Notices. Notice of availability

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BILLING CODE 6750-07-M GENERAL SERVICES ADMINISTRATION Public Building Service; Notice of Availability; Master Site Plan and Environmental Impact Statement for the Denver Federal Center, Lakewood, CO AGENCY: Public Building Service, General Services Administration. ACTION: Notice of availability. SUMMARY: In accordance with the National Environmental Policy Act of 1969, and the President's Council on Environmental Quality Regulations (40 CFR parts 1500-1508), as implemented by General Services Administration

(GSA)Order PBS P 1095.4D, GSA announces its Notice of Availability

(NOA)of the Proposed Master Site Plan and Draft Environmental Impact Statement

(DEIS)for the Denver Federal Center in Lakewood, Colorado. DATES: *Public Meeting:* Public meetings will be conducted to provide the public with an opportunity to present comments, ask questions, and discuss concerns regarding the DEIS with GSA representatives. GSA will host public meetings on Wednesday, May 16 from 11 a.m. to 1 p.m. at Building 41, Denver Federal Center, Lakewood, CO, and again on May 16 from 4 p.m. to 8 p.m. at Creighton Middle School, Lakewood, CO, and on Thursday May 17 from 11 a.m. to 1 p.m. at Building 25, Denver Federal Center, Lakewood, CO. More specific information about the meetings will be noticed in local media and on the GSA Web site at *http://www.gsa.gov/dfcsiteplan.* ADDRESSES: To obtain a copy of the document, visit the web site at *http://www.gsa.gov/dfcsiteplan* and follow the instructions. FOR FURTHER INFORMATION CONTACT: Lisa Morpurgo by telephone at

(303)236-8000 ext. 5039 or by e-mail at *http://www.dfcsiteplan@gsa.gov.* SUPPLEMENTARY INFORMATION: Since 1997, when the last Master Site Plan was completed, potential development and redevelopment opportunities and the changing real estate market have been identified. The analysis in EIS includes a review of all existing buildings on site, all existing and planned infrastructure systems and improvements, necessary capital investment needs and all vacant land. A primary focus is on short and long term planning for Federal agency needs and requirements. A No Action alternative is studied that to evaluate the consequences of not implementing an action alternative. This alternative is included to provide a basis for comparison to the action alternatives described above as required under NEPA regulations (40 CFR 1002.14(d)). The EIS addressed the potential impacts of three alternatives considered: The Federal Quad Alternative is defined by the use of a central “Quad” located in the center of the site. A mixed use center would be encouraged in this area with enhanced streetscape woven into the fabric of the surrounding neighborhoods and commercial districts with road and land use connections; the Federal Mall Alternative creates a linear “Federal Mall” which would enhance the aesthetics of the site to create a grand entry and pedestrian access from the western boundary into the heart of the central core to an which open space square would serve as an amenity to the Mall district as well as other surrounding uses; and No-Action Alternative (currently planned upgrades would continue). GSA invites individuals, organizations and agencies to submit comments concerning the scope of the EIS. The public review period starts with the publication of this notice in the **Federal Register** and will continue for forty five

(45)days from the date of this notice. GSA will consider all comments received or postmarked by June 11, 2007. The GSA will consider and respond to comments received on the Draft EIS in preparing the Final EIS. GSA expects to issue a Final EIS by fall, 2007 at which time its availability will be announced in the **Federal Register** and local media. A “No Action” comment period will commence upon the publication of the Record of Decision. Public meetings will be conducted to provide the public with an opportunity to present comments, ask questions, and discuss concerns regarding the DEIS with GSA representatives. GSA will host public meetings on Wednesday, May 16 from 11 a.m. to 1 p.m. at Building 41, Denver Federal Center, Lakewood, CO, and again on May 16 from 4 p.m. to 8 p.m. at Creighton Middle School, Lakewood, CO, and on Thursday May 17 from 11 a.m. to 1 p.m. at Building 25, Denver Federal Center, Lakewood, CO. More specific information about the meetings will be noticed in local media and on the GSA Web site at *http://www.gsa.gov/dfcsiteplan.* Dated: April 18, 2007. Lisa Dorsey Morpurgo, Senior Project Manager, General Services Administration, DFC Service Center, PBS, Rocky Mountain Region. [FR Doc. E7-8152 Filed 4-26-07; 8:45 am] BILLING CODE 6820-BK-P GENERAL SERVICES ADMINISTRATION [PBS-N01] Notice of Availability to Distribute the Record of Decision for the Construction of a New Border Station Facility in Madawaska, Maine AGENCY: Public Buildings Service, GSA. ACTION: Notice of Availability. SUMMARY: The General Services Administration

(GSA)announces its intent to distribute the Record of Decision

(ROD)under the National Environmental Policy Act

(NEPA)of 1969, as amended, 42 USC 4321 - 4347 ( NEPA ) to assess the potential impacts of the construction of a New Border Station Facility in Madawaska, Maine (the “Proposed Action”). At the request of Customs and Border Protection (CBP), the GSA is proposing to construct a new border station facility which meets their needs, and the design requirements of the GSA. The existing facilities are undersized and obsolete, and consequently incapable of providing the level of security now required. The Proposed Action has been defined and includes:

(a)Identification of land requirements, including acquisition of adjoining land;

(b)demolition of existing government structures at the border station;

(c)construction of a main administration building and ancillary support buildings; and

(d)consequent potential alterations to secondary roads. Studied alternatives have identified alternative locations for the components of the border station including the main administration and ancillary support buildings, the associated roadway network and parking. A No Action alternative has also been studied and evaluates the consequences of not constructing the new border station facility.This alternative has been included to provide a basis for comparison to the action alternatives described above as required by NEPA regulations (40 CFR 1002.14(d)). DATES: May 29, 2007. FOR FURTHER INFORMATION CONTACT: David M. Drevinsky P.E., PMP, Regional Environmental Quality Advocate (REQA), U.S. General Services Administration, 10 Causeway Street, Room 975, Boston, MA 02222. Fax:

(617)565-5967. Phone:

(617)565-6596. E-mail: *david.drevinsky@gsa.gov* . **DISTRIBUTION:** GSA will distribute ten reading copies of the Record of Decision at both the Middle / High School Library located on 135 Seventh Avenue in Madawaska and the Madawaska Library located on 393 Main Street. Glenn C. Rotondo, Assistant Regional Administrator,Public Buildings Service, New England Region Record of Decision The General Services Administration has published a final environmental impact statement on the following project: *Madawaska Border Station* *Madawaska, Aroostook County, Maine* Purpose and Needs The purpose of the proposed project is to replace the undersized and functionally obsolete land port of entry at Madawaska with a new facility that meets the needs of the U.S. Customs and Border Protection (CBP), complies with the design requirements of the GSA, and provides efficient and safe inspection and processing of vehicles and people at the border crossing. The proposed project is needed because the size and conditions of the existing building and overall site are substandard, preventing the agencies assigned to the port from adequately fulfilling their respective missions. This condition has become more noticeable in recent years due to the increase in commercial truck traffic and heightened security at the border following the terrorist attacks in 2001. The deficiencies with the existing facilities have led to extensive traffic delays, for vehicles entering the U.S., of up to 2 miles on the streets of Edmundston. The deficiencies fall into three broad categories: 1) Building deficiencies, 2) overall site deficiencies, and 3) insufficient security. Alternatives The following alternatives were analyzed to determine which best satisfied the purpose and needs: *The No-build Alternative* Under the no-build alternative, operation of the border station would continue at its existing location and using the existing facilities. With the exception of minor repairs and upgrades to existing equipment, no new construction or demolition would take place. No new inspection lanes or facilities would be built. *The Selected Alternative* The selected alternative, initially known as Alternative D, consists of a new facility on property that is not immediately adjacent to the existing border station. The approximately 12.9-acre site used for alternative D is about 1,600 feet west of the existing border station and owned by Fraser Papers, the MM&A Railroad, and the Madawaska Regional Health Center. Vehicles traveling from the International Bridge would make a 90-degree turn west, and proceed approximately 1,600 feet on a secure access road and bridge over the MM&A railroad tracks to the site of the new border station. The GSA would own and maintain the access road and bridge. A pedestrian-only processing facility would be located at the U.S. end of the International Bridge on the site of the current border station. Alternative D was identified as GSA’s preferred alternative in the draft environmental impact statement, and as the selected alternative in the final environmental impact statement, because it best satisfied the project purpose and needs with the least adverse environmental impact. Three alternatives - alternatives A, B, and C -were developed that attempted to locate the new port facilities within a small geographical area immediately adjacent to the existing port site, roughly bordered by the Fraser Papers mill, the Saint John River, and Bridge and Mill Streets. These three alternatives only marginally met the project‘s purpose and need and had greater adverse environmental impacts than the selected alternative. The GSA identified Alternative D as the environmentally preferable alternative. *Alternatives Dismissed* Alternative A consisted of demolishing the existing building, building new ones on the existing site, and expanding it in an attempt to meet the required space standards and increased security requirements of the CBP. This alternative locates the entire border station between the Fraser Papers mill and the Saint John River, straddling the MM&;A railroad tracks. Alternative A had the advantages of reusing the existing site of the border station, having a compact layout requiring acquisition of less property than the other alternatives, and using property not intensely used by Fraser Papers. However, the compact layout of alternative A results in several disadvantages. The three at-grade crossings of the MM&A railroad tracks would cause train-vehicle conflicts; traffic circulation would be cumbersome and non-intuitive; trucks would have to back up into the travel lane to exit the secondary inspection area; and the VACIS unit could not be enclosed. Alternative B consisted of demolishing the existing border station building and constructing a new border station immediately south of the MM&A railroad tracks within Bridge Street and on property owned by Fraser Papers along Bridge Street and Mill Street. The primary inspection area for all vehicles would be in Bridge Street and on property owned by Fraser Papers. Secondary inspection for trucks and personally owned vehicles

