary:* Individuals and Households. This information collection allows for the verification of immigration status of certain persons applying for benefits under certain entitlement programs.
(5)*An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond:* Form G-845 and G-845S: 260,026 responses at 5 minutes (.083) per response; Supplement: 128,072 responses at 5 minutes (.083) per response; and electronic queries 9,850,134 queries at 5 minutes (.083) per query.
(6)*An estimate of the total public burden (in hours) associated with the collection:* 849,773 annual burden hours. If you have additional comments, suggestions, or need a copy of the proposed information collection instrument with instructions, or additional information, please visit the USCIS Web site at: *http://www.regulations.gov/search/index.jsp* If additional information is required contact: USCIS, Regulatory Management Division, 111 Massachusetts Avenue, Suite 3008, Washington, DC 20529,
(202)272-8377. Dated: May 13, 2008. Stephen Tarragon, Acting Chief, Regulatory Management Division, U.S. Citizenship and Immigration Services, Department of Homeland Security. [FR Doc. E8-11037 Filed 5-15-08; 8:45 am] BILLING CODE 9111-97-P DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services Agency Information Collection Activities: Form I-730, Extension of an Existing Information Collection; Comment Request ACTION: 60-Day Notice of Information Collection Under Review: Form I-730, Refugee/Asylee Relative Petition; OMB Control No. 1615-0037. The Department of Homeland Security, U.S. Citizenship and Immigration Services (USCIS) has submitted the following information collection request for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection is published to obtain comments from the public and affected agencies. Comments are encouraged and will be accepted for sixty days until July 15, 2008. Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the Department of Homeland Security (DHS), USCIS, Chief, Regulatory Management Division, Clearance Office, 111 Massachusetts Avenue, 3rd floor, Washington, DC 20529. Comments may also be submitted to DHS via facsimile to 202-272-8352 or via e-mail at *rfs.regs@dhs.gov.* When submitting comments by e-mail, please make sure to add OMB Control Number 1615-0037 in the subject box. During this 60-day period USCIS will be evaluating whether to revise the Form I-730. Should USCIS decide to revise the Form I-730 it will advise the public when it publishes the 30-day notice in the **Federal Register** in accordance with the Paperwork Reduction Act. The public will then have 30-days to comment on any revisions to the Form I-730. Written comments and suggestions from the public and affected agencies should address one or more of the following four points:
(1)Evaluate whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2)Evaluate the accuracy of the agencies estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;
(3)Enhance the quality, utility, and clarity of the information to be collected; and
(4)Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques, or other forms of information technology, e.g., permitting electronic submission of responses. Overview of This Information Collection
(1)*Type of Information Collection:* Extension of an existing information collection.
(2)*Title of the Form/Collection:* Refugee/ Asylee Relative Petition.
(3)*Agency form number, if any, and the applicable component of the Department of Homeland Security sponsoring the collection:* Form I-730. U.S. Citizenship and Immigration Services.
(4)*Affected public who will be asked or required to respond, as well as a brief abstract: Primary:* Individuals or households. This form will be used by an asylee or refugee to file on behalf of his or her spouse and/or children provided that the relationship to the refugee/asylee existed prior to their admission to the United States. The information collected on this form will be used by USCIS to determine eligibility for the requested immigration benefit.
(5)*An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond:* 86,400 responses at 35 minutes (.583) per response.
(6)*An estimate of the total public burden (in hours) associated with the collection:* 50,371 annual burden hours. If you have additional comments, suggestions, or need a copy of the information collection instrument, please visit: *http://www.regulations.gov/search/index.jsp.* We may also be contacted at: USCIS, Regulatory Management Division, 111 Massachusetts Avenue, NW., Suite 3008, Washington, DC 20529, telephone number 202-272-8377. Dated: May 13, 2008. Stephen Tarragon, Acting Chief, Regulatory Management Division, U.S. Citizenship and Immigration Services, Department of Homeland Security. [FR Doc. E8-11049 Filed 5-15-08; 8:45 am] BILLING CODE 9111-97-P DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services Agency Information Collection Activities: Form N-400, Extension of an Existing Information Collection; Comment Request ACTION: 60-Day Notice of Information Collection Under Review; Form N-400, Application for Naturalization; OMB Control No. 1615-0052. The Department Homeland Security, U.S. Citizenship and Immigration Services, has submitted the following information collection request for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection is published to obtain comments from the public and affected agencies. Comments are encouraged and will be accepted for 60 days until July 15, 2008. Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the Department of Homeland Security (DHS), USCIS, Chief, Regulatory Management Division, Clearance Officer, 111 Massachusetts Avenue, 3rd floor, Suite 3008, Washington, DC 20529. Comments may also be submitted to DHS via facsimile to 202-272-8352 or via e-mail at *rfs.regs@dhs.gov.* When submitting comments by e-mail, please make sure to add OMB Control No. 1615-0052 in the subject box. During this 60-day period USCIS will be evaluating whether to revise the Form N-400. Should USCIS decide to revise the Form N-400 it will advise the public when it publishes the 30-day notice in the **Federal Register** in accordance with the Paperwork Reduction Act. The public will then have 30-days to comment on any revisions to the Form N-400. Written comments and suggestions from the public and affected agencies concerning the collection of information should address one or more of the following four points:
(1)Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2)Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3)Enhance the quality, utility, and clarity of the information to be collected; and
(4)Minimize the burden of the collection of information on those who are to respond including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, *e.g.* , permitting electronic submission of responses. Overview of This Information Collection
(1)*Type of Information Collection:* Extension of an existing information collection.
(2)*Title of the Form/Collection:* Application for Naturalization.
(3)*Agency form number, if any, and the applicable component of the Department of Homeland Security sponsoring the collection:* Form N-400; U.S. Citizenship and Immigration Services.
(4)*Affected public who will be asked or required to respond, as well as a brief abstract: Primary:* Individuals or households. USCIS uses the information on this form to determine an applicant's eligibility for naturalization.
(5)*An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond:* 700,000 responses at 6 hours and 8 minutes (6.13 hours) per response.
(6)*An estimate of the total public burden (in hours) associated with the collection:* 4,291,000 annual burden hours. If you have additional comments, suggestions, or need a copy of the information collection instrument, please visit: *http://www.regulations.gov/search/index.jsp.* We may also be contacted at: USCIS, Regulatory Management Division, 111 Massachusetts Avenue, NW., Suite 3008, Washington, DC 20529, telephone number 202-272-8377. Dated: May 13, 2008. Stephen Tarragon, Acting Chief, Regulatory Management Division, U.S. Citizenship and Immigration Services, Department of Homeland Security. [FR Doc. E8-11050 Filed 5-15-08; 8:45 am] BILLING CODE 9111-97-P DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5186-N-20] Federal Property Suitable as Facilities To Assist the Homeless AGENCY: Office of the Assistant Secretary for Community Planning and Development, HUD. ACTION: Notice. SUMMARY: This Notice identifies unutilized, underutilized, excess, and surplus Federal property reviewed by HUD for suitability for possible use to assist the homeless. DATES: *Effective Date: May 16, 2008* . FOR FURTHER INFORMATION CONTACT: Kathy Ezzell, Department of Housing and Urban Development, 451 Seventh Street, SW., Room 7262, Washington, DC 20410; telephone
(202)708-1234; TTY number for the hearing- and speech-impaired
(202)708-2565, (these telephone numbers are not toll-free), or call the toll-free Title V information line at 800-927-7588. SUPPLEMENTARY INFORMATION: In accordance with the December 12, 1988 court order in *National Coalition for the Homeless* v. *Veterans Administration* , No. 88-2503-OG (D.D.C.), HUD publishes a Notice, on a weekly basis, identifying unutilized, underutilized, excess and surplus Federal buildings and real property that HUD has reviewed for suitability for use to assist the homeless. Today's Notice is for the purpose of announcing that no additional properties have been determined suitable or unsuitable this week. Dated: May 8, 2008. Mark R. Johnston, Deputy Assistant Secretary for Special Needs. [FR Doc. E8-10630 Filed 5-15-08; 8:45 am] BILLING CODE 4210-67-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS-R2-ES-2008-N0116; 21012-11130000-C2] Draft Bexar County Karst Invertebrates Recovery Plan AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of document availability. SUMMARY: We, the U.S. Fish and Wildlife Service (Service), announce the availability of the Draft Bexar County Karst Invertebrates Recovery Plan. We are soliciting review and comment from the public on this draft recovery plan. DATES: To ensure consideration, we must receive comments by July 15, 2008. ADDRESSES: You may obtain copies of the draft recovery plan from Cyndee Watson, U.S. Fish and Wildlife Service, 10711 Burnet Road, Suite #200, Austin, Texas, (512-490-0057 ext. 223) or download it from the internet at *http://www.fws.gov/southwest/es/Library/* (type “Bexar County” in the document title search field). FOR FURTHER INFORMATION CONTACT: Adam Zerrenner, Field Supervisor, U.S. Fish and Wildlife Service, 10711 Burnet Road Suite #200, Austin, Texas 78758; telephone 512-490-0057 ext 249. SUPPLEMENTARY INFORMATION: Background The Endangered Species Act of 1973 (Act), as amended (16 U.S.C. 1531 *et. seq* .) requires the development of recovery plans for listed species unless such a plan would not promote the conservation of a particular species. Section 4(f) of the Act, as amended in 1988, requires that public notice and an opportunity for public review and comment be provided during recovery plan development. The Service considers all information provided during a public comment period prior to approval of each new recovery plan. The Service and others take these comments into account in the course of implementing recovery plans. Nine Bexar County karst invertebrates were listed as endangered species on December 26, 2000 (65 FR 81419 81433). These invertebrates are troglobites, spending their entire lives underground. They inhabit caves and mesocaverns (humanly impassable voids in karst limestone) in Bexar County, Texas. They are characterized by small or absent eyes and pale coloration. These species are *Rhadine exilis, Rhadine infernalis, Batrisodes venyivi, Texella cokendolpheri, Neoleptoneta microps, Cicurina baroni, Cicurina madla, Cicurina venii,* and *Cicurina vespera.* The draft recovery plan includes scientific information about the species and provides objectives and actions needed to recover the Bexar County karst invertebrates and to ultimately remove them from the list of threatened and endangered species. Recovery actions designed to achieve these objectives include reducing threats to the species by securing an adequate quantity and quality of habitat. This includes selecting caves or cave clusters that represent the range of the species and potential genetic diversity for the nine species, then preserving these karst habitats by preserving their drainage basins and surface communities upon which they rely. Because many aspects of the population dynamics and habitat requirements of the species are poorly understood, recovery is also dependant on incorporating research findings into adaptive management actions. Because four of these species are known to occur in only one cave, full recovery may not be possible for these species. Public Comments To comment on the plan, please mail comments to the Field Supervisor, Attention Draft Bexar County Karst Invertebrate Recovery Plan, U.S. Fish and Wildlife Service, Austin Ecological Services Field Office, 10711 Burnet Road, Suite 200, Austin, Texas 78758. You may also submit comments electronically to *BexarKIrecplan@fws.gov* or fax to 512-490-0974. Public Availability of Comments Before including your address, phone number, e-mail address, or other personal identifying information in your comment, you should be aware that your entire comment, including your personal identifying information, may be made publicly available at any time. While we will try to honor your written request to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so. Authority The authority for this action is section 4(f) of the Endangered Species Act, 16 U.S.C. 1533(f). Dated: April 24, 2008. Christopher T. Jones, Acting Regional Director, Region 2. [FR Doc. E8-10996 Filed 5-15-08; 8:45 am] BILLING CODE 4310-55-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS-R8-ES-2008-N0082; 1112-0000-81420-F2] East Bay Municipal Utility District Habitat Conservation Plan, East Bay Watershed Lands, Alameda and Contra Costa Counties, CA AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of availability: Proposed low-effect habitat conservation plan; request for comment. SUMMARY: The East Bay Municipal Utility District, Oakland (EBMUD or applicant) has applied to the Fish and Wildlife Service (Service) for a 30-year incidental take permit for seven species pursuant to section 10(a)(1)(B) of the Endangered Species Act of 1973, as amended
(Act)(16 U.S.C. 1531 *et seq* .). The application addresses the potential for “take” of two listed animals, two listed plants, and three currently unlisted species. The applicant would implement a conservation program to minimize and mitigate the project activities, as described in the East Bay Municipal Utility District Low-Effect East Bay Habitat Conservation Plan (plan). We request comments on the applicant's application and plan, and the preliminary determination that the plan qualifies as a “low-effect” habitat conservation plan, eligible for a Categorical Exclusion under the National Environmental Policy Act of 1969, as amended (NEPA). We discuss our basis for this determination in our Environmental Action Statement (EAS), which is also available for public review. DATES: We must receive written comments on or before June 16, 2008. ADDRESSES: Please address written comments to Sheila Larsen, Conservation Planning Branch, Fish and Wildlife Service, Sacramento Fish and Wildlife Office, 2800 Cottage Way, W-2605, Sacramento, CA 95825. Alternatively, you may send comments by facsimile to
(916)414-6713. FOR FURTHER INFORMATION CONTACT: Sheila Larsen, or Eric Tattersall, Branch Chief, Conservation Planning Branch, at the address shown above or at 916-414-6600 (telephone). SUPPLEMENTARY INFORMATION: Availability of Documents Copies of the permit application, plan, and EAS can be obtained from the individuals named above (see FOR FURTHER INFORMATION CONTACT ). Copies of these documents are available for public inspection, by appointment, during regular business hours, at the Sacramento Fish and Wildlife Office (see ADDRESSES ). Documents also are available for public inspection, during regular business hours, at the East Bay Municipal Utility District, Orinda, Natural Resources Department, 500 San Pablo Dam Road, Orinda, CA 94563. Public Availability of Comments Before including your address, phone number, e-mail address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so. Background Information Section 9 of the Act (16 U.S.C. 1531 *et seq.* ) and its implementing Federal regulations prohibit the “take” of fish or wildlife species listed as endangered or threatened. “Take” is defined under the Act to include the following activities: To harass, harm, pursue, hunt, shoot, wound, kill, trap, capture or collect listed animal species, or to attempt to engage in such conduct. However, under section 10(a)(1)(B) of the Act, we may issue permits to authorize incidental take of listed species. “Incidental take” is defined by the Act as take that is incidental to, and not the purpose of, carrying out an otherwise lawful activity. Regulations governing incidental take permits for endangered and threatened species, respectively, are in the Code of Federal Regulations at 50 CFR 17.22 and 50 CFR 17.32. Although take of listed plant species is not prohibited under the Act, and therefore cannot be authorized under an incidental take permit, plant species may be included on a permit in recognition of the conservation benefits provided to them under a habitat conservation plan. All species included on the incidental take permit would receive assurances under the Services' “No Surprises” regulations (50 CFR 17.22(b)(5) and 17.32(b)(5). The applicant seeks an incident take permit for covered activities within 28,200 acres of watershed lands owned by EBMUD located in Contra Costa and Alameda Counties, California. EBMUD is requesting permits for take of two federally listed animal species, both listed as threatened: California red-legged frog ( *Rana aurora draytonii* ) and Alameda whipsnake ( *Masticophis lateralis euryxanthus* ). The two federally listed plant species, both listed as threatened, are Santa Cruz tarplant ( *Holocarpha macradenia* ) and pallid manzanita ( *Arctostaphylos pallida* ). The proposed covered species also include three wildlife species that are not currently listed under the Act—western pond turtle ( *Clemmys marmorata* ), pallid bat ( *Antrozous pallidus* ), and an unlisted resident population of rainbow trout ( *O. mykiss* )—should these species be listed during the life of the permit. These rainbow trout are genetically identical to steelhead, a fish species federally listed as threatened. However, these trout are landlocked above Upper San Leandro Dam, and are considered rainbow trout, not steelhead. Collectively, all of these species are referred to as “covered species” in the plan. EBMUD owns and manages watershed lands in Alameda and Contra Costa Counties, located in the San Francisco Bay Area of California. These lands surround five reservoirs (Briones, San Pablo, Upper San Leandro, Chabot, and Lafayette) and a portion of one basin that does not have a reservoir (Pinole Valley). EBMUD reservoirs store drinking water and emergency water supplies for 1.3 million people residing in Alameda and Contra Costa Counties. Covered activities include the following watershed management and maintenance activities: A biodiversity program; forestry program; livestock grazing; agricultural operations; fire and fuels management; a trench spoils storage and removal program for the north and south watershed areas; maintenance activities related to recreational activities; and permitted watershed access on fire roads and designated trails. The implementation of mitigation measures such as creek restoration activities are also included as covered activities. The covered activities are described more fully in the plan, and additional information on EBMUD management activities can be found in their East Bay Watershed Master Plan, Fire Management Plan, and EBMUD's Range Resource Management Plan. EBMUD's watershed planning documents are available at this link: *http://www.ebmud.com/water_&_environment/environmental_protection/* . The applicant proposes to avoid, minimize, and mitigate the effects to the covered species associated with the covered activities by fully implementing the plan. To minimize and mitigate the impacts of the covered activities, the applicant will continue ongoing conservation activities and develop additional measures for the further protection of covered species, if necessary. Minimization measures will include, but are not limited to, seasonal restrictions on when work may be conducted, preconstruction surveys, and temporary removal of covered species from work areas. General mitigation measures will include restoration of disturbed habitat, improved grazing practices, maintenance of stockponds for California red-legged frogs and western pond turtles, riparian restoration, and conversion of non-native forests to native species. Santa Cruz tarplant is represented by a single experimental population that has not been observed for 10 years. It will be adaptively managed to encourage the re-establishment of this fire-adapted species. Pallid manzanita will not be affected by covered activities, but competition with other species will be reduced through pruning of nearby vegetation. Rainbow trout habitat will be improved through revegetation of affected areas and fencing of creek corridors, and placement of spawning gravel to provide substrate if no spawning is observed on EBMUD lands. Coastal scrub that provides habitat for Alameda whipsnakes will be allowed to encroach into grassland so that the overall amount of this vegetation community does not vary by more than 1 percent due to covered activities. Mitigation measures for pallid bat include maintenance of moderate grazing levels; education of grazing lessees, signage on the known habitat, and installation of bat boxes adjacent to the currently used site. Alternatives The Service's proposed action consists approving the applicant's plan and issuance of an incidental take permit for the applicant's Covered Activities. As required by the Act, the applicant's plan considers alternatives to the take under the proposed action. The plan considers the environmental consequences of one alternative to the proposed action, the No Action alternative. Under the No Action Alternative, no permit would be issued and projects would be reviewed and permitted on an individual basis. The proposed action alternative consists of issuance of the incidental take permit for the applicant's proposed project, which includes the activities described above. National Environmental Policy Act As described in our EAS, we have made the preliminary determination that approval of the proposed plan and issuance of the permit would qualify as a categorical exclusion under NEPA, as provided by Federal regulations (40 CFR 1500, 5(k), 1507.3(b)(2), 1508.4) and the Department of the Interior Manual (516 DM 2 and 516 DM 8). Our EAS found that the proposed plan qualifies as a “low-effect” habitat conservation plan, as defined by the Service's Habitat Conservation Planning Handbook (November 1996). Determination of low-effect habitat conservation plans is based on the following three criteria:
(1)Implementation of the proposed plan would result in minor or negligible effects on federally listed, proposed, and candidate species and their habitats;
(2)implementation of the proposed plan would result in minor or negligible effects on other environmental values or resources; and
(3)impacts of the plan, considered together with the impacts of other past, present, and reasonably foreseeable similarly situated projects, would not result, over time, in cumulative effects to environmental values or resources that would be considered significant. Based upon the preliminary determinations in the EAS, we do not intend to prepare further NEPA documentation. We will consider public comments when making the final determination on whether to prepare an additional NEPA document on the proposed action. We provide this notice pursuant to section 10(c) of the Act and the NEPA public-involvement regulations (40 CFR 1500.1(b), 1500.2(d), and 1506.6). We will evaluate the permit application, including the plan, and comments submitted thereon to determine whether the application meets the requirements of section 10(a) of the Act. If the requirements are met, we will issue a permit to the applicant for the incidental take of the California red-legged frog, Alameda whipsnake, western pond turtle, pallid bat, rainbow trout, Santa Cruz tarplant, and pallid manzanita, from the implementation of the covered activities described in the plan, or from mitigation conducted as part of this plan. We will make the final permit decision no sooner than 30 days after the date of this notice. Dated: May 12, 2008. Susan K. Moore, Field Supervisor, Sacramento Fish and Wildlife Office, Sacramento, California. [FR Doc. E8-10994 Filed 5-15-08; 8:45 am] BILLING CODE 4310-55-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS-R2-ES-2008-N0086; 20124-11120000-F2] Regional Habitat Conservation Plan, Hays County, TX AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of intent to prepare an environmental impact statement; announcement of public scoping meeting; request for comments. SUMMARY: We, the U.S. Fish and Wildlife Service (Service), advise the public that we intend to prepare an Environmental Impact Statement
(EIS)to evaluate the impacts of, and alternatives to, the proposed issuance of an Incidental Take Permit
(ITP)under the Endangered Species Act of 1973 (Act), as amended (16 U.S.C. 1531 *et seq.* ) to Hays County, Texas (Applicant). We also announce a public scoping meeting and public comment period. DATES: We must receive written comments on alternatives and issues to be addressed in the EIS by July 18, 2008. We will hold a public scoping meeting on June 18, 2008, from 5:30 p.m. to 8:30 p.m. at the San Marcos Activity Center, 501 E. Hopkins Road, San Marcos, TX 78666. ADDRESSES: Send your comments or request for information by any one of the following methods: • *U.S. mail:* Field Supervisor, Fish and Wildlife Service, 10711 Burnet Road, Suite 200, Austin, TX 78758. • *Facsimile:* 512-490-0974. • *E-mail: info@hayscountyhcp.com* . FOR FURTHER INFORMATION CONTACT: • *EIS Information:* Ms. Allison Arnold, U.S. Fish and Wildlife Service, 10711 Burnet Road, Suite 200, Austin, TX 78758; 512-490-0057 (phone); 512-490-0974 (fax); or *Allison_Arnold@fws.gov* (e-mail). • *Hays County RHCP Information:* County Judge Liz Sumter, 111 E. San Antonio St., Suite 300, San Marcos, TX 78666; 512-393-2205 (phone); or 512-393-2282 (fax). • *Other Information:* You may obtain additional information on the Hays County RHCP on the Internet at *http://www.hayscountyhcp.com* . SUPPLEMENTARY INFORMATION: We intend to prepare an EIS to evaluate the impacts of, and alternatives to, the proposed issuance of an ITP under the Act, to the Applicant. We also announce a public scoping meeting and public comment period. The Applicant proposes to apply for an ITP supported by development and implementation of the Hays County Regional Habitat Conservation Plan (RHCP). The Hays County RHCP will include measures necessary to minimize and mitigate the impacts of the proposed taking on the federally-listed species. We furnish this notice in compliance with the National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.), and its implementing regulations (40 CFR 1500-1508), in order to:
(1)Advise other Federal and state agencies, affected tribes, and the public of our intent to prepare an EIS;
(2)announce the initiation of a public scoping period; and
(3)obtain suggestions and information on the scope of issues and alternatives we will consider in our EIS. We intend to gather the information necessary to determine impacts and alternatives for an EIS regarding our potential issuance of an ITP to the Applicant, and the implementation of the Hays County RHCP. Purpose and Need for Action Section 9 of the Act and its implementing regulations prohibit take of species listed under the Act as endangered or threatened. The definition of “take” under the Act includes the following activities: To harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect listed animal species, or attempt to engage in any such conduct (16 U.S.C. 1538). Regulations define “harm” as significant habitat modification or degradation that results in actual death or injury to the listed species by significantly impairing essential behavioral patterns, including breeding, feeding, or sheltering (50 CFR 17.3). Section 10(a)(1)(B) of the Act requires us to issue ITPs to non-Federal entities for take of endangered and threatened species, provided the following criteria are met:
(1)The taking will be incidental;
(2)the applicant will, to the maximum extent practicable, minimize and mitigate the impact of such taking;
(3)the applicant will develop a habitat conservation plan and ensure that adequate funding for the plan will be provided;
(4)the taking will not appreciably reduce the likelihood of the survival and recovery of the species in the wild; and
(5)the applicant will carry out any other measures that we may require as being necessary or appropriate for the purposes of the habitat conservation plan. We anticipate that under the ITP, the Applicant will request coverage for a period of 30 years from the date of the RHCP approval. Implementation of the Hays County RHCP would result in the establishment of preserves intended to provide for the conservation of the covered species occupying those preserves. Research, monitoring, and adaptive management would be used to facilitate accomplishment of these goals. Proposed Action The proposed action is the issuance of an ITP for the covered species in Hays County. The Applicant would develop and implement the Hays County RHCP, which must meet the requirements in section 10(a)(2)(A) of the Act by providing measures necessary to minimize and mitigate the impacts of the proposed taking on the covered species. Activities proposed for coverage under the ITP include otherwise lawful activities that would occur consistent with the Hays County RHCP and include, but are not limited to, construction and maintenance of public projects and infrastructure as well as residential, commercial, and industrial development. Species the Applicant has recommended for inclusion as covered species in the Hays County RHCP include the golden-cheeked warbler ( *Dendroica chrysoparia* ) and black-capped vireo ( *Vireo atricapilla* ). For these covered species, Hays County would seek incidental take authorization. The Hays County RHCP would also address 40 “evaluation species” (39 terrestrial or aquatic karst species and the Cagle's map turtle ( *Graptemys caglei* )) and 15 “additional species” (6 listed aquatic species, 3 unlisted plants, and 6 unlisted surface aquatic species). Incidental take authorization for the evaluation species may become necessary to include in the proposed ITP over the term of the Hays County RHCP; however, these species will not be initially included as “covered” species. Evaluation species may be currently unlisted, but could become listed in the foreseeable future. The Hays County RHCP may include conservation measures to benefit evaluation species, where practicable, and support research to help fill data gaps regarding the biology, habitat, distribution, or management of these species. The research supported by the RHCP may aide in the conservation of these species or facilitate obtaining incidental take coverage, if these species become listed in the future. For the 15 “additional species,” Hays County would not seek incidental take authorization because these species either are not currently listed as threatened or endangered, or are not likely to experience take from covered activities, or insufficient information is available to adequately evaluate take and mitigation. Alternatives The proposed action and alternatives that will be developed in the EIS will be assessed against the No Action/No Project Alternative, which assumes that some or all of the current and future take of covered species in Hays County would be implemented individually, one at a time, and be in compliance with the Act. The No Action/No Project alternative implies that the impacts from these potential activities on the covered species would be evaluated and mitigated on a project-by-project basis, as is currently the case. For any activities involving take of listed species due to non-Federal actions, individual Section 10(a)(1)(B) permits would be required. Without a coordinated, comprehensive conservation approach for Hays County, listed species may not be adequately addressed by individual project-specific mitigation requirements, unlisted candidate and other rare species would not receive proactive conservation actions, and mitigation would be less cost effective in helping Federal and non-Federal agencies work toward recovery of listed species. Current independent conservation actions would continue, although some of these are not yet funded. A reasonable range of alternatives would also be considered, along with the associated impacts of the various alternatives. Scoping Meeting A primary purpose of the scoping process is to receive suggestions and information on the scope of issues and alternatives to consider when drafting the EIS, and to identify, rather than debate, significant issues related to the proposed action. In order to ensure that we identify a range of issues and alternatives related to the proposed action, we invite comments and suggestions from all interested parties. We will accept oral and written comments at this meeting. You may also submit your comments to the address listed in ADDRESSES . Once the draft EIS RHCP are completed, additional opportunity for public comment on the content of these documents and an additional public meeting will be provided. We will conduct a review of this project according to the requirements of NEPA and its regulations; other appropriate Federal laws, regulations, policies, and guidance; and Service procedures for compliance with those regulations. Persons needing reasonable accommodations in order to attend and participate in the public meeting should contact the Service at the address below no later than one week before the public meeting. Information regarding this proposed action is available in alternative formats upon request. Public Availability of Comments All comments we receive become part of the public record. Requests for comments will be handled in accordance with the Freedom of Information Act, NEPA, and Service and Department of the Interior policies and procedures. Before including your address, phone number, e-mail address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us to withhold your personal identifying information from public review, we cannot guarantee we will be able to do so. Environmental Review The EIS will be prepared in accordance with the requirements of NEPA, its implementing regulations (40 CFR parts 1500-1508), other applicable regulations, and the Service's procedures for compliance with those regulations. The EIS will analyze the proposed action, as well as a range of reasonable alternatives and the associated impacts of each. The EIS will be the basis for our evaluation of impacts to the covered species and the range of alternatives to be addressed. We expect the EIS to provide biological descriptions of the affected species and habitats, as well as the effects of the proposed action on resources such as: vegetation, wetlands, wildlife, threatened or endangered species and rare species, geology and soils, air quality, water resources, flood control, water quality, cultural resources (prehistoric, historic, and traditional cultural properties), land use, recreation, water use, local economy, and environmental justice. After the environmental review is complete, we will publish a notice of availability along with a request for comment on the draft EIS and the applicant's permit application, which will include the Hays County RHCP. The draft EIS and RHCP are expected to be completed and available to the public by January 2009. Thomas L. Bauer, Acting Regional Director, Southwest Region, Albuquerque, New Mexico. [FR Doc. E8-10941 Filed 5-15-08; 8:45 am] BILLING CODE 4510-55-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS-R2-ES-2008-N0024]; [20124-1113-0000-F2] Williamson County Regional Habitat Conservation Plan AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of availability: draft environmental impact statement, draft habitat conservation plan, and permit application; announcement of a public hearing. SUMMARY: Williamson County, Texas (Applicant), has applied to the U.S. Fish and Wildlife Service (Service) for an incidental take permit (TE-181840-0) under section 10(a)(1)(B) of the Endangered Species Act
(Act)of 1973, as amended. The requested permit, which would be in effect for a period of 30 years, if granted, would authorize incidental take of the following federally listed species: Golden-cheeked warbler ( *Dendroica chrysoparia* ), black-capped vireo ( *Vireo atricapilla* ), Bone Cave harvestman ( *Texella reyesi* ), and Coffin Cave mold beetle ( *Batrisodes texanus* ). The proposed take would occur in Williamson County, Texas, as a result of activities including, but not limited to, road construction, maintenance, and improvement projects; utility construction and maintenance; school development and construction; public or private construction and development; and land clearing. Such actions cause effects to upland
(bird)and underground (karst) habitats. Williamson County has completed a draft Habitat Conservation Plan
(dHCP)as part of the application package. We have issued a draft environmental impact statement
(dEIS)that evaluates the impacts of, and alternatives to, possible issuance of an incidental take permit (ITP). DATES: To ensure consideration, we must receive written comments on or before close of business (4:30 p.m. CST) July 15, 2008. We will also accept oral and written comments at a public hearing to be held on June 16, 2008, 5 p.m.to 8 p.m., Williamson County Courthouse, Commissioners Court—2nd Floor West, 710 Austin Avenue, Georgetown, Texas 78626. ADDRESSES: You may obtain copies of the dEIS and dHCP by going to the Williamson County Conservation Foundation Web site at *http://wilcogov.org/wccf/report.htm* . Alternatively, you may obtain compact disks with electronic copies of these documents by writing to Mr. Adam Zerrenner, Field Supervisor, U.S. Fish and Wildlife Service, 10711 Burnet Road, Suite 200, Austin, TX 78758; calling
(512)490-0057; or faxing
(512)490-0974. A limited number of printed copies of the dEIS and dHCP are also available, by request, from Mr. Zerrenner. Copies of the dEIS and dHCP are also available for public inspection and review at the following locations (by appointment only at government offices): —Department of the Interior, Natural Resources Library, 1849 C. St., NW., Washington, DC 20240. —U.S. Fish and Wildlife Service, 500 Gold Avenue, SW., Room 4012, Albuquerque, NM 87102. —U.S. Fish and Wildlife Service, 10711 Burnet Road, Suite 200, Austin, TX 78758. Persons wishing to review the application may obtain a copy by writing to the Regional Director, U.S. Fish and Wildlife Service, P.O. Box 1306, Room 4012, Albuquerque, NM 87103. FOR FURTHER INFORMATION CONTACT: Mr. Adam Zerrenner, Field Supervisor, U.S. Fish and Wildlife Service, 10711 Burnet Road, Suite 200, Austin, TX 78758 or
(512)490-0057. SUPPLEMENTARY INFORMATION: Written comments may be submitted to Mr. Adam Zerrenner (see above). We will also accept written and oral comments at a public hearing (see DATES ). Public Availability of Comments Written comments we receive become part of the public record associated with this action. Before including your address, phone number, e-mail address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can request in your comment that we withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so. We will not consider anonymous comments. All submissions from organizations or businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses, will be made available for public disclosure in their entirety. Under the National Environmental Policy Act (NEPA), this notice advises the public that we have gathered the information necessary to determine impacts and formulate alternatives for the EIS related to the potential issuance of an ITP to Williamson County; and that the Applicant has developed an HCP which describes the measures the applicant has agreed to undertake to minimize and mitigate the effects of incidental take of federally listed species to the maximum extent practicable, pursuant to section 10(a)(1)(B) of the Act. Background Our initial notice of intent to prepare an EIS and hold public scoping meetings published in the **Federal Register** on June 1, 2007 (64 FR 30604). A summary of comments provided during the 2007 scoping periods, which included a public meeting held June 14, 2007, in Georgetown, Texas, is available on the Williamson County Conservation Foundation Web site at *http://wilcogov.org/wccf/report.htm* . The Williamson County Regional Habitat Conservation Plan (WCRHCP) and the conservation program described in the plan were developed in a process involving participants and stakeholders from potentially affected or interested groups in Williamson County. The groups are organized into a Citizens Advisory Committee and a Biological Advisory Team that have overseen the development of the WCRHCP. The Williamson County Conservation Foundation Web site contains information on meetings, documents, and the status of the process. Proposed Action The proposed action involves the issuance of an ITP by the Service for covered activities in Williamson County, pursuant to section 10(a)(1)(B) of the Act. The activities that would be covered by the ITP are road construction, maintenance, and improvement projects; utility construction and maintenance; school development and construction; public or private construction and development; and land clearing. The ITP will cover Williamson County, Texas, within the range of the covered species. The requested term of the permit is 30 years. To meet the requirements of a section 10(a)(1)(B) ITP, the Applicant has developed and will implement the WCRHCP, which describes the conservation measures the Applicant has agreed to undertake to minimize and mitigate for incidental take of golden-cheeked warbler, black-capped vireo, Bone Cave harvestman, and Coffin Cave mold beetle to the maximum extent practicable, and ensures that incidental take will not appreciably reduce the likelihood of the survival and recovery of these species in the wild. *Alternatives:* Two alternatives to the proposed action we are considering as part of this process are: 1. No Action—No ITP would be issued. This alternative would require individuals to seek authorization through section 7 or section 10(a)(1)(B) to address incidental take resulting from their actions in Williamson County or avoid taking actions that would result in incidental take. 2. Modified (Reduced Take and Mitigation) WCRHCP—This alternative would only cover take of the golden-cheeked warbler and Bone Cave harvestman. The amount of authorized take and mitigation would be reduced for both species. Section 9 of the Act and its implementing regulations prohibit the “taking” of threatened and endangered species. However, under limited circumstances, we may issue permits to take listed wildlife species incidental to, and not the purpose of, otherwise lawful activities. We provide this notice under section 10(c) of the Act (16 U.S.C. 1531 *et seq* .) and its implementing regulations (50 CFR 17.22) and NEPA (42 U.S.C. 4371 *et seq* .) and its implementing regulations (40 CFR 1506.6). In addition, Chapter 83 of the Texas Parks and Wildlife Code places State-law requirements on the development of regional HCPs. In accordance with Chapter 83.015(f) of the Code, after notice and hearing, a regional HCP, including any mitigation fee, and the size of the habitat preserves may be based on any recovery criteria applicable to each endangered species to be covered by the regional HCP. Christopher T. Jones, Regional Director, Southwest Region, Albuquerque, New Mexico. [FR Doc. E8-10942 Filed 5-15-08; 8:45 am] BILLING CODE 4310-55-P DEPARTMENT OF THE INTERIOR Geological Survey Announcement of National Geospatial Advisory Committee Meeting AGENCY: U.S. Geological Survey, Interior. ACTION: Notice of meeting. SUMMARY: The National Geospatial Advisory Committee
(NGAC)will meet on June 3-4, 2008 in the 2nd Floor Boardroom of the American Institute of Architects Building, 1735 New York Avenue, NW., Washington, DC 20006. The NGAC, which is composed of representatives from governmental, private sector, non-profit, and academic organizations, has been established to advise the Chair of the Federal Geographic Data Committee on management of Federal geospatial programs, the development of the National Spatial Data Infrastructure, and the implementation of Office of Management and Budget
(OMB)Circular A-16. Topics to be addressed at the meeting include: —Discussion of NGAC Bylaws/NGAC Mission —Geospatial Line of Business/OMB Circular A-16 —Imagery for the Nation —Subcommittee Reports —National Geospatial Strategy Design The meeting will include an opportunity for public comment during the morning of June 4. Comments may also be submitted to the NGAC in writing. While the meeting will be open to the public, seating may be limited due to room capacity. DATES: The meeting will be held on June 3-4, from 1 p.m. to 5 p.m. on June 3, and from 9 a.m. to 5 p.m. on June 4. FOR FURTHER INFORMATION CONTACT: John Mahoney, U.S. Geological Survey (206-220-4621). SUPPLEMENTARY INFORMATION: Meetings of the National Geospatial Advisory Committee are open to the public. Additional information about the NGAC and the meeting are available at *http://www.fgdc.gov/ngac* . Dated: May 12, 2008. Ivan DeLoatch, Staff Director, Federal Geographic Data Committee. [FR Doc. E8-10928 Filed 5-15-08; 8:45 am] BILLING CODE 4311-AM-M DEPARTMENT OF THE INTERIOR Bureau of Land Management [AA-6652-J, AA-6652-K, AA-6652-A2; AK-964-1410-KC-P] Alaska Native Claims Selection AGENCY: Bureau of Land Management, Interior. ACTION: Notice of decision approving lands for conveyance. SUMMARY: As required by 43 CFR 2650.7(d), notice is hereby given that an appealable decision approving lands for conveyance pursuant to the Alaska Native Claims Settlement Act will be issued to Far West Incorporated. The lands are in the vicinity of Chignik, Alaska, and are located in: Seward Meridian, Alaska T. 42 S., R. 57 W., Secs. 28 and 29; Secs. 32, 33, and 34. Containing approximately 3,199 acres. T. 43 S., R. 57 W., Secs. 13 and 14. Containing approximately 345 acres. Aggregating approximately 3,544 acres. The subsurface estate in these lands will be conveyed to Bristol Bay Native Corporation when the surface estate is conveyed to Far West Incorporated. Notice of the decision will also be published four times in the Bristol Bay Times. DATES: The time limits for filing an appeal are: 1. Any party claiming a property interest which is adversely affected by the decision shall have until June 16, 2008 to file an appeal. 2. Parties receiving service of the decision by certified mail shall have 30 days from the date of receipt to file an appeal. Parties who do not file an appeal in accordance with the requirements of 43 CFR Part 4, Subpart E, shall be deemed to have waived their rights. ADDRESSES: A copy of the decision may be obtained from: Bureau of Land Management, Alaska State Office, 222 West Seventh Avenue, #13, Anchorage, Alaska 99513-7504. FOR FURTHER INFORMATION CONTACT: The Bureau of Land Management by phone at 907-271-5960, or by e-mail at *ak.blm.conveyance@ak.blm.gov.* Persons who use a telecommunication device
(TTD)may call the Federal Information Relay Service
(FIRS)at 1-800-877-8330, 24 hours a day, seven days a week, to contact the Bureau of Land Management. Jason Robinson, Land Law Examiner, Land Transfer Adjudication I. [FR Doc. E8-10990 Filed 5-15-08; 8:45 am] BILLING CODE 4310-JA-P DEPARTMENT OF THE INTERIOR Bureau of Land Management [WO-300-9131-PP] Information Notice of Planning Criteria for the Programmatic Environmental Impact Statement for Leasing of Geothermal Resources AGENCY: Bureau of Land Management, Interior. ACTION: Information Notice of Planning Criteria. SUMMARY: On June 13, 2007, the Department of the Interior, Bureau of Land Management (BLM), and the United States Department of Agriculture, Forest Service (FS), published in the **Federal Register** [72FR32679] a Notice of Intent
(NOI)to prepare a joint Programmatic Environmental Impact Statement
(PEIS)to analyze the leasing of BLM- and FS-administered lands with potential for geothermal resources in 11 western states and Alaska. The Federal Land Policy and Management Act (FLPMA) requires the BLM to develop land use plans, also known as Resource Management Plans (RMPs), to guide the BLM's management of the public lands. The BLM's land use planning regulations, which implement FLPMA, require the BLM to publish, and provide for public review of, the proposed planning criteria that will guide the BLM's land use planning process. The purpose of this Information Notice is to identify the RMPs that the BLM may amend and set out the proposed planning criteria that would guide the BLM's planning amendment process. Please note that while the preparation of the PEIS is a joint project with the FS, this Notice applies only to public lands that the BLM manages and does not apply in any way to lands that the FS administers. The FS manages lands that are under its jurisdiction under a separate statutory and regulatory framework. DATES: Comments concerning the BLM's preliminary list of RMPs to be amended (identified by Field Office) and proposed planning criteria should be received by June 16, 2008. Individuals, groups, or other agencies who responded to previous scoping efforts for this PEIS are not required to respond to this Notice. The BLM considered comments submitted in response to the previous Notice during development of the planning criteria proposed in this Notice. ADDRESSES: You may submit comments by any of the following methods: • *E-mail:* *geothermal_EIS@blm.gov* . • *Fax:* 1-866-625-0707. • *U.S. Mail:* Geothermal Programmatic EIS, c/o EMPS Inc., 182 Howard Street, Suite 110, San Francisco, CA 94105. FOR FURTHER INFORMATION CONTACT: For further information, including information on how to comment, you may contact Jack G. Peterson, Bureau of Land Management, at 208-373-4048, *Jack_G_Peterson@blm.gov* or visit the PEIS Web site at *http://www.blm.gov/Geothermal_EIS* . SUPPLEMENTARY INFORMATION: FLPMA requires the BLM to develop land use plans, also known as RMPs, to guide the BLM's management of the public lands. In order for geothermal resource leasing and development to take place on the public lands that the BLM manages, such activities must be provided for in these RMPs. The aforementioned NOI published by the BLM and the FS initiated a lengthy and comprehensive scoping process, including 10 public meetings held throughout the western United States. This Notice fulfills the BLM's obligation under FLPMA and the BLM's planning regulations (43 CFR 1610.2(f) and 43 CFR 1610.4-2) to notify the public that in response to input during the scoping process, the BLM has developed proposed planning criteria to guide the amendment of the listed RMPs, including the analysis of the amendments and their reasonable alternatives in the PEIS. Please note that while the preparation of the PEIS is a joint project with the FS, this Notice applies only to public lands that the BLM manages and does not apply in any way to lands that the FS administers. The FS manages lands that are under its jurisdiction under a separate statutory and regulatory framework. Planning criteria are the constraints, standards, and guidelines that determine what the BLM will or will not consider during its planning process. As such, they establish parameters and help focus analysis of the issues identified in scoping, and structure the preparation of the PEIS in so far as it addresses amendment of BLM RMPs, including data collection, analysis and decision making. The BLM welcomes public comment on the following proposed planning criteria, which would be used in the development of the PEIS as it is prepared to analyze these BLM RMP amendments: • The BLM will prepare the PEIS and BLM RMP amendments in compliance with the Federal Land Policy and Management Act, the Endangered Species Act, the Clean Water Act, the Clean Air Act, the National Environmental Policy Act and all other applicable laws, Executive Orders and BLM management policies. • The BLM will use the PEIS as the analytical basis for any decision it makes to amend an individual land use plan as necessary to respond to the potential for increased levels of geothermal resource leasing and development on BLM-administered lands. • The BLM will develop a reasonably foreseeable development
(RFD)scenario to predict levels of development and will identify lands to be allocated as open, closed, and open with restrictive stipulations to geothermal leasing in the affected plans. • The BLM will limit its amendment of these plans to geothermal resource leasing and development issues and will not address management of other resources, although the BLM will consider and analyze the impacts from this increased use on other managed resource values. • The BLM will continue to manage other resources in the affected planning areas under the pre-existing terms, conditions and decisions in the applicable RMPs for those other resources. • The BLM will recognize valid existing rights under the RMPs, as amended. • The BLM will coordinate with local, state, tribal and Federal agencies in the PEIS and plan amendment process to strive for consistency with their existing plans and policies, to the extent practicable. • The BLM will coordinate with tribal governments and will provide strategies for the protection of recognized traditional uses in the PEIS and plan amendment process. • The BLM will take into account appropriate protection and management of cultural and historic resources in the PEIS and plan amendment process, and will engage in all required consultation. • The BLM will recognize in the PEIS and plan amendments the specific niche occupied by public lands in the life of the communities that surround them and in the nation as a whole. • The BLM will make every effort to encourage public participation throughout the process. • The BLM has the authority to develop protective management prescriptions for lands with wilderness characteristics within RMPs. As part of the public involvement process for land use planning, the BLM will consider public input regarding lands to be managed to maintain wilderness characteristics. • Environmental protection and energy production are both desirable and necessary objectives of sound land management practices and are not to be considered mutually exclusive priorities. • The BLM will consider and analyze relevant climate change impacts in its land use plans and associated NEPA documents, including the anticipated climate change benefits of geothermal energy. • The BLM will prepare the PEIS in compliance with the Geothermal Steam Act, as amended, and the legislative directives set forth in the Energy Policy Act of 2005. • The BLM will use geospatial data that are automated within a Geographic Information System
(GIS)to facilitate discussions of the affected environment, formulation of alternatives, analysis of environmental consequences, and display of results. The following is a list of BLM Field Offices that manage lands that BLM has identified as having geothermal potential. You may view these areas on a map with a GIS overlay showing the BLM and the FS jurisdictional boundaries at *http://www.blm.gov/Geothermal_EIS* . Some BLM offices may decide not to use this PEIS and amendment process to amend certain RMPs that appear on this list because those offices may already have land use plan amendments or revisions underway or recently completed. Please contact your local BLM office for more information. In addition, the BLM will exclude many units or areas within certain RMPs from any consideration for geothermal development. The plan amendments will reflect the fact that some units or portions of the areas identified as having geothermal resource potential will not be developed because they are unavailable for leasing, either by statute, regulation or other authority. These designations are described at 43 CFR 3201.11, and include, but are not limited to: Lands where the Secretary has determined that issuing a lease would cause unnecessary or undue degradation to public lands and resources; lands contained within a unit of the National Park System, lands within a National Recreation Area; and lands where the Secretary determines after notice and comment that geothermal operations are reasonably likely to result in a significant adverse effect on a significant thermal feature within a National Park System unit, for example, the geothermal features in Yellowstone National Park; wilderness areas; wilderness study areas; fish hatcheries; wildlife management areas; Indian trust lands; and other areas referred to in the above regulation. As mentioned above, this Notice does not address the FS lands. Therefore, no affected Forests are listed below. The BLM Field Offices that manage lands that have geothermal resource potential are as follows (Where the name of the BLM Field Office that has jurisdiction over a Resource Area differs from the name of the District Office, the name of the District office appears in parentheses following the name of the Field Office. A table identifying the affected Field Offices along with the name of the affected RMP under its jurisdiction, which sometimes differ, will appear in the Draft EIS, and on the Web site above in the near future. State Field office (district office) Alaska Central Yukon (Fairbanks). Anchorage (Anchorage). Glennallen (Anchorage). Arizona Arizona Strip (Arizona Strip). Kingman (Colorado River). Lake Havasu (Colorado River). Yuma (Colorado River). Safford (Gila). Tucson (Gila). Hassayampa (Phoenix). Lower Sonoran (Phoenix). California Barstow (California Desert). El Centro (California Desert). Needles (California Desert). Palm Springs-South Coast (California Desert). Ridgecrest (California Desert). Alturas. Arcata. Bakersfield. Bishop. Eagle Lake. Hollister. Redding. Surprise. Ukiah. Colorado Columbine (San Juan). Del Norte (San Luis Valley). Dolores (San Juan). Glenwood Springs. Grand Junction. Gunnison. Kremmling. La Jara (San Luis Valley). Little Snake. Pagosa Springs (San Juan). Royal Gorge. Saguache (San Luis Valley). Uncompahgre. White River. Idaho Bruneau (Boise). Four Rivers (Boise). Owyhee (Boise). Cottonwood (Coeur d'Alene). Challis (Idaho Falls). Pocatello (Idaho Falls). Salmon (Idaho Falls). Upper Snake (Idaho Falls). Burley (Twin Falls). Jarbridge (Twin Falls). Shoshone (Twin Falls). Montana Billings. Butte. Dillon. Lewistown. Malta. Miles City. Missoula. Nevada Carson City. Battle Mountain. Carson City. Elko. Ely. Las Vegas. Winnemucca. New Mexico Rio Puerco (Albuquerque). Soccoro (Albuquerque). Farmington. Taos (Farmington). Las Cruces. Carlsbad (Pecos). Roswell (Pecos). Oregon/Washington Andrews (Burns). Three Rivers (Burns). Upper Willamette (Eugene). Klamath Falls (Lakeview). Lakeview (Lakeview). Ashland (Medford). Butte Falls (Medford). Central Oregon (Prineville). Deschutes (Prineville). Cascades (Salem). Border (Spokane). Wenatchee (Spokane). Baker (Vale). Jordan (Vale). Malheur (Vale). Utah Cedar City. Fillmore. Kanab. Richfield. Salt Lake. St. George. Vernal. Wyoming Buffalo. Casper. Cody. Kemmerer. Lander. Newcastle. Pinedale. Rawlins. Rock Springs. Worland. You may submit comments in writing on the stated planning criteria and plans to be amended using one of the methods listed in the ADDRESSES section. Before including your address, phone number, e-mail address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so. Authority: 43 CFR 1610.2(f)(2). Michael D. Nedd, Assistant Director, Minerals and Realty Management, Bureau of Land Management. [FR Doc. E8-11059 Filed 5-15-08; 8:45 am] BILLING CODE 4310-84-P DEPARTMENT OF THE INTERIOR Minerals Management Service [Docket No. MMS-2008-OMM-0025] MMS Information Collection Activity: 1010-0170 Coastal Impact Assistance Program (CIAP), Revision of a Collection; Submitted for Office of Management and Budget
(OMB)Review; Comment Request AGENCY: Minerals Management Service (MMS), Interior. ACTION: Notice of a revised information collection (1010-0170). SUMMARY: To comply with the Paperwork Reduction Act of 1995 (PRA), we are notifying the public that we have submitted to OMB an information collection request
(ICR)to revise an approval of the paperwork requirements that address the MMS's Coastal Impact Assistance Program
(CIAP)which is a grant program. This notice also provides the public a second opportunity to comment on the paperwork burden of these requirements. DATES: Submit written comments by June 16, 2008. ADDRESSES: You may submit comments by any either of the following methods listed below. • Either by fax
(202)395-6566 or e-mail ( *OIRA_DOCKET@omb.eop.gov* ) directly to the Office of Information and Regulatory Affairs, OMB, Attention: Desk Officer for the Department of the Interior (1010-0170). • *Electronically:* go to *http://www.regulations.gov.* Under the tab “More Search Options,” click Advanced Docket Search, then select “Minerals Management Service” from the agency drop-down menu, then click “submit.” In the Docket ID column, select MMS-2008-OMM-0025 to submit public comments and to view supporting and related materials available for this rulemaking. Information on using *Regulations.gov,* including instructions for accessing documents, submitting comments, and viewing the docket after the close of the comment period, is available through the site's “User Tips” link. The MMS will post all comments. • Mail or hand-carry comments to the Department of the Interior; Minerals Management Service; Attention: Cheryl Blundon; 381 Elden Street, MS-4024; Herndon, Virginia 20170-4817. Please reference “Information Collection 1010-0170” in your subject line and mark your message for return receipt. Include your name and return address in your message text. FOR FURTHER INFORMATION CONTACT: Cheryl Blundon, Regulations and Standards Branch,
(703)787-1607. You may also contact Cheryl Blundon to obtain a copy, at no cost, of the ICR and the authority that requires the subject collection of information. SUPPLEMENTARY INFORMATION: *Title:* Coastal Impact Assistance Program. *OMB Control Number:* 1010-0170. *Abstract:* With the passage of the Energy Policy Act of 2005 (EPAct), the Minerals Management Service
(MMS)was given responsibility for the Coastal Impact Assistance Program
(CIAP)through the amendment of section 31 of the Outer Continental Shelf Lands Act (43 U.S.C. 1356a Appendix A). The following requirements from this amendment necessitate the collection of information.
(d)AUTHORIZED USES.—
(1)IN GENERAL.—A producing State or coastal political subdivision shall use all amounts received under this section, including any amount deposited in a trust fund that is administered by the State or coastal political subdivision and dedicated to uses consistent with this section, in accordance with all applicable Federal and State law, only for 1 or more of the following purposes:
(A)Projects and activities for the conservation, protection, or restoration of coastal areas, including wetland.
(B)Mitigation of damage to fish, wildlife, or natural resources.
(C)Planning assistance and the administrative costs of complying with this section.
(D)Implementation of a federally-approved marine, coastal, or comprehensive conservation management plan.
(E)Mitigation of the impact of outer Continental Shelf activities through funding of onshore infrastructure projects and public service needs.
(2)COMPLIANCE WITH AUTHORIZED USES.—If the Secretary determines that any expenditure made by a producing State or coastal political subdivision is not consistent with this subsection, the Secretary shall not disburse any additional amount under this section to the producing State or the coastal political subdivision until such time as all amounts obligated for unauthorized uses have been repaid or reobligated for authorized uses.
(3)LIMITATION—Not more than 23 percent of amounts received by a producing State or coastal political subdivision for any 1 fiscal year shall be used for the purposes described* * * In September 2006, CIAP draft guidelines were written which were then amended. As this program has evolved and developed, more information needs to be submitted by the government jurisdictions to meet all the requirements of the CIAP State Plan Guidelines as well as requirements on the procurement contracts. Responses are mandatory or required to obtain or retain a benefit. No questions of a “sensitive” nature are asked. The MMS protects information considered proprietary according to the Freedom of Information Act (5 U.S.C. 552) and its implementing regulations (43 CFR 2). In order to receive funds, according to the EPAct, the states must submit CIAP State Plans that contain required components including an implementation plan of the state's program and identification of the proposed use of CIAP funds. The identification will be brief descriptions of the proposed projects. Upon approval, recipients will be able to submit grant applications for a project. Applicants submit proposals for funding in response to a Notice of Funding Availability that we publish on Grants.gov and on our program web pages. Proposals are submitted through Grants.gov, e-mail, or mail. An application consists of OMB required forms for grants; a detailed project description or narrative to demonstrate that the project has maintained the integrity of the brief description in the Plan and still meets EPAct criteria; and documentation such as Federal, State, or local government required permits with which the recipient is stating it has met Federal, State, or local laws. Once an application for a project is approved, the MMS is required to monitor the projects to determine that the CIAP funds are being used for appropriate expenses. The monitoring will be achieved through the grant regulations that require, at a minimum, a recipient to provide an annual progress and financial status reports. Recipients are evaluated by contracting officers via Grants.gov application efforts. The recipients that are determined by the evaluations to likely have difficulties in implementing and managing the CIAP funded projects will be required to submit semi-annual reports. Once the recipient has demonstrated the ability to implement and manage their projects, the requirement can be returned to annual reports. The MMS needs the information required so that technical experts can determine how well it addresses the requirements identified in the authorizing EPAct legislation and monitor the projects to meet specific requirements. *Frequency:* Submissions are annually, bi-annually, or specific to the requirement which is usually on occasion. *Estimated Number and Description of Respondents:* Approximately 73 total respondents. This includes 6 states and 67 boroughs, parishes, etc. *Estimated Reporting and Recordkeeping “Hour” Burden:* The estimated annual “hour” burden for this information collection is a total of 13,339 hours. In calculating the burdens, we assumed that respondents perform certain requirements in the normal course of their activities. We consider these to be usual and customary and took that into account in estimating the burden. CIAP reporting and/or recordkeeping requirement Hour burden Average No. of annual reponses Annual burden hours Submit Project Narrative. 42 192 projects 8,064 Submit annual Performance Reports. 8 192 reports 1,536 Submit bi-annual performance reports 8 192 reports 1,536 Notify MMS in case of delays, adverse conditions, etc., which impair ability to meet objectives of the award including statement of action take or contemplated or assistance required (included non-construction and construction grants) 8 45 notifications 360 Request termination and supporting information * 6 7 requests 42 Retain all records/documentation for 3 years * .5 192 projects 96 Retain records longer than 3 years if they relate to claim, audit, litigation, etc Exempt under 5 CFR 1320.4(a)(2),
(c)0 Telephone follow-up discussion on Financial Capabilities 8 76 discussions 608 Develop language and individual signage at CIAP Sites—Estimated 30 construction projects with temp signs initially—permanent signs 2-4years * 8 30 signs 240 Submission of photographs/cds of projects for tracking purposes * 4 200 projects 800 Voluntarily submit draft Coastal Impact Assistance Plan with appropriate supporting documentation 1 4 plans 4 Submit final Coastal Impact Assistance Plan and all supporting documentation (i.e., Governor's certification of public participation; Appendices C, D, and E) 1 4 plans 4 Request delay by states for submitting final plan, with relevant data 1 1 request 1 Request minor changes and/or amendments to a plan 8 6 requests 48 Subtotal 1,141 Responses 13,339 * Initially determined that this will be minimal burden until more respondents are actively involved in a CIAP project. *Estimated Reporting and Recordkeeping “Non-Hour Cost” Burden:* We have identified no paperwork “non-hour cost” burdens associated with the collection of information. *Public Disclosure Statement:* The PRA (44 U.S.C. 3501, *et seq.* ) provides that an agency may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. Until OMB approves a collection of information, you are not obligated to respond. *Comments:* Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3501, *et seq* .) requires each agency “* * * to provide notice * * * and otherwise consult with members of the public and affected agencies concerning each proposed collection of information * * *.” Agencies must specifically solicit comments to:
(a)Evaluate whether the proposed collection of information is necessary for the agency to perform its duties, including whether the information is useful;
(b)evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information;
(c)enhance the quality, usefulness, and clarity of the information to be collected; and
(d)minimize the burden on the respondents, including the use of automated collection techniques or other forms of information technology. To comply with the public consultation process, on February 11, 2008, we published a **Federal Register** notice (73 FR 7759) outlining the collection of information and announcing that we would submit this ICR to OMB for approval. The notice provided the required 60-day comment period. We have received no comments in response to this effort. If you wish to comment in response to this notice, you may send your comments to the offices listed under the ADDRESSES section of this notice. The OMB has up to 60 days to approve or disapprove the information collection but may respond after 30 days. Therefore, to ensure maximum consideration, OMB should receive public comments by June 16, 2008. *Public Comment Procedures:* Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment-including your personal identifying information-may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so. *MMS Information Collection Clearance Officer:* Arlene Bajusz
(202)208-7744. Dated: April 21, 2008. E.P. Danenberger, Chief, Office of Offshore Regulatory Programs. [FR Doc. E8-11003 Filed 5-15-08; 8:45 am] BILLING CODE 4310-MR-P DEPARTMENT OF THE INTERIOR National Park Service Boston Harbor Islands National Recreation Area Advisory Council; Notice of Public Meeting AGENCY: Department of the Interior, National Park Service, Boston Harbor Islands National Recreation Area. ACTION: Notice of meeting. SUMMARY: Notice is hereby given that a meeting of the Boston Harbor Islands National Recreation Area Advisory Council will be held on Wednesday, June 4, 2008, at 4 p.m. to 6 p.m. at Massachusetts State House, 24 Beacon Street, Gardner Auditorium, Boston, MA 02133. This will be a quarterly meeting of the Council. The agenda will include a discussion of a proposal for a learning center, next steps for the council, report from the Superintendent, and public comment. The meeting will be open to the public. Any person may file with the Superintendent a written statement concerning the matters to be discussed. Persons who wish to file a written statement at the meeting or who want further information concerning the meeting may contact Superintendent Bruce Jacobson at
(617)223-8667. DATES: June 4, 2008 at 4 p.m. ADDRESSES: Massachusetts State House, 24 Beacon Street, Gardner Auditorium, Boston, MA 02133. FOR FURTHER INFORMATION CONTACT: Superintendent Bruce Jacobson,
(617)223-8667. SUPPLEMENTARY INFORMATION: The Advisory Council was appointed by the Director of National Park Service pursuant to Public Law 104-333. The 28 members represent business, educational/cultural, community and environmental entities; municipalities surrounding Boston Harbor; Boston Harbor advocates; and Native American interests. The purpose of the Council is to advise and make recommendations to the Boston Harbor Islands Partnership with respect to the development and implementation of a management plan and the operations of the Boston Harbor Islands NRA. Dated: April 28, 2008. Bruce Jacobson, Superintendent, Boston Harbor Islands NRA. [FR Doc. E8-10992 Filed 5-15-08; 8:45 am] BILLING CODE 4310-86-P DEPARTMENT OF THE INTERIOR National Park Service Chesapeake and Ohio Canal National Historical Park Advisory Commission; Notice of Public Meeting AGENCY: Department of the Interior, National Park Service, Chesapeake and Ohio Canal National Historical Park. ACTION: Notice of meeting. SUMMARY: Notice is hereby given that a meeting of the Chesapeake and Ohio Canal National Historical Park Advisory Commission will be held at 9:30 a.m., on Friday, July 25, 2008, at the Chesapeake and Ohio Canal National Historical Park Headquarters, 1850 Dual Highway, Hagerstown, Maryland 21740. DATES: Friday, July 25, 2008. ADDRESSES: Chesapeake and Ohio Canal National Historical Park Headquarters, 1850 Dual Highway, Hagerstown, Maryland 21740. FOR FURTHER INFORMATION CONTACT: Kevin Brandt, Superintendent, Chesapeake and Ohio Canal National Historical Park, 1850 Dual Highway, Suite 100, Hagerstown, Maryland 21740, telephone:
(301)714-2201. SUPPLEMENTARY INFORMATION: The Commission was established by Public Law 91-664 to meet and consult with the Secretary of the Interior on general policies and specific matters related to the administration and development of the Chesapeake and Ohio Canal National Historical Park. The members of the Commission are as follows: Mrs. Sheila Rabb Weidenfeld, Chairperson Mr. Charles J. Weir Mr. Barry A. Passett Mr. James G. McCleaf II Mr. John A. Ziegler Mrs. Mary E. Woodward Mrs. Donna Printz Mrs. Ferial S. Bishop Ms. Nancy C. Long Mrs. Jo Reynolds Dr. James H. Gilford Brother James Kirkpatrick Dr. George E. Lewis, Jr. Mr. Charles D. McElrath Ms. Patricia Schooley Mr. Jack Reeder Ms. Merrily Pierce Topics that will be presented during the meeting include: 1. Update on park operations. 2. Update on major construction/development projects. 3. Update on partnership projects. The meeting will be open to the public. Any member of the public may file with the Commission a written statement concerning the matters to be discussed. Persons wishing further information concerning this meeting, or who wish to submit written statements, may contact Kevin Brandt, Superintendent, Chesapeake and Ohio Canal National Historical Park. Minutes of the meeting will be available for public inspection six weeks after the meeting at Chesapeake and Ohio Canal National Historical Park Headquarters, 1850 Dual Highway, Suite 100, Hagerstown, Maryland 21740. Dated: April 23, 2008. Kevin D. Brandt, Superintendent, Chesapeake and Ohio Canal, National Historical Park. [FR Doc. E8-10989 Filed 5-15-08; 8:45 am] BILLING CODE 4310-6V-P DEPARTMENT OF THE INTERIOR National Park Service National Park System Advisory Board; Meeting AGENCY: National Park Service, Interior. ACTION: Notice of meeting. SUMMARY: Notice is hereby given in accordance with the Federal Advisory Committee Act, 5 U.S.C. Appendix, and part 65 of title 36 of the Code of Federal Regulations, that the National Park System Advisory Board will meet July 21-22, 2008, in Washington, DC. The Board will have an orientation session on the morning of July 21, and in the afternoon tour park sites in the National Capital Region. On July 22, the Board will convene its business meeting from 8:30 a.m., to 5 p.m. DATES: July 21-22, 2008. *Location:* American Geophysical Union (AGU), Meeting Room A, 2000 Florida Avenue, NW., Washington, DC 20009-1277; 202-462-6900. FOR FURTHER INFORMATION CONTACT:
(a)For information concerning the National Park System Advisory Board or to request to address the Board, contact Ms. Jennifer Lee, Office of the Director, National Park Service, 1849 C Street, NW., Room 2023, Washington, DC 20240; telephone 202-219-1689.
(b)To submit a written statement specific to, or request information about, any National Historic Landmarks matter listed below, or for information about the National Historic Landmarks Program or National Historic Landmarks designation process and the effects of designation, contact J. Paul Loether, Chief, National Register of Historic Places and National Historic Landmarks Program, National Park Service, 1849 C Street, NW. (2280), Washington, DC 20240; e-mail *Paul_Loether@nps.gov* . SUPPLEMENTARY INFORMATION: On July 21, the Board will convene from 8:30 a.m. to 2:30 p.m., for an orientation session for Board members, followed by a tour of national park sites of the National Capital Region. The Board will convene its business meeting on July 22 at 8:30 a.m. and adjourn at 5 p.m. During the course of the two days, the Board will be addressed by Secretary of the Interior Dirk Kempthorne and National Park Service Director Mary Bomar, and will be briefed by park officials regarding environmental, education, and partnership programs. The Board will receive status reports on matters pending before the Board, including health and recreation, education, national historic landmarks, and science. Other officials of the Department of the Interior and the National Park Service may address the Board, and other miscellaneous topics and reports may be covered. National Historic Landmarks Program matters will be considered in the morning session of the business meeting, during which the Board may consider the following:
(A)Nominations California • The Forty Acres, Delano, CA. Florida • Freedom Tower, Miami, FL. Georgia • Woodrow Wilson Boyhood Home, Augusta, GA. Louisiana • Shreveport Municipal Memorial Auditorium, Shreveport, LA. Massachusetts • Alden, John And Priscilla, Family Sites, Duxbury, MA. Mississippi • Lyceum—The Circle Historic District, Oxford, MS. Montana • Rosebud Battlefield/Where the Girl Saved Her Brother, Big Horn County, MT. • Wolf Mountains Battlefield/Where Big Crow Walked Back and Forth, Rosebud County, MT. New York • Aaron Copland House, Cortlandt Manor, NY. • Camp Uncas, Hamilton County, NY. • First Reformed Protestant Dutch Church Of Kingston, Kingston, NY. • The Frick Collection and Art Reference Library Building, New York, NY. • Solomon R. Guggenheim Museum, New York, NY. Pennsylvania • Bryn Athyn Historic District, Bryn Athyn, PA. • The College of Physicians of Philadelphia Building, Philadelphia, PA. Virginia • Skyline Drive, Shenandoah National Park, VA. Washington • B Reactor, Benton County, WA.
