Tap any paragraph to write a margin note. Your notes collect in the Desk below the text and file under cases with @. The side-by-side margin rail opens on a larger screen.

§
Marginalia
Code · REGISTER · 2006-03-16 · Corporation for National and Community Service · Notices

Notices. Notice

16,795 words·~76 min read·/register/2006/03/16/06-2539·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 6351-01-M CORPORATION FOR NATIONAL AND COMMUNITY SERVICE Information Collection; Submission for OMB Review, Comment Request AGENCY: Corporation for National and Community Service. ACTION: Notice. SUMMARY: The Corporation for National and Community Service (hereinafter the “Corporation”), has submitted a public information collection request
(ICR)entitled Collection of State Service Plans from State Commissions, to the Office of Management and Budget
(OMB)for review and approval in accordance with the Paperwork Reduction Act of 1995, Public Law 104-13, (44 U.S.C. Chapter 35). A copy of this ICR, with applicable supporting documentation, may be obtained by contacting the Corporation for National and Community Service, AmeriCorps, Amy Borgstrom, Associate Director of Policy,
(202)606-6930, or by e-mail at * ABorstrom@cns.gov.* Individuals who use a telecommunications device for the deaf (TTY-TDD) may call
(202)606-3472 between 8:30 a.m. and 5 p.m. eastern time, Monday through Friday. ADDRESSES: Comments may be submitted, identified by the title of the information collection activity, to Office of Information and Regulatory Affairs, Attn: Ms. Rachel Potter, OMB Desk Officer for the Corporation for National and Community Service, by any of the following two methods within 30 days from the date of publication in this **Federal Register** :
(a)By fax to:
(202)395-6974, Attention: Ms. Rachel Potter, OMB Desk Officer for the Corporation for National and Community Service; and
(b)Electronically by e-mail to: *Rachel_F._Potter@omb.eop.gov.* SUPPLEMENTARY INFORMATION: The OMB is particularly interested in comments which: • Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Corporation, 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; • Propose ways to enhance the quality, utility, and clarity of the information to be collected; and • Propose 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, *e.g.,* permitting electronic submissions of responses. Comments A 60-day public comment Notice was published in the **Federal Register** on November 25, 2005. This comment period ended January 24, 2006. No public comments were received from this notice. Currently, the Corporation is soliciting comments concerning its proposed collection of State Service Plans from State Commissions. These plans are submitted by State Commissions as required by statute. The plans are elicited in order to assure that national service and volunteer service entities within a state are aware of each other and are coordinating activities to maximize their ability to leverage both human and financial resources in order to address significant unmet community needs. This new proposed information collection consists of the following instruction: In 2006, the Corporation requests that you address the following questions in order to comply with the statutory requirement to provide a State Service Plan: 1. Please describe your projected program focus for the next three years of planned state service activities. 2. Please describe ongoing efforts or special initiatives that involve collaborating with the Corporation State Office, State Education Agencies, state networks of volunteer centers, Campus Compacts, National Direct grantees and/or other service organizations within the state. 3. What non-monetary support do you believe you need from the Corporation (Headquarter Offices and/or your State Office) in order for your State Plan to be successful (such as training and technical assistance, for example)? Your State Service Plan may also include other elements that you and your service partners find useful. *Type of Review:* New. *Agency:* Corporation for National and Community Service. *Title:* State Service Plans. *OMB Number:* None. *Agency Number:* None. *Affected Public:* State Service Commissions. *Total Respondents:* 54. *Frequency:* Once every three years. *Average Time Per Response:* 24 hours. *Estimated Total Burden Hours:* 1296 hours. *Total Burden Cost (capital/startup):* None. *Total Burden Cost (operating/maintenance):* None. Dated: March 10, 2006. Mark Abbott, Senior Advisor, Office of the Chief Operating Officer, Corporation for National and Community Service. [FR Doc. E6-3837 Filed 3-15-06; 8:45 am] BILLING CODE 6050-$$-P CORPORATION FOR NATIONAL AND COMMUNITY SERVICE Information Collection; Submission for OMB Review, Comment Request AGENCY: Corporation for National and Community Service. ACTION: Notice. SUMMARY: The Corporation for National and Community Service (hereinafter the “Corporation”), has submitted a public information collection request
(ICR)entitled the National Evaluation of Youth Corps to the Office of Management and Budget
(OMB)for review and approval in accordance with the Paperwork Reduction Act of 1995, Public Law 104-13, (44 U.S.C. Chapter 35). Copies of this ICR, with applicable supporting documentation, may be obtained by calling the Corporation for National and Community Service, Ms. Lillian Dote at
(202)606-6984. Individuals who use a telecommunications device for the deaf (TTY-TDD) may call
(202)606-3472 between 8:30 a.m. and 5 p.m. eastern time, Monday through Friday. ADDRESSES: Comments may be submitted, identified by the title of the information collection activity, to the Office of Information and Regulatory Affairs, Attn: Ms. Rachel Potter, OMB Desk Officer for the Corporation for National and Community Service, by any of the following two methods within 30 days from the date of publication in this **Federal Register** :
(1)By fax to:
(202)395-6974, Attention: Ms. Rachel Potter, OMB Desk Officer for the Corporation for National and Community Service; and
(2)Electronically by e-mail to: *Rachel_F._Potter@omb.eop.gov.* SUPPLEMENTARY INFORMATION: The OMB is particularly interested in comments which: • Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Corporation, 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; • Propose ways to enhance the quality, utility, and clarity of the information to be collected; and • Propose 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, e.g., permitting electronic submissions of responses. Comments A 60-day public comment Notice was published in the **Federal Register** on January 4, 2006. This comment period ended March 6, 2006. No public comments were received from this notice. *Description:* The Corporation is seeking approval of the National Evaluation of Youth Corps which will be used to learn about the effects of national service on youth corps participants. The study uses an experimental design to assess the outcomes associated with participation in national service. The information collection will be completed by individuals applying to Youth Corps programs. *Type of Review:* New. *Agency:* Corporation for National and Community Service. *Title:* National Evaluation of Youth Corps. *OMB Number:* None. *Agency Number:* None. *Affected Public:* Applicants to Youth Corps programs. *Total Respondents:* 7,500. *Frequency:* On occasion. *Average Time Per Response:* 35 minutes. *Estimated Total Burden Hours:* 4,375 hours. *Total Burden Cost (capital/startup):* None. *Total Burden Cost (operating/maintenance):* None. Dated: March 10, 2006. Robert Grimm, Director, Office of Research and Policy Development. [FR Doc. E6-3838 Filed 3-15-06; 8:45 am] BILLING CODE 6050-$$-P DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Oak Ridge Reservation 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), Oak Ridge Reservation. The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public notice of this meeting be announced in the **Federal Register.** DATES: Wednesday, April 12, 2006, 6 p.m. ADDRESSES: DOE Information Center, 475 Oak Ridge Turnpike, Oak Ridge, Tennessee. FOR FURTHER INFORMATION CONTACT: Pat Halsey, Federal Coordinator, Department of Energy Oak Ridge Operations Office, P.O. Box 2001, EM-90, Oak Ridge, TN 37831. Phone
(865)576-4025; Fax
(865)576-5333 or e-mail: * halseypj@oro.doe.gov* or check the Web site at *http://www.oakridge.doe.gov/em/ssab.* 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 Agenda:* Oak Ridge Reservation Planning—Integrating Multiple Land Uses *Public Participaton:* 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 statements pertaining to the agenda item should contact Pat Halsey at the address or telephone number listed above. Requests 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 of this meeting will be available for public review and copying at the Department of Energy's Information Center at 475 Oak Ridge Turnpike, Oak Ridge, TN between 8 a.m. and 5 p.m., Monday through Friday, or by writing to Pat Halsey, Department of Energy Oak Ridge Operations Office, P.O. Box 2001, EM-90, Oak Ridge, TN 37831, or by calling her at
(865)576-4025. Issued at Washington, DC on March 13, 2006. Rachel M. Samuel, Deputy Advisory Committee Management Officer. [FR Doc. E6-3817 Filed 3-15-06; 8:45 am] BILLING CODE 6450-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket Nos. EC06-88-000, et al.] ArcLight Energy Partners Fund III, L.P., et al.; Electric Rate and Corporate Filings March 8, 2006. The following filings have been made with the Commission. The filings are listed in ascending order within each docket classification. 1. ArcLight Energy Partners Fund III, L.P. [Docket No. EC06-88-000] Take notice that on March 2, 2006 ArcLight Energy Partners Fund III, L.P. filed an Application, pursuant to section 203(a) of the Federal Power Act, for authorization to acquire indirectly 50% equity interest in Sabine Cogen, L.P from AL Cogen, Inc. and Al Cogen Partner, Inc. *Comment Date:* 5 p.m. Eastern Time on March 23, 2006. 2. Entergy Nuclear Indian Point 2, LLC, Entergy Nuclear Indian Point 3, LLC, Entergy Nuclear Generation Company, Entergy Nuclear FitzPatrick, LLC, Entergy Nuclear Vermont Yankee, LLC, Entergy Nuclear Power Marketing, LLC [Docket No. EC06-89-000] Take notice that on March 3, 2006, Entergy Services, Inc. (Entergy Services), as agent for Entergy Nuclear Indian Point 2, LLC, Entergy Nuclear Indian Point 3, LLC, Entergy Nuclear Generation Company, Entergy Nuclear FitzPatrick LLC, Entergy Nuclear Vermont Yankee, LLC (ENIP2, ENIP3, ENG, ENF and VY are collectively Entergy Northeast Nuclear Generating Companies), and Entergy Nuclear Power Marketing, LLC (ENPM), submitted an application pursuant to section 203 of the Federal Power Act to the Federal Energy Regulatory Commission requesting authorization for the Entergy Northeast Nuclear Generating Companies to transfer several power sales agreements to ENPM. *Comment Date:* 5 p.m. Eastern Time on March 24, 2006. 3. Allegheny Energy, Inc., Monongahela Power Company, The Potomac Edison Company, West Penn Power Company [Docket No. EL06-54-000] Take notice that on February 28, 2006, Allegheny Energy, Inc., Monongahela Power Company, The Potomac Edison Company, and West Penn Power Company (collectively, Allegheny Energy Companies) submitted a petition requesting that the Commission issue a declaratory order approving proposed incentive rate treatments for a new 500 k V transmission project that the Allegheny Energy Companies propose to construct across the “APS Zone” of PJM Interconnection, Inc.. The proposed construction will be undertaken by one or more of Monongahela Power Company, The Potomac Edison Company, or West Penn Power Company, a subsidiary of one or more of the Allegheny Power companies, or a subsidiary of Allegheny Energy, Inc. The Allegheny Energy Companies state the proposed project will run from the existing Wylie Ridge Substation on the western side of the AP Zone to a proposed Kemptown Substation, to be located on the eastern side of the AP Zone. *Comment Date:* 5 p.m. Eastern Time on March 29, 2006. 