(POVs)and buses would take place in Mill Street and on property to the south of Mill Street owned by Fraser Papers and used for employee parking. Thirteenth through Sixteenth Avenues and a portion of Mill Street would be closed to through traffic. Vehicle circulation through the secondary POV and bus inspection area would be challenging, because there is a dramatic rise in grade from one side of this area to the other. The exit of the secondary inspection area would intersect with a steep portion of Bridge Street, which is a safety concern. Following secondary inspection, alternative B would require trucks returning to Canada to be escorted by border station personnel back to the International Bridge, by way of public streets. This alternative would remove a considerable amount of employee parking from Fraser Papers and would require trucks to circulate through town to access the paper mill. Alternative C consisted of demolishing the existing border station building and constructing a new border station along the MM&A railroad tracks, Bridge Street, and a portion of the Fraser Papers parking areas adjacent to Mill Street. Alternative C proposed the complete separation of inspections for trucks and POVs and buses. Primary and secondary inspection of trucks would occur on the existing border station site and additional MM&A railroad-owned property to the south and west. Primary inspection of POVs and buses would occur in Bridge Street and on property owned by Fraser Papers and used for employee parking. Secondary POV and bus inspection would occur on land owned by Fraser Papers at the corner of Bridge and Mill Streets. Thirteenth Avenue would be closed to through traffic. Alternatives A, B, and C would only marginally satisfy the project’s purpose and needs because the building and site layout are not ideal, on-site traffic circulation is cumbersome, and security, while improved over existing conditions, would not fully meet the CBP’s requirements. Additionally, they would likely result in substantial disruption to operations of Fraser Papers and the MM&A Railroad. Due to the many problems associated with them and because another alternative exists that fully satisfies the project’s purpose and needs with less adverse impact, alternatives A, B, and C were dismissed from further consideration. Environmental Consequences of the Project The selected alternative would have a small impact on the natural and social environment of Madawaska. The selected alternative would impact Fraser Papers’ use of the site for truck and outdoor material storage, a railroad siding and buildings owned by the MM&A Railroad, and displace the Madawaska Regional Health Center, a medical office and outpatient care facility. The selected alternative would result in minor changes or impacts in traffic, noise, surface water runoff, and increased lighting. In each case, the changes would not be significant. The selected alternative would not adversely impact special events like the International Snowmobile Festival. According to officials at the CBP, it is anticipated that vehicle idle time will be significantly less than 5 minutes. As a final design for the facility is developed, the GSA/CBP will evaluate traffic processing flow and wait times and, if necessary, identify appropriate idling reduction strategies. Such strategies may include development of signage at strategic locations and/or educational outreach to local industries whose drivers frequently use the border crossing. Decision The GSA has decided to construct the selected alternative because it best meets the purpose and needs of the project, and would have positive impacts on inbound traffic compared to the no-build alternative. The traffic circulation patterns of the selected alternative, with the installation of increased security and technology measures, would result in shorter vehicle queues and more effective and faster processing times for inbound vehicles. The separation of POVs from trucks and buses would greatly reduce queuing that occurs with the no-build alternative when more than one truck is present for processing. The number of inbound booths for processing vehicular traffic would increase from two (one POV lane and one shared lane) to four (two POV lanes, one truck lane, and one bus lane). Traffic backups into Canada would be reduced with the additional lanes combined with the increased stacking area along the proposed access road. The GSA selected the environmentally preferable alternative. The selected and environmentally preferable alternative best met the purpose and needs for the project with the least impact to the natural and social environments, and best protects, preserves, and enhances the historic, cultural, and natural resources of the area. The following economic, technical, and GSA mission considerations were weighed in reaching the decision: The selected alternative would adequately address the problem that the existing building, although well maintained, does not meet the GSA’s or accessibility guidelines and provides only a small percentage of the total building square foot area required to meet the needs of the CBP and other agencies. It also addresses the problem that the existing border station suffers from a variety of basic deficiencies that hamper the CBP and other agencies in providing safe and efficient processing of vehicular and pedestrian traffic including: •Deficiencies in the main building (size, accessibility, structural, etc.) •Deficiencies in site circulation and layout •Deficiencies in processing of inbound commercial and non-commercial vehicles, especially in the lack of space to perform secondary inspections of large commercial vehicles •Deficiencies in processing outbound vehicular and pedestrian traffic •Lack of parking spaces •Lack of designated delivery area •Deficiencies in exterior lighting •Deficiencies related to security measures (equipment, fencing, building setbacks, etc.) The DEIS identified a preferred alternative. The DEIS was circulated and a public hearing was held to receive comments. No major substantive comments on the DEIS were received. All practicable means of avoiding or minimizing environmental harm from the selected alternative were adopted, through the attached program of mitigation, monitoring, or enforcement. [FR Doc. E7-8065 Filed 4-26-07; 8:45 am] BILLING CODE 6820-A8-S GENERAL SERVICES ADMINISTRATION Office of Small Business Utilization; Small Business Advisory Committee; Notification of a Public Meeting of the Small Business Advisory Committee AGENCY: Office of Small Business Utilization, GSA. ACTION: Notice. SUMMARY: The General Services Administration

(GSA)is announcing a public meeting of the GSA Small Business Advisory Committee (the Committee). DATES: The meeting will take place May 14, 2007. The meeting will begin 1 p.m. and conclude no later than 6 p.m. that day. The Committee will accept oral public comments at this meeting and has reserved a total of thirty minutes for this purpose. Members of the public wishing to reserve speaking time must contact Aaron Collmann in writing at: *sbac@gsa.gov* or by fax at

(202)501-2590, no later than one week prior to the meeting. ADDRESSES: GSA Expo 2007, Orange County Convention Center, Room W240B, 9800 International Drive, Orlando, FL. FOR FURTHER INFORMATION CONTACT: Aaron Collmann, Room 6029, GSA Building, 1800 F Street, NW., Washington, DC 20405

(202)501-1021 or e-mail at *sbac@gsa.gov.* SUPPLEMENTARY INFORMATION: This notice is published in accordance with the provisions of the Federal Advisory Committee Act

(FACA)(Pub. L. 92-463). The purpose of this meeting is to develop the topics generated during the previous meeting December 6-7, 2006; to receive briefings from small business topical experts, and to hear from interested members of the public on proposals to improve GSA’s small business contracting performance. Topics to be discussed from the previous meeting may include, but are not limited to, Contractor Teaming Agreements and the Small Business Set-asides on the GSA Multiple Awards Schedules Program. Information from previous meetings can be found online at *http://www.gsa.gov/sbac.* Dated: April 20, 2007. Felipe Mendoza, Associate Administrator,Office of Small Business Utilization,General Services Administration. [FR Doc. E7-8066 Filed 4-26-07; 8:45 am] BILLING CODE 6820-34-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary [Document Identifier: OS-0990-0000]; [30-day notice] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Office of the Secretary, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects:

(1)The necessity and utility of the proposed information collection for the proper performance of the agency's functions;

(2)the accuracy of the estimated burden;

(3)ways to enhance the quality, utility, and clarity of the information to be collected; and

(4)the use of automated collection techniques or other forms of information technology to minimize the information collection burden. *Type of Information Collection Request:* New collection. *Title of Information Collection:* A National Survey to Measure the Adoption of Electronic Health Records

(EHR)among Physicians and Group Practices. *Frequency:* One year. *Form/OMB No.:* 0990-New. *Use:* The Office of the Secretary will evaluate barriers and facilitators to acquisition of electronic record keeping in medical practices. This will allow the Secretary to identify policy choices to encourage use of EHR thereby improving the flow of medical information. *Frequency:* One time reporting. *Affected Public:* Business or other for-profit and Not-for-profit institutions. *Annual Number of Respondents:* 6,000. *Total Annual Responses:* 1. *Average Burden per Response:* 15 minutes. *Total Annual Hours:* 1500. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, e-mail your request, including your address, phone number, OMB number, and OS document identifier, to *Sherette.funncoleman@hhs.gov,* or call the Reports Clearance Office on

