Center for Scientific Review; Notice of Closed Meetings, 11120-11121 [E9-5639]

Download as PDF 11120 Federal Register / Vol. 74, No. 49 / Monday, March 16, 2009 / Notices ∑ Risk management approach to consumer protection and industry regulation ∑ How quality management systems (including corrective and preventive action) contribute to product cycle improvement ∑ Supplier management and component controls for drugs and devices ∑ Adverse drug event reporting requirements ∑ Medical device reporting requirements ∑ Recalls, corrections and removals ∑ Complaint handling from the FDA investigator’s perspective. FDA has made education of the drug and device manufacturing community a high priority to help ensure the quality of FDA-regulated drugs and devices. The workshop helps to achieve objectives set forth in section 406 of the Food and Drug Administration Modernization Act of 1997 (21 U.S.C. 393) which includes working closely with stakeholders and maximizing the availability and clarity of information to stakeholders and the public. The workshop also is consistent with the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104– 121), as outreach activities by Government agencies to small businesses. Dated: March 4, 2009. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E9–5648 Filed 3–13–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0664] Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Orthopaedic and Rehabilitation 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. VerDate Nov<24>2008 15:38 Mar 13, 2009 Jkt 217001 Date and Time: The meeting will be held on March 31, 2009, from 8 a.m. to 5 p.m. Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and C, 620 Perry Pkwy., Gaithersburg, MD. Contact Person: Ronald P. Jean, Center for Devices and Radiological Health (HFZ–410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD, 20850, 240–276–3676, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512521. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last 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: The committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for OP-1 Putty, sponsored by Stryker Biotech. This combination product is indicated for posterolateral spinal fusion procedures in skeletally mature patients with lumbar spondylolisthesis who have failed at least 6 months of conservative nonsurgical treatment. 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/ohrms/ dockets/ac/acmenu.htm, click on the year 2009 and 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 March 24, 2009. Oral presentations from the public will be scheduled for 30 minutes at the beginning of the committee deliberations and for 30 minutes near the end of the deliberations. 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 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 participants, and an indication of the approximate time requested to make their presentation on or before March 20, 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 March 23, 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, 240–276–8932, 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/oc/advisory/ default.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: March 10, 2009. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E9–5644 Filed 3–13–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which E:\FR\FM\16MRN1.SGM 16MRN1 Federal Register / Vol. 74, No. 49 / Monday, March 16, 2009 / Notices would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel, Fellowships: Diversity Program. Date: March 23, 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: Peter J. Perrin, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2180, MSC 7818, Bethesda, MD 20892, (301) 435– 0682, perrinp@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel, Neurodevelopment and Neurobiology. Date: March 24–25, 2009. Time: 9 a.m. to 11 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Peter B. Guthrie, Ph.D., Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4142, MSC 7850, Bethesda, MD 20892, (301) 435– 1239, guthriep@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel, HIV Behavioral Interventions Member Conflicts. Date: March 27, 2009. Time: 12 p.m. to 3 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Jose H. Guerrier, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5218, MSC 7852, Bethesda, MD 20892, 301–435– 1137, guerriej@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel, Kidney Dialysis, Monitoring, and Therapeutics Small Business Review. Date: April 1–2, 2009. Time: 10 a.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Krystyna E. Rys-Sikora, Ph.D., Scientific Review Officer, Center for VerDate Nov<24>2008 15:38 Mar 13, 2009 Jkt 217001 Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4112, MSC 7814, Bethesda, MD 20892, 301–451– 1325, ryssokok@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel, AMCB, VACC, ADDT, ACE and AIP Member Conflicts. Date: April 2–3, 2009. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Eduardo A. Montalvo, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5212, MSC 7852, Bethesda, MD 20892, (301) 435– 1168, montalve@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel, Neuronal Development, Synaptic Transmission and Neuropathy. Date: April 14, 2009. Time: 1 p.m. to 2:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Carol Hamelink, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5040H, MSC 7850, Bethesda, MD 20892, (301) 451– 1328, hamelinc@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel, Member Conflict Panel. Date: April 22, 2009. Time: 11 a.m. to 1 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Raymond Jacobson, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, MSC 7849, Bethesda, MD 20892, 301–435–0483, jacobsonrh@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) Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–5639 Filed 3–13–09; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 11121 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Eye Institute; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Eye Institute Special Emphasis Panel; NEI K99 Pathways to Independence Grant Applications. Date: April 7, 2009. Time: 10 a.m. to 1 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 5635 Fishers Lane, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Anne E Schaffner, PhD, Scientific Review Officer, Division of Extramural Research, National Eye Institute, 5635 Fishers Lane, Suite 1300, MSC 9300, Bethesda, MD 20892–9300, (301) 451–2020, aes@nei.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.867, Vision Research, National Institutes of Health, HHS) Dated: March 9, 2009. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–5475 Filed 3–13–09; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Environmental Health Sciences; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and552b(c)(6), Title 5 U.S.C., E:\FR\FM\16MRN1.SGM 16MRN1