(B)Proposed Amendments to Existing Designations • Coltsville Historic District, Hartford, CT (name change, boundary revision and additional documentation). • Newport Historic District, Newport, RI (boundary revision and updated documentation). • Skidmore/Old Town Historic District, Portland, OR (updated documentation). The Board meeting will be open to the public. The order of the agenda may be changed, if necessary, to accommodate travel schedules or for other reasons. Space and facilities to accommodate the public are limited and attendees will be accommodated on a first-come basis. Anyone may file with the Board a written statement concerning matters to be discussed. The Board also will permit attendees to address the Board, but may restrict the length of the presentations, as necessary to allow the Board to complete its agenda within the allotted time. Draft minutes of the meeting will be available for public inspection about 12 weeks after the meeting, in room 7252, Main Interior Building, 1849 C Street, NW., Washington, DC. Dated: May 12, 2008. Bernard Fagan, Deputy Chief, Office of Policy. [FR Doc. E8-10988 Filed 5-15-08; 8:45 am] BILLING CODE 4310-70-P DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement Notice of Proposed Information Collection for 1029-0091 and 1029-0118 AGENCY: Office of Surface Mining Reclamation and Enforcement. ACTION: Notice and request for comments. SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the Office of Surface Mining Reclamation and Enforcement
(OSM)is announcing that the information collection requests for the titles described below have been forwarded to the Office of Management and Budget
(OMB)for review and comment. The information collection requests describe the nature of the information collections and the expected burden and cost for 30 CFR parts 750 and 842. DATES: OMB has up to 60 days to approve or disapprove the information collections but may respond after 30 days. Therefore, public comments should be submitted to OMB by June 16, 2008, in order to be assured of consideration. FOR FURTHER INFORMATION CONTACT: To request a copy of either information collection request, explanatory information and related form, contact John A. Trelease at
(202)208-2783, or electronically to *jtrelease@osmre.gov.* ADDRESSES: Submit comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Department of Interior Desk Officer, by telefax at
(202)395-6566 or via e-mail to *OIRA_Docket@omb.eop.gov* . Also, please send a copy of your comments to John Trelease, Office of Surface Mining Reclamation and Enforcement, 1951 Constitution Ave, NW., Room 202 - SIB, Washington, DC 20240, or electronically to *jtrelease@osmre.gov.* SUPPLEMENTARY INFORMATION: OMB regulations at 5 CFR 1320, which implement provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13), require that interested members of the public and affected agencies have an opportunity to comment on information collection and recordkeeping activities [see 5 CFR 1320.8(d)]. OSM has submitted two requests to OMB to renew its approval of the collections of information contained in 30 CFR part 750, Requirements for surface coal mining and reclamation operations on Indian Lands; and 30 CFR part 842, Federal inspections and monitoring. OSM is requesting a 3-year term of approval for each information collection activity. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for these collections of information are 1029-0091 for part 750, and 1029-0118 for part 842. As required under 5 CFR 1320.8(d), a **Federal Register** notice soliciting comments for these collections of information was published on February 1, 2008 (73 FR 6203). No comments were received. This notice provides the public with an additional 30 days in which to comment on the following information collection activities: *Title:* Requirements for surface coal mining and reclamation operations on Indian Lands—30 CFR part 750. *OMB Control Number:* 1029-0091. *Summary:* Surface coal mining permit applicants who conduct or propose to conduct surface coal mining and reclamation operations on Indian lands must comply with the requirements of 30 CFR 750 pursuant to section 710 of SMCRA. Applicants are required to respondent to obtain a benefit. *Bureau Form Number:* None. *Frequency of Collection:* Once. *Description of Respondents:* Applicants for coal mining permits. *Total Annual Responses:* One new permit/significant revision annually. *Total Annual Burden Hours:* 1,300 hours annually. *Total Annual Non-wage Costs:* $15,000 for filings fees for each new permits/significant revision. *Title:* 30 CFR part 842—Federal inspections and monitoring. *OMB Control Number:* 1029-0118. *Summary:* For purposes of information collection, this part establishes the procedures for any person to notify the Office of Surface Mining in writing of any violation that may exist at a surface coal mining operation. The information will be used to investigate potential violations of the Act or applicable State regulations. Response is required to request an inspection. *Bureau Form:* How to request a state or federal inspection of a coal mine (no form number). *Frequency of Collection:* Once. *Description of Respondents:* Citizens and State regulatory authorities. *Total Annual Responses:* 44. *Total Annual Burden Hours:* 451. *Total Annual Non-wage Costs:* $0. Send comments on the need for the collection of information for the performance of the functions of the agency; the accuracy of the agency's burden estimates; ways to enhance the quality, utility and clarity of the information collection; and ways to minimize the information collection burden on respondents, such as use of automated means of collection of the information, to the addresses listed under ADDRESSES . Please refer to the appropriate OMB control numbers in your correspondence. Before including your address, phone number, e-mail address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so. Dated: May 8, 2008. John R. Craynon, Chief, Division of Regulatory Support. [FR Doc. E8-10641 Filed 5-15-08; 8:45 am] BILLING CODE 4310-05-M INTERNATIONAL TRADE COMMISSION [Investigation Nos. 731-TA-1146-1147 (Preliminary)] 1-Hydroxyethylidene-1,1-Diphosphonic Acid
(HEDP)From China and India Determination On the basis of the record 1 developed in the subject investigations, the United States International Trade Commission (Commission) determines, pursuant to section 733(a) of the Tariff Act of 1930 (19 U.S.C. 1673b(a)) (the Act), that there is a reasonable indication that an industry in the United States is materially injured by reason of imports from China and India of 1-Hydroxyethylidene-1, 1-diphosphonic acid (HEDP), provided for in subheading 2931.00 of the armonized Tariff Schedule of the United States, that are alleged to be sold in the United States at less than fair value (LTFV). 1 The record is defined in sec. 207.2(f) of the Commission's Rules of Practice and Procedure (19 CFR § 207.2(f)). Commencement of Final Phase Investigation Pursuant to section 207.18 of the Commission's rules, the Commission also gives notice of the commencement of the final phase of its investigations. The Commission will issue a final phase notice of scheduling, which will be published in the **Federal Register** as provided in section 207.21 of the Commission's rules, upon notice from the Department of Commerce (Commerce) of an affirmative preliminary determination in the investigation under section 733(b) of the Act, or, if the preliminary determination is negative, upon notice of an affirmative final determination in that investigation under section 735(a) of the Act. Parties that filed entries of appearance in the preliminary phase of the investigations need not enter a separate appearance for the final phase of the investigations. Industrial users, and, if the merchandise under investigation is sold at the retail level, representative consumer organizations have the right to appear as parties in Commission antidumping duty investigations. The Secretary will prepare a public service list containing the names and addresses of all persons, or their representatives, who are parties to the investigations. Background On March 19, 2008, a petition was filed with the Commission and Commerce by Compass Chemical International LLC, Huntsville, TX, alleging that an industry in the United States is materially injured or threatened with material injury by reason of LTFV imports of 1-hydroxyethylidene-1,1-diphosphonic acid from China and India. Accordingly, effective March 19, 2008, the Commission instituted antidumping duty investigation Nos. 731-TA-1146-1147 (Preliminary). Notice of the institution of the Commission's investigations and of a public conference to be held in connection therewith was given by posting copies of the notice in the Office of the Secretary, U.S. International Trade Commission, Washington, DC, and by publishing the notice in the **Federal Register** of March 26, 2008 (73 FR 16058). The conference was held in Washington, DC, on April 9, 2008, and all persons who requested the opportunity were permitted to appear in person or by counsel. The Commission transmitted its determinations in these investigations to the Secretary of Commerce on May 5, 2008. The views of the Commission are contained in USITC Publication 3998 (May 2008), entitled *1-Hydroxyethylidene-1, 1-Diphosphonic Acid
(HEDP)from China and India:* Investigation Nos. 731-TA-1146-1147 (Preliminary). By order of the Commission. Issued: May 12, 2008. Marilyn R. Abbott, Secretary to the Commission. [FR Doc. E8-10966 Filed 5-15-08; 8:45 am] BILLING CODE 7020-02-P INTERNATIONAL TRADE COMMISSION [Investigation No. 731-TA-1148 (Preliminary)] Frontseating Service Valves From China Determination On the basis of the record 1 developed in the subject investigation, the United States International Trade Commission (Commission) determines, pursuant to section 733(a) of the Tariff Act of 1930 (19 U.S.C. 1673b(a)) (the Act), that there is a reasonable indication that an industry in the United States is materially injured by reason of imports from China of frontseating service valves that are alleged to be sold in the United States at less than fair value (LTFV). 1 The record is defined in sec. 207.2(f) of the Commission's Rules of Practice and Procedure (19 CFR § 207.2(f)). Commencement of Final Phase Investigation Pursuant to section 207.18 of the Commission's rules, the Commission also gives notice of the commencement of the final phase of its investigation concerning frontseating service valves from China. The Commission will issue a final phase notice of scheduling, which will be published in the **Federal Register** as provided in section 207.21 of the Commission's rules, upon notice from the Department of Commerce (Commerce) of an affirmative preliminary determination in the investigation under section 733(b) of the Act, or, if the preliminary determination is negative, upon notice of an affirmative final determination in this investigation under sections 735(a) of the Act. Parties that filed entries of appearance in the preliminary phase of the investigation need not enter a separate appearance for the final phase of the investigation. Industrial users, and, if the merchandise under investigation is sold at the retail level, representative consumer organizations have the right to appear as parties in Commission antidumping duty investigations. The Secretary will prepare a public service list containing the names and addresses of all persons, or their representatives, who are parties to the investigation. Background On March 19, 2008, a petition was filed with the Commission and Commerce by Parker-Hannifin Corp., Cleveland, OH, alleging that an industry in the United States is materially injured or threatened with material injury by reason of LTFV imports of frontseating service valves from China. Accordingly, effective March 19, 2008, the Commission instituted antidumping duty investigation No. 731-TA-1148 (Preliminary). Notice of the institution of the Commission's investigation and of a public conference to be held in connection therewith was given by posting copies of the notice in the Office of the Secretary, U.S. International Trade Commission, Washington, DC, and by publishing the notice in the **Federal Register** of March 26, 2008 (73 FR 16059). The conference was held in Washington, DC, on April 8, 2008, and all persons who requested the opportunity were permitted to appear in person or by counsel. The Commission transmitted its determination in this investigation to the Secretary of Commerce on May 5, 2008. The views of the Commission are contained in USITC Publication 3999 (May 2008), entitled *Frontseating Service Valves from China: Investigation No. 731-TA-1148 (Preliminary)* . By order of the Commission. Issued: May 12, 2008. Marilyn R. Abbott, Secretary to the Commission. [FR Doc. E8-10967 Filed 5-15-08; 8:45 am] BILLING CODE 7020-02-P DEPARTMENT OF JUSTICE Antitrust Division Notice Pursuant to the National Cooperative Research and Production Act of 1993—Semiconductor Test Consortium, Inc. Notice is hereby given that, on April 14, 2008, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301 *et seq.* (“the Act”), Semiconductor Test Consortium, Inc. has filed written notifications simultaneously with the Attorney General and the Federal Trade Commission disclosing changes in its membership. The notifications were filed for the purpose of extending the Act's provisions limiting the recovery of antitrust plaintiffs to actual damages under specified circumstances. Specifically, Kennan Yilmaz individual member), Redmond, WA; Genesis Technology, Hyogo, Japan; and Toshiba Corp. Semiconductor Co. Semiconductor Sys. Engineering Ctr., Kawasaki, Japan have withdrawn as parties to this venture. Also, the following members have changed their names: Octavian Scientific to Advanced Inquiry Systems, Inc., Hillsboro, OR; and Fujitsu Ltd. to Fujitsu Microelectronics Ltd., Tokyo, Japan. No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and Semiconductor Test Consortium, Inc. intends to file additional written notifications disclosing all changes in membership. On May 27, 2003, Semiconductor Test Consortium, Inc. filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the **Federal Register** pursuant to Section 6(b) of the Act on June 17, 2003 (68 FR 35913). The last notification was filed with the Department on January 28, 2008. A notice was published in the **Federal Register** pursuant to Section 6(b) of the Act on February 28, 2008 (73 FR 10807). Patricia A. Brink, Deputy Director of Operations, Antitrust Division. [FR Doc. E8-10843 Filed 5-15-08; 8:45 am] BILLING CODE 4410-11-M DEPARTMENT OF JUSTICE Antitrust Division Notice Pursuant to the National Cooperative Research and Production Act of 1993—OpenSAF Foundation Notice is hereby given that, on April 8, 2008, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. *et seq.* (“the Act”), OpenSAF Foundation has filed written notifications simultaneously with the Attorney General and the Federal Trade Commission disclosing
(1)the identities of the parties to the venture and
(2)the nature and objectives of the venture. The notifications were filed for the purpose of invoking the Act's provisions limiting the recovery of antitrust plaintiffs to actual damages under specified circumstances. Pursuant to Section 6(b) of the Act, the identities of the parties to the venture are: Wind River Systems, Alameda, CA; Hewlett-Packard Company, Palo Alto, CA; Emerson Network Power Embedded Computing, Tempe, AZ; Sun Microsystems, Inc., Santa Clara, CA; Ericsson AB, Alvsjo, Sweden; and Nokia Siemens Networks, Espoo, Finland. The general area of OpenSAF Foundation's planned activity are to enable and facilitate the creation of high availability vendor-neutral open source software tools (the “Foundation Software”) generally consistent with SA Forum specifications and to disseminate, promote and encourage the use of the Foundation Software worldwide to ensure broad adoption. OpenSAF Foundation will pursue these purposes through additional activities such as providing for testing and conformity assessment of Foundation Software; the creation and ownership of distinctive trademarks; and the operation of a branding program based upon distinctive trademarks to create high customer awareness of, demand for, and confidence in products incorporating or interoperable with Foundation Software and/or Specifications. OpenSAF Foundation may also create specifications where they are not available from other sources and undertake those other activities which its Board may from time to time approve in connection with the foregoing. Patricia A. Brink, Deputy Director of Operations, Antitrust Division. [FR Doc. E8-10842 Filed 5-15-08; 8:45 am] BILLING CODE 4410-11-M DEPARTMENT OF LABOR Employment and Training Administration Proposed Information Collection Request Submitted for Sixty Days' Public Comment; O*NET Data Collection Program, Extension of Currently Approved Collection Without Change AGENCY: Employment and Training Administration. ACTION: Notice. SUMMARY: The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden conducts a preclearance consultation program to provide the general public and federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA 95) [44 U.S.C. 3506(c)(2)(A)]. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Employment and Training Administration is soliciting comments concerning the proposed extension of the O*NET (Occupational Information Network) Data Collection Program. A copy of the proposed information collection request
(ICR)can be obtained by contacting the office listed below in the addressee section of this notice or by accessing: *http://www.doleta.gov/OMBCN/OMBControlNumber.cfm* . DATES: Written comments must be submitted to the office listed in the addressee's section below on or before July 15, 2008. ADDRESSES: Submit written comments to the Employment and Training Administration, 200 Constitution Avenue, NW., Room S-4231, Washington, DC 20210, Attention: Pam Frugoli, Telephone number: 202-693-3643 (this is not a toll-free number). Fax: 202-693-3015. E-mail: *O*NET@doleta.gov* . SUPPLEMENTARY INFORMATION: I. Background The O*NET Data Collection Program is a continuing effort to collect and maintain current information on detailed characteristics of occupations and skills for over 800 occupations. The resulting database is and will continue to be the most comprehensive standard source of occupational and skills information in the nation. O*NET information is used by a wide range of audiences, from individuals making career decisions, to public agencies and schools providing career exploration services and planning workforce investment programs, to businesses making staffing and training decisions. The O*NET system provides a common language, framework and database to meet the administrative needs of various federal programs, including workforce investment and training programs of the Departments of Labor, Education, and Health and Human Services. Section 309 of the Workforce Investment Act requires the Secretary of Labor to oversee the “development, maintenance, and continuous improvement of a nationwide employment statistics system” which shall include, among other components, “skill trends by occupation and industry.” The States are to develop similar statewide employment statistics systems. The O*NET Data Collection Program is the primary vehicle for collecting skills and occupational information across all occupations nationwide. The continued population and completion of the entire O*NET database is a critical component of the nationwide labor market information system to support employer, workforce, and education information needs. O*NET succeeds the Dictionary of Occupational Titles
(DOT)and is a powerful tool for various critical federal and state workforce investment functions. O*NET integrates a powerful relational database and a common language for occupational and skill descriptions into a value-added tool for business, job seekers, and the workforce investment professionals who help bring them together. By providing information organized according to the O*NET Content Model, the O*NET database is an important tool for keeping up with today's rapidly changing world of work. The O*NET database provides: • Detailed information for more than 800 occupations. • Descriptive information on standardized descriptors of skills, abilities, interests, knowledge, work values, education, training, work context, and work activities. • Occupational coding based on the 2000 Standard Occupational Classification (SOC). The O*NET electronic database serves as the underpinning for hundreds of publicly and privately developed products and resources in the marketplace and can be found at *http://www.onetcenter.org/database.html* . These products and resources are being used to serve millions of customers. II. Review Focus The Department of Labor is particularly interested in comments which: • Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; • Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; • Enhance the quality, utility, and clarity of the information to be collected; and • Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses. III. Current Actions *Type of Review:* Extension. *Agency:* Employment and Training Administration. *Title:* O*NET Data Collection Program. *OMB Number:* 1205-0421. *Affected Public:* Business/Employers (includes private and not-for-profit businesses and government); individuals (incumbent workers, subject-matter experts). *Form:* O*NET Data Collection Program. *Total Respondents:* 85,780. *Frequency:* Annual. *Total Responses:* 85,780. *Average Time Per Response:* Employer response time is 70 minutes. Incumbent worker response time is 30 minutes. Subject-matter expert response time is 2 hours. *Estimated Total Burden Hours:* 43,857. *Total Burden Cost:* $1,355,266. Comments submitted in response to this comment request will be summarized and/or included in the request for the Office of Management and Budget approval of the information collection request. They will also become a matter of public record. Signed: At Washington, DC, this 8th day of May, 2008. Gay M. Gilbert, Administrator, Office of Workforce Investment, Employment & Training Administration. [FR Doc. E8-10934 Filed 5-15-08; 8:45 am] BILLING CODE 4510-FN-P DEPARTMENT OF LABOR Employment and Training Administration Notice of Availability of Funds and Solicitation for Grant Applications
(SGA)To Fund Demonstration Projects Targeting Dislocated Workers *Announcement type:* New, Notice of Solicitation for Grant Applications. *Funding Opportunity Number:* SGA/DFA PY-07-10. *Catalog of Federal Assistance Number:* 17.269. *Key Dates:* The closing date for receipt of applications under this announcement is June 13, 2008. Applications must be received at the address below no later than 4:30 p.m. (Eastern Time). Application and submission information is explained in detail in Part IV of this SGA. SUMMARY: The U.S. Department of Labor (DOL), Employment and Training Administration
(ETA)announces the availability of approximately $20 million to fund grants to State Workforce Agencies
(SWAs)for demonstration projects targeting Workforce Investment Act
(WIA)dislocated workers. This solicitation provides SWAs with the option to choose from four categories under which applicants can submit a single grant application. Please note that two options exist under category one and two options exist under category three. If the applicant chooses to apply under categories one or three, the applicant must indicate which option the proposal addresses. Applicants may only submit a grant application under *one* category and only *one* application per SWA will be accepted. Applicants must indicate in the abstract of their proposal the category under which they are applying. Category 1—Entrepreneurship Opportunities for Dislocated Workers (two options). Category 2—Getting Ahead of the Curve: Raising Educational/Skill Levels of Workers in Declining Industries. Category 3—Innovative Adult Learning Models for Dislocated Workers (two options). Category 4—Preventing Dislocations of TANF Recipients Moving Into Entry Level Jobs Subject to Economic Churn. Additional background information is provided under Part I. ADDRESSES: Mailed applications must be addressed to the U.S. Department of Labor, Employment and Training Administration, Division of Federal Assistance, Attention: BJai Johnson, Reference SGA/DFA PY-07-10, 200 Constitution Avenue, NW., Room N-4716, Washington, DC 20210. Facsimile applications will not be accepted. Information about applying online can be found in Part V.C. of this document. Applicants are advised that mail delivery in the Washington, DC, area may be delayed due to mail decontamination procedures. Hand delivered proposals will be received at the above address. SUPPLEMENTARY INFORMATION: *This solicitation consists of eight parts:* Part I provides background information for each category. Part II describes award information. Part III describes eligibility information. Part IV describes the application and submission process. Part V describes the applications review process. Part VI contains award administration information. Part VII contains DOL agency contact information. Part VIII lists additional resources of interest to applicants. Part I. Background Information This section provides background information for each of the four categories for grant applications. In some cases the background information is applicable to more than one category and is identified as such. Background Information for Category 1—Entrepreneurship Opportunities for Dislocated Workers: *Applicants may submit an application under only one of the following options:* Option A—Project GATE (Growing America Through Entrepreneurship) for Dislocated Workers in Rural Areas or Option B—Project GATE for Dislocated Workers Fifty Years and Older. This background information is relevant to both options. Although many Americans have neither the skills nor the desire to be self-employed (more than 90 percent of employed Americans work for other people in “wage and salary” jobs) some Americans do want to be self-employed. Some have a passion for a particular business idea, while others want to be their own bosses, have no access to wage and salary jobs in which they can use their skills, or desire the flexibility of self-employment. These people often are willing to work hard, and have specific skills, interests, and talents they can use in a business. Many aspiring entrepreneurs' lack of business knowledge and access to credit poses significant barriers to self-employment. This lack of knowledge may encompass marketing, finance, regulations, how to develop a business plan, or other aspects of developing and running a business. Disadvantaged populations in particular are less likely to have access to the information sources that would make such knowledge and skills available to them. Many people may need loans to start their businesses but have little collateral and poor or no credit histories. Moreover, commercial banks frequently are reluctant to make loans to small, risky ventures. In providing assistance designed to surmount these obstacles to self-employment, Project GATE aims to promote both workforce and economic development. In improving the likelihood of being successful at self-employment, the project sought to increase employment, earnings, and the self-sufficiency of GATE participants. Even if not successful at self-employment, the program could have improved success at wage and salary employment by providing GATE participants with contacts, business skills, or just the knowledge that entrepreneurship is not for them. By promoting small businesses and the jobs they create, Project GATE also aimed to promote economic development in some low-income areas. 1. Project GATE Demonstration This initiative builds on the prior Project GATE Demonstration funded by ETA which began in early fall 2003 and was implemented in three states-Pennsylvania, Minnesota, and Maine. Participants in Project GATE were offered assessments, classroom training and one-on-one business counseling in developing their businesses and applying for a Small Business Administration
(SBA)Microloan or other source of business finance. Nonprofit Community-Based Organizations and the SBA's Small Business Development Centers provided the classroom training and business counseling. One-Stop Career Centers were the gateways to the program. These centers conducted outreach for Project GATE and hosted the program's orientation session. Project GATE added a new service to the One-Stop Career Centers' arsenal of employment services—helping people become self-employed. In addition, Project GATE attracted new and diverse customers to the participating One-Stop Career Centers. The Project GATE demonstration also provided technical assistance to grantees to implement the project. In addition, the Project GATE demonstration was also evaluated to determine whether the project works and whether it could be replicated on a broader scale. Below is a summary of the findings from the first 18 months of the Project GATE demonstration, which have led ETA to announce a new round of Project GATE grants. *Self-employment service programs can be offered at One-Stop Career Centers.* During the demonstration, Project GATE was implemented successfully across a wide variety of sites. While One-Stop Career Centers are not traditionally known as places to go for self-employment services, Project GATE was able, with some marketing, to draw entrepreneurs and prospective entrepreneurs into the centers. As long as local training and business counseling providers with a reputation for providing good quality services are willing to participate in the program, Project GATE, or a similar program, could be offered as an additional service at One-Stop Career Centers. *The Project GATE service model appears to have several advantages over the existing self-employment services available within participating communities.* In addition to receiving more hours of self-employment services, Project GATE participants reported higher levels of satisfaction with the services received than did control group members. Offering a one-on-one assessment with a trained business counselor and a choice of quality local service providers appears to have added value to the existing service network within the local communities. *GATE participants started businesses at a higher rate than control group members.* Over the 18-month follow up period, participation in Project GATE led to an increase in business ownership. While the increase in business ownership was statistically significant, the magnitude of the impact was relatively modest-six percentage points. It is important to note, however, that an analysis of the impact of Project GATE on the unemployed found more substantial program impacts for this subgroup. *Project GATE had larger impacts on business ownership among Unemployment Insurance
(UI)recipients.* Over the entire follow-up period, the impact of Project GATE on business ownership among UI recipients was nine percentage points (statistically significant), compared with no impact on those who did not receive UI. Project GATE may have had a larger impact on those who were receiving UI benefits when they applied because they had fewer alternative opportunities in the regular labor market. Moreover, not having a wage and salary job provided them with more time to work on their businesses, while the UI benefits provided a regular income. *Project GATE had much larger impacts on business ownership among recent UI recipients in Minnesota, where job search requirements were waived for GATE program group members.* For the recent UI recipients in Minnesota, the impact of Project GATE on business ownership started at +12 percentage points in the first quarter of the follow-up period and increased to +15 percentage points in the last quarter, all statistically significant. One reason for larger impacts among recent UI recipients in Minnesota may be attributable to the fact that the job search requirements that accompany the receipt of UI were waived for GATE participants which allowed them to continue receiving benefits while concentrating on their businesses, rather than looking for a wage and salary job Finally, Project GATE is a successful entrepreneurial training model in rural areas. Rural areas in the demonstration were especially innovative in providing access to training and business counseling to entrepreneurs. For more information on Project GATE, please visit the following weblink: *http://wdr.doleta.gov/research/keyword.cfm?fuseaction=dsp_resultDetails&pub_id=2337&mp=y.* 2. Necessary Project Components The new Project GATE grantees would follow the service delivery strategy employed by the successful Project GATE Demonstration. Intake for the grants would involve three steps:
(1)Registration,
(2)orientation, and
(3)completion of an application package. These are described in detail below. • *Registration.* Persons interested in applying for training under the grant must first signal their interest in the program by registration. This would be done at a participating One-Stop Career Center, at the GATE Web site, by mailing a postcard, or by calling a toll-free number. Registered individuals will be notified by mail of the times and locations of the GATE orientations in their areas. The Project GATE Web site will be reactivated for the purposes of the grants. Other outreach materials developed for the GATE demonstration will be adapted for use under the grants. Registrants will be asked to contact a One-Stop Career Center to select which orientation they plan to attend. • *Orientation.* The GATE orientation has four main objectives. First, it aims to provide the attendees with a balanced picture of both the positive and negative aspects of self-employment. Second, the orientation describes GATE services so that applicants have realistic expectations about services provided and do not expect to become eligible for grants or loans directly from GATE. Third, the orientation describes the services provided by the One-Stop Career Center. Finally, One-Stop Career Center staff members describe the GATE application process and offer each attendee an application package. • *Application Package.* Orientation attendees will be given an application package. The application collects information for the evaluation. It also is used to check on eligibility for Project GATE and to provide the assessment counselor (see below) with some information about the participant's needs. The applicant will be required to send the application package to the evaluation contractor. Forms that are less than 90 percent complete will be returned to the applicant for completion. 3. Necessary Project Services *Each Project GATE grantee must offer at minimum three basic services:*
(1)An assessment,
(2)classroom training, and
(3)one-on-one business counseling. All Project GATE grant participants must receive an assessment. After the assessment, participants may receive classroom training only, business counseling only, or both. • *Assessment.* Soon after being accepted into the project, each participant should meet with a GATE assessment counselor. The GATE counselor is generally a member of a local economic development entity such as a chamber of commerce or small business development center. The main objective of the assessment is to recommend the services and providers that best meet the participant's needs. On the basis of this review, the counselor recommends the appropriate set of services to the participant and refers them to a training or business counseling provider. • *Training.* The training courses offered will vary by provider. Many providers offer multiple training courses. At minimum, service providers must offer basic courses for those just starting businesses that focus on developing a business plan. Topics covered in these basic courses may also include: Market research, marketing, pricing, financing, cash flow, accounting, hiring, permits and licenses, and legal issues. Other courses should target participants who already have developed business plans and may have started their businesses, but need assistance in growing the business. These more advanced courses may cover topics such as growth strategies, business planning, and customer relations. In addition to training courses, some providers also may offer seminars on specific business types ( *e.g.* , child-care businesses), e-commerce, or accounting software packages. • *Business Counseling.* All Project GATE grant participants may meet one-on-one with a business counselor to receive assistance with their specific businesses or business ideas. The amount of business counseling received should be tailored to the needs of the participants. Suggested topics to be covered in business counseling sessions may include refinement of the business idea, business plan writing and development, marketing, budget and cash flow projections, and availability of financing. For those in need of financing for their businesses, the counselors may provide assistance in applying for loans from the SBA or other funding sources. Individual business counseling is an important and effective strategy for assisting entrepreneurs with their business needs. Existing small business owners who do not need classroom training often use one-on-one business counseling to work through specific business issues. Individuals at the business start-up phase often use technical assistance to help work through specific issues after completing classroom training. Not only do these sessions provide practical advice on business-related issues, but they also allow counselors the opportunity to provide emotional support and encouragement when participants face difficulties in the business development process. Background Information for Category 2—Getting Ahead of the Curve: Raising Educational/Skill Levels of Workers in Declining Industries: Today's global economy is marked by tremendous advancements in communication, travel, and trade—allowing individuals instant access to commerce from almost anywhere in the world. At the same time, American businesses find themselves competing not only with companies across the street, but also with companies around the globe. As a result, many companies are streamlining or reinventing their operations. Long-term employees in these companies find themselves at a disadvantage because of outdated skills. Because of their skill deficit, they face dislocation not only in the face of plant closures or relocations but in the case of reinvention, where companies and industries must modify their core competency and skill requirements to remain competitive in the global marketplace. The roots of the workforce investment system were designed to meet the needs of a different economy than we are in today. The system was designed for an economy characterized by interchangeable labor, cyclical layoffs, and employers that, for the most part, required a workforce with no more than a high school diploma from workers. In the 21st century globally competitive economy, it is becoming increasingly important that the workforce investment system act as a strategic partner in regional economic and talent development. A critical part of talent development that helps create a competitive advantage for a region is to develop innovative strategies to assist businesses in layoff aversion by raising the education and skill levels of workers in declining or at-risk industries, or industries that are transforming. This requires strategic partnerships with employers, education and training providers at all levels, including apprenticeship providers, economic development entities, local, regional, and state governments, the philanthropic community, faith-based and community organizations, research institutions, and other civic leaders with a stake in economic growth and talent development. 1. Getting Ahead of the Curve Demonstration Under this category, the strategies employed to upgrade workers skills should be designed to
(a)meet employers' critical skill needs, enhancing employers' ability to avoid layoffs; and/or
(b)provide workers with updated transferable skills to enhance their ability to transition to other occupations and/or careers. Solutions should examine the concept of career lattices based on competencies. The objective is to enhance the value of workers to their current employer and to raise their education and skill levels to position them to quickly move into new jobs, either within or outside their current employer/industry if their current jobs are eliminated. 2. Necessary Project Components *Applications under this category must consist of the following two components:*
(1)Development of an “early warning system” for tracking declining industries/businesses. The early warning system can involve coordination and evaluation of current activities as well as creation of new activities.
(2)Engagement with businesses in declining industries, such as traditional manufacturing, or transforming industries that require new skill sets, such as information technology and advanced manufacturing, to collaboratively develop strategies to raise the education and skill levels of the current workforce. This may be focused on either lay-off aversion or to position workers to advance in their current careers, while increasing worker productivity, but it also supports their potential need to transition to other occupations if employment in the industry or business is no longer viable. It is ETA's expectation that workers will receive training as part of grant activities. *Early Warning System and engagement with businesses in at-risk industries to provide training:* In 1988, Congress passed the Worker Adjustment and Retraining Notification
(WARN)Act to provide workers with sufficient time to prepare for the transition between the jobs they currently hold and new jobs. The WARN Act requires employers to provide written notice at least 60 calendar days in advance of covered plant closings and mass layoffs. Once receiving a WARN notice, state and local workforce agencies engage the employer and its employees in rapid response activities. Additionally, many states have created their own regulations around advanced notices that place further restrictions on employers. These models, while valuable, represent a more reactive approach to assisting both employers and workers and are also limited in their coverage. In today's global economy, rapid response and other actions targeting individuals at risk for dislocation need to be proactive rather than reactive. In fact, proactive strategies targeting businesses at-risk for closure or realignment and employees at-risk for dislocation are a vital part of retaining competitive advantage in a regional economic and talent development framework. Some state and local workforce agencies are working with employers and other state agencies to create “early warning” systems. These systems track companies and industries that are likely to experience closures, move to another location/state, experience layoffs, or face industry transformation that requires a substantive change in skill requirements. This demonstration intends to support the development and implementation of replicable models for early warning systems. Using the early warning systems, the workforce investment system and its partners should work together to provide workers at risk for layoff with training to upgrade their skills. 3. Early Warning System Requirements Early warning enables the workforce investment system and its economic development, education, and other partners to strategically deploy regional assets to support industry transformation and up-skill or re-skill the workforce to ensure successful transitions into new occupations and industries. Early warning systems will vary based on the needs in each state and region, however they should include at a minimum: • Strong collaboration with state Labor Market Information departments to understand how and where the state and regional economy is transitioning and how to identify declining industries and companies. • Partnerships between the workforce investment system at the state and local levels, governmental and non-governmental economic development agencies at the state and local levels, educational entities at all levels, businesses, industry associations, and outplacement firms. Additionally, optional partners include philanthropic organizations, faith and community-based organizations, governmental and non-governmental education agencies, and labor management organizations if applicable. • Aligning the resources and activities of different federal, state, and local governments. For example rapid response, Regional Innovation Grants, Trade Act funding (including the Trade Adjustment Assistance for Firms program operated under the Department of Commerce's Economic Development Administration (EDA)), state and local WIA dislocated worker funds, federal, state, and local economic development resources (such as EDA grants), and any other federal and state resources that align with the goals of serving dislocated workers. • Leveraging resources from governmental and non-governmental partners. • Outreach and education strategies to business and industry about benefits of collaboration. • Creation of a replication model to be disseminated to other workforce agencies. • A plan for sustainability beyond the life of the grant. It is expected that by the end of year one of the grant, the grantee will have established an early warning system and that the grantee will constantly assess and evaluate the effectiveness of their model and make changes as needed. 4. Business Engagement Strategies and Training Requirement A regional economy's competitiveness depends on the skills of its workers. According to the Bureau of Labor Statistics, Americans now average 14 jobs between the ages of 18 and 34—or approximately one new job every 14 months. This statistic demonstrates the need for a flexible workforce that receives competency-based training as part of a lifelong learning strategy. Workers with outdated skills in declining industries represent untapped potential that can be difficult to reach. The purpose of this component is to support the development of partnerships and business engagement strategies that ultimately result in these workers receiving competency-based training to allow them to quickly adapt to changes in their current occupation or industry or move to new industries should their current environment no longer present viable career options. ETA's goal is not only to enhance the value of workers in their current jobs but also to position them to move into new jobs quickly if their current jobs are eliminated. Declining industries are not defined in this solicitation but ETA intends them to be those traditional industries that have been in decline for the past decade, such as traditional manufacturing, textiles, furniture production, tobacco, etc. Transforming industries are also not strictly defined but are intended to be those facing significant changes in the skill requirements of their occupations and career ladders due to shifts in the industry requirements, such as information technology and advanced manufacturing. Applicants who make a persuasive case that a non-traditional industry is in decline or transforming in their area will also be considered. Business engagement strategies will vary based on the needs of the state and applicants are encouraged to be innovative in their proposed activities. Applicants' business engagement strategies and subsequent training strategies may focus on outreach to affected businesses and industries, lay-off aversion, increasing worker productivity, and/or positioning workers to advance in their current careers. However, training must also support workers' potential need to transition to other occupations if the industry or business is no longer viable. ETA intends grants to include a planning period of up to one year to identify declining, at-risk, or transforming industries, build business and education partnerships, and understand training strategies that will respond to the needs of employers and workers in the context of the regional economy. Years two and three are intended to serve as the implementation period, when the workforce investment system will use the early warning system to identify specific employers, identify or design appropriate incumbent-worker training programs, and deliver training to workers at risk for layoff. The one-year planning period should include, at a minimum, the following elements: • Partnership with economic development organizations, business and industry, and education and training providers to create a consensus about skills gaps between the skills of the industry or industries in decline and growth sectors and the skills that are needed in the 21st century industry competencies. This may include development and administration of assessments, surveys of employers and industry associations, identification of requirements in current industry certifications, and a mapping of the existing skills areas against those that are needed. • Partnership with the One-Stop Career Center system and its partners and faith and community-based organizations to examine support options to support participant success in education and training programs. • Connection to ongoing activities with similar goals, such as Regional Innovation Grants, Base Realignment and Closure activities, Workforce Innovation in Regional Economic Development Grants, and other federal, state or local efforts that have begun planning or are implementing activities in the area. • Identification of existing education and training models, remediation models, competency-based models, career ladders, curricula, and other materials. • Identification of, or where necessary development of, curricula, competency-based models, career ladders, and other materials to support training. • Creation of a sustainability plan to continue engagement with at-risk businesses after the grant ends. The implementation period should be a minimum of two years and it may overlap with the planning period. The implementation phase should incorporate the information gathered through the Early Warning System created in year one of the grant. The implementation period should include, at a minimum, the following elements: • Partnerships with education and training providers to provide the necessary education and training to individuals at risk for dislocation including work readiness; remediation; science, technology, engineering and math (STEM); and other industry required competencies and curricula. • Leveraging financial and non-financial resources to support training, including existing curricula, space, equipment, faculty, and other resources. • Outcomes appropriate to the nature of the solution, including the number of businesses impacted, the return of investment to the business, the number of individuals who receive services, the number of individuals who receive training, the number of individuals who complete training, the number of credentials awarded, ETA's common measures (entered employment, employment retention, average earnings), wage gains, promotions, and other outcomes determined important by the applicant. Outcomes for each grantee will be negotiated following grant award based on the information contained in their grant agreement and the needs of ETA's independent evaluation of the demonstration if applicable. • Creation of a replication model to be disseminated to other workforce agencies. Background Information for Category 3—Innovative Adult Learning Models for Dislocated Workers: Applicants may only submit an application under one of the following options: Option A—Innovative Adult Learning Strategies or Option B—Innovative Earn/Learn Models Using Apprenticeship. This background information is relevant to both options. More than three million jobs have been lost between 1998 and 2003, with 2.7 million lost since the immediate pre-recession year of 2000. Manufacturing job losses have primarily been in traditional sectors such as automotive and textiles, and now with the economic slowdown, layoffs are projected in finance, construction and other industries. Many of these are jobs that will likely not come back. The 21st century economy demands a workforce with postsecondary education credentials, and the adaptability to respond immediately to changing economic and business needs. Innovative approaches need to be tried to retrain and retool dislocated workers for high-demand jobs in industries that will be here for the long term and can provide wages comparable to what they have been earning such as Information Technology, Healthcare, Biotechnology, Advanced Manufacturing, Energy and others. The public workforce investment system plays a leadership role in meeting these demands by catalyzing the implementation of innovative talent development and lifelong learning strategies that will enable American workers to advance their skills and remain competitive in the global economy. 1. Innovative Adult Learning Models Demonstration This demonstration is focused on creating new or identifying existing innovative strategies for educating and training dislocated workers. *These strategies must address the issues commonly faced by dislocated workers including:*
(1)The need to earn income while in training,
(2)the need for basic skills remediation, particularly for STEM 1 areas and literacy, to achieve skill levels required for education and training programs,
(3)difficulty learning in traditional education formats,
(4)accelerated learning options to shorten the time of skills upgrading. Applicants may only submit an application under one of the following options: Option A—Innovative Adult Learning Strategies or Option B—Innovative Earn/Learn Models Using Apprenticeship. Applicants may only submit an application under one option. 1 Science, Technology, Engineering and Mathematics. Option A—Innovative Adult Learning Strategies (Including, But Not Limited to Earn/Learn) A.1. Adult Learning Strategies Demonstration Under this option, projects will focus on identifying successful adult learning education and training models and implementing a demonstration of the model or models in a state, region, or local area targeting adult dislocated workers. Projects will adapt the education and training model, which may have been developed for adult populations in specific target populations, and demonstrate the viability of the model in helping workers learn new skills at a faster and more in-depth rate while allowing the ability to earn income. Education and training must focus on state, regional, or local high-growth, high-demand industries. This demonstration will require strong partnerships among State Workforce Agencies, state and local workforce investment boards, One-Stop Career Centers, businesses (existing or new partners), education and training providers including community colleges, adult and vocational education providers, 4-year universities, other training providers, and community or faith based organizations. A.2. Necessary Project Components Applicants will identify innovative adult learning strategies and models that address the needs dislocated workers have for: accelerated time to credential, blended learning strategies, remediation in foundational academics, different learning environments, and accessing learning on different schedules and using different modalities. These models may *not* include apprenticeship components, but may include on-the-job training. Applicants will select a least one model to be adapted for their demonstration. Each applicant must determine what high-growth, high-demand industries are driving their economy and where there are job and skill shortages. This should be done in collaboration with state Labor Market Information agencies, economic development agencies, business and industry partners, and education and training providers. This model will require a formal partnership between the applicant SWA and at least one entity from each of the following: local workforce investment board/One-Stop Career Center; an education or training provider, and an individual business or industry association. Multiple partners in these categories are not required but are strongly encouraged. Economic development organizations and faith and community-based organizations are not required but are also strongly encouraged. The SWA, in conjunction with its local workforce investment board(s) will oversee the design and operation of this demonstration. It is expected that the demonstration will accomplish a seamless transition for dislocated workers who will be retrained under the innovative adult learning strategy or model for jobs in high-growth and high-demand industries. Using leveraged resources, incentives may be provided to dislocated workers including, but not limited to, wrap around supportive services including stipends. However, it is not ETA's intent to have grant funds used in the provision of supportive services under this component. A.3. Project Requirements The Innovative Adult Learning Strategies Demonstration is not intended to fund the creation of entirely new training models. Rather, projects should be innovative in how they adapt existing models to the adult dislocated worker population and be tailored to the specific needs of workers in their region. *Applications must include, but are not limited, to the following elements:* • A demonstration of need in the area of the demonstration, including identification of: the dislocated worker pool, the high-growth, high-demand industries in the area, the occupations on which to focus retraining efforts, the skills and competencies required in those occupations, and the assets the currently exist for the project to leverage. • A description of the roles of current and future partners in the grant and the leveraged resources they will bring to the table. • A description of how the innovative training model was identified and selected to be adapted for demonstration. A discussion of the ways in which the model will need to be adapted to meet the education and training needs of the targeted dislocated workers including the need to earn while they learn, an accelerated timeline, remediation, and different learning schedules and modalities. Additionally, applicants should describe anticipated skill assessments and mapping to high growth, high demand industries. • A description of the projected number of individuals to be trained under the grants and the expected outcomes including ETA's common measures (entered employment, employment retention, and average earnings), the number of credentials awarded, and other outcomes determined important by the applicant. Specific outcomes for each grantee will be negotiated following grant award based on the information contained in their grant agreement and the needs of ETA's independent evaluation of the demonstration if applicable. • A commitment to documenting the training model in such a way that the model can be disseminated to other workforce agencies. Option B—Innovative Earn/Learn Model Using Apprenticeship B.1. Earn/Learn Using Apprenticeship Demonstration This option focuses on demonstrating innovative and fresh approaches in retraining and re-skilling adult learners and dislocated workers through Registered Apprenticeship in high-demand industries. Projects must demonstrate the viability of the model in helping adult workers learn new skills at a faster and more in-depth rate for high growth industries such as advanced manufacturing, biotechnology, energy, health care, and information technology. This demonstration will require strong partnerships among WIA state agencies, Workforce Investment Boards, One-Stop Career Centers, businesses (existing or potential apprenticeship sponsors), labor organizations, industry, education/training providers, Registered Apprenticeship offices (the federal Office of Apprenticeship or a State Apprenticeship Agency) and any other appropriate federal or state offices or other entities with resources that can be leveraged to make the project a success. The strategy may be incorporated into regional economic development goals to build a globally competitive and prepared workforce. A goal of this option is to develop and register new apprenticeship programs to serve dislocated workers and adult learners. Registered Apprenticeship is a critical postsecondary education, training, and employment option available in every state in the country, and is an important component of talent development strategies. The model is an excellent option for dislocated workers and others who are transitioning from declining industries to new occupations because it provides immediate employment for apprentices. Registered Apprenticeship is a national training system that combines paid learning on-the-job and related technical and theoretical instruction in a skilled occupation with guaranteed wage structures. As an “earn-while-you-learn” model, Registered Apprenticeship is particularly attractive for dislocated workers with families and financial obligations who must have a paycheck while they gain additional education or workforce skills while transitioning to a new career. Most dislocated workers may not be able to go to school full time without benefit of a job. Registered Apprenticeships provide access to education and training that may not otherwise be accessible to many adults. Additionally, regions that adopt robust Registered Apprenticeship programs in the context of economic development strategies create seamless pipelines of skilled workers and flexible career pathways to meet current and future workforce demands. Upon completion of the apprenticeship, apprentices earn certificates that are recognized nationwide as portable industry credentials. Many apprenticeship programs-particularly in high-growth industries such as health care, advanced manufacturing and transportation—also offer interim credentials and training certificates based on a competency model that leads to a Certificate of Completion. There may be beginning, intermediate, advanced, and specialty certification levels. Registered Apprenticeship programs also allow credit for previous apprenticeship-related experience. Registered Apprenticeship is a highly versatile training strategy that aligns with and advances the goals of key workforce investment system initiatives. By coordinating and collaborating with the knowledgeable professionals that make up the Registered Apprenticeship system, the workforce system can increase the quality of its services to both its employer and worker customers and enhance activities in support of current workforce system priorities. B.2. Necessary Project Components Applicants will develop a registered apprenticeship model that targets dislocated workers and adult learners to help them transition into a high-demand industry. The Registered Apprenticeship programs are expected to produce skilled workers that are in demand in a minimum of one high-growth industry in local area(s) where dislocation occurs. Each location must determine what high-demand industries are driving their economy and where there are job and skill shortages. This model will require applicants to form formal partnerships and/or consortia among WIA, employers (current and/or potential apprenticeship sponsors), organized labor, employer associations, educational institutions, state apprenticeship agencies, or the federal Office of Apprenticeship and other entities whose resources can be leveraged to make the program a success. Members of the partnership/consortium will oversee the design and operation of this initiative. It is expected that the project will accomplish a seamless transition for adult learners and dislocated workers who will be retrained through Registered Apprenticeship for high demand jobs in industries that will be here for a long time and can provide wages comparable to what they have been earning. Using leveraged resources, incentives may be provided including, but not limited to, wrap around supportive services including stipends. However, it is not ETA's intent to have grant funds used in the provision of supportive services under this component. Projects should be innovative, fresh approaches to retraining and re-skilling dislocated workers and mature adult learners for high-demand jobs. The following are possible models and linkages with registered apprenticeship to transition dislocated workers to new industries and which consortia/partnerships may want to test. However, applicants are not limited to these suggestions. • Identify companies and geographic areas with large concentrations of requests for H-1B visas and develop a demonstration to train and employ dislocated workers to fill these jobs. • Develop a demonstration which leverages competency-based registered apprenticeship occupations. • Develop models and linkages with registered apprenticeship to transition workers to the nuclear and alternative energy industries drawing from laid off workers in these communities. • Explore options for developing “green collar” apprenticeships. • Promote Registered Apprenticeship as a career development strategy in industries with high turnover. B.3. Project Requirements *Additionally, applicants must include the following in their grant application:* • Description of model. • Description of the types of High Growth Industry apprenticeable occupations in which the registered apprenticeship program's plans to train and employ workers. • Description of each partner's role in recruiting, selecting, training, placing and retaining workers in registered apprenticeships in the project. • Strategies for identifying the employers who will train and employ Adult Learners and/or Dislocated Workers. • Discuss in detail how the applicant and its partnership/consortium plan to:
(1)Conduct outreach strategies to declining businesses and industries;
(2)outreach strategies to industries that will employ the dislocated and/or mature adult workers;
(3)conduct outreach strategies and orientation sessions to recruit dislocated workers into education and training;
(4)utilize support groups and facilitating networks for Dislocated Workers in registered apprenticeships, on or off the job site, to improve their retention. • Description of all services that will be offered and who will provide them. • Describe how the partners will assure that there are or will be suitable and appropriate positions available in the High Growth Industry registered apprenticeship programs. • Activities and Timeline. • Description of Outcomes. Please note, ETA will consider the successful placement of a minimum of 50 Adult learners and/or Dislocated Workers in High Growth industry registered apprenticeships the primary successful outcome a grantee can achieve. • Budget. Background Information for Category 4—Preventing Dislocations of TANF Recipients Moving Into Entry Level Jobs Subject to Economic Churn: 1. Preventing Dislocations of TANF Recipients Demonstration Since the passage of the Temporary Assistance to Needy Families
(TANF)program in 1996, there has been success in transitioning individuals off welfare and into transitional employment. Transitional employment opportunities typically are located on the lowest rung of the career ladder and require work readiness and basic education and skill training. These positions are most susceptible to churn resulting from economic shifts that cause employment opportunities to grow and contract on a regular basis depending on the state of the economy or the season. The result is individuals cycling between low-level employment and government assistance, such as unemployment insurance benefits and food stamps. Former TANF recipients who have moved into employment are becoming the next generation of employees most at risk for dislocation. Given that unemployment insurance is becoming the new safety net for those former TANF recipients that are moving into the workforce, the goal of this demonstration is to provide additional education and training to former TANF recipients, who have successfully entered transitional employment, to move them up the career ladder in the high-growth, high-demand sectors of healthcare, hospitality, and retail resulting in:
(1)An increase in the employment retention of former TANF recipients,
(2)a reduction in the number of former TANF recipients that are unemployed, and
(3)an increase in earnings for former TANF recipients through placement in career-ladder positions to enable them to achieve self sufficiency. This will require partnerships with the TANF system at the state and local level, education and training providers including adult education and community colleges, and business and industry. 2. Necessary Project Components Applicants must include the following project components: partner roles and industry focus. These are described in detail below. • Partner Roles. Required partners in this demonstration include: the State Workforce Agency (applicant) and at least one entity from each of the following categories: local workforce investment board and One-Stop Career Center, state TANF agency, local TANF agency, community or technical college, adult or vocational education provider, business and industry, and faith and community-based organizations. Additional partners are encouraged, but not required, including economic development agencies, the state adult education agency, K-12 high school systems, four year universities, and philanthropic organizations. Partners must submit letters of commitment detailing their roles in the project. At a minimum, the partner should contribute the following to the demonstration: • The State Workforce Agency should be responsible for coordinating the work of the partners and reaching out to other state agencies. • Local workforce investment boards and One-Stop Career Centers should at a minimum: • Work with state or local TANF agencies to identify former TANF recipients who obtained successful entered transitional employment but
(1)are currently receiving unemployment insurance or
(2)are at risk of unemployment; • Assess and refer candidates to trainings; and • Track outcomes of candidates. • State and local TANF agencies should work with the local workforce investment system to identify former TANF recipients for training; share expertise and models in moving individuals into employment; and leveraging resources where appropriate. • Community Colleges should map the competencies needed to advance up the chosen career ladder, assist in design and provision of remediation, and provide education and training. • Adult or Vocational Education Providers should assist in the design and provision of remediation, and provide education and training. • Business and Industry partners should assist in identifying individuals for the demonstration, identify career ladder opportunities, and work with education and training partners to develop demand-driven training to move individuals up career ladders. • Faith and Community Based Organizations should share expertise in successful strategies for working with the target population and should provide outreach and wrap around support services as needed. For applicants partnering with faith and community based organizations please visit *http://www.dol.gov/cfbci/accesspoints.htm* for specific mechanisms and strategies for integrating these organizations into the proposal. Additional partners, including those listed above, will enhance the depth and breadth of the demonstration and are strongly encouraged. • Industry Focus. This project is intended to be a sectoral demonstration focused on the healthcare, hospitality, and retail industries. Education and training must be focused on career ladder opportunities in one of these industries. Examples of career-ladder based education and training programs already demonstrated either under the High Growth Job Training Initiative and Community-Based Job Training Grants and by state and local areas, educational institutions and non-profit organizations can be found at *www.workforce3one.org.* The Workforce3 One Web site is a valuable resource for information about demand-driven projects of the workforce investment system, educators, employers, and economic development representatives. ETA encourages applicants to look to existing education and training models that may be adaptable to serve the target population and goals outlined in this Solicitation. 3. Project Requirements ETA is seeking innovative solutions to address the goal of moving former-TANF recipients up the career ladder in the healthcare, hospitality, and retail industries. The demonstration should meet the needs of former TANF recipients as well as business and industry. In addition, ETA is looking for demonstrations that include *at least two* of the following components: • Use of college-bridge programs for individuals with low skills. Bridge programs offer a way for low-skilled individuals to successfully complete education and training in a college environment. The bridge program offers an intermediate step between the individual's current position and full integration into college-level coursework; • Use of contextualized learning to integrate basic skills remediation into industry skills training curricula; • Use of on-the-job training or other learn/earn education strategies; • “Grow your own” strategies with employers committing to education and training onsite to advance employees in low-level positions and partnering with state and local workforce and TANF agencies to backfill entry-level positions with individuals currently receiving TANF but who are ready to move into transitional employment; • Non-traditional education models that utilize flexible schedules to accommodate individuals' work and family schedules; • Development of modularized credit-based courses that allow individuals to break up certificate or degree programs into shorter, more manageable tracks; or • Inclusion of career counseling and mentors. Part II. Award Information 1. Award Amount ETA anticipates awarding between 16 and 20 grants under this solicitation, with individual grants ranging in value from $500,000 to $2 million. However, this does not preclude ETA from funding grants at either a lower or higher amount, or funding a smaller or larger number of projects, based on the type and the number of quality submissions. Applicants are encouraged to submit budgets for quality projects at whatever funding level is appropriate to their project. 2. Period of Performance The period of grant performance will be up to 36 months from the date of execution of the grant documents. This performance period shall include all necessary implementation and start-up activities, participant follow-up for performance outcomes, and grant close-out activities. ETA may elect to exercise its option to award no-cost extensions to grants for an additional period, based on the success of the program and other relevant factors, if the grantee requests, and provides a significant justification for, such an extension. 3. Leveraged Resources Under this funding opportunity, ETA is not requiring the applicants to provide leveraged resources. However, projects funded under this solicitation should leverage resources per the rating criteria from key entities in the strategic partnership. Businesses, faith-based and community organizations, economic development entities, education systems, and philanthropic foundations often invest resources to support workforce development. In addition, other federal, state, and local government programs may have resources available that can be integrated into the proposed project. Examples of such programs include other Department of Labor programs such as registered apprenticeship, as well as non-DOL One-Stop partner programs such as Vocational Rehabilitation, Adult Education, and Department of Education Pell Grants. As applicable, applications will be scored based on the quality and the degree to which the source and use of leveraged funds are clearly explained and the extent to which they are integrated into the project in support of grant outcomes. Leveraging resources in the context of strategic partnerships accomplishes three goals:
(1)It allows for the strategic pursuit of resources;
(2)it increases stakeholder investment in the project at all levels including design and implementation phases; and
(3)it broadens the impact of the project itself. Applicants are encouraged to leverage significant resources from key partners and other organizations to maximize the impact of the project on the community. Leveraged Resources include the value of goods and services that would be allowable costs if paid for with grant funds whether incurred as a cost by the recipient or a sub-recipient and paid for with either non-federal or federal dollars, or provided as volunteer services valued in accordance with the provisions at 29 CFR part 95.23(d) and
(e)or part 97.24(c)(1) and (2), as appropriate. Also, leveraged resources are subject to monitoring reviews. Partnering organizations may provide resources such as supportive services, mentoring, tutoring, and volunteers—all of which are important for grantees to leverage when assisting certain individuals targeted by these funds. For applicants who choose to leverage resources, please include the following information in the technical proposal:
(1)The total amount leveraged from federal sources;
(2)the total amount leveraged from non-federal sources;
(3)the partners contributing the resources; and
(4)the projected activities, broken out by the source of the leveraged resource (federal or nonfederal), to be implemented utilizing these resources. Applicants should address leveraged resources (as applicable) in the technical proposal but should not reflect the leveraged resources on the SF424A form. ETA encourages applicants and their strategic partners to be entrepreneurial as they seek out, utilize, and sustain these resources, whether they are in-kind or cash contributions, when creating strategic partnerships under this solicitation. 4. Funding Restrictions Determinations of allowable costs will be made in accordance with the applicable Federal cost principles. Disallowed costs are those charges to a grant that the grantor agency or its representative determines not to be allowed in accordance with the applicable Federal cost principles or other conditions contained in the grant. Applicants will not be entitled to reimbursement of pre-award costs. *Limitations on Cost Per Participant.* Since training costs may vary considerably depending on the skills and competencies required, flexibility will be provided on cost per participant. However, applications for funding will be reviewed to determine if the cost of the training is appropriate and will produce the outcomes identified. Applicants should demonstrate that the proposed cost per participant is aligned with existing price structures for similar training in the local area or other areas with similar characteristics. When calculating cost per participant, applicants must distinguish between non-training and training costs utilizing grant funds. *Indirect Costs.* As specified in the Office of Management and Budget Circular Cost Principles, indirect costs are those that have been incurred for common or joint objectives and cannot be readily identified with a particular cost objective. An indirect cost rate
(ICR)is required when an organization operates under more than one grant or other activity whether Federally-assisted or not. Organizations must use the ICR supplied by the cognizant Federal agency. If an organization requires a new ICR or has a pending ICR, the Grant Officer will award a temporary billing rate for 90 days until a provisional rate can be issued. This rate is based on the fact that an organization has not established an ICR agreement. Within this 90 day period, the organization must submit an acceptable indirect cost proposal to their Federal cognizant agency to obtain a provisional ICR. *Administrative Costs.* An entity that receives a grant to carry out a project or program under one of the categories in this solicitation may not use more than 10 percent of the amount of the grant to pay administrative costs associated with the program or project. Administrative costs could be both direct and indirect costs and are defined at 20 CFR 667.220. Administrative costs do not need to be identified separately from program costs on the Standard Form 424A Budget Information Form. Administrative costs should be discussed in the budget narrative and tracked through the grantee's accounting system. To claim any administrative costs that are also indirect costs, the applicant must obtain an indirect cost rate agreement from its Federal cognizant agency as specified above. *Use of Funds for Supportive Services.* It is not ETA's intent for grant funds to be used for the provision of supportive services, such as transportation and childcare, including funds provided through stipends for such purposes. However, applicants are encouraged to identify strategic partners as appropriate who can provide these services as leveraged resources. If supportive services are proposed as an integral part of the project, use of grant funds for this purpose will require a one-time approval from the Grant Officer prior to the grantee incurring these costs. *Salary and Bonus Limitations.* None of the funds appropriated in Public Law 109-149, Public Law 110-5, or prior Acts under the heading “Employment and Training” that are available for expenditure on or after June 15, 2006, shall be used by a recipient or sub-recipient of such funds to pay the salary and bonuses of an individual, either as direct costs or indirect costs, at a rate in excess of Executive Level II, except as provided for under section 101 of Public Law 109-149. This limitation shall not apply to vendors providing goods and services as defined in Office of Management and Budget
(OMB)Circular A-133. See Training and Employment Guidance Letter number 5-06 for further clarification: *http://wdr.doleta.gov/directives/corr_doc.cfm?DOCN=2262.* *Legal Rules Pertaining to Inherently Religious Activities by Organizations that Receive Federal Financial Assistance.* The government is generally prohibited from providing direct financial assistance for inherently religious activities (please see 29 CFR part 2, subpart D). These grants may not be used for religious instruction, worship, prayer, proselytizing or other inherently religious activities except as provided in those regulations. Neutral, non-religious criteria that neither favors nor disfavors religion will be employed in the selection of grant recipients and must be employed by grantees in the selection of sub-recipients. *ETA Intellectual Property Rights.* Applicants should note that grantees must agree to provide ETA a paid-up, nonexclusive and irrevocable license to reproduce, publish, or otherwise use for Federal purposes all products developed or for which ownership was purchased under an award, including but not limited to curricula, training models, technical assistance products, and any related materials, and to authorize them to do so. Such uses include, but are not limited to, the right to modify and distribute such products worldwide by any means, electronically or otherwise. *Distribution Rights.* Selected applicants must agree to give ETA the right to use and distribute all materials developed with grant funds such as training models, curricula, technical assistance products, etc. Materials developed with grant resources are in the public domain; therefore, ETA has the right to use, reuse, modify, and distribute all grant-funded materials and products to any interested party, including broad distribution to the public workforce investment system via the Internet or other means. Part III. Eligibility Information 1. Eligible Applicants. Eligible applicants for the grants under all categories shall be SWAs including the five territories of Puerto Rico, Virgin Islands, Guam, Northern Mariana Islands and American Samoa. Each SWA would be required to identify the local workforce investment boards and One-Stop Career Center as established under Section 121 of WIA, [29 U.S.C. 2841] that would be participating in the proposed project. Applicants must submit a letter of commitment from each of the partners participating in the proposed project. 2. Participant Eligibility Requirements Dislocated Workers. Under Categories 1, 3 and 4, the eligible participants for these demonstrations are dislocated workers. Dislocated Workers eligibility is defined under WIA Section 101(9) as follows. The term “dislocated worker” means an individual who— (A)(i) has been terminated or laid off, or who has received a notice of termination or layoff, from employment; (ii)(I) is eligible for or has exhausted entitlement to unemployment compensation; or
(II)has been employed for a duration sufficient to demonstrate, to the appropriate entity at a one-stop center referred to in section 134(c), attachment to the workforce, but is not eligible for unemployment compensation due to insufficient earnings or having performed services for an employer that were not covered under a State unemployment compensation law; and
(iii)is unlikely to return to a previous industry or occupation; (B)(i) has been terminated or laid off, or has received a notice of termination or layoff, from employment as a result of any permanent closure of, or any substantial layoff at, a plant, facility, or enterprise;
(ii)is employed at a facility at which the employer has made a general announcement that such facility will close within 180 days; or
(iii)for purposes of eligibility to receive services other than training services described in section 134(d)(4), intensive services described in section 134(d)(3), or supportive services, is employed at a facility at which the employer has made a general announcement that such facility will close;
(C)was self-employed (including employment as a farmer, a rancher, or a fisherman) but is unemployed as a result of general economic conditions in the community in which the individual resides or because of natural disasters; or
(D)is a displaced homemaker. *Incumbent Workers.* Under Category 2, the eligible participants are incumbent workers at risk for dislocation. Incumbent Workers at risk for dislocation are defined as those workers who are in declining, at risk, or transforming industries who are in need of skill upgrades to avert lay off in the their current position or to obtain new employment in the same or a different industry should their current employment no longer be viable. *TANF Recipients.* Under Category 4, eligible participants will meet the definition of a dislocated worker as stated above and will have received assistance under the Temporary Assistance for Needy Families Act within the past five years. *Veterans Priority.* The Jobs for Veterans Act (Pub. L. 107-288) provides priority of service to veterans and spouses of certain veterans for the receipt of employment, training, and placement services in any job training program directly funded, in whole or in part, by the Department of Labor. In circumstances where a grantee must choose between two equally qualified candidates for training, one of whom is a veteran, the Jobs for Veterans Act requires that the grantee give the veteran priority of service by admitting him or her into the program. Please note that, to obtain priority of service, a veteran must meet the program's eligibility requirements. ETA Training and Employment Guidance Letter
(TEGL)No. 5-03 (September 16, 2003) provides general guidance on the scope of the Job for Veterans Act and its effect on current employment and training programs. TEGL No. 5-03, along with additional guidance, is available at the Jobs for Veterans Priority of Service Web site: *http://www.doleta.gov/programs/vets.* Part IV. Application and Submission Process A. Address to Request Application Package This SGA contains all of the information and links to forms needed to apply for grant funding. B. Content and Form of Application Submission Applicants may submit only *one* application under this solicitation. Applications submitted after receipt of the initial application will not be accepted unless the initial application is withdrawn in accordance with Section E. of this part. The proposal must consist of two
(2)separate and distinct parts, Parts I—The Cost Proposal and Part II—The Technical Proposal. Applications that fail to adhere to the instructions in this section will be considered non-responsive and may not be given further consideration. Applicants who wish to apply do not need to submit a Letter of Intent. The completed application package is all that is required. Part I—The Cost Proposal must include the following three items: • The Standard Form
(SF)424, “Application for Federal Assistance” (available at *http://www.doleta.gov/sga/forms.cfm* ). The SF 424 must clearly identify the applicant and be signed by an individual with authority to enter into a grant agreement. Upon confirmation of an award, the individual signing the SF 424 on behalf of the applicant will be considered the Authorized Representative of the applicant. • All applicants for Federal grant and funding opportunities are required to have a Data Universal Numbering System
(DUNS)number provided by Dun and Bradstreet. See OMB Notice of Final Policy Issuance, 68 FR 38402 (June 27, 2003). Applicants must supply their DUNS number on the SF 424. The DUNS number is a nine-digit identification number that uniquely identifies business entities. Obtaining a DUNS number is easy and there is no charge. To obtain a DUNS number, access this Web site, *www.dunandbradstreet.com,* or call 1-866-705-5711. • The SF 424A Budget Information Form (available at *http://www.doleta.gov/sga/forms.cfm* ). In preparing the Budget Information Form, the applicant must provide a concise narrative explanation to support the request. The budget narrative should explain the administrative costs and how they support the project goals. All applicants should indicate training costs-per-participant by dividing the total amount of the budget designated for training by the number of participants trained. Please note that applicants that fail to provide an SF 424, SF 424A and a budget narrative will be removed from consideration prior to the technical review process. If the proposal calls for integrating WIA or other federal funds or includes other leveraged resources, these funds should not be listed on the SF 424 or SF 424A, Budget Information Form, but should be described in the budget narrative. The amount of Federal funding requested for the entire period of performance should be shown together on the SF 424 and SF 424A Budget Information Form. Applicants are also encouraged, but not required, to submit the OMB Survey No. 1890-0014: Survey on Ensuring Equal Opportunity for Applicants, which can be found at: *http://www.doleta.gov/sga/forms.cfm.* Part II—The Technical Proposal of the application demonstrates the applicant's capabilities to fulfill the intention of the category selected. The Technical Proposal is limited to twenty
(20)double-spaced, single-sided, 8.5 inch x 11 inch pages with twelve point text font and one-inch margins. The first page of Part II—The Technical Proposal must consist entirely of an executive summary not to exceed one page. Applicants should number the Technical Proposal beginning with page number one. Any pages over the 20-page limit will not be reviewed. The required letter(s) of commitment and/or documentation of partnership must be submitted and will not count against the 20 page limit. Please note, letters of commitment should be sent with or attached to the application. Additionally, the applicant must reference grant partners by organizational name in the text of the Technical Proposal. No cost data or reference to prices should be included in the Technical Proposal. Applications may be submitted electronically on *http://www.grants.gov* or in hard-copy via U.S. mail, professional overnight delivery service, or hand delivery. These processes are described in further detail in Part IV.C. Applicants submitting proposals in hard-copy must submit an original signed application (including the SF 424) and one
(1)“copy-ready” version free of bindings, staples or protruding tabs to ease in the reproduction of the proposal by USDOL/ETA. C. Submission Date, Times and Mailing Address The closing date for receipt of applications under this announcement is June 13, 2008. Applications must be received at the address below no later than 4:30 p.m. (Eastern Time). Applications sent by e-mail, telegram, or facsimile will not be accepted. Applications that do not meet the conditions set forth in this notice will not be honored. No exceptions to the mailing and delivery requirements set forth in this notice will be granted. Please submit one
(1)blue-ink signed, typewritten original of the application and two
(2)signed photocopies in one package to the U.S. Department of Labor, Employment and Training Administration, Division of Federal Assistance, Attention: BJai Johnson, Reference SGA/DFA PY-07-10, 200 Constitution Avenue, NW., Room N-4716, Washington, DC 20210. Information about applying online through *www.grants.gov* can be found in Section IV.C of this document. Applicants are advised that mail delivery in the Washington area is delayed due to mail decontamination procedures. Hand delivered proposals will be received at the above address. Also, applicants may apply online through grants.gov ( *http://www.grants.gov* ). It is strongly recommended that applicants applying online for the first time via grants.gov immediately initiate and complete the “Get Registered” registration steps at *http://www.grants.gov/applicants/get_registered.jsp.* These steps may take multiple days or weeks to complete, and this time should be factored into plans for electronic application submission in order to avoid unexpected delays that could result in the rejection of an application. It is highly recommended that online submissions be completed at least three
(3)working days prior to the date specified for the receipt of applications to ensure that the applicant still has the option to submit by overnight delivery service in the event of any electronic submission problems. If submitting electronically through grants.gov, the components of the application must be saved as either .doc, .xls or .pdf files. *Late Applications.* Any application received after the exact date and time specified for receipt at the office designated in this notice will not be considered, unless it is received before awards are made, was properly addressed, and:
(a)Was sent by U.S. Postal Service registered or certified mail not later than the fifth calendar day before the date specified for receipt of applications ( *e.g.* , an application required to be received by the 20th of the month must be post marked by the 15th of that month) or
(b)was sent by professional overnight delivery service or submitted on grants.gov to the addressee not later than one working day prior to the date specified for receipt of applications. It is highly recommended that online submissions be completed three working days prior to the date specified for receipt of applications to ensure that the applicant still has the option to submit by professional overnight delivery service in the event of any electronic submission problems. Applicants take a significant risk by waiting until the last day to submit by grants.gov. “Postmarked” means a printed, stamped or otherwise placed impression that is readily identifiable, without further action, as having been supplied or affixed on the date of mailing by an employee of the U.S. Postal Service. Therefore, applicants should request the postal clerk to place a legible hand cancellation “bull's eye” postmark on both the receipt and the package. Failure to adhere to the above instructions will be a basis for a determination of non-responsiveness. Evidence of timely submission by a professional overnight delivery service must be demonstrated by equally reliable evidence created by the delivery service provider indicating the time and place of receipt. D. Intergovernmental Review This funding opportunity is not subject to Executive Order