(202)690-6162. Written comments and recommendations for the proposed information collections must be received within 30 days of this notice directly to the Desk Officer at the address below: OMB Desk Officer: John Kraemer, OMB Human Resources and Housing Branch, Attention: (OMB #0990-New), New Executive Office Building, Room 10235, Washington, DC 20503. Dated: April 17, 2007. Alice Bettencourt, Office of the Secretary, Paperwork Reduction Act Reports Clearance Officer. [FR Doc. E7-8049 Filed 4-26-07; 8:45 am] BILLING CODE 4150-45-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary [Document Identifier: OS-0990-0000]; [30-day notice] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Office of the Secretary, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects:

(1)The necessity and utility of the proposed information collection for the proper performance of the agency's functions;

(2)the accuracy of the estimated burden;

(3)ways to enhance the quality, utility, and clarity of the information to be collected; and

(4)the use of automated collection techniques or other forms of information technology to minimize the information collection burden. *Type of Information Collection Request:* New Collection. *Title of Information Collection:* The National Evaluation of the Rural/Frontier Women's Health Coordinator Center Program. *Form/OMB No.:* 0990-New. *Use:* The Department of Health and Human Services Office on Women's Health

(OWH)is seeking clearance to conduct data collection efforts as part of the National Evaluation of the Rural/Frontier Coordinating Center

(RFCC)program. The Office on Women's Health funded the creation of three RFCCs in September 2004, and awarded eight additional RFCC contracts in fiscal year 2005. The impetus for creating the RFCCs was to identify, coordinate, and leverage the network of existing resources to provide a full range of culturally and linguistically appropriate health services to women and their families. To effectively meet the numerous health care needs of this diverse population, rural health providers must not only offer comprehensive health care services but also integrate these services to maximize awareness, access, and quality. RFCCs were created to accomplish this task. Evaluating the effectiveness of RFCCs is essential for determining whether these centers are the best vehicles for coordinating and leveraging new and existing resources for women's health in rural and frontier communities. The OWH is seeking to evaluate all eleven RFCCs. This evaluation will also enable the OWH to determine *how well* RFCCs are facilitating access to integrated and comprehensive primary care services to women and their families residing in rural and frontier regions of the U.S. *Frequency:* Report on Occasion. *Affected Public:* Not-for-profit institutions. *Annual Number of Respondents:* 833. *Total Annual Responses:* 833. *Average Burden per Response:* 34 minutes. *Total Annual Hours:* 472. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, e-mail your request, including your address, phone number, OMB number, and OS document identifier, to *Sherette.funncoleman@hhs.gov,* or call the Reports Clearance Office on

(202)690-6162. Written comments and recommendations for the proposed information collections must be received within 30 days of this notice directly to the Desk Officer at the address below: OMB Desk Officer: John Kraemer, OMB Human Resources and Housing Branch, Attention: (OMB #0990-New), New Executive Office Building, Room 10235, Washington, DC 20503. Dated: April 17, 2007. Alice Bettencourt, Office of the Secretary, Paperwork Reduction Act Reports Clearance Officer. [FR Doc. E7-8050 Filed 4-26-07; 8:45 am] BILLING CODE 4150-33-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-07-07AW] Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention

(CDC)will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-639-5960 and send comments to Joan Karr, CDC Acting Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to *omb@cdc.gov.* Comments are invited on:

(a)Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;

(b)the accuracy of the agency's estimate of the burden of the proposed collection of information;

(c)ways to enhance the quality, utility, and clarity of the information to be collected; and

(SARS)can be spread when people produce clouds of droplets (called aerosols) by coughing or sneezing. Aerosol transmission of infectious diseases is of particular interest today because of increased concern over a possible global influenza pandemic. The possible airborne spread of influenza is especially important to health-care workers and emergency responders, who face a much greater risk of exposure than does the general public. However, substantial gaps exist in our understanding of the generation and spread of infectious aerosols containing influenza. This lack of information hampers the ability of health scientists to model and predict the transmission of influenza by airborne particles and to understand whether or not aerosols are likely to be an important route of transmission of influenza during a pandemic. The purpose of this study is to gain a better understanding of the production and dissemination of aerosols containing the influenza virus. The results of this research will give scientists and health professional's greater insight into the airborne transmission of influenza and allow them to better assess the potential effectiveness of preventive measures. The first part of this study will measure the quantity and size distribution of aerosol droplets produced by people with influenza when they cough. To accomplish this, volunteers with influenza-like illness will be asked to provide an oral swab for influenza testing, and then will cough into a spirometer. The aerosol produced by each person will be measured using commercially-available instrumentation. The oral swabs will be processed after the aerosol experiments are completed. The second part of this study will determine the amount and size of airborne particles containing influenza virus that are present in a hospital emergency department during influenza season. Health care workers will be recruited to wear small aerosol collection devices as they go about their normal duties. The collected samples will then be analyzed for influenza virus. Adult patients in the emergency department with influenza-like illness will be asked to provide an oral swab to test for the flu virus in order to estimate the number of potential sources of viral-laden airborne particles. There will be no costs to study participants other than their time. Estimated Annualized Burden Hours Respondents Number of respondents Number of responses per respondent Average burden per response (in hours) Total burden (in hours) Part 1 participants 40 2 1 80 Part 2 health care workers 30 1 1 30 Part 2 patients 15 1 0.5 8.0 Total 118 Dated: April 23, 2007. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E7-8073 Filed 4-26-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-07-07AY] Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention

(a)Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;

(b)the accuracy of the agency's estimate of the burden of the proposed collection of information;

(c)ways to enhance the quality, utility, and clarity of the information to be collected; and

(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice. Proposed Project Long-Term Efficacy of a Program to Prevent Beryllium Disease—New—National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC). Background and Brief Description Beryllium is a lightweight metal with many applications. Exposed workers may be found in the primary production, nuclear power and weapons, aerospace, scrap metal reclamation, specialty ceramics, and electronics industries, among others. The size of the USA workforce at risk of chronic beryllium disease (CBD), from either current or past work-related exposure to the metal, may be as high as one million. Demand for beryllium is growing worldwide, which means that increasing numbers of workers are likely to be exposed. Exposure to beryllium can lead to sensitization and cause an immunologic granulomatous lung disease. Sensitization is a cell-mediated allergic-type response that may be detected in the peripheral blood with the beryllium lymphocyte proliferation test (BeLPT), which is used by the industry as a surveillance tool. Workers found to be sensitized may be clinically evaluated for CBD with tests including bronchoalveolar lavage and transbronchial biopsy. Cross-sectional studies in various beryllium workplace populations have identified sensitization in the range of less than 1% to 14% of workers. The proportion of sensitized workers who have beryllium disease at initial clinical evaluation has varied from 10 to 100% in different workplaces. Sensitized workers not initially diagnosed with CBD are often diagnosed with the disease upon follow-up, but whether all sensitized workers will eventually develop beryllium disease is unknown. Industry screening programs have enabled the identification of CBD in persons without apparent symptoms, often early in disease progression (often referred to as “subclinical disease”). Progression from sensitization to subclinical disease to clinical impairment, while difficult to predict for any one individual, is not uncommon. Currently, there are no preventive programs that have been demonstrated to have long-term effectiveness in preventing beryllium sensitization and CBD among beryllium-exposed workers. In the United States, recent short-term evidence (i.e., average work tenure 16 months, maximum four years) at one facility suggests that the comprehensive preventive program that was implemented by company management beginning in 2000 has successfully reduced the incidence of beryllium sensitization, as defined by the occurrence of confirmed abnormal BeLPTs. However, the follow-up has thus far been limited to current workers, the duration has been too short to document a reduced incidence of CBD, and it is possible that sensitization has been delayed, rather than prevented. Evaluation of this program's effectiveness would therefore be more complete by including individuals who have left employment and documenting whether:

(1)The program was effective at two other facilities at which it was implemented,

(2)the program prevented beryllium sensitization over a longer period of time (i.e., up to eight years); and

(3)the program prevented CBD, which generally takes longer to develop. Study Design This proposed study is designed to evaluate the effectiveness of a comprehensive preventive program at three beryllium plants. Eligible workers for this survey include those hired between implementation of a comprehensive program (2000-01) and December 31, 2008, including any already known to be sensitized. NIOSH will offer all eligible current and former workers the BeLPT to identify sensitization and administer a work and medical history questionnaire. There are no costs to former worker respondents except their time to participate in the interview. Current workers will participate during work hours, and will thus be compensated for their time by their employer. Former workers will participate during their own time. Estimate of Annualized Burden Hours Respondents Number of respondents Number of responses/respondent Avg. burden/response (in hours) Total burden (in hours) Current Workers 239 1 45/60 179 Former Workers 340 1 45/60 255 Total 579 434 Dated: April 23, 2007. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E7-8075 Filed 4-26-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Optimal Resources and Care for Children With Craniofacial Malformations, Request for Applications