4. ANP Blackstone Energy Company, LLC, ANP Marketing Company, ANP Funding I, LLC, Milford Power Limited Partnership, ANP Bellingham Energy Company, LLC [Docket Nos. ER00-2118-004; ER00-1828-004; ER00-3751-004; ER93-493-016; ER00-2117-004] Take notice that on March 6, 2006, ANP Blackstone Energy Company, LLC; ANP Marketing Company; ANP Funding I, LLC; Milford Power Limited Partnership; and ANP Bellingham Energy Company, LLC tendered for filing an amendment to its Rate Schedule FERC No. 1. *Comment Date:* 5 p.m. Eastern Time on March 14, 2006. 5. BIV Generation Company, L.L.C. [Docket No. ER06-474-001] Take notice that on March 3, 2006, BIV Generation Company, L.L.C. filed with the Commission revised sheets to its market-based rate tariff pursuant to section 205 of the Federal Power Act. *Comment Date:* 5 p.m. Eastern Time on March 14, 2006. 6. MGE Energy, Inc. [Docket No. PH06-11-000] Take notice that on March 2, 2006, MGE Energy, Inc. filed a Notice of Waiver of the Requirements of The Public Utility Holding Company Act of 2005 pursuant to 18 CFR 366.3 and 366.4 of the Commission's regulations on the basis that substantially all of the its public utility operations occur in the state of Wisconsin. *Comment Date:* 5 p.m. Eastern Time on March 23, 2006. 7. DTE Energy Company [Docket No. PH06-12-000] Take notice that on March 2, 2006, DTE Energy, Inc., on behalf of its wholly-owned subsidiary, Michigan Consolidated Gas Company, filed a Notice of Exemption from the Requirements of The Public Utility Holding Company Act of 2005 pursuant to 18 CFR 366.4 of the Commission's regulations. *Comment Date:* 5 p.m. Eastern Time on March 23, 2006. 8. MGE Energy, Inc. [Docket No. PH06-13-000] Take notice that on March 2, 2006, MGE Energy, Inc. filed a Notice of Exemption from the Requirements of The Public Utility Holding Company Act of 2005 pursuant to 18 CFR 366.4 of the Commission's regulations. *Comment Date:* 5 p.m. Eastern Time on March 23, 2006. Standard Paragraph 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. Magalie R. Salas, Secretary. [FR Doc. E6-3760 Filed 3-15-06; 8:45 am] BILLING CODE 6717-01-P ENVIRONMENTAL PROTECTION AGENCY [FRL-8045-8] Agency Information Collection Activities OMB Responses AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: This document announces the Office of Management and Budget's
(OMB)responses to Agency Clearance requests, in compliance with the Paperwork Reduction Act (44 U.S.C. 3501 *et. seq* ). 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 EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15. FOR FURTHER INFORMATION CONTACT: Susan Auby
(202)566-1672, or e-mail at *auby.susan@epa.gov* and please refer to the appropriate EPA Information Collection Request
(ICR)Number. SUPPLEMENTARY INFORMATION: OMB Responses to Agency Clearance Requests OMB Approvals EPA ICR No. 1613.02; Data Reporting Requirements for State and Local Vehicle Emission Inspection and Maintenance (I/M) Programs (Reinstatement); in 40 CFR part 51, subpart S; was approved February 22, 2006; OMB Number 2060-0252; expires February 28, 2009. EPA ICR No. 1852.03; Exclusion Determinations for New Non-road Spark-ignited Engines at or Below 19 Kilowatts, New Non-road Compression-ignited Engines, New Marine Engines, and New On-road Heavy Duty Engines (Renewal); in 40 CFR part 85, subpart R; 40 CFR part 89, subpart A; 40 CFR part 90, subpart J; 40 CFR part 91, subpart K; was approved February 22, 2006; OMB Number 2060-0395; expires February 28, 2009. EPA ICR No. 2186.01; National Emissions Standards for Hazardous Air Pollutants from Plating and Polishing Operations; was approved February 22, 2006; OMB Number 2060-0577; expires February 28, 2009. EPA ICR No. 1801.04; NESHAP for Portland Cement (Renewal); in 40 CFR part 63, subpart LLL; was approved February 22, 2006; OMB Number 2060-0416; expires February 28, 2009. EPA ICR No. 1867.03; Voluntary Aluminum Industrial Partnership
(VAIP)(Renewal); was approved February 17, 2006; OMB Number 2060-0411; expires February 28, 2009. EPA ICR No. 1856.05; NESHAP for Primary Lead Smelters (Renewal); in 40 CFR part 63, subpart TTT); was approved February 10, 2006; OMB Number 2060-0414; expires February 28, 2009. EPA ICR No. 0983.08; NSPS for Equipment Leaks of VOC in Petroleum Refineries (Renewal); in 40 CFR part 60, subpart GGG; was approved February 14, 2006; OMB Number 2060-0067; expires February 28, 2009. EPA ICR No. 1060.13; NSPS for Steel Plants; Electric Arc Furnaces and Argon-Oxygen Decarburization Vessels (Final Rule Amendments); in 40 CFR part 60, subparts AA and AAa); was approved February 10, 2006; OMB Number 2060-0038; expires November 30, 2006. EPA ICR No. 1821.05; NESHAP for Steel Pickling (Renewal); in 40 CFR part 63, subpart CCC); was approved February 10, 2006; OMB Number 2060-0419; expires February 28, 2009. EPA ICR No. 1363.14; Toxic Chemical Release Reporting (Form R) (Renewal); in 40 CFR part 372; was approved March 3, 2006; OMB Number 2070-0093; expires January 31, 2008. EPA ICR No. 1704.08; Toxic Chemical Release Reporting, Alternate Threshold for Low Annual Reportable Amounts (Form A) (Renewal); in 40 CFR part 372; was approved March 3, 2006; OMB Number 2070-0143; expires January 31, 2008. EPA ICR No. 1871.04; NESHAP for Source Categories (Renewal); Generic Maximum Achievable Control Technology Standards; in 40 CFR part 63, subpart YY; was approved March 3, 2006; OMB Number 2060-0420; expires March 31, 2009. EPA ICR No. 0660.09; NSPS for Metal Coil Surface Coating (Renewal); in 40 CFR part 60, subpart TT; was approved February 17, 2006; OMB Number 2060-0107; expires February 28, 2009. EPA ICR No. 1788.06; NESHAP for Oil and Natural Gas Production (Renewal); in 40 CFR part 63, subpart HH; was approved March 3, 2006; OMB Number 2060-0417; expires March 31, 2009. EPA ICR No. 2163.02; NSPS: Other Solid Waste Incineration
(OSWI)Units (Final Rule); in 40 CFR part 60, subpart EEEE; was approved March 6, 2006; OMB Number 2060-0563; expires March 31, 2009. EPA ICR No. 2164.02; Emission Guidelines for Existing Other Solid Waste Incineration
(OSWI)Units (Final Rule); in 40 CFR part 60, subpart FFFF; was approved March 6, 2006; OMB Number 2060-0562; expires March 31, 2009. EPA ICR No. 1591.16; Regulation of Fuels and Fuel Additives (Direct Final and Proposed Rules for Butane and Attest Engagements); was approved March 6, 2006; OMB Number 2060-0277; expires October 31, 2007. EPA ICR No. 1964.03; NESHAP for Wet-formed Fiberglass Mat Production (Renewal); in 40 CFR part 63, subpart HHHH; was approved March 6, 2006; OMB Number 2060-0496; expires March 31, 2009. EPA ICR No. 2180.02; Recordkeeping and Reporting for the Performance-Based Qualification of Test Methods for Diesel Fuel (Renewal); in 40 CFR 80.29; 40 CFR 80.240; 40 CFR 80.530-80.532; 40 CFR 80.535-80.536; 40 CFR 80.550-80.555; 40 CFR 80.560-80.561; 40 CFR 80.590-80.594; 40 CFR 80.597; 40 CFR 80.600-80.604; 40 CFR 80.607; 40 CFR 80.620; was approved March 6, 2006; OMB Number 2060-0566; expires March 31, 2009. Short Term Extensions EPA ICR No. 0575.09; Health and Safety Data Reporting; Submission of Lists and Copies of Health and Safety Studies; OMB Number 2070-0004; on February 22, 2006 OMB extended the expiration date to May 31, 2006. Comment Filed EPA ICR No. 0783.48; Fuel Economy Labeling of Motor Vehicles (Proposed Rule); OMB Number 2060-0104; OMB filed comments on March 6, 2006. Dated: March 8, 2006. Oscar Morales, Director, Collection Strategies Division. [FR Doc. E6-3814 Filed 3-15-06; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY [Regional Docket No. V-2005-1, FRL-8045-7] Clean Air Act Operating Permit Program; Petition for Objection to State Operating Permit for Onyx Environmental Services AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of final order on petition to object to a title V operating permit. SUMMARY: This document announces that the EPA Administrator has responded to a citizen petition asking EPA to object to a Clean Air Act
(Act)title V operating permit proposed by the Illinois Environmental Protection Agency (IEPA). Specifically, the Administrator has partially granted and partially denied the petition submitted by the Sierra Club and American Bottom Conservancy to object to the proposed operating permit for Onyx Environmental Services. Pursuant to section 505(b)(2) of the Act, a petitioner may seek in the United States Court of Appeals for the appropriate circuit judicial review of those portions of the petition which EPA denied. Any petition for review shall be filed within 60 days from the date a notice appears in the **Federal Register** , pursuant to section 307 of the Act. ADDRESSES: You may review copies of the final orders, the petitions, and other supporting information at the EPA Region 5 Office, 77 West Jackson Boulevard, Chicago, Illinois 60604. If you wish to examine these documents, you should make an appointment at least 24 hours before visiting day. Additionally, the final order for Onyx Environmental Services is available electronically at: *http://www.epa.gov/region07/programs/artd/air/title5/petitiondb/petitiondb2004.htm.* FOR FURTHER INFORMATION CONTACT: Pamela Blakley, Chief, Air Permitting Section, Air Programs Branch, Air and Radiation Division, EPA, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, telephone
(312)886-4447. SUPPLEMENTARY INFORMATION: The Act affords EPA a 45-day period to review, and to object to as appropriate, a title V operating permit proposed by a state permitting authority. Section 505(b)(2) of the Act, 42 U.S.C. 7661d(b)(2), authorizes any person to petition the EPA Administrator within 60 days after the expiration of the EPA review period to object to a title V operating permit if EPA has not done so. Petitions must be based only on objections to the permit that were raised with reasonable specificity during the public comment period, unless the petitioner demonstrates that it was impracticable to raise the issues during the comment period, or the grounds for the issues arose after the public comment period. On February 18, 2004, the EPA received from the Sierra Club and American Bottom Conservancy a petition requesting that EPA object to the proposed title V operating permit for Onyx Environmental Services. The Sierra Club and American Bottom Conservancy alleged that the proposed permit
(1)violates EPA's commitments and obligations to address environmental justice issues;
(2)lacks a compliance schedule and certification of compliance;
(3)does not address modifications Onyx allegedly took that triggered new source review requirements;
(4)is based on an eight-year old application;
(5)lacks practically enforceable conditions;
(6)contains a permit shield that broadly insulates it from ongoing and recent violations;
(7)fails to include conditions that meet the legal requirements for monitoring;
(8)does not contain a statement of basis;
(9)does not require prompt reporting of violations; and
(10)fails to establish annual mercury and lead limits. On February 1, 2006, the Administrator signed an order partially granting and partially denying the petition. The order explains the reasons behind EPA's conclusion that the IEPA must:
(1)Address the significant comments concerning the possible need for a compliance schedule in the proposed permit;
(2)require Onyx Environmental Services to submit a current compliance certification;
(3)address comments concerning modifications made at the Onyx facility and the potential applicability of new source review requirements;
(4)require Onyx Environmental Services to submit an updated application that reflects all applicable requirements for the source;
(5)make clear either in the permit or statement of basis what constitutes “normal” operating conditions;