(EO)12372, “Intergovernmental Review of Federal Programs.” E. Withdrawal of applications Applications may be withdrawn by written notice at any time before an award is made. Applications may be withdrawn in person by the applicant or by an authorized representative thereof, if the representative's identity is made known and the representative signs a receipt for the proposal. Part V. Applications Review Process This section identifies and describes the criteria that will be used to evaluate proposals under each of the four categories. In some cases the evaluation criteria are the same for more than one category and such is identified. Category 1—Entrepreneurship Opportunities for Dislocated Workers The criteria and point values for Option A—Project GATE for Dislocated Workers in Rural Areas and Option B—Project GATE for Dislocated Workers Fifty Years and Older are listed in the table below. 1.A. Option Selected for Grant Application N/A 1.B. Expanding Entrepreneurial Training Opportunities for Dislocated Workers 30 1.C. Strategic Partnerships for Entrepreneurship Development 25 1.D. Program Design and Outcomes 30 1.E. Comprehensive Training Program Leading to Business Formation 10 1.F. Integration with Regional Economic and Talent Development Strategies 5 1.G. Bonus Points 10 1.A. Option Selected for Grant Application This category contains two project options; therefore, the applicant must indicate under which option they are submitting their grant application. The same application will *not* be reviewed under both categories. 1.B. Expanding Entrepreneurial Training Opportunities for Dislocated Workers (up to 30 points) As described below, the applicant must show in detail how the grant resources will expand and/or improve upon entrepreneurial training opportunities for WIA Dislocated Workers. • *Need for Federal Investment (10 points)* —Applicants must clearly outline the need for additional capacity for entrepreneurial training, as well as the necessity of the Federal investment. Successful applications will describe in detail the current challenges the proposal seeks to overcome and must demonstrate how the proposed project will increase opportunities for entrepreneurial training for WIA Dislocated Workers in rural areas *or* WIA Dislocated Workers 50 years and older. • *Expanding Entrepreneurial Training Opportunities for Dislocated Workers (15 points)* —Applicants must clearly show how the grant resources will expand the entrepreneurial training options available to WIA Dislocated Workers. Applications must clearly show how many more individuals will be served than are currently being served by existing programs. Applications will be scored on how well they clearly describe the pipeline of individuals that would be trained and the recruitment strategy by which they would learn of the training opportunity. ETA expects that at minimum 200 individuals would be trained per $1 million in grant award. • *Sustainability and Scalability (5 points)* —ETA places a high premium on demonstrations that can be sustainable after the grant period has ended. Proposals should outline plans for sustainability of the program post-grant in regard to the program and partnerships. Also, applications will outline the feasibility of expanding a successful program in terms of geographic reach, sites served, numbers of individuals trained, and program replication. 1.C. Strategic Partners for Entrepreneurial Development (up to 25 points) Each SWA would be required to identify the local workforce investment boards and One-Stop Career Centers that would be participating in the project. In addition, the SWA must identify the sources of local entrepreneurial technical assistance and training that will be employed for project participants. These sources could include small business development centers, women's business development centers, minority business development centers, community-based or faith-based service providers, local chambers of commerce, or other local economic development entities including rural economic development organization. Applicants must provide letters of commitment from each partner detailing their involvement in the proposal. • *Strategic Partners (10 points)* —The strength of the strategic partnership is critical to the successful execution of the proposal and the post-grant viability of the program. Applicants must clearly explain how the range of partners matches the needs of participants and provides the deepest possible reach into the affected community. In addition, the strategic partners must be engaged to the fullest extent possible and articulate how each partner's area of expertise will be utilized in the project. Letters of commitment from each partner detailing their participation in each stage of the project are required. The applicant must discuss how the partners will interact at each stage of the project and the ability of the lead organization to successfully manage the partnership and project. In selecting strategic partners, it is important to engage those partners that can provide a complete service delivery strategy for project participants. This complete strategy would include partners that provide assistance with business counseling, entrepreneurial training, and loan application and financial assistance. • *Economic Development Institutions (10 points)* —Critical to the success of the grants will be the participation of key economic development institutions in the local area. These institutions could include small business development centers, women's business development centers, minority business development centers, local chambers of commerce, or other local economic development entities including rural economic development organizations. For example, applicants would leverage the business counseling expertise of a local small business development center or SCORE (Counselors to America's Small Business) chapter. Applicants will be scored based upon how well they describe the role of the economic development institutions in the project and how they will integrate into a seamless service delivery strategy for project participants. • *Organizational Capacity (5 points)* —The applicant must discuss their ability to successfully manage the project and partnership. Applications will be scored based on how well they detail each partner's experience, expertise, and ability to fulfill their part of the proposal and document any history of past collaborations (if applicable). In addition, expertise in previous demonstration grant projects and entrepreneurship projects should be well documented. 1.D. Program Design and Outcomes (up to 30 points) In evaluating the quality of the program design and management plan for each proposal, ETA will consider the following elements. • *Program Design (25 points)* —Applicants must clearly outline the training or learning program to be developed, expanded, and/or created, and include timelines for implementation and benchmark evaluations as appropriate. Applicants will be scored on this criteria based on their ability to implement the GATE model as described in Part I of this SGA. Applicants will also be scored on the extent to which the management plan appears likely to achieve the objectives of the project in meeting the goals of the Project GATE grant. • *Performance Management and Outcomes (5 points)* —Applications will project the increased number of individuals that will be able to receive training and business counseling. Estimations of projected increases in individuals trained should be compelling and fully formed, and include consideration from all appropriate factors. 1. E. Comprehensive Training Program Leading to Business Formation (up to 10 Points) The applicant must describe the type of curriculum being used for the entrepreneurial training portion of the grant. At minimum, training providers must offer basic courses for those just starting businesses that focus on developing a business plan. Topics covered in these basic courses should include: the development of a business plan, market research, marketing, pricing, financing, cash flow, accounting, hiring, permits and licenses, and legal issues. Other courses should target participants who already have developed business plans and may have started their businesses, but need assistance in growing the business. These more advanced courses may cover topics such as growth strategies, business planning, and customer relations. 1.F. Integration with Regional Economic and Talent Development Strategies (up to 5 points) Scoring on this criterion will be based on the applicant's ability to demonstrate that their project is aligned with and integrated into their region's talent development and economic development strategy. Applicants may receive up to 5 points by: • Summarizing the region's strategic vision and workforce education strategies in support of talent development and economic growth. • Either describing how their capacity building and training solution is part of or complements existing approaches under regional talent development and economic development plans and initiatives; or describing how their project is a catalyst for bringing partners together to begin the analysis and strategic planning in their region. • Describing any regional partnerships that are part of their capacity building and training plans and detail how the partnerships are broader and deeper in scope than the local partnerships in place for the proposed capacity building and training activity. Regional partners may include regional business leadership and organizations, such as chambers of commerce; economic development entities at the regional level; the philanthropic community; seed and venture capital organizations or individuals; investor networks; entrepreneurs; and faith and community-based organizations. • For applicants leveraging resources, describing how the funds leveraged come from regional partners or from existing or planned talent development efforts within the region. 1.G. Bonus Points (up to 10 points) ETA will award a total of ten bonus points to applicants who address the following two criteria. • *Financial Assistance (5 points)* —Additional points will be awarded to SWAs that identify service providers for their client service delivery plan that provide direct financial assistance to their clients. Types of direct financial assistance may include, but are not limited to, individual development accounts, low-cost, low-documentation loans, grants, seed money, or angel investment. • *Work Search Waiver (5 points)* —Additional points will be awarded to those states that provide dislocated workers receiving unemployment compensation a waiver from the work search requirement while engaged in entrepreneurial training. Category 2—Getting Ahead of the Curve: Raising Educational/Skill Levels of Workers in Declining Industries The criteria and point values for this category are listed in the table below. 2.A. Statement of Need 10 2.B. Strategic Partnerships 20 2.C. Project Design and Implementation 40 2.D. Work plan, Timeline, and Outcomes 15 2.E. Program Management and Organizational Capacity, and Budget 10 2.F. Integration with Regional Economic and Talent Development Strategies 5 2.A. Statement of Need (up to 10 points) Applicants must clearly outline the need in their state for an early warning network and strategies to engage businesses in delivering incumbent worker training in declining industries. Successful applicants will describe in detail the current challenges in their state in identifying industries and companies in decline or transformation and in re-skilling or up-skilling incumbent workers to avoid dislocation. Additionally, the applicant should describe the workforce system's current relationship with businesses and how the proposed project will increase the engagement with at-risk business with the result of raising the education and skill levels of their workers. 2.B. Strategic Partnerships (up to 20 points) The applicant must demonstrate that strategic partnerships are an integral component of their Early Warning Network and Business Engagement Strategy and are comprised at a minimum of: the workforce system, education and training providers (which may include community and technical colleges, adult education and vocational education programs or providers, alternative education programs or providers, four-year universities, and other private or not-for-profit training providers), business and industry, and economic development entities. *Applicants must:* • Identify all current and potential partners and explain the meaningful role that each partner will play in the project. ○ Required partners include the workforce system at the state and local levels, governmental and/or non-governmental economic development agencies at the state and/or local levels, one or more educational or training entities, one or more companies or business or industry associations, and one or more outplacement firms. Additionally, optional partners include philanthropic organizations, faith and community-based organizations, governmental and non-governmental education agencies, and labor management organizations if applicable. • Describe how new and existing partnerships will be engaged to plan and implement the Early Warning Network and Business engagement strategy. • Identify the sources of leveraged resources and what activities will be implemented using those resources • Elaborate on how leveraged resources and partnerships will achieve more significant impacts • Demonstrate existing coordination of partnerships or capacity to quickly establish these links • Demonstrate that the project has the partnerships necessary to have broad community reach. *Points for this criterion will be awarded based on several factors:* • The completeness of the partnership, based on project design; • The degree of meaningful engagement of partners in project activities; and • The extent to which the applicant integrates partners' strengths and assets into project design and implementation; and; • The extent to which strategic partnerships meet the elements laid our under the early warning system and business engagement planning and implementation sections of this Solicitation. 2.C. Project Design and Implementation (up to 40 points) The applicant must fully describe all features of the proposed project, how it would be operationalized and how all activities, strategies, and resources would be integrated to support the goal of raising the education and skill levels of workers at risk of dislocation. *Elements in this section should address:* • A description of the strategies that will be employed to create the early warning system including the demonstration of strong collaboration with state Labor Market Information
(LMI)departments through documented ongoing working relationships with LMI staff; working knowledge of core products, services, reports and Web sites; selection of targeted occupations and industries based on Workforce Information; and collaboration with LMI departments to develop new products and services to assist in the prediction of economic change; • Aligning resources between different federal, state, and local governments; • Leveraging financial and non-financial resources from governmental and non-governmental partners; • Outreach and education strategies to business and industry about benefits of collaboration with the workforce system, early notice of potential layoffs, and the benefits of incumbent worker training for the purposes of up-skilling or re-skilling employees; • Strategy for provision of incumbent worker training and the credentials to be associated with training; • Strategy for re-employment of individual following completion of training, either within the same company or industry or in a new industry or occupation; • Creation of a replication model to be disseminated to other workforce agencies; • A plan for sustainability beyond the life of the grant; • Identification of existing education and training models, remediation models, competency models, career ladders, curricula, and other materials; and • A plan for identifying or creating curricula, competency models, career ladders, and other materials to support training. *Points for this criterion will be awarded based on several factors:* • The completeness of the project description and evidence that proposed activities will achieve the objectives of this Solicitation as described in this Solicitation, including clear strategies for planning and implementation phases; • Demonstrated capacity of the application to align resources and provide services; • Evidence that the proposed activities are clearly linked to the need in the region; and • The existence of a clear sustainability plan that will continue to support the early warning network and business engagements strategies to identify or design appropriate incumbent-worker training programs, and deliver training to workers at risk for layoff. 2.D. Work plan, Timeline, and Outcomes (up to 15 points) In this section, applicants will provide a plan of work that outlines how the early warning network and business engagement activities and incumbent worker training will be accomplished. The work plan should include a timeline as well as the lead partner for each activity/strategy. Applicants are encouraged to create tight work plans that will provide actionable activities during the period of performance for this grant. It is not necessary to have an extensive list of strategies, but rather strategies that will bring about the desired outcomes and address the challenges laid out in the statement of need. In addition, the applicant must provide information on the outcomes which are expected to be achieved. Applicants are not required to include specific numerical outcome projections but should include a detailed summary of the projected outcomes and impacts appropriate to the nature of their project including the number of businesses impacted, the return of investment to the business, the number of individuals who receive services, the number of individuals who receive training, the number of individuals who complete training, the number of credentials awarded, ETA's common measures (entered employment, employment retention, average earnings), wage gains, promotions, and other outcomes determined important by the applicant. *Scoring on this section will be based on the extent to which applicants provide the following:* • The potential for the work plan to achieve the desired outcomes; • The viability of the timeline; • The extent to which the expected project outcomes are identified, realistic and consistent with the objectives of the project; • The ability of the project to achieve the outcomes in the stated timeframe; and • The appropriateness of the outcomes with respect to the challenges described in the statement of need and the proposed project activities listed in the project design and implementation section. 2.E. Program Management, Organizational Capacity, and Budget (10 points) To satisfy this criterion, applicants must describe their proposed project management structure including, where appropriate, the identification of a proposed project manager, discussion of the proposed staffing pattern, and the qualifications and experience of key staff members. Applicants should also show evidence of the use of data systems to track outcomes in a timely and accurate manner. The applicant should include a description of organizational capacity and the organization's track record in projects similar to that described in the proposal and/or related activities of the primary partners. *Scoring under this criterion will be based on the extent to which applicants provide evidence of the following:* • The time commitment of the proposed staff is sufficient to ensure proper direction, management, and timely completion of the project; • The roles and contribution of staff, consultants, and collaborative organizations are clearly defined and linked to specific objects and tasks; • The background, experience, and other qualifications of the staff are sufficient to carry out their designated roles; • The applicant organization has significant capacity to accomplish the goals and outcomes of the project, including the ability to collect and manage data in a way that allows consistent, accurate, and expedient reporting; and • The budget is sufficient to meet project goals. 2.F. Integration with Regional Economic and Talent Development Strategies (up to 5 points) Scoring on this criterion will be based on the applicant's ability to demonstrate that their project is aligned with and integrated into their region's talent development and economic development strategy. *Applicants may receive up to 5 points by:* • Summarizing the region's strategic vision and workforce education strategies in support of talent development and economic growth. • Either describing how their capacity building and training solution is part of or complements existing approaches under regional talent development and economic development plans and initiatives; or describing how their project is a catalyst for bringing partners together to begin the analysis and strategic planning in their region. • Describing any regional partnerships that are part of their capacity building and training plans and detail how the partnerships are broader and deeper in scope than the local partnerships in place for the proposed capacity building and training activity. Regional partners may include regional business leadership and organizations, such as chambers of commerce; economic development entities at the regional level; the philanthropic community; seed and venture capital organizations or individuals; investor networks; entrepreneurs; and faith and community-based organizations. • For applicants leveraging resources, describing how the funds leveraged come from regional partners or from existing or planned talent development efforts within the region. Category 3—Innovative Adult Learning Models for Dislocated Workers The rating criteria listed below apply to applications focusing on either Option A or Option B. All applicants are required to use the rating criteria format when developing their proposals. Up to 100 points may be awarded to an application. 10 bonus points are available for applications focusing on Option B—Apprenticeship strategies. There are no bonus points for applications submitted under Option A. The criteria and point values for this category are listed in the table below. 3.A. Option Selected for Grant Application N/A 3.B. Statement of Need 10 3.C. Partnership Composition, Capacity and Management 25 3.D. Project Description, Strategies, Work Plan and Time Line 30 3.E. Scope of Project and Projected Outcomes 30 3.F. Integration with Regional Economic and Talent Development Strategies 5 3.G. Bonus for Option B—Innovative Earn/Learn Model Using Apprenticeship 10 3.A. Option Selected for Grant Application This category contains two grant award options; therefore, the applicant must indicate under which option they are submitting their grant application: Option A—Innovative Adult Learning Strategies or Option B—Innovative Earn/Learn Models Using Apprenticeship. 3.B. Statement of Need (up to 10 points) Applicants must clearly outline the need for innovative adult learning strategies in the community or communities to be served. Successful applicants will describe in detail:
(1)The current unemployment and poverty rates in the targeted community(ies) of the project;
(2)the layoffs/dislocations in the community(ies); and
(3)the high growth high demand industries and occupations in the area, and 4) the skill requirements in the high growth and high demand community or communities to which most of the dislocated workers will be re-employed. *The applicant must:* • Describe the need for this project in the communities to be served. • Describe unemployment and poverty rates in these communities. • Describe the layoffs/dislocations that have occurred in the past three years. • Describe skill and job shortages in the communities to which most of the dislocated workers will be re-employed. 3.C. Partnership Composition, Capacity and Management (up to 25 points) The applicant must demonstrate that the proposed project will be implemented by a strategic partnership. The applicant must identify the partners by organizational name and category, explain the meaningful role each partner will play in the project, and document the leveraged resources from each partner. The amount of leveraged resources will not be factored into the score for this section, rather applications will be scored on the quality and the degree to which the source and use of the funds are clearly explained and integrated into the project in support of grant outcomes. Additionally, the applicant must describe its (or the consortium of partners) capacity to manage the project, including identifying all key tasks, the hours required for the completion of such tasks, and the partner/persons responsible for completing each task. The applicant must describe in detail their experience, capability and qualifications for administering this project. Scoring on this criterion will be based on the extent to which applicant provide evidence of the following: *To be considered fully responsive, the applicant must address all of the following:* • Describe each partner's experience, how and why the partners were selected and clearly define why what they bring to the partnership will make it make it successful; • Describe each partner's role in recruiting, selecting, training, placing and retaining workers into employment. • Describe each partner's specific role and tasks in the project and that their commitment to sustainability is sufficient to ensure both successful completion of the project and its sustainability after the end of the grant. • Each partner has a well-defined role in recruiting, selecting, training, placing and/or retaining workers into employment. • Describe how the management structure and staffing of the organizations are aligned with the grant requirements, vision, and goals; and how the structure and staffing are designed to ensure responsible general management of the project. • Identify all key tasks, the hours required for the completion of such tasks, and the partner/persons responsible for completing each task. • Where applicable, clearly differentiate between the roles and contributions of:
(1)The applicant or, the partnership/consortium (where applicable) under the grant,
(2)staff, and
(3)any proposed consultants or subcontractors and, providing information on each of the above, link each entity to specific objects and tasks; • The time commitment of the proposed staff is sufficient to ensure proper direction, management, and timely completion of the project; • Provide resumes of individuals who will manage and staff the project and describe why the background, experience, and other qualifications of the staff are sufficient to carry out their designated roles; and • The applicant organization has significant capacity to accomplish the goals and outcomes of the project, including the ability to collect and manage data in a way that allows consistent, accurate, and expedient reporting. Applicants must clearly address the above elements. In addition to the above, when evaluating proposals, reviewers will be using the following questions. Please make sure that these questions are addressed in the proposal. • Does the applicant clearly indicate an understanding of each element in the specific program? • Will the partners identified and their proposed roles meet the objectives outlined in the Solicitation? • Do the partnership roles thoroughly identify, describe and consider each element related to partnership outlined in this category of the Solicitation? 3.D. Project Description, Strategies, Work Plan and Time Line (up to 30 points) In this section the applicant will clearly describe the vision and blueprint for their project and how it will be developed, including providing sufficient explanation and detail about the types of activities and strategies which that will be used. Applicant must also include a clear and detailed work plan with a timeline that outlines how the work will be accomplished in a manner that is realistic and sufficient to meet the goals of objectives of the project within in the identified budget and timeframe. Applicants must clearly address the above elements. In addition to the above, when evaluating proposals, reviewers will be using the following questions. Please make sure that these questions are addressed in the proposal. • Does the applicant clearly indicate an understanding of each element specified in the project requirements section of this Solicitation? • Are the proposed solutions logical, reasonable, and comprehensive? Will they meet the objectives outlined in the SGA? • Does the proposal thoroughly identify, describe, and consider each element of the specific program? • Is the proposal presented in a clear and concise format? 3.E. Scope of Project and Projected Outcomes (up to 30 points) In this section, applicants will provide a plan of work that clearly conveys the scope of the project and the outcomes projected to be achieved during the life of the grant. Through its project scope and projected outcomes, the applicant must demonstrate the viability of its model in helping mature adult workers/dislocated workers learn new skills at a faster and more in-depth rate. *Scoring on this section will be based on the extent to which applicants provide the following: * • *Discuss in detail how they plan to present a clear strategy to:*
(1)Conduct outreach strategies to businesses and industries who will employ the dislocated and/or mature adult workers and develop outreach strategies and orientation sessions to recruit dislocated workers into education and training;
(2)develop outreach and education strategies to declining businesses and industries to advise them of the grant's purpose and activities and seek their participation and support; • Describe the outcomes the applicant anticipates as a result of the project that include but are not limited to: ETA's common measures, the number of Dislocated Workers to be placed in employment, and the number of credentials to be awarded; • The extent to which the projected outcomes are realistic and consistent with the objectives of the project; • The potential for the proposed project to achieve the desired outcomes; • The appropriateness of the outcomes with respect to the challenges described in the statement of needs and the proposed project activities detailed in the work plan. • Document any leveraged resources or funding anticipated for the accomplishment of the proposed project and a description of how the funds will be used. *Please note,* to be considered fully responsive and able to achieve full points in this section, each of the above must be addressed. 3.F. Integration with Regional Economic and Talent Development Strategies (up to 5 points) Scoring on this criterion will be based on the applicant's ability to demonstrate that their project is aligned with and integrated into their region's talent development and economic development strategy. *Applicants may receive up to 5 points by: * • Summarizing the region's strategic vision and workforce education strategies in support of talent development and economic growth. • Either describing how their capacity building and training solution is part of or complements existing approaches under regional talent development and economic development plans and initiatives; or describing how their project is a catalyst for bringing partners together to begin the analysis and strategic planning in their region. • Describing any regional partnerships that are part of their capacity building and training plans and detail how the partnerships are broader and deeper in scope than the local partnerships in place for the proposed capacity building and training activity. Regional partners may include regional business leadership and organizations, such as chambers of commerce; economic development entities at the regional level; the philanthropic community; seed and venture capital organizations or individuals; investor networks; entrepreneurs; and faith and community-based organizations. • For applicants leveraging resources, describing how the funds leveraged come from regional partners or from existing or planned talent development efforts within the region. 3.G. Bonus Points for applicants focusing on Apprenticeship strategies (Option B) (up to 10 points) Bonus points will be awarded for proposals that demonstrate the following: • Capacity to graduate 100 or more apprentices (10 points) into apprenticeships/jobs. Category 4—Preventing Dislocations of TANF Recipients Moving Into Entry Level Jobs Subject to Economic Churn The criteria and point values for the evaluation criteria under this category are listed in the table below: 4.A. Statement of Need 10 4.B. Partnership Composition, Capacity and Management 25 4.C. Project Description, Strategies, Work Plan and Time Line 30 4.D. Scope of Project and Projected Outcomes 30 4.E. Integration with Regional Economic and Talent Development Strategies 5 4.A. Statement of Need (up to 10 points) Applicants must clearly outline the need for innovative adult learning strategies in the community to advance dislocated former TANF recipients up the career ladder. Successful applicants will describe in detail:
(1)The pool of former TANF recipients who are unemployed or at risk for unemployment;
(2)the occupations and industries of those individuals;
(3)the career ladder opportunities for individuals to advance into; and
(4)how the project will enhance coordination between federal, state, and local agencies in serving this target population. *The applicant must: describe the need for this project in the communities to be served by indentifying: * • The pool of former TANF recipients who are unemployed or at risk for unemployment, • The occupations and industries of those individuals; • The career ladder opportunities for individuals to advance into; and • How the project will enhance coordination between federal, state, and local agencies in serving this target population. 4.B. Partnership Composition, Capacity and Management (up to 25 points) The applicant must demonstrate that the proposed project will be implemented by a strategic partnership. The applicant must identify the partners by organizational name and category, explain the meaningful role each partner will play in the project, and document the leveraged resources from each partner. The amount of leveraged resources will not be factored into the score for this section, rather applications will be scored on the quality and the degree to which the source and use of the funds are clearly explained and integrated into the project in support of grant outcomes. Additionally, the applicant must describe its (or the consortium of partners) capacity to manage the project, including identifying all key tasks, the hours required for the completion of such tasks, and the partner/persons responsible for completing each task. The applicant will also describe in detail their experience, capability and qualifications for administering this project. * Scoring on this criterion will be based on the extent to which applicant provide evidence of the following: * • How and why partners were selected and what they bring to the partnership to make it successful; • How partners will provide maximum depth and breadth to the project including providing access to poor, disadvantaged, and disconnected populations; • How each partner's specific role and tasks in the project is sufficient to ensure both successful completion of the project and its sustainability after the end of the grant; • Each partner has a well-defined role in recruiting, selecting, training, placing and/or retaining workers into employment; • The management structure and staffing of the organizations are aligned with the grant requirements, vision, and goals; and how the structure and staffing are designed to assure responsible general management of the project; • Clearly define the roles and contributions of:
(1)The applicant or the partnership/consortium (where applicable),
(2)staff, and
(3)any proposed consultants or subcontractors and link each entity to specific objects and tasks; • The time commitment of the proposed staff is sufficient to ensure proper direction, management, and timely completion of the project; • Provide resumes of individuals who will manage and staff the project and describe why the background, experience, and other qualifications of the staff are sufficient to carry out their designated roles; and • The applicant organization has significant capacity to accomplish the goals and outcomes of the project, including the ability to collect and manage data in a way that allows consistent, accurate, and expedient reporting. Applicants must clearly address the above elements. In addition to the above, when evaluating proposals, reviewers will be using the following questions. Please make sure that these questions are addressed in the proposal. • Does the applicant clearly indicate an understanding of each element in the specific program? • Will the partners identified and their proposed roles meet the objectives outlines in the Solicitation? • Do the partnership roles thoroughly identify, describe and consider each element related to partnership outlined in this category of the Solicitation? 4.C. Project Description, Strategies, Work Plan and Time Line (up to 30 points) In this section the applicant will clearly describe the vision for their project and how it will be developed, including providing sufficient explanation and detail about the types of activities and strategies that will be used. Applicant must also include a clear and detailed work plan with a timeline that outlines how the work will be accomplished in a manner that is realistic and sufficient to meet the goals of objectives of the project within in the identified budget and timeframe. Applicants must clearly address the above. In addition to the above, when evaluating proposals, reviewers must address the following questions. Does the applicant clearly indicate an understanding of each element specified in the project requirements section of this Solicitation? • Are the proposed solutions logical, reasonable, and comprehensive? Will they meet the objectives outlined in the SGA? • Does the proposal thoroughly identify, describe, and consider each element of the specific program? • Is the proposal presented in a clear and concise format? 4.D. Scope of Project and Projected Outcomes (up to 30 points) In this section, applicants will provide a plan of work that clearly conveys the scope of the project and the outcomes projected to be achieved during the life of the grant. Through its project scope and projected outcomes, the applicant must demonstrate the viability of its model in helping mature adult workers/dislocated workers learn new skills at a faster and more in-depth rate. *Scoring on this section will be based on the extent to which applicants provide the following: * • Presentation of a clear strategy to:
(1)Conduct outreach strategies to businesses and industries who will employ the dislocated former TANF recipients; and
(2)conduct outreach strategies and orientation sessions to recruit dislocated former TANF recipients into education and training with a special emphasis on community and faith-based groups that operate in targeted neighborhoods and communities; • Comprehensive outcomes anticipated as a result of the project that include, but are not limited to: ETA's common measures, the number of Dislocated Workers to be placed in employment, and the number of credentials to be awarded; • The extent to which the projected outcomes are realistic and consistent with the objectives of the project; • The potential for the proposed project to achieve the desired outcomes; • The appropriateness of the outcomes with respect to the challenges described in the statement of needs and the proposed project activities detailed in the *Project Description, Strategies, Work Plan and Time Line* section. 4.E. Integration With Regional Economic and Talent Development Strategies (up to 5 Points) Scoring on this criterion will be based on the applicant's ability to demonstrate that their project is aligned with and integrated into their region's talent development and economic development strategy. *Applicants may receive up to 5 points by:* • Summarizing the region's strategic vision and workforce education strategies in support of talent development and economic growth. • Either describing how their capacity building and training solution is part of or complements existing approaches under regional talent development and economic development plans and initiatives; or describing how their project is a catalyst for bringing partners together to begin the analysis and strategic planning in their region. • Describing any regional partnerships that are part of their capacity building and training plans and detail how the partnerships are broader and deeper in scope than the local partnerships in place for the proposed capacity building and training activity. Regional partners may include regional business leadership and organizations, such as chambers of commerce; economic development entities at the regional level; the philanthropic community; seed and venture capital organizations or individuals; investor networks; entrepreneurs; and faith and community-based organizations. • For applicants leveraging resources, describing how the funds leveraged come from regional partners or from existing or planned talent development efforts within the region. *Review and Selection Process.* Applications will be accepted after the publication of this announcement until the closing date. Applicants may submit only one application under this solicitation. Applications submitted after receipt of the initial application will not be accepted unless the initial application is withdrawn in accordance with Section E. of this part. A technical review panel will make a careful evaluation of applications against the criteria set forth in Part V of this Solicitation. These criteria are based on the policy goals, priorities, and emphases set forth in this SGA. The ranked scores will serve as the primary basis for selection of applications for funding, in conjunction with other factors such as: urban, rural, and geographic balance; the availability of funds; and which proposals are most advantageous to the Government. The panel results are advisory in nature and not binding on the Grant Officer, who may consider any information that comes to his attention. ETA may or may not award grants under each Category of this Solicitation, depending on the quality and quantity of proposals submitted. Separate panels for each category will be convened to score proposals. The Grant Officer may choose to select a lower scoring proposal from one category (or option) over a higher scoring proposal from another category or option if she determines that such a selection is more advantageous to the government. ETA may elect to award the grant(s) with or without prior discussions with the applicants. The Government will consider applications rated by the evaluation panels with a score of 80 or above to be eligible for a grant award. Applicants that score less than 80 will not be eligible for a grant award. Should a grant be awarded without discussions, the award will be based on the applicant's signature on the SF 424, which constitutes a binding offer. Part VI. Award Administration Information A. Award Notices All award notifications will be posted on the ETA Web site at *http://www.doleta.gov.* Applicants selected for award will be contacted directly before the grant's execution. Applicants not selected for award will be notified by mail as soon as possible. Note: Selection of an organization as a grantee does not constitute approval of the grant application as submitted. Before the actual grant is awarded, ETA may enter into negotiations about such items as programs components, staffing, and administrative systems in place to support grant implementation. If negotiations do not result in a mutually acceptable submission, the Grant Officer reserves the right to terminate the negotiation and decline to fund the application. B. Administrative and National Policy Requirements 1. Administrative Program Requirements All grantees will be subject to all applicable Federal laws, regulations, and the applicable OMB Circulars. The grant(s) awarded under this SGA will be subject to the following administrative standards and provisions, if applicable: a. Workforce Investment Act—20 CFR part 667 (General Fiscal and Administrative Rules). b. Non-Profit Organizations—OMB Circulars A-122 (Cost Principles) and 29 CFR part 95 (Administrative Requirements). c. Educational Institutions—OMB Circulars A-21 (Cost Principles) and 29 CFR part 95 (Administrative Requirements). d. State and Local Governments—OMB Circulars A-87 (Cost Principles) and 29 CFR part 97 (Administrative Requirements). e. Profit Making Commercial Firms—FAR—48 CFR Part 31 (Cost Principles), and 29 CFR part 95 (Administrative Requirements). f. All entities must comply with 29 CFR parts 93 and 98, and, where applicable, 29 CFR parts 96 and 99. g. The following administrative standards and provisions may also be applicable: i. 29 CFR part 2, subpart D—Equal Treatment in Department of Labor Programs for Religious Organizations, Protection of Religious Liberty of Department of Labor Social Service Providers and Beneficiaries; ii. 29 CFR part 30—Equal Employment Opportunity in Apprenticeship and Training; iii. 29 CFR part 31—Nondiscrimination in Federally Assisted Programs of the Department of Labor—Effectuation of Title VI of the Civil Rights Act of 1964; iv. 29 CFR part 32—Nondiscrimination on the Basis of Handicap in Programs and Activities Receiving or Benefiting from Federal Financial Assistance; v. 29 CFR part 33—Enforcement of Nondiscrimination on the Basis of Handicap in Programs or Activities Conducted by the Department of Labor; vi. 29 CFR part 35—Nondiscrimination on the Basis of Age in Programs or Activities Receiving Federal Financial Assistance from the Department of Labor; vii. 29 CFR part 36—Nondiscrimination on the Basis of Sex in Education Programs or Activities Receiving Federal Financial Assistance; vii. 29 CFR part 37—Implementation of the Nondiscrimination and Equal Opportunity Provisions of the Workforce Investment Act of 1998. In accordance with Section 18 of the Lobbying Disclosure Act of 1995 (Pub. L. 104-65) (2 U.S.C. 1611) non-profit entities incorporated under Internal Revenue Service Code section 501(c)
(4)that engage in lobbying activities are not eligible to receive Federal funds and grants. Note: Except as specifically provided in this Notice, ETA's acceptance of a proposal and an award of Federal funds to sponsor any program(s) does not provide a waiver of any grant requirements and/or procedures. For example, OMB Circulars require that an entity's procurement procedures must ensure that all procurement transactions are conducted, as much as practical, to provide open and free competition. If a proposal identifies a specific entity to provide services, ETA's award does not provide the justification or basis to sole source the procurement, i.e., avoid competition, unless the activity is regarded as the primary work of an official partner to the application. C. Special Program Requirements ETA will require that the program or project participate in an evaluation of overall performance. To measure the impact of the grant program, ETA will arrange for or conduct an independent evaluation of the outcomes and benefits of the projects. Grantees must agree to make records on participants, employers and funding available, and to provide access to program operating personnel and participants, as specified by the evaluator(s) under the direction of ETA, including after the expiration date of the grant. D. Reporting As a condition of participation in the grant program, applicants will be required to submit periodic reports such as the Quarterly Financial Reports, Progress Reports and Final Reports as follows: *Quarterly Financial Reports.* A Quarterly Financial Status Report (ETA 9130)/OMB Approval No. 1205-0461 is required until such time as all funds have been expended and/or the grant period has expired. Quarterly financial reports are due 45 days after the end of each calendar year quarter. Grantees must use ETA's Online Electronic Reporting System. *Quarterly Progress Reports.* The grantee must submit a quarterly Performance Progress Report, SF-PPR/OMB Approval Number: 0970-0443 to the designated Federal Project Officer within 45 days after the end of each calendar year quarter. Two copies are to be submitted providing a detailed account of activities undertaken during that quarter. ETA may require additional data elements to be collected and reported on either a regular basis or special request basis. Grantees must agree to meet ETA's reporting requirements. The quarterly progress report must be in narrative form and must include: In-depth information on accomplishments including project success stories, upcoming grant activities, promising approaches and processes, and progress toward performance outcomes, among others. Also, reports should include updates on product, curricula, training development, challenges, barriers, or concerns regarding project progress. Reports should also include lessons learned in the areas of project administration and management, project implementation, partnership relationships, and other related information. ETA will provide grantees with guidance and tools to help develop the quarterly reports once the grants are awarded. *Final Report.* A draft final report must be submitted no later than 60 days prior to the expiration date of the grant. This report must summarize project activities, employment outcomes, and related results of the training project, and should thoroughly document capacity building and training approaches. The final report should also include copies of all deliverables, *e.g.* curricula and competency models. After responding to ETA questions and comments on the draft report, three copies of the final report must be submitted no later than the grant expiration date. Grantees must agree to use a designated format specified by ETA for preparing the final report. Part VII. Agency Contact Information For further information regarding this SGA, please contact BJai Johnson, Grants Management Specialist,
(202)693-3296. (Please note this is not a toll-free number) Applicants should fax all technical questions to
(202)693-2879 and must specifically address the fax to the attention of BJai Johnson and should include SGA/DFA PY-07-10, a contact name, fax and phone number, and e-mail address. This announcement is being made available on the ETA Web site at *http://www.doleta.gov/sga/sga.cfm,* at *http://www.grants.gov,* as well as in the **Federal Register** . Part VIII. Additional Resources of Interest to Applicants Resources for the Applicant ETA maintains a number of web-based resources that may be of assistance to applicants. • America's Service Locator at *www.servicelocator.org* provides a directory of the nation's One-Stop Career Centers. • Applicants are encouraged to review “Help with Solicitation for Grant Applications” at *http://www.dol.gov/cfbci/sgabrochure.htm.* • For a basic understanding of the grants process and basic responsibilities of receiving Federal grant support, please see ”Guidance for Faith-Based and Community Organizations on Partnering with the Federal Government” available at *http://www.whitehouse.gov/government/fbci/guidance/index.html.* Other Information *OMB Information Collection No.* 1205-0458. *Expires:* September 30, 2009. According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. Public reporting burden for this collection of information is estimated to average 20 hours per response, including time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding the burden estimated or any other aspect of this collection of information, including suggestions for reducing this burden, to the U.S. Department of Labor, the OMB Desk Officer for ETA, Office of Management and Budget, 200 Constitution Avenue, NW., Room N-1031, Washington, DC 20210. Please do not return the completed application to the OMB. Send it to the sponsoring agency as specified in this solicitation. This information is being collected for the purpose of awarding a grant. The information collected through this ”Solicitation for Grant Applications” will be used by the Department of Labor to ensure that grants are awarded to the applicants best suited to perform the functions of the grant. Submission of this information is required in order for the applicant to be considered for award of this grant. Unless otherwise specifically noted in this announcement, information submitted in the respondent's application is not considered to be confidential. Signed at Washington, DC this 8th day of May, 2008. James W. Stockton, Grant Officer. [FR Doc. E8-10971 Filed 5-15-08; 8:45 am] BILLING CODE 4510-FN-P DEPARTMENT OF LABOR Mine Safety and Health Administration Petitions for Modification AGENCY: Mine Safety and Health Administration, Labor. ACTION: Notice of petitions for modification of existing mandatory safety standards. SUMMARY: Section 101(c) of the Federal Mine Safety and Health Act of 1977 and 30 CFR Part 44 govern the application, processing, and disposition of petitions for modification. This notice is a summary of petitions for modification filed by the parties listed below to modify the application of existing mandatory safety standards published in Title 30 of the Code of Federal Regulations. DATES: All comments on the petitions must be received by the Office of Standards, Regulations, and Variances on or before June 16, 2008. ADDRESSES: You may submit your comments, identified by “docket number” on the subject line, by any of the following methods: 1. *Electronic mail:* *Standards-Petitions@dol.gov.* 2. *Facsimile:* 1-202-693-9441. 3. *Regular Mail:* MSHA, Office of Standards, Regulations, and Variances, 1100 Wilson Boulevard, Room 2349, Arlington, Virginia 22209, Attention: Patricia W. Silvey, Director, Office of Standards, Regulations, and Variances. 4. *Hand-Delivery or Courier:* MSHA, Office of Standards, Regulations, and Variances, 1100 Wilson Boulevard, Room 2349, Arlington, Virginia 22209, Attention: Patricia W. Silvey, Director, Office of Standards, Regulations, and Variances. We will consider only comments postmarked by the U.S. Postal Service or proof of delivery from another delivery service such as UPS or Federal Express on or before the deadline for comments. Individuals who submit comments by hand-delivery are required to check in at the receptionist desk on the 21st floor. Individuals may inspect copies of the petitions and comments during normal business hours at the address listed above. FOR FURTHER INFORMATION CONTACT: Lawrence D. Reynolds, Office of Standards, Regulations, and Variances at 202-693-9449 (Voice), *reynolds.lawrence@dol.gov* (E-mail), or 202-693-9441 (Telefax), or contact Barbara Barron at 202-693-9447 (Voice), *barron.barbara@dol.gov* (E-mail), or 202-693-9441 (Telefax). [These are not toll-free numbers]. SUPPLEMENTARY INFORMATION: I. Background Section 101(c) of the Federal Mine Safety and Health Act of 1977 (Mine Act) allows the mine operator or representative of miners to file a petition to modify the application of any mandatory safety standard to a coal or other mine if the Secretary determines that:
(1)An alternative method of achieving the result of such standard exists which will at all times guarantee no less than the same measure of protection afforded the miners of such mine by such standard; or
(2)that the application of such standard to such mine will result in a diminution of safety to the miners in such mine. In addition, the regulations at 30 CFR 44.10 and 44.11 establish the requirements and procedures for filing petitions for modifications. II. Petitions for Modification *Docket Number:* M-2008-012-C. *Petitioner:* Blue Diamond Coal Company, P.O. Box 47, Slemp, Kentucky 41763. *Mine:* Mine #81, MSHA I.D. No. 15-12753, located in Leslie County, Kentucky. *Regulation Affected:* 30 CFR 75.364(b)(1) (Weekly examination). *Modification Request:* The petitioner requests a modification of the existing standard to permit check points (examination points) to be established in six locations of the Turkey Creek Cutout Mains due to poor roof conditions. The petitioner proposes to establish examination points at certain points to evaluate airflow entering the Turkey Creek Cutout Mains and exiting the Turkey Creek Cutout Mains. The petitioner also proposes to establish ventilation check points between certain breaks of the Turkey Creek Cutout Mains. The petitioner states that:
(1)The size of the areas that has adverse roof conditions is substantial and would expose rehabilitation crews to draw rock hazards unnecessarily;
(2)the Turkey Creek Cutout Mains has value for the mines from a ventilation standpoint and it is mine managements' desire not to seal these portals;
(3)the areas are no longer utilized from supplies or personnel travel;
(4)the area will continue to be examined as required by the standard, but evaluation of the inlet and outlet would provide the necessary examination without exposing the mine personnel to roof hazards; and
(5)no less degree of safety is ensured by traveling to both ends of the mains and verifying adequate air volume and quality at the noted evaluation points and check points. The petitioner asserts that the proposed alternative method will at all times guarantee no less than the same measure of protection afforded by the existing standard. *Docket Number:* M-2008-013-C. *Petitioner:* South Tamaqua Coal Pockets, Inc., 804 West Penn Pike, Tamaqua, Pennsylvania 18252. *Mine:* Yorktown Operation, MSHA I.D. No. 36-09088, located in Luzerne County, Pennsylvania. *Regulation Affected:* 30 CFR 77.1200(c) &
(k)(Mine map). *Modification Request:* The petitioner requests a modification of the existing standard to permit the use of cross-sections in lieu of contour lines at regular intervals through the area to be mined and to limit the required mapping of mine workings below to those present within 100 feet of the vein(s) being mined. The petitioner states that:
(1)Due to the steep pitch encountered in mining anthracite coal veins, contours provide no useful information and their presence would make portions of the map illegible;
(2)use of cross-sections in lieu of contour lines has been practiced since the late 1800's thereby providing critical information relative to the spacing between veins and proximity to other mine workings which fluctuate considerably;
(3)the vast majority of current surface anthracite mining involves either the mining of remnant pillars from previous mining/mine operators or the mining of veins of lower quality in proximity to inaccessible and frequently flooded abandoned mine workings which may or may not be mapped; and
(4)the mine workings below are usually inactive and abandoned, and therefore, are not subject to changes during the life of the mine, but active mines will be mapped. The petitioner asserts that the proposed alternative method will in no way provide less than the same measure of protection than that afforded the miners under the existing standard. *Docket Number:* M-2008-014-C through M-2008-018-C. *Petitioner:* AMFIRE Mining Company, LLC, One Energy Place, Latrobe, Pennsylvania 15650. *Mine:* Ondo Extension Mine, MSHA I.D. No. 36-09005, Nolo Mine, MSHA I.D. No. 36-08850, Gillhouser Run Mine, MSHA I.D. No. 36-09033, all located in Indiana County, Pennsylvania; Madison Mine, MSHA I.D. No. 36-09127, located in Cambria County, Pennsylvania; and Dora 8 Mine, MSHA I.D. No. 36-08704, located in Jefferson County, Pennsylvania. *Regulation Affected:* 30 CFR 75.500(d) (Permissible electric equipment). *Modification Request:* The petitioner requests a modification of the existing standard to permit the use of low-voltage or battery-powered non-permissible electronic testing and diagnostic equipment in or inby the last open crosscut or within 150 feet of pillar workings, under controlled conditions, for testing and diagnosing mining equipment. The petitioner proposes to use the following equipment within 150 feet of pillar workings. The petitioner seeks modification of 30 CFR 75.500(d) and any other applicable standards as they pertain to restricting the use of non-permissible or non-intrinsically safe electrical testing and diagnostic equipment used by maintenance personnel for trouble shooting and repair of mining equipment commonly used and accepted which may include, but is not limited to: Laptop computers, oscilloscopes, vibration analysis machines, cable fault detectors, point temperature probes, infrared temperature devices, insulation testers (meggers), voltage, current and power measurement devices and recorders, pressure flow measurement devices, signal analyzer devices, ultrasonic thickness gauges, electronic component testers, and electronic tachometers. The petitioner states that:
(1)Application of the existing standard will result in a diminution of safety to the miners;
(2)mining equipment by its nature, size, complexity, and location require that when disabled and requiring repair the equipment is nearly impossible and potentially unsafe to move or attempt to move to a location out by the last open crosscut in order to use non-permissible testing and diagnostic equipment;
(3)all non-permissible electronic testing and diagnostic equipment used in or inby the last open crosscut will be examined by a qualified person as defined in 30 CFR 75.153 prior to use to ensure the equipment is being maintained in a safe operating condition;
(4)examination results will be recorded in the weekly examination of electrical equipment book;
(5)a qualified person will continuously monitor for methane immediately before and during the use of non-permissible electronic test and diagnostic equipment in or inby the last open crosscut;
(6)if 1.0 percent or more of methane is detected while the non-permissible electronic testing and diagnostic equipment is being used, the equipment will be de-energized immediately and the non-permissible electronic equipment will be withdrawn outby the last open crosscut or to a minimum of 150 feet outby the pillar workings;
(7)all hand-held methane detectors will be MSHA-approved and maintained in permissible and proper operating condition as defined under 30 CFR 75.75.320; and
(8)qualified personnel using the electronic test and diagnostic equipment will be properly trained to recognize the hazards and limitations associated with the use of electronic test and diagnostic equipment. The petitioner further states that the proposed methods and conditions will be included in the initial and annual refresher training and the approved Part 48 training plans, to ensure that miners are aware of the stipulations contained in this petition. Persons may review a complete description of petitioner's alternative method and procedures at the MSHA address listed in the notice. The petitioner asserts that the proposed alternative method will in no way provide less than the same measure of protection than that afforded the miners under the existing standard. *Docket Number:* M-2008-019-C. *Petitioner:* White County Coal, LLC, 1525 County Road 1300 N, P.O. Box 457, Carmi, Illinois 62821. *Mine:* Pattiki Mine, MSHA I.D. No. 11-03058, located in White County, Illinois. *Regulation Affected:* 30 CFR 75.503 (Permissible electric face equipment; maintenance) and 30 CFR 18.35(a)(5)(i) and
(ii)(Portable (trailing) cables and cords). *Modification Request:* The petitioner requests a modification of the existing standard to permit the maximum length of trailing cables to be increased for supplying power to permissible pumps. The petitioner states that:
(1)This petition will only apply to trailing cables supplying three-phase 480-volt power for permissible pumps;
(2)the maximum length of the 480-volt power for permissible pumps will be 4000 feet;
(3)the 480-volt power for permissible pump trailing cables will not be smaller than #6 American Wire Gauge (AWG);
(4)all circuit breakers used to protect #6 AWG trailing cables exceeding 500 feet in length will have an instantaneous trip unit calibrated to trip at 60 amperes;
(5)the circuit breakers trip setting will be sealed or locked, and have permanent legible labels identifying the circuit breakers as being suitable for protecting #6 AWG cables;
(6)replacement of instantaneous trip units used to protect #6 AWG trailing cables exceeding 500 feet in length will be calibrated to trip at 60 amperes and this setting will be sealed or locked;
(7)all circuit breakers used to protect #2 AWG trailing cables exceeding 500 feet in length will have instantaneous trip units calibrated to trip at 150 amperes and the trip setting of these circuit breakers will be sealed or locked and will have permanent legible labels that will be maintained as legible to identify the circuit breaker as being suitable for protecting #2 AWG cables;
(8)replacement of instantaneous trip units, used to protect #2 AWG trailing cables exceeding 500 feet in length will be calibrated to trip at 150 feet in length and calibrated to trip at 150 amperes and the setting will be sealed or locked; and
(9)permanent warning labels will be installed and maintained on the cover(s) of the power center identifying the location of each sealed or locked short-circuit protection device to warn the miners not to change or alter the short-circuit settings. Persons may review a complete description of petitioner's alternative method and procedures at the MSHA address listed in the notice. The petitioner states that the alternative method will not be implemented until miners designated to examine the integrity of the seals or locks verify the short-circuit settings, and proper procedures training has been provided for examining trailing cables for defects and damage. The training for the miners will include the following elements:
(1)Training in mining methods and operating procedures for protecting the trailing cables against damage;
(2)training in the proper procedures for examining the trailing cables to ensure safe operating conditions;
(3)training in the hazards of setting the instantaneous circuit breakers too high to adequately protect the trailing cables; and
(4)training on how to verify that interrupting device(s) protecting the trailing cable(s) are properly set and maintained. The petitioner further states that within 60 days after the petition is granted, revisions to the Part 48 training plan will be submitted to the District Manager for the area in which the mine is located. The petitioner asserts that the proposed alternative method will at all times guarantee no less than the same measure of protection to the miners as would be provided by the existing standard. Dated: May 12, 2008. Jack Powasnik, Deputy Director, Office of Standards, Regulations, and Variances. [FR Doc. E8-10943 Filed 5-15-08; 8:45 am] BILLING CODE 4510-43-P DEPARTMENT OF LABOR Occupational Safety and Health Administration [Docket No. OSHA-2008-0002] National Advisory Committee on Occupational Safety and Health (NACOSH); Announcement of Meeting AGENCY: Occupational Safety and Health Administration (OSHA), Labor. ACTION: Announcement of meeting. SUMMARY: The National Advisory Committee on Occupational Safety and Health (NACOSH) will meet May 29, 2008, in Washington, DC. DATES: *NACOSH meeting:* NACOSH will meet from 9 a.m. to 4 p.m., Thursday, May 29, 2008. *Submission of comments and requests to speak:* Comments and requests to speak at the NACOSH meeting must be received by Thursday, May 22, 2008. ADDRESSES: *NACOSH meeting:* NACOSH will meet in Room N-3437 A/B/C/D, U.S. Department of Labor, 200 Constitution Avenue, NW., Washington, DC 20210. *Submission of comments and requests to speak:* Comments and requests to speak at the NACOSH meeting, identified by docket number for this **Federal Register** notice (Docket No. OSHA-2008-0002), may be submitted by any of the following methods: *Electronically:* You may submit materials, including attachments, electronically at: *http://www.regulations.gov,* the Federal eRulemaking Portal. Follow the online instructions for making submissions. *Facsimile:* If your submission, including attachments, does not exceed 10 pages, you may fax it to the OSHA Docket Office at
(202)693-1648. *Mail, express delivery, hand delivery, messenger or courier service:* Submit three copies of your submissions to the OSHA Docket Office, Room N-2625, U.S. Department of Labor, 200 Constitution Avenue, NW., Washington, DC 20210, telephone
(202)693-2350 (TTY
(877)889-5627). Deliveries (hand, express mail, messenger and courier service) are accepted during the Department of Labor's and OSHA Docket Office's normal business hours, 8:15 a.m. to 4:45 p.m., *et.* *Instructions:* All submissions must include the Agency name and docket number for this **Federal Register** notice (Docket No. OSHA-2008-0002). Submissions in response to this notice, including personal information provided, will be posted without change at *http:www.regulations.gov.* Therefore, OSHA cautions interested parties about submitting personal information such as social security numbers and birth dates. Because of security-related procedures, submissions by regular mail may result in a significant delay in their receipt. Please contact the OSHA Docket Office, at the address above, for information about security procedures concerning submitting materials by hand delivery, express delivery, and messenger or courier service. For additional information on submitting comments and requests to speak, see the SUPPLEMENTARY INFORMATION section below. *Docket:* To read or download submissions, go to *http://www.regulations.gov.* Although listed in the index, some documents ( *e.g.* , copyrighted material) are not publicly available to read or download through *http://www.regulations.gov.* All submissions, including copyrighted material, are available for inspection and copying at the OSHA Docket Office at the address above. FOR FURTHER INFORMATION CONTACT: *For general information:* Deborah Crawford, OSHA, Directorate of Evaluation and Analysis, U.S. Department of Labor, Room N-3641, 200 Constitution Avenue, NW., Washington, DC 20210; telephone
(202)693-1932; fax
(202)693-1641; e-mail *crawford.deborah@dol.gov* *For special accommodations for the NACOSH meeting:* Veneta Chatmon, OSHA, Office of Communications, Room N-3647, U.S. Department of Labor, 200 Constitution Avenue, NW., Washington, DC 20210; telephone
(202)693-1999; e-mail *chatmon.veneta@dol.gov.* SUPPLEMENTARY INFORMATION: NACOSH will meet Thursday, May 29, 2008, in Washington, DC. All NACOSH meetings are open to the public. Section 7(a) of the Occupational Safety and Health Act of 1970 (OSH Act) (29 U.S.C. 656) authorizes NACOSH to advise the Secretary of Labor and the Secretary of Health and Human Services on matters relating to the administration of the OSH Act. NACOSH is a continuing advisory body and operates in compliance with provisions in the OSH Act, the Federal Advisory Committee Act (5 U.S.C. App. 2), and regulations issued pursuant to those laws (29 CFR 1912a, 41 CFR part 101-6 and 102-3). *The tentative agenda for the NACOSH meeting includes presentations on the following:* • Public and municipal employees; • Global harmonization; • Aging workforce; • Motor vehicle safety; and • Worklife Initiative. NACOSH meetings are transcribed and detailed minutes of the meetings are prepared. Meeting transcripts and minutes are included in the official record of NACOSH meetings (Docket No OSHA-2008-0002). Interested parties may submit a request to make an oral presentation to NACOSH by one of the methods listed in the ADDRESSES section above. The request must state the amount of time requested to speak, the interest represented ( *e.g.* , organization name), if any, and a brief outline of the presentation. Requests to address NACOSH may be granted as time permits and at the discretion of the NACOSH chair. Interested parties also may submit comments, including data and other information using any of the methods listed in the ADDRESSES section above. OSHA will provide all submissions to NACOSH members. Individuals who need special accommodation to attend the NACOSH meeting should contact Veneta Chatmon, at the address above, at least seven days before the meeting. Public Participation—Submissions and Access to Official Meeting Record You may submit comments and requests to speak
(1)electronically,
(2)by facsimile, or
(3)by hard copy. All submissions, including attachments and other materials, must identify the Agency name and the docket number for this notice (Docket No. OSHA-2008-20002). You may supplement electronic submissions by uploading documents electronically. If, instead, you wish to submit hard copies of supplementary documents, you must submit three copies to the OSHA Docket Office using the instructions in the ADDRESSES section above. The additional materials must clearly identify your electronic submission by name, date and docket number. Because of security-related procedures, the use of regular mail may cause a significant delay in the receipt of submissions. For information about security procedures concerning submissions by hand, express delivery, messenger or courier service, please contact the OSHA Docket Office at
(202)693-2350 (TTY
(877)889-5627). Meeting transcripts and minutes as well as submissions in response to this **Federal Register** notice are included in the official record of the NACOSH meeting (Docket No. OSHA-2008-0002). Submissions are posted without change at *http://www.regulations.gov.* Therefore, OSHA cautions interested parties about submitting personal information such as social security numbers and birth dates. Although all submissions are listed in the *http://www.regulations.gov* index, some documents ( *e.g.* , copyrighted materials) are not publicly available to read or download through *http://www.regulations.gov.* All submissions, including copyrighted material, are available for inspection and copying at the OSHA Docket Office. Information on using the *http://www.regulations.gov* Web site to make submissions and to access the docket and exhibits is available at the Web site's User Tips link. Contact the OSHA Docket Office for information about materials not available through the Web site and for assistance in using the Internet to locate submissions and other documents in the docket. Electronic copies of this **Federal Register** notice are available at *http://www.regulations.gov.* This notice, as well as news releases and other relevant information, is also available on the OSHA Web page at *http://www.osha.gov.* Authority and Signature Edwin G. Foulke, Jr., Assistant Secretary of Labor for Occupational Safety and Health, directed the preparation of this notice under the authority granted by section 7 of the Occupational Safety and Health Act of 1970 (29 U.S.C. 656), 29 CFR 1912a, the Federal Advisory Committee Act (5 U.S.C. App. 2), and Secretary of Labor's Order No. 5-2007 (72 FR 31160). Signed at Washington, DC, this 13th day of May 2008. Edwin G. Foulke, Jr., Assistant Secretary of Labor for Occupational Safety and Health. [FR Doc. E8-10995 Filed 5-15-08; 8:45 am] BILLING CODE 4510-26-P NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (08-044)] NASA International Space Station Advisory Committee; Meeting AGENCY: National Aeronautics and Space Administration (NASA). ACTION: Notice of meeting. SUMMARY: In accordance with the Federal Advisory Committee Act, Public Law 92-463, as amended, the National Aeronautics and Space Administration announces an open meeting of the NASA International Space Station Advisory Committee. DATES: May 30, 2008, 1-1:30 p.m. Eastern Daylight Time. ADDRESSES: National Aeronautics and Space Administration Headquarters, 300 E Street, SW., Room 7U38, Washington, DC 20546. FOR FURTHER INFORMATION CONTACT: Dr. Glen R. Asner, Office of External Relations,
(202)358-0903, National Aeronautics and Space Administration, Washington, DC 20546-0001. SUPPLEMENTARY INFORMATION: This meeting will be open to the public up to the seating capacity of the room. Five seats will be reserved for members of the press. The purpose of the meeting is to assess NASA and Roscosmos plans to support a six-person crew aboard the International Space Station, including transportation, crew rotation, training, and micro meteoroid and orbital debris shielding. Attendees will be requested to sign a register and to comply with NASA security requirements, including the presentation of a valid picture ID, before receiving an access badge. Foreign nationals attending this meeting will be required to provide the following information: Full name; gender; date/place of birth; citizenship; visa/green card information (number, type, expiration date); passport information (number, country, expiration date); employer/affiliation information (name of institution, address, country, phone); title/position of attendee. To expedite admittance, attendees should provide identifying information in advance by contacting Glen Asner via e-mail at *glen.asner@nasa.gov* or by telephone at
(202)358-0903 by May 15, 2008. It is imperative that the meeting be held on this date to accommodate the scheduling priorities of the key participants. Dated: May 7, 2008. P. Diane Rausch, Advisory Committee Management Officer, National Aeronautics and Space Administration. [FR Doc. E8-10711 Filed 5-15-08; 8:45 am] BILLING CODE 7510-13-P NATIONAL SCIENCE FOUNDATION Agency Information Collection Activities: Comment Request AGENCY: National Science Foundation. ACTION: Submission for OMB Review; Comment Request. SUMMARY: The National Science Foundation
(NSF)has submitted the following information collection requirement to OMB for review and clearance under the Paperwork Reduction Act of 1995, Pub. L. 104-13. This is the second notice for public comment; the first was published in the **Federal Register** at 73 FR 12470, and no substantial comments were received. NSF is forwarding the proposed renewal submission to the Office of Management and Budget
(OMB)for clearance simultaneously with the publication of this second notice. Comments regarding
(a)Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(b)the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used;
(c)ways to enhance the quality, utility and clarity of the information to be collected;
(d)ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology should be addressed to: Office of Information and Regulatory Affairs of OMB, Attention: Desk Officer for National Science Foundation, 725 17th Street, NW., Room 10235, Washington, DC 20503, and to Suzanne H. Plimpton, Reports Clearance Officer, National Science Foundation, 4201 Wilson Boulevard, Suite 295, Arlington, Virginia 22230 or send e-mail to *splimpto@nsf.gov.* Comments regarding these information collections are best assured of having their full effect if received within 30 days of this notification. Copies of the submission may be obtained by calling 703-292-7556. NSF may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number. SUPPLEMENTARY INFORMATION: *Title of Collection:* 2008 Survey of Doctorate Recipients. *OMB Approval Number:* 3145-0020. *Type of Request:* Intent to seek approval to extend an information collection for three years. 1. Abstract The Survey of Doctorate Recipients
(SDR)has been conducted biennially since the 1970s. The 2008 SDR will consist of a sample of individuals under age 76 who have earned a science, engineering or health doctorate from a U.S. university. The purpose of this longitudinal study is to provide national estimates on the doctoral science, engineering and health workforce and changes in employment, education and demographic characteristics of that workforce. The study is one of three components of the Scientists and Engineers Statistical Data System (SESTAT), which produces national estimates of the size and characteristics of the nation's science and engineering workforce. The National Science Foundation Act of 1950, as subsequently amended, includes a statutory charge to “ * * * provide a central clearinghouse for the collection, interpretation, and analysis of data on scientific and engineering resources, and to provide a source of information for policy formulation by other agencies of the Federal Government.” The SDR is designed to comply with these mandates by providing information on the supply and utilization of the nation's doctoral scientists and engineers. Collected data will be used to produce estimates of the characteristics of these individuals. They will also provide necessary input into the SESTAT data system, which produces national estimates of the size and characteristics of the country's science and engineering personnel. The Foundation uses this information to prepare congressionally mandated reports such as *Women, Minorities and Persons with Disabilities in Science and Engineering and Science and Engineering Indicators.* A public release file of collected data, designed to protect respondent confidentiality, will be made available to researchers on CD-ROM and on the World Wide Web. The National Opinion Research Center
(NORC)at the University of Chicago will conduct the study for NSF. Data collection will begin in October 2008 by mail, Web survey and computer-assisted telephone interview. The survey will be collected in conformance with the Confidential Information Protection and Statistical Efficiency Act of 2002 and Privacy Act of 1974. The individual's response to the survey is voluntary. NSF will insure that all information collected will be kept strictly confidential and will be used only for research or statistical purposes. 2. Expected Respondents A statistical sample of approximately 42,600 persons, identified as having a doctorate in a science, engineering or health field from a U.S. university will be contacted. The total response rate in 2006 was 79%. 3. Burden on the Public The amount of time to complete the questionnaire may vary depending on an individual's circumstances; however, on average it will take approximately 25 minutes to complete the survey. Assuming an 80% response rate, NSF estimates that the total burden for the 2008 SDR will be 15,200 hours. Dated: May 12, 2008. Suzanne H. Plimpton, Reports Clearance Officer, National Science Foundation. [FR Doc. E8-10937 Filed 5-15-08; 8:45 am] BILLING CODE 7555-01-P NATIONAL SCIENCE FOUNDATION Agency Information Collection Activities: Comment Request AGENCY: National Science Foundation. ACTION: Submission for OMB review; comment request. SUMMARY: The National Science Foundation
(NSF)has submitted the following information collection requirement to OMB for review and clearance under the Paperwork Reduction Act of 1995, Pub. L. 104-13. This is the second notice for public comment; the first was published in the **Federal Register** at 73 FR 12471, and no substantial comments were received. NSF is forwarding the proposed renewal submission to the Office of Management and Budget
(OMB)for clearance simultaneously with the publication of this second notice. Comments regarding
(a)Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(b)the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used;
(c)ways to enhance the quality, utility and clarity of the information to be collected;
(d)ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology should be addressed to: Office of Information and Regulatory Affairs of OMB, Attention: Desk Officer for National Science Foundation, 725 17th Street, NW., Room 10235, Washington, DC 20503, and to Suzanne H. Plimpton, Reports Clearance Officer, National Science Foundation, 4201 Wilson Boulevard, Suite 295, Arlington, Virginia 22230 or send e-mail to *splimpto@nsf.gov.* Comments regarding these information collections are best assured of having their full effect if received within 30 days of this notification. Copies of the submission may be obtained by calling 703-292-7556. NSF may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number. SUPPLEMENTARY INFORMATION: *Title of Collection:* 2008 National Survey of Recent College Graduates. *OMB Approval Number:* 3145-0077. *Type of Request:* Intent to seek approval to extend an information collection for three years. 1. Abstract The National Survey of Recent College Graduates (NSRCG) has been conducted biennially since 1974. The 2008 NSRCG will consist of a sample of individuals who have recently completed bachelor's and master's degrees in science, engineering and health from U.S. institutions. The purpose of this study is to provide national estimates on the new entrants in the science and engineering workforce and to provide estimates on the characteristics of recent bachelor's and master's graduates with science, engineering, and health degrees. The study is one of three components of the Scientists and Engineers Statistical Data System (SESTAT), which produces national estimates of the size and characteristics of the nation's science and engineering workforce. The National Science Foundation Act of 1950, as subsequently amended, includes a statutory charge to “ * * * provide a central clearinghouse for the collection, interpretation, and analysis of data on scientific and engineering resources, and to provide a source of information for policy formulation by other agencies of the Federal Government.” The NSRCG is designed to comply with these mandates by providing information on the supply and utilization of the nation's recent bachelor's and master's level scientists and engineers. Collected data will be used to produce estimates of the characteristics of these individuals. They will also provide necessary input into the SESTAT labor force data system, which produces national estimates of the size and characteristics of the country's science and engineering personnel. The Foundation uses this information to prepare congressionally mandated reports such as *Women, Minorities and Persons with Disabilities in Science and Engineering and Science and Engineering Indicators.* NSF publishes statistics from the survey in many reports, but primarily in the biennial series, *Characteristics of Recent Science and Engineering Graduates in the United States.* A public release file of collected data, designed to protect respondent confidentiality, will be made available to researchers on CD-ROM and on the World Wide Web. Mathematica Policy Research will conduct the study under contract for NSF. Data are obtained by mail questionnaire, computer assisted telephone interview and web survey beginning October 2008. The survey will be collected in conformance with the Confidential Information Protection and Statistical Efficiency Act of 2002 and Privacy Act of 1974. The individual's response to the survey is voluntary. NSF will insure that all information collected will be kept strictly confidential and will be used only for research or statistical purposes. 2. Expected Respondents A statistical sample of approximately 18,000 bachelor's and master's degree recipients in science, engineering, and health from the academic years 2006 and 2007 will be contacted in 2008. The total response rate in 2006 was 67%. 3. Burden on the Public The amount of time to complete the questionnaire may vary depending on an individual's circumstances; however, on average it will take approximately 25 minutes to complete the survey. Assuming a 80% response rate, NSF estimates that the total burden for the 2008 NSRCG will be 6,100 hours. Dated: May 12, 2008. Suzanne H. Plimpton, Reports Clearance Officer, National Science Foundation. [FR Doc. E8-10938 Filed 5-15-08; 8:45 am] BILLING CODE 7555-01-P NATIONAL SCIENCE FOUNDATION Agency Information Collection Activities: Comment Request AGENCY: National Science Foundation. ACTION: Submission for OMB review; comment request. SUMMARY: The National Science Foundation
(NSF)has submitted the following information collection requirement to OMB for review and clearance under the Paperwork Reduction Act of 1995, Pub. L. 104-13. This is the second notice for public comment; the first was published in the **Federal Register** at 73 FR 12470, and no substantial comments were received. NSF is forwarding the proposed renewal submission to the Office of Management and Budget
(OMB)for clearance simultaneously with the publication of this second notice. Comments regarding
(a)Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(b)the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used;
(c)ways to enhance the quality, utility and clarity of the information to be collected;
(d)ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology should be addressed to: Office of Information and Regulatory Affairs of OMB, Attention: Desk Officer for National Science Foundation, 725 7th Street, NW., Room 10235, Washington, DC 20503, and to Suzanne H. Plimpton, Reports Clearance Officer, National Science Foundation, 4201 Wilson Boulevard, Suite 295, Arlington, Virginia 22230 or send e-mail to *splimpto@nsf.gov* . Comments regarding these information collections are best assured of having their full effect if received within 30 days of this notification. Copies of the submission may be obtained by calling 703-292-7556. NSF may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number. SUPPLEMENTARY INFORMATION: *Title of Collection:* 2008 National Survey of College Graduates. *OMB Approval Number:* 3145-0141. *Expiration Date of Approval:* February 28, 2009. *Type of Request:* Intent to seek approval to extend an information collection for three years. 1. Abstract The National Survey of College Graduates (NSCG), formerly called the National Survey of Natural and Social Scientists and Engineers, has been conducted biennially since the 1970s. The 2008 NSCG will consist of a sample of individuals under age 76 who had responded to the 2006 NSCG, and the 2006 National Survey of Recent College Graduates who either have at least one bachelor's degree in a science and engineering (S&E) field, or have at least a bachelor's degree in a non-S&E field but work in an S&E occupation. The purpose of this longitudinal study is to provide national estimates on the science and engineering workforce and changes in employment, education and demographic characteristics. The study is one of three components of the Scientists and Engineers Statistical Data System (SESTAT), which produces national estimates of the size and characteristics of the nation's science and engineering workforce. The National Science Foundation Act of 1950, as subsequently amended, includes a statutory charge to “ * * * provide a central clearinghouse for the collection, interpretation, and analysis of data on scientific and engineering resources, and to provide a source of information for policy formulation by other agencies of the Federal Government.” The NSCG is designed to comply with these mandates by providing information on the supply and utilization of the nation's scientists and engineers. Collected data will be used to produce estimates of the characteristics of these individuals. They will also provide necessary input into the SESTAT labor force data system, which produces national estimates of the size and characteristics of the country's science and engineering personnel. The Foundation uses this information to prepare congressionally mandated reports such as *Women, Minorities and Persons with Disabilities in Science and Engineering and Science and Engineering Indicators.* A public release file of the SESTAT collected data, designed to protect respondent confidentiality, will be made available to researchers on CD-ROM and on the World Wide Web. The Bureau of the Census, as in the past, will conduct the study for NSF. Questionnaires will be mailed in October 2008 and nonrespondents to the mail questionnaire will be followed up by computer-assisted telephone interviewing. The survey will be collected in conformance with the Confidential Information Protection and Statistical Efficiency Act of 2002 and Privacy Act of 1974. The individual's response to the survey is voluntary. NSF will insure that all information collected will be kept strictly confidential and will be used only for research or statistical purposes. 2. Expected Respondents A statistical sample of approximately 68,000 persons, identified as having at least one bachelor's degree in a science and engineering (S&E) field, or having at least a bachelor's degree in a non-S&E field but working in an S&E occupation, will be contacted. The total response rate in 2006 was 87%. 3. Burden on the Public The amount of time to complete the questionnaire may vary depending on an individual's circumstances; however, on average it will take approximately 25 minutes to complete the survey. Assuming a 90% response rate, NSF estimates that the total burden for the 2008 NSCG will be 25,600 hours. Dated: May 12, 2008. Suzanne H. Plimpton, Reports Clearance Officer, National Science Foundation. [FR Doc. E8-10939 Filed 5-15-08; 8:45 am] BILLING CODE 7555-01-P NUCLEAR REGULATORY COMMISSION [Docket Nos. 50-336 and 50-423] Dominion Nuclear Connecticut, Inc.; Notice of Consideration of Issuance of Amendment to Renewed Facility Operating License, Proposed No Significant Hazards Consideration Determination, and Opportunity for a Hearing The U.S. Nuclear Regulatory Commission (the Commission) is considering issuance of an amendment to Renewed Facility Operating License Nos. DPR-65 and NPF-49 issued to Dominion Nuclear Connecticut, Inc. (DNC, the licensee), for operation of the Millstone Power Station, Unit Nos. 2
(MPS2)and 3 (MPS3), located in New London County, Connecticut. The proposed amendment would modify the Technical Specifications
(TSs)and facility operating licenses in response to the application dated July 13, 2007, as supplemented by letters dated December 7, 2007, March 5 and 25, 2008, and April 28, 2008. The proposed amendment would establish more effective and appropriate action, surveillance, and administrative requirements related to ensuring the habitability of the control room envelope
(CRE)in accordance with the Commission-approved TS Task Force
(TSTF)Standard Technical Specification change traveler TSTF-448, Revision 3, “Control Room Habitability.” Additionally, the proposed amendment would change the “irradiated fuel movement” terminology and adopt “movement of recently irradiated fuel assemblies” terminology consistent with TSTF-448, Revision 3. Before issuance of the proposed license amendment, the Commission will have made findings required by the Atomic Energy Act of 1954, as amended (the Act), and the Commission's regulations. The Commission has made a proposed determination that the amendment request involves no significant hazards consideration. Under the Commission's regulations in Title 10 of the Code of Federal Regulations (10 CFR), Section 50.92, this means that operation of the facility in accordance with the proposed amendment would not
(1)involve a significant increase in the probability or consequences of an accident previously evaluated; or
(2)create the possibility of a new or different kind of accident from any accident previously evaluated; or
(3)involve a significant reduction in a margin of safety. As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below: Criterion 1—The Proposed Change Does Not Involve a Significant Increase in the Probability or Consequences of an Accident Previously Evaluated
(a)The proposed change does not adversely affect accident initiators or precursors nor alter the design assumptions, conditions, or configuration of the facility. The proposed change does not alter or prevent the ability of structures, systems, and components
(SSCs)to perform their intended function to mitigate the consequences of an initiating event within the assumed acceptance limits. The proposed change revises the TS for the CRE emergency ventilation system, which is a mitigation system designed to minimize unfiltered air leakage into the CRE and to filter the CRE atmosphere to protect the CRE occupants in the event of accidents previously analyzed. An important part of the CRE emergency ventilation system is the CRE boundary. The CRE emergency ventilation system is not an initiator or precursor to any accident previously evaluated. Therefore, the probability of any accident previously evaluated is not increased. Performing tests to verify the operability of the CRE boundary and implementing a program to assess and maintain CRE habitability ensure that the CRE emergency ventilation system is capable of adequately mitigating radiological consequences to CRE occupants during accident conditions, and that the CRE emergency ventilation system will perform as assumed in the consequence analyses of design basis accidents. Thus, the consequences of any accident previously evaluated are not increased. Therefore, the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.
(b)The proposed change revising the TS from “irradiated fuel movement” to “movement of recently irradiated fuel assemblies,” referred to hereafter as the “recently irradiated fuel” change, is used to establish operational conditions on CRE emergency ventilation where significant radioactive releases can be postulated. These operational conditions are consistent with the design basis analysis. Inoperability of the CRE emergency ventilation system cannot increase the probability of a fuel handling accident
(FHA)because the CRE emergency ventilation system is not considered an initiator to a FHA. The definition will allow fuel movement without the requirement of an operable CRE emergency ventilation system as long as fuel exceeds the decay time specified in the TS bases. As submitted to the NRC in the Response to Request for Additional Information, dated December 7, 2007, this decay time is 300 hours for MPS2 and MPS3 (350 hours for MPS3 [Stretch Power Uprate] SPU). The consequences of a FHA while moving non-recently irradiated fuel without an operable CRE emergency ventilation system remain less than the limits specified in 10 CFR 50.67. Other TS changes relating to “recently irradiated fuel” do not involve any accidents previously evaluated. Therefore the proposed “recently irradiated fuel” change does not involve a significant increase in the probability or consequences of an accident previously evaluated. Criterion 2—The Proposed Change Does Not Create the Possibility of a New or Different Kind of Accident From Any Accident Previously Evaluated
(a)The proposed change does not impact the accident analysis. The proposed change does not alter the required mitigation capability of the CRE emergency ventilation system, or its functioning during accident conditions as assumed in the licensing basis analyses of design basis accident radiological consequences to CRE occupants. No new or different accidents result from performing the new surveillance or following the new program. The proposed change does not involve a physical alteration of the plant (i.e., no new or different type of equipment will be installed) or a significant change in the methods governing normal plant operation. The proposed change does not alter any safety analysis assumptions and is consistent with current plant operating practice. Therefore, this change does not create the possibility of a new or different kind of accident from any accident previously evaluated.
(b)The proposed “recently irradiated fuel” change does not affect nor create a different type of FHA. The FHA analyses continue to assume that all the iodine and noble gases that become airborne, escape and reach the CRE with no credit taken for deposition, filtration, or containment of the release. The proposed “recently irradiated fuel” change does not involve the addition or modification of equipment or the design of plant systems. The proposed “recently irradiated fuel” change does not alter the mitigating capability of the CRE emergency ventilation system after a FHA involving recently irradiated fuel. This change only permits the CRE emergency ventilation system to be inoperable for a FHA involving fuel that has decayed beyond the “recently irradiated fuel” definition in the TS Bases. For this consideration, the dose consequences to CR occupants remain below the limits required in 10 CFR 50.67. No new or different accidents result from defining the time after shutdown that CRE emergency ventilation system is required to be operable. Other TS changes relating to “recently irradiated fuel” do not create any accidents. Therefore, the proposed “recently irradiated fuel” change regarding recently irradiated fuel does not create the possibility of a new or different kind of accident from any previously analyzed. Criterion 3—The Proposed Change Does Not Involve a Significant Reduction in the Margin of Safety
(a)The proposed change does not alter the manner in which safety limits, limiting safety system settings or limiting conditions for operation are determined. The proposed change does not affect safety analysis acceptance criteria. The proposed change will not result in plant operation in a configuration outside the design basis for an unacceptable period of time without compensatory measures. The proposed change does not adversely affect systems that respond to safely shut down the plant and to maintain the plant in a safe shutdown condition. Therefore, the proposed change does not involve a significant reduction in a margin of safety.