(RFA)DD07-008 and Public Health Research Grants on Orofacial Clefts and Craniosynostosis, RFA DD07-009 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 of the aforementioned SEP: *Time and Date:* 1 p.m.-4 p.m., June 4, 2007 (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 scientific merit of grant applications received in response to RFA DD07-008, “Optimal Resources and Care for Children with Craniofacial Malformations,” and RFA DD07-009, “Public Health Research Grants on Orofacial Clefts and Craniosynostosis,” RFA DD07-009. *Contact Person for More Information:* Maurine Goodman, MA, MPH, Scientific Review Administrator, Centers for Disease Control and Prevention, 1600 Clifton Road, NE., Mailstop D72, Atlanta, GA 30333, Telephone 404.639.4737. 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: April 20, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E7-8074 Filed 4-26-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10108, CMS-10219, CMS-10097] Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY: Centers for Medicare & Medicaid Services. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services, is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects:

(1)The necessity and utility of the proposed information collection for the proper performance of the Agency's function;

(2)the accuracy of the estimated burden;

(3)ways to enhance the quality, utility, and clarity of the information to be collected; and

(4)the use of automated collection techniques or other forms of information technology to minimize the information collection burden. 1. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* Medicaid Managed Care Regulations for 42 CFR 438.6, 438.8, 438.10, 438.12, 438.50, 438.56, 438.102, 438.114, 438.202, 438.204, 438.206, 438.207, 438.240, 438.242, 438.402, 438.404, 438.406, 438.408, 438.410, 438.414, 438.416, 438.604, 437.710, 438.722, 438.724, and 438.810; *Use:* These information collection requirements implement regulations that allow States greater flexibility to implement mandatory managed care program, implement new beneficiary protections, and eliminate certain requirements viewed by State agencies as impediments to the growth of managed care programs. Information collected includes information about managed care programs, grievances and appeals, enrollment broker contracts, and managed care organizational capacity to provide health care services. *Form Number:* CMS-10108 (OMB#: 0938-0920); *Frequency:* Reporting: Occasionally; *Affected Public:* State, Local, or Tribal Government; *Number of Respondents:* 39,114,558; *Total Annual Responses:* 4,640,344; *Total Annual Hours:* 3,930,093.5. 2. *Type of Information Collection Request:* New collection; *Title of Information Collection:* Health Plan Employer Data and Information Set (HEDIS®); *Use:* The Centers for Medicare & Medicaid Services

(CMS)collects quality performance measures in order to hold the Medicare managed care industry accountable for the care being delivered, to enable quality improvement, and to provide quality information to Medicare beneficiaries in order to promote an informed choice. It is critical to CMS' mission that we collect and disseminate information that will help beneficiaries choose among health plans, contribute to improved quality of care through identification of improvement opportunities, and assist CMS in carrying out its oversight and purchasing responsibilities. In December 1997, OMB approved the request from CMS for the information collections under HEDIS® and assigned the agency form number CMS-R-200. The collections approved under that request included the HEDIS® collection (following the technical specifications contained in Volume 2, published by the National Committee for Quality Assurance (NCQA); the Health of Seniors/Health Outcomes Survey (HOS); and the Medicare CAHPS® survey. Since that approval there has been a change in the statutory authority as a result of the Balanced Budget Act of 1997. During the latter part of 2000, CMS instituted several policy changes regarding this collection which reduced burden substantially on the part of the managed care organizations and the process for finalizing and publishing that policy delayed the request for OMB approval. In addition, the renewal of OMB authority for the Medicare CAHPS survey was completed as a separate request. The HOS renewal was also submitted separately. This request is solely for the approval of the HEDIS collection, which is now a stand alone collection. *Form Number:* CMS-10219 (OMB#: 0938-NEW); *Frequency:* Yearly; *Affected Public:* Business or other for-profit and Not-for-profit institutions; *Number of Respondents:* 705; *Total Annual Responses:* 705; *Total Annual Hours:* 33,840. 3. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* Medicare Contractor Provider Satisfaction Survey (MCPSS); *Form No.:* CMS-10097 (OMB#: 0938-0915); *Use:* The Centers for Medicare & Medicaid Services will obtain feedback from Medicare providers via a survey about satisfaction, attitudes and perceptions regarding the services provided by Medicare Fee-for-Service

(FFS)Carriers, Fiscal Intermediaries, Durable Medical Equipment Suppliers, and Regional Home Health Intermediaries and Medicare Administrative Contractors. The survey focuses on basic business functions provided by the Medicare Contractors such as inquiries, provider communications, claims processing, appeals, provider enrollment, medical review and provider audit & reimbursement. Providers will receive a notice requesting they use a specially constructed web site to respond to a set of questions customized for their contractor's responsibilities. The survey will be conducted yearly and annual reports of the survey results will be available via an online reporting system for use by CMS, Medicare Contractors, and the general public. Due to changes in CMS' reporting needs, CMS is requesting a potential increase in the number of completed surveys. This increase will allow CMS to have not only Contractor-specific, but also jurisdiction and state-specific data which, in turn, will enable Contractors to increase and implement performance improvement activities within their organizations. This increase will affect the 2008 and 2009 administrations of the survey. *Frequency:* Reporting—Annually; *Affected Public:* Business or other for-profit, Not-for-profit institutions; *Number of Respondents:* 24,279; *Total Annual Responses:* 24,279; *Total Annual Hours:* 8,346. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS Web site address at *http://www.cms.hhs.gov/PaperworkReductionActof1995,* or E-mail your request, including your address, phone number, OMB number, and CMS document identifier, to *Paperwork@cms.hhs.gov,* or call the Reports Clearance Office on

(410)786-1326. Written comments and recommendations for the proposed information collections must be mailed or faxed within 30 days of this notice directly to the OMB desk officer: OMB Human Resources and Housing Branch, Attention: Carolyn Lovett, New Executive Office Building, Room 10235, Washington, DC 20503, Fax Number:

(202)395-6974. Dated: April 20, 2007. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E7-7954 Filed 4-26-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10225, CMS-10116, CMS-R-39, and CMS-1500 (08-05)] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Centers for Medicare & Medicaid Services, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services

(CMS)is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects:

(1)The necessity and utility of the proposed information collection for the proper performance of the agency's functions;

(2)the accuracy of the estimated burden;

(3)ways to enhance the quality, utility, and clarity of the information to be collected; and

(4)the use of automated collection techniques or other forms of information technology to minimize the information collection burden. 1. *Type of Information Collection Request:* New collection; *Title of Information Collection:* Disclosures to Patients by Certain Hospitals and Critical Access Hospitals; *Form Numbers:* CMS-10225 (OMB#: 0938-New); *Use:* There is no Medicare prohibition against physician investment in a hospital or critical access hospital (CAH). Likewise, there is no Medicare requirement that a hospital or CAH have a physician on-site at all times, although there is a requirement that they be able to provide basic elements of emergency care to their patients. Medicare quality and safety standards are designed to provide a national framework that is sufficiently flexible to apply simultaneously to hospitals of varying sizes, offering varying ranges of services in differing settings across the nation. At the same time, however, patients might consider an ownership interest by their referring physician and/or the presence of a physician on-site to be important factors in their decisions about where to seek hospital care. A well-educated consumer is essential to improving the quality and efficiency of the healthcare system. Accordingly, patients should be made aware of the physician ownership of a hospital, whether or not a physician is present in the hospital at all times, and the hospital's plans to address patients' emergency medical conditions when a physician is not present. The intent of the proposed disclosures is to increase the transparency of the hospital's ownership and operations to patients as they make decisions about receiving care at the hospital. *Frequency:* Recordkeeping, Third-party disclosure—On occasion; *Affected Public:* Business or for-profits, Not-for-profit institutions; *Number of Respondents:* 2,679; *Total Annual Responses:* 2,925,468; *Total Annual Hours:* 59,473. 2. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* Medicare Program; Conditions of Payment of Power Mobility Devices, Including Power Wheelchairs and Power-Operated Vehicles (CMS-3017-F); *Form Numbers:* CMS-10116 (OMB#: 0938-0971); *Use:* The CMS is seeking the reapproval of the collection requirements associated with the final rule, CMS-3017-F (71 FR 17021), which was published on April 5, 2006, and became effective on June 5, 2006. Specifically, we are seeking OMB approval for the following terms of clearance identified in the Notice of Action dated October 16, 2006, of which OMB has requested CMS to monitor the paperwork burden required of providers and suppliers to determine if the paperwork requirements impose any unnecessary burden on the industry and/or need to be revised in order to improve the utility of the information. After analyzing the documentation requirements burden, CMS does not believe that the documentation requirements impose any additional unnecessary burden on the durable medical equipment

