Office of the Director, National Institutes of Health; Notice of Meeting, 54583-54584 [E9-25403]

Download as PDF Federal Register / Vol. 74, No. 203 / Thursday, October 22, 2009 / Notices pay the premiums for dually-eligible beneficiaries. Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. This notice will not have a substantial effect on State or local governments. In accordance with the provisions of Executive Order 12866, this notice was reviewed by the Office of Management and Budget. (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance) Dated: September 1, 2009. Charlene Frizzera, Acting Administrator, Centers for Medicare & Medicaid Services. Dated: September 17, 2009. Kathleen Sebelius, Secretary. [FR Doc. E9–25371 Filed 10–16–09; 4:15 pm] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0664] Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. dcolon on DSK2BSOYB1PROD with NOTICES This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Radiological 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 November 17 and 18, 2009, from 8 a.m. to 5:30 p.m. Location: Holiday Inn, Ballroom, Two Montgomery Village Ave., Gaithersburg, MD. Contact Person: Toby Lowe, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301–796– 6512, or FDA Advisory Committee Information Line, 1–800–741–8138 (301– 443–0572 in the Washington, DC area), code 3014512526. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last VerDate Nov<24>2008 15:13 Oct 21, 2009 Jkt 220001 minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: On November 17, 2009, the committee will discuss and make recommendations regarding the agency’s regulatory strategy for Full Field Digital Mammography (FFDM) Devices. The committee will discuss the public comments received in response to the publication of the draft guidance document entitled ‘‘Class II Special Controls Guidance Document: Full Field Digital Mammography System.’’ This guidance document can be found on the FDA Web site at https://www.fda.gov/ MedicalDevices/DeviceRegulation andGuidance/GuidanceDocuments/ ucm107552.htm. On November 18, 2009, the committee will discuss and make recommendations regarding the agency’s regulatory strategy for computer-assisted detection (CADe) devices for radiological devices. CADe devices are devices intended to identify, mark, highlight or in any other manner direct attention to potential abnormalities revealed in radiological data of the human body or imaging device data during interpretation of patient images or patient imaging data by a physician or other health care professional. The committee will discuss two draft guidance documents entitled ‘‘ComputerAssisted Detection Devices Applied to Radiology Images and Radiology Device Data—Premarket Notification [510(k)] Submissions’’ and ‘‘Clinical Performance Assessment: Considerations for ComputerAssisted Detection Devices Applied to Radiology Images and Radiology Device Data—Premarket Approval (PMA) and Premarket Notification [510(k)] Submissions.’’ These guidance documents can be found on the FDA Web site at https:// www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/Guidance Documents. Type in the title of the guidance document included in this notice. The guidance documents will also be available as background materials. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https:// www.fda.gov/AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee link. Procedure: 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 on or before November 12, 2009. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. on both PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 54583 days. Those desiring to make formal oral presentations should notify the contact person 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 on or before November 6, 2009. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by November 9, 2009. 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, 301–796–5966, at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/ AdvisoryCommittees/AboutAdvisory Committees/ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: October 16, 2009. David Horowitz, Assistant Commissioner for Policy. [FR Doc. E9–25406 Filed 10–21–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Office of the Director, National Institutes of Health; Notice of Meeting Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the Scientific Management Review Board. The NIH Reform Act of 2006 (Pub. L.109–482) provides organizational authorities to HHS and NIH officials to: (1) Establish or abolish national research institutes; (2) reorganize the offices within the Office of the Director, NIH including adding, removing, or transferring the functions of such offices or establishing or terminating such offices; and (3) reorganize, divisions, centers, or