(b)The proposed “recently irradiated fuel” change decay time limits on recently irradiated fuel are used to establish operational conditions on the CRE emergency ventilation system where specific activities represent situations where significant radioactive releases can be postulated. Safety margins and analytical conservatisms have been evaluated through the use of accepted methodology. Although CRE doses have slightly increased for all but the MPS3 [Alternate Source Term] AST, there was not a significant reduction in the margin of safety. These operational conditions are consistent with the design basis analysis and are established such that the radiological consequences to the CRE occupants are below the limits specified in 10 CFR 50.67. Other TS changes relating to “recently irradiated fuel” are not related to a margin of safety. Therefore, operations of the facility in accordance with the proposed “recently irradiated fuel” changes would not involve a significant reduction in the margin of safety. Based upon the above assessment and the previous discussion of the amendment request, DNC concludes that the proposed change does not involve a significant hazards consideration. The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration. The Commission is seeking public comments on this proposed determination. Any comments received within 30 days after the date of publication of this notice will be considered in making any final determination. Normally, the Commission will not issue the amendment until the expiration of 60 days after the date of publication of this notice. The Commission may issue the license amendment before expiration of the 60-day period provided that its final determination is that the amendment involves no significant hazards consideration. In addition, the Commission may issue the amendment prior to the expiration of the 30-day comment period should circumstances change during the 30-day comment period such that failure to act in a timely way would result, for example, in derating or shutdown of the facility. Should the Commission take action prior to the expiration of either the comment period or the notice period, it will publish in the **Federal Register** a notice of issuance. Should the Commission make a final No Significant Hazards Consideration Determination, any hearing will take place after issuance. The Commission expects that the need to take this action will occur very infrequently. Written comments may be submitted by mail to the Chief, Rulemaking, Directives and Editing Branch, Division of Administrative Services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, and should cite the publication date and page number of this **Federal Register** notice. Written comments may also be delivered to Room 6D59, Two White Flint North, 11545 Rockville Pike, Rockville, Maryland, from 7:30 a.m. to 4:15 p.m. Federal workdays. Documents may be examined, and/or copied for a fee, at the NRC's Public Document Room (PDR), located at One White Flint North, Public File Area O1 F21, 11555 Rockville Pike (first floor), Rockville, Maryland. The filing of requests for hearing and petitions for leave to intervene is discussed below. Within 60 days after the date of publication of this notice, the person(s) may file a request for a hearing with respect to issuance of the amendment to the subject facility operating license and any person(s) whose interest may be affected by this proceeding and who wishes to participate as a party in the proceeding must file a written request via electronic submission through the NRC E-filing system for a hearing and a petition for leave to intervene. Requests for a hearing and a petition for leave to intervene shall be filed in accordance with the Commission's “Rules of Practice for Domestic Licensing Proceedings” in 10 CFR part 2. Interested person(s) should consult a current copy of 10 CFR 2.309, which is available at the Commission's PDR, located at One White Flint North, Public File Area O1 F21, 11555 Rockville Pike (first floor), Rockville, Maryland. Publicly available records will be accessible from the Agencywide Documents Access and Management System's (ADAMS) Public Electronic Reading Room on the Internet at the NRC Web site, *http://www.nrc.gov/reading-rm/doc-collections/cfr/.* If a request for a hearing or petition for leave to intervene is filed by the above date, the Commission or a presiding officer designated by the Commission or by the Chief Administrative Judge of the Atomic Safety and Licensing Board Panel, will rule on the request and/or petition; and the Secretary or the Chief Administrative Judge of the Atomic Safety and Licensing Board will issue a notice of a hearing or an appropriate order. As required by 10 CFR 2.309, a petition for leave to intervene shall set forth with particularity the interest of the petitioner in the proceeding, and how that interest may be affected by the results of the proceeding. The petition should specifically explain the reasons why intervention should be permitted with particular reference to the following general requirements:
(1)The name, address and telephone number of the requestor or petitioner;
(2)the nature of the requestor's/petitioner's right under the Act to be made a party to the proceeding;
(3)the nature and extent of the requestor's/petitioner's property, financial, or other interest in the proceeding; and
(4)the possible effect of any decision or order which may be entered in the proceeding on the requestor's/petitioner's interest. The petition must also identify the specific contentions which the petitioner/requestor seeks to have litigated at the proceeding. Each contention must consist of a specific statement of the issue of law or fact to be raised or controverted. In addition, the petitioner/requestor shall provide a brief explanation of the bases for the contention and a concise statement of the alleged facts or expert opinion which support the contention and on which the petitioner intends to rely in proving the contention at the hearing. The petitioner/requestor must also provide references to those specific sources and documents of which the petitioner is aware and on which the petitioner intends to rely to establish those facts or expert opinion. The petition must include sufficient information to show that a genuine dispute exists with the applicant on a material issue of law or fact. Contentions shall be limited to matters within the scope of the amendment under consideration. The contention must be one which, if proven, would entitle the petitioner to relief. A petitioner/requestor who fails to satisfy these requirements with respect to at least one contention will not be permitted to participate as a party. Those permitted to intervene become parties to the proceeding, subject to any limitations in the order granting leave to intervene, and have the opportunity to participate fully in the conduct of the hearing. If a hearing is requested, the Commission will make a final determination on the issue of no significant hazards consideration. The final determination will serve to decide when the hearing is held. If the final determination is that the amendment request involves no significant hazards consideration, the Commission may issue the amendment and make it immediately effective, notwithstanding the request for a hearing. Any hearing held would take place after issuance of the amendment. If the final determination is that the amendment request involves a significant hazards consideration, any hearing held would take place before the issuance of any amendment. A request for hearing or a petition for leave to intervene must be filed in accordance with the NRC E-Filing rule, which the NRC promulgated on August 28, 2007 (72 FR 49139). The E-Filing process requires participants to submit and serve documents over the internet or in some cases to mail copies on electronic storage media. Participants may not submit paper copies of their filings unless they seek a waiver in accordance with the procedures described below. To comply with the procedural requirements of E-Filing, at least five
(5)days prior to the filing deadline, the petitioner/requestor must contact the Office of the Secretary by e-mail at *HEARINGDOCKET@NRC.GOV,* or by calling
(301)415-1677, to request
(1)a digital ID certificate, which allows the participant (or its counsel or representative) to digitally sign documents and access the E-Submittal server for any proceeding in which it is participating; and/or
(2)creation of an electronic docket for the proceeding (even in instances in which the petitioner/requestor (or its counsel or representative) already holds an NRC-issued digital ID certificate). Each petitioner/requestor will need to download the Workplace Forms Viewer TM to access the Electronic Information Exchange (EIE), a component of the E-Filing system. The Workplace Forms Viewer TM is free and is available at *http://www.nrc.gov/site-help/e-submittals/install-viewer.html.* Information about applying for a digital ID certificate is available on NRC's public Web site at *http://www.nrc.gov/site-help/e-submittals/apply-certificates.html.* Once a petitioner/requestor has obtained a digital ID certificate, had a docket created, and downloaded the EIE viewer, it can then submit a request for hearing or petition for leave to intervene. Submissions should be in Portable Document Format
(PDF)in accordance with NRC guidance available on the NRC public Web site at *http://www.nrc.gov/site-help/e-submittals.html.* A filing is considered complete at the time the filer submits its documents through EIE. To be timely, an electronic filing must be submitted to the EIE system no later than 11:59 p.m. Eastern Time on the due date. Upon receipt of a transmission, the E-Filing system time-stamps the document and sends the submitter an e-mail notice confirming receipt of the document. The EIE system also distributes an e-mail notice that provides access to the document to the NRC Office of the General Counsel and any others who have advised the Office of the Secretary that they wish to participate in the proceeding, so that the filer need not serve the documents on those participants separately. Therefore, applicants and other participants (or their counsel or representative) must apply for and receive a digital ID certificate before a hearing request/petition to intervene is filed so that they can obtain access to the document via the E-Filing system. A person filing electronically may seek assistance through the ``Contact Us'' link located on the NRC Web site at *http://www.nrc.gov/site-help/e-submittals.html* or by calling the NRC technical help line, which is available between 8:30 a.m. and 4:15 p.m., Eastern Time, Monday through Friday. The help line number is
(800)397-4209 or locally,
(301)415-4737. Participants who believe that they have a good cause for not submitting documents electronically must file a motion, in accordance with 10 CFR 2.302(g), with their initial paper filing requesting authorization to continue to submit documents in paper format. Such filings must be submitted by:
(1)First class mail addressed to the Office of the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemaking and Adjudications Staff; or
(2)courier, express mail, or expedited delivery service to the Office of the Secretary, Sixteenth Floor, One White Flint North, 11555 Rockville Pike, Rockville, Maryland, 20852, Attention: Rulemaking and Adjudications Staff. Participants filing a document in this manner are responsible for serving the document on all other participants. Filing is considered complete by first-class mail as of the time of deposit in the mail, or by courier, express mail, or expedited delivery service upon depositing the document with the provider of the service. Non-timely requests and/or petitions and contentions will not be entertained absent a determination by the Commission, the presiding officer, or the Atomic Safety and Licensing Board that the petition and/or request should be granted and/or the contentions should be admitted, based on a balancing of the factors specified in 10 CFR 2.309(c)(1)(i)-(viii). To be timely, filings must be submitted no later than 11:59 p.m. Eastern Time on the due date. Documents submitted in adjudicatory proceedings will appear in NRC's electronic hearing docket which is available to the public at *http://ehd.nrc.gov/EHD_Proceeding/home.asp* , unless excluded pursuant to an order of the Commission, an Atomic Safety and Licensing Board, or a Presiding Officer. Participants are requested not to include personal privacy information, such as social security numbers, home addresses, or home phone numbers in their filings. With respect to copyrighted works, except for limited excerpts that serve the purpose of the adjudicatory filings and would constitute a Fair Use application, Participants are requested not to include copyrighted materials in their submissions. For further details with respect to this license amendment application, see the application for amendment dated July 13, 2007, as supplemented by letters dated December 7, 2007, March 5 and 25, 2008, and April 28, 2008, which are available for public inspection at the Commission's PDR, located at One White Flint North, File Public Area O1 F21, 11555 Rockville Pike (first floor), Rockville, Maryland. Publicly available records will be accessible electronically from the Agencywide Documents Access and Management System's (ADAMS) Public Electronic Reading Room on the Internet at the NRC Web site, *http://www.nrc.gov/reading-rm/adams.html.* Persons who do not have access to ADAMS or who encounter problems in accessing the documents located in ADAMS, should contact the NRC PDR Reference staff by telephone at 1-800-397-4209, 301-415-4737, or by e-mail to *pdr@nrc.gov.* Dated at Rockville, Maryland, this 9th day of May 2008. For the Nuclear Regulatory Commission. John D. Hughey, Project Manager, Plant Licensing Branch I-2, Division of Operating Reactor Licensing, Office of Nuclear Reactor Regulation. [FR Doc. E8-11030 Filed 5-15-08; 8:45 am] BILLING CODE 7590-01-P RAILROAD RETIREMENT BOARD Agency Forms Submitted for OMB Review, Request for Comments SUMMARY: In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Railroad Retirement Board
(RRB)is forwarding an Information Collection Request
(ICR)to the Office of Information and Regulatory Affairs (OIRA), Office of Management and Budget
(OMB)to request an extension of a currently approved collection of information: 3220-0099, Statement Regarding Contributions and Support. Our ICR describes the information we seek to collect from the public. Review and approval by OIRA ensures that we impose appropriate paperwork burdens. The RRB invites comments on the proposed collection of information to determine:
(1)The practical utility of the collection;
(2)the accuracy of the estimated burden of the collection;
(3)ways to enhance the quality, utility and clarity of the information that is the subject of collection; and
(4)ways to minimize the burden of collections on respondents, including the use of automated collection techniques or other forms of information technology. Comments to RRB or OIRA must contain the OMB control number of the ICR. For proper consideration of your comments, it is best if RRB and OIRA receive them within 30 days of publication date. Under Section 2 of the Railroad Retirement Act, dependency on an employee for one-half support at the time of an employee's death can be a condition affecting entitlement to a survivor annuity and can affect the amount of both spouse and survivor annuities. One-half support is also a condition which may negate the public service pension offset in Tier I for a spouse or widow(er). The Railroad Retirement Board
(RRB)utilizes Form G-134, Statement Regarding Contributions and Support, to secure information needed to adequately determine if the applicant meets the one-half support requirement. One form is completed by each respondent. The RRB proposes no changes to Form G-134. *Previous Requests for Comments:* The RRB has already published the initial 60-day notice (73 FR 2069 on January 11, 2008) required by 44 U.S.C. 3506(c)(2). That request elicited no comments. Information Collection Request
(ICR)*Title:* Statement Regarding Contributions and Support. *OMB Control Number:* OMB 3220-0099. *Form(s) submitted:* G-134. *Type of request:* Extension without change of a currently approved collection. *Affected public:* Individuals or Households. *Abstract:* Dependency on the employee for one-half support at the time of the employee's death can be a condition affecting eligibility for a survivor annuity provided for under Section 2 of the Railroad Retirement Act. One-half support is also a condition which may negate the public service pension offset in Tier I for a spouse or widow(er). *Changes Proposed:* The RRB proposes no changes to Form G-134. *The burden estimate for the ICR is as follows:* *Estimated Completion Time for Form(s):* Completion time for Form G-134 is estimated at 147 minutes (with assistance) to 180 minutes (without assistance). *Estimated annual number of respondents:* 100. *Total annual responses:* 100. *Total annual reporting hours:* 259. *Additional Information or Comments:* Copies of the form and supporting documents can be obtained from Charles Mierzwa, the agency clearance officer at (312-751-3363) or *Charles.Mierzwa@rrb.gov.* Comments regarding the information collection should be addressed to Ronald J. Hodapp, Railroad Retirement Board, 844 North Rush Street, Chicago, Illinois 60611-2092 or *Ronald.Hodapp@rrb.gov* and to the OMB Desk Officer for the RRB, at the Office of Management and Budget, Room 10230, New Executive Office Building, Washington, DC 20503. Charles Mierzwa, Clearance Officer. [FR Doc. E8-11038 Filed 5-15-08; 8:45 am] BILLING CODE 7905-01-P RAILROAD RETIREMENT BOARD Agency Forms Submitted for OMB Review, Request for Comments SUMMARY: In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Railroad Retirement Board
(RRB)is forwarding an Information Collection Request
(ICR)to the Office of Information and Regulatory Affairs (OIRA), Office of Management and Budget
(OMB)to request an extension of a currently approved collection of information: 3220-0016, Certification of Termination of Service and Relinquishment of Rights. Our ICR describes the information we seek to collect from the public. Review and approval by OIRA ensures that we impose appropriate paperwork burdens. The RRB invites comments on the proposed collection of information to determine:
(1)The practical utility of the collection;
(2)the accuracy of the estimated burden of the collection;
(3)ways to enhance the quality, utility and clarity of the information that is the subject of collection; and
(4)ways to minimize the burden of collections on respondents, including the use of automated collection techniques or other forms of information technology. Comments to RRB or OIRA must contain the OMB control number of the ICR. For proper consideration of your comments, it is best if RRB and OIRA receive them within 30 days of publication date. Under Section 2(e)(2) of the Railroad Retirement Act (RRA), an age and service annuity, spouse annuity, or divorced spouse annuity cannot be paid unless the Railroad Retirement Board
(RRB)has evidence that the applicant has ceased railroad employment and relinquished rights to return to the service of a railroad employer. The procedure pertaining to the relinquishment of rights by an annuity applicant is prescribed in 20 CFR 216.24. Under Section 2(f)(6) of the RRA, earnings deductions are required each month an annuitant works in certain nonrailroad employment termed Last Pre-Retirement Non-Railroad Employment. Normally, the employee, spouse, or divorced spouse relinquish rights and certify that employment has ended as part of the annuity application process. However, this is not always the case. In limited circumstances, the RRB utilizes Form G-88, *Certification of Termination of Service and Relinquishment of Rights,* to obtain an applicant's report of termination of employment and relinquishment of rights. One response is required of each respondent. Responses are required to obtain or retain benefits. The RRB proposes no changes to Form G-88. *Previous Requests for Comments:* The RRB has already published the initial 60-day notice (73 FR 10074 on February 25, 2008) required by 44 U.S.C. 3506(c)(2). That request elicited no comments. Information Collection Request
(ICR)*Title:* Certification of Relinquishment of Rights. *OMB Control Number:* OMB 3220-0016. *Form(s) submitted:* G-88. *Type of request:* Extension without change of a currently approved collection. *Affected public:* Individuals or Households. *Abstract:* Under Section 2(e)(2) of the Railroad Retirement Act, the Railroad Retirement Board must have evidence that an annuitant for an age and service, spouse, or divorced spouse annuity has ceased railroad employment and relinquished their rights to return to the service of a railroad employer. The collection provides the means for obtaining this evidence. *Changes Proposed:* The RRB proposes no changes to Form G-88. *The burden estimate for the ICR is as follows:* *Estimated Completion Time for Form(s):* Completion time for Form G-88 is estimated at 6 minutes. *Estimated annual number of respondents:* 3,600. *Total annual responses:* 3,600. *Total annual reporting hours:* 360. *Additional Information or Comments:* Copies of the form and supporting documents can be obtained from Charles Mierzwa, the agency clearance officer at (312-751-3363) or *Charles.Mierzwa@rrb.gov.* Comments regarding the information collection should be addressed to Ronald J. Hodapp, Railroad Retirement Board, 844 North Rush Street, Chicago, Illinois, 60611-2092 or *Ronald.Hodapp@rrb.gov* and to the OMB Desk Officer for the RRB, at the Office of Management and Budget, Room 10230, New Executive Office Building, Washington, DC 20503. Charles Mierzwa, Clearance Officer. [FR Doc. E8-11041 Filed 5-15-08; 8:45 am] BILLING CODE 7905-01-P SECURITIES AND EXCHANGE COMMISSION [Release No. 34-57813; File No. SR-NSCC-2007-12] Self-Regulatory Organizations; National Securities Clearing Corporation; Order Granting Approval of a Proposed Rule Change To Provide a New Alternative Investments Products Service May 12, 2008. I. Introduction On July 17, 2007, National Securities Clearing Corporation (“NSCC”) filed with the Securities and Exchange Commission (“Commission”) and on February 19, 2008, amended proposed rule change SR-NSCC-2007-12 pursuant to section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”). 1 Notice of the proposal was published in the **Federal Register** on March 17, 2008. 2 No comment letters were received. For the reasons discussed below, the Commission is approving the proposed rule change. 1 15 U.S.C. 78s(b)(1). 2 Securities Exchange Act Release No. 57461 (March 10, 2008), 73 FR 14294. II. Description NSCC is establishing a new Alternative Investment Products service (“AIP Service”), a processing platform for alternative investment products such as hedge funds, funds of hedge funds, commodities pools, managed futures, and real estate investment trusts (“REITs”).
(1)Summary of AIP Service The AIP Service will provide for processing of information relating to transactions in alternative investment products and for settlement of related payments (“AIP Payments”). It will facilitate, among other things, processing activities such as subscriptions and redemptions, distributions, position reporting, and account maintenance. Activities that will be supported by the AIP Service are more fully described below in the section titled “Scope of AIP Service.” Settlement of AIP Payments through NSCC will be done on a prefunded basis. NSCC will simply pass-through AIP Payments from AIP members to the contraside AIP members without netting or without guaranteeing payment in the event of contraside default. NSCC will not be liable to make payment to an AIP member in the event of a default in payment by the contraside AIP member. Settlement of AIP Payments (“AIP Settlement”) will be segregated from all other money settlements at NSCC. NSCC will have no exposure to credit risk as a result of the operation of the AIP Settlement. AIP Settlement is more fully described below in the section titled “AIP Settlement.” Participation in the AIP Service will be governed by NSCC's Rules and procedures applicable to the AIP Service. Each user of the AIP Service (“AIP Member”) will be required to enter into an AIP membership agreement with NSCC that will govern its use of the AIP Service. Entities eligible for membership will include entities subject to regulation under U.S. federal or state laws such as registered broker-dealers, investment advisers, banks, and insurance companies. Because of the unique processing and distribution features of alternative investment products and because NSCC will have no exposure to the credit risk of AIP Members and will have no liability to make payments in the event of an AIP Member's AIP Settlement default, entities that are not required to register under applicable U.S. federal or state law and entities organized under applicable law outside of the U.S. will also be eligible to become AIP Members. Membership in the AIP Service is more fully described below in the section titled “AIP Members.” NSCC developed the concept and functionality for the AIP Service at the request of and in consultation with industry participants, many of which were NSCC members using other NSCC services. Some of these interested parties committed to become pilot subscribers to the proposed AIP Service and committed to assist NSCC in funding the launch of the AIP Service. These parties are more fully described below in the section titled “AIP Pilot Group.”
(2)Alternative Investment Products Alternative investment products are typically illiquid, pooled investment products that are exempt from registration under the Security Act of 1933 and the Investment Company Act of 1940 and that are offered through private placements to high net worth individuals and institutional investors such as pension funds. Alternative investment products may be placed and held by an end investor through a direct relationship with the issuer or manufacturer of an alternative investment product (called the “AIP Manufacturer” for purposes of NSCC Rules) or through an entity acting on behalf of an issuer or manufacturer. They may also be placed and held through a distribution channel such as a registered broker-dealer that facilitates transactions as a processing contraparty to the AIP Manufacturer (called the “AIP Distributor” for purposes of NSCC Rules). Alternative investment products are not generally traded in the secondary market. In this respect, the distribution for alternative investment products is similar to the distribution of mutual funds on NSCC's Fund/SERV system. Alternative investment products have processing characteristics and risk profiles that differ from those of mutual funds, and those differences have been taken into account and reflected in the functionality of the AIP Service and in NSCC Rules and procedures. Increasingly, investors and their advisers are including alternative investment products as part of their portfolios. The alternative investment products market currently represents over $1 trillion in assets and continues to grow. Despite the large asset base, processing remains extremely manual using methods such as delivery of hard-copy documents, transmission of information by fax, e-mail messages and spreadsheets, and telephone calls. The lack of automation and standardized, centralized processing is inefficient, prolongs transaction processing time, results in high costs per transaction, and increases the likelihood of errors—factors that increase in importance as the volume of transactions in alternative investment products continues to increase as it has in recent years.
(3)AIP Pilot Group Accordingly, several industry participants (many of which were members of NSCC) approached NSCC to explore whether NSCC could bring automation and standardization to the alternative investment product market analogous to that which NSCC's Mutual Fund Services has provided to the mutual fund market. Mutual funds and alternative investment products frequently share similar distribution channels and are frequently both included in an investor's portfolio for which a financial intermediary consolidates asset reporting and servicing. NSCC solicited its members to assess industry interest. A pilot group of interested broker-dealers, alternative product manufacturers, and fund administrators was formed to determine the feasibility of NSCC providing such a service and if feasible to assist in the development of the business requirements and functional specifications for such a service. Some members of the pilot group committed to assist in the costs of development of such a service through payment of a fixed amount that would be applied to their respective usage fees when the service was in production. Consistent with this commitment to support the costs developing and implementing the service, NSCC agreed to consult with the members of the pilot group in refining and enhancing the necessary functionality for the service. The functionality for the initial scope of the AIP Service is described below in the section titled “Scope of AIP Service.”
(4)Eligible AIP Products Alternative investment products that can be processed through NSCC's AIP Service (“Eligible AIP Products”) will initially include the types of products referenced above ( *i.e.* , hedge funds, funds of hedge funds, commodities pools, managed futures, and REITs). Additional products could be added in the initial phase or from time to time as requested by industry participants and as approved by NSCC. 3 Eligible AIP Products may include those registered with the Commission and those not required to be registered. When an AIP Manufacturer submits an alternative investment product for processing through the AIP Service, pursuant to NSCC rules and procedures, it represents and warrants to NSCC that the offer and sale of the investment product complies with applicable law. 3 Due to the nature of alternative investment products, NSCC retains the right to refuse to process a specific product or type of product through the AIP Service or to require that a product or type of product no longer be processed through the AIP service if NSCC deems it to be in the interests of NSCC and its members to do so.
(5)AIP Members The following types of entities will be eligible to become AIP Manufacturers or AIP Distributors:
(i)A broker-dealer registered under the Exchange Act or a non-US broker-dealer subject to regulation by the appropriate financial services regulator in its home jurisdiction;
(ii)A bank or trust company under supervision of federal or state banking authorities or a non-US bank subject to regulation in its home jurisdiction;
(iii)An investment company registered under the Investment Company Act or an issuer (structured as a fund or other pooled investment vehicle) that is not required to register thereunder;
(iv)An investment adviser as defined under the Investment Advisers Act of 1940 regardless of whether it is registered under the Investment Advisors Act or is exempt from registration;
(v)A commodity pool operator or commodity trading advisor as defined in the Commodity Exchange Act regardless of whether the commodity pool operator or commodity trading advisor is registered pursuant to the Commodity Exchange Act or is exempt from registration thereunder;
(vi)An insurance company regulated under state insurance law or a non-US insurance company subject to regulation by the appropriate insurance regulator in its home jurisdiction;
(vii)An AIP Manufacturer that is an entity engaged under contract to provide administrative services to one or more Eligible AIP Products; or
(viii)An entity that does not qualify as one of the above entities but that has demonstrated to the Board of Directors of NSCC that its business and capabilities are such that it could reasonably expect material benefit from direct access to the AIP Service. Because AIP Settlement will be prefunded and because NSCC will be insulated from exposure to the credit risk of AIP Members and will have no liability to make payments in the event of an AIP Member's AIP Settlement default, there are no financial requirements for participation in the AIP Service. Members will be required to meet NSCC's operational requirements and general standards applicable to competency for membership and to meet such other requirements as NSCC may establish from time to time. 4 4 NSCC's general standards applicable to competency are designed to screen for any action or condition of an applicant or member that could in the judgment of NSCC present undue risk to NSCC or its members.
(6)Scope of AIP Services The AIP Service will support communication of information and settlement of AIP Payments between AIP Manufacturers and the AIP Distributors in order to facilitate the processing of subscriptions and purchases, tenders and redemptions, dividends and distributions, commissions and fees, position reporting, product information, account maintenance, automated transmission of imaged documents, and such other actions as NSCC may determine from time to time. The AIP Service will provide AIP Members with the ability to transmit data in connection with transactions whether the payments are made outside of NSCC or through the AIP Service. As with all NSCC services, NSCC will not be responsible for the completeness or accuracy of data transmitted through the AIP Services or for any errors, omissions, or delays which may occur in the absence of gross negligence on the part of NSCC. Fees for the use of the AIP Service have not yet been established and will be the subject of a subsequent proposed rule change filed under section 19(b)(3)(A) of the Act if this proposed rule filing is approved.
(7)AIP Settlement AIP Settlement will be in same day funds over fedwire and will be segregated from all other settlement payments at NSCC. Unless otherwise provided by NSCC, AIP Members will be required to appoint a settling bank (“AIP Settling Bank”) for purposes of settlement similar to NSCC settlement procedures for its other money settlements. NSCC will maintain credit balances and debit balances for each AIP Member to which NSCC will post gross credits and gross debits for settlement on the date designated for settlement by the AIP Member (“Settlement Date”). AIP Settlement will be on a gross bais meaning that the credit balance of an AIP Member will not be netted against its debit balance. If NSCC does not receive funds from an AIP Member in the amount of the debit balance by the requisite time on the Settlement Date, NSCC will reduce the corresponding settlement credit balances of the AIP Members that are the contrasides to the AIP Member that did not pay its gross debit balance. Nonpayment of a debit balance will not be deemed a payment default under NSCC Rules, but NSCC may establish fees for late payment or nonpayment and may establish a threshold number of instances of late payment or nonpayment which would result in other sanctions, including NSCC's ceasing to act for such an AIP Member. After receipt of an AIP Member's debit balance from the AIP Member's AIP Settling Bank on Settlement Date, NSCC will transfer to the AIP Settling Bank(s) of the contraside AIP Member(s) the settlement credit balance(s). NSCC's payment will include gross credit balances which may have been reduced to reflect the reversal of any credits with respect to debit balance amounts that were not paid by a contraside AIP Member. Use of NSCC's AIP Service will provide the alternative investment product industry with the ability to process transactions and to settle funds on a centralized, fully redundant platform that will provide more robust business continuity in the event of interruption to processing on a primary system, better audit trails on transactions, lower costs, and fewer errors and delays than is currently the case. Settlement on the basis of gross debits and gross credits without offsets insulates NSCC from any financial risks associated with Eligible AIP Products and AIP Members. Because NSCC's obligation to pay a credit balance will be conditioned upon receipt by NSCC of the debit balance from the contraside AIP Member, NSCC will not bear the risk that an AIP Member may default at settlement.
(8)AIP Document Transmission The AIP Service will automate the transmission of imaged hard-copy documents (“paper workflow”) between AIP Manufacturers and AIP Distributors. The alternative investment industry has a number of investment instruments that are private or are traded outside of the normal processes and that require the exchange of documentation. It is not untypical for the parties to exchange up to forty pages of hard-copy documents. Subaccount documentation is typically sent for both initial and subsequent subscriptions, depending on the requirements of the alternative investment product, and for tender offers. The paper workflow component of the AIP Service will allow parties to scan and to convert documents to a file format such as portable document format (“PDF”) file for transmission with or without a pending transaction message.
(9)Proposed Changes to NSCC Rules A new Rule 53, “Alternative Investment Product Services and Members,” will be added to NSCC's Rules, and additional confirming changes will be made elsewhere throughout NSCC's Rules as needed to provide consistency with the new Rule 53. III. Discussion Section 17A(b)(3)(F) of the Act requires, among other things, that the rules of a clearing agency be designed to remove impediments to and to perfect the mechanism of a national system for prompt and accurate clearance and settlement of securities transactions. 5 By facilitating the transmission of standardized information for alternative investment products on a centralized communications platform and by automating money settlements through a centralized facility in the same day funds, the AIP Service will provide increased efficiencies and reduced risks that are typically associated with the current alternative investment products processing. As such, the proposed changes will help remove impediments to and perfect the mechanism of a national system for the prompt and accurate clearance and settlement of securities transactions. 5 15 U.S.C. 78q-1(b)(3)(F). IV. Conclusion On the basis of the foregoing, the Commission finds that the proposed rule change is consistent with the requirements of the Act and in particular section 17A of the Act and the rules and regulations thereunder. 6 6 In approving the proposed rule change, the Commission considered the proposal's impact on efficiency, competition, and capital formation. 15 U.S.C. 78c(f). *It is therefore ordered* , pursuant to section 19(b)(2) of the Act, that the proposed rule change (File No. SR-NSCC-2007-12) be and hereby is approved. For the Commission by the Division of Trading and Markets, pursuant to delegated authority. 7 7 17 CFR 200.30-3(a)(12). Florence E. Harmon, Deputy Secretary. [FR Doc. E8-10968 Filed 5-15-08; 8:45 am] BILLING CODE 8010-01-P SECURITIES AND EXCHANGE COMMISSION [Release No. 34-57806; File No. SR-Phlx-2008-34] Self-Regulatory Organizations; Philadelphia Stock Exchange, Inc.; Notice of Filing and Order Granting Accelerated Approval of Proposed Rule Change Consolidating Into a Single Rule Certain Requirements for Products Traded on the Exchange Pursuant to Unlisted Trading Privileges May 9, 2008. Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”) 1 and Rule 19b-4 thereunder, 2 notice is hereby given that on May 5, 2008, the Philadelphia Stock Exchange, Inc. (“Phlx” or “Exchange”) filed with the Securities and Exchange Commission (“Commission”) the proposed rule change as described in Items I and II below, which Items have been substantially prepared by the Exchange. This order provides notice of the proposed rule change and approves the proposal on an accelerated basis. 1 15 U.S.C. 78s(b)(1). 2 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change The Exchange proposes to amend its rules to consolidate into a single rule certain requirements for products traded on the Exchange pursuant to unlisted trading privileges (“UTP”) that have been established in various new products proposals previously approved by the Commission. The text of the proposed rule change is available at the Exchange's principal office, on the Exchange's Web site ( *www.phlx.com* ), and at the Commission's Public Reference Room. II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change In its filing with the Commission, Phlx included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item III below. Phlx has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements. A. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change 1. Purpose The Exchange proposes to amend its rules to consolidate into a single rule certain requirements for products traded on the Exchange pursuant to UTP. Many of these products have been established in various new products proposals previously approved by the Commission. The Exchange proposes to amend Phlx Rule 803 to set forth a new rule, Phlx Rule 803(o), regarding the extension of UTP to an NMS stock that is listed on another national securities exchange. Any such security will be subject to all Exchange trading rules applicable to NMS stocks, unless otherwise noted. The Exchange will file with the Commission a Form 19b-4(e) with respect to any such security that is a “new derivative securities product” (“NDSP”) as defined in Rule 19b-4(e) under the Act. 3 In addition, any NDSP traded on the Exchange pursuant to proposed Phlx Rule 803(o) will be subject to the following criteria. 3 17 CFR 240.19b-4(e). Proposed Phlx Rule 803(o)(2)(A) provides that the Exchange will distribute an information circular prior to the commencement of trading in such NDSP which generally will include the same information as the information circular provided by the listing exchange, including:
(1)The special risks of trading the NDSP;
(2)the Exchange's rules that will apply to the NSDP, including the suitability rule;
(3)information about dissemination of the value of the underlying assets or indexes; and
(4)the risks of trading during the Pre Market and Post Market Sessions 4 due to the lack of calculation or dissemination of the underlying index value, the Intraday Indicative Value, the Indicative Optimized Portfolio Value, or other comparable estimate of the value of a share of the NDSP. 4 *See* Phlx Rule 101, Supplementary Material .02(1), (3). Proposed Phlx Rule 803(o)(2)(B) reminds members and member organizations that they are subject to the prospectus delivery requirements under the Securities Act of 1933, unless the NDSP is the subject of an order by the Commission exempting the product from certain prospectus delivery requirements under Section 24(d) of the Investment Company Act of 1940, the product is not otherwise subject to prospectus delivery requirements under the Securities Act of 1933. The Exchange shall inform its members and member organizations regarding the application of the provisions of this subparagraph to an NDSP by means of an information circular. Phlx Rule 136(c)-(e) addresses trading halts in NDSPs traded on the Exchange pursuant to UTP. Phlx Rule 136(e)(1) would be amended to state that the term “Derivative Securities Product” is modified to “New Derivative Securities Product” and shall have the same meaning as new derivative securities product in Rule 803(o). The term “New Derivative Securities Product” is intended to include any products that are included in the current term “Derivative Securities Product.” In addition, throughout Phlx Rule 136(c)-(e), the term “Derivative Securities Product” is modified to “New Derivative Securities Product” to reflect the change in Phlx Rule 136(e)(1). Phlx Rule 136(d)(1) provides that, if an NDSP begins trading on XLE in the Pre Market Session and subsequently a temporary interruption occurs in the calculation or wide dissemination of an applicable Required Value, 5 XLE may continue to trade the NDSP for the remainder of the Pre Market Session. Phlx Rule 136(d)(2) provides that, during the Core Session, 6 if a temporary interruption occurs in the calculation or wide dissemination of an applicable Required Value, and the listing market halts trading in the NDSP, Phlx, upon notification by the listing market of a halt due to such temporary interruption, also shall immediately halt trading in the NDSP on XLE. Phlx 136(d)(3) provides that, if an applicable Required Value continues not to be calculated or widely disseminated after the close of the Core Session, XLE may trade the NDSP in the Post Market Session only if the listing market traded the NDSP until the close of its regular trading session without a halt. Further, if an applicable Required Value continues not to be calculated or widely disseminated as of the beginning of the Pre Market Session on the next trading day, XLE shall not commence trading of the NDSP in the Pre Market Session that day. If an interruption in the calculation or wide dissemination of an applicable Required Value continues, XLE may resume trading in the NDSP only if calculation and wide dissemination of the applicable Required Value resumes or trading in the NDSP resumes in the listing market. Finally, proposed Phlx Rule 136(d)(4) provides that, for an NDSP where a net asset value (and, in the case of managed fund share or actively managed exchange-traded fund, a “disclosed portfolio”) is disseminated, Phlx will immediately halt trading in such security upon notification by the listing market that the net asset value and if applicable, such disclosed portfolio is not being disseminated to all market participants at the same time. Phlx may resume trading in the NDSP only when trading in the NDSP resumes on the listing market. 5 Proposed Phlx 136(e)(2) states that “`Required Value' shall mean
(1)the value of any security or index underlying a New Derivative Securities Product, and
(2)the Intraday Indicative Value (as defined in Rule 803), or the Indicative Optimized Portfolio Value or other comparable estimate of the value of a share of a New Derivative Securities Product updated regularly during the trading day.” 6 *See* Phlx Rule 101, Supplementary Material .02(2). Proposed Phlx Rule 803(o)(2)(C) provides for restrictions for any XLE Participant registered as a Market Maker (“Restricted Market Maker”) in an NDSP that derives its value from one or more currencies, commodities, or derivatives based on one or more currencies or commodities, or is based on a basket or index comprised of currencies or commodities (collectively, “Reference Assets”). Specifically, proposed Phlx Rule 803(o)(2)(C)(i) provides that a Restricted Market Maker in an NDSP is prohibited from acting or registering as a market maker in any Reference Asset of that NDSP or any derivative instrument based on a Reference Asset of that NDSP (collectively, with Reference Assets, “Related Instruments”). Proposed Phlx Rule 803(o)(2)(C)(ii) provides that a Restricted Market Maker shall, in a manner prescribed by Phlx, file with Phlx and keep current a list identifying any accounts (“Related Instrument Trading Accounts”) for which Related Instruments are traded:
(1)In which the Restricted Market Maker holds an interest;
(2)over which it has investment discretion; or
(3)in which it shares in the profits and/or losses. In addition, a Restricted Market Maker may not have an interest in, exercise investment discretion over, or share in the profits and/or losses of a Related Instrument Trading Account which has not been reported to Phlx as required by this rule. Proposed Phlx Rule 803(o)(2)(C)(iii) provides that, in addition to the existing obligations under Phlx rules regarding the production of books and records, a Restricted Market Maker shall, upon request by Phlx, make available to Phlx any books, records, or other information pertaining to any Related Instrument Trading Account or to the account of any registered or non-registered employee affiliated with the Restricted Market Maker for which Related Instruments are traded. Finally, proposed Phlx Rule 803(o)(2)(C)(iv) provides that a Restricted Market Maker shall not use any material nonpublic information in connection with trading a Related Instrument. Lastly, Phlx represents that the Exchange's surveillance procedures for NDSPs traded on the Exchange pursuant to UTP will be similar to the procedures used for equity securities traded on the Exchange and will incorporate and rely upon existing Exchange surveillance systems. The Exchange will closely monitor activity in NDSPs traded on the Exchange pursuant to UTP and deter any potential improper trading activity. Proposed Phlx Rule 803(o)(2)(D) also provides that the Exchange will enter into a comprehensive surveillance sharing agreement (“CSSA”) with a market trading components of the index or portfolio on which the new derivative securities product is based to the same extent as the listing exchange's rules require the listing market to enter into a CSSA with such market. 2. Statutory Basis The Exchange believes that its proposal is consistent with Section 6(b) of the Act 7 in general, and furthers the objectives of Section 6(b)(5) of the Act 8 in particular, in that it is designed to promote just and equitable principles of trade, to remove impediments to and perfect the mechanism of a free and open market and a national market system, and, in general to protect investors and the public interest, by providing for the trading of securities, including NDSPs, on Phlx pursuant to UTP, subject to consistent and reasonable standards. 7 15 U.S.C. 78f(b). 8 15 U.S.C. 78f(b)(5). B. Self-Regulatory Organization's Statement on Burden on Competition The Exchange believes that the proposed rule change does not impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants or Others No comments were either solicited or received. III. Solicitation of Comments Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods: Electronic Comments • Use the Commission's Internet comment form ( *http://www.sec.gov/rules/sro.shtml* ); or • Send an e-mail to *rule-comments@sec.gov* . Please include File Number SR-Phlx-2008-34 on the subject line. Paper Comments • Send paper comments in triplicate to Nancy M. Morris, Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549. All submissions should refer to File Number SR-Phlx-2008-34. This file number should be included on the subject line if e-mail is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet Web site ( *http://www.sec.gov/rules/sro.shtml* ). Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for inspection and copying in the Commission's Public Reference Room, 100 F Street, NE., Washington, DC 20549, on official business days between the hours of 10 a.m. and 3 p.m. Copies of the filing also will be available for inspection and copying at the principal office of Phlx. All comments received will be posted without change; the Commission does not edit personal identifying information from submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-Phlx-2008-34 and should be submitted on or before June 6, 2008. IV. Commission's Findings and Order Granting Accelerated Approval of the Proposed Rule Change After careful review, the Commission finds that the proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder applicable to a national securities exchange. 9 In particular, the Commission finds that the proposal is consistent with Section 6(b)(5) of the Act in that it is designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, to foster cooperation and coordination with persons engaged in facilitating transactions in securities, to remove impediments to and perfect the mechanism of a free and open market and a national market system, and in general to protect investors and the public interest. 9 In approving this rule change, the Commission notes that it has considered the proposed rule's impact on efficiency, competition, and capital formation. *See* 15 U.S.C. 78c(f). This proposal would consolidate into a single rule various provisions related to UTP that have been established in other new products proposals previously approved by the Commission. 10 The Commission finds good cause for approving the proposed rule change prior to the 30th day after the date of publication of the notice of filing thereof in the **Federal Register** . Phlx's proposal does not raise any novel issues, and accelerated approval thereof will expedite the trading of additional products by the Exchange, subject to consistent and reasonable standards. Therefore, the Commission finds good cause, consistent with Section 19(b)(2) of the Act, to approve the proposed rule change on an accelerated basis. 10 *See* ISE Rule 2101 and Securities Exchange Act Release No. 57387 (February 27, 2008), 73 FR 11965 (March 5, 2008) (SR-ISE-2007-99); NSX Rule 15.9 and Securities Exchange Act Release No. 57448 (March 6, 2008), 73 FR 13597 (March 13, 2008)(SR-NSX-2008-05); NYSE Arca Equities Rule 5.2(j)(6), Commentary .01(a)-(d) and Securities Exchange Act Release No. 54189 (July 21, 2006), 71 FR 43263 (July 31, 2006) (NYSEArca-2006-17) (in connection with Phlx Rule 803(o)(2)(C)). V. Conclusion *It is therefore ordered* , pursuant to Section 19(b)(2) of the Act, 11 that the proposed rule change (SR-Phlx-2008-34) is hereby approved on an accelerated basis. 11 15 U.S.C. 78s(b)(2). For the Commission, by the Division of Trading and Markets, pursuant to delegated authority. 12 12 17 CFR 200.30-3(a)(12). Florence E. Harmon, Deputy Secretary. [FR Doc. E8-10944 Filed 5-15-08; 8:45 am] BILLING CODE 8010-01-P SMALL BUSINESS ADMINISTRATION Data Collection Available for Public Comments and Recommendations ACTION: Notice and request for comments. SUMMARY: In accordance with the Paperwork Reduction Act of 1995, this notice announces the Small Business Administration's intentions to request approval on a new and/or currently approved information collection. DATES: Submit comments on or before July 15, 2008. ADDRESSES: Send all comments regarding whether this information collection is necessary for the proper performance of the function of the agency, whether the burden estimates are accurate, and if there are ways to minimize the estimated burden and enhance the quality of the collection, to Louis Cupp, New Markets Policy Analyst, Office of Investment, Small Business Administration, 409 3rd Street SW., 8th floor, Wash., DC 20416 FOR FURTHER INFORMATION CONTACT: Louis Cupp, New Market Policy Analyst, Office of Investment, 202-619-0511 *louis.cupp@sba.gov* or Curtis B. Rich, Management Analyst, 202-205-7030 *curtis.rich@sba.gov* . SUPPLEMENTARY INFORMATION: SBA uses the information collected for the New Market Venture Capital
(NMVC)Program for proper oversight within the scope of the Small Business Act to access NMVC Program applicants and participants. *Title:* “New Markets Venture Capital
(NMVC)Program Application Funding and Reporting.” *Description of Respondents:* Programs Applications and participants, SSBIC receiving grants under the NMVC program. *Form Numbers:* SF-269, 270, 272, 424 SBA-2184, 2185, 2216, 34, 2211, 2210. *Annual Responses:* 1,131. *Annual Burden:* 1,151. Jacqueline White, Chief, Administrative Information Branch. [FR Doc. E8-10940 Filed 5-15-08; 8:45 am] BILLING CODE 8025-01-P SMALL BUSINESS ADMINISTRATION [Disaster Declaration # 11206 and # 11207] Arkansas Disaster Number AR-00018 AGENCY: U.S. Small Business Administration. ACTION: Amendment 7. SUMMARY: This is an amendment of the Presidential declaration of a major disaster for the State of Arkansas (FEMA-1751-DR), dated 03/28/2008. *Incident:* Severe Storms, Tornadoes, and Flooding. *Incident Period:* 03/18/2008 through 04/28/2008. DATES: *Effective Date:* 04/29/2008. *Physical Loan Application Deadline Date:* 06/27/2008. *EIDL Loan Application Deadline Date:* 12/29/2008. ADDRESSES: Submit completed loan applications to: U.S. Small Business Administration, Processing And Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155. FOR FURTHER INFORMATION CONTACT: M. Mitravich, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street, SW., Suite 6050, Washington, DC 20416. SUPPLEMENTARY INFORMATION: The notice of the President's major disaster declaration for the State of Arkansas, dated 03/28/2008 is hereby amended to extend the deadline for filing applications for physical damages as a result of this disaster to 06/27/2008. All other information in the original declaration remains unchanged. (Catalog of Federal Domestic Assistance Numbers 59002 and 59008) Herbert L. Mitchell, Associate Administrator for Disaster Assistance. [FR Doc. E8-10972 Filed 5-15-08; 8:45 am] BILLING CODE 8025-01-M SMALL BUSINESS ADMINISTRATION Small Business Size Standards: Waiver of the Nonmanufacturer Rule AGENCY: U.S. Small Business Administration. ACTION: Notice of Intent To Waive the Nonmanufacturer Rule for Other Aircraft Parts and Auxiliary Equipment Manufacturing (Drones, Miscellaneous Aircraft Accessories, and Components; Aircraft Launching Equipment). SUMMARY: The U. S. Small Business Administration
(SBA)is considering granting a request for a waiver of the Nonmanufacturer Rule for Other Aircraft Parts and Auxiliary Equipment Manufacturing (Drones, Miscellaneous Aircraft Accessories, and Components; Aircraft Launching Equipment). According to the request, no small business manufacturers supply these classes of products to the Federal government. If granted, the waiver would allow otherwise qualified regular dealers to supply the products of any domestic manufacturer on a Federal contract set aside for small businesses; service-disabled veteran-owned small businesses or SBA's 8(a) Business Development Program. DATES: Comments and source information must be submitted June 2, 2008. ADDRESSES: You may submit comments and source information to Pamela M. McClam, Program Analyst, U.S. Small Business Administration, Office of Government Contracting, 409 3rd Street, SW., Suite 8800, Washington, DC 20416. FOR FURTHER INFORMATION CONTACT: Pamela M. McClam, Program Analyst, by telephone at
(202)205-7408; by FAX at
(202)481-4783; or by e-mail at *Pamela.McClam@sba.gov* . SUPPLEMENTARY INFORMATION: Section 8(a)(17) of the Small Business Act (Act), 15 U.S.C. 637(a)(17), requires that recipients of Federal contracts set aside for small businesses, service-disabled veteran-owned small businesses, or SBA's 8(a) Business Development Program provide the product of a small business manufacturer or processor, if the recipient is other than the actual manufacturer or processor of the product. This requirement is commonly referred to as the Nonmanufacturer Rule. The SBA regulations imposing this requirement are found at 13 CFR 121.406(b). Section 8(a)(17)(b)(iv) of the Act authorizes SBA to waive the Nonmanufacturer Rule for any “class of products” for which there are no small business manufacturers or processors available to participate in the Federal market. As implemented in SBA's regulations at 13 CFR 121.1202(c), in order to be considered available to participate in the Federal market for a class of products, a small business manufacturer must have submitted a proposal for a contract solicitation or received a contract from the Federal government within the last 24 months. The SBA defines “class of products” based on six digit coding system. The coding system is the Office of Management and Budget North American Industry Classification System (NAICS). The SBA is currently processing a request to waive the Nonmanufacturer Rule for Other Aircraft Parts and Auxiliary Equipment Manufacturing (Drones, Miscellaneous Aircraft Accessories, and Components; Aircraft Launching Equipment). North American Industry Classification System (NAICS) code 336413, Product Service Codes 1550, 1680 and 1720. The public is invited to comment or provide source information to SBA on the proposed waivers of the Nonmanufacturer Rule for this class of NAICS code within 15 days after date of publication in the **Federal Register** . Dated: May 8, 2008. Linda Korbol, Acting Director, Office of Government Contracting. [FR Doc. E8-10980 Filed 5-15-08; 8:45 am] BILLING CODE 8025-01-P DEPARTMENT OF STATE [Public Notice 6230] Culturally Significant Objects Imported for Exhibition Determinations: “The Tsar and the President: Alexander II and Abraham Lincoln” SUMMARY: Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681, *et seq.* ; 22 U.S.C. 6501 note, *et seq.* ), Delegation of Authority No. 234 of October 1, 1999, Delegation of Authority No. 236 of October 19, 1999, as amended, and Delegation of Authority No. 257 of April 15, 2003 [68 FR 19875], I hereby determine that the objects to be included in the exhibition “The Tsar and the President: Alexander II and Abraham Lincoln”, imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to loan agreements with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit objects at the Oshkosh Public Museum, Oshkosh, Wisconsin, from on or about July 12, 2008, until on or about October 19, 2008, and at the Union Station Kansas City Museum, Kansas City, Missouri, from on or about November 1, 2008, until on or about April 9, 2009, and at possible additional exhibitions or venues yet to be determined, is in the national interest. Public Notice of these Determinations is ordered to be published in the **Federal Register** . FOR FURTHER INFORMATION CONTACT: For further information, including a list of the exhibit objects, contact Wolodymyr Sulzynsky, Attorney-Adviser, Office of the Legal Adviser, U.S. Department of State (telephone: 202/453-8050). The address is U.S. Department of State, SA-44, 301 4th Street, SW., Room 700, Washington, DC 20547-0001. Dated: May 9, 2008. C. Miller Crouch, Principal Deputy Assistant Secretary for Educational and Cultural Affairs, Department of State. [FR Doc. E8-11046 Filed 5-15-08; 8:45 am] BILLING CODE 4710-05-P DEPARTMENT OF STATE [Public Notice 6231] Determination Pursuant to the Department of State, Foreign Operations, and Related Programs Appropriations Act, 2008, related to the Provision of Military Assistance in Support of a Southern Sudan Security Sector Transformation Program Pursuant to the authority vested in me by the laws of the United States, including Section 666(e) of the Department of State, Foreign Operations, and Related Programs Appropriations Act, 2008 (Div. J, Pub. L. 110-161) and Delegation of Authority 245, I hereby determine that the provision to the Government of Southern Sudan of non-lethal military assistance, military education and training, and defense services controlled under the International Traffic in Arms Regulations is in the national interest of the United States, and that such assistance may be provided pursuant to section 666(e). This determination shall be transmitted to the Congress and published in the **Federal Register** . Dated: April 28, 2008. John D. Negroponte, Deputy Secretary of State, Department of State. [FR Doc. E8-11062 Filed 5-15-08; 8:45 am] BILLING CODE 4710-26-P DEPARTMENT OF STATE [Public Notice 6224] Shipping Coordinating Committee; Notice of Subcommittee Meetings Various subcommittees of the Shipping Coordinating Committee
(SHC)will be holding public meetings in May 2008. Members of the public may attend these meetings up to the seating capacity of the rooms. Details for the meetings are provided in this notice. I. Flag State Implementation The SHC's Subcommittee on Flag State Implementation will conduct an open meeting at 1:30 p.m. on Thursday, May 22, 2008, in Room 2415 of the U.S. Coast Guard Headquarters Building, 2100 2nd Street, SW., Washington, DC, 20593. The primary purpose of the meeting is to prepare for the 16th Session of the International Maritime Organization
(IMO)Sub-Committee on Flag State Implementation to be held at IMO Headquarters in London, United Kingdom from June 2 to June 6, 2008. The primary matters to be considered include: —Responsibilities of Governments and measures to encourage flag State compliance; —Port State Control
(PSC)Guidelines on seafarers' working hours; —Harmonization of port State control activities; —Comprehensive analysis of difficulties encountered in the implementation of IMO instruments; —Mandatory reports under International Convention for the Prevention of Pollution from Ships, 1973, as modified by the Protocol of 1978 (MARPOL 73/78); —Casualty statistics and investigations; —Review of the Code for the Implementation of Mandatory IMO Instruments; —Review of the Survey Guidelines under the Harmonized System of Survey and Certification (HSSC)—(resolution A.948(23)); —Development of guidelines on port State control under the 2004 Ballast Water Management
(BWM)Convention; —Port reception facilities-related issues; —Illegal, unregulated and unreported
(IUU)fishing and implementation of resolution A.925(22); and —Consideration of International Association of Classification Societies
(IACS)unified interpretations. Members of the public may attend this meeting up to the seating capacity of the room. To facilitate the building security process, those who plan to attend should call or send an e-mail message at least two days before the SHC subcommittee meeting to *Emanuel.J.TerminellaJr@uscg.mil* . Interested persons may seek additional information by writing to Mr. E.J. Terminella, Commandant (CG-5432), U.S. Coast Guard Headquarters, 2100 Second Street, SW., Room 1116, Washington, DC 20593-0001, by calling
(202)372-1239, or by e-mail. II. IMO Administration and Budgeting; IMO Technical Cooperation The SHC's Subcommittee on IMO Administration and Budgeting and the SHC's Subcommittee on IMO Technical Cooperation will conduct an open meeting at 10 a.m. on Tuesday, May 27, 2008 in Room 4420, at U.S. Coast Guard Headquarters, 2100 2nd Street, SW., Washington, DC, 20593. The purpose of this meeting will be to finalize preparations for the 100th Session of IMO's Council and the 58th Session of IMO's Technical Co-Operation Committee. The 100th Session of IMO's Council is scheduled for 16-20 June, 2008 in London, United Kingdom. At the May 27th SHC subcommittee meeting, papers received and draft U.S. positions will be discussed. *The Council items of interest include:* —Report of the Secretary-General on credentials; —Strategy and planning; —Program for change; —Resource management; —Voluntary IMO Member State Audit Scheme; —Protection of vital shipping lanes; —Consideration of the report of the Marine Environment Protection Committee; —Consideration of the report of the Maritime Safety Committee; —Consideration of the report of the Technical Co-operation Committee; —Technical Co-operation Fund: Report on activities of the 2006-2007 programme; —Report on the 29th Consultative Meeting of Contracting Parties to the London Convention 1972 and the 2nd Meeting of Contracting Parties to the 1996 Protocol to the London Convention; —World Maritime University; —IMO International Maritime Law Institute; —External relations; —Report on the status of the Convention and membership of the Organization; —Report on the status of conventions and other multilateral instruments in respect of which the Organization performs functions; and —Date and place of the next session of the Council. The 58th Session of IMO's Technical Co-Operation
(TC)Committee is scheduled for 10-12 June, 2008 in London, United Kingdom. At the May 27th SHC subcommittee meeting, papers received and the draft U.S. positions for TC 58 will be discussed. The TC Committee items of particular interest include: —Integrated Technical Co-operation Programme (ITCP); —Financing the Integrated Technical Co-operation Programme (ITCP); —Impact assessment of technical co-operation activities during 2004-2007; —Partnership for progress; —Voluntary IMO Member State Audit Scheme; —Programme on the integration of women in the maritime sector; —Institutional development and fellowships; —Work of other bodies and organizations; —Rules of Procedure and Methods of Work of the TC Committee; and —Election of the Chairman and Vice-Chairman for 2009. Members of the public may attend the May 27th SHC subcommittee meeting up to the seating capacity of the room. Interested persons may seek information by writing to LCDR Jason Smith, Commandant (CG-5212), U.S. Coast Guard Headquarters, 2100 2nd Street, SW., Room 1218, Washington, DC 20593-0001 or by calling
(202)372-1376. Dated: May 9, 2008. Mark Skolnicki, Executive Secretary, Shipping Coordinating Committee, Department of State. [FR Doc. E8-11066 Filed 5-15-08; 8:45 am] BILLING CODE 4710-09-P SUSQUEHANNA RIVER BASIN COMMISSION Notice of Public Comment and Public Hearings AGENCY: Susquehanna River Basin Commission. ACTION: Notice of public comment and public hearings. SUMMARY: The Susquehanna River Basin Commission
(SRBC)has released its draft revised Comprehensive Plan for a 90-day public review and comment period. To facilitate public comment, three public hearings will be held on the draft Plan. Details concerning the subject matter of the public hearings are contained in the Supplementary Information section of this notice. DATES: Public Hearings—(1) July 8, 2008 at 2 p.m.;
(2)July 9, 2008 at 2 p.m.;
(3)July 10, 2008 at 10 a.m.; Comment Period—May 19, 2008 to August 18, 2008. ADDRESSES:
(1)July 8—Treadway Inn and Suites, 1100 State Route17C, Owego, NY 13827;
(2)July 9—Days Inn and Conference Center, 50 Sheraton Drive, Danville, PA 17821;
(3)July 10—Best Western Eden Resort, 222 Eden Road, Lancaster, PA 17603. FOR FURTHER INFORMATION CONTACT: The draft Comprehensive Plan can be obtained from SRBC's Web site at *http://www.srbc.net/programs/planning/compplanfiles.asp* or by calling Deborah Dickey at
(717)238-0422, ext.301. SUPPLEMENTARY INFORMATION: As noted in the summary, the purpose of the 90-day comment period is to receive comments on a proposed revision of the entire SRBC Comprehensive Plan and the hearings are being held in conjunction with the 90-day public comment period. The Comprehensive Plan provides an overarching framework for SRBC to manage and develop the basin's water resources and serves as a guide for all SRBC programs and activities, as required by the Susquehanna River Basin Compact, U.S. Public Law 91-575. It is further intended as a useful resource for SRBC's member jurisdictions, water resource managers, private sector interests and others in the basin. The Comprehensive Plan was last revised in 1987. Opportunity To Appear and Comment Interested parties may appear at the above hearings to offer written or oral comments to the Commission. The chair of the Commission reserves the right to limit oral statements in the interest of time and to otherwise control the course of the hearings. Persons planning to comment at the public hearings should contact Richard A. Cairo, General Counsel, SRBC, 1721 N. Front Street, Harrisburg, PA 17102-2391;
(717)238-0423, Ext. 306 by July 1, 2008. Written comments will also be accepted during the 90-day comment period, which ends August 18, 2008, and may be sent to Mr. Cairo by mail, by e-mail at *Comp_Plan_Comments@srbc.net* , and by fax at
(717)238-2436. Authority: Pub. L. 91-575, 84 Stat. 1509 *et seq.* , 18 CFR Parts 806, 807, and 808. Dated: May 9, 2008. Thomas W. Beauduy, Deputy Director. [FR Doc. E8-11044 Filed 5-15-08; 8:45 am] BILLING CODE 7040-01-P TENNESSEE VALLEY AUTHORITY Meetings; Sunshine Act Agency Holding the Meeting: Tennessee Valley Authority (Meeting No. 08-03). Time and Date: 2 p.m. CDT, May 19, 2008, The Marriott Shoals Hotel & Spa, 800 Cox Creek Parkway South, Florence, Alabama 35630. Agenda Old Business Approval of minutes of April 3, 2008, Board Meeting. 1. Chairman's Report: A. Governance Changes and Committee Assignments. 2. President's Report. 3. Report of the Operations, Environment, and Safety Committee: A. Environmental Policy. 4. Report of the Ad Hoc Committee on Energy Efficiency, Demand Response, and Renewable Energy: A. Energy Efficiency and Demand Response Guiding Principles; B. Renewable and Clean Energy Guiding Principles. 5. Report of the Human Resources Committee. For more information: Please call TVA Media Relations at
(865)632-6000, Knoxville, Tennessee. People who plan to attend the meeting and have special needs should call
(865)632-6000. Anyone who wishes to comment on any of the agenda in writing may send their comments to: TVA Board of Directors, Board Agenda Comments, 400 West Summit Hill Drive, Knoxville, Tennessee 37902. Dated: May 12, 2008. Maureen H. Dunn, General Counsel and Secretary. [FR Doc. E8-10979 Filed 5-15-08; 8:45 am] BILLING CODE 8120-08-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration [Summary Notice No. PE-2008-19] Petition for Exemption; Summary of Petition Received AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of petition for exemption received. SUMMARY: This notice contains a summary of a petition seeking relief from specified requirements of 14 CFR. The purpose of this notice is to improve the public's awareness of, and participation in, this aspect of FAA's regulatory activities. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition. DATES: Comments on this petition must identify the petition docket number involved and must be received on or before June 5, 2008. ADDRESSES: You may send comments identified by Docket Number FAA-2008-0219 using any of the following methods: • *Government-wide rulemaking Web site:* Go to *http://www.regulations.gov* and follow the instructions for sending your comments electronically. • *Mail:* Send comments to the Docket Management Facility; U.S. Department of Transportation, 1200 New Jersey Avenue, SE., West Building Ground Floor, Room W12-140, Washington, DC 20590. • *Fax:* Fax comments to the Docket Management Facility at 202-493-2251. • *Hand Delivery:* Bring comments to the Docket Management Facility in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. *Privacy:* We will post all comments we receive, without change, to *http://www.regulations.gov,* including any personal information you provide. Using the search function of our docket Web site, anyone can find and read the comments received into any of our dockets, including the name of the individual sending the comment (or signing the comment for an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the **Federal Register** published on April 11, 2000 (65 FR 19477-78). *Docket:* To read background documents or comments received, go to *http://www.regulations.gov* at any time or to the Docket Management Facility in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: Annette K. Kovite,
(425)227-1262, Transport Airplane Directorate, Federal Aviation Administration, 1601 Lind Avenue, SW., Renton, WA 98057-3356, or Frances Shaver,
(202)267-9681, Office of Rulemaking, Federal Aviation Administration, 800 Independence Avenue, SW., Washington, DC 20591. This notice is published pursuant to 14 CFR 11.85. Issued in Washington, DC, on May 12, 2008. Pamela Hamilton-Powell, Director, Office of Rulemaking. Petition for Exemption *Docket No.:* FAA-2008-0219. *Petitioner:* The Boeing Company. *Section of 14 CFR Affected:* § 26.11(g). *Description of Relief Sought:* Boeing requests an exemption from the requirements to develop and make available to affected persons Electrical Wiring Interconnection System
(EWIS)instructions for continued airworthiness for their Boeing Models 707 and 720 on the basis that these airplanes are not subject to an operational rule requiring an update of their maintenance programs. Boeing states that these airplanes are not currently operated commercially in the United States nor are they expected to operate in the United States in the future. [FR Doc. E8-11011 Filed 5-15-08; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration [Summary Notice No. PE-2008-23] Petitions for Exemption; Summary of Petitions Received AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of petitions for exemption received. SUMMARY: This notice contains a summary of certain petitions seeking relief from specified requirements of 14 CFR. The purpose of this notice is to improve the public's awareness of, and participation in, this aspect of FAA's regulatory activities. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of any petition or its final disposition. DATES: Comments on petitions received must identify the petition docket number involved and must be received on or before June 5, 2008. ADDRESSES: You may send comments identified by Docket Number FAA-2008-0081 using any of the following methods: • *Government-wide rulemaking Web site:* Go to *http://www.regulations.gov* and follow the instructions for sending your comments electronically. • *Mail:* Send comments to the Docket Management Facility; U.S. Department of Transportation, 1200 New Jersey Avenue, SE., West Building Ground Floor, Room W12-140, Washington, DC 20590. • *Fax:* Fax comments to the Docket Management Facility at 202-493-2251. • *Hand Delivery:* Bring comments to the Docket Management Facility in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. • *Docket:* To read background documents or comments received, go to *http://www.regulations.gov* at any time or to the Docket Management Facility in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. SUPPLEMENTARY INFORMATION: We will post all comments we receive, without change, to *http://www.regulations.gov,* including any personal information you provide. Using the search function of our docket Web site, anyone can find and read the comments received into any of our dockets, including the name of the individual sending the comment (or signing the comment for an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the **Federal Register** published on April 11, 2000 (65 FR 19477-78). FOR FURTHER INFORMATION CONTACT: Tyneka Thomas
(202)267-7626 or Frances Shaver
(202)267-9681, Office of Rulemaking, Federal Aviation Administration, 800 Independence Avenue, SW., Washington, DC 20591. This notice is published pursuant to 14 CFR 11.85. Issued in Washington, DC, on May 12, 2008. Pamela Hamilton-Powell, Director, Office of Rulemaking. Petitions for Exemption *Docket No.:* FAA-2008-0081. *Petitioner:* NorthStar Trekking, LLC. *Section of 14 CFR Affected:* 14 CFR 136.9(a) and 136.11(c)(2). *Description of Relief Sought:* To allow NorthStar to conduct commercial air tour flights from Juneau, Alaska to the glaciers of the Juneau Icefield in NorthStar's helicopters with life preservers that are readily available for their intended use and easily accessible to each occupant rather than the occupants wearing a life preserver and to not have helicopter floats. [FR Doc. E8-11010 Filed 5-15-08; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration Petition for Exemption From the Vehicle Theft Prevention Standard; smart USA Distributor LLC AGENCY: National Highway Traffic Safety Administration (NHTSA) Department of Transportation (DOT). ACTION: Grant of petition for exemption. SUMMARY: This document grants in full the petition of smart USA Distributor LLC (smart USA) in accordance with § 543.9(c)(2) of 49 CFR Part 543, *Exemption from the Theft Prevention Standard,* for the smart fortwo vehicle line beginning with model year
(MY)2009. This petition is granted because the agency has determined that the antitheft device to be placed on the line as standard equipment is likely to be as effective in reducing and deterring motor vehicle theft as compliance with the parts-marking requirements of the Theft Prevention Standard. smart USA is an authorized importer of smart brand vehicles manufactured by Daimler AG. smart USA requested confidential treatment for the information and attachments submitted in support of its petition. The agency will address smart USA's request for confidential treatment by separate letter. DATES: The exemption granted by this notice is effective beginning with model year
(MY)2009. FOR FURTHER INFORMATION CONTACT: Ms. Deborah Mazyck, International Policy, Fuel Economy and Consumer Programs, NHTSA, 1200 New Jersey Avenue, SE., Washington, DC 20590. Ms. Mazyck's telephone number is
(202)366-0846. Her fax number is
(202)493-2990. SUPPLEMENTARY INFORMATION: In a petition dated January 22, 2008, smart USA requested an exemption from the parts-marking requirements of the Theft Prevention Standard (49 CFR Part 541) for the smart USA fortwo vehicle line beginning with MY 2009. The petition requested an exemption from parts-marking pursuant to 49 CFR Part 543, *Exemption from Vehicle Theft Prevention Standard,* based on the installation of an antitheft device as standard equipment for an entire vehicle line. Under § 543.5(a), a manufacturer may petition NHTSA to grant an exemption for one of its vehicle lines per year. smart USA's submission is considered a complete petition as required by 49 CFR 543.7, in that it meets the general requirements contained in § 543.5 and the specific content requirements of § 543.6. smart USA's petition provided a detailed description and diagram of the identity, design, and location of the components of the antitheft device for the fortwo vehicle line. Although smart USA has requested confidential treatment of specific details of the system's operation, design, effectiveness and durability, NHTSA is, for the purposes of this petition, disclosing the following general information. smart USA will install its passive antitheft device as standard equipment on the vehicle line beginning with MY 2009. The antitheft device to be installed on the MY 2009 fortwo is equipped with an access code protected locking system and a transponder-based electronic immobilizer system. Features of the antitheft device will include an immobilizer consisting of an operational controller (SAM), transponder ignition keys and an engine control transponder reader unit as standard equipment. smart USA states that the vehicle key, SAM, engine control unit, fuel injection system and starter must all independently verify the presence of a code unique only to that vehicle. The smart USA fortwo will be installed with a malfunction warning symbol indicator on the instrument cluster. Additionally, the fortwo vehicle line will have an optional alarm system which will monitor all the doors and tailgate of the vehicle. The audible and visual alarms are activated when an unauthorized person attempts to enter or move the vehicle by unauthorized means. smart USA stated that the immobilizer device prevents the engine from running unless a valid key is put into the ignition. Turning the valid key in the ignition is required to activate or deactivate the immobilizer. smart USA further stated that the immobilizer is armed immediately after the ignition is turned off regardless of whether the doors are opened or are locked. There is currently no available theft rate data for the fortwo vehicle line as it is a new vehicle line beginning with MY 2008. smart USA provided Mercedes-Benz C-Line Chassis vehicle line as an example of a vehicle line subject to the parts-marking requirements (49 CFR part 541) that are equipped with ignition immobilizer systems as standard equipment. smart USA reported that NHTSA's theft rate for the C-Line Chassis vehicle for model years prior to 1998 (1994 through 1997) when an immobilizer was not installed as standard equipment resulted in an average theft rate of 1.6437. smart USA reported that, since the introduction of immobilizer systems as standard equipment on the C-Line Chassis vehicles, the average theft rate for MY's 1998 through 2004 is 1.4167, which is below the 1990/1991 median theft rate of 3.5826. smart USA stated that it believes the data indicate that the immobilizer system was effective in contributing to a reduction in theft rates for the C-Line Chassis at an average of 13.8 percent. On the basis of this comparison, smart USA stated that the immobilizer in the fortwo vehicle line is functionally equivalent to the systems used in the Mercedes-Benz S-Line, E-Line and C-Line Chassis vehicles beginning with MY 2006, 2007 and 2008, respectively. smart USA has concluded that the proposed antitheft device is no less effective than those devices installed on lines for which NHTSA has already granted full exemption from the parts-marking requirements. In addressing the specific content requirements of 543.6, smart USA provided information on the reliability and durability of its proposed device. Daimler AG has conducted tests based on its own specified standards for reliability and durability. smart USA provided a detailed list of the tests conducted, and believes that the device is reliable and durable since the device complied with its specified requirements for each test. Additionally, smart USA stated that it has obtained test approval according to regulatory requirements that are based on the testing parameters of the International Standards Organization regulations. Based on the confidential material submitted by smart USA, the agency believes that the antitheft device for the fortwo vehicle line is likely to be as effective in reducing and deterring motor vehicle theft as compliance with the parts-marking requirements of the Theft Prevention Standard (49 CFR part 541). Based on the information smart USA provided about the device, the agency concludes that the device will provide four of the five types of performance listed in § 543.6(a)(3): Promoting activation; preventing defeat or circumvention of the device by unauthorized persons; preventing operation of the vehicle by unauthorized entrants; and ensuring the reliability and durability of the device. As required by 49 U.S.C. 33106 and 49 CFR part 543.6(a)(4) and (5), the agency finds that smart USA has provided adequate reasons for its belief that the antitheft device will reduce and deter theft. This conclusion is based on the information smart USA provided about its antitheft device. For the foregoing reasons, the agency hereby grants in full smart USA's petition for exemption for the fortwo vehicle line from the parts-marking requirements of 49 CFR part 541. The agency notes that 49 CFR part 541, Appendix A-1, identifies those lines that are exempted from the Theft Prevention Standard for a given model year. 49 CFR part 543.7(f) contains publication requirements incident to the disposition of all part 543 petitions. Advanced listing, including the release of future product nameplates, the beginning model year for which the petition is granted and a general description of the antitheft device is necessary in order to notify law enforcement agencies of new vehicle lines exempted from the parts-marking requirements of the Theft Prevention Standard. If smart USA decides not to use the exemption for this line, it must formally notify the agency. If such a decision is made, the line must be fully marked according to the requirements under 49 CFR parts 541.5 and 541.6 (marking of major component parts and replacement parts). NHTSA notes that if smart USA wishes in the future to modify the device on which this exemption is based, the company may have to submit a petition to modify the exemption. Part 543.7(d) states that a part 543 exemption applies only to vehicles that belong to a line exempted under this part and equipped with the anti-theft device on which the line's exemption is based. Further, part 543.9(c)(2) provides for the submission of petitions “to modify an exemption to permit the use of an antitheft device similar to but differing from the one specified in that exemption.” The agency wishes to minimize the administrative burden that part 543.9(c)(2) could place on exempted vehicle manufacturers and itself. The agency did not intend in drafting part 543 to require the submission of a modification petition for every change to the components or design of an antitheft device. The significance of many such changes could be *de minimis* . Therefore, NHTSA suggests that if the manufacturer contemplates making any changes, the effects of which might be characterized as *de minimis* , it should consult the agency before preparing and submitting a petition to modify. Authority: 49 U.S.C. 33106; delegation of authority at 49 CFR 1.50. Issued on: May 12, 2008. Stephen R. Kratzke, Associate Administrator for Rulemaking. [FR Doc. E8-10983 Filed 5-15-08; 8:45 am] BILLING CODE 4910-59-P DEPARTMENT OF TRANSPORTATION Surface Transportation Board [STB Finance Docket No. 35138] Patriot Rail, LLC, Patriot Rail Holdings LLC, and Patriot Rail Corp.—Control Exemption—The Louisiana and North West Railroad Company LLC Patriot Rail, LLC
(PRL)and its subsidiaries, Patriot Rail Holdings LLC
(PRH)and Patriot Rail Corp. (Patriot) (collectively, applicants), jointly have filed a verified notice of exemption to permit PRL, PRH, and Patriot to acquire control of The Louisiana and North West Railroad Company LLC (L&NW) through Patriot's acquisition of 100% of the membership interests and/or substantially all of the assets of L&NW, pursuant to a Letter of Intent dated April 8, 2008. 1 Applicants state that a Purchase and Sale Agreement, as required by 49 CFR 1180.6(a)(7)(ii), will be entered prior to closing. 1 A redacted version of the Letter of Intent was included with the notice. The full version of the Letter of Intent was concurrently filed under seal along with a motion for protective order. The motion for protective order is being addressed in a separate decision. PRL is a noncarrier limited liability company that owns 51% of the equity interests in PRH, which, in turn, owns 100% of the stock of Patriot. Patriot is a noncarrier holding company that controls the following Class III railroads:
(1)The Tennessee Southern Railroad Company, operating in Tennessee and Alabama;
(2)Rarus Railway Company, operating in Montana;
(3)Utah Central Railway Company, operating in Utah; and
(4)Sacramento Valley Railroad, Inc., operating in California. LN&W, a Class III rail carrier, owns and operates an approximately 62.6-mile line of railroad between McNeil, AR, and Gibsland, LA, and leases a 6.5-mile line of railroad between McNeil and Magnolia, AR, from the Union Pacific Railroad Company. Pursuant to the transaction, Patriot will acquire direct control of L&NW. PRL and PRH, through their control of Patriot, will acquire indirect control of L&NW. The transaction is scheduled to be consummated on or after the date that this notice becomes effective (which will occur on May 30, 2008). *Applicants state that:*
(i)The rail lines involved in this transaction do not connect with any rail lines now controlled, directly or indirectly, by PRL, PRH, or Patriot;
(ii)the acquisition of control of L&NW by PRL, PRH, and Patriot is not part of a series of anticipated transactions that would connect any of these railroads with each other or any railroad in their corporate family; and
(iii)this transaction does not involve a Class I carrier. Therefore, this transaction is exempt from the prior approval requirements of 49 U.S.C. 11323. *See* 49 CFR 1180.2(d)(2). Under 49 U.S.C. 10502(g), the Board may not use its exemption authority to relieve a rail carrier of its statutory obligation to protect the interests of its employees. Section 11326(c), however, does not provide for labor protection for transactions under sections 11324 and 11325 that involve only Class III rail carriers. Accordingly, the Board may not impose labor protective conditions here, because all of the carriers involved are Class III rail carriers. If the verified notice contains false or misleading information, the exemption is void *ab initio* . Petitions to revoke the exemption under 49 U.S.C. 10502(d) may be filed at any time. The filing of a petition to revoke will not automatically stay the effectiveness of the exemption. Petitions for stay must be filed no later than May 23, 2008 (at least 7 days before the exemption becomes effective). An original and 10 copies of all pleadings, referring to STB Finance Docket No. 35138, must be filed with the Surface Transportation Board, 395 E Street, SW., Washington, DC 20423-0001. In addition, a copy of each pleading must be served on Louis E. Gitomer, Esq., Law Offices of Louis E. Gitomer, 600 Baltimore Avenue, Suite 301, Towson, MD 21204. Board decisions and notices are available on our Web site at *http://www.stb.dot.gov* . Decided: May 8, 2008. By the Board, David M. Konschnik, Director, Office of Proceedings. Anne K. Quinlan, Acting Secretary. [FR Doc. E8-10848 Filed 5-15-08; 8:45 am] BILLING CODE 4915-01-P DEPARTMENT OF TRANSPORTATION Surface Transportation Board [STB Finance Docket No. 35134] Squaw Creek Southern Railroad, Inc.—Lease and Operation Exemption—Central of Georgia Railroad Company Squaw Creek Southern Railroad, Inc. (SCS), a Class III rail carrier, has filed a verified notice of exemption under 49 CFR 1150.41 to lease and operate, pursuant to a lease agreement (Lease) reached with Central of Georgia Railroad Company (CGA), a wholly owned subsidiary of Norfolk Southern Railway Company (NSR), approximately 21.75 miles of rail line currently owned and operated by CGA, which is located between milepost F-53.75 at Machen, Jasper County, GA, and milepost F-75.5 at Madison, Morgan County, GA. As a result of this transaction, the subject line will connect with CGA, CSX Transportation, Inc., and The Great Walton Railroad Company, Inc. According to SCS, the Lease specifically provides that there is no restriction on SCS's ability to interchange traffic with a connecting carrier other than CGA or NSR, but SCS explains that, under the Lease, it will receive rental credits and handling fees from CGA and NSR for cars interchanged with CGA. The transaction is scheduled to become effective on June 1, 2008. The earliest this transaction can be consummated is May 30, 2008, the effective date of the exemption (30 days after the exemption is filed). SCS certifies that its projected annual revenues as a result of this transaction will not exceed those that qualify it as a Class III rail carrier and will not exceed $5 million. Pursuant to the Consolidated Appropriations Act, 2008, Pub. L. 110-161, § 193, 121 Stat. 1844 (2007), nothing in this decision authorizes the following activities at any solid waste rail transfer facility: collecting, storing or transferring solid waste outside of its original shipping container; or separating or processing solid waste (including baling, crushing, compacting and shredding). The term “solid waste” is defined in section 1004 of the Solid Waste Disposal Act, 42 U.S.C. 6903. If the verified notice contains false or misleading information, the exemption is void *ab initio* . Petitions to revoke the exemption under 49 U.S.C. 10502(d) may be filed at any time. The filing of a petition to revoke will not automatically stay the effectiveness of the exemption. Petitions to stay must be filed by no later than May 23, 2008 (at least 7 days before the exemption becomes effective). An original and 10 copies of all pleadings, referring to STB Finance Docket No. 35134 must be filed with the Surface Transportation Board, 395 E Street, SW., Washington, DC 20423-0001. In addition, a copy must be served on Andrew P. Goldstein or John M. Cutler, Jr., McCarthy, Sweeney and Harkaway, P.C., 2175 K Street, NW., Suite 600, Washington, DC 20037. Board decisions and notices are available on our Web site at *http://www.stb.dot.gov* . Decided: May 12, 2008. By the Board, David M. Konschnik, Director, Office of Proceedings. Anne K. Quinlan, Acting Secretary. [FR Doc. E8-11002 Filed 5-15-08; 8:45 am] BILLING CODE 4915-01-P DEPARTMENT OF TRANSPORTATION Surface Transportation Board [STB Finance Docket No. 35127] CSX Transportation, Inc.—Trackage Rights Exemption—Central Railroad of Indianapolis D/B/A Chicago, Fort Wayne and Eastern Pursuant to a written trackage rights agreement, Central Railroad of Indianapolis d/b/a Chicago, Fort Wayne and Eastern
(CFE)has agreed to grant limited non-exclusive overhead trackage rights to CSX Transportation, Inc.