(6)amend the permit to limit Onyx Environmental Service's election to regulatory requirements applicable to hazardous waste incinerators;
(7)define the terms “container” and “containerized solids,” or explain in the statement of basis where the terms are defined;
(8)provide information on where the applicable specifications pertaining to “manufacturer's specifications” can be located;
(9)provide a statement of basis that complies with the requirements of EPA regulations and post its statement of basis on a Web site, or make available to the public on the Web site a notice telling the public where it can obtain the statement of basis; and
(10)explain how a thirty day reporting requirement for all deviations is prompt or require a shorter reporting period for deviations as is provided for in 40 CFR part 71. The order also explains the reasons for denying Sierra Club and American Bottom Conservancy's remaining claims. Pursuant to sections 505(b)(2) and 307 of the Act, Petitioners have 60 days from the date that this notice appears in the **Federal Register** to petition the United States Court of Appeals for the Seventh Circuit for review of the portions of the petition which EPA denied. Dated: March 2, 2006. Bharat Mathur, Acting Regional Administrator, Region 5. [FR Doc. E6-3812 Filed 3-15-06; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OAR-2006-0094; FRL-8045-6] Proposed Approval of Central Characterization Project's Transuranic Waste Characterization Program at the Savannah River Site AGENCY: Environmental Protection Agency. ACTION: Notice of availability; opening of public comment period. SUMMARY: The Environmental Protection Agency (“EPA” or “we”) is announcing the availability of, and soliciting public comments for 45 days on, the proposed approval of the waste characterization program implemented by the Central Characterization Project (“CCP”) to characterize transuranic (“TRU”) radioactive waste at the Savannah River Site
(SRS)proposed for disposal at the Waste Isolation Pilot Plant (“WIPP”). In accordance with the WIPP Compliance Criteria, EPA evaluated the CCP's characterization of TRU debris waste and soils/gravel from SRS during an inspection conducted October 31-November 3, 2005. Using the systems and processes developed as part of the Department of Energy's (“DOE's”) Carlsbad Field Office (“CBFO”) CCP, EPA verified whether DOE could adequately characterize TRU waste consistent with the Compliance Criteria. The results of EPA's evaluation of the SRS CCP program and the proposed approval are described in EPA's inspection report, which is available for review in the public dockets listed in ADDRESSES . We will consider public comments received on or before the due date mentioned in DATES . This notice summarizes the waste characterization processes EPA evaluated, the “tier” EPA assigned to each waste characterization process component, and the TRU waste categories proposed for approval. As required by the 40 CFR 194.8 changes promulgated in July 2004, at the end of a 45-day comment period EPA will evaluate public comments received, finalize the report responding to the relevant public comments, and issue the final report and an approval letter to DOE's Carlsbad Field Office. Waste that is characterized by the SRS CCP is *not* eligible for disposal at WIPP until EPA formally grants its approval. DATES: Comments must be received on or before May 1, 2006. ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-OAR-2006-0094, by one of the following methods: • *http://www.regulations.gov:* Follow the on-line instructions for submitting comments. • E-mail: to *a-and-r-docket@epa.gov.* • Fax: 202-566-1741. • Mail: Air and Radiation Docket and Information Center, Environmental Protection Agency, Mailcode: 6102T, 1200 Pennsylvania Ave., NW., Washington, DC 20460. *Instructions:* Direct your comments to Attn: Docket ID No. EPA-HQ-OAR-2006-0094. The Agency'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. For additional information about EPA's public docket visit the EPA Docket Center homepage at *http://www.epa.gov/epahome/dockets.htm.* *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 at *http://www.regulations.gov* or in hard copy at the Air and Radiation Docket in the EPA Docket Center, (EPA/DC) EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center 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 Air and Radiation Docket is 202-566-1742. These documents are also available for review in hard-copy form at the following three EPA WIPP informational docket locations in New Mexico: in Carlsbad at the Municipal Library, Hours: Monday-Thursday, 10 a.m.-9 p.m., Friday-Saturday, 10 a.m.-6 p.m., and Sunday, 1 p.m.-5 p.m., phone number: 505-885-0731; in Albuquerque at the Government Publications Department, Zimmerman Library, University of New Mexico, Hours: Vary by semester, phone number: 505-277-2003; and in Santa Fe at the New Mexico State Library, Hours: Monday-Friday, 9 a.m.-5 p.m., phone number: 505-476-9700. As provided in EPA's regulations at 40 CFR part 2, and in accordance with normal EPA docket procedures, if copies of any docket materials are requested, a reasonable fee may be charged for photocopying. FOR FURTHER INFORMATION CONTACT: Rajani Joglekar, Radiation Protection Division, Center for Federal Regulations, Mail Code 6608J, U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, Washington, DC 20460; telephone number: 202-343-9601; fax number: 202-343-2305; e-mail address: *joglekar.rajani@epa.gov.* SUPPLEMENTARY INFORMATION: I. General Information A. What Should I Consider as I Prepare My Comments for EPA? 1. *Submitting CBI.* Do not submit this information to EPA through *http://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. II. Background DOE is developing the WIPP near Carlsbad in southeastern New Mexico as a deep geologic repository for disposal of TRU radioactive waste. As defined by the WIPP Land Withdrawal Act
(LWA)of 1992 (Pub. L. 102-579), as amended (Pub. L. 104-201), TRU waste consists of materials containing processes having atomic numbers greater than 92 (with half-lives greater than twenty years), in concentrations greater than 100 nanocuries of alpha-emitting TRU isotopes per gram of waste. Much of the existing TRU waste consists of items contaminated during the production of nuclear weapons, such as rags, equipment, tools, and sludges. On May 13, 1998, EPA announced its final compliance certification decision to the Secretary of Energy (published May 18, 1998, 63 FR 27354). This decision stated that the WIPP will comply with EPA's radioactive waste disposal regulations at 40 CFR part 191, subparts B and C. The final WIPP certification decision includes conditions that
(1)prohibit shipment of TRU waste for disposal at WIPP from any site other than the Los Alamos National Laboratories
(LANL)until the EPA determines that the site has established and executed a quality assurance program, in accordance with §§ 194.22(a)(2)(i), 194.24(c)(3), and 194.24(c)(5) for waste characterization activities and assumptions (Condition 2 of Appendix A to 40 CFR part 194); and
(2)(with the exception of specific, limited waste streams and equipment at LANL) prohibit shipment of TRU waste for disposal at WIPP (from LANL or any other site) until EPA has approved the procedures developed to comply with the waste characterization requirements of § 194.22(c)(4) (Condition 3 of Appendix A to 40 CFR part 194). The EPA's approval process for waste generator sites is described in § 194.8. In July 2004, EPA promulgated changes to the “Criteria for the Certification and Recertification of the Waste Isolation Pilot Plant's Compliance with Disposal Regulations” (69 FR 42571-42583, July 16, 2004). These changes went into effect October 14, 2004, which modified the EPA approval of waste characterization (“WC”) programs at DOE's TRU waste sites. These revisions provide equivalent or improved oversight and better prioritization of technical issues in EPA inspections to evaluate WC activities at DOE WIPP waste generator sites, and also offer more direct public input into the Agency's decisions about what waste can be disposed of at WIPP. They do not modify the technical approach that EPA has employed since the 1998 WIPP Certification Decision. Condition 3 of the WIPP Certification Decision requires that EPA conduct independent inspections at DOE's waste generator/storage sites of their TRU waste characterization capabilities before approving their program and the waste for disposal at the WIPP. The revised inspection and approval process gives EPA greater
(a)discretion in establishing technical priorities,
(b)ability to accommodate variation in the site's waste characterization capabilities, and
(c)flexibility in scheduling site WC inspections. The § 194.8 changes require that EPA conduct a baseline inspection at every previously approved TRU site (such as SRS CCP). EPA expects that within two years after the effective date of October 2004 most of the previously approved TRU sites (such as Hanford, Los Alamos CCP, and Savannah River Site CCP) will undergo EPA baseline inspections. Following these inspections, the Agency will issue a new baseline compliance decision for these sites. As part of the baseline inspection, EPA must evaluate each WC process component (equipment, procedures, and personnel training/experience) for its adequacy and appropriateness in characterizing TRU waste destined for the disposal at WIPP. During the inspection, the site demonstrates its capabilities to characterize TRU waste(s) and its ability to comply with the regulatory limits and tracking requirements under § 194.24. The baseline inspection can result in approval with limitations/conditions or may require follow-up inspection(s) before approval. The approval must specify what subsequent WC program changes or expansion should be reported to EPA. The Agency is required to assign Tier 1 (“TI”) and Tier 2 (“T2”) to the reportable changes depending on their potential impact on data quality. A T1 designation requires that the site must notify EPA of proposed changes to the approved components of an individual WC process (such as radioassay equipment or personnel), and EPA must also approve the change before it can be implemented. A WC element with a T2 designation allows the site to implement changes to the approved components of individual WC processes (such as visual examination procedures) but requires EPA notification. The Agency may choose to inspect the site to evaluate technical adequacy before approval. EPA inspections conducted to evaluate T1 or T2 changes are follow-up inspections under the authority of § 194.24(h). In addition to the follow-up inspections, if warranted, EPA may opt to conduct continued compliance inspections at TRU waste sites with a baseline approval under the authority of § 194.24(h). The revisions to the site inspection and approval process outlined in § 194.8 require EPA to issue a **Federal Register** notice proposing the baseline compliance decision, docket the inspection report for public review, and seek public comment on the proposed decision for a period of 45 days. The report must describe the WC processes EPA inspected at the site, as well as their compliance with § 194.24 requirements. III. Proposed Baseline Compliance Decision From October 31-November 3, 2005, EPA performed a baseline inspection of TRU waste characterization activities of the DOE's CCP staff at SRS (EPA Inspection No. EPA-SRS-CCP-10.05-8). This inspection is the second baseline inspection that EPA has performed under the § 194.8 regulatory changes promulgated in July 2004. The CCP is a mobile characterization program that assists TRU waste generator sites with complex waste characterization activities. At some sites (such as Los Alamos National Laboratory and Savannah River Site) and small TRU waste generator sites (such as Argonne National Laboratory and Lawrence Livermore National Laboratory) the CCP has the sole responsibility to characterize contact-handled (“CH”), retrievably-stored TRU waste destined for the disposal at the WIPP. The purpose of EPA's inspection was to verify that CCP is characterizing CH TRU retrievably-stored debris waste (S5000) and soils/gravel (S4000) from SRS properly and in compliance with the regulatory requirements at 40 CFR 194.24. EPA did not evaluate the characterization of solid waste (S3000) at this time and will inspect this at a later date. During the inspection, EPA also evaluated CCP's use of the WIPP Waste Information System (“WWIS”) for tracking the contents of CH TRU waste containers destined for disposal at WIPP. This tracking ensures that the volume emplaced in the WIPP repository and characteristics of the emplaced wastes conform to the requirements of the WIPP LWA and the specific conditions of the WIPP Certification Decision. During the inspection, EPA evaluated the adequacy, implementation, and effectiveness of SRS-CCP's waste characterization activities. The Agency's evaluation focused on the individual components—equipment, procedures, and personnel training/experience of the following waste characterization processes: Acceptable knowledge (“AK”), nondestructive assay (“NDA”), visual examination techniques (“VET”), visual examination/real-time radiography (“VE/RTR”), load management, and the WWIS. The overall program adequacy and effectiveness of SRS-CCP was based on the following DOE-provided upper-tier documents:
(1)CCP-PO-001—Revision 11, 3/10/05—CCP Transuranic Waste Characterization Quality Assurance Project Plan and
(2)CCP-PO-002—Revision 12, 3/10/05—CCP Transuranic Waste Certification Plan. EPA evaluated the CCP-implemented waste characterization processes at SRS for specific CH TRU waste categories, as follows: • Acceptable knowledge
(AK)and load management for contact-handled (“CH”) retrievably-stored and newly-generated TRU debris waste (S5000) and soil/gravel waste (S4000). • Visual examination techniques (“VET”) for CH newly-generated debris waste (S5000) and soil/gravel waste (S4000). • Visual examination (“VE”) as a quality control check of real-time radiography (“RTR”) for CH retrievably-stored TRU debris waste (S5000) and soil/gravel waste (S4000). • RTR for CH retrievably-stored TRU debris waste (S5000) and soil/gravel waste (S4000). • Nondestructive assay (“NDA”) and the WIPP Waste Information System (“WWIS”) for CH retrievably-stored and newly-generated TRU debris waste (S5000) and soil/gravel waste (S4000). Two NDA systems (Imaging Passive-Active Neutron/Gamma Energy Analysis [“IPAN/GEA”] system and the MCS IQ3 gamma system) were evaluated for characterizing debris (S5000) and soil/gravel (S4000) wastes. In addition to reviewing individual components (namely, procedures, and equipment) of each of the WC processes (AK, NDA, VET, VE/RTR, load management, and the WWIS), the Agency interviewed and reviewed training records of personnel responsible for compiling data, analyzing waste contents, operating equipment, and preparing data for WWIS tracking. EPA also required radioassay replicate analysis on selected containers from the population of previously analyzed waste containers on the same system or instrument for the two different waste categories. The purpose of this replicate testing is to provide EPA with an independent means to verify that the radioassay equipment being assessed for approval can provide consistent, reproducible results for the determination of the quantity of 10 WIPP-tracked radionuclides (241Am, 137Cs, 238Pu, 239Pu, 240Pu, 242Pu, 90Sr, 233U, 234U, and 238U) as well as TRU alpha concentration. The results of the replicate analysis help EPA to determine whether: • The instrument produces results consistent with the reported total measurement uncertainty (“TMU”) by comparing the sample standard deviation for a number of replicate measurements taken over several hours or days to the reported TMU. • The instrument provides reproducible results over longer periods of time, such as weeks or months, by comparing the results of the replicate measurement(s) to the original reported values. EPA's inspection team identified one finding and five concerns. The one finding and two of the concerns required a response from DOE. All concerns and findings are documented on EPA Inspection Issue Tracking Forms (see Attachments C.1 through C.6 of the baseline Inspection Report available in the EPA Docket). The Agency received responses to the one finding and two concerns which required responses and, upon further evaluation, concluded that the responses were adequate. As a result, there are no open issues resulting from this inspection. EPA's inspection team determined that SRS-CCP's WC program activities were technically adequate. EPA is proposing to approve the SRS-CCP WC program in the configuration observed during this inspection and described in this report and in the checklists in Attachment A. This proposed approval includes the following waste characterization activities:
(1)The AK and load management process for CH retrievably-stored TRU debris and soil/gravel,
(2)The IPAN and IQ3 NDA systems for assaying soil/gravel and debris waste,
(3)VE as a QC check of the RTR process for retrievably-stored soil/gravel and debris waste,
(4)The VET process for newly-generated debris and soil/gravel wastes,
(5)The nondestructive examination process of RTR for retrievably-stored soil/gravel and debris wastes, and
(6)The WWIS process for tracking of waste contents of debris and soil/gravel wastes. As required by the new (194.8 revisions, EPA has assigned specific “tiers” to the different waste characterization processes. As seen from the table below, both T1 and T2 changes are reportable changes. A T1 change requires EPA approval prior to implementation of the change and may require EPA inspection to determine technical adequacy. A T2 change may be implemented prior to EPA approval; however, this type of change must be reported to EPA quarterly. Any changes to WC activities from the date of the baseline inspection must be reported to and, if applicable, approved by EPA, according to the following table: Proposed Tiering of TRU WC Processes Implemented by SRS-CCP [Based on October 31-November 3, 2005, Baseline Inspection] WC process elements SRS-CCP WC process specific T1 changes SRS-CCP WC process specific T2 changes* SRS-CCP general T2 changes* AK including Load Management Any new waste category Changes to WWIS algorithms specific to load management WSPFs, including updates or additions to waste stream(s) within an approved waste category (see Section 8.1) Changes in load management status of approved waste stream(s) Changes to site procedures requiring CBFO approvals and other changes as discussed in Section 8.1 of this report. NDA New equipment or physical modifications to approved equipment.** Changes to approved calibration range for approved equipment (see Section 8.2) Changes to software for approved equipment (see Section 8.2) Changes to operating range(s) upon CBFO approval Changes to site procedures requiring CBFO approvals and other changes as discussed in Section 8.2 of this report. RTR N/A New equipment or changes to approved equipment Changes to site procedures requiring CBFO approvals and other changes as discussed in Section 8.3 of this report. VE and VET Changes in vendor performing VE and/or VET N/A Changes to site procedures requiring CBFO approvals and other changes as discussed in Section 8.4 of this report. WWIS N/A N/A Changes to site procedures requiring CBFO approvals and other changes as discussed in Section 8.5 of this report. * Upon receiving EPA approval, SRS-CCP will report all T2 changes to EPA every three months. ** Modifications to approved equipment include all changes with the potential to affect NDA data relative to waste isolation and exclude minor changes, such as the addition of safety-related equipment. EPA will notify the public of the results of its evaluations of proposed T1 and T2 changes through the WIPP Website and by sending messages via the WIPP-NEWS e-mail listserv. All T1 changes must be submitted for approval before their implementation and will be evaluated by EPA. Upon approval, EPA will post the results of the evaluations via the WIPP Website and the WIPP-NEWS listserv, as described above. The Agency will post T2 changes approximately every three months beginning with the date of EPA's approval of the TRU WC program implemented at SRS-CCP. EPA expects the first report of SRS-CCP's T2 changes approximately three months from the date of EPA's approval of the TRU WC program implemented at SRS-CCP. The scope of the proposed site baseline compliance decision is based on EPA's inspection completed on November 3, 2005. The Agency will not approve any changes to the SRS-CCP program until this proposed baseline approval is finalized. Based on prior approvals, SRS-CCP is currently approved to dispose of debris waste (S5000) at the WIPP. SRS-CCP is permitted to continue WC and disposal of debris waste while EPA evaluates public comment to this proposed approval and establishes a final approval. IV. Availability of the Baseline Inspection Report for Public Comment EPA has placed the report discussing the results of EPA's inspection of the CCP at SRS in the public docket as described in ADDRESSES . In accordance with 40 CFR 194.8, EPA is providing the public 45 days to comment on these documents. The Agency requests comments on the tiering designations and the proposed approval decision. EPA will accept public comment on this notice and supplemental information as described in Section 1.B. above. The EPA will not make a determination of compliance before the 45-day comment period ends. At the end of the public comment period, EPA will evaluate all relevant public comment and revise the inspection report as necessary. The Agency will then issue an approval letter and the final inspection report, both of which will be posted on the WIPP Web site. The letter of approval will allow CCP to use the approved TRU waste characterization processes to characterize TRU waste at SRS. Information on the certification decision is filed in the official EPA Air Docket, Docket No. A-93-02 and is available for review in Washington, DC, and at the three EPA WIPP informational docket locations in New Mexico (as listed in ADDRESSES ). The dockets in New Mexico contain only major items from the official Air Docket in Washington, DC, plus those documents added to the official Air Docket since the October 1992 enactment of the WIPP LWA. Dated: March 9, 2006. William L. Wehrum, Acting Assistant Administrator for Air and Radiation. [FR Doc. E6-3813 Filed 3-15-06; 8:45 am] BILLING CODE 6560-50-P FEDERAL MARITIME COMMISSION [Docket No. 06-04] Revocation of Licenses for Failure To Comply With the Financial Responsibility Requirements of the Shipping Act of 1984; Order To Show Cause Since enactment of the Shipping Act of 1984 (“1984 Act”), 46 U.S.C. app. §§ 1701-1721, section 19 1 of the statute set forth the licensing and bonding requirements applicable to ocean freight forwarders, while section 23 of the 1984 Act established separate bonding requirements for non-vessel-operating common carriers (“NVOCCs”). Effective May 1, 1999, the 1984 Act was modified and updated by the passage of the Ocean Shipping Reform Act of 1998 (“OSRA”), Public Law 105-258, 112 Stat. 1902. OSRA delineated a new category of regulated the entities called an ocean transportation intermediary (“OTI”), defined to include both freight forwarders and NVOCCs. While continuing the statutory requirements of the 1984 Act that all OTIs submit a surety bond as proof of financial responsibility, a revised section 19 for the first time required that NVOCCs operating in the United States be licensed by the Federal Maritime Commission (“Commission”). 