other administrative units within an NIH national research E:\FR\FM\22OCN1.SGM 22OCN1 54584 Federal Register / Vol. 74, No. 203 / Thursday, October 22, 2009 / Notices dcolon on DSK2BSOYB1PROD with NOTICES institute or national center including adding, removing, or transferring the functions of such units, or establishing or terminating such units. The purpose of the Scientific Management Review Board (also referred to as SMRB or Board) is to advise appropriate HHS and NIH officials on the use of these organizational authorities and identify the reasons underlying the recommendations. The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. Name of Committee: Scientific Management Review Board. Date: November 12–13, 2009. Time: November 12, 2009, 1 p.m. to 5 p.m. Agenda: Presentation and discussion will include updates from SMRB Working Groups: Deliberating Organizational Change and Effectiveness; NIH Intramural Research Program; and Substance Use, Abuse, and Addiction. There will also be time allotted on the agenda for public comment. Sign up for public comment will begin at approximately 12 p.m. In the event that time does not allow for all those interested to present oral comments, anyone may file written comments using the address below. Place: National Institutes of Health, Building 31, 6th Floor, Conference Room 6, 31 Center Drive, Bethesda, MD 20892. Time: November 13, 2009, 8:30 a.m. to 12 p.m. Agenda: Continuation of November 12th meeting. Place: National Institutes of Health, Building 31, 6th Floor, Conference Room 6, 31 Center Drive, Bethesda, MD 20892. Contact Person: Dr. Lyric Jorgenson, PhD, NIH–AAAS Science and Technology Policy Fellow, Office of Science Policy, Office of the Director, NIH, National Institutes of Health, Building 1 Room 218 MSC 0166, 9000 Rockville Pike, Bethesda, MD 20892, smrb@mail.nih.gov, (301) 496–6837. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. The meeting will also be webcast. The draft meeting agenda and other information about the SMRB, including information about access to the webcast, will be available at https://smrb.od.nih.gov. In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxis, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver’s license, or passport) and to state the purpose of their visit. VerDate Nov<24>2008 15:13 Oct 21, 2009 Jkt 220001 (Catalogue of Federal Domestic Assistance Program Nos. 93.14, Intramural Research Training Award; 93.22, Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds; 93.232, Loan Repayment Program for Research Generally; 93.39, Academic Research Enhancement Award; 93.936, NIH Acquired Immunodeficiency Syndrome Research Loan Repayment Program; 93.187, Undergraduate Scholarship Program for Individuals from Disadvantaged Backgrounds, National Institutes of Health, HHS) Dated: October 15, 2009. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–25403 Filed 10–21–09; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: AIDS and Related Research Integrated Review Group; AIDS Discovery and Development of Therapeutics Study Section. Date: November 13, 2009. Time: 8 a.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: The Ritz Carlton Hotel, 1150 22nd Street, NW., Washington, DC 20037. Contact Person: Shiv A. Prasad, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5220, MSC 7852, Bethesda, MD 20892, 301–443– 5779, prasads@csr.nih.gov. Name of Committee: AIDS and Related Research Integrated Review Group; NeuroAIDS and other End-Organ Diseases Study Section. Date: November 13, 2009. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: InterContinental Mark Hopkins San Francisco, One Nob Hill, San Francisco, CA 94108. PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 Contact Person: Mary Clare Walker, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5208, MSC 7852, Bethesda, MD 20892, (301) 435– 1165, walkermc@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business Grant Applications: Immunology. Date: November 16–17, 2009. Time: 8:30 a.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: The River Inn, 924 25th Street, NW., Washington, DC 20037. Contact Person: Stephen M. Nigida, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4212, MSC 7812, Bethesda, MD 20892, 301–435– 1222, nigidas@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business Innovation Research Grants. Date: November 17, 2009. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Rass M. Shayiq, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2182, MSC 7818, Bethesda, MD 20892, (301) 435– 2359, shayiqr@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: October 14, 2009. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–25402 Filed 10–21–09; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract E:\FR\FM\22OCN1.SGM 22OCN1