(DME)industry. We believe that most physicians are already conducting a face-to-face examination before prescribing a wheelchair. Given that physicians and treating practitioners can now prescribe power-operated vehicles (POVs), thereby removing the requirement that a specialist can order a POV, CMS believes that the increased burden of 48,600 hours for physicians and treating practitioners is based on the Congressional decision to allow a broader range of physicians and treating practitioners to prescribe POVs. This increased burden is offset by the new payments implemented in connection with the Final Rule, which is demonstrated by the shift in prescriptions from one class of equipment, power wheelchairs, to another class of equipment, POVs. In addition, CMS believes that with the recent coverage decision on Mobility Assistive Equipment, the implementing details in the Final Rule ( *e.g.* improved documentation for suppliers; physician and treating practitioner payments; improved classification of mobility equipment; the elimination of the certificate of medical necessity (CMN)), and the provider outreach and education provided by CMS, the DME program safeguard contractors

(PSCs)and DME Medicare administrative contractors (MACs), the needs of mobility-impaired beneficiaries and the needs of suppliers have been better met. *Frequency:* Recordkeeping—On occasion; *Affected Public:* Business or for-profits, Not-for-profit institutions, and State, Local or Tribal governments; *Number of Respondents:* 38,000; *Total Annual Responses:* 342,000; *Total Annual Hours:* 48,600. 3. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* Home Health Conditions of Participation

(CoP)Information Collection Requirements and Supporting Regulations in 42 CFR 484.10, 484.12, 484.16, 484.18, 484.36, 484.48, 484.52; *Form Numbers:* CMS-R-39 (OMB#: 0938-0365); *Use:* The information collection requirements contained in this request are part of the requirements classified as the conditions of participation

(CoPs)which are based on criteria prescribed in law and are standards designed to ensure that each facility has properly trained staff to provide the appropriate safe physical environment for patients. These particular standards reflect comparable standards developed by industry organizations such as the Joint Commission on Accreditation of Healthcare Organizations, and the Community Health Accreditation Program. The primary users of this information will be State agency surveyors, the regional home health intermediaries, CMS and home health agencies

(HHAs)for the purpose of ensuring compliance with Medicare CoPs as well as ensuring the quality of care provided by HHA patients. *Frequency:* Recordkeeping and Reporting—Annually, On occasion; *Affected Public:* Business or for-profits, Not-for-profit institutions, and State, Local or Tribal governments; *Number of Respondents:* 9,354; *Total Annual Responses:* 9,354; *Total Annual Hours:* 1,048,483.5. 4. *Type of Information Collection Request:* Revision of a currently approved collection; *Title of Information Collection:* Health Insurance Common Claims Form and Supporting Regulations at 42 CFR Part 424, Subpart C; *Form Number:* CMS-1500(08-05), CMS-1490-S (OMB#: 0938-0999); *Use:* The Form CMS-1500 answers the needs of many health insurers. It is the basic form prescribed by CMS for the Medicare program for claims from physicians and suppliers. The Medicaid State Agencies, CHAMPUS/TriCare, Blue Cross/Blue Shield Plans, the Federal Employees Health Benefit Plan, and several private health plans also use it; it is the de facto standard “professional” claim form. Medicare carriers use the data collected on the CMS-1500 and the CMS-1490S to determine the proper amount of reimbursement for Part B medical and other health services (as listed in section 1861(s) of the Social Security Act) provided by physicians and suppliers to beneficiaries. The CMS-1500 is submitted by physicians/suppliers for all Part B Medicare. Serving as a common claim form, the CMS-1500 can be used by other third-party payers (commercial and nonprofit health insurers) and other Federal programs ( *e.g.* , CHAMPUS/TriCare, Railroad Retirement Board (RRB), and Medicaid). However, as the CMS-1500 displays data items required for other third-party payers in addition to Medicare, the form is considered too complex for use by beneficiaries when they file their own claims. Therefore, the CMS-1490S (Patient's Request for Medicare Payment) was explicitly developed for easy use by beneficiaries who file their own claims. The form can be obtained from any Social Security office or Medicare carrier. Since the last submission of this information collection request, we discontinued form CMS-1490U which was used by employers, unions, employer-employee organizations that pay physicians and suppliers for their services to employees, group practice prepayment plans, and health maintenance organizations. Therefore, this collection will no longer contain the CMS-1490U. In sum, the CMS-1500 and CMS-1490S result in less paperwork burden placed on the public. The CMS-1500 provides efficiency in office procedures for physicians and suppliers; the CMS-1490S provides beneficiaries with a relatively easy form to use when filing their claims. Without the collection of this information, claims for reimbursement relating to the provision of Part B medical services/supplies could not be acted upon. This would result in a nationwide paralysis of the operation of the Federal Government's Medicare Part B program, and major problems for the other health plans that use the CMS-1500, inflicting severe physical and financial hardship on providers/suppliers as well as beneficiaries. *Frequency:* Reporting—On occasion; *Affected Public:* State, Local, or Tribal Government, Business or other-for-profit, Not-for-profit institutions; *Number of Respondents:* 1,048,243; *Total Annual Responses:* 970,174,260; *Total Annual Hours:* 33,067,757. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS' Web Site address at *http://www.cms.hhs.gov/PaperworkReductionActof1995,* or E-mail your request, including your address, phone number, OMB number, and CMS document identifier, to *Paperwork@cms.hhs.gov,* or call the Reports Clearance Office on

(410)786-1326. To be assured consideration, comments and recommendations for the proposed information collections must be received at the address below, no later than 5 p.m. on June 26, 2007. CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development—B, Attention: William N. Parham, III, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Dated: April 20, 2007. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E7-7955 Filed 4-26-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-1387-N] Medicare Program; Meeting of the Practicing Physicians Advisory Council, May 21, 2007 AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. SUMMARY: This notice announces a quarterly meeting of the Practicing Physicians Advisory Council (the Council). The Council will meet to discuss certain proposed changes in regulations and manual instructions related to physicians' services, as identified by the Secretary of Health and Human Services (the Secretary). This meeting is open to the public. DATES: *Meeting Date:* Monday, May 21, 2007, from 8:30 a.m. to 5 p.m. e.d.t. *Deadline for Registration without Oral Presentation:* Friday, May 18, 2007, 12 noon, e.d.t. *Deadline for Registration of Oral Presentations:* Friday, May 4, 2007, 12 noon, e.d.t. *Deadline for Submission of Oral Remarks and Written Comments:* Wednesday, May 9, 2007, 12 noon, e.d.t. *Deadline for Requesting Special Accommodations:* Monday, May 14, 2007, 12 noon, e.d.t. ADDRESSES: *Meeting Location:* The meeting will be held in Room 705A, 7th floor, in the Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201. *Submission of Testimony:* Testimonies should be mailed to Kelly Buchanan, DFO, Centers for Medicare and Medicaid Services, 7500 Security Boulevard, Mail stop C4-13-07, Baltimore, MD 21244-1850, or contact the DFO via e-mail at *PPAC@cms.hhs.gov.* FOR FURTHER INFORMATION CONTACT: Kelly Buchanan, the Designated Federal Official (DFO),

(410)786-6132, or e-mail *PPAC@cms.hhs.gov.* News media representatives must contact the CMS Press Office,

(202)690-6145. Please refer to the CMS Advisory Committees' Information Line (1-877-449-5659 toll free),

(410)786-9379 local) or the Internet at *http://www.cms.hhs.gov/home/regsguidance.asp* for additional information and updates on committee activities. SUPPLEMENTARY INFORMATION: I. Background In accordance with section 10(a) of the Federal Advisory Committee Act, this notice announces the quarterly meeting of the Practicing Physicians Advisory Council (the Council). The Secretary is mandated by section 1868(a)(1) of the Social Security Act (the Act) to appoint a Practicing Physicians Advisory Council based on nominations submitted by medical organizations representing physicians. The Council meets quarterly to discuss certain proposed changes in regulations and manual instructions related to physicians' services, as identified by the Secretary. To the extent feasible and consistent with statutory deadlines, the Council's consultation must occur before **Federal Register** publication of the proposed changes. The Council submits an annual report on its recommendations to the Secretary and the Administrator of the Centers for Medicare & Medicaid Services