1 46 U.S.C. app. 1718 (1984). Concurrent with the effective date of OSRA, the Commission prescribed new regulations at 46 CFR Part 515 ( *Licensing, Financial Responsibility Requirements, and General Duties for Ocean Transportation Intermediaries* ), implementing those revisions to the 1984 Act with respect to OTI licensing and financial responsibility (64 FR 11156, March 8, 1999). The Commission's OTI regulations specify that each OTI must establish its financial responsibility by furnishing the Commission a surety bond, evidence of insurance or evidence of guaranty to provide coverage for damages, reparations or penalties arising from the OTI's transportation-related activities. * See* 46 CFR 515.22. In the case of surety bonds, the regulations specify that such bonds must be issued by a surety company found acceptable by the Secretary of the Treasury. 46 CFR 515.22(a). 2 2 The Department of Treasury maintains an extensive list of approved surety bonding companies, known as Circular 570. Circular 570 is published on Treasury's Web site at: *http://www.fms.treas.gov/c570/index.html.* By notice issued June 23, 2003, the Department of Treasury terminated the Certificate of Authority issued to American Motorists Insurance Company, which had qualified that company as an acceptable surety on Federal bonds. Under the Treasury program, bonds that are continuous in nature remain valid and effective for the purposes issued, but may no longer be renewed. Commencing with the anniversary date of such termination, OTIs holding surety bonds issued by American Motorists Insurance Company were obligated to replace their OTI bond with a valid bond issued by a surety company currently certified by Treasury. Contacts by Commission staff over an extended period have resulted in licensees voluntarily furnishing replacement evidence of financial responsibility with respect to all but 21 of the licensees previously covered by American Motorists Insurance Company bonds. In October and November 2005, the Commission contacted the licensees by phone and by formal letter, notifying each remaining licensee that continued failure to comply with bonding requirements placed them at risk of license revocation or other action to suspend such OTI's right to continue operations in the U.S. trades. Following direct notice to the affected parties and an extended period to bring themselves into compliance, it appears that the 8 OTIs listed in the attached Schedule A no longer meet the requirements for demonstrating financial responsibility imposed by section 19 of the 1984 Act. Now therefore, it is ordered that pursuant to section 11 of the Shipping Act of 1984, 46 U.S.C. app. 1710, the entities listed in Schedule A to this Order are directed to show cause why the Commission should not revoke their licenses for failure to comply with section 19 of the Shipping Act of 1984, 46 U.S.C. app. 1718, as amended, and 46 CFR 515.22(a). It is further ordered that pursuant to section 11 of the Shipping Act of 1984, the entities listed in Schedule A to this Order are directed to show cause why the Commission should not order each of them to cease and desist from operating as an ocean transportation intermediary in the foreign trade of the United States, for failure to comply with section 19 of the Shipping Act of 1984, as amended, and 46 CFR Part 515; It is further ordered that this proceeding is limited to the submission of affidavits of facts and memoranda of law; It is further ordered that any person having an interest and desiring to intervene in this proceeding shall file a petition for leave to intervene in accordance with Rule 72 of the Commission's Rules of Practice and Procedure, 46 CFR 502.72. Such petition shall be accompanied by the petitioner's memorandum of law and affidavits of fact, if any, and shall be filed no later than the day fixed below; It is further ordered that the entities listed in Schedule A to this Order are named as Respondents in this proceeding. Affidavits of fact and memoranda of law shall be filed by Respondents and any intervenors in support of Respondents no later than April 17, 2006; It is further ordered that the Commission's Bureau of Enforcement be made a party to this proceeding; It is further ordered that reply affidavits and memoranda of law shall be filed by the Bureau of Enforcement and any intervenors in opposition to Respondents no later than May 17, 2006; It is further ordered that rebuttal affidavits and memoranda of law shall be filed by Respondents and intervenors in support no later than June 1, 2006; It is further ordered that:
(a)Should any party believe that an evidentiary hearing is required, that party must submit a request for such hearing together with a statement setting forth in detail the facts to be proved, the relevance of those facts to the issues in this proceeding, a description of the evidence which would be adduced, and why such evidence cannot be submitted by affidavit;
(b)Should any party believe that an oral argument is required, that party must submit a request specifying the reasons therefore and why argument by memorandum is inadequate to present the party's case; and
(c)Any request for evidentiary hearing or oral argument shall be filed no later than May 17, 2006; It is further ordered that notice of this Order to Show Cause be published in the **Federal Register** , and that a copy thereof be served upon each respondent at its last known address; It is further ordered that all documents submitted by any party of record in this proceeding shall be filed in accordance with Rule 118 of the Commission's Rules of Practice and Procedure, 46 CFR 502.118, and be mailed directly to all parties of record; Finally, it is ordered that pursuant to the terms of Rule 61 of the Commission's Rules of Practice and Procedure, 46 CFR 502.61, the final decision of the Commission in this proceeding shall be issued by October 31, 2006. By the Commission. Bryant L. VanBrakle, Secretary. Schedule A.—Licensees in the United States Organization No. Name 004278 Cambell & Gardiner, Inc. 008727 Ken Lehat & Associates, Inc. 015494 Ocean Transportation Services, LLC. 011405 Interfreight, Inc. 016391 Caribbean American Shipping Corp. 008751 Ford International Forwarding, Inc. 016817 Independence Shipping Lines, Ltd. 017387 S & B International Freight Forwarders, Inc. [FR Doc. E6-3789 Filed 3-15-06; 8:45 am] BILLING CODE 6730-01-P FEDERAL RESERVE SYSTEM Change in Bank Control Notices; Acquisition of Shares of Bank or Bank Holding Companies The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board’s Regulation Y (12 CFR 225.41) to acquire a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)). The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the office of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than March 31, 2006. **A. Federal Reserve Bank of Atlanta** (Andre Anderson, Vice President) 1000 Peachtree Street, N.E., Atlanta, Georgia 30303: *1. W.C. Martin, Jr.; Jean Wood Martin; Donald Wayne Sanders; Mary Martin Noland; Donald Martin Sanders; Rebecca Martin Sanders; William Matthew Sanders* , all of Aliceville, Alabama; Alice Susan Martin, Chattanooga, Tennessee, Milton Barrett Noland, Carrollton, Alabama; and Karrie Noland Beasley, Tuscaloosa, Alabama, to retain voting shares of First National Bancshares of Central Alabama, Inc., and thereby indirectly retain voting shares of First National Bank of Central Alabama, both of Aliceville, Alabama. Board of Governors of the Federal Reserve System, March 13, 2006. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E6-3811 Filed 3-15-06; 8:45 am] BILLING CODE 6210-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Toxicology Program (NTP), NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Notice of Availability of a Revised List of Recommended Reference Substances for Validation of In Vitro Estrogen and Androgen Receptor Binding and Transcriptional Activation Assays: Request for Comments and Submission of In Vivo and In Vitro Data AGENCY: National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH). ACTION: Request for Comments and Submission of Data. SUMMARY: The National Toxicology Program
(NTP)Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announces the availability of an addendum to the report entitled, “Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Evaluation of *In Vitro* Test Methods for Detecting Potential Endocrine Disruptors: Estrogen Receptor and Androgen Receptor Binding and Transcriptional Activation Assays” [NIH Publication 03-4503]. The addendum describes the rationale for proposed revisions to the original list of recommended reference substances for validation of *in vitro* estrogen receptor
(ER)and androgen receptor
(AR)binding and transcriptional activation
(TA)assays. The original list was made publicly available in June 2003 ( **Federal Register** , Vol. 68, No. 106, pp. 33171-33172, June 3, 2003). NICEATM requests public comments on the substances proposed as substitutes for six of the 78 substances in the original list. Data are also requested from *in vitro* and *in vivo* studies evaluating the estrogenic and androgenic activity of the 78 substances in the revised list of reference substances. DATES: Comments and data submissions should be received by May 1, 2006. ADDRESSES: Correspondence should be sent by mail, fax, or e-mail to Dr. William S. Stokes, NICEATM Director, NIEHS, P. O. Box 12233, MD EC-17, Research Triangle Park, NC, 27709, (phone) 919-541-2384,
(fax)919-541-0947, (e-mail) *niceatm@niehs.nih.gov.* SUPPLEMENTARY INFORMATION: Background In April 2000, the Environmental Protection Agency
(EPA)asked ICCVAM to evaluate the validation status of *in vitro* ER and AR binding and TA assays that were proposed as possible components of the EPA Endocrine Disruptor Screening Program Tier 1 screening battery. ICCVAM agreed to evaluate these test methods based on their potential interagency applicability and public health significance. NICEATM, which administers and provides scientific support for ICCVAM, subsequently compiled available data and information on in vitro ER and AR binding and TA assays in four draft Background Review Documents
(BRDs)(available at *http://iccvam.niehs.nih.gov/methods/endocrine.htm* ). In collaboration with the ICCVAM Endocrine Disruptor Working Group, NICEATM organized an independent scientific evaluation of the validation status of the four types of in vitro endocrine disruptor screening test methods on May 20-21, 2002, in Research Triangle Park, NC ( **Federal Register** , Vol. 66, No. 57, pp. 16278-16279, March 23, 2001 and **Federal Register** , Vol. 66, No. 67, pp. 16415-16416, April 5, 2002) (available at *http://iccvam.niehs.nih.gov/methods/endocrine.htm* ). The final BRDs and the ICCVAM Test Method Evaluation Report, which includes the expert panel report, public comments, and other relevant documents, were published in May 2003 and announced in a **Federal Register** notice (Vol. 68, No. 106, pp. 33171-33172, June 3, 2003) (available at *http://iccvam.niehs.nih.gov/methods/endocrine.htm* ). NICEATM recently reviewed the commercial availability and cost for the 78 substances recommended by ICCVAM for use in *in vitro* ER and AR binding and TA validation studies. A minimum of 44 substances are recommended for AR binding and TA assays, while a minimum of 53 substances are recommended for ER binding and TA assays. This review indicated that three substances [anastrazole, CGS 18320B, fadrozole] are not commercially available, one substance has restricted commercial availability [ICI 182,780] and six others [actinomycin D, hydroxyflutamide, 4-hydroxytamoxifen, methyltrienolone, 12-O-tetradecanoylphorbol-13-acetate, zearalenone] have costs that are considered excessive. ICCVAM proposes replacing the four substances that are not commercially available or have restricted availability with ones having similar ER and AR activity profiles [4-hydroxyandrostenedione, chrysin, dicofol, raloxifene HCl]. Suitable