(CSXT)over a CFE line of railroad between milepost QF 191.28, at the west end of CSXT's Crestline Yard, at Crestline, OH, and milepost QFS 62.85 at Spore, OH, 1 via CFE's Ft. Wayne Line Subdivision, a distance of approximately 15.16 miles. 2 1 CSXT's and CFE's trackage connects at the west end of CSXT's Crestline Yard. CSXT will operate along the Ft. Wayne Subdivision until it reaches milepost 200.05 near Bucyrus, OH. At that point, CSXT will enter the Spore Industrial Track, which begins at milepost QFS 69.24. CSXT will traverse the Spore Industrial Track to the end at Spore, milepost QFS 62.85, where the privately owned track of National Lime and Stone
(NLS)begins. Loaded trains from NLS will be operated in the reverse move. 2 A redacted draft version of the trackage rights agreement between CFE and CSXT was filed with the notice of exemption. The full draft version was concurrently filed under seal along with a motion for protective order, which will be addressed in a separate decision. The transaction may be consummated on or after May 31, 2008, the effective date of the exemption (30 days after the exemption was filed). 3 3 CSXT incorrectly states that the effective date of this exemption is May 30, 2008. Under the trackage rights agreement, CSXT's trains will move to and from the end points of the line in the interests of economy and efficiency, in connection with a transition in CSXT's operations, which transition will be implemented to improve traffic flow by avoiding time consuming and unnecessary interchange of loaded/empty unit trains between CFE, CSXT, and their respective crews. The trackage rights are limited to:
(1)The months between and including April through November of each calendar year, and
(2)a maximum of three loaded unit trains of crushed limestone and three empty unit trains per week, with a maximum of 60 cars per unit train. CSXT will not provide local service over the line. As a condition to this exemption, any employees affected by the trackage rights will be protected by the conditions imposed in *Norfolk and Western Ry. Co.—Trackage Rights—BN* , 354 I.C.C. 605 (1978), as modified in *Mendocino Coast Ry., Inc.—Lease and Operate* , 360 I.C.C. 653 (1980). This notice is filed under 49 CFR 1180.2(d)(7). If the notice contains false or misleading information, the exemption is void *ab initio* . Petitions to revoke the exemption under 49 U.S.C. 10502(d) may be filed at any time. The filing of a petition to revoke will not automatically stay the effectiveness of the exemption. Stay petitions must be filed by May 23, 2008 (at least 7 days before the exemption becomes effective). Pursuant to the Consolidated Appropriations Act, 2008, Public Law No. 110-161, § 193, 121 Stat. 1844 (2007), nothing in this decision authorizes the following activities at any solid waste rail transfer facility: collecting, storing or transferring solid waste outside of its original shipping container; or separating or processing solid waste (including baling, crushing, compacting and shredding). The term “solid waste” is defined in section 1004 of the Solid Waste Disposal Act, 42 U.S.C. 6903. An original and 10 copies of all pleadings, referring to STB Finance Docket No. 35127, must be filed with the Surface Transportation Board, 395 E Street, SW., Washington, DC 20423-0001. In addition, a copy of each pleading must be served on Steven C. Armbrust and John N. Booth, III, 500 Water Street, Suites J-150 and J-315, Jacksonville, FL 32202. Board decisions and notices are available on our Web site at *http://www.stb.dot.gov* . Decided: May 9, 2008. By the Board, David M. Konschnik, Director, Office of Proceedings. Anne K. Quinlan, Acting Secretary. [FR Doc. E8-10874 Filed 5-15-08; 8:45 am] BILLING CODE 4915-01-P DEPARTMENT OF THE TREASURY Office of the Comptroller of the Currency Agency Information Collection Activities: Proposed Information Collection; Comment Request AGENCY: Office of the Comptroller of the Currency (OCC), Treasury. ACTION: Notice and request for comment. SUMMARY: The OCC, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. An agency may not conduct or sponsor, and a respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget
(OMB)control number. The OCC is soliciting comment concerning its information collection titled “Loans in Areas Having Special Flood Hazards (12 CFR 22).” The OCC is also giving notice that it has submitted the collection to OMB for review. DATES: You should submit written comments by: June 16, 2008. ADDRESSES: Communications Division, Office of the Comptroller of the Currency, Public Information Room, Mail Stop 1-5, Attention: 1557-0202, 250 E Street, SW., Washington, DC 20219. In addition, comments may be sent by fax to
(202)874-4448, or by electronic mail to *regs.comments@occ.treas.gov* . You may personally inspect and photocopy comments at the OCC's Public Information Room, 250 E Street, SW., Washington, DC. For security reasons, the OCC requires that visitors make an appointment to inspect comments. You may do so by calling
(202)874-5043. Upon arrival, visitors will be required to present valid government-issued photo identification and submit to security screening in order to inspect and photocopy comments. Additionally, you should send a copy of your comments to OCC Desk Officer, 1557-0202, by mail to U.S. Office of Management and Budget, 725 17th Street, NW., #10235, Washington, DC 20503, or by fax to
(202)395-6974. FOR FURTHER INFORMATION CONTACT: You can request additional information or a copy of the collection from Mary Gottlieb,
(202)874-5090, Legislative and Regulatory Activities Division, Office of the Comptroller of the Currency, 250 E Street, SW., Washington, DC 20219. SUPPLEMENTARY INFORMATION: The OCC is proposing to extend OMB approval of the following information collection: *Title:* Loans in Areas Having Special Flood Hazards—12 CFR 22. *OMB Control Number:* 1557-0202. *Description:* The regulation requires national banks to make disclosures and keep records regarding whether a property securing a loan is located in a special flood hazard area. This information collection is required by section 303(a) 1 and title V of the Riegle Community Development and Regulatory Improvement Act, 2 the National Flood Insurance Reform Act of 1994 amendments to the National Flood Insurance Act of 1968 3 and the Flood Disaster Protection Act of 1973, 4 and by OCC regulations implementing those statutes. The information collection requirements are contained in 12 CFR part 22. 1 12 U.S.C. 4804. 2 42 U.S.C. 4104(a). 3 12 U.S.C. 4104a and 4104b. 4 12 U.S.C. 4012a and 4106(b). Section 22.6 requires a national bank to use and maintain a copy of the Standard Flood Hazard Determination Form developed by the Federal Emergency Management Agency (FEMA). Section 22.7 requires a national bank or its loan servicer, if a borrower has not obtained flood insurance, to notify the borrower to obtain adequate flood insurance coverage or the bank or servicer will purchase flood insurance on the borrower's behalf. Section 22.9 requires a national bank making, extending, increasing or renewing a loan secured by a building or a mobile home located in a special flood hazard area to advise the borrower and the loan servicer that the property is located in a special flood hazard area, provide a description of the flood insurance purchase requirements, and provide information regarding the availability of insurance under the National Flood Insurance Program and Federal assistance in the event of a declared Federal flood disaster. The bank must maintain a record of the borrower's and loan servicer's receipts of these notices. Section 22.10 requires a national bank making, increasing, extending, renewing, selling or transferring a loan secured by a building or a mobile home located in a special flood hazard area to notify FEMA of the identity of the servicer, and of any change in servicers. These information collection requirements ensure bank compliance with applicable Federal law, further bank safety and soundness, provide protections for banks and the public, and further public policy interests. *Type of Review:* Regular review. *Affected Public:* Businesses or other for-profit. *Estimated Number of Respondents:* 2,300. *Estimated Total Annual Responses:* 230,000. *Estimated Frequency of Response:* On occasion. *Estimated Time per Respondent:* 25.5 hours. *Estimated Total Annual Burden:* 58,650 hours. An agency may not conduct or sponsor, and a respondent is not required to respond to, an information collection unless the information collection displays a currently valid OMB control number. On March 10, 2008, the OCC published a notice in the **Federal Register** soliciting comments for 60 days on this information collection (73 FR 12799). No comments were received. Comments continue to be invited on:
(a)Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;
(b)The accuracy of the agency's estimate of the burden of the collection of information;
(c)Ways to enhance the quality, utility, and clarity of the information to be collected;
(d)Ways to minimize the burden of the collection on respondents, including through the use of automated collection techniques or other forms of information technology; and
(e)Estimates of capital or startup costs and costs of operation, maintenance, and purchase of services to provide information. Dated: May 12, 2008. Michele Meyer, Assistant Director, Legislative & Regulatory Activities Division, Office of the Comptroller of the Currency. [FR Doc. E8-10945 Filed 5-15-08; 8:45 am] BILLING CODE 4810-33-P DEPARTMENT OF THE TREASURY Office of the Comptroller of the Currency Agency Information Collection Activities: Proposed Information Collection; Comment Request AGENCY: Office of the Comptroller of the Currency (OCC), Treasury. ACTION: Notice and request for comment. SUMMARY: The OCC, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. An agency may not conduct or sponsor, and a respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget
(OMB)control number. The OCC is soliciting comment concerning its information collection titled, “Management Official Interlocks—12 CFR 26.” The OCC is also giving notice that it has submitted the collection to OMB for review. DATES: You should submit written comments by June 16, 2008. ADDRESSES: Communications Division, Office of the Comptroller of the Currency, Public Information Room, Mail Stop 1-5, Attention: 1557-0196, 250 E Street, SW., Washington, DC 20219. In addition, comments may be sent by fax to
(202)874-4448, or by electronic mail to *regs.comments@occ.treas.gov* . You may personally inspect and photocopy comments at the OCC's Public Information Room, 250 E Street, SW., Washington, DC. For security reasons, the OCC requires that visitors make an appointment to inspect comments. You may do so by calling
(202)874-5043. Upon arrival, visitors will be required to present valid government-issued photo identification and submit to security screening in order to inspect and photocopy comments. Additionally, you should send a copy of your comments to OCC Desk Officer, 1557-0196, by mail to U.S. Office of Management and Budget, 725 17th Street, NW., #10235, Washington, DC 20503, or by fax to
(202)395-6974. FOR FURTHER INFORMATION CONTACT: You can request additional information or a copy of the collection from Mary Gottlieb,
(202)874-5090, Legislative and Regulatory Activities Division, Office of the Comptroller of the Currency, 250 E Street, SW., Washington, DC 20219. SUPPLEMENTARY INFORMATION: The OCC is proposing to extend OMB approval of the following information collection: *Title:* (MA)-Management Official Interlocks—12 CFR 26. *OMB Control Number:* 1557-0196. *Description:* Under the Interlocks Act, two competing depository institutions generally may not share management officials. However, the OCC has legal authority to implement exemptions to this general prohibition. One such prohibition prohibits a management official of a depository organization from serving at the same time as a management official of an unaffiliated depository organization if the depository organizations in question (or a depository institution affiliate thereof) have offices in the same relevant metropolitan statistical area and each depository organization has total assets of $20 million or more. Section 610 of the Financial Services Regulatory Relief Act of 2006 (12 U.S.C. 3202(1)) raises the total asset threshold of the depository organization to $50 million. The change was effective as of October 13, 2006 and adopted by the OCC on January 11, 2007. This submission covers this change. The information is needed to prevent any management official interlock that would result in a monopoly or substantial lessening of competition. The OCC needs the information to grant exemptions that foster competition between unaffiliated institutions. The OCC uses the information to ensure that a proposed management interlock is permitted under statute, is eligible for an exemption under section 2210(c) of the Economic Growth and Regulatory Paperwork Reduction Act of 1996 (12 U.S.C. 3207), and does not have an anticompetitive effect. *Type of Review:* Regular Review. *Affected Public:* Businesses or other for-profit. *Estimated Number of Respondents:* 2. *Estimated Total Annual Responses:* 2. *Estimated Frequency of Response:* On occasion. *Estimated Time per Respondent:* 2 hours. *Estimated Total Annual Burden:* 4 hours. An agency may not conduct or sponsor, and a respondent is not required to respond to, an information collection unless the information collection displays a currently valid OMB control number. On March 10, 2008, the OCC published a notice in the **Federal Register** soliciting comments for 60 days on this information collection (73 FR 12799). No comments were received. Comments continue to be invited on:
(a)Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information has practical utility;
(b)The accuracy of the agency's estimate of the burden of the collection of information;
(c)Ways to enhance the quality, utility, and clarity of the information to be collected;
(d)Ways to minimize the burden of the collection on respondents, including through the use of automated collection techniques or other forms of information technology; and
(e)Estimates of capital or startup costs and costs of operation, maintenance, and purchase of services to provide information. Dated: May 12, 2008. Michele Meyer, Assistant Director, Legislative and Regulatory Activities Division, Office of the Comptroller of the Currency. [FR Doc. E8-10946 Filed 5-15-08; 8:45 am] BILLING CODE 4810-33-P DEPARTMENT OF THE TREASURY Internal Revenue Service Art Advisory Panel—Notice of Closed Meeting AGENCY: Internal Revenue Service, Treasury. ACTION: Notice of Closed Meeting of Art Advisory Panel. SUMMARY: Closed meeting of the Art Advisory Panel will be held in Washington, DC. DATES: The meeting will be held June 10, 2008. ADDRESSES: The closed meeting of the Art Advisory Panel will be held on June 10, 2008, in Room 4200E beginning at 9:30 a.m., Franklin Court Building, 1099 14th Street, NW., Washington, DC 20005. FOR FURTHER INFORMATION CONTACT: Karen Carolan, C:AP:AS, 1099 14th Street, NW., Washington, DC 20005. Telephone
(202)435-5609 (not a toll free number). SUPPLEMENTARY INFORMATION: Notice is hereby given pursuant to section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App., that a closed meeting of the Art Advisory Panel will be held on June 10, 2008, in Room 4200E beginning at 9:30 a.m., Franklin Court Building, 1099 14th Street, NW., Washington, DC 20005. The agenda will consist of the review and evaluation of the acceptability of fair market value appraisals of works of art involved in Federal income, estate, or gift tax returns. This will involve the discussion of material in individual tax returns made confidential by the provisions of 26 U.S.C. 6103. A determination as required by section 10(d) of the Federal Advisory Committee Act has been made that this meeting is concerned with matters listed in section 552b(c)(3), (4), (6), and (7), and that the meeting will not be open to the public. Sarah Hall Ingram, Chief, Appeals. [FR Doc. E8-10844 Filed 5-15-08; 8:45 am] BILLING CODE 4830-01-M 73 96 Friday, May 16, 2008 Proposed Rules Part II Department of Health and Human Services Centers for Medicare & Medicaid Services 42 CFR Parts 422 and 423 Medicare Program; Revisions to the Medicare Advantage and Prescription Drug Benefit Programs; Proposed Rule DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Parts 422 and 423 [CMS 4131-P] RIN 0938-AP24 Medicare Program; Revisions to the Medicare Advantage and Prescription Drug Benefit Programs AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Proposed rule. SUMMARY: This proposed rule would make revisions to the Medicare Advantage
(MA)program (Part C) and prescription drug benefit program (Part D). The regulation contains new regulatory provisions regarding special needs plans, medical savings accounts
(MSA)plans, and cost-sharing for dual eligible enrollees in the MA program, the prescription drug payment and novation processes in the Part D program, and the enrollment, appeals, and marketing processes for both programs. We are proposing these changes based on lessons learned since 2006, the initial year of the prescription drug program and the revised MA program. DATES: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on July 15, 2008. ADDRESSES: In commenting, please refer to file code CMS-4131-P. Because of staff and resource limitations, we cannot accept comments by facsimile
(FAX)transmission. You may submit comments in one of four ways (please choose only one of the ways listed): 1. *Electronically.* You may submit electronic comments on this regulation to *http://www.regulations.gov* . Follow the instructions for “Comment or Submission” and enter the filecode to find the document accepting comments. 2. *By regular mail.* You may mail written comments (one original and two copies) to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, *Attention:* CMS- *4131* -P, P.O. Box 8016, Baltimore, MD 21244-8016. Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. *By express or overnight mail.* You may send written comments (one original and two copies) to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, *Attention:* CMS- *4131* -P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. 4. *By hand or courier.* If you prefer, you may deliver (by hand or courier) your written comments (one original and two copies) before the close of the comment period to either of the following addresses: a. Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201. (Because access to the interior of the HHH Building is not readily available to persons without Federal Government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.) b. 7500 Security Boulevard, Baltimore, MD 21244-1850. If you intend to deliver your comments to the Baltimore address, please call telephone number
(410)786-7195 in advance to schedule your arrival with one of our staff members. Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period. *Submission of comments on paperwork requirements.* You may submit comments on this document's paperwork requirements by following the instructions at the end of the “Collection of Information Requirements” section in this document. For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: Special Needs Plans—LaVern Baty, 410-786-5480. Contracts with MA Organizations—Chris McClintick, 410-786-4682. Medicare Medical Savings Account Plans—Anne Manley, 410-786-1096. Enrollment—Lynn Orlosky, 410-786-9064. Payment—Frank Szeflinski, 303-844-7119. Civil Money Penalties—Christine Reinhard, 410-786-2987. Reconsiderations— • John Scott, 410-786-3636. • Kathryn McCann Smith, 410-786-7623. Marketing—Elizabeth Jacob, 410-786-8658. Change of Ownership—Scott Nelson, 410-786-1038. Low-income Cost-Sharing—Christine Hinds, 410-786-4578. Definitions related to the Part D drug benefit. Subparts F and G—Deondra Moseley,
(410)786-4577 or Meghan Elrington,
(410)786-8675. Subpart R—David Mlawsky,
(410)786-6851. SUPPLEMENTARY INFORMATION: *Inspection of Public Comments:* All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: *http://www.regulations.gov* . Follow the search instructions on that Web site to view public comments. Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951. I. Background A. Overview of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 The Medicare Prescription Drug, Improvement, and Modernization Act of 2003
(MMA)(Pub. L. 108-173) was enacted on December 8, 2003. The MMA established the Medicare prescription drug benefit program (Part D) and made revisions to the provisions in Medicare Part C, governing what is now called the Medicare Advantage
(MA)program (formerly Medicare+Choice). The MMA directed that important aspects of the new Medicare prescription drug benefit program under Part D be similar to and coordinated with regulations for the MA program. The MMA also directed implementation of the prescription drug benefit and revised MA program provisions by January 1, 2006. The final rules for the MA and Part D prescription drug programs appeared in the **Federal Register** on January 28, 2005 (70 FR 4588 through 4741 and 70 FR 4194 through 4585, respectively). Many of the provisions relating to applications, marketing, contracts, and the new bidding process, for the MA program, became effective on March 22, 2005, 60 days after publication of the rule, so that the requirements for both programs could be implemented by January 1, 2006. All of the provisions regarding the new Part D prescription drug program became effective on March 22, 2005. As we have gained more experience with the MA program and the prescription drug benefit program, we are proposing to revise areas of both programs. Many of these revisions clarify existing policies or codify current guidance for both programs. We believe that these changes would help plans understand and comply with our policies for both programs and aid MA organizations and Part D plan sponsors in implementing their health care and prescription drug benefit plans. B. Relevant Legislative History and Overview The Balanced Budget Act of 1997
(BBA)(Pub. L. 105-33) established a new “Part C” in the Medicare statute (sections 1851 through 1859 of the Social Security Act (the Act)) which provided for a Medicare+Choice (M+C) program. Under section 1851(a)(1) of the Act, every individual entitled to Medicare Part A and enrolled under Medicare Part B, except for most individuals with end-stage renal disease (ESRD), could elect to receive benefits either through the original Medicare program or an M+C plan, if one was offered where he or she lived. The primary goal of the M+C program was to provide Medicare beneficiaries with a wider range of health plan choices. The Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999 (BBRA), Public Law 106-111, amended the M+C provisions of the BBA. Further amendments were made to the M+C program by the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000
(BIPA)(Pub. L. 106-554), enacted December 21, 2000. As noted above, the MMA was enacted on December 8, 2003. Title I of the MMA added a new “Part D” to the Medicare statute (sections 1860D-1 through 1860D-42) creating the Medicare Prescription Drug Benefit Program, the most significant change to the Medicare program since its inception in 1965. Sections 201 through 241 of Title II of the MMA made significant changes to the M+C program which was established by the Balanced Budget Act of 1997
(BBA)(Pub. L. 105-33). Title II of the MMA renamed the M+C program the MA program and included new payment and bidding provisions, new regional MA plans and special needs plans, reestablished authority for medical savings account
(MSA)plans that had been provided in the BBA on a temporary basis, and other changes. Title I of the MMA created prescription drug benefits under Medicare Part D, and a new retiree drug subsidy program. Both the MA and prescription drug benefit regulations were published separately, as proposed and final rules, though their development and publication were closely coordinated. On August 3, 2004, we published in the **Federal Register** proposed rules for the MA program (69 FR 46866 through 46977) and the prescription drug benefit program (69 FR 46632 through 46863). In response to public comments on the proposed rules, we made several revisions to the proposed policies for both programs. For further discussion of these revisions, see the respective final rules (70 FR 4588-4741) and (70 FR 4194-4585). II. Provisions of the Proposed Regulations In the sections that follow, we discuss the proposed changes to the regulations in parts 422 and 423 governing the MA and prescription drug benefit programs. Several of the proposed revisions and clarifications affect both programs. In our discussion, we note when a provision would affect both the MA and prescription drug benefit and include in section II C, a table comparing the proposed Part C and D program changes by specifying each issue and the sections of the Code of Federal Regulations that we propose to revise for both programs. A. Proposed Changes to Part 422—Medicare Advantage Program 1. Special Needs Plans The Congress first authorized special needs plans
(SNP)to exclusively or disproportionately serve individuals with special needs. The three types of special needs individuals eligible for enrollment identified by the Congress include
(1)institutionalized individuals (defined in 42 CFR 422.2 as an individual residing or expecting to reside for 90 days or longer in a long term care facility),
(2)individuals entitled to medical assistance under a State plan under title XIX, and
(3)other individuals with severe or disabling chronic conditions that would benefit from enrollment in a SNP. The number of SNPs approved as of January 2008, is 787. This figure includes 442 dual eligible SNPs, 256 chronic care SNPs, and 89 institutional SNPs. a. Ensuring Special Needs Plans Serve Primarily Special Needs Individuals (§ 422.4) Section 231 of the MMA authorized MA organizations to offer a specialized MA plan that “exclusively,” or “disproportionately,” “serves” one of three categories of “special needs” individuals: Individuals dually-eligible for both Medicare and Medicaid, institutionalized individuals, and individuals with severe or disabling chronic conditions that the Secretary determines would benefit from enrollment in a SNP. As noted above, the final rule implementing the MMA changes to the MA program, including these SNP provisions, was issued on January 28, 2005 (70 FR 4588). In the preamble to the proposed rule we proposed to interpret the term “serves” special needs individuals to mean markets to, and enrolls, special needs individuals. This was intended to permit an MA Plan with existing non-special needs enrollees to be designated a SNP if it prospectively, exclusively, or disproportionately enrolled special needs individuals. We also proposed to interpret the statutory phrase, “disproportionately serve[s] special needs individuals” to refer to a SNP that enrolls special needs individuals in a proportion greater than such individuals exist in the area served by the plan (69 FR 46874). We asked for public comments regarding whether we should specify a percentage, such as 50 percent or more, as the minimum enrollment for a plan to be considered a SNP. We did not receive any comments on this proposed provision. Therefore, in the final rule we established the disproportionate percentage methodology based on the test we proposed in the proposed rule, that is, a comparison of the proportion of the special needs individuals the plan enrolls relative to non-special needs enrollees and the proportion of special needs individuals in the plan's service area. If the proportion of special needs to non-special needs individuals being enrolled in the plan was greater than the proportion in the plan's service area, the plan could be considered a disproportionate share SNP. Our expectation was that only a limited number of non-special needs individuals would be likely to enroll in a SNP, such as spouses or children of special needs individuals who wish to enroll in the same MA plan as the spouse or parent. However, such plans may be attractive to other non-special needs individuals because they may offer additional benefits beyond what Medicare covers. Also, individuals who are in the early stages of one of the chronic conditions covered by a disproportionate percentage, chronic care SNP may find the benefits or the network of participating specialists attractive. Disproportionate percentage SNPs have proliferated since the implementation of the Part D program, due, in part, to the fact that both dual eligible individuals and institutionalized individuals are permitted to enroll in MA plans year round, and dual eligible and institutional SNPs are thus permitted to market year round. CMS' information shows that a significant number of the dual-eligible disproportionate percentage SNPs may have between 25 percent and 40 percent of their enrollment composed of non-special needs individuals. As a result, we are concerned that disproportionate percentage SNPs are enrolling significant numbers of non-special needs individuals, thus diluting the focus on serving those individuals with special needs. Therefore, in order to ensure that existing and future SNPs maintain a primary focus on individuals with special needs, we are proposing to amend our regulations at § 422.4(a)(1)(iv)(B) to require that MA organizations offering SNPs limit new enrollment of non-special needs members to no more than 10 percent of new enrollees, and that 90 percent of new enrollees must be special needs individuals as defined in § 422.2. We believe this threshold would continue to allow the small number of non-SNP eligible spouses and children to continue to enroll in the same MA plan as their SNP eligible spouse or parent while ensuring that the SNP retains its focus on serving the special needs individuals for which it is specifically designed. We understand that the majority of SNPs that currently enroll both special needs and non-special needs individuals have current enrollments of non-special needs individuals that exceed 10 percent. Because the new limitation only applies to new enrollees, these plans would be able to continue to serve their existing membership. Organizations offering disproportionate enrollment SNPs would not be permitted to enroll new non-special needs individuals, however, without first enrolling enough special needs individuals to ensure that the percentage of new non-special needs enrollees remains below 10 percent. Furthermore, as specified in § 422.4, those enrollees deemed continuously eligible per § 422.52(d) are considered special needs individuals for the purpose of determining the disproportionate percentage. On an ongoing basis plans would need to monitor their enrollment to ensure that the 10 percent limit on new enrollments is met. This means that plans would need to monitor their enrollment to ensure that they were enrolling nine special needs individuals for every non-special needs individual to keep the ratio of new enrollees who were non-special needs individuals below 10 percent of new enrollees. MA organizations offering disproportionate SNPs would have to have a mechanism to ensure that a non-special needs individual could not enroll until a sufficient number of special needs individuals were enrolled to keep new enrollment of non-special needs individuals below 10 percent of new enrollments. For example, if a SNP receives completed enrollment elections from non-special needs individuals when such an enrollment would push the percentage of new enrollees over 10 percent, it could—(1) deny the enrollment due to the onset of the limit; or
(2)place the enrollment on a waiting list to be processed after a sufficient number of special needs individuals have been enrolled. The plan would need to ensure that once enrollments are accepted for non-special needs individuals, that this is done on a non-discriminatory basis. We believe that this approach will encourage SNPs to design benefit packages that best serve the certain special needs populations for which they have been created. We welcome comments on the appropriateness of the 10 percent standard for new enrollees, as well as the most effective and least burdensome ways for plans to monitor the proportions of new enrollments. b. Ensuring Eligibility To Elect an MA Plan for Special Needs Individuals (§ 422.52) In order to elect a SNP, an individual must meet the eligibility requirements for the specific type of SNP in which the individual wishes to enroll. For example, to enroll in a dual eligible SNP, the individual must be eligible for both Medicare and Medicaid. It is the responsibility of the MA organization offering the SNP to verify eligibility during the enrollment process. We are concerned that some dual eligible SNPs may not be appropriately verifying Medicaid eligibility of applicants for enrollment, and therefore may be enrolling beneficiaries who are not eligible for both Medicare and Medicaid. Similarly, some chronic care SNPs may encounter difficulties having providers verify that the applicants have the condition(s) established as the focus of the chronic care SNP. We propose to clarify in our regulations that MA organizations must establish a process to verify that potential SNP enrollees meet the SNP's specific eligibility requirements. While this issue is addressed, to some degree, in our manual guidance (section 20.11 of Chapter 2 of the Medicare Managed Care Manual), we believe that it is important to ensure that plans are aware of and meet their obligations to verify an applicant's eligibility prior to enrolling individuals in a SNP through rule making. Therefore, we are proposing in § 422.52(g) that MA organizations offering SNPs for dual eligible beneficiaries establish a process approved by CMS to obtain information from the State about the applicant's Medicaid status and that this verification must be obtained prior to enrollment. This would likely require the SNP to enter into an agreement with the State to obtain this information on a routine and timely basis. We address the issue of a relationship with the State Medicaid program in the case of a dual eligible SNP in more detail in section II, below. Those organizations offering chronic care SNPs must attempt to obtain verifying information directly from the beneficiary's provider or the organization may use the disease-specific pre-qualification assessment questions developed by, and available from CMS (model language) as an alternative methodology. In the 2008 MA application solicitation, we required SNPs to identify their processes for verifying a beneficiary's chronic condition before enrollment. Specifically, each applicant was required to contact the enrollee's physician to verify eligibility for the specific chronic condition SNP. We subsequently received industry comments that SNP staff sometimes experience significant delays in obtaining physician verification of the beneficiary's chronic condition and, as a consequence, there was delay in enrolling an eligible beneficiary. In response to this information, we developed an additional option to facilitate chronic condition verification. In a May 31, 2007 memorandum, we notified chronic condition SNPs that they could develop a pre-enrollment qualification assessment tool to expedite verification that beneficiaries had the chronic condition for which they were enrolled (see * https://32.90.191.19/hpms/upload_area/NewsArchive_ MassEmail/000001696/CHVHPMS%20v2.pdf * ). We simultaneously posted an example of an acceptable verification tool for coronary artery disease, congestive heart failure, and/or cerebrovascular accident (stroke) on HPMS (see *https://32.90.191.19/hpms/upload_area/NewsArchive_MassEmail/000001696/Draft%20pre-Qual%for%20chronic%20SNP%20verification%205%2007%20(2).pdf* ). The notification memorandum instructed SNPs to draft a verification tool, complete an attestation form asserting compliance with CMS conditions listed on the form, and to submit the tool to CMS for review and approval prior to using the tool. Concurrently, we collaborated with physician experts in chronic disease management to develop a series of questions related to several chronic conditions listed in HPMS as of January 2, 2007, representing potentially severe or disabling primary chronic conditions. Questions similar to the above example were developed for chronic obstructive pulmonary disease, diabetes mellitus, hypertension, chronic renal failure, depression, schizophrenia, bipolar disorder, dementia, and chronic alcohol or drug dependence. Because chronic condition SNPs request CMS approval for their proposed pre-enrollment qualification assessment tools, we use the disease-specific questions to guide the SNP in the design of an appropriate tool. Having the additional option of using a pre-enrollment qualification assessment tool gives SNPs three means of meeting the verification requirement—written documentation from the beneficiary's former physician, telephonic confirmation by the beneficiary's former physician, or use of the verification tool followed by post-enrollment confirmation by any physician. Similarly, organizations offering a SNP for institutionalized individuals must verify each enrollee's institutional status with the facility or appropriate State agency. c. Model of Care (422.101(f)) As noted above, the MMA permitted MA organizations to offer care targeted to beneficiaries with special health care needs through SNPs. The MMA specified that a special needs individual was an individual who was “institutionalized” (as defined by the Secretary), is entitled to medical assistance under a State plan under title XIX (Medicaid), or “meets such requirements as the Secretary may determine would benefit from enrollment” in a SNP for individuals “with severe or disabling chronic conditions.” In order to ensure that SNPs are providing care targeted to such special needs beneficiaries, under our authority in section 1856(b)(1) of the Act to establish standards by regulation, we are proposing that SNPs develop a model of care specific to the special needs population they are serving. In order to more clearly establish and clarify delivery of care standards for SNPs and to codify standards which we have included in other CMS guidance and instructions (the 2008 and 2009 Call Letters, “Special Needs Plan Solicitation 1 ”), we propose to add new paragraph
(f)to § 422.101. Section 422.101(f) would specify that SNPs must have networks with clinical expertise specific to the special needs population of the plan; use performance measures to evaluate models of care; and be able to coordinate and deliver care targeted to the frail/disabled, and those near the end of life based on appropriate protocols. We believe that these measures are critical to providing care to the types of special needs populations served by SNPs. 1 The solicitation may be found at *http://www.cms.hhs.gov/SpecialNeedsPlans.* For example, CMS anticipates that a chronic condition SNP serving beneficiaries having severe or disabling diabetes mellitus would establish a provider network that afforded access to diabetes experts such as endocrinologists who consult on pharmacotherapy for the fragile diabetic, vitreo-retinal ophthalmologists for diabetic retinopathy management, nephrologists for diabetic nephropathy management, neurologists having diabetic neuropathy expertise, nurses having specialized training in diabetes education, and nutritionists with expertise in diabetic counseling. The SNP might enroll diabetic beneficiaries who develop chronic renal failure related to diabetic nephropathy and require dialysis. The SNP might choose to contract or partner with these specialized diabetes experts and/or dialysis facilities, but, as a special needs plan targeting beneficiaries with specialized diabetic needs, the SNP is obligated to provide services to manage the expected disease-specific complications of a diabetic with severe or disabling disease progression. We also expect that the chronic condition SNP serving diabetic beneficiaries would develop diabetes-specific performance measures to evaluate its own systems, experts, and health outcomes related to its diabetes management. The SNP's own internal quality assurance and performance improvement program should examine the effectiveness of its model of care for diabetes management. For example, if the SNPs provider network applied the American Diabetes Association's clinical practice guideline for reducing the risk of or slowing the progression of diabetic nephropathy by optimizing glucose control (see National Guidelines Clearinghouse, 2008; *http://www.guideline.gov/summary/summary.aspx?doc_id=10401* ), an appropriate performance measure to evaluate management of diabetic beneficiaries would be a process measure to determine the percentage of diabetics having glycosylated hemoglobin (Hgb A <sup>1C</sup> ) measured in the last 6 months or an outcome measure to determine how many diabetics had an A <sup>1C</sup> measuring less than 7 percent (see National Quality Measures Clearinghouse, 2008; *http://www.guideline.gov/browse/xrefnqmc.aspx* ). We recognize there is a broad range of chronic disease management systems and evidence-based clinical practice guidelines available to SNPs; consequently, we have deliberately guided SNPs toward the conceptual framework of a model of care without being prescriptive about the specific staff structure, provider network, clinical protocols, performance improvement, and communication systems. We also expect that within the target population of beneficiaries having severe or disabling diabetes mellitus, SNPs would have a subpopulation of diabetics who are frail, near the end of life, or disabled by other morbidities (for example, neurological disorders, mental disorders, etc.) that would need additional specialized benefits and services that should be addressed in the model of care. For example, the diabetic beneficiary with diabetic complications who is near the end of life might require assisted living or institutional services for which the SNP would develop different goals, expanded specialty services and facilities in their provider network, different performance measures, and additional protocols. d. Dual Eligible SNPs and Arrangements With States (§ 422.107) CMS' review of SNPs targeting beneficiaries eligible for both Medicare and Medicaid (dual eligible SNPs) over the past few years suggests to us that for such SNPs to serve this population of beneficiaries, a plan should have a documented relationship with the State Medicaid agency in the State in which its members reside. Dual eligible SNPs that have not established a working relationship with the State may encounter difficulties verifying eligibility for Medicaid prior to enrollment in a SNP and, thus, may inappropriately enroll members who are not eligible for Medicaid. Also, without an arrangement with the State, SNPs may not have the information necessary to guide beneficiaries to providers that can deliver both Medicare and Medicaid services. Further, Medicaid often provides additional health services not covered by Medicare through the SNP. Medicare Advantage organizations (MA organization) with no State relationship may be advising dual eligible members that services are not covered at all because they are not covered under the SNP, even though the services are covered through Medicaid. Consequently, if the MA organization is not aware of the benefits available to its members through other sources, such as Medicaid, it cannot ensure that the model of care it delivers offers adequate coordination of the essential services. In order to ensure that beneficiaries are able to access essential services that are available through Medicaid in addition to those benefits available through the SNP, we propose to add a new § 422.107 which would require that an MA organization seeking to offer a SNP to serve the dual eligible population must have, at a minimum, a documented relationship, such as a contract, memorandum of understanding (MOU), data exchange agreement, or some other agreed upon arrangement with the State Medicaid agency for the State in which the dual eligible SNP is operating, in an effort to improve Medicare and Medicaid integration. We propose in § 422.107(a) that all SNPs, whether entering the market or already established at the time these regulations become effective, must have in place a dual eligibility verification arrangement and information sharing on Medicaid providers and benefits. We also propose in § 422.107(b) that within 3 years of the effective date of these regulations, all dual eligible SNPs already offering contracts are required to develop additional formal arrangements with States, and that new SNPs offering contracts after these regulations are effective, are required to have formal arrangements by their third contract year. CMS is allowing 3 years because we understand that it may take this long for contractual arrangements between the State and an MA plan to be implemented, particularly if Medicaid capitation and a request for proposal
(RFP)are involved. We believe that by providing States and MA organizations with the maximum amount of flexibility for having a documented relationship, it will encourage States to actively participate in the development of integrated Medicare and Medicaid products with MA organizations. We believe 3 years is a reasonable and sufficient amount of time for MA organizations to develop documented arrangements with their respective States. We understand that some States are not yet ready to engage and participate in providing health care through MA organizations for their Medicaid-eligible populations and, are, therefore, providing a 3-year window for development and implementation. Examples of additional formal arrangements range from documentation of a cooperative arrangement with the State to coordinate benefits to a contractual arrangement between the State Medicaid agency and the MA organization offering the SNP, under an RFP process, or under a Medicaid capitation arrangement. e. Special Needs Plans and Other MA Plans With Dual Eligibles: Responsibility for Cost-Sharing (§ 422.504(g)(1)) CMS' review of MA plans serving dual eligible beneficiaries over the past few years has identified that a number of providers are charging the beneficiaries Medicare Parts A and B cost sharing that is the responsibility of the State. Additionally, many dual eligible enrollees are unclear about the Medicare and Medicaid rules and benefits. Some new enrollees have experienced interruptions in treatment, resulting in a negative impact on their health. These experiences suggest that additional requirements are needed to ensure that both providers and beneficiaries understand Medicare and Medicaid rules and that beneficiaries do not pay cost-sharing for which they are not responsible. In order to protect beneficiaries and ensure that providers do not bill for cost-sharing that is not the beneficiary's responsibility, we have amended § 422.504(g)(1)(i) and (g)(1)(ii) to require that all MA organizations, including SNPs, with enrollees who are eligible for both Medicare and Medicaid specify in their contracts with providers that enrollees will not be held liable for Medicare Parts A and B cost sharing when the State is liable for the cost-sharing. We are proposing, therefore, that contracts with providers state that the provider will do this by either accepting the MA plan payment in full (§ 422.504(g)(1)(iii)(A)) or by billing the appropriate State source (for example, Medicaid) (§ 422.504(g)(1)(iii)(B)). Additionally, we are proposing that all MA organizations with enrollees eligible for both Medicare and Medicaid must inform providers of the Medicare and Medicaid benefits and rules for enrollees eligible for Medicare and Medicaid (§ 422.504(g)(1)(iii)). Medicare Advantage organizations have flexibility in establishing arrangements with States. The arrangements could include discussing and identifying both the Medicare and Medicaid benefits and rules. A list of the services, as well as the rules applicable to enrollees eligible for Medicare and Medicaid could be disseminated to providers and updated as necessary. A contact person or liaison could be identified for each MA plan who could assist with questions and with the maintenance of current information. 2. MA MSA Transparency (§ 422.103(e)) As noted above, the MMA restored authority for “Medical Savings Account”
(MSA)plans that had been provided for in the BBA on a temporary basis, but which expired without any such plan ever being offered. MSA plans are MA plans under which a portion of the total MA capitation rate is paid to the MA organization for a high-deductible policy that covers Medicare covered services after the high deductible is met. The remainder of the amount is placed into a savings account to be used to cover health care costs until the deductible is met. Any amounts not used in a given year accumulate for use in a future year. As noted, under the original BBA authority, no MA organization chose to offer an MSA plan. We believe that this might be attributable in part to differences between the rules for MSA plans and the more popular health savings account
(HSA)arrangements available for non-Medicare beneficiaries. In order to encourage the offering of MSA plans, and to test whether changing some rules would be beneficial, we initiated an “MSA demonstration” under which some MSA rules were waived. As part of this demonstration, we required that participating MA organizations provide MSA plan enrollees with cost and quality information that they could use to make informed choices as to where they would get health care. Consistent with the best practices of HSAs and other high-deductible health plans, we propose in new § 422.103(e) to require that all MSA plans provide enrollees with information on the cost and quality of services as specified by CMS and provide information to CMS on how they would provide this information to enrollees. 2 2 HSAs are health insurance plans with a high deductible and a savings account for the under 65 population and are administered by the U.S. Department of the Treasury. Medicare MSAs are a type of medical savings account, also with a high deductible and a savings account, designed for the Medicare population and are administered by the U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services. HSAs and MSAs are governed by different statutes, and while these health insurance products are similar in many ways, there are also important differences between them. For further information on HSAs, go to *http://www.ustreas.gov/offices/public-affairs/hsa/* . The purpose of reporting cost/quality information to consumers, a practice known as “transparency,” is to permit plan enrollees to compare costs for specific services and to compare providers on cost and quality, with the high deductible acting as an added incentive to shop around. This proposal would implement a basic tenet of high-deductible health plans, the availability of useful cost and quality information to support consumer shopping. We recognize that the Congress exempted MSA plans from the quality improvement program requirements in section 1852(e)(1) of the Act, and thus from the data collection and reporting requirements in section 1852(e)(3) of the Act. We would not, under this requirement, be mandating the same level of data collection required under those provisions, or the reporting of quality data to CMS. Rather, we are presuming that MA organizations in the business of offering an MSA product are committed to facilitating the intended benefits of this model—that consumers make informed choices as to their health care purchases during the deductible period and beyond. We would expect that such organizations already have mechanisms in place, in connection with their commercial lines of business, for providing their beneficiaries with cost or quality information. Indeed, in the case of Medicare participating providers, such information is available from CMS through our own transparency initiatives. Our view that quality and cost information would be available, or reasonably accessible, to organizations in the business of offering an MSA plan is supported by the fact that the MA organizations participating in the MSA demonstration have agreed to provide the information to their enrollees. We invite public comments on this issue. We are proposing to revise the regulations to require that MA organizations offering MSA plans provide their enrollees with quality and cost information, to the extent available, concerning services in the plan's service area, and to report to CMS on its approach to providing this information. Below are examples of what a plan could be expected to address: • How the organization will provide cost and quality information to enrollees, including screenshots for any Web-based tools used to meet this requirement. • If they will use a Web-based product to meet this requirement, how they will provide this information to enrollees that do not have access to the Internet. • How their organization will obtain information regarding cost and quality in the requested service area and whether this information will be personalized to the member. B. Proposed Changes to Part 423—Medicare Prescription Drug Benefit Program 1. Passive Election for Full Benefit Dual Eligible Individuals Who Are Qualifying Covered Retirees (§ 423.34) Section 1860D-1(b)(1)(C) of the Act, and implementing regulations at 42 CFR 423.34(d), require that CMS automatically enroll a full-benefit dual eligible
(FBDE)individual who has
(1)failed to enroll in a prescription drug plan
(PDP)or MA-PD into a PDP at or below the premium subsidy amount, and, per the last sentence in section 1860D-1(b)(1)(C) of the Act,
(2)has not declined Part D enrollment, into a PDP with a premium at or below the full premium subsidy amount. Further, the statute requires that if there is more than one such plan the “Secretary shall enroll such an individual on a random basis among all such plans in the PDP region.” Our general policy in implementing these provisions is to notify individuals in advance about their pending auto-enrollment, and to include in that notice information about other plans available to the individual and about how to decline Part D coverage, and thus opt out of the default enrollment process. For the overwhelming majority of FBDE individuals, default enrollment into a PDP is a favorable outcome that ensures that they receive prescription drug coverage without costs for premiums and deductibles, and with only nominal costs for cost sharing. In many cases, the Part D enrollment is also beneficial for FBDE individuals with retiree coverage, since the Part D drug coverage may well be available at a lower cost than the coverage offered through the employer plan. However, for a significant number of FBDE individuals with drug coverage through an employer group plan—especially those with full health care coverage—automatic enrollment into a PDP can have serious and sometimes irreversible negative consequences, either for the beneficiary and/or for family members. For example, under the terms of a particular employer group plan, an individual may lose employer group retiree medical coverage upon enrollment in a Part D plan, or worse, an individual's automatic enrollment in a PDP can result not only in the individual's disenrollment from the employer plan, but the disenrollment of a spouse or other family member. Although we were aware of this possibility at the outset of the program, we had no information about the extent to which FBDE individuals might already have retiree group coverage, and we believed that to the extent there were individuals in this situation, the number would be extremely small. Thus, we did not make any special rules for this population. Since January 2006, however, we have received a relatively small, but steady, series of complaints about this issue. We have attempted to work with employers to resolve individual situations as they arose, but have not had complete success. A recent survey of large employers found that 36 percent of the firms indicated retirees would lose all retiree medical coverage upon enrollment in a Part D plan, and another 32 percent specified the retirees would lose their employer group drug coverage only. More importantly, 82 percent of employers indicated that if a retiree is enrolled in a Medicare Part D plan, the spouse of that individual would not be allowed to keep employer sponsored coverage. Finally, 57 percent of the firms surveyed indicated that they would not allow retirees to rejoin the company's coverage in the future, should they decide that they would prefer the employer coverage to the Part D coverage in which they were automatically enrolled based on their FBDE status. (See December 13, 2006, Kaiser/Hewitt Survey Report of Large Employers at *http://www.kff.org/medicare/med121306nr.cfm* ). To address those concerns, we propose to revise § 423.34(d)(1), and add new § 423.34(d)(3), to establish a process under which FBDE individuals who we know to be enrolled in a qualifying employer group plan would be deemed to decline Part D coverage if, following a notice of their options, they do not indicate that they wish to receive it. As a result, these individuals would not be part of the group that is subject to default auto-enrollment. In order to ensure that only individuals with creditable employer coverage would be included in this process, we would limit the applicability of this process to individuals enrolled in a plan for which CMS is paying an employer subsidy. Under our proposal, the individuals would be notified in advance by CMS of their prospective auto-enrollment, and of the need to carefully consider the possible repercussions of such an enrollment, including the impact that enrollment into Medicare Part D would have on their retiree coverage for themselves and other family members. We would recommend contacting the sponsor or administrator of the retiree group plan to discuss the effect of enrollment in Medicare Part D on the retiree coverage. Individuals would further be informed that by taking no action, they will be deemed to have elected to decline enrollment into a Part D plan. We would further inform them that they could enroll in a Part D plan at any time in the future if they wish to do so, and that the enrollment could be made retroactive. Thus, absent a confirmation of the individual's desire to be auto-enrolled into a Part D plan, he or she would retain the employer group coverage. In considering whether to adopt this approach, we recognized that to the extent that declining Part D could possibly have any negative consequences for FBDE individuals who are not auto-enrolled, CMS has the discretionary authority to make retroactive enrollment changes that can address such problems. In contrast, CMS has no authority to insist that a retiree plan sponsor allow individuals back into its plan should the retirees or their family members be adversely affected by auto enrollment. Given that 56 percent of employers surveyed have specifically stated that they would not allow re-enrollment into their retiree plans after an individual began Part D coverage, we believe that our proposed change in policy would clearly be in the best interests of the FBDE population with retiree coverage. 2. Part D Late Enrollment Penalty (§ 423.46) Section 1860D-22(b) of the Act established a Part D late enrollment penalty
(LEP)for beneficiaries who have a continuous period of 63 days or longer following the end of an individual's Part D initial enrollment period without creditable prescription drug coverage. This requirement is codified in § 423.46. Although § 423.46 describes which individuals would be subject to a penalty, it does not specify the role of the Part D plan in the LEP determination process. We have subsequently outlined plan responsibilities in our existing guidance (Chapter 4 of the Medicare Prescription Drug Benefit Manual) and now propose to clarify the general responsibilities of Part D plans in our regulations. First, we would clarify under § 423.46(b) that Part D plans must obtain information on prior creditable coverage from all enrolled or enrolling beneficiaries. Under this process, plans first query CMS systems for previous plan enrollment information, which is a standard part of the beneficiary enrollment process. When no previous enrollment information exists, however, the process for obtaining creditable coverage information must also include plan interaction with the beneficiary. This is due in large part to the limited information available in CMS' systems about forms of creditable coverage other than Part D coverage or coverage through an employer group under the retiree drug subsidy (RDS). Therefore, it is critical that plans obtain historical creditable coverage information from the beneficiary in order to determine the number of uncovered months, if any, and retain any information collected concerning that determination (as specified under proposed § 423.46(d)). The related requirement that we are proposing under § 423.46(b) is that plans must then report creditable coverage information in a manner specified by CMS. Specifically, that would entail reporting the number of uncovered months to CMS, which will then calculate the penalty and report the penalty back to the plan. The plan then notifies the beneficiary of the determination of the LEP amount and of their ability to request a reconsideration of this determination. Thus, we would also establish under § 423.46(c) that, consistent with section 1860(D)-22(b)(6)(C) of the Act, individuals who are determined to have a late enrollment penalty, have the opportunity to ask for a reconsideration of this determination. (Note that existing § 423.56(g) briefly references the ability to “apply to CMS” when an individual believes that he or she was not adequately informed that his or her prescription drug coverage was not creditable, and we would cross-reference that section here.) We believe that the statute clearly intends that individuals have an opportunity to provide CMS, or an independent review entity acting under CMS' authority, with additional information related to prior prescription drug coverage in support of a request for reconsideration of a late enrollment penalty determination. While the statute expressly provides for this opportunity only with respect to an argument that proper notice was not given concerning whether existing coverage was creditable, we believe that the same rationale could apply to other arguments that the penalty should not apply (for example, an argument that the individual is eligible for a waiver of the penalty under a demonstration project). Finally, we would specify that a beneficiary would not have the right to further review of the reconsideration decision of CMS, or the independent review entity acting under CMS' authority. CMS would, however, have the discretion to reopen, review, and revise such a decision. 3. Medicare Prescription Drug Benefit Program Definitions These proposed clarifications to our policies associated with the Medicare Prescription Drug Benefit (also known as Medicare Part D) include refining our definitions related to what may be included in the drug costs Part D sponsors use as the basis for calculating beneficiary cost sharing, reporting drug costs to CMS for the purposes of reinsurance reconciliation and risk sharing, as well as submitting bids to CMS. We also propose a new definition for administrative costs in order to further clarify costs that must not be included in Part D drug costs. We also propose to create corollary definitions for drug cost reporting for purposes of the Retiree Drug Subsidy (RDS). We propose that the effective date of these changes be the effective date of a final rule with the exception of specific changes to the Part D definition of “negotiated prices”, “gross covered prescription drug costs”, and “allowable risk corridor costs” related to the use of pass-through versus lock-in prices, which we propose to be effective for coverage year 2010. We propose that the effective date of the RDS definitions be the effective date of a final rule, that is, for all plan years beginning after the effective date of a final rule. a. Subpart C—Benefits and Beneficiary Protections (Definitions) i. Incurred Costs CMS is proposing to amend the definition of “incurred costs” to reflect our current policy that certain nominal co-payments assessed by manufacturer Patient Assistance Programs
(PAPs)can be applied toward an enrollee's TrOOP balance or total drug spend (the accumulated total prices for covered Part D drugs paid by the plan or by or on behalf of the beneficiary). CMS allows PAPs to provide assistance for covered Part D drugs to Part D enrollees outside the Part D benefit. This means that payments made by PAPs do not count toward enrollees' TrOOP or total drug spend balances. However, if a PAP requires their enrollees—including those enrolled in a Part D plan—to pay a nominal copayment when they fill a prescription for a covered Part D drug for which the PAP provides assistance, such amounts would count toward TrOOP if the plan is notified of the copayment. As explained in Appendix C of Chapter 14 (Coordination of Benefits) of the Prescription Drug Benefit Manual, these nominal PAP copayment amounts, when paid by or on behalf of a Part D enrollee, are applicable to the enrollee's TrOOP and total drug spend balances, provided the enrollee submits appropriate documentation to their Part D plan. We are proposing to revise the definition of incurred costs to clearly indicate that these nominal PAP copayments are included in incurred costs. This revision to the definition of “incurred costs” in § 423.100 is consistent with the proposed changes to the definition of “gross covered prescription drug costs”, which has also been revised to ensure that these nominal PAP copayments are included in gross covered prescription drug costs and allowable reinsurance costs. ii. Negotiated Prices In the January 2005 final rule, CMS defined a number of terms related to drug prices and costs in order to identify the costs that should be used to calculate beneficiary cost sharing, to advance the beneficiary through the benefit, and to calculate final plan payments for reinsurance subsidies and risk sharing during payment reconciliation. For instance, under § 423.104(d)(2)(i), beneficiary cost sharing under the initial coverage limit is equal to 25 percent of “actual cost.” (70 FR 4535) “Actual cost” is defined in § 423.100 as “the negotiated price for a covered Part D drug when the drug is purchased at a network pharmacy, and the usual and customary price when a beneficiary purchases the drug at an out-of-network pharmacy consistent with § 423.124(a).” (70 FR 4533) And in § 423.100, the term “negotiated prices” is defined as “prices for covered Part D drugs that
(1)are available to beneficiaries at the point of sale at network pharmacies;
(2)are reduced by those discounts, direct or indirect subsidies, rebates, other price concessions, and direct or indirect remunerations that the Part D sponsor has elected to pass through to Part D enrollees at the point of sale; and
(3)includes any dispensing fees. (70 FR 4534) Since that time, we have received questions over what we meant in this last definition when we refer to prices for covered Part D drugs that are available to beneficiaries at the point of sale. These questions are particularly important because beneficiary cost sharing is a function of the negotiated price, either directly as in coinsurance percentages of negotiated price, or indirectly, as copayments are ultimately tied to actuarial equivalence requirements based on negotiated prices. That is, for instance, the higher the negotiated prices, the higher the fixed copayments must be to result in actuarial equivalence to 25 percent in the aggregate in the initial coverage phase. The “total drug spend” (the accumulated total prices for covered Part D drugs paid at the point of sale by the plan or by or on behalf of the beneficiary) also is a function of the negotiated price. Because the total drug spend is used to determine when the beneficiary advances through the deductible and the initial coverage phases of the Part D benefit, higher negotiated drug prices would cause the beneficiary to more quickly advance through those various phases. Accordingly, because higher negotiated prices would advance the beneficiary through the initial coverage phase more quickly, fewer prescriptions on average would be subsidized by the plan through the initial coverage period. Also, a beneficiary enrolled in basic prescription drug coverage (as defined in § 423.100) would reach the coverage gap more quickly, with the costs of covered Part D drugs purchased during the coverage gap phase financed entirely by the beneficiary. In addition, since beneficiaries must have access to the same negotiated prices during the coverage gap, the higher the negotiated prices, the higher the amounts paid by beneficiaries for drugs in the coverage gap may be. Similarly, higher negotiated prices would mean higher cost-sharing for beneficiaries who reach the catastrophic threshold. Because cost-sharing for the catastrophic phase of the benefit generally is based on 5 percent of the negotiated price, the higher the negotiated price, the higher the cost-sharing at the catastrophic level. For all these same reasons, higher negotiated prices would mean higher low-income cost sharing subsidies paid by the government. Under the low-income cost sharing subsidy, low-income subsidy eligible individuals pay reduced or no cost sharing for covered Part D drugs. The government subsidizes the cost sharing for these beneficiaries by reimbursing Part D sponsors for the difference between the cost sharing paid by other Part D beneficiaries and the cost sharing paid by low-income subsidy
(LIS)eligible individuals. Higher negotiated prices would result in higher cost sharing paid by other Part D beneficiaries and therefore, higher low-income cost sharing subsidies paid by the government to plan sponsors. Because higher negotiated prices (and therefore, higher total drug spend) will advance beneficiaries through the phases of the Part D benefit more quickly, a greater number of beneficiaries will reach the catastrophic phase of the benefit more quickly. In addition, higher negotiated prices generally will result in higher covered Part D drug costs during the catastrophic phase. As a result, the reinsurance subsidies paid by the government to Part D sponsors to reimburse 80 percent of the covered Part D drug costs in the catastrophic phase of the benefit will be higher. We believe that, in a competitive market, negotiated prices would be minimized when such prices are fully transparent to plan sponsors and beneficiaries. Consequently we strove to base our guidance on the principle of limiting drug costs to the price paid at the pharmacy (meaning any pharmacy, including mail-order pharmacies). In the preamble to the final rule we explained that drug costs include: Ingredient cost, dispensing fee, and sales tax (70 FR 4307). These three terms refer to specific fields on the automated prescription drug claim transaction that unambiguously indicate the amounts paid to the pharmacy by the payer of the claim. Therefore, by using these terms, CMS intended to refer to the price paid at the pharmacy and not the price paid by the sponsor to the PBM. Furthermore, the preamble states that “we assume that ingredient cost and dispensing fee reflect point of sale price concessions in accordance with purchase contracts between plans (or their agents, such as PBMs) and pharmacies * * *” (70 FR 4307), and that ingredient cost and dispensing fee reflect the drug price paid to the pharmacy and should reflect any point-of-sale price concessions from the pharmacy whether they are provided directly to the Part D sponsor or indirectly through a contracted PBM. Thus, we intended to define the term “negotiated prices” consistent with “pass-through” prices, an industry term for the prices negotiated with and paid to the pharmacy (either directly by the sponsor or indirectly through an intermediary contracting organization, such as a PBM on the sponsor's behalf). With “pass-through” prices, the price paid to the pharmacy is the price passed on to the beneficiary (and, in the case of LIS eligible individuals, to the government) at the point of sale. However, after publication of the final rule and issuance of clarifying subregulatory guidance in Spring 2006, CMS received comments that the notice and comment rulemaking had not made this point clearly, and that the regulation could be read to allow an alternative interpretation of the price paid at the point of sale. Specifically, these comments asserted that the “lock-in” pricing approach, a contract method by which a plan sponsor agrees to pay a PBM a set rate for a particular drug which may vary from the price that the PBM negotiates with each pharmacy, also met the definition of negotiated prices issued in the regulation. Under such pricing arrangements, the PBM consistently bills one “lock-in” price negotiated with the sponsor for a drug (often based on AWP), but may pay a variety of different prices to network pharmacies based on varying contractual terms. On any given drug purchase, the PBM may pay the pharmacy a higher or lower price than it will bill the plan sponsor. However, we assume that the prices billed to the plan sponsor are generally higher than the prices paid to pharmacies, resulting in an overall net profit to the PBM that is marketed as a “risk premium” earned for shielding the sponsor from price variability. We welcome comments on this assumption. Commenters argued that these stable prices negotiated between the sponsor and the PBM also met the definition of “negotiated prices” in the final rule. (We note that when the negotiated price under the plan is the lock-in price, if the pharmacy price is lower than the lock-in price, the pharmacy will still have to collect the higher lock-in price from the beneficiary during the deductible or coverage gap and transfer the excess amount to the PBM in some manner.) On the basis of that alternative interpretation, some Part D sponsor applicants who held network contracts through PBMs based on the lock-in pricing methodology had based their 2006 and 2007 bids on such prices and could not renegotiate such contracts easily. Consequently, on July 20, 2006, we issued guidance to Part D sponsors stating that, in order to minimize disruption to plan operations, for 2006 and 2007, sponsors could, at their option, base beneficiary cost-sharing not on the price ultimately charged by the pharmacy for the drug, but on the “lock-in” price, the price the sponsor paid a pharmacy benefit manager
(PBM)or other intermediary for the drug. We also stated our intent to issue a proposed rule that would require a single approach for calculating beneficiary cost sharing, based upon the price ultimately received by the pharmacy. Therefore, we are now proposing to amend our definition of negotiated prices. We previously proposed to amend this definition in the notice of proposed rule making, Policy and Technical Changes to the Medicare Prescription Drug Benefit (72 FR 29403-29423). However, we chose not to finalize this proposed definition in the final rule (73 FR 20486-20509) in order to further examine the impact of this proposal and provide the public with an additional opportunity to comment on this proposed definition. We have noted below, some of the impact concerns for which we would like to receive additional comments. We will consider the comments received on this definition from the previous proposed rule, as well as comments received on this proposed rule when determining whether to finalize this policy. In order to resolve the confusion caused by the Prescription Drug Benefit final rule, we are now proposing to amend the definition of “negotiated prices” (to be effective for Part D contract year 2010) to require that Part D sponsors base beneficiary cost sharing on the price ultimately received by the pharmacy or other dispensing provider. Specifically, we are proposing to revise § 423.100 so that the first part of the definition of “negotiated prices” would state that negotiated prices are prices that the Part D sponsor (or other intermediary contracting organization) and the network dispensing pharmacy or other network dispensing provider have negotiated as the amount the network dispensing pharmacy or other network dispensing provider will receive, in total, for a particular drug. The term “intermediary contracting organization” refers to organizations such as pharmacy benefit managers
(PBMs)that contract with plan sponsors to provide one or more of a variety of administrative functions on the sponsor's behalf, such as negotiating pharmacy contracts, negotiating rebates and other price concessions from manufacturers, and/or providing drug utilization management or benefit adjudication services. The term “intermediary contracting organization” encompasses any entity that contracts with a plan sponsor to pay pharmacies and other dispensers for Part D drugs provided to enrollees in the Part D sponsor's plan, regardless of whether the intermediary contracting organization negotiates pharmacy contracts on behalf of the plan sponsor or on its own behalf. Similarly, the term “intermediary contracting organization” encompasses any entity that negotiates rebates or other price concessions with manufacturers for Part D drugs provided to enrollees in the Part D sponsor's plan, regardless of whether the intermediary contracting organization negotiates the rebate agreements explicitly on behalf of the plan sponsor or on its own behalf. Our proposed definition excludes any differential between the price paid to the pharmacy and the price paid to the PBM or other intermediary contracting organization, and instead treats that differential (or “risk premium”) as an administrative cost paid to the PBM or intermediary contracting organization rather than a drug cost under Part D. We elaborate on our reasons for in effect proposing to require the reporting of “pass-through” versus “lock-in” prices for Part D drug costs further below, as well as solicit specific comments from multiple stakeholders to ensure we are aware of all of the ramifications of this proposed policy. We would also revise the definition of “negotiated prices” (to be effective upon the effective date of a final rule) to include prices for covered Part D drugs negotiated between the Part D sponsor (or its intermediary contracting organization) and other network dispensing providers. Part D sponsors can contract with providers other than a pharmacy to dispense covered Part D drugs, including them in their network. Therefore, we are amending the definition of negotiated prices to reflect the prices for covered Part D drugs that Part D sponsors (or their intermediary contracting organizations) negotiate with all their network dispensing providers. There are a number of reasons for our decided preference for drug costs at the point of sale to be based on the amount actually paid to the pharmacy or other dispensing provider (hereafter referred to as pass-through prices) as opposed to the amount paid to the PBM (hereafter referred to as lock-in prices). In addition to our original intentions discussed above, we believe that continuing to allow lock-in prices to be used for Part D drug cost calculations and reporting could have several undesirable results: 1. Continued and probably increased cost shifting from the government to beneficiaries in the form of higher beneficiary out-of-pocket costs. 2. Interference with market competition among Part D sponsors. 3. Beneficiary confusion over actual drug prices. 4. Difficulties for pharmacies in explaining drug prices to customers and managing cash transfers to Part D sponsors or their intermediary contracting organizations contracting. 5. Continued and possibly increased risk of government risk-sharing on amounts that reflect administrative costs, contrary to Congressional intent to exclude risk-sharing on administrative expenses. First, relative to pass-through prices, lock-in prices result in a cost shift from costs that would otherwise be fully paid by the government in the administrative cost portion of the basic Part D bid to costs that are paid in full or in part by the beneficiary. When the differential between the price paid to the pharmacy and the price paid to the PBM (sometimes referred to as “PBM spread” or “risk premium”) is treated as a drug cost, this amount is part of the cost basis on which beneficiary cost sharing is calculated. This is true whether the beneficiary is paying the total cost of the drug in the deductible or coverage gap in a basic plan, or whether cost sharing is structured as coinsurance or fixed copayments. Again, cost sharing for the basic portion of a Part D plan is based on the negotiated prices either directly, as a coinsurance percentage of the price of the drug, or indirectly, as a fixed copayment derived to result in actuarial equivalence in the aggregate to 25 percent of drug prices in the initial coverage phase or to approximately 5 percent in the catastrophic phase. Thus, when the PBM spread is added to the pharmacy's price in computing cost sharing, a beneficiary who utilizes drugs will generally pay more in cost sharing both during covered benefit intervals and during deductible and coverage gap periods for their drugs when the negotiated price is based on lock-in prices rather than pass-through prices, resulting in higher out-of-pocket beneficiary costs. On the other hand, when the PBM spread is included in the administrative costs component of a Part D sponsor's bid, as opposed to being treated as a drug cost, the plan sponsor's bid would be increased by these amounts. Consequently, all other things being equal, the sponsor's bid must be higher with pass-through prices than with lock-in prices. While a higher bid increases premiums for the beneficiary and direct subsidy costs for the government, because of the formulas for calculating premiums and federal subsidies, the beneficiary only pays about 25 percent of this increase and the government pays the other approximately 75 percent. Under the pass-through approach, therefore, for the vast majority of beneficiaries who utilize Part D drugs, total out-of-pocket costs, including both monthly Part D premiums and cost-sharing, are lower because
(1)cost sharing per script is lower,
(2)the lower drug costs advance the beneficiary through the benefit more slowly—allowing in general more scripts to be subsidized in the initial coverage phase, and
(3)increased premium costs are principally borne by the government. On net, beneficiaries who utilize their drug benefits pay less under our proposed approach with negotiated prices based on pass-through prices because out-of-pocket costs are 100% borne by the beneficiary, but the beneficiary only pays about 25% of the premium. We believe that the beneficiary is almost always better off paying the lowest possible point-of-sale price. Under the lock-in pricing approach, the lock-in prices that some plan sponsors pay to their PBMs are uniform for each drug across multiple network pharmacies. However, the pass-through prices paid to the pharmacy may differ across network pharmacies. Some plan sponsors may perceive value in the use of lock-in prices to define negotiated prices, so that beneficiaries may pay a uniform price across different network pharmacies. However, we believe that beneficiaries receive no value from paying more for drugs in return for always paying a uniform stable price. Therefore, we believe that beneficiaries who utilize their Part D benefits are almost always better off paying pass-through prices under our proposed approach. We would acknowledge that lower premiums at the expense of higher out-of-pocket costs would advantage some Part D beneficiaries who are non- or very low utilizers of the benefit. However, from a public policy perspective, lowering premiums at the expense of higher cost sharing for those individuals who most need the benefit dilutes the insurance principle. The drug purchases of those beneficiaries who utilize their Part D benefits are subsidized in part by those who do not need the benefit. Shifting costs from premiums to cost sharing would reduce the sharing of risk and drug costs across beneficiaries by shifting a greater percentage of the drug costs to those beneficiaries who use more prescription drugs and, therefore, pay more cost sharing. Those beneficiaries who use fewer prescription drugs are more likely to enroll in those plans with lower premiums and higher cost sharing (for example, plans that utilize lock-in prices). Less healthy beneficiaries who use more prescription drugs are more likely to enroll in those plans with higher premiums and lower cost sharing (for example, plans that use pass-through prices). This would distort the risk pool for those plans using pass-through prices and drive their costs up as those enrollees who use fewer prescription drugs disenroll from these plans as the premiums increase to reflect the increased percentage of high utilizers in the plan. It is important to create and maintain the most robust risk pool possible under the Medicare Part D to maintain program stability. In addition, as noted in the preamble to the final rule: “[a]s required under section 1860D-11(e)(2)(D)(i) of the Act and in § 423.272(b)(2), the structure of the benefit design (including cost sharing provisions and formulary design) must not be discriminatory; that is, it must not discourage enrollment by any Part D enrollee on the basis of health status * * *”. (70 FR 4297) We could argue that a business model and resulting benefit structure that by design shifts costs from the premium (where they would be paid by all) to cost sharing (where they are paid only by benefit utilizers) is per se discriminatory. That is, knowledgeable beneficiaries who seek to minimize their costs, who must utilize numerous prescription drugs due to their health status, and who use a tool such as the Medicare Prescription Drug Plan Finder, will determine that their costs are never minimized in a plan that bases their costs on lock-in prices—despite the lower premiums—and they will elect not to join that plan. Only non- or low utilizers of drug benefits might find that this plan design minimizes their costs. We believe that Congress instructed CMS to review Part D benefits in order to prohibit just this sort of systematically discriminatory benefit design. All other things being equal then, requiring that those amounts paid by sponsors to PBMs (or other intermediary contracting organizations) that exceed the amounts paid by PBMs (or other intermediary contracting organizations) to pharmacies be treated as administrative costs will increase the basic Part D bid for any plan sponsor that previously based its bid on lock-in prices, shifting the majority of the cost to the direct subsidy paid by the government. This increase in direct subsidy costs will be offset somewhat by other payment impacts on the government. Specifically, reinsurance payments will be lower because
(1)reinsurance payments are based on drug costs which generally are lower using pass-through prices, and