(CMS)not later than December 31 of each year. The Council consists of 15 physicians, including the Chair. Members of the Council include both participating and nonparticipating physicians, and physicians practicing in rural and underserved urban areas. At least 11 members of the Council must be physicians as described in section 1861(r)(1) of the Act; that is, State-licensed doctors of medicine or osteopathy. The remaining 4 members may include dentists, podiatrists, optometrists and chiropractors. Members serve for overlapping 4-year terms. Section 1868(a)(2) of the Act provides that the Council meet quarterly to discuss certain proposed changes in regulations and manual issuances that relate to physicians' services, identified by the Secretary. Section 1868(a)(3) of the Act provides for payment of expenses and per diem for Council members in the same manner as members of other advisory committees appointed by the Secretary. In addition to making these payments, the Department of Health and Human Services and CMS provide management and support services to the Council. The Secretary will appoint new members to the Council from among those candidates determined to have the expertise required to meet specific agency needs in a manner to ensure appropriate balance of the Council's membership. The Council held its first meeting on May 11, 1992. The current members are: Anthony Senagore, M.D., Chairperson; Jose Azocar, M.D.; M. Leroy Sprang, M.D.; Karen S. Williams, M.D.; Peter Grimm, D.O.; Jonathon E. Siff, M.D., MBA; John E. Arradondo, M.D., MPH; Helena Wachslicht Rodbard, M.D.; Vincent J. Bufalino, M.D.; Tye J. Ouzounian, M.D.; Geraldine O'Shea, D.O.; Arthur D. Snow, Jr., M.D.; Gregory J. Przybylski, M.D.; Jeffrey A. Ross, DPM, M.D.; and Roger L. Jordan, O.D. II. Meeting Format and Agenda The meeting will commence with the Council's Executive Director providing a status report, and the CMS responses to the recommendations made by the Council at the March 5, 2007 meeting, as well as prior meeting recommendations. Additionally, an update will be provided on the Physician Regulatory Issues Team. In accordance with the Council charter, we are requesting assistance with the following agenda topics: • Post Acute Care Project. • National Provider Identifier (NPI). • Physician Quality Reporting Initiative (PQRI). • Personal Health Records. • Durable Medical Equipment

(DME)Final Rule. • Contractor Reform Update. For additional information and clarification on these topics, contact the DFO as provided in the FOR FURTHER INFORMATION CONTACT section of this notice. Individual physicians or medical organizations that represent physicians wishing to present a 5-minute oral testimony on agenda issues must register with the DFO by the date listed in the DATES section of this notice. Testimony is limited to agenda topics only. The number of oral testimonies may be limited by the time available. A written copy of the presenter's oral remarks must be submitted to the DFO for distribution to Council members for review before the meeting by the date listed in the DATES section of this notice. Physicians and medical organizations not scheduled to speak may also submit written comments to the DFO for distribution by the date listed in the DATES section of this notice. III. Meeting Registration and Security Information The meeting is open to the public, but attendance is limited to the space available. Persons wishing to attend this meeting must register by contacting the DFO at the address listed in the ADDRESSES section of this notice or by telephone at

(410)786-6132 by the date specified in the DATES section of this notice. Since this meeting will be held in a Federal Government Building, the Hubert H. Humphrey Building, Federal security measures are applicable. As noted above, in planning your arrival time, we recommend allowing additional time to clear security. In order to gain access to the building, participants will be required to show a government-issued photo identification (for example, driver's license, or passport), and must be listed on an approved security list before persons are permitted entrance. Persons not registered in advance will not be permitted into the Hubert H. Humphrey Building and will not be permitted to attend the Council meeting. All persons entering the building must pass through a metal detector. In addition, all items brought to the Hubert H. Humphrey Building, whether personal or for the purpose of presentation, are subject to inspection. We cannot assume responsibility for coordinating the receipt, transfer, transport, storage, set-up, safety, or timely arrival of any personal belongings or items used for the purpose of presentation. Individuals requiring sign language interpretation or other special accommodation must contact the DFO via the contact information specified in the FOR FUTHER INFORMATION CONTACT section of this notice by the date listed in the DATES section of this notice. Authority: (Section 1868 of the Social Security Act (42 U.S.C. 1395ee) and section 10(a) of Pub. L. 92-463 (5 U.S.C. App. 2, section 10(a)).) Dated: April 10, 2007. Leslie V. Norwalk, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. E7-7382 Filed 4-26-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0018] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products: Establishment Registration and Listing; Form Food and Drug Administration 3356; Eligibility Determination for Donors; and Current Good Tissue Practice 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 May 29, 2007. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974. All comments should be identified with the OMB control number 0910-0543. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Human Cells, Tissues, and Cellular and Tissue-Based Products: Establishment Registration and Listing; Form Food and Drug Administration 3356; Eligibility Determination for Donors; and Current Good Tissue Practice (OMB Control Number 0910-0543)—Extension Under section 361 of the Public Health Service Act (the PHS Act) (42 U.S.C. 264), FDA may issue and enforce regulations necessary to prevent the introduction, transmission, or spread of communicable diseases between the States or possessions or from foreign countries into the States. As derivatives of the human body, all human cells, tissues, and cellular and tissue-based products (HCT/Ps) pose some risk of carrying pathogens that could potentially infect recipients or handlers. FDA has issued regulations related to HCT/Ps involving establishment registration and listing using Form FDA 3356; eligibility determination for donors; and current good tissue practice (CGTP). Establishment Registration and Listing; Form FDA 3356 The regulations in part 1271 (21 CFR part 1271) require domestic and foreign establishments that recover, process, store, label, package, or distribute any HCT/Ps, or that perform screening or testing of the cell or tissue donor to register with FDA (§ 1271.10(b)(1)) and submit a list of each HCT/P manufactured (§ 1271.10(b)(2)).Section 1271.21(a) requires the initial establishment registration, and § 1271.25(a) and

(b)identifies the required initial registration and HCT/P listing information. Section 1271.21(b) requires an annual update of the establishment registration. Section 1271.21(c)(ii) requires establishments to submit HCT/P listing updates when an HCT/P is changed as described in § 1271.25(c). Section 1271.25(c) identifies the required HCT/P listing update information. Section 1271.26 requires establishments to submit an amendment if ownership or location of the establishment changes. FDA requires the use of a registration and listing form (Form FDA 3356: Establishment Registration and Listing for Human Cells, Tissues, and Cellular and Tissue-Based Products to submit the required information (§§ 1271.10, 1271.21, 1271.25, and 1271.26)). To further facilitate the ease and speed of submissions, electronic submission is accepted ( *http://www.fda.gov/cber/tissue/tisreg.htm* ). Eligibility Determination for Donors FDA requires HCT/P establishments described in § 1271.1(b) to screen and test the donors of cells and tissue used in those products for risk factors for and clinical evidence of relevant communicable diseases agents and diseases. The documented determination of a donor's eligibility is made by a responsible person and is based on the results of required donor screening, which includes a donor medical history interview (defined in § 1271.3(n)), and testing (§ 1271.50(a)). HCT/P establishments are permitted to ship an HCT/P only if it is accompanied by documentation of the donor-eligibility determination (§ 1271.55(a)). This requirement applies to an HCT/P from a donor determined to be eligible as well as to a product from a donor who is determined to be ineligible and made available for use under certain provisions. The accompanying documentation must contain a summary of records used to determine donor eligibility, and a statement whether, based on the results of the screening and testing of the donor, that the donor is determined to be eligible or ineligible. Records used in determining the eligibility of a donor, i.e., results and interpretations of screening and testing, the donor eligibility determination, the name and address of the testing laboratory or laboratories, and the name of the responsible person who made the determination and the date, must be maintained (§ 1271.55(d)(1)). If any information on the donor is not in English, the HCT/P establishment must retain the original record and the statement of authenticity from the translator (§ 1271.55(d)(2)). HCT/P establishments must retain the records pertaining to HCT/Ps at least 10 years after the date of administration, distribution, disposition, or expiration, whichever is latest (§ 1271.55(d)(4)). When a product is shipped in quarantine, before completion of screening and testing, the HCT/P establishment must provide the donor identification, a statement that the donor-eligibility determination is not completed and that the product is not to be used until eligibility determination is completed (§ 1271.60(c)). With the use of a product from an incompletely tested donor, the results of any completed donor screening and testing, and a list of any required screening and testing not yet completed must accompany the HCT/P (§ 1271.60(d)(2)). When using an HCT/P from an ineligible donor, documentation by the HCT/P establishment is required showing that the recipient's physician received notification of the screening and testing results (§§ 1271.60(d)(3) and 1271.65(b)(3)). An HCT/P establishment is also required to establish and maintain procedures for all steps that are performed in determining eligibility (§ 1271.47(a)), including the use of a product from a donor testing positive for cytomegalovirus (§ 1271.85(b)(2)). The HCT/P establishment must record any departure from the procedures (§ 1271.47(d)). Current Good Tissue Practice FDA requires certain HCT/P establishments to follow CGTPs. Section 1271.155(a) permits the submission of a request for FDA approval of an exemption or an alternative from any requirement in subpart C or D of part 1271. Section 1271.290(c) requires the establishment to affix a distinct identification code to each HCT/P relating the HCT/P to the donor and all records pertaining to the HCT/P. Whenever an establishment initially distributes an HCT/P to a consignee, § 1271.290(f) requires the establishment to inform the consignee, in writing, of the product tracking requirements and the methods the establishment uses to fulfill the requirements. Non-reproductive HCT/P establishments described in § 1271.10 are required under § 1271.350(a)(1), and (b)(1) and (b)(2) to investigate and report to FDA adverse reactions (defined in § 1271.3(y)) and HCT/P deviations (defined in § 1271.3(dd)). Section 1271.370(b) and