replacements (19-nortestosterone and resveratrol) were identified for metyltrienolone and zearalenone, respectively, for two of the expensive substances. NICEATM would also prefer to replace four of the highly priced substances [actinomycin D, hydroxyflutamide, 4-hydroxytamoxifen, 12-O-tetradecanoy.lphorbol-13-acetate], but has been unable to identify suitable replacements because of their unique activity profiles and/or chemical/physical properties. The revised list of 78 substances and a discussion about the proposed revisions are included and discussed in the “Addendum to the ICCVAM Evaluation of In Vitro Test Methods for Detecting Potential Endocrine Disruptors: Estrogen Receptor and Androgen Receptor Binding and Transcriptional Activation Assays,” (available at *http://iccvam.niehs.nih.gov* see “Test Method Evaluations”) or by contacting NICEATM (see ADDRESSES above.) ICCVAM will finalize this list after considering any public comments received and forward it to U.S. Federal agencies for their information and consideration. Request for Comments and Request for Data NICEATM requests public comments on the four substances (listed above) proposed as replacements for substances on the list that are not readily commercially available. NICEATM also requests public comments on the proposed replacements for the two expensive substances for which replacements have been identified, and suggestions for replacements for the four expensive substances that remain on the recommended list. In order to update the reference substance database, NICEATM request data from completed *in vitro* studies using or evaluating ER and AR binding and/or TA assays, and information about ongoing or planned studies using or evaluating these test methods. NICEATM also requests the submission of data from animal studies that have evaluated the endocrine activity of chemicals using, for example, the uterotropic, Hershberger, intact male, or male/female pubertal assays. NICEATM is especially interested in receiving additional data or information on any of the 78 substances included in the reference list. NICEATM previously requested data from completed studies using or evaluating ER and AR binding and/or TA assays, and information about ongoing or planned *in vitro* or *in vivo* studies using or evaluating these test methods ( **Federal Register** , Vol. 66, No. 57, pp. 16278-16279, March 23, 2001). Submitted data will be used to update and supplement the existing NICEATM database; the current database can be accessed in the ICCVAM Test Method Evaluation Report [NIH Publication No. 03-4503] and the four final BRDs on ER and AR binding and TA assays [NIH Publication No. 03-4504, 03-4505, 03-4506, and 03-4507] (available at *http://iccvam.niehs.nih.gov/methods/endocrine.htm* ). When submitting chemical and protocol information/test data, please reference this **Federal Register** notice and provide appropriate contact information (name, affiliation, mailing address, phone, fax, e-mail, and sponsoring organization, as applicable). NICEATM prefers data to be submitted as copies of pages from study notebooks and/or study reports, if available. Raw data and analyses available in electronic format may also be submitted. If data are published in the peer-reviewed literature, citations should be provided. Each submission for a chemical should preferably include the following information, as appropriate: • Common and trade name • Chemical Abstracts Service Registry Number (CASRN) • Chemical class • Product class • Commercial source • *In vitro* test protocol used • *In vitro* test results • *In vivo* test protocol used • *In vivo* test results • The extent to which the study complied with national or international Good Laboratory Practice
(GLP)guidelines • Date and testing organization Background Information on ICCVAM and NICEATM ICCVAM is an interagency committee composed of representatives from 15 Federal regulatory and research agencies that use or generate toxicological information. ICCVAM conducts technical evaluations of new, revised, and alternative methods with regulatory applicability and promotes the scientific validation and regulatory acceptance of toxicological test methods that more accurately assess the safety and hazards of chemicals and products and that refine, reduce, or replace animal use. The ICCVAM Authorization Act of 2000 (Pub. L. 106-545) establishes ICCVAM as a permanent interagency committee of the NIEHS under the NICEATM. NICEATM administers the ICCVAM and provides scientific and operational support for ICCVAM-related activities. NICEATM and ICCVAM work collaboratively to evaluate new and improved test methods applicable to the needs of Federal agencies. Additional information about ICCVAM and NICEATM can be found at the following Web site: *http://www.iccvam.niehs.nih.gov.* Dated: March 7, 2006. Samuel H. Wilson, Deputy Director, National Institute of Environmental Health Sciences and National Toxicology Program. [FR Doc. E6-3763 Filed 3-15-06; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panels (SEP): Emerging Infections Sentinel Network Research, Request for Applications CI 06-002 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: *Name:* Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Emerging Infections Sentinel Network Research, Request for Applications CI 06-002. *Time and Date:* 12 p.m.-4 p.m., April 11, 2006 (Closed). *Place:* Teleconference. *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 Emerging Infections Sentinel Network Research, Request for Applications CI 06-002. *Contact Person for More Information:* Chris Langub, Ph.D., Scientific Review Administrator, National Institute for Occupational Safety and Health, CDC, 1600 Clifton Road NE, Mailstop E74, Atlanta, GA 30333, Telephone 404.498.2531. 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: March 10, 2006. Alvin Hall, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E6-3793 Filed 3-15-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0081] Agency Information Collection Activities: Proposed Collection; Comment Request; Prescription Drug Marketing Act of 1987 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the reporting and recordkeeping requirements contained in the regulations implementing the Prescription Drug Marketing Act of 1987 (PDMA). DATES: Submit written or electronic comments on the collection of information by May 15, 2006. ADDRESSES: Submit electronic comments on the collection of information to *http://www.fda.gov/dockets/ecomments.* Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Karen Nelson, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1482. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget
(OMB)for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics:
(1)Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;
(2)the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3)ways to enhance the quality, utility, and clarity of the information to be collected; and
(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Prescription Drug Marketing Act of 1987; Administrative Procedures, Policies, and Requirements—21 CFR Part 203 (OMB Control Number 0910-0435)—Extension FDA is requesting OMB approval under the PRA for the reporting and recordkeeping requirements contained in the regulations implementing the Prescription Drug Marketing Act of 1987
(PDMA)(Public Law 100-293). PDMA was intended to ensure that drug products purchased by consumers are safe and effective and to avoid an unacceptable risk that counterfeit, adulterated, misbranded, subpotent, or expired drugs are sold. PDMA was enacted by Congress because there were insufficient safeguards in the drug distribution system to prevent the introduction and retail sale of substandard, ineffective, or counterfeit drugs, and that a wholesale drug diversion submarket had developed that prevented effective control over the true sources of drugs. Congress found that large amounts of drugs had been reimported into the United States as U.S. goods returned causing a health and safety risk to U.S. consumers because the drugs may become subpotent or adulterated during foreign handling and shipping. Congress also found that a ready market for prescription drug reimports had been the catalyst for a continuing series of frauds against U.S. manufacturers and had provided the cover for the importation of foreign counterfeit drugs. Congress also determined that the system of providing drug samples to physicians through manufacturers' representatives had resulted in the sale to consumers of misbranded, expired, and adulterated pharmaceuticals. The bulk resale of below wholesale priced prescription drugs by health care entities for ultimate sale at retail also helped to fuel the diversion market and was an unfair form of competition to wholesalers and retailers who had to pay otherwise prevailing market prices. FDA is requesting OMB approval for the following reporting and recordkeeping requirements: **Table 1.—Reporting Requirements** 21 CFR Section Reporting Requirements 203.11 Applications for reimportation to provide emergency medical care 203.30(a)(1) and
(b)Drug sample requests (drug samples distributed by mail or common carrier) 203.30(a)(3), (a)(4), and
(c)Drug sample receipts (receipts for drug samples distributed by mail or common carrier) 203.31(a)(1) and
(b)Drug sample requests (drug samples distributed by means other than the mail or a common carrier) 203.31(a)(3), (a)(4), and
(c)Drug sample receipts (drug samples distributed by means other than the mail or a common carrier) 203.37(a) Investigation of falsification of drug sample records 203.37(b) Investigation of a significant loss or known theft of drug samples 203.37(c) Notification that a representative has been convicted of certain offenses involving drug samples 203.37(d) Notification of the individual responsible for responding to a request for information about drug samples 203.39(g) Preparation by a charitable institution of a reconciliation report for donated drug samples **Table 2.—Recordkeeping Requirements** 21 CFR Section Recordkeeping Requirements 203.23(a) and
(b)Credit memo for returned drugs 203.23(c) Documentation of proper storage, handling, and shipping conditions for returned drugs 203.30(a)(2) and 203.31(a)(2) Verification that a practitioner requesting a drug sample is licensed or authorized to prescribe the product 203.31(d)(1) and (d)(2) Contents of the inventory record and reconciliation report required for drug samples distributed by representatives 203.31(d)(4) Investigation of apparent discrepancies and significant losses revealed through the reconciliation report 203.31(e) Lists of manufacturers' and distributors' representatives 203.34 Written policies and procedures describing administrative systems 203.37(a) Report of investigation of falsification of drug sample records 203.37(b) Report of investigation of significant loss or known theft of drug samples 203.38(b) Records of drug sample distribution identifying lot or control numbers of samples distributed. (The information collection in 21 CFR 203.38(b) is already approved under OMB Control Number 0910-0139) 203.39(d) Records of drug samples destroyed or returned by a charitable institution 203.39(e) Record of drug samples donated to a charitable institution 203.39(f) Records of donation and distribution or other disposition of donated drug samples 203.39(g) Inventory and reconciliation of drug samples donated to charitable institutions 203.50(a) Drug origin statement 203.50(b) Retention of drug origin statement for 3 years 203.50(d) List of authorized distributors of record The reporting and recordkeeping requirements are intended to help achieve the following goals: 1. To ban the reimportation of prescription drugs produced in the United States, except when reimported by the manufacturer or under FDA authorization for emergency medical care; 2. To ban the sale, purchase, or trade, or the offer to sell, purchase, or trade, of any prescription drug sample; 3. To limit the distribution of drug samples to practitioners licensed or authorized to prescribe such drugs or to pharmacies of hospitals or other health care entities at the request of a licensed or authorized practitioner; 4 To require licensed or authorized practitioners to request prescription drug samples in writing; 5. To mandate storage, handling, and recordkeeping requirements for prescription drug samples; 6. To prohibit, with certain exceptions, the sale, purchase, or trade of, or the offer to sell, purchase, or trade, prescription drugs that were purchased by hospitals or other health care entities, or which were donated or supplied at a reduced price to a charitable organization; 7. To require unauthorized wholesale distributors to provide, prior to the wholesale distribution of a prescription drug to another wholesale distributor or retail pharmacy, a statement identifying each prior sale, purchase, or trade of the drug. FDA estimates the burden of this collection of information as follows: ** Table 3.—Estimated Annual Reporting Burden 1 ** 21 CFR Section No. of Respondents No. of Responses per Respondent Total Annual Responses Hours per Response Total Hours 203.11 12 1 12 .5 6 203.30(a)(1) and