(2)fewer beneficiaries will reach catastrophic coverage due to being advanced through the earlier phases of the benefit more slowly. Similarly, the government's payments for low-income subsidy cost sharing are lower, as these subsidies are based on the negotiated price, which as previously explained is generally lower when based on pass-through prices. Thus, overall, a change from lock-in to pass-through prices will result in a cost shift from the beneficiaries who need the benefit most to the government—a result that, as we have argued above, is more consistent with the insurance principle. The second potential undesirable impact of lock-in prices being used for drug cost calculations and reporting under the Part D program is interference with market competition. Because the cost shift from the government to the beneficiary lowers the bid, it also causes the plan's bid to become relatively more competitive. In fact, utilizing lock-in prices would seem to provide a competitive advantage to plans relative to other comparable plans that use pass-through prices, since premium levels are tied to the relationship between the plan's bid and the national average bid amount. The lower the plan's bid, the lower the difference between the plan's bid and the national average bid amount, and therefore, the lower the plan's premium. Unlike sponsors who do not use PBMs or other intermediary contracting organizations and, therefore, must base their bids on pass-through prices, those using PBMs or other intermediary contracting organizations currently have the option of using either pass-through or lock-in prices as the basis for their bids. This greater flexibility may give the latter a competitive advantage over the former. For example, to the extent a sponsor believes a lower premium rather than lower cost-sharing makes its plan more marketable, a sponsor contracting with a PBM may decide to use lock-in prices in its bid in order to obtain a lower premium. In addition, a sponsor may use lock-in prices in its bid to increase the likelihood that its plan qualifies for auto-enrollment and facilitated enrollment of LIS eligible individuals. To qualify for auto-enrollment and facilitated enrollment, a plan's premium must be at or below the low-income premium subsidy amount. A sponsor that is trying to gain or retain enrollment of LIS eligible individuals may use lock-in prices to help ensure that its plan premium is below the low-income premium subsidy amount. Thus, CMS believes that allowing both pricing approaches creates an unlevel playing field among plan sponsors. We specifically solicit comments on the economic and public policy impacts of this differential and whether it does in fact create an undesirable unlevel playing field, as between Part D sponsors contracting with PBMs or other intermediary contracting organizations and those who do not. We also solicit comments on each of the potential undesirable results discussed above. In the discussion above we assumed that all other things were equal, and that the shift from one pricing methodology to the other only resulted in a shift in costs between the government and the beneficiary. That is, that overall program costs remained the same under either policy. However, arguments can be made that costs, both administrative as well as drug costs, would not remain the same under our proposed single approach. On the one hand, some proponents of the lock-in approach have expressed concerns that our proposal would increase drug costs over time by discouraging the risk premium inherent in the lock-in method. They assert that the resultant pressure for downward pricing from the Part D sponsor would create a disincentive for PBMs to enter into this type of payment arrangement with plan sponsors. They are concerned that the demise of the lock-in model would result in the PBMs' role being reduced to one of mere claims processing agents with less incentive to negotiate the lowest possible network pharmacy discounts. In contrast, they contend that the risk premium incentives inherent in the lock-in approach result in significantly lower drug costs for Part D sponsors than other contractual models, and that the loss of this model could potentially increase drug costs, bids, premiums, and Part D program costs. On the other hand, however, in response to the contention that the risk premium payment results in lower drug prices in the long run, we could argue that in a competitive market any potential increase in administrative fees (from transferring the spread to administrative costs) would be negotiated away in whole or in part with more perfect information in a fully transparent environment. For instance, our proposed changes do not prohibit Part D sponsors from contracting with PBMs for drug utilization management services and paying administrative incentive fees for reducing costs through such services. In a transparent environment, plans would be negotiating on lowest possible drug prices, as well as minimizing administrative costs, and these would be more clearly comparable among PBMs (or other intermediaries). It is not clear to us why PBMs would compete any less vigorously for the same level of profits included in administrative fees, or for the lowest possible network pharmacy negotiated prices in order to earn those fees. Therefore, we are more persuaded by the counterargument that the PBM spread is in fact an additional profit earned due to asymmetry in market information that might well be reduced with more transparency in pricing. Under these assumptions, leaving the additional costs in administrative costs would reduce bids, premiums, and total Part D program costs over time. Moreover, nothing in our proposed rule prohibits the payment of a risk premium to the PBM by the plan sponsor. Our proposed changes to the definition of negotiated prices do not interfere with the negotiations between Part D sponsors, pharmacy benefit managers, and pharmacies for covered Part D drugs. Rather, we propose that Part D sponsors would be required to use the price ultimately received by the pharmacy (or other dispensing provider) as the basis for calculating beneficiary cost sharing, total drug spend, and cost reporting to CMS. We do not require a Part D sponsor to use a particular pricing approach in its contracting agreements with PBMs. Part D sponsors may continue to use either the pass-through or lock-in pricing approach when contracting with a PBM—provided that beneficiary cost sharing, total drug spend, and the drug costs reported to us are based on the price ultimately received by the pharmacy. To the extent that Part D sponsors believe that the lock-in pricing contracting approach reduces their total costs, we expect that they will continue to use it when contracting with a PBM. We solicit comments on whether Part D sponsors and PBMs would use the lock-in pricing contracting approach in certain cases if the proposed policy were finalized. We solicit comments from plan sponsors, other industry contracting experts, benefit consultants, and market analysts on the impact of our proposed change on aggregate pricing exhibited between plans and PBMs, as well as on the prevalence of and trends in lock-in pricing arrangements between plan sponsors and PBMs. In particular, we are soliciting comments on whether lock-in pricing truly offers benefits to sponsors equal to the value of the risk premium, or whether the existence of the risk premium is in effect a higher price exacted from sponsors without the leverage to negotiate lower costs or due to asymmetry in market information as between PBMs and sponsors. We also solicit comments on whether stakeholders consider the proposed definition of “negotiated prices” to represent strictly a change in reporting requirements for Part D plan sponsors. We solicit comments on how contractual relationships and requirements may change between and among Part D plan sponsors and their first-tier, downstream, and related entities. Our third concern with lock-in pricing involves the confusion that may be caused for beneficiaries whenever they see the difference between the price paid to the pharmacy and the price charged to the plan sponsor. While we understand that the intent is for the beneficiary to see the same information on drug prices on the pharmacy's receipt, on the Medicare Prescription Drug Plan Finder, and on the plan's Explanation of Benefits (EOB), this does not always happen. Under lock-in pricing, the EOB which the beneficiary receives from the plan may currently reflect the price the plan sponsor pays its PBM (the lock-in price) instead of the price negotiated with the pharmacy. We understand that pharmacies generally do not customize receipts for payers, and those that print total amounts paid on their receipts will not always be able to alter those amounts to correspond to the prices the plan sponsor pays its PBM. Even for cases in which the pharmacy does not print out total amounts received on its receipt, the same issues may occur in the deductible or coverage gap when the patient pay amount may equal the lock-in price, which could be higher than the price paid to the pharmacy. Whenever the pharmacy receipt does display the pharmacy's price, the beneficiary may see the discrepancy in price between the receipt and the plan's EOB. Even when receipts display the plan's price, the beneficiary may see discrepancies between the price they pay and pharmacy advertised specials or prices offered to a friend and believe the price they paid was wrong. Beneficiaries may perceive these discrepancies in drug prices as fraud and place complaints or inquiries. Reviewing and addressing these types of inquiries serves to increase administrative costs for pharmacies, plan sponsors, and the government. Moreover, if pharmacies were to err and charge pass-through prices during the coverage gap instead of the lock-in prices, actual beneficiary true out-of-pocket (TrOOP) expenses might diverge from the amounts reported on the plan's EOB, possibly leading to an overstatement of TrOOP costs in plan
(PBM)claims payment systems. We solicit comments, particularly from beneficiary advocates, on the extent to which they are hearing of beneficiary concerns around such discrepancies. The fourth potential undesirable impact concerns difficulties that may be caused for pharmacies in explaining apparent price discrepancies to customers, as well as the additional administrative burden of managing the resulting cash transfers between the beneficiary and the PBM. If a beneficiary notices an apparent price discrepancy as described above, the beneficiary is likely to ask the pharmacy for an explanation. We believe the pharmacy must then expend scarce staff resources on explaining the discrepancy and managing the beneficiary's reaction. Moreover, whenever the additional amount that exceeds the price negotiated between the PBM and pharmacy has been collected from the beneficiary, the pharmacy must have in place and manage accounting processes to transfer the additional amounts to the PBM and support ongoing reconciliations. We solicit comments from both chain and independent pharmacies on the extent to which these or any other impacts from lock-in prices have been incurred. We are not aware of any advantages to pharmacies from lock-in prices. We have heard the argument that the proposed changes would have a disproportionately negative impact on small independent pharmacies. Under the lock-in pricing approach, Part D sponsors negotiate a single rate with their contracted PBMs and, therefore, are generally not aware of the different rates paid by the PBMs to each pharmacy. This argument suggests that under the revised definition of negotiated prices, Part D sponsors would be made aware of the different rates paid to each pharmacy, and, in particular, Part D sponsors would become aware of higher-cost pharmacy providers, which are generally small independent pharmacies that are unable to offer the more aggressive drug prices provided by retail chain pharmacies. This argument presupposes that in their efforts to reduce drug costs, Part D sponsors would then remove these higher-cost pharmacies from their pharmacy networks, leading to a significant impact on the financial viability of these pharmacies. We are not persuaded by this argument at this time. First, as discussed above, we believe that under the revised definition of negotiated prices Part D sponsors may still use either the pass-through or lock-in pricing approach in their contracts with PBMs if sponsors continue to place value on being shielded from price variations. Moreover, even under transparent pricing arrangements, we expect that Part D sponsors would continue to contract with small independent pharmacies in order to satisfy our pharmacy access standards as outlined in § 423.120. In order to meet these rigorous pharmacy access standards, Part D sponsors would have to continue to contract with many if not most of these independent pharmacies and include them in their pharmacy networks. Moreover, we expect that Part D sponsors likely will determine that the proportion of their utilization that comes through independent pharmacies with the leverage to negotiate significantly higher reimbursements is generally not sufficiently large to significantly affect aggregate drug costs. Therefore, we are unable to conclude at this time that these proposed changes would have any adverse effects on pharmacies, including small independent pharmacies, and we solicit comments from all pharmacies on this question. The final potential undesirable impact we attribute to lock-in prices is the continued, and possibly increased, risk of government risk-sharing on costs that may be better treated as administrative expenses. The payment of risk-sharing on those portions of “drug costs” under the lock-in methodology that are retained by the PBM or other intermediary appears contrary to Congressional intent. For both reinsurance and risk-sharing payments CMS is required to exclude “administrative costs” from the calculations. In accordance with § 1860D-15(b)(2) of the statute, and as codified at § 423.308, “allowable reinsurance costs” are defined as a subset of “gross covered prescription drug costs.” “Gross covered prescription drug costs” are defined as “ * * * the costs incurred under the plan, not including administrative costs, but including costs directly related to the dispensing of covered Part D drugs * * *” (§ 1860D-15(b)(3)). Similarly, definitions of “allowable risk corridor costs”, at § 1860D-15(e)(1)(B) of the statute and § 423.308 of the regulations, exclude administrative costs. We believe that any “risk premium” paid to the PBM to smooth actual drug expenses should be considered an administrative contracting cost, or like a drug utilization management program cost to the plan. Thus, in order to exclude those amounts from being included in the reinsurance and risk-sharing calculations, we believe CMS should treat these costs as administrative costs and not as drug costs. While there is no question that reinsurance costs to the government increase with lock-in prices (since per claim drug costs are higher and a greater number of beneficiaries will reach catastrophic coverage), it is possible that there would be no significant difference between the lock-in and pass-through prices with respect to government risk sharing *under certain constraints* . Very simply stated, risk sharing involves comparing the sum of drug costs anticipated in the plan sponsor's bid and paid prospectively through government and beneficiary monthly premiums (the “target amount”) to the drug costs actually incurred, with the government then paying or recouping a portion of the difference. As long as the drug costs reflected in the bid are calculated in precisely the same way as the drug costs submitted to CMS as allowable costs, the target amount and the allowable costs will rise together. However, if a plan were to submit bids based on one level of PBM spread, but then submit costs to CMS reflecting a higher level of spread, then the difference between prospective costs and incurred costs would be increased. In the long run we believe lack of transparency could allow plans to game risk sharing and include extra administrative costs in the allowable drug cost reporting. If this would happen, and the plans used lower drug costs in the bid but included additional administrative costs in the allowable costs submitted in reconciliation, then the government risk sharing costs would increase. We solicit comments on the issues identified above concerning government risk sharing on costs that may more appropriately be considered administrative expenses. b. Subpart G—Payments to Part D Plan Sponsors for Qualified Prescription Drug Coverage (Definitions and Terminology, § 423.308) i. Actually Paid (§ 423.308) In the April 2006 Call Letter, CMS stated that Part D sponsors must report 100 percent of the rebates and price concessions they receive, including the portion of manufacturer rebates retained by PBMs. In other words, in defining price concessions that must be netted from drug costs, CMS does not make a distinction between a price concession that is passed fully through to the plan sponsor by the PBM (or any other intermediary contracting organization) and a price concession that is partially passed on and partially retained by the PBM (or any other intermediary contracting organization). When a PBM retains rebate amounts associated with drugs being purchased for enrollees in a Part D plan with which the PBM contracts, this revenue permits the PBM to charge the Part D sponsor a lower amount in administrative fees and still make the same income on the transaction. When a rebate of x amount is paid to the PBM, the Part D sponsor benefits from that rebate whether it is passed on to the sponsor in its entirety, or it is available as revenue to the PBM. Thus, regardless of whether the PBM passes through 100% of rebates and the Part D sponsor in turn writes a check for 100% of administrative fees owed the PBM, or whether the PBM retains a portion of rebates and the Part D sponsor benefits from the fact that this revenue permits the PBM to charge a lower administrative fee for the transaction—the result is the same. The total amount of rebates received by the PBM for the Part D drugs dispensed under the Part D sponsor's contract must be reported as a price concession through DIR reporting to CMS. If we did not adopt this approach, a PBM and a Part D sponsor would be able to manipulate the amount reported in amounts actually paid simply by recasting administrative fees, which must be excluded, as rebates retained by the PBM that would not have to be reported as rebates to the PDP sponsor that benefits from the PBM's receipt of this revenue. Therefore, we are proposing to include language in the definition of “actually paid” that codifies and clarifies our previous guidance, and provides that direct or indirect remuneration includes discounts, chargebacks or rebates, cash discounts, free goods contingent on a purchase agreement, up-front payments, coupons, goods in kind, free or reduced-price services, grants, or other price concessions or similar benefits from manufacturers, pharmacies or similar entities obtained by an intermediary contracting organization with which the Part D sponsor has contracted for administrative services, regardless of whether the intermediary contracting organization retains all or a portion of the direct and indirect remuneration or passes the entire direct and indirect remuneration to the Part D sponsor. Similarly, we are clarifying that this definition of actually paid applies regardless of the terms of the contract between the plan sponsor and any intermediary contracting organization. We solicit comment on this proposed clarification. We believe that the above analysis has equal applicability in the Retiree Drug Subsidy
(RDS)context, when a qualified retiree prescription drug plan contracts with a PBM, and the PBM retains rebate amounts associated with drugs obtained for a qualifying covered retiree. Again, the qualified retiree prescription drug plan benefits from the fact that revenue attributable to drugs purchased for its retirees is available to the PBM, because the PBM would not need to charge the sponsor of the qualified retiree prescription drug plan as much in administrative fees to make the same revenue on the transaction. As in the case of a Part D sponsor, if rebate amounts retained by a PBM were not deducted from the qualified retiree prescription drug plan's costs, the plan and the PBM could ensure higher RDS payments simply by recasting administrative costs as retained rebates. Therefore, as discussed below, we are proposing to make similar amendments to the definitions in Subpart R that apply to the RDS program. ii. Administrative Costs (§ 423.308) The statute requires CMS to exclude administrative costs from the calculation of gross covered prescription drug costs and allowable risk corridor costs. However, administrative costs are not defined in either the statute or the January 28, 2005 final rule. Therefore, to explain this term and clarify which costs are included in administrative costs, we are proposing to add a definition for the term “administrative costs”. We previously proposed to add this definition in the notice of proposed rule making, Policy and Technical Changes to the Medicare Prescription Drug Benefit (72 FR 29403 through 29423). However, we chose not to finalize this proposed definition in order to further examine the impact of this proposal and provide the public with an additional opportunity to comment on this proposed definition. We will consider the comments received on this definition from the previous proposed rule, as well as comments received on this proposed rule when finalizing this rule. In this definition, we propose to define “administrative costs” as the Part D sponsor's costs other than those incurred to purchase or reimburse the purchase of Part D drugs under the Part D plan. Included in the definition of administrative costs are any costs incurred by Part D plans on drug claims that differ from the price charged by a dispensing entity for covered Part D drugs. As discussed above in the section on Negotiated Prices, any net profit (or “risk premium”) retained by a PBM that is added to the prices paid to pharmacies and billed to a Part D sponsor would be considered an administrative cost and not a drug cost. As discussed above, we believe this is because such amounts are more appropriately considered costs the plan chooses to incur to mitigate its market risk around the costs of drugs, rather than the cost of the drugs itself, and should be viewed as analogous to the cost of drug utilization management programs and similar services purchased from PBMs to manage drug costs. In order to create a level playing field around the treatment of all such related costs, we propose to clearly categorize this “net profit”, “risk premium”, or “PBM spread” as an administrative cost to the Part D plan sponsor. The proposed policy would also refine our interpretation of the statutory and regulatory definitions of “allowable reinsurance costs” and “allowable risk corridor costs,” which in both cases exclude any administrative costs of the sponsor. By statute, “allowable reinsurance costs” are a subset of “gross covered prescription drug costs,” and Congress specifically defined these gross costs as “not including administrative costs.” (See sections 1860D-15(b)(2) and 1860D-15(b)(3) of the Act.) Similarly, Congress defined “allowable risk corridor costs” as “not including administrative costs.” (See section 1860D-15(e)(1)(B) of the Act.) In the January 28, 2005 final rule, we adopted these definitions. (70 FR 4547.) As noted above, we interpret administrative costs to include any net profit (or loss) incurred by an intermediary contracting organization (for example, a pharmacy benefit manager (PBM)) as a result of lock-in pricing. Therefore, this net profit or loss must not be included in the reinsurance and risk corridor payments made by the government, as these payments exclude administrative fees. Thus, the Ingredient Cost, Dispensing Fee, Sales Tax, Gross Drug Cost below the Out of Pocket Threshold, and Gross Drug Cost above the Out of Pocket Threshold fields on Prescription Drug Event
(PDE)records submitted to CMS would need to reflect the final amount ultimately received by the pharmacy at the point of sale. We are aware of concerns that the proposed definition of administrative costs would indirectly prohibit the purchase of drugs from certain entities such as PBMs. In addition, it has been argued that any costs incurred to buy drugs should be considered drug costs regardless of the party from whom the drug is purchased. However, the proposed definition for administrative costs would not directly or indirectly require Part D sponsors to purchase drugs from dispensing providers only. Part D sponsors would continue to have the option to contract or purchase drugs from other entities such as PBMs. However, to the extent that the amounts paid to a PBM for administrative services provided to a Part D sponsor are included in the cost of the drug under the lock-in pricing approach, Part D sponsors would be required to report this spread amount as an administrative cost. These administrative costs would be excluded from the Part D sponsor's allowable reinsurance and allowable risk corridor costs as required by statute. The proposed definition of administrative cost does not include administrative fees or other remuneration that a PBM receives on behalf of a plan from pharmaceutical manufacturers or biotechnology companies. CMS considers these amounts price concessions which directly or indirectly reduce the Part D sponsor's costs under its Part D plan. Therefore, Part D sponsors would continue to report these administrative fees as DIR to ensure that they are excluded from allowable reinsurance costs and allowable risk corridor costs. Again, this same analysis applies in the RDS context to amounts a PBM retains in connection with price concessions that reduce the qualified retiree prescription drug plan's drug costs. iii. Gross Covered Prescription Drug Costs and Allowable Risk Corridor Costs (§ 423.308) Part D sponsors are required to report drug costs to CMS for the purposes of reconciliation and risk sharing. We are required by statute to calculate reinsurance payments using “allowable reinsurance costs,” a subset of “gross covered prescription drug costs,” which Congress specifically defined as “not including administrative costs.” (See sections 1860D-15(b)(2) and 1860D-15(b)(3)of the Act). Risk sharing payments are calculated using “allowable risk corridor costs,” which are also defined as “not including administrative costs.” (See section 1860D-15(e)(1)(B) of the Act.) There have been several questions regarding the appropriate drug costs to report, particularly when a Part D sponsor has contracted with a PBM. The January 28, 2005 final rule defines “gross covered prescription drug costs” as “those actually paid costs incurred under a Part D plan, excluding administrative costs * * * [equal to:]
(1)All reimbursement paid by a Part D sponsor to a pharmacy (or other intermediary) * * * plus
(2)All amounts paid under the Part D plan by or on behalf of an enrollee (such as the deductible, coinsurance, cost sharing, or amounts between the initial coverage limit and the out-of-pocket threshold) in order to obtain drugs covered under the Part D plan.” (70 FR 4547) The January 28, 2005 final rule definition of “gross covered prescription drug costs” specifically recognizes that reimbursement may be paid by a Part D sponsor “to a pharmacy (or other intermediary).” (70 FR 4547) Many interpreted the term “intermediary” to mean PBM (rather than an agent of the pharmacy or other dispensing provider). Using this definition, many plan sponsors reported as gross covered prescription drug costs the prices they negotiated with their PBMs, rather than the prices that were agreed upon as the amount to be received by the pharmacies. We propose rectifying these conflicting definitions to require the plan sponsor to include the net profit or loss retained or incurred by a PBM as part of lock-in pricing to be part of the administrative costs of the plan sponsor. This would require the amount ultimately received by the pharmacy (minus any other point-of-sale price concessions) to be used in calculating cost sharing for plan years 2010 and beyond. We previously proposed to amend this definition in the notice of proposed rule making, Policy and Technical Changes to the Medicare Prescription Drug Benefit (72 FR 29403-29423). However, we chose not to finalize this proposed definition in the final rule (73 FR 20486-20509) in order to further examine the impact of this proposal and provide the public with an additional opportunity to comment on this proposed definition. We will consider the comments received on this definition from the previous proposed rule, as well as comments received on this proposed rule when determining whether to finalize this policy. Specifically, we are proposing to amend the definition of “gross covered prescription drug costs” to eliminate the parenthetical “or other intermediary” to require that all plan sponsors report the amount ultimately received by the pharmacy or other dispensing provider. We propose that the amount ultimately received by the pharmacy or other dispensing provider (whether directly or indirectly) for the particular drug will be the basis for accumulating gross covered drug costs and reporting drug costs on the Prescription Drug Event
(PDE)records. Similarly, we propose clarifying our definition of “allowable risk corridor costs” so that it is clear that these costs are only based upon the amounts received directly by the pharmacy or other dispensing provider. This is because we would consider any net profit (or loss) earned by a PBM or other entity negotiating contracts with pharmacies to constitute an administrative cost, and therefore, to be exempt from the definition of allowable risk corridor costs, as well as gross covered prescription drug costs. Thus, for example, if a Part D sponsor pays a PBM a certain amount for a particular drug, and then the PBM negotiates a different price with the pharmacy, any differential retained or lost by the PBM would be considered an administrative cost, and could not be reported as part of drug costs. As discussed above in the section on Negotiated Prices, the net profit or loss (or “risk premium”) retained by a PBM that is added to the prices paid to pharmacies and billed to a Part D sponsor under the lock-in pricing approach would be considered an administrative cost. As argued above, such amounts are more appropriately considered costs that the plan chooses to incur to mitigate its market risk around the costs of drugs, rather than the cost of the drugs itself, and should be viewed as analogous to the cost of drug utilization management programs and similar services purchased from PBMs to manage drug costs. In order to create a level playing field around the treatment of all such related costs, we propose to clearly categorize this “profit”, “risk premium”, or “PBM spread” as an administrative cost to the Part D plan sponsor and to explicitly disallow it from gross covered prescription drug costs, allowable reinsurance costs (a subset of gross covered prescription drug costs), and allowable risk corridor costs. We, therefore, propose revising the definitions of “gross covered prescription drug costs” and “allowable risk corridor costs” to establish that the amount received by the dispensing pharmacy or other dispensing provider (whether directly or through an intermediary contracting organization) is the basis for drug cost that must be reported to CMS, and not the amount paid by the Part D sponsor to the PBM. Accordingly, we are revising § 423.308 to incorporate these changes. We are aware of concerns that these proposed changes to the definitions of gross covered drug costs and allowable risk corridor costs may require Part D sponsors to depend heavily on information traditionally held exclusively by PBMs. For the sponsor's convenience, or for other reasons, such as to protect the privacy of beneficiary personal health information data, a Part D sponsor's contractor may submit drug cost data on the Part D sponsor's behalf to CMS directly rather than through the Part D sponsor. Therefore, some have argued, the Part D sponsor cannot attest to the validity of drug cost data it does not see. However, because we contract with Part D sponsors for the provision of the Medicare prescription drug benefit, Part D sponsors, and not their subcontractors, are ultimately responsible for the quality of data submitted to us. Part D sponsors that choose to contract with a PBM or any other third party administrator, therefore, must take reasonable steps to ensure that the data submitted to us on their behalf is accurate and timely. For example, the sponsor may engage an independent auditor to audit the data prior to its submission to us. We also propose amending the definition of “gross covered prescription drug costs” and “allowable risk corridor costs” to ensure that when entities other than pharmacies dispense Part D drugs and receive payment for Part D drugs, these expenditures also are reflected in gross covered prescription drug costs and allowable reinsurance costs, as well as allowable risk corridor costs. For instance, reimbursement for a vaccine that must be administered in a physician's office and reimbursement made to a third party payer in accordance with our coordination of benefits
(COB)requirements are both legitimate drug costs that have been incurred through the payments indicated. In addition, in accordance with § 423.464, the Part D sponsor must coordinate benefits with other Part D plans as the result of any reconciliation process developed by CMS under § 423.464, such as when another Part D plan mistakenly paid for a prescription drug on the beneficiary's behalf based on an erroneous belief that the beneficiary was actually enrolled in its plan. In these cases, when the enrollment error is corrected, the beneficiary's true plan generally will reconcile payments with the original payer. The drug costs paid by Part D plans (as well as by the beneficiary) under these reconciliation processes reflect drug costs incurred by the plan's enrollees that a payer other than the correct Part D plan of record paid as primary. As drug costs paid for Part D covered drugs under Part D plans, these costs are included in the calculations of reinsurance costs and risk corridor costs. Therefore, we have amended the definition of “gross covered prescription drug costs” and “allowable risk corridor costs” in § 423.308 to include all these drug costs. We also propose amending the definition of “gross covered prescription drug costs” to ensure that when a beneficiary is responsible for 100 percent of the cost for a covered Part D drug (as in any applicable deductible or coverage gap of a basic plan), and the beneficiary obtains that covered Part D drug at a network pharmacy for a price below the plan's negotiated price, the beneficiary's out-of-pocket costs that are considered “incurred costs” for covered Part D drugs count toward both TrOOP and total drug spending. This is consistent with guidance released via Q&A 7944 (issued May 9, 2006 *http://questions.cms.hhs.gov/cgi-bin/cmshhs.cfg/php/enduser/std_alp.php?p_sid=gIVVcxhi.* ) For example, when an enrollee is in an applicable coverage gap or deductible phase of the Part D benefit, the enrollee may be able to obtain a better cash price for a covered Part D drug at a network pharmacy than the plan offers via its negotiated price. The enrollee may take advantage of a special cash price or discount being offered to all pharmacy customers for the covered Part D drug or, alternatively, use a discount card. In such cases, the enrollee purchases a covered Part D drug without using the membership card for his or her Part D plan. If that purchase price is lower than the Part D plan's negotiated price, it will count toward TrOOP and total drug spend balances, provided the Part D plan finds out about the purchase. When the enrollee chooses not to use his/her membership card at a network pharmacy, that enrollee must take responsibility for submitting the appropriate documentation to the enrollee's Part D plan, consistent with plan-established processes and instructions for submitting that information, in order to have that amount aggregated to the beneficiary's TrOOP and total drug spend balances. We are aware of concerns that it is overly burdensome to require beneficiaries to submit claims for these reduced price purchases. However, we cannot require in-network pharmacies to submit these claims to Part D sponsors electronically, because at this time the HIPAA standard for claims submission does not accommodate the electronic transmission of this claim information by network pharmacies. To the extent that a future revision of the HIPAA standard does accommodate such transactions, we would support minimizing the submission of paper claims by beneficiaries. The applicability of beneficiary out-of-pocket expenditures made outside the Part D benefit to TrOOP and total drug spend also extends to any nominal copayments assessed by manufacturer patient assistance programs
(PAPs)that provide assistance with covered Part D drug costs to Part D enrollees outside the Part D benefit. Consistent with guidance provided via Q&A 7942 ( *http://questions.cms.hhs.gov/cgi-bin/cmshhs.cfg/php/enduser/std_alp.php?p_sid=gIVVcxhi* ), providing assistance with covered Part D drug costs to Part D enrollees outside the Part D benefit does not preclude a PAP sponsor from requiring its enrollees (including those enrolled in a Part D plan) from paying a nominal copayment when they fill a prescription for a covered Part D drug for which they provide assistance. We note that any copayments assessed by PAPs operating outside the Part D benefit should be nominal, since only nominal beneficiary cost-sharing is consistent with the concept of operating outside Part D. Moreover, given that copayments are typically assessed for purposes of minimizing drug over-utilization, the assessment of anything but nominal cost-sharing by PAPs is seemingly inconsistent with the mission of a charitable organization structured to provide assistance with prescription drug costs to low-income patients. Although PAP payments made for covered Part D drugs outside the Part D benefit do not count toward enrollees' TrOOP or total drug spend balances, nominal PAP copayment amounts paid by affected Part D enrollees can be applied to their TrOOP and total drug spend balances, provided the enrollees submit the appropriate documentation to their plan consistent with plan-established processes and instructions for submitting the information. We are proposing to revise the definition of “gross covered prescription drug costs”, as well as the definition of “incurred costs” in § 423.100, to include these drug costs and to reflect this sub-regulatory guidance. We also note that § 423.308 includes a definition of the term “target” amount. Due to a technical formatting error, this definition appears to be the second paragraph of the definition of gross covered prescription drug costs. To clarify that the definition of “target amount” is not part or a component of the definition of gross covered prescription drug costs, but is a separate definition of a different term, we are proposing to revise the current discussion of “target amount” and are providing an amendatory instruction to add the definition in § 423.308. We are proposing technical edits to this definition to ensure that the structure of the definition is similar to that of other definitions in this section. We are proposing no substantive changes to the definition. c. Subpart R: Payments to Sponsors of Retiree Prescription Drug Programs (Definitions, § 423.882) Section 423.882 codifies existing guidance. Given the similarities between the statutory definitions of “gross covered prescription drug costs” under section 1860D-15(b)(3) of the Act and “gross covered retiree plan-related prescription drug costs” under section 1860D-22(a)(3)(C)(ii) of the Act, we have consistently stated our intent to determine gross covered retiree plan-related prescription drug costs in a manner corresponding to our determination of gross covered prescription drug costs. Additionally, given the similarities between the statutory definitions of “allowable reinsurance costs” under section 1860D-15(b)(2) of the Act and “allowable retiree costs” under section 1860D-22(a)(3)(C)(i) of the Act, we determine allowable retiree costs in a manner parallel to how we determine allowable reinsurance costs. For example, for terminology not specifically defined under § 423.882, we generally utilize the relevant Part D definitions to the extent that they are consistent with the statutory provisions under section 1860D-22 of the Act. In addition, our RDS guidance related to the calculation of gross covered retiree plan-related prescription drug costs (or “gross retiree costs”) and allowable retiree costs generally corresponds with the Part D guidance on the calculation of gross covered prescription drug costs and allowable reinsurance costs. In order to ensure continued consistency between the RDS program and Part D, and because, as noted above, we believe the same policy arguments in favor of the Part D definitions apply to similar arrangements under the RDS program, we believe that the regulatory definitions under § 423.882 applicable to the RDS program should mirror the corresponding Part D definitions under § 423.100 and § 423.308. Accordingly, we propose to make the following additions and revisions to § 423.882 to be consistent with the corresponding existing and proposed definitions under § 423.100 and § 423.308. The proposed definitions under § 423.882 include codification of existing CMS guidance. • *Actually Paid:* We propose to add this definition to mirror the proposed revised definition under § 423.308, with the exception of technical changes and clarifications to reflect its application to the RDS program. Specifically, we propose to define actually paid to mean that the costs must be actually incurred by the qualified retiree prescription drug plan (and/or the qualifying covered retiree) and must be net of any direct or indirect remuneration from any source (including manufacturers, pharmacies, qualifying covered retirees, or any other person) that would serve to decrease the costs incurred under the qualified retiree prescription drug plan. Similarly, we are also proposing to include language in this definition that provides that direct or indirect remuneration includes discounts, chargebacks or rebates, cash discounts, free goods contingent on a purchase agreement, up-front payments, coupons, goods in kind, free or reduced-price services, grants, or other price concessions or similar benefits from manufacturers, pharmacies or similar entities obtained by an intermediary contracting organization with which the sponsor of the qualified retiree prescription drug plan has contracted for administrative services, regardless of whether the intermediary contracting organization retains all or a portion of the direct and indirect remuneration or passes the entire direct and indirect remuneration to the sponsor of the qualified retiree prescription drug plan. Similarly, we are clarifying that this definition of actually paid applies regardless of the terms of the contract between the sponsor of the qualified retiree prescription drug plan and any intermediary contracting organization. • *Administrative costs:* We propose to add this definition to mirror the proposed revised definition under § 423.308 with the exception of minimal changes to reflect the RDS terminology. Specifically, we propose to define administrative costs to mean costs incurred by a qualified retiree prescription drug plan that are not drug costs incurred to purchase or reimburse the purchase of Part D drugs and that differ from the amount paid by or on behalf of the plan to a pharmacy or other entity that is the final dispenser of the drug. Similarly, we are proposing to include language in this definition that any profit or loss retained by the intermediary contracting organization (through discounts, rebates, or other direct or indirect price concessions) when negotiating prices with dispensing entities is considered an administrative cost. • *Allowable Retiree Costs:* We propose to make changes to the existing definition to mirror the relevant portions of the existing definition of “allowable reinsurance costs” under § 423.308. Specifically, we propose to revise the definition of allowable retiree costs under § 423.882 by clarifying that allowable retiree costs are the subset of gross covered retiree plan-related prescription drug costs actually paid by the qualified retiree prescription drug plan or by or on behalf of a qualifying covered retiree. • *Gross covered retiree plan-related prescription drug costs:* We propose to revise the existing definition of “gross covered retiree plan-related prescription drug costs” (or “gross retiree costs”) to mirror the proposed definition of “gross covered prescription drug costs” under § 423.308, with the exception of minimal changes to reflect the RDS terminology. Specifically, we propose to revise our definition of gross retiree costs to clarify that these costs equate to the sum of the negotiated prices (as defined in the proposed definition) actually paid by the qualified retiree prescription drug plan (and/or qualifying covered retirees) and received by the dispensing pharmacy (or other dispensing entity), or received by other entities pursuant to the plan's coordination of benefits
(COB)activities. As with our existing definition of gross retiree costs, our proposed definition would exclude administrative costs from gross retiree costs. • *Negotiated Prices:* We propose to add this definition to mirror the proposed definition of negotiated prices under § 423.100 with the exception of minimal changes to reflect RDS terminology. Specifically, we propose to define negotiated prices for Part D drugs as the prices that the qualified retiree prescription drug plan (or other intermediary contracting organization) and the network dispensing pharmacy or other network dispensing provider have negotiated as the amount such network entity will receive, in total, for a particular drug, net of discounts, direct or indirect subsidies, rebates, other price concessions, and direct or indirect remuneration that the qualified retiree prescription drug plan has elected to pass through to qualifying covered retirees at the point of sale. Similarly, we are proposing that negotiated prices include any dispensing fees. Under these proposed definitions, payments made to RDS plan sponsors of qualified retiree prescription drug plans (or “RDS sponsors”) would be based upon “pass-through” prices and not “lock-in” prices that the RDS plan sponsor pays to a PBM or other intermediary contracting organization. We elaborate on our reasons for requiring “pass-through” versus “lock-in” prices for RDS plan drug costs further below, as well as solicit specific comments from stakeholders to ensure we are aware of all of the ramifications of this proposed policy. The “pass through” vs. “lock in” approach is being proposed for RDS plan sponsors for many of the same policy considerations that, as discussed in section II.B.4 of this proposed rule, underlie our proposed modifications to the Part D definitions of “negotiated prices,” “administrative costs,” “allowable risk corridor costs,” and “gross prescription drug costs” under § 423.100 and § 423.308. Specifically, the RDS payment is calculated based on allowable retiree costs, which in turn is a subset of gross retiree costs. (See sections 1860D-22(a)(3)(A),(C)(i), and (C)(ii) of the Act.) The statute requires CMS to exclude administrative costs from the calculation of gross covered retiree plan-related prescription drug costs and subsidizing these costs would therefore be contrary to Congressional intent. (See section 1860D-22(a)(3)(C)(ii) of the Act.) As explained in section II.B.3.a.ii of this proposed rule, discussing the proposed Part D definition of Negotiated Prices, we believe any net profit (or “risk premium”) retained by a PBM that is added to the prices paid to pharmacies and billed to a Part D sponsor should be considered an administrative cost and not a drug cost. This same principle equally applies to the RDS program. Because we believe any net profit or risk premium retained by a PBM or similar intermediary contracting organization should be considered administrative costs and not drugs costs, we believe including these costs in gross retiree costs and allowable retiree costs would be contrary to Congressional intent that the RDS payment not subsidize an RDS sponsor's administrative costs. To ensure that these amounts are excluded from gross and allowable retiree costs, we, therefore, propose to define administrative costs as including any profit or loss retained by an intermediary contracting organization contracting with an RDS sponsor that differs from the amount paid to a pharmacy or other entity that is the final dispenser for drugs dispensed to qualifying covered retirees. We solicit comments on all proposed definitions discussed above. We note that our proposed definition of administrative costs would not directly or indirectly require RDS plan sponsors to purchase drugs from dispensing providers only, and RDS plan sponsors would continue to have the option to contract or purchase drugs from other entities such as PBMs. However, to the extent that the amounts paid to a PBM or similar intermediary contracting organization for administrative services provided to a RDS plan sponsor are included in the cost of the drug under the lock-in pricing approach, RDS plan sponsors would be required to treat this spread amount as an administrative cost and these administrative costs would be excluded from the RDS plan sponsor's allowable retiree costs. Our proposal would not require an RDS plan sponsor to use a particular pricing approach in its contracting agreements with PBMs. RDS plan sponsors may continue to use either the pass-through or lock-in pricing approach when contracting with a PBM—provided that drug costs reported to us are based on the price ultimately received by the pharmacy. There may be concerns that these proposed changes may require RDS plan sponsors to depend heavily on information traditionally held exclusively by PBMs. To protect the privacy of beneficiary personal health information data, an RDS sponsor's PBM or other intermediary contracting organization may submit drug cost data on the RDS sponsor's behalf to CMS directly rather than through the RDS sponsor. However, RDS plan sponsors, and not the intermediary contracting organizations, are ultimately responsible for the data submitted to us, and those that choose to contract with a PBM or other third party to submit data to CMS, therefore, must take reasonable steps to ensure that the data submitted to us on their behalf is accurate and timely. 4. Limiting Copayments to a Part D Plan's Negotiated Price (§ 423.104) Section 1860D-2(d)(1) of the Act requires Part D sponsors to offer their enrollees access to negotiated prices used for payment for covered Part D drugs. In previous operational guidance, Part D sponsors were advised that it was optional when administering a Part D plan's benefit to apply either a copayment (if the sponsor elected to charge a flat copayment in lieu of coinsurance) or the actual negotiated price of the drug when that amount was lower than the copayment as outlined in the plan benefit package. Although we expected that very few Part D sponsors would choose to impose a cost sharing charge higher than the negotiated price of the drug, we allowed the option consistent with commercial practices. In practice, CMS found that the majority of Part D sponsors administer the benefit in such a way that the lesser of a cost sharing charge or the negotiated price of the drug is applied to the beneficiary at the point of sale. Based on our experience in implementing the benefit, we believe that a policy where the plan sponsor charges the beneficiary the lesser of the cost sharing amount or the negotiated prices is more consistent with the intent of section 1860D-2(d) of the Act. Accordingly, we propose to revise our policy so that, for example, a beneficiary who is subject to a $5 copayment during the coverage gap cannot be required to pay more than the negotiated price of the covered Part D drug, if the negotiated price is less than $5. Specifically, we propose to revise the requirements related to qualified prescription drug coverage at § 423.104(g) to make clear that Part D sponsors must provide enrollees with access to, or make available at the point-of-sale, its negotiated prices of covered Part D drugs when the covered Part D drugs' cost-share is more than the Part D sponsor's negotiated price. In other words, if the negotiated price for a covered Part D drug under a Part D sponsor's benefit package is less than the applicable cost-sharing before the application of any deductible, before any initial coverage limit, before the annual out-of-pocket threshold, and after the annual out-of-pocket threshold. 5. Timeline for Providing Written Explanation of Plan Benefits (§ 423.128) In accordance with the requirements of section 1860D-4(a)(4) of the Act, § 423.128(e) of our final rule implementing the provisions of the Part D program (which appeared in the **Federal Register** on January 28, 2005, and the provisions of which became effective March 22, 2005), requires Part D sponsors to furnish to enrollees who receive covered Part D drugs an explanation of benefits
(EOB)when prescription drug benefits are provided. As articulated in the preamble to our January 2005 final rule, our intent was to ensure that an EOB was provided to Part D enrollees at least monthly if they used their prescription drug benefits in a given month. Section 423.128(e)(6) specifically requires that an EOB be provided “ *during* any month when prescription drug benefits are provided * * *.”. This was an inadvertent error given that, operationally, it is not feasible for Part D sponsors to mail their members an EOB during the same month in which they used their prescription drug benefits. Sponsors must build into their EOB mailing cycles sufficient time to not only process each member's EOB, but also to produce and mail an EOB to each member with activity in a given month. Since the implementation of the Part D program in January 2006, it has become clear that a more reasonable timeframe for the provision of an EOB is warranted given the operational impossibility of providing an EOB for a month in which a member used his or her benefits during that same month. We therefore propose a revision to § 423.128(e)(6) to require sponsors to provide an EOB no later than the end of the month following the month in which an enrollee uses his or her Part D benefits. We believe that our proposed revision to § 423.128(e)(6) strikes a reasonable balance between Part D sponsor production constraints and the timely provision of claims information to Part D enrollees. 6. Low-Income Subsidy Provisions a. Low-Income Cost-Sharing and Payment Adjustments for Qualified Prescription Drug Coverage (§ 423.329) CMS currently makes prospective payments to Part D plan sponsors of the low-income cost sharing subsidy
(LICS)based solely on estimates provided as part of the annual bidding process. When LICS estimates are too high, excessive prospective payments are made that (under our current process) are not recovered until the year end reconciliation. In its report “Medicare Part D Sponsors: Estimated Reconciliation Amounts for 2006,” released October 2007, the HHS Office of the Inspector General recommended that CMS explore other payment methodologies to recoup excessive LICS payments earlier. Section 1860D-14(c)(1)(C) of the Act, when providing for administration of the subsidy program, gives the Secretary flexibility in determining a process for payment of the LICS subsidies as long as plan sponsors are reimbursed “periodically and on a timely basis.” The Part D program regulations at 42 CFR 423.329(d)(2) state that payments of the LICS subsidy under this section are based on a method that CMS determines. However, in paragraph (d)(2)(i) we also stated that LICS interim payments are to be made based on the low-income cost-sharing assumptions submitted with plan bids under § 423.265(d)(2)(iv) and negotiated and approved under § 423.272. The language of § 423.329(d)(2)(i) regarding interim payments of the LICS subsidies has proven overly restrictive and has had the unintended effect of requiring CMS to make payments to Part D plan sponsors that are subsequently determined to have been significantly different from their actual costs, and which will not be recovered until payment reconciliation is completed. In contrast, the regulation governing interim payment of Part D reinsurance affords greater flexibility to CMS to determine the most appropriate interim payment methodology. The regulation at § 423.329(c)(2)(i) states that, “CMS establishes a payment method by which payments of [reinsurance] are made on a monthly basis during the year, based on either estimated or incurred allowable reinsurance costs.” Therefore, we propose to add to the end of § 423.329(d)(2)(i) the following qualifying statement: “or by an alternative method that CMS determines.” This proposed revision would afford CMS additional flexibility to make mid-year LICS payment adjustments or other modifications to the LICS interim payment methodology, as appropriate. b. Lesser of Policy for Low-Income Subsidy Individuals (§ 423.782) Section 1860D-14 of the Act establishes the low-income subsidy program available to Part D sponsors to provide low-income individuals assistance with their Part D plan cost-sharing amounts and premiums. The amount of a Part D sponsor's low-income cost-sharing subsidy is based upon the difference between the amount the non-subsidized beneficiary pays for his/her Part D covered drug under the plan's benefit package and the maximum cost-sharing amounts established in statute at section 1860D-14(a) of the Act. For calendar year 2008, full subsidy eligible individuals (as defined in the current regulation at 42 CFR 423.773(b)) are not subject to any deductible and cannot be charged cost sharing above the maximum cost sharing amounts of $1.05/$2.25 for generics and preferred multi-source brand name drugs; and $3.10/$5.60 for other brand name drugs in 2008. Other low-income subsidy eligible individuals, as defined at 42 CFR 423.780(d), cannot be charged more than $56 towards a Part D sponsor's deductible, and cannot be charged more per prescription than an amount equal to 15 percent coinsurance. When we originally drafted the regulations, we assumed that the Part D sponsor benefit packages would routinely result in higher cost sharing amounts for non-subsidized beneficiaries than the maximum low-income subsidy deductible and cost sharing amounts. However, when Part D sponsors offer benefit packages that already provide beneficiaries with a deductible and cost sharing less than the low-income deductible and cost sharing maximum amounts established in statute (such as for zero dollar generics), this turns out not to always be the case. There are also instances when the Part D sponsor's negotiated prices used for payment for covered Part D drugs are less than the low-income cost sharing amounts. In these cases, our operational guidance (Prescription Drug Event or PDE training guide *http://www.medicaretraining.net/federalemployees/ParticipantGuide.pdf* ) has instructed that Part D sponsors charge low-income beneficiaries the lesser of
(1)its plan benefit package's prescribed cost-sharing,
(2)the sponsor's negotiated rate for the drug, or
(3)the LIS cost sharing amount established in statute. If the Part D sponsor's plan deductible was either less than the maximum low-income subsidy deductible amount or zero, the beneficiary should not be charged more than the plan's actual deductible. The basis of our PDE guidance is found both in regulation and in statute. Section 1860D-14(a) of the Act provides that a beneficiary is eligible for a “ *reduction* in the annual deductible” and “ *reduction* in cost-sharing [above or below] the out-of-pocket threshold.” We believe the statute does not require that the low-income subsidy beneficiary be charged the statutorily-defined cost-sharing amounts if the approved cost sharing for a specific drug under a plan is less than that amount. Nor does the statute require that the low-income subsidy beneficiary be subject to a defined deductible when a Part D sponsor's plan benefit structure does not include a deductible. Thus, our previously issued guidance is consistent with the statutory parameters outlining the reductions in beneficiary out-of-pocket cost sharing amounts. The statute at 1860D-2(d)(1) of the Act also requires Part D sponsors to offer their enrollees access to negotiated prices used for payment for covered Part D drugs. We believe a Part D sponsor that imposes the statutory low-income cost sharing amounts on low-income subsidy beneficiaries when the PDP sponsor's negotiated prices are less than the low-income cost sharing amounts, violates 1860D-2(d) of the Act with regard to an enrollee's access to negotiated drug prices. Furthermore, our current regulations at 42 CFR 423.104(b) sets forth the requirement that Part D sponsors must offer the same drug plan to all Part D eligible beneficiaries residing in their plan service area. We commonly refer to this section of the regulation as the uniform benefit rule. This section prohibits Part D sponsors from varying plan benefits to beneficiaries in a service region and further supports the policy that low-income subsidy beneficiaries not be charged more than what they, or other non-LIS beneficiaries would be charged under the Part D sponsor's plan benefit package. For an extensive discussion of the statutory basis for 42 CFR 423.104(b), see 70 FR 4245 of the preamble to the final Medicare Prescription Drug Benefit Rule published January 28, 2005. To ensure low-income subsidy eligible beneficiaries are not harmed when the statutory low-income subsidy cost-sharing amounts are in excess of cost-sharing imposed under their plan's benefit package, we propose to codify our existing guidance in regulation. We propose adding a new paragraph
(c)to § 423.782 which would clarify that the cost-sharing subsidy under § 423.782(a) and
(b)is not available when an individual's out-of-pocket costs, under his or her Part D sponsor's plan benefit package, are less than the amounts described in § 423.782(a) and (b). c. Using Best Available Evidence to Determine Low-Income Subsidy Eligibility Status (§§ 423.772, 423.800) Section 1860D-14(a)(3)(B)(v) of the Act requires the Secretary to treat Part D eligible individuals who are full-benefit dual eligible individuals (as defined under 1935(c)(6)) or recipients of supplemental security income under title XVI as full low-income subsidy eligible individuals. Section 1860D-14(c)(1) of the Act further requires that the Secretary provide for a process under which
(1)the Secretary notifies the PDP sponsor that an individual is eligible for a low income subsidy, and
(2)the PDP sponsor is required to reduce the premiums and cost sharing for such individuals to the amount a low-income subsidy eligible individual is required to pay. The primary process CMS has employed to implement these requirements is for CMS to identify low-income subsidy-eligible individuals based upon information from the States on Medicaid eligibility and Social Security on SSI eligibility and the eligibility of LIS applicants. Because we do not always have timely or up-to-date information from these sources, however, we developed a process under which sponsors accept and use reliable documentation, known as “best available evidence,” to establish a beneficiary's low-income subsidy eligibility status and communicate this information to the Secretary. This “best available evidence” policy derives from the fact that, while section 1860D-14(c)(1)(A) of the Act provides for CMS to inform sponsors of low-income subsidy eligibility, the sponsor's obligation under section 1860D-14(c)(1)(B) of the Act to reduce premiums and cost-sharing for all such individuals is not contingent upon CMS doing so. While CMS attempts to identify all subsidy eligible individuals to the full extent possible, experience has shown that this does not necessarily result in every such individual being successfully identified. CMS believes, therefore, that the Sponsors have an obligation to take reasonable steps to respond to documentation that identifies such individuals when they have not been identified by CMS, in order to fulfill their statutory obligation to reduce premiums and cost-sharing for such individuals. Given the importance of this policy, we propose to codify it in § 423.800(b) and (d). Specifically, we propose to include in regulations text guidance ( *Part D Guidance—Low-Income Subsidy
(LIS)Status Corrections Based on Best Available Evidence* , dated June 27, 2007, available at: *http://www.cms.hhs.gov/PrescriptionDrugCovContra/Downloads/Final%20Sponsor%20Guidance%20on%20BAE%20062707.zip* ) we have issued to Part D sponsors concerning our best available evidence
(BAE)policy. These revisions to § 423.800 reflect our current policy that Part D sponsors must accept and use BAE in those instances when this evidence, submitted by the beneficiary or another person on the beneficiary's behalf, substantiates that the beneficiary's information in CMS systems is not accurate. To ensure the appropriateness of corrections based on BAE, CMS policy requires sponsors to maintain for 10 years the original documentation used to substantiate requests for manual updating of the CMS system to accommodate subsequent periodic government audits. In addition, we plan to establish a feedback mechanism to the States to confirm the LIS corrections based on BAE and identify and address any problems in State to CMS reporting. As noted above, this policy is necessary because the monthly files from the States and Social Security CMS uses to establish an individual's low-income subsidy eligibility pursuant to section 1860D-14(c)(1)(A) of the Act do not always accurately reflect an individual's true eligibility status. In certain cases, for example, the State has not yet reported the individual as Medicaid eligible, or has not reported him/her as institutionalized. As a result, CMS systems do not reflect a beneficiary's correct low-income subsidy
(LIS)status at that point in time. As a result, accurate subsidy information on these individuals has not been communicated to the Part D plan. In these circumstances, beneficiaries, advocates or pharmacies have brought such errors to the Part D sponsor's attention. CMS believes that the Part D sponsor is in the best position to address such errors and appropriately apply the subsidy as it is required by statute to do under section 1860D-14(c)(1)(B) of the Act. This led to CMS's development of the best available evidence
(BAE)policy that we are proposing to incorporate in this proposed rule. Specifically, we are proposing to amend the regulations to require that Part D sponsors use BAE to substantiate a beneficiary's eligibility for a reduction in premiums and or cost-sharing in the case of individuals who indicate they are eligible for the low-income subsidy. These include full-benefit dual eligible individuals, partial dual eligible individuals (that is, those who are enrolled in a Medicare Savings Program as a Qualified Medicare Beneficiary, Specified Low-Income Medicare Beneficiary or Qualifying Individual), people who receive Supplemental Security Income
(SSI)benefits but not Medicaid, and people who apply for and are determined eligible for a subsidy. Under the BAE policy we propose to incorporate in this proposed rule, sponsors are required to accept and use BAE to correct the beneficiary's low-income subsidy data in the sponsor's system and, as applicable, document requests for CMS to correct the beneficiary's low-income subsidy data in our system when the change has not occurred as a result of the routine reporting. CMS continues to work to improve low-income subsidy data reporting. Such improvements would include, for example, permitting more frequent State submission of data files to CMS, more frequent CMS processing of data files and improved communication of the information to Part D sponsors. Nevertheless, we anticipate that the BAE policy will remain in place for the indefinite future. As a result, we are proposing to modify § 423.800 by adding a fourth paragraph, consistent with our current policy, that would require Part D sponsors to use the CMS-developed BAE process to establish the appropriate cost-sharing for low-income beneficiaries whose information in CMS systems is not correct. By adding this provision to the regulation, we are ensuring that our best available evidence policy and its requirements are clear to all parties and, in so doing, that the administration of the low-income subsidy program takes advantage of all data currently available to the Part D sponsors to ensure low-income beneficiaries are not burdened by unnecessary cost sharing at the point of sale. We also believe we will be in a stronger position from a compliance perspective, as it will strengthen our ability to take action against plans that fail to implement our best available evidence process. We expect that CMS guidance implementing the BAE policy will be updated as necessary to reflect appropriate process modifications as they become warranted, based on changes in technology and the types of documents that could in the future prove to reliably verify a beneficiary's status as an individual eligible for a full low-income subsidy. We propose to define best available evidence at § 423.772 as documentation or information that is directly tied to authoritative sources, confirms that an individual meets the requirements for the low-income subsidy, and is used to support a change in an individual's low-income subsidy status. We are not proposing to specify in the regulation the specific documents that would meet these criteria, as there may be documents that meet these criteria in the future that do not currently exist. Currently, however, evidence sufficient to make a change to a beneficiary's low-income status includes any one of the following: • A copy of the member's Medicaid card which includes the member's name and an eligibility date during the discrepant period or no later than July of the preceding year. • A report of contact including the date a verification call was made to the State Medicaid Agency and the name, title and telephone number of the state staff person who verified the Medicaid status during the discrepant period; • A copy of a state document that confirms active Medicaid status during the discrepant period; • A print out from the State electronic enrollment file showing Medicaid status during the discrepant period; • A screen print from the State's Medicaid systems showing Medicaid status during the discrepant period; or • Other documentation provided by the State showing Medicaid status during the discrepant period. In addition, evidence to establish that a beneficiary is institutionalized and qualifies for zero cost-sharing includes any one of the following: • A remittance from the facility showing Medicaid payment for a full calendar month for that individual during the discrepant period; • A copy of a state document that confirms Medicaid payment to the facility for a full calendar month on behalf of the individual; or • A screen print from the State's Medicaid systems showing that individual's institutional status based on at least a full calendar month stay for Medicaid payment purposes during the discrepant period. Again, the proposed changes described in this portion of the proposed rule would not change current BAE policy. Rather they would codify existing operational processes and reflect our historic policy that Part D sponsors use BAE when this evidence substantiates that the beneficiary's information in CMS systems is not accurate. We invite comment on methods by which we can improve this policy in the future. 7. Certification of Allowable Costs (§ 423.505) We propose, by revising § 423.505(k)(5), to clarify that the certification of allowable costs for risk corridor and reinsurance information includes direct and indirect remuneration that serves to decrease the costs incurred by a Part D sponsor for a Part D drug. The submission of accurate and complete data regarding direct and indirect remuneration that reduces a Part D sponsor's costs for Part D drugs under the Medicare prescription drug benefit is necessary to ensure accurate reinsurance and risk corridor payments. 8. Change of Ownership Provisions (§ 423.551) We propose to amend the change of ownership provisions in 42 CFR 423.551, by adding paragraph
(g)to clarify that PDP sponsors may not sell or transfer individual beneficiaries or groups of beneficiaries enrolled in any of their plan benefit packages (PBPs). This new provision is simply a clarification of an existing restriction on PDP sponsors' ability to sell portions of their Part D lines of business. This proposed restriction on the sale of beneficiaries is based on two CMS determinations. First, in the preamble to the current Part D rule that published in the **Federal Register** January 28, 2005 (70 FR 4341), CMS stated that we would recognize the sale of PDP lines of business as asset transfers that constitute a change ownership which CMS may recognize through the execution of an agreement to novate the selling sponsor's PDP sponsor contract to a second qualified sponsor. Using a common understanding of the phrase “line of business” as referring to a company's set of products or services, CMS maintains that a “PDP line of business” includes a PBP as well as the beneficiaries enrolled in that PBP. Therefore, there can be no sale of a line of business consisting solely of a set of beneficiaries without the accompanying transfer to the succeeding sponsor of the obligation to continue to provide the PBP services the beneficiaries have already elected. Second, the sale of individual beneficiaries would allow PDP sponsors effectively to make enrollment elections on behalf of beneficiaries when the Part D statute grants that authority exclusively to beneficiaries (see section 1860D-1(a)(1)(A) of the Act) and, in the case of full-benefit dual eligible beneficiaries, CMS (see section 1860D-1(b)(1)(C) of the Act). The change of ownership provisions of subpart L may not be read as a grant of enrollment election authority to PDP sponsors. We propose to add § 423.551(g) to provide necessary clarification on this change of ownership issue. During the first 2 years of the Part D program, several PDP sponsors have requested CMS approval of transactions involving the sale of beneficiaries. This clarification will minimize the number of sponsors that mistakenly begin negotiations on such sale agreements. C. Proposed Changes to the MA and Prescription Drug Benefit Programs In order to assist readers in understanding how the proposed provisions we discuss in this section would apply to both programs, we are including Table 1, which highlights the provisions affecting both programs and the pertinent Part 422 and Part 423 CFR sections. Table 1.—Provisions Affecting Both the Part C and Part D Programs Provision Part 422 Subpart Part 422 CFR section Part 423 Subpart Part 423 CFR section Passive enrollment procedures Subpart B 422.60 Subpart B 423.32 Involuntary disenrollment and non-payment of premium Subpart B 422.74 Subpart B 423.44 Disclosure of plan information Subpart C 422.111 Subpart C 423.128 Retroactive premium collection and beneficiary repayment options Subpart F 422.262 Subpart F 423.293 Prohibiting improper billing of monthly premiums Subpart F 422.262 Subpart F 423.293 Non-renewal notification timelines Subpart K 422.506 Subpart K 423.507 Reconsiderations Subpart M 422.578, 422.582 Subpart M 423.560, 423.580, 423.582 Civil money penalties Subpart O 422.760 Subpart O 423.760 *Marketing:* Definitions Subpart V (all marketing sections) 422.2260 Subpart V (all marketing sections 423.2260 *Marketing:* Review and distribution of marketing materials 422.2262 423.2262 *Marketing:* Guidelines for CMS review 422.2264 423.2264 *Marketing:* Deemed approval 422.2266 423.2266 *Marketing:* Standards for MA/Part D marketing 422.2268 423.2268 *Marketing:* Licensing of marketing representatives and confirmation of marketing resources 422.2272 423.2272 *Marketing:* Broker and agent commissions 422.2274 423.2274 *Marketing:* Employer and group retiree marketing (MA provision only) 422.2276 423.2276 1. Authorization of Automatic or Passive Enrollment Procedures (§§ 422.60 and 423.32) Section 1851(c)(1) of the Act directs the Secretary to establish a process through which an individual makes an “election” to receive Medicare coverage through an MA plan or original Medicare, or to change from one MA plan to another, including the form and manner in which such elections are made. Section 1860D-1(b)(1)(A) of the Act similarly directs the Secretary to establish a process for enrolling in or disenrolling from a PDP, or changing enrollment from one PDP to another. This authority is implemented for MA plans in §§ 422.60, 422.62, 422.66, and 422.74, and for Medicare prescription drug plans in §§ 423.32 and 423.36, as well as in CMS manuals. In rare instances, CMS is faced with situations in which organizations become insolvent, or are determined to have such serious compliance issues that immediate plan terminations may become necessary. Normally, an organization that elects to non-renew its contract for the following year is required to notify CMS in July of the contract year, several months before the non-renewal takes effect. All beneficiaries enrolled in that plan are required to be notified in early October, providing individuals at least 3 months to evaluate other plan options, and make a plan election for the subsequent year. Consistent with existing regulations and guidance, such elections would normally entail “active” measures, such as signing an enrollment form, submitting an on-line enrollment request or calling a plan to enroll. However, when CMS identifies a situation that requires an immediate plan termination, or other situations in which CMS determines plan members might be harmed by remaining in their current plan, CMS believes that it is in the best interests of beneficiaries to protect those that may not have adequate time to elect a plan due to emergency terminations as well as those unable to, or who otherwise do not, focus on their plan options. In these circumstances, our primary goal is to ensure that minimal harm comes to the beneficiary who fails to act on his or her election options. To achieve this goal, we have determined that it is sometimes appropriate to use “passive” enrollment procedures under which an individual is notified that he or she can make an enrollment “election” by taking no action. Under these procedures, we strive, when possible, to select plans for individuals that will maintain a level of coverage equal to or better than their current coverage, without incurring additional costs. We also generally assume that individuals who are currently enrolled in a particular type of coverage, such as prescription drug coverage, would want to maintain this type of coverage. Similarly, we assume that LIS-eligible individuals would prefer a plan where their premiums and deductibles were fully subsidized. In addition to termination situations, we have provided for “passive” enrollment in cases in which a failure to elect the enrollment in question would harm the beneficiary. For example, we have employed passive enrollment in the case of employer group members who would lose employer benefits if they were not passively enrolled. We also have provided for passive enrollment in which the particular plan in which the beneficiary is enrolled was being terminated by CMS due to compliance and insolvency issues, as well as instances when a beneficiary was enrolled in a terminating plan but a similar plan was offered by the same organization with which the beneficiary had already chosen to enroll. We are proposing to incorporate our current passive enrollment policies in the regulations in a new § 422.60(g) and § 423.32(g). These new provisions would set forth in the regulations that CMS may authorize plans to carry out “passive” enrollment procedures in situations involving immediate plan terminations or potential beneficiary harm from remaining enrolled in the beneficiary's current plan. Under these enrollment procedures, individuals will be notified that they will be deemed to have elected the MA or PDP plan selected for them by CMS if they take no action to cancel such enrollment. In conjunction with these provisions, we would set forth several key beneficiary protections that would be required any time such an enrollment would occur. Such protections would include requiring that the organization that is receiving the enrollment notify all prospective enrollees of the passive enrollment prior to the effective date of the passive enrollment or as soon as possible after the enrollment effective date if prior notification is not possible under the circumstances. The notices to the enrollees would be approved by CMS and would explain their right to choose another plan, and describe the costs and benefits of the new plan and how to access care under the plan, as well and any other conditions of enrollment established by CMS. We would also specify that affected individuals would be entitled to a special enrollment period after their new enrollment took effect, as permitted under §§ 422.62(b)(4) and 423.38(c)(8)(ii). 2. Involuntary Disenrollment for Nonpayment of Premium (§§ 422.74 and 423.44) The MMA provides individuals with the option to choose to have their premiums for either MA or PDP membership withheld from their Social Security benefit, as described in 42 CFR 422.262(f) and 423.293, respectively. Section 1851(g)(3)(A) of the Act provides Medicare Advantage organizations the option to disenroll members who fail to pay basic and supplemental monthly premiums, as set forth at 42 CFR 422.74(d)(1). Section 1860D-1(b)(1)(B)(v) of the Act makes this provision applicable to PDP sponsors. See 42 CFR 423.44(d)(1). Although MA organizations and PDP sponsors may disenroll individuals for failing to pay premiums in a timely manner, we believe that such disenrollments should be an option only in cases where individuals pay their required premiums directly to the plan, as opposed to individuals who have chosen to have their premiums automatically withheld from their Social Security benefits. In cases where MA organizations or PDP sponsors are not receiving premiums on a timely basis from members who have chosen the premium withhold option, the member is clearly not at fault if the premium for some reason is not being deducted or paid to the plan properly. Thus, we do not believe that the organization or sponsor should have the option to disenroll a member in that situation. Similarly, individuals who have elected the premium withhold option also should not be subject to disenrollment during the time needed to initially establish premium withhold status on an individual account. Therefore, we are revising the MA and Part D regulations in § 422.74(d)(1) and § 423.44(d)(1) by adding the cross reference to paragraph (d)(1)(iv) to prohibit plans from disenrolling individuals for failure to pay premiums if they have either requested the premium withhold option or if they are already in premium withhold status. Plans may initiate disenrollments for failure to pay premium only after an individual in “direct bill” status has been notified of the premium owed and, in the case of MA plans, provided the grace period required under § 422.74(d)(1)(i)(B), as currently outlined in the MA and Part D regulations discussed above. 3. Disclosure of Plan Information (§§ 422.111 and 423.128) As provided in section 1852(c)(1) of the Act, MA organizations and prescription drug benefit plan
(PDP)sponsors must disclose detailed information about the plans they offer to their enrollees. This detailed information is specified in section 1852(c)(1) of the Act and §§ 422.111(b) and 423.128(b) of the Part C and Part D program regulations, respectively. Sections 422.111(a)(3) and 423.128(a)(3), as well as our Marketing Guidelines require that this information be disclosed at the time of enrollment and at least annually thereafter. In addition, the Marketing Guidelines specify that current enrollees must receive the annual notice of change
(ANOC)by October 31 and the evidence of coverage
(EOC)annually. We propose clarifying in §§ 422.111(a)(3) and 423.128(a)(3) that plans must disclose the information specified in §§ 422.111(b) and 423.128(b) of the MA and Part D program regulations, respectively, both at the time of enrollment and at least annually thereafter, 15 days before the annual coordinated election period. Making this clarification is essential to ensuring that current enrollees receive comprehensive information necessary for making an informed decision regarding their health care options prior to the annual coordinated election period. 4. Retroactive Premium Collections and Beneficiary Repayment Options (§§ 422.262 and 423.293) Routine changes in a beneficiary's plan status (for example, plan switching) or systems issues can result in a need for retroactive premium collections. Many beneficiaries can be financially harmed when required to pay the full amount of a retroactively-due premium in addition to their current month's premium in a single lump sum. Section 1860D-13(c)(1) of the Act states that “the provisions of § 1854(d) shall apply to PDP sponsors and premiums (and any late enrollment penalty) under this part in the same manner as they apply to MA organizations and beneficiary premiums under Part C.” Section 1854(d)(1) and
(2)of the Act direct MA organizations to permit the payment of MA “monthly basic, prescription drug, and supplemental beneficiary premiums on a monthly basis” and “in accordance with regulations, an MA organization shall permit each enrollee, at the enrollee's option, to make payment of premiums (if any) under this part to the organization through” withholding, electronic funds transfer, or “such other means as the Secretary may specify.” We believe it would be consistent with these provisions to provide beneficiaries with the option of prorating past due premiums over a period of monthly payments when the reason for the premium arrearage is other than a member's willful refusal to remit the premium. Specifically, we believe that beneficiaries should be able to spread out their obligation over at least the same period for which the premiums were due. That is, if 7 months of premiums are due, the member should have at least 7 months to repay. Accordingly, we propose to amend the MA regulations at § 422.262 by adding new paragraph
(h)and the Part D regulations at § 423.293 by revising paragraph
(a)to expressly provide for this option. 5. Prohibiting Improper Billing of Monthly Premiums (§§ 422.262 and 423.293) Under some circumstances operational failures cause CMS payment delays with respect to premiums collected by Social Security withholding. When this has happened, some PDP sponsors and MA organizations have erroneously opted to directly bill members for premiums that the members have requested be withheld from their Social Security payments. Sections 1860D-13(a) (for Part D) and 1854(b) (for Part C) of the Act establish specific formulas (based on annual bidding) for calculation of monthly premiums. Members who have submitted a request that premiums be withheld under section 1860D-13(c) of the Act for Part D or section 1854(d) of the Act for Part C have the right to have their premiums taken only out of their Social Security payments. Therefore, it is impermissible to bill a member for such premiums. Accordingly, we are proposing to revise the MA regulations by adding new paragraph
(g)to § 422.262 and the Part D regulations by adding new paragraph
(e)to § 423.293, to explicitly prohibit such improper billing. Note that under circumstances when CMS cannot effectuate the premium withhold option for beneficiaries, we will set beneficiaries back to direct bill. In those cases, plans will be able to directly bill beneficiaries for premium amounts owed. 6. Non-Renewal Notification Timelines (§§ 422.506 and 423.507) Non-renewals of MA or prescription drug plan contracts require the MA organization, the Part D sponsor, or CMS to notify both the enrollees of the organization or sponsor and the general public of the non-renewal. Existing regulations require notification 90 days prior to the effective date of the non-renewal for notification to enrollees and 90 days prior to the end of the calendar year to the general public. The effective date of contract non-renewals in the MA and prescription drug plan programs is January 1st of each calendar year. Currently, CMS regulations concerning contract non-renewals require that CMS notify an MA organization or a prescription drug plan sponsor (PDP sponsor) of a non-renewal by August 1 of the current contract calendar year. In cases where CMS announces its intention to non-renew an MA organization or a PDP sponsor, the MA organization or PDP sponsor has certain contract appeal rights. Note that in instances where an MA organization or PDP sponsor announces its intent to non-renew its contract with CMS, there is no similar contract appeals process available. Should an MA organization or PDP sponsor decide to pursue an appeal of CMS' decision to non-renew the organization or sponsor's contract, we believe it is appropriate that the appeals process be concluded in time for there to be a final decision on the non-renewal, and for there to be sufficient time for the enrollees and the general public to be notified of a contract non-renewal prior to January 1 of the following year. Presently, the 90 day notice requirement requires contract non-renewal appeals process to be completed in only 60 days (from August 1st which is the date of notification of non-renewal, until October 1st,in order for the notice period to have run prior to January 1st). Our experience is that the contract non-renewal appeals process is likely to extend beyond 60 days. For this reason, we propose revising § 422.506(a)(2)(ii), (a)(2)(iii), (b)(2)(ii), and (b)(2)(iii) of the MA regulations and § 423.507(a)(2)(ii), (a)(2)(iii), (b)(2)(ii) and (b)(2)(iii) of the Part D regulations, to change the beneficiary and public notice requirement from at least 90 days to at least 60 days, thus allowing more time for the contract non-renewal process to conclude, while still allowing for a sufficient beneficiary notice period, prior to January 1st. This change will help ensure that all termination decisions are final, prior to the start of marketing and enrollment activities. CMS also believes that a 60 day notification requirement better aligns itself with other important CMS notification and election requirements. For example, CMS currently requires that all MA organizations and PDP sponsors provide annual notice of change