(c)requires establishments to include specific information either on the HCT/P label or in the package insert. The standard operating procedures

(SOP)provisions under part 1271 include the following:

(1)Section 1271.160(b)(2) (receiving, investigation, evaluating, and documenting information relating to core CGTP requirements received from other sources and for sharing information with consignees and other establishments);

(2)section 1271.180(a) (to meet core CGTP requirements for all steps performed in the manufacture of HCT/Ps);

(3)section 1271.190(d)(1) (facility cleaning and sanitization);

(4)section 1271.200(b) (cleaning, sanitizing, and maintenance of equipment);

(5)section 1271.200(c) (calibration of equipment);

(6)section 1271.230(a) (verification or validation of changes to a process);

(7)section 1271.250(a) (controls for labeling HCT/Ps);

(8)section 1271.265(e) (receipt, pre-distribution shipment, availability for distribution, and packaging and shipping of HCT/Ps);

(9)section 1271.265(f) (suitable for return to inventory);

(10)section 1271.270(b) (records management system);

(11)section 1271.290(b)(1) (system of HCT/P tracking); and

(12)section 1271.320(a) (review, evaluation, and documentation of all complaints). Section 1271.155(f) requires an establishment operating under the terms of an exemption or alternative to maintain documentation of the terms and date of FDA approval. Section 1271.160(b)(3) requires documentation of corrective actions taken as a result of an audit of the quality program. Section 1271.160(b)(6) requires documentation of HCT/P deviations. Section 1271.160(d) requires documentation of computer validation or verification activities and results when computers are used to comply with the core CGTP requirements for its intended use. Section 1271.190(d)(2) requires documentation of all significant facility cleaning and sanitation. Section 1271.195(d) requires documentation of environmental control and monitoring activities. Section 1271.200(e) requires documentation of all equipment maintenance, cleaning, sanitizing, calibration, and other activities. Section 1271.210(d) requires documentation of the receipt, verification, and use of each supply or reagent. Section 1271.230(a) requires documentation of validation activities when the results of a process cannot be fully verified by subsequent inspection and tests. Section 1271.230(c) requires documentation of the review and evaluation of a process and revalidation of the process, if necessary, when any changes to a validated process occur. Section 1271.260(d) and

(e)requires documentation of any corrective action taken when acceptable storage conditions are not met and documentation of the storage temperature of HCT/Ps. Section 1271.265(c)(1) requires documentation that all release criteria are met before distribution of an HCT/P. Section 1271.265(c)(3) requires documentation of any departure from a procedure at the time of occurrence. Section 1271.265(e) requires documentation of the receipt, pre-distribution shipment, distribution, and packaging and shipping of HCT/Ps. Section 1271.270(a) requires documentation of each step in manufacturing required in part 1271, subparts C and D. Section 1271.270(e) requires documentation of the name and address, and a list of responsibilities of any establishment that performs a manufacturing step for the establishment. Section 1271.290(d) and

(e)requires documentation of a method for the recording and disposition of each HCT/P as part of its tracking system. Section 1271.320(b) requires an establishment to maintain a record of each complaint that it receives, including a review and evaluation. Respondents to this information collection are establishments that recover, process, store, label, package or distribute any HCT/P, or perform donor screening or testing. The estimates provided below are based on information from FDA's database system and trade organizations for 2006. The hours per response and hours per record are based on data provided by the Eastern Research Group, or FDA experience with similar recordkeeping or reporting requirements. There are an estimated 2,017 HCT/P (conventional tissue, eye tissue, peripheral blood stem cell, stem cell products from cord blood, reproductive tissue, and sperm banks) establishments, including 481 manufacturers of HCT/P products regulated under the Federal Food, Drug, and Cosmetic Act and section 351 of the PHS Act that have registered and listed with FDA. In addition, we estimate that 241 new establishments have registered with FDA (§§ 1271.10(b)(1) and (b)(2) and 1271.25(a) and (b)). There are an estimated 3,289 listing updates (§§ 1271.10(b)(2), 1271.21(c)(2)(ii) and 1271.25(c)) and 500 location/ownership amendments (§ 1271.26). Under § 1271.55(a), an estimated 1,677,105 HCT/Ps (approximately 1,500,000 conventional tissues, 44,186 eye tissues, 7,919 hematopoetic stem cells/progenitor cells (total of 1,552,105 non-reproductive cells and tissues), and 125,000 reproductive cells and tissues) are distributed per year by an estimated 1,536 establishments (2,017 - 481 establishments with approved applications). Under § 1271.60(c), FDA estimates that 1,200 establishments shipped an estimated 250,000 HCT/P under quarantine, and that an estimated 8 establishments requested an exemption from or alternative to any requirement under part 1271, subpart C or D, specifically under § 1271.155(a). Under §§ 1271.290(c) and 1271.370(b) and (c), the estimated 1,449 non-reproductive HCT/P establishments label each of their 1,552,105 HCT/Ps with certain information. These establishments are also required to inform their consignees in writing of the requirements for tracking and of their established tracking system under § 1271.290(f). FDA estimates 42 HCT/P establishments submitted 67 adverse reaction reports involving communicable disease (§ 1271.350(a)(1)), and 81 establishments submitted 144 deviation reports relating to the core CGTP requirements (§ 1271.350(b)(1)). FDA estimates that 241 new establishments will create SOPs, and that 2,017 establishments will review and revise existing SOPs annually. FDA estimates that 1,009 HCT/P establishments (2,017 x 50% = 1,009) and 725 non-reproductive HCT/P establishments (1,449 x 50% = 725) record and justify a departure from the procedures (§ 1271.47(d) and § 1271.265(c)(3)). Under § 1271.50(a), HCT/P establishments are required to have a documented medical history interview about the donor's medical history and relevant social behavior as part of the donor's relevant medical records for each of the estimated 77,944 donors (approximately 23,295 conventional tissue donors, 42,649 eye tissue donors, 7,000 peripheral and cord blood stem cell donors (72,944 non-reproductive cells and tissue donors), and 5,000 reproductive cell and tissue donors). FDA estimates that 605 HCT/P establishments (2,017 x 30% = 605) document an urgent medical need of the product to notify the physician using the HCT/P (§§ 1271.60(d)(3) and 1271.65(b)(3)).FDA also estimates that 1614 HCT/P establishments (2,017 x 80% = 1,614) have to maintain records for an average of 2 contract establishments to perform their manufacturing process (§ 1271.270(e)) and 1,009 HCT/P establishments maintain an average of 5 complaint records annually (§ 1271.320(b)). In some cases, the estimated burden may appear to be lower or higher than the burden experienced by individual establishments. The estimated burden in these charts is an estimated average burden, taking into account the range of impact each regulation may have. In the **Federal Register** of January 26, 2007 (72 FR 3858), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. **Table 1.—Estimated Annual Reporting Burden** 1 21 CFR Section No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 1271.10(b)(1) and 1271.21(b)(2) 2 2,017 1 2,017 0.5 1,009 1271.21(a), and 1271.25(a) and

(b)2 241 1 241 0.75 181 1271.10(b)(2), 1271.21(c)(ii) and 1271.25(c) 2 3,289 1 3,289 0.5 1,644 1271.26 2 500 1 500 0.25 125 1271.55(a) 1,536 1,091.87 1,677,105 0.5 838,553 1271.60(c) and (d)(2) 1,200 208.33 250,000 0.5 125,000 1271.155(a) 8 1 8 3 24 1271.290(c) 1,449 1,071.16 1,552,105 0.08 124,168.33 1271.290(f) 1,449 1 1,449 1 1,449 1271.350(a)(1) 42 1.60 67 1 67 1271.350(b)(1) and (b)(2) 81 1.78 144 1 144 1271.370(b) and