(b)61,961 12 743,532 .06 44,612 203.30(a)(3), (a)(4), and
(c)61,961 12 743,532 .06 44,612 203.31(a)(1) and
(b)232,355 135 31,367,925 .04 1,254,717 203.31(a)(3), (a)(4), and
(c)232,355 135 31,367,925 .03 941,038 203.37(a) 25 1 25 6.00 150 203.37(b) 200 1 200 6.00 1,200 203.37(c) 50 1 50 1.00 50 203.37(d) 2,208 1 2,208 .08 177 203.39(g) 3,221 1 3,221 2.00 6,442 Total Reporting Burden Hours 2,293,004 1 There are no capital costs or operating and maintenance costs associated with this collection of information. ** Table 4.—Estimated Annual Recordkeeping Burden 1 ** 21 CFR Section No. of Recordkeepers No. of Responses per Recordkeeper Total Annual Records Hours per Record Total Hours 203.23(a) and
(b)31,676 5 158,380 .25 39,595 203.23(c) 31,676 5 158,380 .08 12,670 203.30(a)(2) and 203.31(a)(2) 2,208 100 220,800 .50 110,400 203.31(d)(1) and (d)(2) 2,208 1 2,208 40.00 88,320 203.31(d)(4) 442 1 442 24.00 10,608 203.31(e) 2,208 1 2,208 1.00 2,208 203.34 2,208 1 2,208 40.00 88,320 203.37(a) 25 1 25 18.00 450 203.37(b) 200 1 200 18.00 3,600 203.39(d) 65 1 65 1.00 65 203.39(e) 3,221 1 3,221 .50 1,610 203.39(f) 3,221 1 3,221 8.00 25,768 203.39(g) 3,221 1 3,221 8.00 25,768 203.50(a) 0 0 0 0 0 203.50(b) 0 0 0 0 0 203.50(d) 0 0 0 0 0 Total Recordkeeping Burden Hours 409,409 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: March 10, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-3818 Filed 3-15-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N-0426] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Notice of Participation 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 April 17, 2006. ADDRESSES: OMB is still experiencing significant delays in the regular mail, including first class and express mail, and messenger deliveries are not being accepted. 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: Fumie Yokota, Desk Officer for FDA, FAX: 202-395-6974. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management Programs (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. Notice of Participation—(OMB Control Number 0910-0191)—Extension Section 12.45 (21 CFR 12.45), issued under section 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371), sets forth the format and procedures for any interested person to file a petition to participate in a formal evidentiary hearing, either personally or through a representative. Section 12.45 requires that any person filing a notice of participation state their specific interest in the proceedings, including the specific issues of fact about which the person desires to be heard. This section also requires that the notice include a statement that the person will present testimony at the hearing and will comply with specific requirements in § 12.85, or, in the case of a hearing before a Public Board of Inquiry (21 CFR 13.25). In accordance with § 12.45(e) the presiding officer may omit a participant's appearance. The presiding officer and other participants will use the collected information in a hearing to identify specific interests to be presented. This preliminary information serves to expedite the pre-hearing conference and commits participation. The respondents are individuals or households, State or local governments, not for profit institutions, and businesses, or other for profit groups and institutions. In the **Federal Register** of November 1, 2005 (70 FR 65904), FDA published a 60-day notice requesting public comment on the information collection provisions to which one comment was received. However, it was not related to the information collection. **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 12.45 264 1 264 3 792 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: March 10, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-3819 Filed 3-15-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N-0422] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Emergency Shortages Data Collection System (Formerly the Emergency Medical Device Shortage Program Survey) 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 April 17, 2006. ADDRESSES: OMB is still experiencing significant delays in the regular mail, including first class and express mail, and messenger deliveries are not being accepted. 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: Fumie Yokota, Desk Officer for FDA, FAX: 202-395-6974. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management Programs (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. Emergency Shortages Data Collection System (Formerly the Emergency Medical Device Shortage Program Survey)—(OMB Control Number 0910-0491)—Extension Under section 903(d)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 393(d)(2)), the Commissioner of Food and Drugs is authorized to implement general powers (including conducting research) to carry out effectively the mission of FDA. Section 510 of the act (21 U.S.C. 360) requires that domestic establishments engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of medical devices intended for human use and commercial distribution register their establishments and list the devices they manufacture with FDA. Section 522 of the act (21 U.S.C. 360(l)) authorizes FDA to require manufacturers to conduct postmarket surveillance of medical devices. Section 705(b) of the act (21 U.S.C. 375(b)) authorizes FDA to collect and disseminate information regarding medical products or cosmetics in situations involving imminent danger to health, or gross deception of the consumer. These sections of the act enable FDA to enhance consumer protection from risks associated with medical device usage that are not foreseen or apparent during the premarket notification and review process. Subsequent to the events of September 11, 2001, FDA's Center for Devices and Radiological Health
(CDRH)began planning for handling medical device shortage issues associated with counter-terrorism. One of the activities related to the planning was that CDRH would establish a data collection system as a supplemental source for available product. Because of events on September 11, 2001, local and State governments have obtained stockpiles of backup supplies within their jurisdiction to cover an emergency for the first 12 hours following a terrorist attack. The second 12 hours will have additional medical devices supplied by the Centers for Disease Control's Strategic National Stockpile and the National Acquisition Center. However, if additional supplies are needed in the first 12 hours, the Department of Health and Human Services
(HHS)will request that FDA provide the number of medical devices readily available to meet demands. HHS has an established transportation and delivery mechanism in place to provide these emergent needs to the local and State authorities. The Emergency Medical Device Shortage Survey was established in 1992 to collect data to assist FDA in implementing an emergency medical device shortage program that would find resources to supplement the needed supplies. In 2004, CDRH changed the process for the data collection and the name was changed to the Emergency Shortages Data Collection System. Because of the confidentiality aspect of the information, the information is only available to those on FDA's Emergency Shortage Team
(EST)and senior management with a need-to-know. The need-to-know personnel include five EST members, the EST leader, the EST data entry technician, and five senior managers. The Emergency Shortages Data Collection System will be updated every 4 months to keep information current. CDRH learned that medical device manufacturers have a high rate of turnover in personnel and in corporate structures due to mergers with larger companies. In addition, with the constant advances in technology, some of these manufacturers are forced to discontinue product lines or add product lines to their inventory. This new data collection system process will update information on a regular basis ensuring more accurate information in an emergency/disaster. The process consists of one scripted telephone call to the designated shortage person at the four or five largest manufacturers of specific medical devices that may be needed by first responders in a national emergency. At the current time, the list contains 67 products from 65 manufacturers. If other products or new technology are deemed necessary to add at a later date, then the EST will conduct the appropriate search to find the four or five largest manufacturers of that product line and request the manufacturer's voluntary inclusion into the program. The Emergency Shortages Data Collection System will only include those medical devices that are expected to be in demand but in short supply in an emergency/disaster. The data collection system includes life-saving and life-sustaining products (i.e., mechanically powered ventilators) as well as products that would require frequent changes resulting in rapidly depleted supplies (i.e., face masks and gloves). In the **Federal Register** of November 4, 2005 (70 FR 67177), 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 No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 65 3 195 .5 98 1 There are no capital costs or operating and maintenance costs associated with this collection of information. FDA based these estimates on past experience with direct contact with the medical device manufacturers. FDA estimates that approximately 65 manufacturers would be contacted by electronic mail three times per year to get updated information at their facilities. Further, it is estimated that the manufacturers may require up to 30 minutes to check if information received previously is still current and send electronic mail back to FDA. Dated: March 10, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-3820 Filed 3-15-06; 8:45 am] BILLING CODE 4160-01-S ] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005E-0238] Determination of Regulatory Review Period for Purposes of Patent Extension; TYSABRI AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)has determined the regulatory review period for TYSABRI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human biological product. ADDRESSES: Submit written or electronic comments and petitions to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . FOR FURTHER INFORMATION CONTACT: Claudia V. Grillo, Office of Regulatory Policy (HFD-013), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 240-453-6681. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA recently approved for marketing the human biological product TYSABRI (natalizumab). TYSABRI is indicated for the treatment of patients, with relapsing forms of multiple sclerosis, to reduce the frequency of clinical exacerbations. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for TYSABRI (U.S. Patent No. 5,840,299) from Athena Neurosciences, Inc., and the Patent and Trademark Office requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated July 8, 2005, FDA advised the Patent and Trademark Office that this human biological product had undergone a regulatory review period and that the approval of TYSABRI represented the first permitted commercial marketing or use of the product. Shortly thereafter, the Patent and Trademark Office requested that FDA determine the product's regulatory review period. FDA has determined that the applicable regulatory review period for TYSABRI is 2,924 days. Of this time, 2,740 days occurred during the testing phase of the regulatory review period, while 184 days occurred during the approval phase. These periods of time were derived from the following dates: 1. *The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective* : November 23, 1996. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on November 23, 1996. 2. *The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262)* : May 24, 2004. FDA has verified the applicant's claim that the product license application