(ANOC)documents to enrollees of Medicare private health plans by October 31st of each year. As mentioned previously, the annual election period runs from November 15th to December 31st of each year. By changing the enrollee notification timeframe from 90 to 60 days, beneficiaries will receive notice of a pending contract non-renewal during the same time period when beneficiaries are making important Medicare coverage decisions for the upcoming calendar year. A 60 day notification period is a sufficient amount of time for enrollees to review other plan options and to make an election for enrollment into a plan for the following calendar year. 7. Reconsiderations (§§ 422.578, 422.582, 423.560, 423.580) We are proposing changes to the reconsideration process for both the MA and prescription drug benefit programs. The overall changes to the first level appeal process will be the same for both programs. However, we discuss the proposed revisions for each program separately because the proposed revisions would vary slightly due to program differences. a. Medicare Advantage Program (§§ 422.578 and 422.582) Under section 1852(g)(3)(A)(ii) of the Act and §§ 422.578 and 422.584 of the regulations, a physician, without regard as to whether the physician is treating the enrollee, is permitted to request an expedited plan reconsideration on behalf of an enrollee without having to be appointed by the enrollee as his or her representative. However, in order to request a standard pre-service plan reconsideration under §§ 422.578 and 422.582, a physician must have been appointed as the enrollee's representative, or be authorized by State law or other applicable law to act on behalf of the enrollee. We are proposing to revise § 422.578 and 422.582 to permit an enrollee's treating physician to request a standard plan reconsideration of a pre-service request on an enrollee's behalf without having been appointed by the enrollee as his or her representative. Section 1852(g)(2) of the Act states that an MA organization “shall provide for reconsideration of a determination described in paragraph (1)(B) upon request by the enrollee involved.” Although the statute does not expressly give any individual other than the enrollee the right to request a standard plan reconsideration, we have long permitted an enrollee to appoint a representative (for example, an attorney or family member) to file a request on behalf of an enrollee. In addition, when an individual is authorized under State law or other applicable law to act on the beneficiary's behalf, such an individual is also permitted to request a plan reconsideration on the enrollee's behalf. With respect to a physician's request for a standard plan reconsideration, the current regulations draw a distinction between a physician who is requesting an organization determination on behalf of an enrollee regarding coverage of services that have not been provided, and a request involving services that the physician has furnished. In the latter case, under § 422.574(b), if the physician has furnished a service to an enrollee and formally waives any right to payment from the enrollee for that service, he or she becomes a “party” to the organization determination, and may, under § 422.578, request a standard plan reconsideration (1st level appeal) without being appointed by the enrollee as a representative. This is a third instance in which someone other than the enrollee can request a standard plan reconsideration. After a number of years experience with the Part C program, we believe it is appropriate to revise the regulations to add a fourth circumstance under which an individual other than an enrollee can request a standard plan reconsideration on the enrollee's behalf. Specifically, we propose to allow the enrollee's physician, who the enrollee has already selected to provide treatment, to request standard plan reconsiderations on his or her patient's behalf without having been appointed as the enrollee's representative. We believe that an enrollee's treating physician already has been selected by the enrollee and occupies a position of trust. We also believe that as a treating physician, he or she is in a good position to know whether a request for plan reconsideration is warranted, and in the enrollee's interests. We have found that in some cases, requiring that the physician take the step of being appointed by the enrollee is a burden that does not serve the enrollee's interests. We are proposing that the physician must be able to demonstrate that he or she is treating the enrollee in question in order to request a plan reconsideration on the enrollee's behalf, and would be required to notify the enrollee that he or she is taking this action. We are not proposing to allow physicians who are not acting as an enrollee's representative to request appeals on behalf of enrollees beyond the plan level, as we believe that the enrollee should be directly involved in a decision to disclose his or her private health information to appeals adjudicators beyond the plan level of appeal because those adjudicators do not have the same relationship with the enrollee that the plan has. b. Prescription Drug Benefit Program i. Definitions (§ 423.560) We propose to revise the regulation text of § 423.560 by adding a new definition for “other prescriber.” This term encompasses health care professionals, other than physicians, with the requisite authority under State law or other applicable law to write prescriptions for Medicare beneficiaries. In conjunction with this proposed new definition, we propose to add “or other prescriber” after “prescribing physician” or “physician” throughout subpart M of part 423 in order to authorize these other prescribers to perform the same functions that prescribing physicians are allowed to perform with respect to the coverage determination and appeals processes as set out in subpart M of part 423. Sections 1860D-4(g) and
(h)of the Act establish the role of the “prescribing physician” in the coverage determination and appeals processes. Specifically, under section 1860D-4(g) of the Act, an enrollee may request an exception to a tiered cost-sharing structure such that a non-preferred drug could be treated as a preferred drug if the prescribing physician “determines that the preferred drug for treatment of the same condition either would not be as effective for the individual or would have adverse effects for the individual, or both.” Section 1860D-4(h) of the Act provides that an enrollee may appeal a determination not to provide coverage for a Part D covered drug that is not on the plan's formulary “only if the prescribing physician determines that all covered Part D drugs on any tier of the formulary for treatment of the same condition would not be as effective for the individual as the nonformulary drug, would have adverse effects for the individual, or both.” However, sections 1860D-4(g) and
(h)of the Act are silent on the role of other health care professionals who have prescribing authority under State law or other applicable law. As the statute reflects, the Congress recognized the important role a prescribing physician plays in the coverage determination and appeals processes. In particular, a prescribing physician is especially well qualified to assist Part D enrollees with certain aspects of the coverage determination and appeals processes. Because sections 1860D-4(g) and
(h)of the Act are silent on the role of other health professionals who have prescribing authority under State law or other applicable law, an enrollee who has his or her prescription written by a non-physician prescriber arguably does not currently have the same protections and assistance in the coverage determination and appeals processes as an enrollee whose prescription is written by a physician. Based on program experience gained since the inception of the Part D program, and recognizing that there are other categories of health care providers who are authorized under State law or other applicable law to prescribe drugs for Part D enrollees, we are proposing to allow non-physician prescribers to perform the same functions as physicians for purposes of subpart M of part 423. This proposed change would ensure that enrollees who have prescriptions written by non-physician prescribers are afforded all of the same protections and assistance in the coverage and appeals processes that are currently available to enrollees whose prescriptions are written by a physician. For example, under § 423.566(c), an enrollee's prescribing physician is permitted to request an expedited or a standard coverage determination on the enrollee's behalf without being his or her representative. Under this proposal, a nurse practitioner or other health care professional who is authorized under State law or other applicable law to write prescriptions would be able to request an expedited or standard coverage determination on behalf of the enrollee. We believe this proposal would ensure that all Part D enrollees have the same protections and access to assistance in the coverage determination and appeals processes, notwithstanding the type of health care professional who writes their prescription. ii. Right to a Redetermination (§ 423.580) We propose to revise the regulation text of § 423.580 to provide prescribing physicians and other prescribers with the ability to request standard redeterminations on behalf of enrollees, and require them to notify enrollees that they are taking this action. Section 1860D-4(g) of the Act requires Part D plan sponsors to “meet the requirements of paragraphs
(1)through
(3)of section 1852(g) with respect to covered benefits under the prescription drug plan it offers under this part in the same manner as such requirements apply to an MA organization with respect to benefits it offers under an MA plan under Part C.” Sections 1852(g)(1) through (g)(3) discuss the requirements for standard and expedited organization determinations and plan reconsiderations by MA organizations. Under current §§ 423.580-423.584, an enrollee's prescribing physician is permitted to file an expedited redetermination on the enrollee's behalf without being his or her representative, but cannot request a standard redetermination without being the enrollee's representative. In accordance with section 1860D-4(g) of the Act, this limitation was carried over from §§ 422.578 and 422.582 of the Medicare Advantage regulations. However, as discussed above, in this proposed rule, we are proposing to revise §§ 422.578 and 422.582 of the regulations to allow non-representative physicians to request standard plan reconsiderations of pre-service requests on behalf of enrollees in MA appeals. In conjunction with that proposed change, and consistent with the requirement under section 1860D-4(g) of the Act that plan redeterminations under Part D be provided in the same manner as plan reconsiderations under Part C, we propose to revise §§ 423.580 and 423.582 to be consistent with our proposed changes to §§ 422.578 and 422.582. However, under Part D, we are not carrying over the limitation from proposed § 422.578 that would prevent a prescribing physician from requesting a standard plan-level appeal for payment. Unlike under Part C, prescribing physicians do not have a financial interest in the payment of Part D claims. Thus, we believe prescribing physicians may make requests for payment on behalf of enrollees under Part D. In addition, consistent with our proposal to afford non-physician prescribers the same authority to assist beneficiaries in the coverage determination process as prescribing physicians, we also propose to allow other prescribers to request plan redeterminations on behalf of enrollees. 8. Civil Money Penalties (§§ 422.760 and 423.760) CMS may impose civil money penalties
(CMPs)on MA organizations and Part D sponsors for certain regulatory offenses, as described in subpart O of both 42 CFR 422 and 42 CFR 423. Section 1857(g)(3)(A) and section 1860D-12(b)(3)(E) of the Act provides CMS with the ability to impose CMPs of up to $25,000 per determination (determinations are those which could otherwise support contract termination, pursuant to §§ 422.509 or 423.510) when the deficiency on which the determination is based adversely affects or has the substantial likelihood of adversely affecting an individual covered under the organization's contract. The current regulations essentially echo the Act's wording with respect to the amount of the penalty that CMS may impose. However, the statute and the existing regulations shed little light on how to determine whether a series of incidents or events, or a single event that individually impacts multiple enrollees, constitutes a single determination or multiple determinations which could justify the calculation of a larger total penalty. It is possible that one incident could negatively affect multiple enrollees, which would provide a justification for the CMP amount to potentially be greater than a CMP based on an event that only affects a few beneficiaries. For example, the failure of an organization or sponsor to timely issue annual notice of change
(ANOC)documents would be a one-time incident that has the potential to have adverse consequences for a large number of enrollees. CMS believes it is appropriate for the specific factors to be considered in calculating a total CMP, such as the number of enrollees affected or potentially affected, whether the ANOCs were significantly delayed (resulting in a substantial decrease in the amount of time an enrollee had to determine whether or not to stay in their plan), or an additional factor was involved that further adversely affected the enrollees. Similarly, one or a small group of marketing agents perpetrating similar misrepresentations over a period of time could constitute a series of incidents or events that CMS believes should be considered in calculating a total CMP. If one agent or several agents are misrepresenting plan benefits, the agent(s) may be repeating the same misrepresentation on multiple occasions and to multiple enrollees. Each time an agent misrepresents the plan's benefits and the enrollee is adversely affected or potentially adversely affected by such inaccurate statements, a determination justifying a CMP could be made based on each enrollee affected by the agent's actions. Given that the Act requires that the deficiency on which the determination is based must have adversely affected or have the substantial likelihood of adversely affecting an individual covered under the organization's contract, CMS believes that a CMP may be calculated based on each enrollee covered under the organization's contract adversely affected or potentially adversely affected by the organization's conduct. The statute clearly specifies that CMPs may be levied at amounts up to but not exceeding $25,000 per determination. We propose to clarify our regulations relating to CMPs in both 42 CFR 422.760 and 42 CFR 423.760 by adding paragraph (b)(2) of the respective sections to state that CMS may impose a penalty of not more than $25,000 for each enrollee covered under the organization's contract that is adversely affected or substantially likely to be adversely affected by the organization's deficiency (or deficiencies). When determining the amount of a penalty per determination, up to the $25,000 maximum, we will continue to take into account factors such as the severity of the infraction, the evidence supporting the infraction, the amount of harm caused to the Medicare beneficiary, and the organization's past conduct. These factors combined will assist us in determining the amount per affected beneficiary that the organization should be penalized. CMS believes this clarification is necessary for both MA organizations and Part D sponsors to fully appreciate the consequences of noncompliance with applicable program requirements. An MA organization or Part D sponsor's conduct that adversely affects a significant number of Medicare beneficiaries may have a significant financial impact on the organization. Our proposed change is aimed at protecting enrollees by clarifying that penalties can be substantial for noncompliance. Adding the option of assessing CMPs at the level of each enrollee covered under the organization's contract—to CMS' existing authority, which enables the Agency to continue to levy CMPs at the “per contract” level—provides necessary flexibility for CMS to better match CMP amounts to the specific nature of the determination that warrants a CMP. However, we acknowledge that there may be alternative or additional approaches to the “per beneficiary” and “per contract” schema described here that would likewise meet the Agency's goals of providing meaningful penalties that deter violations of Medicare program requirements and protect Medicare beneficiaries. For example, tying CMP amounts to the number of days that violations existed may likewise be an effective approach for assessing meaningful CMPs. We therefore seek comments on our proposed clarification as well as whether any other approaches would more effectively deter MA organizations and Part D sponsors from engaging in conduct which is in violation of CMS requirements. We also seek comment as to the appropriate monetary range for CMPs imposed on MA organizations and Part D sponsors and as to whether some upper limit should exist on the total amount of a penalty imposed on an organization when a deficiency has adversely impacted a large number of enrollees covered by an MA organization or Part D sponsor. 9. Medicare Advantage and Prescription Drug Program Marketing Requirements (Proposed New Subparts V) a. General Section 1851 of the Act sets forth provisions relating to beneficiaries making choices as to how they want to receive their Medicare benefits. Specifically, it addresses the provision of information to beneficiaries on their Medicare health care options, the marketing of such health care options, and the timing and method for making a choice among health care options, and enrollment in, disenrollment from, or a change in, the health care option of the beneficiary's choice. Sections 1851(h)(1) through
(5)of the Act govern the marketing of MA plans to Medicare beneficiaries by MA organizations. Section 1851(h)(1) of the Act requires that marketing material be submitted to CMS for approval before it is used, and provides for deemed approval after 45 days (or 10 days in certain cases) if CMS does not disapprove the material. Section 1851(h)(2) provides for CMS to establish “standards” for the review of marketing material, and requires that material be disapproved if it “is materially inaccurate or misleading or otherwise makes a material misrepresentation.” Section 1851(h)(3) of the Act provides that material approved for use in one geographic area is deemed approved in other areas except with respect to material specific to the area involved, and section 1851(h)(5) of the Act provides that if model language approved by CMS is used, it can be used only 10 days after submitting it to CMS for approval. Finally, section 1851(h)(4) of the Act requires that MA organizations conform to “fair marketing standards,” including those established by CMS by regulation, and requires that such standards prohibit an MA organization from providing for cash or rebates as an inducement to enroll, or otherwise, and may include a prohibition on an MA organization or its agent filling out an enrollment form for individuals. With respect to marketing by PDP sponsors, section 1860D-1(B)(1)(vi) of the Act requires CMS to use rules “similar to (and coordinated with)” the foregoing marketing rules set forth in section 1851(h). Regulations at §§ 422.80 and 423.50 and detailed operational guidance found in “ *The Medicare Marketing Guidelines for Medicare Advantage plans, Medicare Advantage prescription drug plans, prescription drug plans, and 1876 cost plans* ,” second revision dated July 25, 2006 (hereinafter referred to as “Marketing Guidelines”), are the current standards by which MA organizations and Part D sponsors must meet in their marketing to eligible individuals regarding their plan choices. In developing these standards, CMS recognized that establishing fair marketing standards encompasses more than CMS approval of marketing materials. It also includes the development of standards related to the dissemination of information through a wide variety of media forms (for example, advertisements and Web sites) and MA organization or Part D sponsor (or their agents') conduct when attempting to persuade a beneficiary to enroll in a particular plan. Both the regulations and the Medicare Marketing Guidelines prohibit organizations from conducting marketing activities that would result in generating misleading information to Medicare beneficiaries. In order to implement standards consistent with “fair marketing” practices in accordance with sections 1851(h) and 1860D-1(b)(1)(B)(vi) of the Act, and to ensure beneficiaries receive the necessary information to make informed choices during the annual election period, we propose to amend and expand our marketing regulations for both the MA and the Part D programs. Moreover, due to the proposed addition of new marketing provisions and the need to clarify current marketing regulations, we propose to remove §§ 422.80 and 423.50 of subpart B, which currently specify the requirements related to the approval of marketing materials and instead include this core of our marketing requirements in a new subpart V of 42 CFR 422 and 423 specific to the marketing regulations for each program. b. Marketing Materials and Marketing Requirements i. Definitions Concerning Marketing Materials (§§ 422.2260, 423.2260) We are making an organizational change for this section consistent with our proposal to create a new subpart V of 42 CFR 422 and 423 specific to marketing. We are moving the definition of marketing materials to §§ 422.2260 and 423.2260 of the Part C and D program regulations, respectively. ii. Review and Distribution of Marketing Materials: File and Use (§§ 422.2262, 423.2262) In addition to moving our requirements concerning the approval of marketing materials and election forms to §§ 422.2262 and 423.2262 of the Part C and D program regulations, respectively, we are proposing to modify the “file and use” review process. While the statute requires the submission of marketing materials to CMS for a 45-day period of CMS review, based on years of program experience CMS recognized that some MA organizations consistently met all marketing standards, and that their marketing materials warranted less scrutiny. CMS accordingly established a file and use policy that was designed to streamline the marketing materials approval process for these MA plans. Under this file and use policy, Medicare health plans that demonstrated to the satisfaction of CMS that they continually met a particular high standard of performance were able to publish and distribute certain marketing materials within 5 days of submission to CMS under section 1851(h)(1), without waiting for a response from CMS. In effect, these materials were deemed approved by CMS after 5 days based on CMS's prior review of earlier materials. The criteria in order to be eligible for the original file and use policy were that a contracting entity had to have submitted at least eighteen months of marketing materials for CMS review, and at least ninety percent of the materials submitted within the past six months had to meet applicable marketing standards. In the regulations implementing the MMA, CMS adopted a separate file and use policy that was based on the nature of the marketing materials in question, rather than the track record of the MA organization or PDP sponsor. Under this policy, an MA organization or PDP sponsor certifies that it is using either model language already reviewed and approved by CMS, or types of marketing materials that CMS has identified as not containing substantive content. As with the original policy that focused on the organization, the materials covered by this new file and use certification policy could be used 5 days after submission, without any explicit approval from CMS. In the case of MA organizations, this certification is made at the time of submission, while PDP sponsors are permitted to so certify in their contracts. In order to level the playing field among contractors, eliminate redundancies, and focus resources on materials that have content that warrants CMS scrutiny, we are proposing to eliminate file and use status based on an organization's track record, and apply a uniform policy of applying the file and use policy to marketing materials that either use model language without substantive modification, or materials that are identified by CMS as not containing substantive content warranting CMS review. The same approach to certifying that these types of materials are being used would apply for both Part C and Part D contractors. We would include the proposed file and use provision in § 422.2262(b) and § 423.2262
(b)of the MA and Part D programs, respectively. iii. Guidelines for CMS (§§ 422.2264, 423.2264) We are making an organizational change for this section consistent with our proposal to create a new subpart V of 42 CFR 422 and 423 specific to marketing regulations. We are moving §§ 422.80(c) and 423.50(d), which describe specific guidelines for CMS review of marketing materials and election forms, to §§ 422.2264 and 423.2264, respectively. iv. Deemed Approval (§§ 422.2266, 423.2266) Consistent with our proposal to create a new subpart V of 42 CFR 422 and 423 specific to marketing regulations, we are making an organizational change for this section. We are removing §§ 422.80(d) and 423.50(e) and creating §§ 422.2266 and 423.2266, respectively. The provision concerns CMS' deemed approval of the distribution of marketing materials. v. Standards for MA and PDP Marketing (§§ 422.2268, 423.2268) We are making an organizational change for this section consistent with our proposal to create a new subpart V of 42 CFR 422 and 423 specific to marketing regulations. We are removing §§ 422.80(e) and 423.50(f) and creating §§ 422.2268 and 423.2268, respectively. vi. Licensing of Marketing Representatives and Confirmation of Marketing Resources (§§ 422.2272, 423.2272) In response to questions from the Part D industry regarding state licensure of marketing representatives, CMS adopted in its Marketing Guidelines the requirement that MA organizations and Part D sponsors that conduct marketing through independent agents use state-licensed, certified, or registered individuals to do so, if a state licenses such agents. The use of only state-licensed marketing representatives helps ensure that the marketing representatives meet minimum standards of integrity and professionalism in order to market to Medicare-eligible beneficiaries. This Medicare requirement permits Medicare to benefit from State efforts to deny licensure to under-educated, unscrupulous or otherwise substandard individuals, and helps ensure that Medicare beneficiaries are not the victims of substandard or inappropriate marketing activities. Based on the experience we have gained since the start of the Part D program, and continued experience with the Medicare Advantage program, we propose to codify in the regulation our existing requirement that MA organizations and Part D sponsors utilize only State-licensed marketing representatives to do marketing where they use independent agents in the States that license such agents. We further propose to add a regulatory requirement to §§ 422.2272 and 423.2272 that MA organizations and PDP sponsors that market through independent agents not only be required to use licensed agents, but would be required to report to States that they are using such agents, in a manner consistent with State appointment laws. State appointment laws require MA and PDP sponsors to appoint marketing representatives before the agent can market a plan's product. Appointment laws may require an insurance plan to maintain a registry of marketers who sell their plans, including maintaining a list of license numbers, dates the individual began selling policies for the insurance company, and stopped selling plans for the insurance company. While we previously required only that licensed agents be used, and did not require that the appointment of such agents be reported to the State agency that regulates agents, we believe this latter requirement would enable States to monitor the agents' activities in connection with their Medicare marketing for the purpose of monitoring the agent's fitness to engage in marketing in the State. We believe Medicare beneficiaries would benefit from this State monitoring. More specifically, we recognize that, under the preemption provisions in section 1856(b)(3) of the Act (incorporated for PDPs under section 1860D-12(g)), States do not have the authority to regulate the marketing of Medicare Part C and D plans. However, as noted, any abuses by an agent in marketing such plans would have direct relevance to the State's oversight of the agent generally, and implications for the agent's marketing of products over which the state has jurisdiction, and Medicare beneficiaries would benefit from having the agents who engage in Medicare marketing subject to this state oversight. Because State laws requiring compliance with an appointment law with respect to Medicare Part C and Part D marketing are pre-empted, however, we do not believe that any fees that would be charged in connection with a State appointment law would apply. Rather, we would limit the requirement to complying with only those aspects of State appointment laws that provide for giving the state information about which agents are marketing the Part C and D plans. In the context of the requirement that MA organizations and Part D sponsors utilize only State-licensed marketing representatives, and report the appointment of such agents to States consistent with the procedures under State appointment laws, it is important to discuss the activities that would not trigger the need for using State-licensed marketing representatives. As standard practice, MA organizations and Part D sponsors employ customer service representatives who answer questions and accept enrollments on behalf of enrollees who have decided to enroll in a particular plan offered by the organization. We recognize that plan customer service representatives play an important role in disseminating information by answering factual questions posed by beneficiaries, and that such an activity is distinguishable from the act of steering to a plan (“marketing,” as defined in the Medicare Marketing Guidelines). Additionally, taking demographic information from someone who has decided to enroll in the plan, in order to complete an application, is not steering in that the beneficiary has already made a choice to enroll in a plan. Accordingly, we believe providing factual information, fulfilling a request for materials, and taking demographic information in order to complete an enrollment application at the initiative of the enrollee by a customer service representative, are legitimate customer service activities that would not trigger the need for using State-licensed marketing representatives. In addition, we also propose to clarify in §§ 422.2268 and 423.2268 several standards for MA and PDP organization marketing. In §§ 422.2268(d) and 423.2268(d) we clarify that the prohibition on door-to-door solicitation includes other unsolicited instances of direct contact, such as outbound calling without the beneficiary initiating contact. We believe this clarification would help prevent inappropriate conduct on the part of agents in aggressively pursuing the marketing of Part C and D plans to beneficiaries (for example, approaching beneficiaries directly in parking lots) outside of approved common areas that may be used for marketing displays and presentations. We would also clarify in §§ 422.2268(l) and 423.2268(l) that plans may not engage in sales activities, including the distribution or collection of plan applications, at educational events. These events may be sponsored by plan(s) or by outside entities, and are events that are promoted to be educational in nature and have multiple vendors, such as health information fairs, conference expositions, state-or community-sponsored events, etc. In §§ 422.2268(k) and 423.2268(k) we clarify that sales activities are only permitted in common areas of health care settings (for example, hospital cafeterias or conference rooms), and would be prohibited in areas where patients primarily intend to receive health care services (for example, waiting rooms and pharmacy counter areas). The term “health care setting” refers to all settings where providers operate, including but not limited to pharmacies, physicians offices, hospitals, and long-term care facilities. We further propose several regulatory requirements in §§ 422.2268 and 423.2268, providing additional protections to ensure beneficiaries are not the victims of inappropriate marketing techniques. These include a new requirement in §§ 422.2268(b) and 423.2268(b) under which organizations would be required to limit the types of promotional items offered to potential enrollees (examples of acceptable items include pens, pill boxes and jar openers) and the value of such items to a nominal amount, established by CMS in operational guidance, and may not provide meals, regardless of value. (Refreshments are allowed, such as coffee, soft drinks, and snacks.) In §§ 422.2268(f) and 423.2268(f), we also propose to prohibit the cross-selling, in any MA or Part D sales activity or presentation, of non-health care-related products to a prospective enrollee. Marketing to current plan members of health care and non-health care-related products would also remain subject to HIPAA rules. In §§ 422.2268(g) and 423.2268(g), we are proposing to limit any appointment with a beneficiary involving marketing of health care-related products (for example, whether Medicare supplement, Medicare Advantage, stand-alone PDP will be discussed) to the scope agreed upon by the beneficiary. In advance of any marketing appointment, the beneficiary must have the opportunity to agree to the range of choices that will be discussed, and that agreement must be documented by the plan. Under proposed §§ 422.2268(h) and 423.2268(h), additional lines of plan business not identified prior to the in-home appointment would require a separate appointment that could not be re-scheduled until 48 hours after the initial appointment. An additional beneficiary protection, proposed in §§ 422.2268(n) and 423.2268(n), would limit the use of names and/or logos of co-branded network providers on plan membership and marketing materials. This proposed requirement will reduce the tendency of members to mistakenly believe they must use the co-branded network provider in order to obtain plan benefits. vii. Broker and Agent Requirements (§§ 422.2274, 423.2274) Section 1851(h)(2) of the Act requires us to establish marketing standards for Medicare Advantage
(MA)plans and under section 1860D-1(b)(1)(B)(vi) of the Act, Medicare prescription drug benefit plans (PDP), to ensure that beneficiaries are not misled or provided inaccurate information. Since the passage of the MMA, CMS has not specified standards in the regulation pertaining to the way brokers or agents (herein after referred to as “agents”) who are used to market MA plans and PDPs are compensated. Currently, the Marketing Guidelines allow agent compensation to vary based on the level of effort and the plan product type. Agents selling MA and PDP products play a significant role in providing guidance and advice to beneficiaries when selecting health plan options. This unique position allows them to influence beneficiary choices. The current compensation structure in the Marketing Guidelines has the potential to create a financial incentive for agents to only market and enroll beneficiaries in some plan products and not others. Based on our experience since the passage of MMA, this compensation structure has lead some agents to encourage beneficiaries to enroll in products that may not meet the beneficiaries' health needs but pays the agents the highest commission. In addition, there is a potential financial incentive for agents to encourage beneficiaries to change plans each year. Therefore, in order to prevent agents from unnecessarily moving beneficiaries from plan to plan and to ensure that beneficiaries are receiving the information and counseling necessary to select the best plan based on their needs, CMS intends to establish guidelines for agent compensation. We propose to add §§ 422.2274(a)(1) and (a)(2) and 423.2274(a)(1) and (a)(2) to include these requirements. Specifically CMS would require MA organizations and PDP sponsors to adopt a commission structure in which: • The commission or other compensation (collectively referred to as “commission”) to an agent or representative in the first year may not exceed the commission the agent would receive for selling or servicing the policy in all subsequent years. • The commission must be the same for all plans and all plan product types offered by the organization's or sponsor's parent. Each organization offering MA and MA-PD products must establish a single commission that may not vary based on the premium of the plan or any other measure and apply this flat fee commission to all products. Each sponsor offering PDP products must establish a single commission that may not vary based on the premium of the plan or any other measure and apply this flat fee commission to all products. Additionally, to ensure beneficiaries are getting the information necessary to make informed decisions, it is critical that agents are trained on Medicare rules, regulations and compliance-related information on the plan products they intend to sell. In addition to the training, we propose to require that agents pass a written test to demonstrate their knowledge of the Medicare program and the plan specific products they intend to sell. We expect MA organizations and PDP sponsors to develop training modules and written or electronic tests based on CMS guidelines. MA organizations and PDP sponsors may also use or accept the training modules and written or electronic tests of third parties or other MA organizations or PDP sponsors. CMS has reviewed sophisticated training and testing software of two major entities offering third party testing. The testing software included important controls to ensure the integrity of the testing. The testing software includes questions developed by test development experts. In addition the software has the ability to generate new questions for agents that require re-testing. CMS will review the training modules and tests during routine or focused monitoring visits. This will ensure that agents fully understand the products they are marketing and selling, that they are providing accurate plan information and are able to provide the best plan recommendations to beneficiaries. We propose to establish guidelines for agent training and testing and require, at CMS request, the reporting of marketing related information. We propose to include these requirements at §§ 422.2274 and 423.2274. Specifically CMS would— • In 422.2274(b) and 423.2274(b), require MA organizations and PDP sponsors to train all agents selling Medicare products on Medicare rules, regulations and compliance-related information. • In 422.2274(c) and 423.2274(c), require agents selling Medicare products to pass written or electronic tests on Medicare rules, regulations and information on the plan products they intend to sell. • In 422.2274(d) and 423.2274(d), require MA organizations and PDP sponsors to provide to CMS the information designated by CMS as necessary to conduct oversight of marketing activities. • In 422.2274(e) and 423.2274(e), require MA organizations and PDP sponsors to comply with State requests for information about the performance of licensed agents or brokers as part of a State investigation into the individual's conduct. CMS will establish and maintain a memorandum of understanding
(MOU)to share compliance and oversight information with States that agree to the MOU. We believe these proposed changes would enable beneficiaries to receive up-to-date information to help them select the best plan. In addition, the proposed changes would ensure that agents receive adequate training to market Medicare products, create a standard agent compensation structure and eliminate the financial incentives to encourage beneficiaries to enroll in a plan that may not be in the beneficiaries' best interest. viii. Employer Group Retiree (§§ 422.2276, 423.2276) We are making an organizational change for this section consistent with our proposal to create a new subpart V of 42 CFR 422 and 423 specific to marketing regulations. We are removing §§ 422.80(f) and creating §§ 422.2276 and, because the provision applies as well to the Part D program, adding new § 423.2276 to Part 423. III. Collection of Information Requirements Under the Paperwork Reduction Act of 1995, we are required to provide 60-day notice in the **Federal Register** and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget
(OMB)for review and approval. In order to fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires that we solicit comment on the following issues: • The need for the information collection and its usefulness in carrying out the proper functions of our agency. • The accuracy of our estimate of the information collection burden. • The quality, utility, and clarity of the information to be collected. • Recommendations to minimize the information collection burden on the affected public, including automated collection techniques. We are soliciting public comment on each of these issues for the following sections of this document that contain information collection requirements (ICRs): Section 422.4 Types of MA Plans Section 422.4(a)(1)(iv)(B) states that MA organizations offering disproportionate percentage SNPs must limit new enrollment of non-special needs members to no more than 10 percent of new enrollees, and that at least 90 percent of new enrollees must be special needs individuals as defined in § 422.2. The burden associated with this requirement is the time and effort put forth by the MA organization to monitor the percentage of non-special needs individuals in the SNP and ensure that this level remains below the established threshold. It will take one MA organization an initial burden of 2 hours to comply with this requirement. Therefore, with 176 disproportionate percentage SNPs in the market, the initial burden associated with this requirement is 352 hours. We estimate it would take one MA organization an additional burden of 1 hour/week to comply with this requirement on an ongoing basis for a total annual burden of 52 hours/year. We estimate 176 MA organizations would be affected annually by this requirement; therefore, the total annual burden associated with this requirement is 9152 hours. Section 422.52 Eligibility To Elect an MA Plan for Special Needs Individuals Section 422.52(g) requires a SNP to establish a process to verify the Medicaid eligibility and special needs status of an individual prior to enrolling the individual in a form and manner specified by CMS. This may require collaborative meetings between MA plan staff and State Medicaid staff to establish the process. This process could include calling the Medicaid eligibility verification system
(EVS)and reviewing appropriate used to determine an individual's special need. The burden associated with this requirement is the time and effort put forth by the SNP to establish a process and to verify eligibility. We estimate it would take one SNP approximately (4680 minutes/78 hours) to comply with this requirement. The total number of respondents affected would be 776 SNPs; therefore, the total annual burden is estimated to be 60,000 hours. Section 422.60 Election Process Section 422.60(g)(2) requires the organization that receives the enrollment to provide notification that describes the costs and benefits of the plan and the process for assessing care under the plan. The notification must be provided to all potential enrollees prior to the enrollment effective date (or as soon as possible after the effective date if prior notice is not practical), in a form and manner determined by CMS. Providing notification may include mailing a brochure or fact sheet with the aforementioned information and contacting potential enrollees to respond to any questions regarding the mailer. The burden associated with this requirement is the time and effort put forth by the organization to provide notification that meets the requirements specified by CMS. We estimate it would take one MA (30 minutes/.5 hours) to comply with this requirement. The total number of organizations affected is 5; therefore, total annual burden hours associated with the requirement is 2.5 hours. Section 422.101 Requirements Relating to Basic Benefits Section 422.101(f)(1) states that MA organizations offering special needs plans must have a model of care plan specifying how the plan will coordinate and deliver care designed for the plan's enrollees. The model of care plan would be developed by the deliberations of the appropriate staff of the MA organization and maintained in a written document. The burden associated with this requirement is the time and effort put forth by the special needs plans to establish a model that meets the requirements specified under Section 422.101(f)(1). We estimate it would take one special needs plan 24 hours for six months to meet this requirement. We estimate 335 special needs plans would be affected by this requirement annually; therefore, the total annual burden associated with the requirement is 8,040 hours. Section 422.103 Benefits Under an MA MSA Plan Section 422.103(e) requires all MA organizations offering MSA plans to provide enrollees with available information on the cost and quality of services in their service area, and to submit to CMS for approval a proposed approach to providing such information. The burden associated with this requirement is the time and effort put forth by the MA organization offering MSA plans to provide information to enrollees and to submit the proposed approach to providing such information to CMS. About 3,300 Medicare beneficiaries are enrolled in Medicare MSA plans in 2008. We expect that the burden upon health plans to develop cost and quality data for use by MSA enrollees would depend upon what data is available in their area. As stated in the preamble, we expect that organizations that already have mechanisms in place in connection with their commercial lines of business for providing their beneficiaries with cost or quality information could offer similar services to Medicare beneficiaries. We estimate that 20 MA plans may wish to participate as MSAs in 2009, which would be double the number participating in 2008. We estimate the burden associated with this requirement in term of time and effort necessary for the plan to develop the information and to submit this information to CMS as a start-up cost of 100 hours per plan to develop this information for a total of 2,000 hours in the first year the plan participates as an MSA plan, with half of that cost occurring in subsequent years for plans to maintain and update this information. In addition, expected additional entry by plans in future years would add start-up costs in the initial year that plans enter. Section 422.107 Special Needs Plans and Dual Eligibles: Arrangements With States Section 422.107(a) states that an MA organization seeking to offer or currently offering a special needs plan primarily serving beneficiaries eligible for both Medicare and Medicaid (dual eligible SNPs) must have a documented relationship with the State Medicaid agency for the State in which the SNP is operating. At a minimum, documented arrangements must include the means to
(1)verify enrollees' eligibility for both Medicare and Medicaid, identify and share information on Medicaid provider participation, and
(3)identify Medicaid benefits which are not covered by Medicare. Medicare Advantage organizations and the respective states may choose to document their relationship in a variety of ways, such as a memorandum of agreement (MOA), a memorandum of understanding (MOU), or a contract. The burden associated with this requirement is the time and effort put forth by each special needs plan to have a documented relationship. We estimate it would take one special needs plan 18 hours for 6 months to comply with this requirement. We estimate 460 special needs plans would be affected annually by this requirement; therefore, the total annual burden associated with this requirement is 8,280 hours. Section 422.504 Contract Provisions Section 422.504(g)(1) states that each MA organization must adopt and maintain arrangements satisfactory to CMS to protect its enrollees from incurring liability for payment of fees that are the legal obligation of the MA organization. This may be done by the establishment of identified liaison staff of the MA plan and the State Medicaid agency, and by conducting regular meetings for the purpose of enrollee review. The burden associated with this requirement is the time and effort put forth by the MA plan to adopt and maintain arrangements. We estimate it would take one MA plan 208 hours to comply with this requirement. We estimate 3400 plans would be affected annually by this requirement; therefore, the total annual burden associated with this requirement is 707,200 hours. Section 422.2260 Definitions Section 422.2260 defines the marketing materials that an MA organization must provide to Medicare beneficiaries. While there is burden associated with this requirement, we feel the burden associated with these requirements is exempt from the requirements of the Paperwork Reduction Act of 1995
(PRA)as defined in 5 CFR 1320.3(b)(2) because the time, effort, and financial resources necessary to comply with the requirement would be incurred by persons in the normal course of their activities. 422.2262 Review and Distribution of Marketing Materials Section 422.2262(a)(1)(i) states that at least 45 days before the date of distribution the MA organization submits the material or form to CMS for review under guidelines in Section 422.2264 of this Part. This may require the development of written marketing materials used to promote an organization, provide enrollment information, and explain benefits, rules or various membership operational policies. The burden associated with this is the time and effort put forth by the MA organization to submit the material to CMS for review. We estimate it would take one MA organization 720 minutes/12 hours to comply with this requirement. We estimate 670 MA organizations would be affected annually by this requirement; therefore, the total annual burden associated with this requirement is 8,040 hours. Section 422.2262(b) requires the MA organization to certify that in the case of these certain marketing materials designated by CMS, it followed all applicable marketing guidelines when applicable or used model language specified by CMS without modification. The burden associated with this requirement is the time and effort put forth by the MA organization to provide such certification. While there is burden associated with this requirement, we feel the burden associated with these requirements is exempt from the requirements of the Paperwork Reduction Act of 1995
(PRA)as defined in 5 CFR 1320.3(h)(1). Section 422.2264 Guidelines for CMS Review and Notification Section 422.2264 states that in reviewing marketing material or election forms under § 422.2262 of this Part, CMS determines that the marketing materials provide, in a format (and, where appropriate, print size), and using standard terminology that may be specified by CMS, the following information to Medicare beneficiaries interested in enrolling:
(a)Adequate written description of rules (including any limitations on the providers from whom services can be obtained), procedures, basic benefits and services, and fees and other charges.
(b)Adequate written description of any supplemental benefits and services.
(c)Adequate written explanation of the grievance and appeals process, including differences between the two, and when it is appropriate to use each.
(d)Any other information necessary to enable beneficiaries to make an informed decision about enrollment.
(e)Notify the general Public of its enrollment period in an appropriate manner, through appropriate media, throughout its service and if applicable, continuation areas.
(f)Includes in the written materials notice that the MA organization is authorized by law to refuse to renew its contract with CMS, that CMS also may refuse to renew the contract, and that termination or non-renewal may result in termination of the beneficiary's enrollment in the plan.
(g)Are not materially inaccurate or misleading or otherwise make material misrepresentations.
(h)For markets with a significant non-English speaking population, provide materials in the language of these individuals. The burden with these guidelines is the time and effort put forth by the MA organization to provide adequate written descriptions of rules, of any supplemental benefits and services, explanation of the grievance and appeals process, and any other information necessary to enable beneficiaries to make an informed decision about enrollment. It also requires the MA organization to notify the general public of its enrollment period in an appropriate manner and include in the written materials notice that the MA organization is authorized by law to refuse to renew its contract with CMS. While there is burden associated with this requirement, we feel the burden associated with these requirements is exempt from the requirements of the Paperwork Reduction Act of 1995
(PRA)as defined in 5 CFR 1320.3(b)(2) because the time, effort, and financial resources necessary to comply with the requirement would be incurred by persons in the normal course of their activities. Section 422.2268 Standards for MA Organization Marketing Section 422.2268(g) states MA organizations cannot market any health care related product during a marketing appointment beyond the scope agreed upon by the beneficiary, and documented by the plan, prior to the appointment. The burden associated with this requirement is the time and effort put forth by the MA organization to document a beneficiary's signed acknowledgement confirming the specific types of choices that the marketing representative is authorized to discuss. While there is burden associated with this requirement, we feel the burden associated with these requirements is exempt from the requirements of the Paperwork Reduction Act of 1995
(PRA)as defined in 5 CFR 1320.3(b)(2) because the time, effort, and financial resources necessary to comply with the requirement would be incurred by persons in the normal course of their activities. Section 422.2272 Licensing of Marketing Representatives and Confirmation of Marketing Resources Section 422.2272(b) states that an MA organization must establish and maintain a system for confirming that enrolled beneficiaries have, in fact, enrolled in the MA plan and understand the rules applicable under the plan. The burden associated with this requirement is the time and effort put forth by the MA organization to establish and maintain such a system. While there is burden associated with this requirement, we feel the burden associated with these requirements is exempt from the requirements of the Paperwork Reduction Act of 1995
(PRA)as defined in 5 CFR 1320.3(b)(2) because the time, effort, and financial resources necessary to comply with the requirement would be incurred by persons in the normal course of their activities. Section 422.2274 Broker and Agent Commissions and Training of Sales Agents Section 422.2274(b) states that if a MA organization markets through independent brokers or agents, they must train and test agents selling Medicare products concerning Medicare rules and regulations specific to the plan products they intend to sell. The burden associated with this requirement is the time and effort put forth by the MA organization to provide training and test agents. While there is burden associated with this requirement, we feel the burden associated with these requirements is exempt from the requirements of the Paperwork Reduction Act of 1995
(PRA)as defined in 5 CFR 1320.3(b)(2) because the time, effort, and financial resources necessary to comply with the requirement would be incurred by persons in the normal course of their activities. Section 422.2274(d) states that upon CMS's request, the MA organization must provide CMS the information necessary for it to conduct oversight of marketing activities. This may require producing information for CMS on marketing materials submitted for review or file and use of training and testing modules. The burden associated with this requirement is the time and effort put forth by the MA organization to produce the information requested by CMS. We estimate it would take one MA organization (480 minutes/8 hours) to comply with this requirement. We estimate 670 MA organizations would be affected annually by this requirement; therefore, the total annual burden associated with this requirement is 5,360 hours. Section 422.2274(e) states that MA organizations must comply with State requests for information about the performance of a licensed agent or broker as part of a state investigation into the individual's conduct. The burden associated with this requirement is the time and effort put forth by the MA organization to comply with the State requests for information. While there is burden associated with this requirement, we feel the burden associated with these requirements is exempt from the requirements of the Paperwork Reduction Act of 1995
(PRA)as defined in 5 CFR 1320.3(b)(2) because the time, effort, and financial resources necessary to comply with the requirement would be incurred by persons in the normal course of their activities. Section 423.34 Enrollment of Full-benefit Dual Eligible Individuals Section 423.34(g)(2) states that the organization that receives the enrollment must provide notification that describes the costs and benefits of the new plan and the process for accessing care under the plan and their ability to decline the enrollment or choose another plan. Such notification must be provided to all potential enrollees prior to the enrollment effective date, in a form and manner determined by CMS. The burden associated with this requirement is the time and effort put forth by the organization to provide such notification. We estimate it would take one organization 207 hours to comply with this requirement. We estimate 42 organizations would be affected annually by this requirement; therefore, the total annual burden associated with this requirement is 8700 hours. Section 423.46 Late Enrollment Penalty Section 423.46(b) states that Part D sponsors must obtain information on prior creditable coverage from all enrolled or enrolling beneficiaries and report this information to CMS in a form and manner determined by CMS. The burden associated with this requirement is the time and effort put forth by the Part D sponsor to obtain the required information. To comply with this requirement, Part D sponsors would expend 15 minutes per new Part D enrollee. We estimate that there will be approximately 500,000 new Part D enrollees. Therefore the total annual burden associated with this requirement will be 125,000 hours/7,500,000 minutes for all enrollees. Section 423.46(d) requires the Part D plan sponsor to retain all information collected concerning a credible coverage period determination in accordance with the enrollment records retention requirements described in subpart K, § 423.505(e)(1)(iii). The burden associated with this requirement is the time and effort put forth by the Part D plan sponsor to retain the required information. To comply with this requirement, Part D sponsors would expend 5 minutes per new Part D enrollee. There are approximately 500,000 enrollees. We estimate the total annual burden associated with this requirement will be 41,667 hours/2,500,000 minutes for all new Part D enrollees. Section 423.505 Contract Provisions Section 423.505(k)(5) states that the Chief Executive Officer, Chief Financial Officer, or an individual delegated the authority to sign on behalf of one of these officers, and who reports directly to the officer, must certify that the information provided is accurate, complete, and truthful and fully conforms to the requirements in §§ 423.336 and 423.343 and acknowledge that this information will be used for the purposes of obtaining Federal reimbursement. While there is burden associated with this requirement, we feel the burden associated with these requirements is exempt from the requirements of the Paperwork Reduction Act of 1995
(PRA)as defined in 5 CFR 1320.3(h)(1). Section 423.580 Right to a Redetermination Section 423.580 provides information on the ways for an enrollee to seek a redetermination. The burden associated with a reconsideration is exempt from the PRA as stipulated under 5 CFR 1320.4. Section 423.2262 Review and Distribution of Marketing Materials Section 423.2262(a)(1)(i) requires the Part D sponsor to submit the marketing material or form to CMS for review under the guidelines in § 423.2264. This may require the development of written marketing materials used to promote an organization, provide enrollment information, and explain benefits, rules or various membership operational policies. The burden associated with these requirements is the time and effort put forth by the Part D sponsor to submit the marketing materials to CMS and to provide certification. We estimate it would take one Part D sponsor (720 minutes/12 hours) to comply with this requirement. We estimate 87 Part D sponsors would be affected annually by this requirement; therefore, the total annual burden associated with this requirement is 1044 hours. Section 423.2264 Guidelines for CMS Review and Notification Section 423.2264 reads that in reviewing marketing material or enrollment forms under § 423.2262, CMS determines (unless otherwise specified in additional guidance) that the marketing materials provide, in a format (and, where appropriate, print size), and using standard terminology that may be specified by CMS, the following information to Medicare beneficiaries interested in enrolling must consist of:
(a)Adequate written description of rules (including any limitations on the providers from whom services can be obtained), procedures, basic benefits and services, and fees and other charges.
(b)Adequate written explanation of the grievance and appeals process, including differences between the two, and when it is appropriate to use each.
(c)Any other information necessary to enable beneficiaries to make an informed decision about enrollment.
(d)Notify the general public of its enrollment period in an appropriate manner, through appropriate media, throughout its service area.
(e)Include in the written materials notice that the Part D plan is authorized by law to refuse to renew its contract with CMS, that CMS also may refuse to renew the contract, and that termination or non-renewal may result in termination of the beneficiary's enrollment in the Part D plan. In addition, the Part D plan may reduce its service area and no longer be offered in the area where a beneficiary resides.
(f)Are not materially inaccurate or misleading or otherwise make material misrepresentations.
(g)For markets with a significant non-English speaking population, provide materials in the language of these individuals. The burden with these guidelines is the time and effort put forth by the Part D plan to provide adequate written descriptions of rules, of the grievance and appeals process, and any other information necessary to enable beneficiaries to make an informed decision about enrollment. It also requires the Part D plan to notify the general public of its enrollment period in an appropriate manner and include in the written materials notice that the Part D plan is authorized by law to refuse to renew its contract with CMS. While there is burden associated with this requirement, we feel the burden associated with these requirements is exempt from the requirements of the Paperwork Reduction Act of 1995
(PRA)as defined in 5 CFR 1320.3(b)(2) because the time, effort, and financial resources necessary to comply with the requirement would be incurred by persons in the normal course of their activities. Section 423.2272 Licensing of Marketing Representatives and Confirmation of Marketing Resources Section 423.2272(b) requires the Part D organization to establish and maintain a system for confirming that enrolled beneficiaries have in fact enrolled in the PDP and understand the rules applicable under the plan. The burden associated with this requirement is the time and effort put forth by the Part D sponsor to establish and maintain such a system. While there is burden associated with this requirement, we feel the burden associated with these requirements is exempt from the requirements of the Paperwork Reduction Act of 1995
(PRA)as defined in 5 CFR 1320.3(b)(2) because the time, effort, and financial resources necessary to comply with the requirement would be incurred by persons in the normal course of their activities. Section 423.2268 Standards for Part D Marketing Section 423.2268(g) states Part D organizations cannot market any health care related product during a marketing appointment beyond the scope agreed upon by the beneficiary, and documented by the plan, prior to the appointment. The burden associated with this requirement is the time and effort put forth by the Part D organization to document a beneficiary's signed acknowledgement confirming the specific types of choices that the marketing representative is authorized to discuss. While there is burden associated with this requirement, we feel the burden associated with these requirements is exempt from the requirements of the Paperwork Reduction Act of 1995
(PRA)as defined in 5 CFR 1320.3(b)(2) because the time, effort, and financial resources necessary to comply with the requirement would be incurred by persons in the normal course of their activities. Section 423.2274 Broker and Agent Commissions and Training of Sales Agents Section 423.2274(b) requires the Part D sponsor to train and test agents selling Medicare products concerning Medicare rules and regulations specific to the plan products they intend to sell. The burden associated with this requirement is the time and effort put forth by the Part D sponsor to provide training and test agents. While there is burden associated with this requirement, we feel the burden associated with these requirements is exempt from the requirements of the Paperwork Reduction Act of 1995
(PRA)as defined in 5 CFR 1320.3(b)(2) because the time, effort, and financial resources necessary to comply with the requirement would be incurred by persons in the normal course of their activities. Section 423.2274(d) states that upon CMS's request, the Part D sponsor must provide CMS the information necessary for it to conduct oversight of marketing activities. This may require producing information for CMS on marketing materials submitted for review or file and use and training and testing modules. The burden associated with this requirement is the time and effort put forth by the Part D sponsor to produce the information requested by CMS. We estimate it would take one Part D sponsor (480 minutes/8 hours) to comply with this requirement. We estimate 87 Part D sponsors would be affected annually by this requirement; therefore, the total annual burden associated with this requirement is 696 hours. Section 423.2274(e) states that Part D organizations must comply with State requests for information about the performance of a licensed agent or broker as part of a state investigation into the individual's conduct. The burden associated with this requirement is the time and effort put forth by the Part D organization to comply with the State requests for information. While there is burden associated with this requirement, we feel the burden associated with these requirements is exempt from the requirements of the Paperwork Reduction Act of 1995
(PRA)as defined in 5 CFR 1320.3(b)(2) because the time, effort, and financial resources necessary to comply with the requirement would be incurred by persons in the normal course of their activities. Please note, CMS will revise the currently OMB approved PRA packages that contain Part 422—Medicare Advantage Program and Part 423—Voluntary Medicare Prescription Drug Benefit to include any new and/or revised burden requirements. The OMB approval numbers for those PRA packages are 0938-0753 and 0938-0964. As reflected in the table that follows, the aggregate annual burden associated with the collection of information section for this proposed rule totals 985,527.5 hours. OMB No. Requirements Number of respondents Burden hours Total annual burden (in hours) 422.4(a) 176 54 9,504 0938-0753 422.52(g) 776 78 60,000 0938-0753 422.60(g)(2) 5 .5 2.5 0938-0753 422.101(f)(1) 335 24 8,040 0938-0753 422.103(e) 20 100 2,000 0938-0753 422.107(a) 460 18 8,280 0938-0753 422.504(g)(1) 3400 208 707,200 None/Exempt 422.2260 N/A N/A N/A 0938-0753 422.2262(a)(1)(i) 670 12 8,040 0938-0753 422.2262(b) N/A N/A N/A 0938-0753 422.2264(a-e) N/A N/A N/A 0938-0753 422.2268(g) N/A N/A N/A 0938-0753 422.2272(b) N/A N/A N/A 0938-0753 422.2274(b)(e) N/A N/A N/A 0938-0753 422.2274(d) 670 8 5,360 0938-0964 423.34(g)(2) 42 207 8,694 0938-0964 423.46(b) 500,000 ( 1 )15 125,000 0938-0964 423.46(d) 500,000 ( 1 )5 41,667 None/Exempt 423.505(k)(5) N/A N/A N/A None/Exempt 423.580 N/A N/A N/A 0938-0964 423.2262(a)(1)(i) 87 12 1,044 0938-0964 423.2264(a-e) N/A N/A N/A 0938-0964 423.2268(g) N/A N/A N/A 0938-0964 423.2272(b) N/A N/A N/A 0938-0964 423.2274(b)(e) N/A N/A N/A 0938-0964 423.2274(d) 87 8 696 Total aggregate burden 985,527.5 1 In minutes. If you comment on these information collection and recordkeeping requirements, please do either of the following: 1. Submit your comments electronically as specified in the ADDRESSES section of this proposed rule; or 2. Mail copies to the address specified in the ADDRESSES section of this proposed rule and to the Office of Information and Regulatory Affairs, Office of Management and Budget, Room 10235, New Executive Office Building, Washington, DC 20503, *Attn:* Carolyn Lovett, CMS Desk Officer, CMS-4131-P *carolyn_lovett@omb.eop.gov* . Fax
(202)395-6974. IV. Response to Comments Because of the large number of public comments we normally receive on **Federal Register** documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document. V. Regulatory Impact Analysis We have examined the impact of this rule as required by Executive Order 12866 (September 1993, Regulatory Planning and Review), the Regulatory Flexibility Act
(RFA)(September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), Executive Order 13132 on Federalism, and the Congressional Review Act (5 U.S.C. 804(2)). Executive Order 12866 (as amended) directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis
(RIA)must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). We estimate that this proposed rule is “economically significant” as measured by the $100 million threshold, and hence a major rule under the Congressional Review Act. Accordingly, we have prepared a Regulatory Impact Analysis. The provisions in this proposed rule would require MA organizations and Part D sponsors to spend a total of approximately 985,527.5 additional hours on the functions addressed, reflecting a cost of $45,940,906. In addition, the provisions associated with our proposed revision to the beneficiary cost sharing and reinsurance subsidy payments are estimated to cost $30 million for FY 2010 and $530 million for FYs 2010 through 2018. The provisions impacting which drug costs are reported to CMS under the Retiree Drug Subsidy
(RDS)program and used as the basis for calculating RDS payments to RDS plan sponsors would result in estimated savings of $30 million for FY 2010 and $510 million for FYs 2010 through 2018. We solicit public comment on the regulatory impact analysis of this proposed rule. We use, as appropriate, the figures of $14.68 (based on the United States Department of Labor
(DOL)statistics for the hourly wages of word processors and typists) and $37.15 (based on DOL statistics for a management analyst) 3 plus the added OMB figures of 12 percent for overhead and 36 percent for benefits, respectively, to represent average costs to plans, sponsors and downstream entities for the provisions discussed in this proposed rule with comment period. (Note that the wages cited for the provisions below include the hourly wage + an additional 48 percent to reflect overhead, benefit costs for total wages of $21.73 and $54.98, respectively). Using these figures the total net cost of our proposals would be approximately $45,940,906. This cost would be spread more or less evenly across participating plans, and hence would impose negligible burden on any plan in relation to existing administrative costs. 3 The hourly rates for the burden requirement were developed using the Department of Labor, Bureau of Labor Statistics for May 2006 (National Occupational Employment and Wage Estimates). In the Regulatory Impact Analysis of the January 28, 2005 final rule (70 FR 4695) revising the Medicare Advantage program, we noted that costs associated with the MA program would be approximately $18.3 billion from 2004 through 2009, 10 percent of which we estimated would be administrative costs. The rule establishing the prescription drug benefit program published on January 28, 2005 (70 FR 4194) made a similar calculation in its Regulatory Impact Statement. Accordingly, the estimated cost of this proposed rule adds negligibly to the total administrative costs of the MA or Part D programs. With respect to economic benefits, we have no reliable basis for estimating the effects of these proposals. Many of the proposed changes clarify or codify existing policies though such clarification could contribute to greater plan efficiency and compliance with program regulations. Accordingly, we estimate that while there could be economic benefits associated with these proposals, they are difficult to gauge at this time. Because there are costs to plans and sponsors associated with several provisions of this proposed rule, however, we indicate general areas affected and specify the costs associated with these. For specific burden associated with the proposed requirements and the bases for our estimates, see section III, Collection of Information Requirements, of this rule. Note that we discuss separately, at the end of this section, provisions associated with our proposed revision to the Part D definitions (discussed in section II.B.3 of this proposed rule). Special Needs Plans Several of our proposed provisions concern special needs plans and strengthening coordination between plans and States to better coordinate care, verify that individuals in dual eligible SNPs are eligible for Medicare, and to ensure that enrollees are not charged for costs that are the responsibility of the State. In addition, we are proposing that MA plans develop models of care that are specifically targeted to the special needs individuals served by their plans. We estimate the total cost of these provisions as $2,718,104. Costs for each provision are as follows: • Verification of Medicaid eligibility or SNP status prior to beneficiary enrolling ($21.73 × 60,000 hours = $1,303,800). • Developing models of care ($54.98 × 8,040 hours = $442,039). • Documenting arrangements with States ($54.98 × 8,280 hours = $455,234). • Monitoring enrollment to meet disproportionate share thresholds ($54.98 × 9,404 hours = $517,031). Medicare Medical Savings Accounts
(MSAs)Costs associated with this proposed provision are for reporting cost and quality information about the plans to enrollees. We estimate the total cost of these provisions as $109,960 ($54.98 × 2,000 hours) for the first year a plan provides such information, and half that cost in subsequent years to maintain and update the information. Enrollment We are proposing requirements concerning Part D sponsor notification of full benefit dual eligible beneficiaries about enrollment options in addition to automatic enrollment, and would require that Part D sponsors obtain from Part D plan enrollees or those considering enrolling information concerning prior creditable coverage, and retain information collected concerning creditable coverage period determinations. We estimate the total cost of these provisions as $42,692,449. The costs for specific provisions are as follows: • Notifying dual eligible beneficiaries of enrollment options in addition to automatic enrollment ($21.73 × 8,694 hours = $188,920). • Obtaining prior creditable coverage information ($21.73 × 125,000 hours = $2,716,250). • Retaining prior creditable coverage information ($21.73 × 41,667 hours = $905,423). • Ensuring through provider contracts that dual eligible beneficiaries are not held liable for costs that are not their responsibility ($54.98 × 707,200 hours = $38,881,856). Marketing We are proposing several marketing provisions that would enhance our efforts to ensure that plans comply with all marketing requirements. The proposed provisions include requiring plans to submit marketing materials to CMS for review, and provide, for CMS oversight purpose, information to CMS concerning marketing activities. We estimate the total costs (MA and Part D programs) of these provisions as $530,353. Costs for each provision, in the context of each program, are as follows: • Submission of marketing materials, MA program ($21.73 × 8,040 hours = $174,709). • Training and testing of agents selling Medicare products, MA program ($54.98 × 5,360 hours = $294,692). • Submission of marketing materials, Part D ($21.73 × 1,044 hours = $22,686). • Training and testing of agents selling Medicare products, Part D ($54.98 × 696 hours = $38,266). The RFA requires that we discuss any alternatives considered. Many of the proposed provisions would clarify or codify current policy which we discuss in section II, Provisions of the Proposed Regulations. As such, we considered whether or not the cost to codify these policies outweighed the need to do so. With one possible exception, we determined that the cost to plans and sponsors to clarify and codify our policies would be minimal and outweighed the minimal costs to implement these. With respect to our proposed provisions concerning Medicare medical savings account plans, we considered the costs to plans of providing cost and quality information. As we discuss in more detail in section II, we believe that such information is readily available to most MSA plans and that, as a result, it would not be an undue burden on plans to provide such information. We would like more information on this subject, however, and have specifically asked for comments on this proposed provision. The RFA requires agencies to analyze options for regulatory relief of small businesses. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of $6.5 million to $31.5 million in any 1 year. Individuals and States are not included in the definition of a small entity. MA organizations and Part D sponsors, the only entities that would be affected by the proposed provisions, are not generally considered small business entities. They must follow minimum enrollment requirements (5,000 in urban areas and 1,500 in non-urban areas) and because of the revenue from such enrollments generally are above the revenue threshold required for analysis. While a very small rural plan could fall below the threshold, we do not believe that there are more than a handful of such plans. A fraction of MA organizations and sponsors are considered small businesses because of their non-profit status. For an analysis to be necessary, however, 3-5 percent of their revenue would have to be affected by the proposed provisions. We do not believe that any of these provisions rise to that threshold. Many of the provisions we are proposing, for example, are clarifications of existing policy or require minimal costs. Because MA organizations and Part D sponsors are the only entities that would be affected by the proposed provisions and because of the minimal costs necessary to implement the proposed provisions, we are not preparing an analysis for the RFA because we have determined, and the Secretary certifies, that this proposed rule would not have a significant economic impact on a substantial number of small entities. With respect to the proposed revision to the Part D definitions, we do not expect a significant impact on small businesses, such as small pharmacies, as a result of changes to the definitions under Part D of negotiated prices, gross covered drug costs, and allowable risk corridor costs in this proposed rule. These changes would primarily impact which drug costs are reported to us and how plans calculate beneficiary cost sharing. Moreover, we assume they would require minimal, if any, changes in health plan, PBM and pharmacy operational systems. We solicit comments on this assumption. Even with the changes to the way in which beneficiary cost sharing is calculated resulting from these definition changes, health plans will still be required to ensure that pharmacies receive their contracted rate. We believe that health plans would account for any additional costs associated with the change in the way beneficiary costs are calculated in their Part D bids. As a result, we expect that these changes would increase Part D bids and Federal Government payments such that the total impact for FY 2010 through 2018 is $530 million. However, we do not expect these changes to significantly increase health plan costs. Table 1 presents the costs associated with the change in the beneficiary costs for FYs 2010-2018. Table 1.—Increase in Subsidy Payments for FY 2010-2018 FY 2010 FY 2011 FY 2012 FY 2013 FY 2014 FY 2015 FY 2016 FY 2017 FY 2018 FYs 2010-18 Increase in Subsidy Payments (millions) $30 $40 $50 $50 $60 $60 $70 $80 $90 $530 With respect to the proposed changes impacting which drug costs are reported to CMS and how Part D plans calculate beneficiary cost-sharing, we believe that the impact on pharmacies would be minimal, as the total compensation received by pharmacies should remain unaffected. However, Part D plans would need to include administrative costs paid to PBMs, which were previously included as drug costs, as administrative cost in their bids. They would also need to factor reductions in beneficiary cost sharing and reinsurance subsidy payments into their bids. The reductions in beneficiary cost sharing are expected to outweigh the estimated increase in costs to the Federal Government. The changes in beneficiary cost sharing and reinsurance subsidy payments are expected to increase Part D bids due to increased plan liability and therefore, would increase the direct subsidy payments made by the Federal Government to health plans. The proposed changes regarding which the reporting of drug costs are also expected to reduce the reinsurance payments and low-income cost sharing subsidy payments made by the Federal Government. We estimate the net cost of these changes to be $30 million for FY 2010 and $530 million for FYs 2010 through 2018. These estimated costs reflect an increase in the direct subsidy payments made by the Federal Government and are net reductions in Federal reinsurance payments and low-income cost sharing subsidy payments. These estimated costs are based on the assumption that overall program costs would remain the same. They do not include any potential reductions in plan administrative costs due to the ability of plan sponsors to negotiate lower administrative fees with PBMs as a result of increased transparency in drug prices. In addition, we expect that the proposed clarifications may require a small number of Part D sponsors to renegotiate their contracts with their PBMs to account for system changes to reflect the appropriate beneficiary cost sharing. We believe that most PBMs would be unaffected by the changes in the reporting drug costs reported and the calculation of beneficiary cost sharing. Thus, we expect that the financial impact of the proposed rule on PBMs would be minimal. With respect to the proposed changes impacting which drug costs are reported to CMS under the Retiree Drug Subsidy
(RDS)program and used as the basis for calculating RDS payments to RDS plan sponsors, this will result in savings to the RDS program since gross costs and allowable retiree costs may, until this proposed regulation becomes effective, include amounts paid by the plan to a PBM for Part D drugs that differ from the amounts paid by the PBM to pharmacies for these drugs (typically called a “risk premium” or “PBM spread”). The proposed revised definitions of administrative costs, gross retiree costs and allowable retiree costs would exclude these risk premium payments from the calculation of RDS payments. The estimated impact of applying the proposed changes is a savings of $510 million for fiscal years 2010 through 2018, as detailed in Table 2. To calculate these savings estimates, we multiplied our assumption for the number of affected beneficiaries in RDS by an estimated per capita drug cost impact and the statutorily-required 28 percent RDS subsidy percentage. Our estimate for the number of affected beneficiaries in RDS is based on the number of RDS beneficiaries assumed to be enrolled in affected RDS plans. In addition, this estimate assumes that only those RDS beneficiaries with drug spending between the cost threshold and the cost limit would be impacted by the proposed change. The proposed change would not affect Plan Sponsors with regard to those individuals below the threshold. With regard to those above the cost limit, a Plan Sponsor generally is eligible for a set amount of subsidy based on the amount of drug costs between the threshold and the limit, regardless of how much above the limit the individual's drug costs are, and regardless of whether pass through or lock in is used. Therefore, the proposed change generally would not affect Plan Sponsors with regard to individuals above the cost limit. We estimated the drug cost impact of switching from lock-in pricing to pass through pricing based on current estimates for 2006 Part D plans. We used the estimated impact for Part D plans because RDS specific information is not currently available to develop this estimate. We welcome comments on the assumptions used to develop the savings estimates from applying the revised definitions to the RDS program. In addition, we expect that the proposed rule's clarifications may result in some plan sponsors incurring nominal additional administrative costs in revising cost reporting methods. Table 2.—Decrease in RDS Payments for FY 2010-2018 FY 2010 FY 2011 FY 2012 FY 2013 FY 2014 FY 2015 FY 2016 FY 2017 FY 2018 FYs 2010-2018 Decrease in RDS Payments by the Federal Government (in millions) $30 $40 $50 $50 $60 $60 $70 $70 $80 $510 In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area and has fewer than 100 beds. We are not preparing an analysis for section 1102(b) of the Act because we have determined, and the Secretary certifies, that this proposed rule would not have a significant impact on the operations of a substantial number of small rural hospitals. Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year by State, local or tribal governments, in the aggregate, or by the private sector of $100 million in 1995 dollars, updated annually for inflation. That threshold level is currently approximately $130 million. This rule would have no consequential effect on State, local, or tribal governments or on the private sector. Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. This rule would not have a substantial direct effect on State or local governments, preempt States, or otherwise have a Federalism implication. Alternatives Considered As discussed earlier, many of the proposed provisions would clarify or codify current policy which we discuss in section II, Provisions of the Proposed Regulations. As such, we considered whether or not the cost to codify these policies outweighed the need to do so. With one possible exception, we determined that the cost to plans and sponsors to clarify and codify our policies would be minimal and outweighed the minimal costs to implement these provisions. With respect to our proposed provisions concerning Medicare medical savings account plans, we considered the costs to plans of providing cost and quality information. As we discuss in more detail in section II, we believe that the information is readily available to most MSA plans and that, as a result, it would not be an undue burden on plans to provide the information. We would like more information on this subject, however, and have specifically asked for comments on this proposed provision. With respect to the proposed changes to the drug cost-related definitions in the Part D and Retiree Drug Subsidy
(RDS)programs, we have discussed the two alternatives at length in the preamble section. The two alternatives are
(1)the current approach of allowing both pass-through and lock-in prices, and
(2)the proposed approach of permitting only pass-through prices as the basis for Part D and RDS costs. As we discuss in section II.B, we believe there may be significant negative impacts on beneficiaries, market competition, pharmacies, and government expenditures associated with maintaining the current dual pricing approach and, therefore, we propose to allow only the single “pass-through” pricing approach as originally intended in the final rule establishing the Part D prescription drug benefit. Accounting Statement As required by OMB Circular A-4 (available at *http://www.whitehouse.gov/omb/circulars/index.html* ), in Table D1 below, we have prepared an accounting statement showing the classification of the expenditures associated with the provisions of this final rule. This table provides our best estimate of the increase in costs as a result of the proposed changes. The costs are classified as either transfers by the Federal Government to Part D plans, or transfers from RDS sponsors to the Federal Government. Table 3.—Accounting Statement: Classification of Estimated Expenditures Category Transfers ($ millions) Increase in Federal Payments, FYs 2010-2018 Annualized Monetized Transfers Using 7% Discount Rate $55.8. Annualized Monetized Transfers Using 3% Discount Rate $57.5. From Whom to Whom Federal Government to Part D Plans. Decrease in RDS Payments for FY 2010-2018 Annualized Monetized Transfers Using 7% Discount Rate $54.1. Annualized Monetized Transfers Using 3% Discount Rate $55.5. From Whom to Whom RDS Sponsors to Federal Government. Cost for all Other Provisions Not Related to the Part D Definitions for FY 2010 Undiscounted Annualized Monetized Transfers $45.94. Who Is Affected MAOs/Part D Sponsors. Conclusion In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget. List of Subjects 42 CFR Part 422 Administrative practice and procedure, Health facilities, Health maintenance organizations (HMO), Medicare, Penalties, Privacy, Reporting and recordkeeping requirements 42 CFR Part 423 Administrative practice and procedure, Emergency medical services, Health facilities, Health maintenance organizations (HMO), Medicare, Penalties, Privacy, Reporting and recordkeeping. For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services proposes to amend 42 CFR chapter IV as set forth below: PART 422—MEDICARE ADVANTAGE PROGRAM 1. The authority citation for part 422 continues to read as follows: Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh). Subpart A—General Provisions 2. Amend § 422.4 by revising paragraph (a)(1)(iv)(B) to read as follows: § 422.4 Types of MA plans.