Agencies

[Federal Register Volume 74, Number 49 (Monday, March 16, 2009)]
[Notices]
[Pages 11120-11121]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-5639]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Center for Scientific Review; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended (5 U.S.C. Appendix 2), notice is hereby given of the following 
meetings.
    The meetings will be closed to the public in accordance with the 
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 
U.S.C., as amended. The grant applications and the discussions could 
disclose confidential trade secrets or commercial property such as 
patentable material, and personal information concerning individuals 
associated with the grant applications, the disclosure of which

[[Page 11121]]

would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel, Fellowships: Diversity Program.
    Date: March 23, 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: Peter J. Perrin, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 2180, MSC 7818, Bethesda, MD 
20892, (301) 435-0682, perrinp@csr.nih.gov.
    This notice is being published less than 15 days prior to the 
meeting due to the timing limitations imposed by the review and 
funding cycle.

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel, Neurodevelopment and Neurobiology.
    Date: March 24-25, 2009.
    Time: 9 a.m. to 11 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892 (Virtual Meeting).
    Contact Person: Peter B. Guthrie, Ph.D., Scientific Review 
Administrator, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 4142, MSC 7850, Bethesda, MD 
20892, (301) 435-1239, guthriep@csr.nih.gov.
    This notice is being published less than 15 days prior to the 
meeting due to the timing limitations imposed by the review and 
funding cycle.

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel, HIV Behavioral Interventions Member Conflicts.
    Date: March 27, 2009.
    Time: 12 p.m. to 3 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892 (Telephone Conference Call).
    Contact Person: Jose H. Guerrier, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 5218, MSC 7852, Bethesda, MD 
20892, 301-435-1137, guerriej@csr.nih.gov.
    This notice is being published less than 15 days prior to the 
meeting due to the timing limitations imposed by the review and 
funding cycle.
    Name of Committee: Center for Scientific Review Special Emphasis 
Panel, Kidney Dialysis, Monitoring, and Therapeutics Small Business 
Review.
    Date: April 1-2, 2009.
    Time: 10 a.m. to 6 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892 (Virtual Meeting).
    Contact Person: Krystyna E. Rys-Sikora, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 4112, MSC 7814, Bethesda, MD 
20892, 301-451-1325, ryssokok@csr.nih.gov.

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel, AMCB, VACC, ADDT, ACE and AIP Member Conflicts.
    Date: April 2-3, 2009.
    Time: 8 a.m. to 5 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892 (Virtual Meeting).
    Contact Person: Eduardo A. Montalvo, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 5212, MSC 7852, Bethesda, MD 
20892, (301) 435-1168, montalve@csr.nih.gov.

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel, Neuronal Development, Synaptic Transmission and Neuropathy.
    Date: April 14, 2009.
    Time: 1 p.m. to 2:30 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892 (Virtual Meeting).
    Contact Person: Carol Hamelink, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 5040H, MSC 7850, Bethesda, MD 
20892, (301) 451-1328, hamelinc@csr.nih.gov.

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel, Member Conflict Panel.
    Date: April 22, 2009.
    Time: 11 a.m. to 1 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892 (Telephone Conference Call).
    Contact Person: Raymond Jacobson, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, MSC 7849, Bethesda, MD 20892, 301-435-
0483, jacobsonrh@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)

Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
 [FR Doc. E9-5639 Filed 3-13-09; 8:45 am]
BILLING CODE 4140-01-P

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