(c)1,449 1,071.16 1,552,105 0.25 388,026.25 Total 1,480,390 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 Using Form FDA 3356. FDA estimates the burden of this collection of information as follows: **Table 2.—Estimated Annual Recordkeeping Burden** 1 21 CFR Section No. of Recordkeepers Annual Frequency per Recordkeeping Total Annual Records Hours per Record Total Hours New SOPs 2 241 1 241 48 11,568 SOP Update 2 2,017 1 2,017 24 48,408 1271.47(d) 1,009 1 1,009 1 1,009 1271.50(a) 2,017 38.64 77,944 5 389,720 1271.55(d)(1) 2,017 38.64 77,944 1 77,944 1271.55(d)(2) 2,017 1 2,017 1 2,017 1271.55(d)(4) 2,017 1 2,017 120 242,040 1271.60(d)(3) and 1271.65(b)(3) 605 1 605 2 1,210 1271.155(f) 8 1 8 0.25 2 1271.160(b)(3) and (b)(6) 1,449 12 17,388 1 17,388 1271.160(d) 1,449 12 17,388 1 17,388 1271.190(d)(2) 1,449 12 17,388 1 17,388 1271.195(d) 1,449 12 17,388 1 17,388 1271.200(e) 1,449 12 17,388 1 17,388 1271.210(d) 1,449 12 17,388 1 17,388 1271.230(a) 1,449 12 17,388 1 17,388 1271.230(c) 1,449 1 1,449 1 1,449 1271.260(d) 1,449 12 17,388 0.25 4,347 1271.260(e) 1,449 365 528,885 0.08 42,310.8 1271.265(c)(1) 1,449 1,071.16 1,552,105 0.08 124,168.33 1271.265(c)(3) 725 1 725 1 725 1271.265(e) 1,449 1,071.16 1,552,105 0.08 124,168.33 1271.270(a) 1,449 1,071.16 1,552,105 0.25 388,026.25 1271.270(e) 1,614 2 3,228 0.5 1,614 1271.290(d) and

(e)1,449 50.34 72,944 0.25 18,236 1271.320(b) 1,009 5 5,045 1 5,045 Total 1,605,723.7 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 Sections 1271.47(a), 1271.85(b)(2), 1271.160(b)(2), 1271.180(a), 1271.190(d)(1), 1271.200(b) and (c), 1271.230(a), 1271.250(a), 1271.265(e), and 1271.320(a). Dated: April 20, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-8038 Filed 4-26-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007P-0149] Canned Pacific Salmon Deviating From Identity Standard; Temporary Permit for Market Testing AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a temporary permit has been issued to Peter Pan Seafoods, Inc., to market test canned Pacific salmon that deviates from the U.S. standard of identity for canned Pacific salmon. The purpose of the temporary permit is to allow the applicant to measure consumer acceptance of the product and assess commercial feasibility. DATES: This permit is effective for 15 months, beginning on the date the permit holder introduces or causes the introduction of the test product into interstate commerce, but not later than July 27, 2007. FOR FURTHER INFORMATION CONTACT: Ritu Nalubola, Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2371. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 130.17 concerning temporary permits to facilitate market testing of foods deviating from the requirements of the standards of identity issued under section 401 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341), FDA is giving notice that a temporary permit has been issued to Peter Pan Seafoods, Inc., 2200 Sixth Ave., suite 1000, Seattle, WA 98121. The permit covers limited interstate marketing tests of products identified as

(1)Deming's “Skinless & Boneless Pink Salmon” and “Skinless & Boneless Red Sockeye Salmon” and

(2)Double“Q” “Skinless & Boneless Pink Salmon” and “Skinless & Boneless Red Sockeye Salmon.” These canned salmon products may deviate from the U.S. standard of identity for canned Pacific salmon (21 CFR 161.170) in that the products are prepared by removing the skin and bones of the salmon used and, therefore, in lieu of the optional forms of pack provided in 21 CFR 161.170(a)(3), this temporary marketing permit provides for an alternate “skinless and boneless” form of pack. The test product meets all the requirements of the standard with the exception of the “skinless and boneless” form of pack. The purpose of the temporary permit is to allow the applicant to measure consumer acceptance of the product, identify mass production problems, and assess commercial feasibility. This permit provides for the temporary marketing of not more than 1.13 million pounds (or 513 thousand kilograms) of the test product annually. The test products will be manufactured by Peter Pan Seafoods, Inc., at its Valdez Facility, P.O. Box 1027, Valdez, AK 99686-1027 and Dillingham Facility, P.O. Box 410, Dillingham, AK 99576. The test products will be distributed by Peter Pan Seafoods, Inc., throughout the United States except Alaska. The information panel of the labels will bear nutrition labeling in accordance with 21 CFR 101.9. Each of the ingredients used in the food must be declared on the labels as required by the applicable sections of 21 CFR part 101. This permit is effective for 15 months, beginning on the date the permit holder introduces or causes the introduction of the product into interstate commerce, but not later than July 27, 2007. Dated: April 20, 2007. Barbara Schneeman, Director, Office of Nutritional Products, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition. [FR Doc. E7-8039 Filed 4-27-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007P-0150] Iceberg Water Deviating From Identity Standard; Temporary Permit for Market Testing AGENCY: Food and Drug Administration, HHS. ACTION: Notice . SUMMARY: The Food and Drug Administration

(FDA)is announcing that a temporary permit has been issued to Canada Ice Enterprises, Inc., to market a product designated as “80 degrees north Iceberg Water” that deviates from the U.S. standard of identity for bottled water. The purpose of the temporary permit is to allow the applicant to measure consumer acceptance of the product, identify mass production problems, and assess commercial feasibility. DATES: This permit is effective for 15 months, beginning on the date the permit holder introduces or causes the introduction of the test product into interstate commerce, but not later than July 27, 2007. FOR FURTHER INFORMATION CONTACT: Loretta A. Carey, Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2371. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 130.17 concerning temporary permits to facilitate market testing of foods deviating from the requirements of the standards of identity issued under section 401 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341), FDA is giving notice that a temporary permit has been issued to Canada Ice Enterprises, Inc., P.O. Box 722, St. Anthony, NL A0K 4S0. This permit covers limited interstate marketing tests of products identified as “80 degrees north Iceberg Water” that deviate from the U.S. standard of identity for bottled water (§ 165.110 (21 CFR 165.110)) in that the source of the water is an iceberg. The test product meets all the requirements of the standard with the exception of the source definition. The purpose of this permit is to allow the applicant to measure consumer acceptance of the product, identify mass production problems, and assess commercial feasibility. This permit provides for the temporary marketing of 500,000 cases of 24 x 500 milliliter bottles and 500,000 cases of 12 x 1 liter bottles, totaling 1 million cases per year. The total fluid quantity covered by this application is 12 million liters (3,170,065 gallons). The test product will be manufactured for Canada Ice Enterprises, Inc., 10 Cremilliare Rd., St. Anthony, NL Canada A0K 4S0. Canada Ice Enterprises, Inc., will distribute the test products throughout the United States. The information panel of the labels must bear nutrition labeling in accordance with 21 CFR 101.9. The bottled water must be manufactured in accordance with the quality standards in § 165.110(b) and the requirements for processing and bottling of bottled drinking water in 21 CFR part 129. This permit is effective for 15 months, beginning on the date the food is introduced or caused to be introduced into interstate commerce, but not later than ( *see* DATES ). Dated: April 20, 2007. Barbara Schneeman, Director, Office of Nutritional Products, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition. [FR Doc. E7-8040 Filed 4-26-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0068] Medical Device User Fee and Modernization Act; Public Meeting; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. SUMMARY: The Food and Drug Administration is correcting a notice that appeared in the **Federal Register** of April 18, 2007 (72 FR 19528). The document announced a public meeting on April 30, 2007, to discuss the agency's proposed recommendations for the reauthorization of the Medical Device User Fee and Modernization Act of 2002 (MUDFMA I) for fiscal years 2008 through 2012, as well as other proposals to improve the review of medical devices and the third party inspection program. The correction is being made to reflect a change in location for the April 30, 2007, meeting. The location of the meeting is being changed because of water damage in the original meeting location. FOR FURTHER INFORMATION CONTACT: *For information regarding this notice and the original notice, contact* : Erik Mettler, Office of Policy and Planning, Food and Drug Administration (HF-11), 5600 Fishers Lane, Rockville, MD 20857, 301-827-3360, FAX 301-594-6777, email: *Erik.Mettler@fda.hhs.gov* . *For information regarding registration, contact* : Cynthia Garris, Office of Communication, Education, and Radiation Programs, Center for Devices and Radiological Health, Food and Drug Administration (HFZ-220), 1350 Piccard Ave., Rockville, MD 20850, 240-276-3150 ext. 121, FAX: 240-276-3151, email: *cynthia.garris@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: In FR Doc. 07-1919, appearing on page 19528 in the **Federal Register** of Wednesday, April 18, 2007, the following correction is made: 1. On page 19528, in the third column, the first sentence under “ ADDRESSES ” is corrected to read “The public meeting will be held at the Food and Drug Administration, White Oak site, at 10903 New Hampshire Ave., Silver Spring, MD 20993, Bldg. 2, rm. 2031.” Dated: April 23, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 07-2085 Filed 4-24-07; 3:18 pm]

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