(a)* * *
(1)* * *
(iv)* * *
(B)Enrolls plan membership that consists of 90 percent or more special needs individuals as defined in § 422.2. ( *1* ) For purposes of meeting the 90 percent threshold, the plan may not disenroll a member who does not meet the special needs individual definition in § 422.2 of this part. ( *2* ) Those enrollees deemed continuously eligible per § 422.52(d) of this part, are considered special needs individuals for the purpose of determining the 90 percent threshold. Subpart B—Eligibility, Election, and Enrollment 3. Amend § 422.52 by adding paragraph
(g)to read as follows: § 422.52 Eligibility to elect an MA plan for special needs individuals.
(g)*Establishing eligibility prior to enrollment* . A SNP must employ a process approved by CMS to verify the Medicaid eligibility or special needs status of an individual prior to enrolling the individual. 4. Amend § 422.60 by adding paragraph
(g)to read as follows: § 422.60 Election process.
(g)*Passive enrollment by CMS* . In situations involving either immediate terminations as provided in § 422.510(a)(5) or other situations in which CMS determines that remaining enrolled in a plan poses potential harm to the members, CMS may implement passive enrollment procedures.
(1)*Passive enrollment procedures* . Individuals will be considered to have elected the plan selected by CMS unless they:
(i)Decline the plan selected by CMS, in a form and manner determined by CMS, or
(ii)Request enrollment in another plan.
(2)*Beneficiary notification* . The organization that receives the enrollment must provide notification that describes the costs and benefits of the plan and the process for accessing care under the plan and clearly explains their ability to decline the enrollment or choose another plan. Such notification must be provided to all potential enrollees prior to the enrollment effective date (or as soon as possible after the effective date if prior notice is not practical), in a form and manner determined by CMS.
(3)*Special election period* . All individuals will be provided with a special election period, as described in § 422.62(b)(4). 5. Amend § 422.74 by revising paragraph (d)(1) introductory text and adding paragraph (d)(1)(iv) to read as follows: § 422.74 Disenrollment by the MA organization.
(d)* * *
(1)Except as specified in paragraph (d)(1)(iv) of this section, an MA organization may disenroll an individual from the MA plan for failure to pay basic and supplementary premiums under the following circumstances:
(iv)An MA organization may not disenroll an individual who has requested to have monthly premiums withheld per § 422.262(f)(1) or who is in premium withhold status. 6. Remove § 422.80. Subpart C—Benefits and Beneficiary Protections 7. Amend § 422.101 by adding paragraph
(f)to read as follows: § 422.101 Requirements relating to basic benefits.
(f)*Special needs plan model of care*
(1)MA organizations offering special needs plans must have a model of care plan specifying how the plan will coordinate and deliver care designed for the plan's enrollees. The model of care plan must provide for the following:
(i)Coordinate care for eligible beneficiaries.
(ii)Include a network of providers/services having relevant clinical expertise.
(iii)Target a special needs population.
(iv)Deliver care based on appropriate protocol for the target enrollees.
(v)Deliver care to frail/disabled enrollees.
(vi)Deliver care to enrollees who are at the end of life.
(vii)Apply performance measures to evaluate processes and outcomes of the model.
(2)[Reserved] 8. Amend § 422.103 by adding new paragraph
(e)to read as follows: § 422.103 Benefits under an MA MSA plan.
(e)All MA organizations offering MSA plans must provide enrollees with available information on the cost and quality of services in their service area, and submit to CMS for approval a proposed approach to providing such information. 9. Add new § 422.107 to read as follows: § 422.107 Special needs plans and dual eligibles: arrangements with States.
(a)*General rule* . An MA organization seeking to offer or currently offering a special needs plan primarily serving beneficiaries eligible for both Medicare and Medicaid (dual eligible SNPs) must have a documented relationship with the State Medicaid agency for the State in which the SNP is operating. At a minimum, documented arrangements must include the means to—
(1)Verify enrollees' eligibility for both Medicare and Medicaid,
(2)Identify and share information on Medicaid provider participation, and
(3)Identify Medicaid benefits which are not covered by Medicare.
(b)*Date of Compliance* . Current SNPs must be in compliance with § 422.107(a) within 3 years after the effective date of the final rule. 10. Amend § 422.111 by revising paragraph (a)(3) to read as follows: § 422.111 Disclosure requirements.
(a)* * *
(3)At the time of enrollment and at least annually thereafter, 15 days before the annual coordinated election period. Subpart F—Submission of Bids, Premiums, and Related Information and Plan Approval 11. Amend § 422.262 by— A. Adding paragraph (g). B. Adding paragraph (h). The additions read as follows: § 422.262 Beneficiary premiums.
(g)*Prohibition on improper billing of premiums* . MA organizations shall not bill an enrollee for a premium payment period if the enrollee has requested that premiums be withheld from his or her Social Security benefit.
(h)*Retroactive collection of premiums* . In circumstances where retroactive collection of premium amounts is necessary and the enrollee is without fault in creating the premium arrearage, the Medicare Advantage organization shall offer the enrollee the option of payment either by lump sum or by equal monthly installment spread out over at least the same period for which the premiums were due. That is, if 7 months of premiums are due, the member would have at least 7 months to repay. Subpart K—Application Procedures and Contracts for Medicare Advantage Organizations 12. Subpart K heading is revised to read as set forth above. 13. Amend § 422.504 by revising paragraph (g)(1) to read as follows: § 422.504 Contract provisions.
(g)* * *
(1)Each MA organization must adopt and maintain arrangements satisfactory to CMS to protect its enrollees from incurring liability (for example, as a result of an organization's insolvency or other financial difficulties) for payment of any fees that are the legal obligation of the MA organization. To meet this requirement, the MA organization must—
(i)Ensure that all contractual or other written arrangements with providers prohibit the organization's providers from holding any enrollee liable for payment of any such fees;
(ii)Indemnify the enrollee for payment of any fees that are the legal obligation of the MA organization for services furnished by providers that do not contract, or that have not otherwise entered into an agreement with the MA organization, to provide services to the organization's enrollees; and
(iii)For all MA organizations with enrollees eligible for both Medicare and Medicaid, specify in contracts with providers that such enrollees will not be held liable for Medicare Part A and B cost sharing when the State is responsible for paying such amounts, and inform providers of Medicare and Medicaid benefits, and rules for enrollees eligible for Medicare and Medicaid. The contracts must state that providers will—
(A)Accept the MA plan payment as payment in full, or
(B)Bill the appropriate State source. 14. Amend § 422.506 by— A. Revising paragraph (a)(2)(ii) and (a)(2)(iii). B. Revising paragraph (b)(2)(ii) and (b)(2)(iii). The revisions read as follows: § 422.506 Non-renewal of contract.
(a)* * *
(2)* * *
(ii)Each Medicare enrollee by mail at least 60 days before the date on which the non-renewal is effective. This notice must include a written description of alternatives available for obtaining Medicare services within the service area, including alternative MA plans, Medigap options, and original Medicare and must receive CMS approval prior to issuance; and,
(iii)The general public, at least 60 days before the date on which the non-renewal is effective, by publishing a notice in one or more newspapers of general circulation in each community or county located in the MA organization's service area.
(b)* * *
(2)* * *
(ii)To each of the MA organization's Medicare enrollees by mail at least 60 days before the date on which the non-renewal is effective; and,
(iii)To the general public, at least 60 days before the date on which the non-renewal is effective, by publishing a notice in one or more newspapers of general circulation in each community or county located in the MA organization's service area. Subpart M—Grievances, Organization Determinations and Appeals 15. Revise § 422.578 to read as follows: § 422.578 Right to a reconsideration. Any party to an organization determination (including one that has been reopened and revised as described in § 422.616) may request that the determination be reconsidered under the procedures described in § 422.582, which address requests for a standard reconsideration. A physician who is providing treatment to an enrollee may, upon providing notice to the enrollee, request a standard reconsideration of a pre-service request for reconsideration on the enrollee's behalf as described in § 422.582. An enrollee or physician (acting on behalf of an enrollee) may request an expedited reconsideration as described in § 422.584. 16. Revise § 422.582 to read as follows: § 422.582 Request for a standard reconsideration.
(a)*Method and place for filing a request* . A party to an organization determination or, upon providing notice to the enrollee, a physician who is treating an enrollee and acting on the enrollee's behalf, must ask for a reconsideration of the determination by making a written request to the MA organization that made the organization determination. The MA organization may adopt a policy for accepting oral requests.
(b)*Timeframe for filing a request* . Except as provided in paragraph
(c)of this section, a request for reconsideration must be filed within 60 calendar days from the date of the notice of the organization determination.
(c)*Extending the time for filing a request* —(1) *General rule* . If a party or physician acting on behalf of an enrollee shows good cause, the MA organization may extend the timeframe for filing a request for reconsideration.
(2)*How to request an extension of timeframe* . If the 60-day period in which to file a request for reconsideration has expired, a party to the organization determination or a physician acting on behalf of an enrollee may file a request for reconsideration with the MA organization. The request for reconsideration and to extend the timeframe must—
(i)Be in writing; and
(ii)State why the request for reconsideration was not filed on time.
(d)*Parties to the reconsideration* . The parties to the reconsideration are the parties to the organization determination, as described in § 422.574, and any other provider or entity (other than the MA organization) whose rights with respect to the organization determination may be affected by the reconsideration, as determined by the entity that conducts the reconsideration.
(e)*Withdrawing a request* . The party or physician acting on behalf of an enrollee who files a request for reconsideration may withdraw it by filing a written request for withdrawal at one of the places listed in paragraph
(a)of this section. Subpart O—Intermediate Sanctions 17. Amend § 422.760 by— A. Redesignating paragraphs (b)(2) and (b)(3) as paragraphs (b)(3) and (b)(4), respectively. B. Adding new paragraph (b)(2) to read as follows: § 422.760 Determinations regarding the amount of civil money penalties and assessment imposed by CMS.
(b)* * *
(2)If the deficiency on which the determination is based has directly adversely affected (or has the substantial likelihood of adversely affecting) one or more MA enrollees, CMS may calculate a CMP of up to $25,000 for each MA enrollee directly adversely affected (or with the substantial likelihood of being adversely affected) by a deficiency. Subpart U—[Added and Reserved] 18. Subpart U is added and reserved. 19. New subpart V is added to read as follows: Subpart V—Medicare Advantage Marketing Requirements Sec. 422.2260 Definitions concerning marketing materials. 422.2262 Review and distribution of marketing materials. 422.2264 Guidelines for CMS review. 422.2266 Deemed approval. 422.2268 Standards for MA organization marketing. 422.2272 Licensing of marketing representatives and confirmation of marketing resources. 422.2274 Broker and agent commissions. 422.2276 Employer group retiree marketing. Subpart V—Medicare Advantage Marketing Requirements § 422.2260 Definitions concerning marketing materials. As used in this subpart— *Marketing materials* .
(1)Marketing materials include any informational materials targeted to Medicare beneficiaries which:
(i)Promote the MA organization, or any MA plan offered by the MA organization.
(ii)Inform Medicare beneficiaries that they may enroll, or remain enrolled in, an MA plan offered by the MA organization.
(iii)Explain the benefits of enrollment in an MA plan, or rules that apply to enrollees.
(iv)Explain how Medicare services are covered under an MA plan, including conditions that apply to such coverage.
(2)Examples of marketing materials include, but are not limited to, the following:
(i)General audience materials such as general circulation brochures, newspapers, magazines, television, radio, billboards, yellow pages, or the Internet.
(ii)Marketing representative materials such as scripts or outlines for telemarketing or other presentations.
(iii)Presentation materials such as slides and charts.
(iv)Promotional materials such as brochures or leaflets, including materials for circulation by third parties (for example, physicians or other providers).
(v)Membership communication materials such as membership rules, subscriber agreements, member handbooks and wallet card instructions to enrollees.
(vi)Letters to members about contractual changes; changes in providers, premiums, benefits, plan procedures etc.
(vii)Membership or claims processing activities (for example, materials on rules involving non-payment of premiums, confirmation of enrollment or disenrollment, or annual notification information). § 422.2262 Review and distribution of marketing materials.
(a)*CMS review of marketing materials* .
(1)Except as provided in paragraph
(b)of this section an MA organization may not distribute any marketing materials (as defined in § 422.2260 of this part), or election forms, or make such materials or forms available to individuals eligible to elect an MA organization unless—
(i)At least 45 days (or 10 days if using marketing materials that use, without modification, proposed model language as specified by CMS) before the date of distribution the MA organization has submitted the material or form to CMS for review under the guidelines in § 422.2264 of this Part; and
(ii)CMS does not disapprove the distribution of new material or form.
(2)[Reserved]
(b)*File and use* . The MA organization may distribute certain types of marketing materials, designated by CMS, 5 days following their submission to CMS if the MA organization certifies that in the case of these designated marketing materials it followed all applicable marketing guidelines and, when applicable, used model language specified by CMS without modification. § 422.2264 Guidelines for CMS review. In reviewing marketing material or election forms under § 422.2262 of this part, CMS determines that the marketing materials—
(a)Provide, in a format (and, where appropriate, print size), and using standard terminology that may be specified by CMS, the following information to Medicare beneficiaries interested in enrolling:
(1)Adequate written description of rules (including any limitations on the providers from whom services can be obtained), procedures, basic benefits and services, and fees and other charges.
(2)Adequate written description of any supplemental benefits and services.
(3)Adequate written explanation of the grievance and appeals process, including differences between the two, and when it is appropriate to use each and
(4)Any other information necessary to enable beneficiaries to make an informed decision about enrollment.
(b)Notify the general public of its enrollment period in an appropriate manner, through appropriate media, throughout its service and if applicable, continuation areas.
(c)Include in written materials notice that the MA organization is authorized by law to refuse to renew its contract with CMS, that CMS also may refuse to renew the contract, and that termination or non-renewal may result in termination of the beneficiary's enrollment in the plan.
(d)Ensure that materials are not materially inaccurate or misleading or otherwise make material misrepresentations.
(e)For markets with a significant non-English speaking population, provide materials in the language of these individuals. § 422.2266 Deemed approval. If CMS has not disapproved the distribution of marketing materials or forms submitted by an MA organization with respect to an MA plan in an area, CMS is deemed not to have disapproved the distribution in all other areas covered by the MA plan and organization except with regard to any portion of the material or form that is specific to the particular area. § 422.2268 Standards for MA organization marketing. In conducting marketing activities, MA organizations may not—
(a)Provide for cash or other monetary rebates as an inducement for enrollment or otherwise. This does not prohibit explanation of any legitimate benefits the beneficiary might obtain as an enrollee of the MA plan, such as eligibility to enroll in a supplemental benefit plan that covers deductibles and coinsurance, or preventive services.
(b)Offer gifts to potential enrollees, unless the gifts are of nominal (as defined in the CMS Marketing Guidelines) value, are offered to all eligible members without discrimination, and are not in the form of cash or other monetary rebates. Providing meals for potential enrollees is prohibited, regardless of value.
(c)Engage in any discriminatory activity such as, for example, attempts to recruit Medicare beneficiaries from higher income areas without making comparable efforts to enroll Medicare beneficiaries from lower income areas.
(d)Solicit door-to-door for Medicare beneficiaries or through other unsolicited means of direct contact, including calling a beneficiary without the beneficiary initiating the contact.
(e)Engage in activities that could mislead or confuse Medicare beneficiaries, or misrepresent the MA organization. The MA organization may not claim that it is recommended or endorsed by CMS or Medicare or that CMS or Medicare recommends that the beneficiary enroll in the MA plan. It may, however, explain that the organization is approved for participation in Medicare.
(f)Market non-health care related products to prospective enrollees during any MA or Part D sales activity or presentation. This is considered cross-selling and is prohibited.
(g)Market any health care related product during a marketing appointment beyond the scope agreed upon by the beneficiary, and documented by the plan, prior to the appointment.
(h)Market additional health related lines of plan business not identified prior to an in-home appointment without a separate appointment that may not be scheduled until 48 hours after the initial appointment.
(i)Distribute marketing materials for which, before expiration of the 45-day period, the MA organization receives from CMS written notice of disapproval because it is inaccurate or misleading, or misrepresents the MA organization, its marketing representatives, or CMS.
(j)Use providers or provider groups to distribute printed information comparing the benefits of different health plans unless the materials have the concurrence of all MA organizations involved.
(k)Conduct sales presentations or distribute and accept plan applications in provider offices or other places where health care is delivered.
(l)Conduct sales presentations or distribute and accept plan applications at educational events.
(m)Employ MA plan names that suggest that a plan is not available to all Medicare beneficiaries. This prohibition shall not apply to MA plan names in effect on July 31, 2000.
(n)Display the names and/or logos of co-branded network providers on the organization's member identification card. Other marketing materials that include names and/or logos of provider co-branding partners must clearly indicate that other providers are available in the network.
(o)Engage in any other marketing activity prohibited by CMS in its marketing guidance. § 422.2272 Licensing of marketing representatives and confirmation of marketing resources. In its marketing the MA organization must—
(a)Demonstrate to CMS' satisfaction that marketing resources are allocated to marketing to disabled Medicare population as well as beneficiaries age 65 and over.
(b)Establish and maintain a system for confirming that enrolled beneficiaries have, in fact, enrolled in the MA plan and understand the rules applicable under the plan.
(c)Employ as marketing representatives only individuals who are licensed by the State to conduct marketing activities (as defined in the Medicare Marketing Guidelines) in that State, and whom the organization has informed that State it has appointed, consistent with the appointment process provided for under State law, except that any fees required under such appointment process do not apply. § 422.2274 Broker and agent commissions. If a Medicare Advantage organization markets through independent brokers or agents— (a)(1) In paying a commission or other compensation (collectively referred to as “commission”) to such agent or representative, the commission the agent would receive for selling or servicing the policy in the first year could not exceed the commission the agent receives for selling or servicing the policy in all subsequent years.
(2)The commission must be the same for all plans and plan product types offered by the MA plan's parent organization.
(b)It must ensure agents selling Medicare products are trained on Medicare rules and regulations specific to the plan products they intend to sell.
(c)It must ensure agents selling Medicare products are tested, as specified in CMS guidance.
(d)Upon CMS's request, the organization must provide to CMS the information necessary for it to conduct oversight of marketing activities.
(e)It must comply with State requests for information about the performance of a licensed agent or broker as part of a state investigation into the individual's conduct. CMS will establish and maintain a memorandum of understanding
(MOU)to share compliance and oversight information with States that agree to the MOU. § 422.2276 Employer group retiree marketing. MA organizations may develop marketing materials designed for members of an employer group who are eligible for employer-sponsored benefits through the MA organization, and furnish these materials only to the group members. These materials are not subject to CMS prior review and approval. PART 423—VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT 20. The authority citation for part 423 continues to read as follows: Authority: Secs. 1102, 1860D-1 through 1860D-42, and 1871 of the Social Security Act (42 U.S.C. 1302, 1395w-101 through 1395w-152, and 1395hh). Subpart B—Eligibility and Enrollment 21. Amend § 423.32 by adding paragraph
(g)to read as follows: § 423.32 Enrollment process.
(g)*Passive enrollment by CMS* . In situations involving either immediate terminations as provided in § 423.509(a)(5) or § 422.510(a)(5), or other situations in which CMS determines that remaining enrolled in a plan poses potential harm to plan members, CMS may implement passive enrollment procedures.
(1)*Passive enrollment procedures* . Individuals will be considered to have enrolled in the plan selected by CMS unless individuals—
(i)Decline the plan selected by CMS, in a form and manner determined by CMS, or
(ii)Request enrollment in another plan.
(2)*Beneficiary notification* . The organization that receives the enrollment must provide notification that describes the costs and benefits of the new plan and the process for accessing care under the plan and the beneficiary's ability to decline the enrollment or choose another plan. Such notification must be provided to all potential enrollees prior to the enrollment effective date (or as soon as possible after the effective date if prior notice is not practical), in a form and manner determined by CMS.
(3)*Special election period* . All individuals will be provided with a special enrollment period, as described in § 423.38(c)(8)(ii). 22. Amend § 423.34 by— A. Revising paragraph (d)(1). B. Adding paragraph (d)(3). The revision and addition reads as follows: § 423.34 Enrollment of full-benefit dual eligible individuals.
(d)*Automatic enrollment rules—(1) General rule* . Except for full-benefit dual eligible individuals who are qualifying covered retirees as specified in paragraph (d)(3) of this section, CMS automatically enrolls full-benefit dual eligible individuals who fail to enroll in a Part D plan into a PDP offering basic prescription drug coverage in the area where the individual resides that has a monthly beneficiary premium amount (as defined in § 423.780(b)). In the event that there is more than one PDP in an area with a monthly beneficiary premium at or below the low-income premium subsidy amount, individuals are enrolled in such PDPs on a random basis.
(3)*Exception for full-benefit dual eligible individuals who are qualifying covered retirees* . Full-benefit dual eligible individuals who are qualifying covered retirees as defined in § 423.882 also are automatically enrolled in a part D plan, consistent with this paragraph, unless they elect to decline that enrollment. Before effectuating such an enrollment, however, CMS will provide notice to such individuals of their choices and advise them to discuss the potential impact of Medicare Part D coverage on their group health plan coverage. This notice informs such individuals that they will be deemed to have declined to enroll in Part D unless they affirmatively enroll in a Part D plan or contact CMS and confirm that they wish to be auto-enrolled in a PDP. Individuals who elect not to be auto-enrolled, may enroll in Medicare Part D at a later time if they choose to do so. 23. Amend § 423.44 by revising paragraph (d)(1) introductory text and adding paragraph (d)(1)(iv) as follows: § 423.44 Involuntary disenrollment by the PDP.
(d)* * *
(1)Except as specified in paragraph (d)(1)(iv) of this section, a PDP sponsor may disenroll an individual from the PDP for failure to pay any monthly premium under the following circumstances:
(iv)A PDP sponsor may not disenroll an individual who has requested to have monthly premiums withheld per § 423.293(a) or who is in premium withhold status, as defined by CMS. 24. Amend § 423.46 by adding paragraph
(b)through
(d)to read as follows: § 423.46 Late enrollment penalty.
(b)*Role of Part D plan in determination of the penalty* . Part D sponsors must obtain information on prior creditable coverage from all enrolled or enrolling beneficiaries and report this information to CMS in a form and manner determined by CMS.
(c)*Reconsideration* . Individuals determined to be subject to a late enrollment penalty may request reconsideration of this determination, consistent with § 423.56(g). Such review will be conducted by CMS, or an independent review entity contracted by CMS, in accordance with guidance issued by CMS. Decisions made through this review are not subject to appeal, but may be reviewed and revised at the discretion of CMS.
(d)*Record retention* . Part D plan sponsors must retain all information collected concerning a creditable coverage period determination in accordance with the enrollment records retention requirements described in subpart K, § 423.505(e)(1)(iii). § 423.50 [Removed] 25. Remove § 423.50. Subpart C—Benefits and Beneficiary Protections 26. Section 423.100 is amended by— A. Revising the definition of “incurred costs.” B. Revising the definition of “negotiated prices.” The revision reads as follows: § 423.100 Definitions. *Incurred costs* means costs incurred by a Part D enrollee for— (1)(i) Covered Part D drugs that are not paid for under the Part D plan as a result of application of any annual deductible or other cost-sharing rules for covered Part D drugs prior to the Part D enrollee satisfying the out-of-pocket threshold under § 423.104(d)(5)(iii), including any price differential for which the Part D enrollee is responsible under § 423.124(b); or
(ii)Nominal cost-sharing paid by or on behalf of an enrollee, which is associated with drugs that would otherwise be covered Part D drugs, as defined in § 423.100, but are instead paid for, with the exception of said nominal cost-sharing, by a patient assistance program providing assistance outside the Part D benefit, provided that documentation of such nominal cost-sharing has been submitted to the Part D plan consistent with the plan processes and instructions for the submission of such information; and
(2)That are paid for—
(i)By the Part D enrollee or on behalf of the Part D enrollee by another person, and the Part D enrollee (or person paying on behalf of the Part D enrollee) is not reimbursed through insurance or otherwise, a group health plan, or other third party payment arrangement, or the person paying on behalf of the Part D enrollee is not paying under insurance or otherwise, a group health plan, or third party payment arrangement;
(ii)Under a State Pharmaceutical Assistance Program (as defined in § 423.454 of this part); or
(iii)Under § 423.782 of this part. *Negotiated prices* means prices for covered Part D drugs that—
(1)The Part D sponsor (or other intermediary contracting organization) and the network dispensing pharmacy or other network dispensing provider have negotiated as the amount such network entity will receive, in total, for a particular drug;
(2)Are reduced by those discounts, direct or indirect subsidies, rebates, other price concessions, and direct or indirect remuneration that the Part D sponsor has elected to pass through to Part D enrollees at the point of sale; and
(3)Includes any dispensing fees. 27. Amend § 423.104 by revising paragraph (g)(1) to read as follows: § 423.104 Requirements related to qualified prescription drug coverage.
(g)* * *
(1)*Access to negotiated prices* . A Part D sponsor is required to provide its Part D enrollees with access to negotiated prices for covered Part D drugs included in its Part D plan's formulary. Negotiated prices must be provided even if no benefits are payable to the beneficiary for covered Part D drugs because of the application of any deductible or 100 percent coinsurance requirement following satisfaction of any initial coverage limit. Negotiated prices must be provided when the negotiated price for a covered Part D drug under a Part D sponsor's benefit package is less than the applicable cost-sharing before the application of any deductible, before any initial coverage limit, before the annual out-of-pocket threshold, and after the annual out-of-pocket threshold. 28. Amend § 423.128 as follows: A. Revise paragraph (a)(3). B. Revise paragraph (e)(6). § 423.128 Dissemination of Part D Plan information.
(a)* * *
(3)At the time of enrollment and at least annually thereafter, 15 days before the annual coordinated election period.
(e)* * *
(6)Be provided no later than the end of the month following any month when prescription drug benefits are provided under this part, including the covered Part D spending between the initial coverage limit described in § 423.104(d)(3) and the out-of-pocket threshold described in § 423.104(d)(5)(iii). Subpart F—Submission of Bids and Monthly Beneficiary Premiums; Plan Approval 29. Amend § 423.293 by— A. Revising paragraph (a). B. Adding paragraph (e). The revision and addition read as follows: § 423.293 Collection of monthly beneficiary premium.
(a)*General rule* . Part D sponsors must charge enrollees a consolidated monthly Part D premium equal to the sum of the Part D monthly premium for basic prescription drug coverage (if any) and the premium for supplemental coverage (if any and if the beneficiary has enrolled in such supplemental coverage). Part D sponsors must also permit each enrollee, at the enrollee's option, to make payment of premiums (if any) under this part to the sponsor using any of the methods listed in § 422.262(f) of this chapter. In circumstances where retroactive collection of premium is necessary and where the member is without fault in creating the premium arrearage, the Part D sponsor shall offer the member the option of payment either by lump sum or by equal monthly installment spread out over the same period for which the premiums were due, that is, if 7 months of premiums are due, the member would have at least 7 months to repay.
(e)*Prohibition on improper billing of premiums* . Part D plan sponsors shall not bill an enrollee for a premium payment period if the enrollee has requested that premiums be withheld from his or her Social Security benefit. Subpart G—Payments to Part D Plan Sponsors for Qualified Prescription Drug Coverage 30. Section 423.308 is amended by— A. Revising the definition of “actually paid.” B. Adding the definition of “administrative costs.” C. Revising the definition of “allowable risk corridor costs.” D. Revising the definition of “gross covered prescription drug costs.” E. Revising the definition of “target amount.” The addition and revisions read as follows: § 423.308 Definitions and terminology. *Actually paid* means that the costs must be actually incurred by the Part D sponsor and must be net of any direct or indirect remuneration (including discounts, chargebacks or rebates, cash discounts, free goods contingent on a purchase agreement, up-front payments, coupons, goods in kind, free or reduced-price services, grants, or other price concessions or similar benefits offered to some or all purchasers) from any source (including manufacturers, pharmacies, enrollees, or any other person) that would serve to decrease the costs incurred under the Part D plan. Direct and indirect remuneration includes discounts, chargebacks or rebates, cash discounts, free goods contingent on a purchase agreement, up-front payments, coupons, goods in kind, free or reduced-price services, grants, or other price concessions or similar benefits from manufacturers, pharmacies or similar entities obtained by an intermediary contracting organization with which the Part D plan sponsor has contracted for administrative services, regardless of whether the intermediary contracting organization retains all or a portion of the direct and indirect remuneration or passes the entire direct and indirect remuneration to the Part D plan sponsor and regardless of the terms of the contract between the plan sponsor and the intermediary contracting organization. *Administrative costs* means costs incurred by a Part D sponsor in complying with the requirements of this Part for a coverage year and that are not drug costs incurred to purchase or reimburse the purchase of Part D drugs. Administrative costs include amounts paid by the Part D sponsor to an intermediary contracting organization for covered Part D drugs dispensed to enrollees in the sponsor's Part D plan that differ from the amount paid by the intermediary contracting organization to a pharmacy or other entity that is the final dispenser of the covered Part D drugs. For example, any profit or loss retained by an intermediary contracting organization (through discounts, rebates, or other direct or indirect price concessions) when negotiating prices with dispensing entities is considered an administrative cost. *Allowable risk corridor costs* means—
(1)The subset of costs incurred under a Part D plan (not including administrative costs, but including dispensing fees) that are attributable to basic prescription drug coverage only and that are incurred and actually paid by the Part D sponsor to—
(i)A dispensing pharmacy or other dispensing provider (whether directly or through an intermediary contracting organization) under the Part D plan;
(ii)The parties listed in § 423.464(f)(1) with which the Part D sponsor must coordinate benefits, including other Part D plans, as the result of any reconciliation process developed by CMS under § 423.464 of this part; or
(iii)An enrollee (or third party paying on behalf of the enrollee) to indemnify the enrollee when the reimbursement is associated with obtaining drugs under the Part D plan; and
(2)These costs must be based upon imposition of the maximum amount of copayments permitted under § 423.782 of this part. The costs for any Part D plan offering enhanced alternative coverage must be adjusted not only to exclude any costs attributable to benefits beyond basic prescription drug coverage, but also to exclude any prescription drug coverage costs determined to be attributable to increased utilization over standard prescription drug coverage as the result of the insurance effect of enhanced alternative coverage in accordance with CMS guidelines on actuarial valuation. *Gross covered prescription drug costs* mean those actually paid costs incurred under a Part D plan, excluding administrative costs, but including dispensing fees, during the coverage year. They equal the sum of the following—
(1)The share of negotiated prices (as defined by § 423.100 of this chapter) actually paid by the Part D plan that is received as reimbursement by the pharmacy or other dispensing entity, reimbursement paid to indemnify an enrollee when the reimbursement is associated with an enrollee obtaining covered Part D drugs under the Part D plan, or payments made by the Part D sponsor to other parties listed in § 423.464(f)(1) with which the Part D sponsor must coordinate benefits, including other Part D plans, or as the result of any reconciliation process developed by CMS under § 423.464 of this chapter.
(2)Nominal cost-sharing paid by or on behalf of an enrollee which is associated with drugs that would otherwise be covered Part D drugs, as defined in § 423.100, but are instead paid for, with the exception of said nominal cost-sharing, by a patient assistance program providing assistance outside the Part D benefit, provided that documentation of such nominal cost-sharing has been submitted to the Part D plan consistent with the plan processes and instructions for the submission of such information.
(3)All amounts paid under the Part D plan by or on behalf of an enrollee (such as the deductible, coinsurance, cost sharing, or amounts between the initial coverage limit and the out-of-pocket threshold) in order to obtain Part D drugs that are covered under the Part D plan. If an enrollee who is paying 100 percent cost sharing (as a result of paying a deductible or because the enrollee is between the initial coverage limit and the out-of-pocket threshold) obtains a covered Part D drug at a lower cost than is available under the Part D plan, such cost-sharing will be considered an amount paid under the plan by or on behalf of an enrollee under the previous sentence of this definition, if the enrollee's costs are incurred costs as defined under § 423.100 of this part and documentation of the incurred costs has been submitted to the Part D plan consistent with plan processes and instructions for the submission of such information. These costs are determined regardless of whether the coverage under the plan exceeds basic prescription drug coverage. *Target amount* means the total amount of payments (from both CMS and by or on behalf of enrollees) to a Part D plan for the coverage year for all standardized bid amounts as risk adjusted under § 423.329(b)(1), less the administrative expenses (including return on investment) assumed in the standardized bids. 31. Amend § 423.329 by revising paragraph (d)(2)(i) to read as follows: § 423.329 Determination of payments.
(d)* * *
(2)* * *
(i)*Interim payments.* CMS establishes a payment method by which interim payments of amounts under this section are made during a year based on the low-income cost-sharing assumptions submitted with plan bids under § 423.265(d)(2)(iv) and negotiated and approved under § 423.272, or by an alternative method that CMS determines. Subpart K—Application Procedures and Contracts With Part D Plan Sponsors 32. Amend § 423.505 by revising paragraph (k)(5) to read as follows: § 423.505 Contract provisions.
(k)* * *
(5)*Certification of allowable costs for risk corridor and reinsurance information.* The Chief Executive Officer, Chief Financial Officer, or an individual delegated the authority to sign on behalf of one of these officers, and who reports directly to the officer, must certify (based on best knowledge, information, and belief) that the information provided for purposes of supporting allowable costs as defined in § 423.308, including data submitted to CMS regarding direct or indirect remuneration
(DIR)that serves to reduce the costs incurred by the Part D sponsor for Part D drugs, is accurate, complete, and truthful and fully conforms to the requirements in § 423.336 and § 423.343 and acknowledge that this information will be used for the purposes of obtaining Federal reimbursement. 33. Amend § 423.507 by— A. Revising paragraphs (a)(2)(ii) and (a)(2)(iii). B. Revising paragraphs (b)(2)(ii) and (b)(2)(iii). The revisions read as follows: § 423.507 Non-renewal of contract.
(a)* * *
(2)* * *
(ii)Each Medicare enrollee by mail at least 60 days before the date on which the non-renewal is effective. This notice must include a written description of alternatives available for obtaining qualified prescription drug coverage within the PDP region, including MA-PD plans, and other PDPs, and must receive CMS approval prior to issuance; and,
(iii)The general public, at least 60 days before the date on which the non-renewal is effective, by publishing a notice in one or more newspapers of general circulation in each community or county located in the Part D plan sponsor's service area.
(b)* * *
(2)* * *
(ii)To each of the Part D plan sponsor's Medicare enrollees by mail at least 60 days before the date on which the non-renewal is effective; and,
(iii)To the general public, at least 60 days before the date on which the non-renewal is effective, by publishing a notice in one or more newspapers of general circulation in each community or county located in the Part D plan sponsor's service area. Subpart L—Effect of Change of Ownership or Leasing of Facilities During Term of Contract 34. Amend § 423.551 by adding paragraph
(g)to read as follows: § 423.551 General provisions.
(g)*Sale of beneficiaries not permitted:* CMS will not recognize as a sale or transfer of a PDP line of business (qualifying as a change of ownership) a transaction that consists solely of the sale or transfer of individual beneficiaries or groups of beneficiaries enrolled in a pharmacy benefit package offered by a PDP sponsor. Subpart M—Grievances, Coverage Determinations, and Appeals 35. Amend § 423.560 by adding, in alphabetical order, the definition for “Other prescriber” as follows— § 423.560 Definitions. Other prescriber means a health care professional other than a physician who is authorized under State law or other applicable law to write prescriptions. 36. Amend § 423.566 by revising paragraph (c)(3) to read as follows: § 423.566 Coverage determinations.
(c)* * *
(3)The prescribing physician or other prescriber, on behalf of the enrollee. 37. Amend § 423.568 by revising paragraph
(a)to read as follows: § 423.568 Standard timeframe and notice requirements for coverage determinations.
(a)*Timeframe for requests for drug benefits.* When a party makes a request for a drug benefit, the Part D plan sponsor must notify the enrollee (and the prescribing physician or other prescriber involved, as appropriate) of its determination as expeditiously as the enrollee's health condition requires, but no later than 72 hours after receipt of the request, or, for an exceptions request, the physician's or other prescriber's supporting statement. 38. Amend § 423.570 by— A. Revising paragraph (a). B. Revising paragraph (b). C. Revising paragraph (c)(1). D. Revising paragraph (c)(3) introductory text. E. Revising paragraph (c)(3)(ii). F. Republishing paragraph
(d)introductory text. G. Revising paragraph (d)(1). H. Revising paragraph (d)(2) introductory text. I. Revising paragraph (d)(2)(iii). The revisions read as follows: § 423.570 Expediting certain coverage determinations.
(a)*Request for expedited determination.* An enrollee or an enrollee's prescribing physician or other prescriber may request that a Part D plan sponsor expedite a coverage determination involving issues described in § 423.566(b). This does not include requests for payment of Part D drugs already furnished.
(b)*How to make a request.*
(1)To ask for an expedited determination, an enrollee or an enrollee's prescribing physician or other prescriber on behalf of the enrollee must submit an oral or written request directly to the Part D plan sponsor or, if applicable, to the entity responsible for making the determination, as directed by the Part D plan sponsor.
(2)A prescribing physician or other prescriber may provide oral or written support for an enrollee's request for an expedited determination.
(c)* * *
(1)An efficient and convenient means for accepting oral or written requests submitted by enrollees, prescribing physicians, or other prescribers.
(3)A means for issuing prompt decisions on expediting a determination, based on the following requirements:
(ii)For a request made or supported by an enrollee's prescribing physician or other prescriber, provide an expedited determination if the physician or other prescriber indicates that applying the standard timeframe for making a determination may seriously jeopardize the life or health of the enrollee or the enrollee's ability to regain maximum function.
(d)*Actions following denial.* If a Part D plan sponsor denies a request for expedited determination, it must take the following actions:
(1)Make the determination within the 72-hour timeframe established in § 423.568(a) for a standard determination. The 72-hour period begins on the day the Part D plan sponsor receives the request for expedited determination, or, for an exceptions request, the physician's or other prescriber's supporting statement.
(2)Give the enrollee and prescribing physician or other prescriber prompt oral notice of the denial that—
(iii)Informs the enrollee of the right to resubmit a request for an expedited determination with the prescribing physician's or other prescriber's support and 39. Amend § 423.572 by revising paragraph
(a)to read as follows: § 423.572 Timeframes and notice requirements for expedited coverage determinations.
(a)*Timeframe for determination and notification.* Except as provided in paragraph
(b)of this section, a Part D plan sponsor that approves a request for expedited determination must make its determination and notify the enrollee (and the prescribing physician or other prescriber involved, as appropriate) of its decision, whether adverse or favorable, as expeditiously as the enrollee's health condition requires, but no later than 24 hours after receiving the request, or, for an exceptions request, the physician's or other prescriber's supporting statement. 40. Amend § 423.578 by— A. Revising paragraph
(a)introductory text. B. Revising paragraph (a)(2) introductory text. C. Revising paragraph (a)(2)(i). D. Revising paragraph (a)(3). E. Revising paragraph (a)(4) introductory text. F. Revising paragraph (a)(5). G. Revising paragraph
(b)introductory text. H. Revising paragraph (b)(2) introductory text. I. Revising paragraph (b)(2)(i), (b)(4), (b)(5) introductory text, and (b)(6). J. Revising paragraph (c)(3)(i), (c)(4)(i) introductory text, and (c)(4)(i)(A). K. Revising paragraph (f). The revisions read as follows: § 423.578 Exceptions process.
(a)*Request for exceptions to a plan's tiered cost-sharing structure.* Each Part D plan sponsor that provides prescription drug benefits for Part D drugs and manages this benefit through the use of a tiered formulary must establish and maintain reasonable and complete exceptions procedures subject to CMS' approval for this type of coverage determination. The Part D plan sponsor grants an exception whenever it determines that the non-preferred drug for treatment of the enrollee's condition is medically necessary, consistent with the physician's or other prescriber's statement under paragraph (a)(4) of this section.
(2)The exceptions criteria of a Part D plan sponsor must include, but are not limited to—
(i)A description of the criteria a Part D plan sponsor uses to evaluate a determination made by the enrollee's prescribing physician or other prescriber under paragraph (a)(4) of this section.
(3)An enrollee or the enrollee's prescribing physician or other prescriber may file a request for an exception.
(4)A prescribing physician or other prescriber must provide an oral or written supporting statement that the preferred drug for the treatment of the enrollee's conditions—
(5)If the physician or other prescriber provides an oral supporting statement, the Part D plan sponsor may require the physician or other prescriber to subsequently provide a written supporting statement to demonstrate the medical necessity of the drug. The Part D plan sponsor may require the prescribing physician or other prescriber to provide additional supporting medical documentation as part of the written follow-up.
(b)*Request for exceptions involving a non-formulary Part D drug.* Each Part D plan sponsor that provides prescription drug benefits for Part D drugs and manages this benefit through the use of a formulary must establish and maintain exceptions procedures subject to CMS' approval for receipt of an off-formulary drug. The Part D plan sponsor must grant an exception whenever it determines that the drug is medically necessary, consistent with the physician's or other prescriber's statement under paragraph (b)(5) of this section, and that the drug would be covered but for the fact that it is an off-formulary drug. Formulary use includes the application of cost utilization tools, such as a dose restriction, including the dosage form, that causes a particular Part D drug not to be covered for the number of doses prescribed or a step therapy requirement that causes a particular Part D drug not to be covered until the requirements of the plan's coverage policy are met, or a therapeutic substitution requirement.
(2)The exception criteria of a Part D plan sponsor must include, but are not limited to—
(i)A description of the criteria a Part D plan sponsor uses to evaluate a prescribing physician's or other prescriber's determination made under paragraph (b)(5) of this section;
(4)An enrollee, the enrollee's appointed representative, or the prescribing physician or other prescriber (on behalf of the enrollee) may file a request for an exception.
(5)A prescribing physician or other prescriber must provide an oral or written supporting statement that the requested prescription drug is medically necessary to treat the enrollee's disease or medical condition because—
(6)If the physician or other prescriber provides an oral supporting statement, the Part D plan sponsor may require the physician or other prescriber to subsequently provide a written supporting statement. The Part D plan sponsor may require the prescribing physician or other prescriber to provide additional supporting medical documentation as part of the written follow-up.
(c)* * *
(3)* * *
(i)The enrollee's prescribing physician or other prescriber continues to prescribe the drug.
(4)* * *
(i)The Part D plan sponsor may not require the enrollee to request approval for a refill, or a new prescription to continue using the Part D prescription drug after the refills for the initial prescription are exhausted, as long as—
(A)The enrollee's prescribing physician or other prescriber continues to prescribe the drug;
(f)*Implication of the physician's or other prescriber's supporting statement.* Nothing in this section should be construed to mean that the physician's or other prescriber's supporting statement required for an exceptions request will result in an automatic favorable decision. 41. Revise § 423.580 to read as follows: § 423.580 Right to a redetermination. An enrollee who has received a coverage determination (including one that is reopened and revised as described in § 423.634) may request that it be redetermined under the procedures described in § 423.582, which address requests for a standard redetermination. The prescribing physician or other prescriber (acting on behalf of an enrollee), upon providing notice to the enrollee, may request a standard redetermination under the procedures described in § 423.582. An enrollee or an enrollee's prescribing physician or other prescriber (acting on behalf of an enrollee) may request an expedited redetermination as specified in § 423.584. 42. Revise § 423.582 to read as follows: § 423.582 Request for a standard redetermination.
(a)*Method and place for filing a request.* An enrollee or an enrollee's prescribing physician or other prescriber (acting on behalf of the enrollee) must ask for a redetermination by making a written request with the Part D plan sponsor that made the coverage determination. The Part D plan sponsor may adopt a policy for accepting oral requests.
(b)*Timeframe for filing a request.* Except as provided in paragraph
(c)of this section, a request for a redetermination must be filed within 60 calendar days from the date of the notice of the coverage determination.
(c)*Extending the time for filing a request* —(1) *General rule.* If an enrollee or prescribing physician or other prescriber acting on behalf of an enrollee shows good cause, the Part D plan sponsor may extend the timeframe for filing a request for redetermination.
(2)*How to request an extension of timeframe.* If the 60-day period in which to file a request for a redetermination has expired, an enrollee or a prescribing physician or other prescriber acting on behalf of an enrollee may file a request for redetermination and extension of timeframe with the Part D plan sponsor. The request for redetermination and to extend the timeframe must—
(i)Be in writing; and
(ii)State why the request for redetermination was not filed on time.
(d)*Withdrawing a request.* The person who files a request for redetermination may withdraw it by filing a written request with the Part D sponsor. 43. Amend § 423.584 by— A. Revising paragraph (a). B. Revising paragraph (b). C. Revising paragraph (c)(2)(ii). D. Revising paragraph (d)(2)(iii). The revisions read as follows: § 423.584 Expediting certain redeterminations.
(a)*Who may request an expedited redetermination.* An enrollee or an enrollee's prescribing physician or other prescriber may request that a Part D plan sponsor expedite a redetermination that involves the issues specified in § 423.566(b). (This does not include requests for payment of drugs already furnished.)
(b)*How to make a request.*
(1)To ask for an expedited redetermination, an enrollee or a prescribing physician or other prescriber acting on behalf of an enrollee must submit an oral or written request directly to the Part D plan sponsor or, if applicable, to the entity responsible for making the redetermination, as directed by the Part D plan sponsor.
(2)A prescribing physician or other prescriber may provide oral or written support for an enrollee's request for an expedited redetermination.
(c)* * *
(2)* * *
(ii)For a request made or supported by a prescribing physician or other prescriber, the Part D plan sponsor must provide an expedited redetermination if the physician or other prescriber indicates that applying the standard timeframe for conducting a redetermination may seriously jeopardize the life or health of the enrollee or the enrollee's ability to regain maximum function.
(d)* * *
(2)* * *
(iii)Informs the enrollee of the right to resubmit a request for an expedited redetermination with the prescribing physician's or other prescriber's support; and 44. Revise § 423.586 to read as follows: § 423.586 Opportunity to submit evidence. The Part D plan sponsor must provide the enrollee or the prescribing physician or other prescriber, as appropriate, with a reasonable opportunity to present evidence and allegations of fact or law, related to the issue in dispute, in person as well as in writing. In the case of an expedited redetermination, the opportunity to present evidence is limited by the short timeframe for making a decision. Therefore, the Part D plan sponsor must inform the enrollee or the prescribing physician or other prescriber of the conditions for submitting the evidence. 45. Amend § 423.590 by revising paragraphs (d)(1), (e), and (f)(2) to read as follows: § 423.590 Timeframes and responsibility for making redeterminations.
(d)*Expedited redetermination* —(1) *Timeframe* . A Part D plan sponsor that approves a request for expedited redetermination must complete its redetermination and give the enrollee (and the prescribing physician or other prescriber involved, as appropriate), notice of its decision as expeditiously as the enrollee's health condition requires but no later than 72 hours after receiving the request.
(e)*Failure to meet timeframe for expedited redetermination* . If the Part D plan sponsor fails to provide the enrollee or the prescribing physician or other prescriber, as appropriate, with the results of its expedited redetermination within the timeframe described in paragraph
(d)of this section, the failure constitutes an adverse redetermination decision, and the Part D plan sponsor must forward the enrollee's request to the IRE within 24 hours of the expiration of the adjudication timeframe.
(f)* * *
(2)When the issue is the denial of coverage based on a lack of medical necessity (or any substantively equivalent term used to describe the concept of medical necessity), the redetermination must be made by a physician with expertise in the field of medicine that is appropriate for the services at issue. The physician making the redetermination need not, in all cases, be of the same specialty or subspecialty as the prescribing physician or other prescriber. 46. Amend § 423.600 by revising paragraphs (b), (c), and
(e)to read as follows: § 423.600 Reconsideration by an independent review entity (IRE).
(b)When an enrollee files an appeal, the IRE is required to solicit the views of the prescribing physician or other prescriber. The IRE may solicit the views of the prescribing physician or other prescriber orally or in writing. A written account of the prescribing physician's or other prescriber's views (prepared by either the prescribing physician, other prescriber, or IRE, as appropriate) must be contained in the IRE's record.
(c)In order for an enrollee to request an IRE reconsideration of a determination by a Part D plan sponsor not to provide for a Part D drug that is not on the formulary, the prescribing physician or other prescriber must determine that all covered Part D drugs on any tier of the formulary for treatment of the same condition would not be as effective for the individual as the non-formulary drug, would have adverse effects for the individual, or both.
(e)When the issue is the denial of coverage based on a lack of medical necessity (or any substantively equivalent term used to describe the concept of medical necessity), the reconsideration must be made by a physician with expertise in the field of medicine that is appropriate for the services at issue. The physician making the reconsideration need not, in all cases, be of the same specialty or subspecialty as the prescribing physician or other prescriber. Subpart O—Intermediate Sanctions 47. Amend § 423.760 by— A. Redesignating paragraphs (b)(2) and (b)(3) as paragraphs (b)(3) and (b)(4), respectively. B. Adding new paragraph (b)(2) to read as follows: § 423.760 Determinations regarding the amount of civil money penalties and assessment imposed by CMS.
(b)* * *
(2)If the deficiency on which the determination is based has directly adversely affected (or has the substantial likelihood of adversely affecting) one or more Part D enrollees, CMS may calculate a CMP of up to $25,000 for each Part D enrollee directly adversely affected (or with a substantial likelihood of being adversely affected) by a deficiency. Subpart P—Premiums and Cost-Sharing Subsidies for Low-Income Individuals 48. Amend § 423.772 by adding the definition for “Best available evidence”, in alphabetical order, to read as follows: § 423.772 Definitions. *Best available evidence* means evidence recognized by CMS as documentation or other information that is directly tied to authoritative sources that confirm an individual's low-income subsidy eligibility status, and that must be accepted and used by the Part D sponsor to change low-income subsidy status. 49. Amend § 423.782 by adding new paragraph
(c)to read as follows: § 423.782 Cost-sharing subsidy.
(c)When the out-of-pocket cost for a covered Part D drug under a Part D sponsor's plan benefit package is less than the maximum allowable copayment, coinsurance or deductible amounts under paragraphs
(a)and
(b)of this section, the Part D sponsor may only charge the lower benefit package amount. 50. Amend § 423.800 by revising paragraph
(b)and adding a new paragraph
(d)to read as follows: § 423.800 Administration of subsidy program.
(b)*Reduction of premium or cost-sharing by PDP sponsor or organization* . Based on information provided by CMS under paragraph
(a)of this section, or obtained under paragraph
(d)of this section, the Part D sponsor offering the Part D plan, in which a subsidy eligible individual is enrolled must reduce the individual's premiums and cost-sharing as applicable, and provide information to CMS on the amount of those reductions, in a manner determined by CMS. The Part D sponsor must track the application of the subsidies under this subpart to be applied to the out-of-pocket threshold.
(d)*Use of the best available evidence process to establish cost-sharing* . Part D sponsors must accept best available evidence as defined in § 423.772 of this part, and update the subsidy eligible individual's LIS status in accordance with a process established by CMS, and within a reasonable timeframe as determined by CMS. Subpart R—Payment to Sponsors of Retiree Prescription Drug Plans 51. Section 423.882 is amended by— A. Adding the definition of “actually paid”. B. Adding the definition of “administrative costs”. C. Revising the definition of “allowable retiree costs”. D. Revising the definition of “gross covered retiree plan-related prescription drug costs”, or “gross retiree costs”. E. Adding the definition of “negotiated prices”. The additions and revisions read as follows: § 423.882 Definitions. *Actually paid* means that the costs must be actually incurred by the qualified retiree prescription drug plan and must be net of any direct or indirect remuneration (including discounts, chargebacks or rebates, cash discounts, free goods contingent on a purchase agreement, up-front payments, coupons, goods in kind, free or reduced-price services, grants, or other price concessions or similar benefits offered to some or all purchasers) from any source (including manufacturers, pharmacies, qualifying covered retirees, or any other person) that would serve to decrease the costs incurred under the qualified retiree prescription drug plan. Direct and indirect remuneration includes discounts, chargebacks or rebates, cash discounts, free goods contingent on a purchase agreement, up-front payments, coupons, goods in kind, free or reduced-price services, grants, or other price concessions or similar benefits from manufacturers, pharmacies or similar entities obtained by an intermediary contracting organization with which the sponsor of the qualified retiree prescription drug plan has contracted for administrative services, regardless of whether the intermediary contracting organization retains all or a portion of the direct and indirect remuneration or passes the entire direct and indirect remuneration to the sponsor of the qualified retiree prescription drug plan and regardless of the terms of the contract between the plan sponsor and the intermediary contracting organization. *Administrative costs* means costs incurred by a qualified retiree prescription drug plan that are not drug costs incurred to purchase or reimburse the purchase of Part D drugs. Administrative costs include amounts paid by the sponsor of a qualified retiree prescription drug plan to an intermediary contracting organization for Part D drugs dispensed to qualifying covered retirees in the sponsor's plan that differ from the amount paid by the intermediary contracting organization to a pharmacy or other entity that is the final dispenser of the Part D drugs. For example, any profit or loss retained by an intermediary contracting organization (through discounts, rebates, or other direct or indirect price concessions) when negotiating prices with dispensing entities is considered an administrative cost. *Allowable retiree costs* means the subset of gross covered retiree plan-related prescription drug costs actually paid by the sponsor of the qualified retiree prescription drug plan or by (or on behalf of) a qualifying covered retiree under the plan. *Gross covered retiree plan-related prescription drug costs* , or *gross retiree costs* , means those actually paid Part D drug costs incurred under a qualified retiree prescription drug plan, excluding administrative costs, but including dispensing fees, during the coverage year. They equal the sum of the following:
(1)The share of negotiated prices (as defined in this section) actually paid by the qualified retiree prescription drug plan that is received as reimbursement by the pharmacy or other dispensing entity, and reimbursement paid to indemnify a qualifying covered retiree when the reimbursement is associated with a qualifying covered retiree obtaining Part D drugs under the qualified retiree prescription drug plan.
(2)All amounts paid under the qualified retiree prescription drug plan by or on behalf of a qualifying covered retiree (such as the deductible, coinsurance, or cost sharing) in order to obtain Part D drugs that are covered under the qualified retiree prescription drug plan. *Negotiated prices* means prices for Part D drugs that—
(1)The qualified retiree prescription drug plan (or other intermediary contracting organization) and the network dispensing pharmacy or other network dispensing provider have negotiated as the amount such network entity will receive, in total, for a particular drug;
(2)Are reduced by those discounts, direct or indirect subsidies, rebates, other price concessions, and direct or indirect remuneration that the qualified retiree prescription drug plan has elected to pass through to qualifying covered retirees at the point of sale; and
(3)Includes any dispensing fees. 52. Add new subpart V to read as follows: Subpart V—Part D Marketing Requirements Sec. 423.2260 Definitions concerning marketing materials. 423.2262 Review and distribution of marketing materials. 423.2264 Guidelines for CMS review. 423.2266 Deemed approval. 423.2268 Standards for Part D marketing. 423.2272 Licensing of marketing representatives and confirmation of marketing resources. 423.2274 Broker and agent commissions. 423.2276 Employer group retiree marketing. Subpart V—Part D Marketing Requirements § 423.2260 Definitions concerning marketing materials. As used in this subpart— *Marketing Materials* .
(1)Marketing Materials include any informational materials targeted to Medicare beneficiaries which—
(i)Promote the Part D plan.
(ii)Inform Medicare beneficiaries that they may enroll, or remain enrolled in a Part D plan.
(iii)Explain the benefits of enrollment in a Part D plan, or rules that apply to enrollees.
(iv)Explain how Medicare services are covered under a Part D plan, including conditions that apply to such coverage.
(2)Examples of marketing materials include, but are not limited to—
(i)General audience materials such as general circulation brochures, newspapers, magazines, television, radio, billboards, yellow pages, or the Internet.
(ii)Marketing representative materials such as scripts or outlines for telemarketing or other presentations.
(iii)Presentation materials such as slides and charts.
(iv)Promotional materials such as brochures or leaflets, including materials for circulation by third parties (for example, physicians or other providers).
(v)Membership communication materials such as membership rules, subscriber agreements, member handbooks and wallet card instructions to enrollees.
(vi)Letters to members about contractual changes; changes in providers, premiums, benefits, plan procedures etc.
(vii)Membership or claims processing activities. § 423.2262 Review and distribution of marketing materials.
(a)*CMS review of marketing materials.*
(1)Except as provided in paragraph (a)(2) of this section a Part D plan may not distribute any marketing materials (as defined in § 423.2260 of this Part), or enrollment forms, or make such materials or forms available to Part D eligible individuals unless—
(i)At least 45 days (or 10 days if using certain types of marketing materials that use, without modification, proposed model language as specified by CMS) before the date of distribution, the Part D sponsor submits the material or form to CMS for review under the guidelines in § 423.2264; and
(ii)CMS does not disapprove the distribution of new material or form.
(2)[Reserved]
(b)*File and use.* The Part D sponsor may distribute certain types of marketing materials, designated by CMS, 5 days following their submission to CMS if the Part D sponsor certifies that in the case of these marketing materials, it followed all applicable marketing guidelines and, when applicable, used model language specified by CMS without modification. § 423.2264 Guidelines for CMS review. In reviewing marketing material or enrollment forms under § 423.2262, CMS determines (unless otherwise specified in additional guidance) that the marketing materials—
(a)Provide, in a format (and, where appropriate, print size), and using standard terminology that may be specified by CMS, the following information to Medicare beneficiaries interested in enrolling must consist of:
(1)Adequate written description of rules (including any limitations on the providers from whom services can be obtained), procedures, basic benefits and services, and fees and other charges.
(2)Adequate written explanation of the grievance and appeals process, including differences between the two, and when it is appropriate to use each.
(3)Any other information necessary to enable beneficiaries to make an informed decision about enrollment.
(b)Notify the general public of its enrollment period in an appropriate manner, through appropriate media, throughout its service area.
(c)Include in the written materials notice that the Part D plan is authorized by law to refuse to renew its contract with CMS, that CMS also may refuse to renew the contract, and that termination or non-renewal may result in termination of the beneficiary's enrollment in the Part D plan. In addition, the Part D plan may reduce its service area and no longer be offered in the area where a beneficiary resides.
(d)Ensure that materials are not materially inaccurate or misleading or otherwise make material misrepresentations.
(e)For markets with a significant non-English speaking population, provide materials in the language of these individuals. § 423.2266 Deemed approval. If CMS has not disapproved the distribution of marketing materials or a form submitted by a Part D sponsor for a Part D plan in a Part D region, CMS is deemed to not have disapproved the distribution of the marketing material or form in all other Part D regions covered by the Part D plan, with the exception of any portion of the material or form that is specific to the Part D region. § 423.2268 Standards for Part D marketing. In conducting marketing activities, a Part D plan may not—
(a)Provide for cash or other remuneration as an inducement for enrollment or otherwise. This does not prohibit explanation of any legitimate benefits the beneficiary might obtain as an enrollee of the Part D plan.
(b)Offer gifts to potential enrollees, unless the gifts are of nominal (as defined in the CMS Marketing Guidelines) value, are offered to all eligible members without discrimination, and are not in the form of cash or other monetary rebates. Providing meals for potential enrollees is prohibited, regardless of value.
(c)Engage in any discriminatory activity such as, including targeted marketing to Medicare beneficiaries from higher income areas without making comparable efforts to enroll Medicare beneficiaries from lower income areas.
(d)Solicit door-to-door for Medicare beneficiaries or through other unsolicited means of direct contact, including calling a beneficiary without the beneficiary initiating the contact.
(e)Engage in activities that could mislead or confuse Medicare beneficiaries, or misrepresent the Part D sponsor or its Part D plan. The Part D organization may not claim that it is recommended or endorsed by CMS or Medicare or the Department of Health and Human Services or that CMS or Medicare or the Department of Health and Human Services recommends that the beneficiary enroll in the Part D plan. The Part D organization may explain that the organization is approved for participation in Medicare.
(f)Market non-health care related products to prospective enrollees during any Part D sales activity or presentation. This is considered cross-selling and is prohibited.
(g)Market any health care related product during a marketing appointment beyond the scope agreed upon by the beneficiary, and documented by the plan, prior to the appointment.
(h)Market additional health related lines of plan business not identified prior to an in-home appointment without a separate appointment that may not be scheduled until 48 hours after the initial appointment.
(i)Distribute marketing materials for which, before expiration of the 45-day period, the PDP Sponsor receives from CMS written notice of disapproval because it is inaccurate or misleading, or misrepresents the PDP Sponsor, its marketing representatives, or CMS.
(j)Use providers, provider groups, or pharmacies to distribute printed information comparing the benefits of different Part D plans unless providers, provider groups or pharmacies accept and display materials from all Part D plan sponsors.
(k)Conduct sales presentations or distribute and accept Part D plan enrollment forms in provider offices, pharmacies or other places where health care is delivered.
(l)Conduct sales presentations or distribute and accept plan applications at educational events.
(m)Employ Part D plan names that suggest that a plan is not available to all Medicare beneficiaries.
(n)Display the names and/or logos of co-branded network providers on the organization's member identification card. Other marketing materials that include names and/or logos of provider co-branding partners must clearly indicate that other providers are available in the network.
(o)Engage in any other marketing activity prohibited by CMS in its marketing guidance. § 423.2272 Licensing of marketing representatives and confirmation of marketing resources. In its marketing, the Part D organization must—
(a)Demonstrate to CMS's satisfaction that marketing resources are allocated to marketing to the disabled Medicare population as well as beneficiaries age 65 and over.
(b)Establish and maintain a system for confirming that enrolled beneficiaries have in fact enrolled in the PDP and understand the rules applicable under the plan.
(c)Employ as marketing representatives only individuals who are licensed by the State to conduct direct marketing activities (as defined in the Medicare Marketing Guidelines) in that State, and whom the sponsor has informed that State it has appointed, consistent with the appointment process provided for under State law, except that any fees required under such appointment process do not apply. § 423.2274 Broker and agent commissions. If a Part D sponsor markets through independent brokers or agents— (a)(1) In paying a commission or other compensation (collectively referred to as “commission”) to such agent or representative, the commission the agent would receive for selling or servicing the policy in the first year could not exceed the commission the agent receives for selling or servicing the policy in all subsequent years.
(2)The commission must be the same for all plans and all plan product types offered by the sponsor's parent organization.
(b)It must ensure agents selling Medicare products are trained on Medicare rules and regulations specific to the plan products they intend to sell.
(c)It must ensure agents selling Medicare products are tested, as specified in CMS guidance.
(d)Upon CMS's request, a sponsor must provide to CMS the information necessary for it to conduct oversight of marketing activities.
(e)It must comply with State requests for information about the performance of a licensed agent or broker as part of a state investigation into the individual's conduct. CMS will establish and maintain a memorandum of understanding
(MOU)to share compliance and oversight information with States that agree to the MOU. § 423.2276 Employer group retiree marketing. Part D sponsors may develop marketing materials designed for members of an employer group who are eligible for employer-sponsored benefits through the Part D sponsor, and furnish these materials only to the group members. These materials are not subject to CMS prior review and approval. Authority: (Catalog of Federal Domestic Assistance Program No. 93.778, Medical Assistance Program) (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program) Dated: January 17, 2008. Kerry Weems, Acting Administrator, Centers for Medicare & Medicaid Services. Approved: February 19, 2008. Michael O. Leavitt, Secretary. [FR Doc. 08-1244 Filed 5-8-08; 8:45 am]
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U.S. Code
- Simplified and expeditious licensing procedures§ 2705
- Repealed. Aug. 26, 1935, ch. 687, title II, § 212, 49 Stat. 847§ 791
- Officials dealing in securities§ 825d
- Congressional declaration of goals and policy§ 1251
- Tolerances and exemptions for pesticide chemical residues§ 346a
- Public information collection activities; submission to Director; approval and delegation§ 3507
- Regulation of biological products§ 262
- Identification of flood-prone areas§ 4101
- Congressional findings and declaration of purposes and policy§ 1531
- Determination of endangered species and threatened species§ 1533
- Congressional declaration of purpose§ 4321
- Prohibited acts§ 1538
- Congressional findings, declarations, and purposes§ 4371
- Coastal impact assistance program§ 1356a
- Public information; agency rules, opinions, orders, records, and proceedings§ 552
- Purposes§ 3501
- Preliminary determinations§ 1673b
- Definitions§ 4301
- Federal agency responsibilities§ 3506
- Exempt organizations§ 1611
- Administration§ 656
- Registration, responsibilities, and oversight of self-regulatory organizations§ 78s
- National system for clearance and settlement of securities transactions§ 78q–1
- Definitions and application§ 78c
- National securities exchanges§ 78f
- Additional powers§ 637
- Immunity from seizure under judicial process of cultural objects imported for temporary exhibition or display§ 2459
- Purposes§ 6501
- Exemption for passenger motor vehicles equipped with anti-theft devices§ 33106
- Consolidation, merger, and acquisition of control§ 11323
- Authority to exempt rail carrier transportation§ 10502
- Definitions§ 6903
- Elimination of duplicative filings§ 4804
- Flood elevation determinations§ 4104
- Dual service of management official as management official of unaffiliated institution or holding company in same area, town, or village prohibited§ 3202
- Rules and regulations§ 3207
- Confidentiality and disclosure of returns and return information§ 6103
- EXPEDITED PROCESSING OF REQUESTS FOR JAPANESE IMPERIAL GOVERNMENT RECORDS.§ 804
- Rules and regulations; impact analyses of Medicare and Medicaid rules and regulations on small rural hospitals§ 1302
CFR
- Filings and Other Submissions.§ 385.2001
- Method of notice; dates established in notice (Rule 210).§ 385.210
- Notice of application and notice of schedule for environmental review.§ 157.9
- Intervention (Rule 214).§ 385.214
- Interventions and protests.§ 157.10
- Protests other than under Rule 208 (Rule 211).§ 385.211
- Procedures for obtaining exempt wholesale generator and foreign utility company status.§ 366.7
- Notice procedure.§ 157.205
- Records.§ 606.160
- Definitions applicable to part 207.§ 207.2
- Filing of petition; service.§ 44.10
- Weekly examination.§ 75.364
- Mine map.§ 77.1200
- Permissible electric equipment.§ 75.500
- Electrical work; qualified person.§ 75.153
- Permissible electric face equipment; maintenance.§ 75.503
- Portable (trailing) cables and cords.§ 18.35
- Notice for public comment; State consultation.§ 50.91
- Accident source term.§ 50.67
- Issuance of amendment.§ 50.92
- Hearing requests, petitions to intervene, requirements for standing, and contentions.§ 2.309
- Filing of documents.§ 2.302
- Relinquishment of rights to return to work.§ 216.24
- Delegation of authority to Director of Division of Trading and Markets.§ 200.30-3
- How does a small business concern qualify to provide manufactured products or other supply items under a small business set-aside, service-disabled veteran-owned small business, HUBZone, WOSB or EDWOSB, or 8(a) contract?§ 121.406
- When will a waiver of the Nonmanufacturer Rule be granted for a class of products?§ 121.1202
- Does FAA invite public comment on petitions for exemption?§ 11.85
- Life preservers for operations over water.§ 136.9
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120 references not yet in our index
- 40 CFR 1501.7
- 10 CFR 1021.311
- Pub. L. 92-463
- 16 USC 791a-825r
- Pub. L. 109-383
- 18 CFR 380
- 18 CFR 45
- 18 CFR 34
- 40 CFR 122.26(b)(14)(x)
- 40 CFR 2
- 40 CFR 124.12
- 40 CFR 122.6
- 40 CFR 122.26(b)(15)(i)
- 40 CFR 122.44(a)(1)
- 40 CFR 125.3(a)(2)(ii)(B)
- 40 CFR 122.44(s)
- 40 CFR 124.5
- 417 F.3d 1272
- 40 CFR 1506.9
- 40 CFR 180
- 40 CFR 180.7(f)
- 40 CFR 180.607
- 40 CFR 180.960
- Pub. L. 92-500
- Pub. L. 95-217
- Pub. L. 100-4
- Pub. L. 109-417
- Pub. L. 110-161
- 45 CFR 16
- 45 CFR 74
- 45 CFR 92
- 42 CFR 422
- 21 CFR 600
- 5 CFR 1320.10
- 50 CFR 17.22
- 50 CFR 17.32
- 50 CFR 17.22(b)(5)
- 40 CFR 1500
- 40 CFR 1500.1(b)
- 50 CFR 17.3
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