Agencies

[Federal Register Volume 74, Number 203 (Thursday, October 22, 2009)]
[Notices]
[Pages 54583-54584]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-25403]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Office of the Director, National Institutes of Health; Notice of 
Meeting

    Pursuant to section 10(a) of the Federal Advisory Committee Act, as 
amended (5 U.S.C. App.), notice is hereby given of a meeting of the 
Scientific Management Review Board.
    The NIH Reform Act of 2006 (Pub. L.109-482) provides organizational 
authorities to HHS and NIH officials to: (1) Establish or abolish 
national research institutes; (2) reorganize the offices within the 
Office of the Director, NIH including adding, removing, or transferring 
the functions of such offices or establishing or terminating such 
offices; and (3) reorganize, divisions, centers, or other 
administrative units within an NIH national research

[[Page 54584]]

institute or national center including adding, removing, or 
transferring the functions of such units, or establishing or 
terminating such units. The purpose of the Scientific Management Review 
Board (also referred to as SMRB or Board) is to advise appropriate HHS 
and NIH officials on the use of these organizational authorities and 
identify the reasons underlying the recommendations.
    The meeting will be open to the public, with attendance limited to 
space available. Individuals who plan to attend and need special 
assistance, such as sign language interpretation or other reasonable 
accommodations, should notify the Contact Person listed below in 
advance of the meeting.

    Name of Committee: Scientific Management Review Board.
    Date: November 12-13, 2009.
    Time: November 12, 2009, 1 p.m. to 5 p.m.
    Agenda: Presentation and discussion will include updates from 
SMRB Working Groups: Deliberating Organizational Change and 
Effectiveness; NIH Intramural Research Program; and Substance Use, 
Abuse, and Addiction. There will also be time allotted on the agenda 
for public comment. Sign up for public comment will begin at 
approximately 12 p.m. In the event that time does not allow for all 
those interested to present oral comments, anyone may file written 
comments using the address below.
    Place: National Institutes of Health, Building 31, 6th Floor, 
Conference Room 6, 31 Center Drive, Bethesda, MD 20892.
    Time: November 13, 2009, 8:30 a.m. to 12 p.m.
    Agenda: Continuation of November 12th meeting.
    Place: National Institutes of Health, Building 31, 6th Floor, 
Conference Room 6, 31 Center Drive, Bethesda, MD 20892.
    Contact Person: Dr. Lyric Jorgenson, PhD, NIH-AAAS Science and 
Technology Policy Fellow, Office of Science Policy, Office of the 
Director, NIH, National Institutes of Health, Building 1 Room 218 
MSC 0166, 9000 Rockville Pike, Bethesda, MD 20892, 
smrb@mail.nih.gov, (301) 496-6837.
    Any interested person may file written comments with the 
committee by forwarding the statement to the Contact Person listed 
on this notice. The statement should include the name, address, 
telephone number and when applicable, the business or professional 
affiliation of the interested person.
    The meeting will also be webcast. The draft meeting agenda and 
other information about the SMRB, including information about access 
to the webcast, will be available at https://smrb.od.nih.gov.
    In the interest of security, NIH has instituted stringent 
procedures for entrance onto the NIH campus. All visitor vehicles, 
including taxis, hotel, and airport shuttles will be inspected 
before being allowed on campus. Visitors will be asked to show one 
form of identification (for example, a government-issued photo ID, 
driver's license, or passport) and to state the purpose of their 
visit.

(Catalogue of Federal Domestic Assistance Program Nos. 93.14, 
Intramural Research Training Award; 93.22, Clinical Research Loan 
Repayment Program for Individuals from Disadvantaged Backgrounds; 
93.232, Loan Repayment Program for Research Generally; 93.39, 
Academic Research Enhancement Award; 93.936, NIH Acquired 
Immunodeficiency Syndrome Research Loan Repayment Program; 93.187, 
Undergraduate Scholarship Program for Individuals from Disadvantaged 
Backgrounds, National Institutes of Health, HHS)

    Dated: October 15, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. E9-25403 Filed 10-21-09; 8:45 am]
BILLING CODE 4140-01-P

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