(BLA)for TYSABRI (BLA 125104) was initially submitted on May 24, 2004. 3. *The date the application was approved* : November 23, 2004. FDA has verified the applicant's claim that BLA 125104 was approved on November 23, 2004. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,189 days of patent term extension. Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments and ask for a redetermination by May 15, 2006. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by September 12, 2006. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Comments and petitions should be submitted to the Division of Dockets Management. Three copies of any mailed information are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: February 13, 2006. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E6-3781 Filed 3-16-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of the meeting will be closed to the public. *Name of the Committee* : Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee. *General Function of the Committee* : To provide advice and recommendations to the agency on FDA's regulatory issues. *Date and Time* : The meeting will be held on March 27, 2006, from 10 a.m. to 5:45 p.m., and on March 28, 2006, from 8 a.m. to 3 p.m. *Location* : Gaithersburg Hilton, Salons A, B, and C, 620 Perry Pkwy., Gaithersburg, MD. *Contact* : Michael Bailey, Center for Devices and Radiological Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1180, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512524. Please call the Information Line for up-to-date information on this meeting. *Agenda* : On March 27, 2006, the committee will discuss, make recommendations, and vote on a premarket approval application for a post-surgical adhesion prevention device for use in patients undergoing gynecological laparoscopic surgical procedures. On March 28, 2006, the committee will have a general topic discussion of clinical trial design issues for new devices intended to treat symptomatic uterine fibroids. Background information, including the agenda and questions for the committee, will be available to the public, 1 business day before the meeting, on the Internet at *http://www.fda.gov/cdrh/panelmtg.html* . *Procedure* : On March 27, 2006, from 10 a.m. to 5:45 p.m., and on March 28, 2006, from 9 a.m. to 3 p.m., the meeting is open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person by March 20, 2006. Oral presentations from the public will be scheduled on March 27, 2006, between approximately 10:10 a.m. and 10:40 a.m. and between approximately 4:15 p.m. and 4:45 p.m., and on March 28, 2006, between approximately 10:15 a.m. and 11:15 a.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before March 20, 2006, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation. *Closed Committee Deliberations* : On March 28, 2006, from 8 a.m. to 9 a.m., the meeting will be closed to permit discussion and review of trade secret and/or confidential information (5 U.S.C. 552b(c)(4)) regarding pending and future device issues. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact AnnMarie Williams, Conference Management Staff, at 240-276-0450, ext. 113, at least 7 days in advance of the meeting. FDA regrets that it was unable to publish this notice 15 days prior to the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee meeting. Because the agency believes there is some urgency to bring these issues to public discussion and qualified members of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee were available at this time, the Commissioner of Food and Drugs concluded that it was in the public interest to hold this meeting even if there was not sufficient time for the customary 15-day public notice. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2). Dated: March 7, 2006. Jason Brodsky, Acting Associate Commissioner for External Relations. [FR Doc. E6-3786 Filed 3-15-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005D-0103] Guidance for Industry on Using a Centralized IRB Process in Multicenter Clinical Trials; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing the availability of a guidance for industry entitled “Using a Centralized IRB Process in Multicenter Clinical Trials.” The guidance is intended to assist sponsors, institutions, institutional review boards (IRBs), and clinical investigators involved in multicenter clinical research in meeting the requirements of FDA regulations by facilitating the use of a centralized IRB review process. DATES: Submit written or electronic comments on agency guidances at any time. ADDRESSES: Submit written requests for single copies of the guidance to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, or the Office of Communication, Training and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. The guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-1800. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Nancy Stanisic, Center for Drug Evaluation and Research (HFD-1), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1660, or Steve Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration,1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210, or David Lepay, Good Clinical Practice Program, Office of Science and Health Coordination (HF-34), 5600 Fishers Lane, Rockville, MD 20857, 301-827-3340. SUPPLEMENTARY INFORMATION: I. Background In the **Federal Register** of March 28, 2005 (70 FR 15635), FDA published a notice announcing the availability of a draft guidance entitled “Using a Centralized IRB Process in Multicenter Clinical Trials.” The notice gave interested persons an opportunity to submit comments by May 27, 2005. The agency received only a small number of comments, and we carefully considered the received comments as we finalized the draft guidance. Other than minor editorial changes and some clarifications, no substantive changes were made to the draft guidance. This guidance is intended to assist sponsors, institutions, IRBs, and clinical investigators involved in multicenter clinical research in meeting the requirements of 21 CFR part 56 by facilitating the use of a centralized IRB review process. The guidance does the following:
(1)Describes the roles of the participants in a centralized IRB review process,
(2)offers guidance on how a centralized IRB review process might consider the concerns and attitudes of the various communities participating in a multicenter clinical trial,
(3)makes recommendations about documenting agreements between a central IRB and the IRBs at institutions involved in the centralized IRB review process concerning the responsibilities of a central IRB and each institution's IRB, and
(4)discusses IRB procedures for implementing a centralized review process. Finally, the guidance recommends how to ensure effective IRB review for clinical trial sites not already affiliated with an IRB. This guidance applies to clinical investigations conducted under 21 CFR part 312 (investigational new drug application or IND regulations). This level 1 guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments on the guidance. Submit a single copy of electronic comments or two paper copies, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The guidance and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. III. Electronic Access Persons with access to the Internet may obtain the guidance at *http://www.fda.gov/cder/guidance/index.htm* . *http://www.fda.gov/cber/guidelines.htm* , or *http://www.fda.gov/ohrms/dockets/default.htm* . Dated: March 7, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-3785 Filed 3-15-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [FDA 225-06-8000] Confidentiality Arrangement Between the United States Food and Drug Administration and the French Health Products Safety Agency AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is providing notice of a confidentiality arrangement between the United States Food and Drug Administration and the French Health Products Safety Agency. The purpose of this confidentiality arrangement is to establish mutual commitments to retain the confidentiality of non-public information shared between the agencies. DATES: The agreement became effective February 8, 2006. FOR FURTHER INFORMATION CONTACT: Matthew E. Eckel, Office of International Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane, Rockville MD, 20857, 301-827-4480, FAX: 301-480-0716. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 20.108(c), which states that all written agreements and understandings between FDA and others shall be published in the **Federal Register** , the agency is publishing notice of this confidentiality arrangement. Dated: March 7, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. BILLING CODE 4160-01-S EN16MR06.001 EN16MR06.002 [FR Doc. 06-2539 Filed 3-15-06; 8:45 am]
Connectionstraces to 26
Traces to 26 documents
46 references not yet in our index
  • Pub. L. 104-13
  • Pub. L. 92-463
  • 40 CFR 9
  • 40 CFR 51
  • 40 CFR 85
  • 40 CFR 89
  • 40 CFR 90
  • 40 CFR 91
  • 40 CFR 63
  • 40 CFR 60
  • 40 CFR 372
  • 40 CFR 80.29
  • 40 CFR 80.240
  • 40 CFR 80.530-80
  • 40 CFR 80.535-80
  • 40 CFR 80.550-80
  • 40 CFR 80.560-80
  • 40 CFR 80.590-80
  • 40 CFR 80.597
  • 40 CFR 80.600-80
  • 40 CFR 80.607
  • 40 CFR 80.620
  • 40 CFR 71
  • 40 CFR 194.8
  • 40 CFR 2
  • Pub. L. 102-579
  • Pub. L. 104-201
  • 40 CFR 191
  • 40 CFR 194
  • 40 CFR 194.24
  • Pub. L. 105-258
  • 46 CFR 515
  • 46 CFR 515.22
  • 46 CFR 515.22(a)
  • 46 CFR 502.72
  • 46 CFR 502.118
  • 46 CFR 502.61
  • Pub. L. 106-545
  • 44 USC 3501-3520
  • 5 CFR 1320.3(c)
+ 6 more
Citation graph
cites case law
Notices
Notice
Stat.Public Law 92–463
C.F.R.§ 366.3
C.F.R.§ 366.4
C.F.R.§ 385.211
U.S.C.§ 3501
U.S.C.§ 7661d
Stat.Public Law 105–257
U.S.C.§ 1817
C.F.R.§ 225.41
Pub. L.Pub. L. 104-13
Pub. L.Pub. L. 92-463
Cite40 CFR 9
Cites 72 · showing 12Cited by 0 across 0 sources
★   the supreme law of the land   ★
Don't Tread on Me
E Pluribus Unum — out of many, one

"If you don't know your rights, you don't have any."

Marginalia · a citizen's law index
A research desk, not legal advice. Always read the cited source before relying on a summary.
Questions or an issue? support@self-law.org
disclaimerMarginalia is a research index, not a law firm. Nothing on this site is legal, tax, or financial advice and no attorney–client relationship is formed by using it. Statutes, regulations, and case law change; summaries, search results, AI output, and member posts may be incomplete, out of date, or wrong. Any interpretation drawn from material on this site should be validated by a licensed attorney in your jurisdiction before you act on it.