National Cancer Institute; Notice of Closed Meeting, 70154-70155 [2011-29141]

Download as PDF 70154 Federal Register / Vol. 76, No. 218 / Thursday, November 10, 2011 / Notices jlentini on DSK4TPTVN1PROD with NOTICES 5. FDA Review Under the pilot program, early feasibility study IDE applications will be reviewed according to the approaches outlined in the early feasibility study draft guidance. The essential elements announced in the early feasibility study draft guidance are: • FDA may approve an IDE application for an early feasibility study, including certain first in human studies, based on less nonclinical data than would be expected for a traditional feasibility or a pivotal study. This is because early feasibility studies are only appropriate where additional nonclinical testing is not available or adequate to provide the information needed to advance the developmental process. Identification of the data necessary to support an early feasibility study should be based on a thorough device evaluation strategy that describes the device and procedure-related attributes and addresses the potential failure modes. Appropriate human subject protection measures and risk mitigation strategies must also be identified. This policy is intended to facilitate initiation of clinical studies in the United States earlier in the device development process than has historically occurred, when appropriate. • New approaches that facilitate timely device and clinical protocol modifications during an early feasibility study while still requiring compliance with the IDE regulations in 21 CFR part 812. FDA has provided additional information regarding its expectations for early feasibility study IDE applications in the early feasibility study draft guidance. D. Duration of the Pilot FDA intends to accept requests for participation in the pilot program for 180 days from the date of publication of this notice. FDA may decide to terminate the pilot program before the close of the 180-day period or extend the pilot program beyond the 180-day period. The decision to terminate or extend the pilot will be announced in the Federal Register. FDA may also decide to modify the pilot program while it is in effect. Any modifications will also be announced in the Federal Register. FDA intends to terminate the pilot program when the early feasibility study draft guidance is finalized. E. Evaluation FDA intends to use the experience gained from the pilot program to inform the final version of the early feasibility study draft guidance. VerDate Mar<15>2010 16:38 Nov 09, 2011 Jkt 226001 Dated: November 4, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–29116 Filed 11–9–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute; 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: National Heart, Lung, and Blood Institute Special Emphasis Panel, Life after Linkage: The Future of Family Studies. Date: December 1–2, 2011. Time: 8:30 a.m. to 5:30 p.m. Agenda: To review and evaluate grant applications. Place: Hilton Garden Inn, 7301 Waverly Street, Bethesda, MD 20814. Contact Person: YingYing Li-Smerin, MD, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7184, Bethesda, MD 20892– 7924. (301) 435–0277. lismerin@nhlbi.nih.gov. Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel, COPD Case Finding Methodology. Date: December 1, 2011. Time: 9 a.m. to 2 p.m. Agenda: To review and evaluate grant applications. Place: Marriott Wardman Park Washington DC Hotel, 2660 Woodley Road NW., Washington, DC 20008. Contact Person: Stephanie J Webb, Ph.D., Scientific Review Officer, Review Branch/ DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7196, Bethesda, MD 20892. (301) 435–0291. stephanie.webb@nih.gov. Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel, PPG Review: Endothelium and cardiovascular function. Date: December 2, 2011. Time: 8:30 a.m. to 4:30 p.m. Agenda: To review and evaluate grant applications. PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 Place: Hyatt Regency Crystal City, 2799 Jefferson Davis Highway, Arlington, VA 22202. Contact Person: Tony L Creazzo, Ph.D., Scientific Review Officer. (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS) Dated: November 4, 2011. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2011–29142 Filed 11–9–11; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; 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 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 Cancer Institute Special Emphasis Panel, Small Grants Program for Cancer Epidemiology. Date: November 17–18, 2011. Time: 8:30 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda North Marriott Hotel & Conference Center, 5701 Marinelli Road, Bethesda, MD 20852. Contact Person: Jeffrey E. DeClue, Ph.D., Scientific Review Officer, Special Review and Logistics Branch, Division of Extramural Activities, National Cancer Institute, NIH, 6116 Executive Boulevard, Room 8059, Bethesda, MD 20892–8329, (301) 496–7904, decluej@mail.nih.gov. This notice is being published less than 15 days prior to the meeting due to scheduling conflicts. Information is also available on the Institute’s/Center’s home page: https:// deainfo.nci.nih.gov/advisory/sep/sep.htm, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; E:\FR\FM\10NON1.SGM 10NON1 Federal Register / Vol. 76, No. 218 / Thursday, November 10, 2011 / Notices 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS) DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: November 4, 2011. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. Notice is hereby given of a change in the meeting of the National Institute of General Medical Sciences Special Emphasis Panel, November 15, 2011, 12 p.m. to November 15, 2011, 5 p.m., National Institutes of Health, Natcher Building, 45 Center Drive, Room 3AN18A, Bethesda, MD 20892 which was published in the Federal Register on November 1, 2011, 76 FR 67467. The meeting date and time have been changed to November 21, 2011, 2 p.m. to November 21, 2011, 5 p.m. The meeting is closed to the public. [FR Doc. 2011–29141 Filed 11–9–11; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting jlentini on DSK4TPTVN1PROD with NOTICES 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 proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel, NIAID Contract Review. Date: December 5, 2011. Time: 8 a.m. to 6 p.m. Agenda: To review and evaluate contract proposals. Place: Bethesda North Marriott Hotel & Conference Center, 5701 Marinelli Road, Bethesda, MD 20852. Contact Person: Brenda Lange-Gustafson, Ph.D., Scientific Review Officer, NIAID/NIH/ DHHS, Scientific Review Program, Room 3122, 6700–B Rockledge Drive, MSC–7616, Bethesda, MD 20892–7616, (301) 451–3684, bgustafson@niaid.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) Dated: November 4, 2011. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2011–29137 Filed 11–9–11; 8:45 am] BILLING CODE 4140–01–P VerDate Mar<15>2010 16:38 Nov 09, 2011 Jkt 226001 National Institutes of Health National Institute of General Medical Sciences; Amended Notice of Meeting Dated: November 4, 2011. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2011–29140 Filed 11–9–11; 8:45 am] BILLING CODE 4140–01–P 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 Advisory Committee to the Director, National Institutes of Health. 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: Advisory Committee to the Director, National Institutes of Health. Date: December 8–9, 2011. Time: December 8, 2011, 9 a.m. to 4 p.m. Agenda: Report from NIH Director, various Working Group reports. Place: National Institutes of Health, Building 31, 31 Center Drive, Bethesda, MD 20892. Time: December 9, 2011, 8:30 a.m. to 12 p.m. Agenda: Report from NCI Director, various Working Group reports. Place: National Institutes of Health, Building 31, 31 Center Drive, Bethesda, MD 20892. Contact Person: Gretchen Wood, Staff Assistant, National Institutes of Health, Office of the Director, One Center Drive, PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 70155 Building 1, Room 103, Bethesda, MD 20892. (301) 496–4272. woodgs@od.nih.gov. 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. In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, 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. Information is also available on the Institute’s/Center’s home page: https:// acd.od.nih.gov, where an agenda and any additional information for the meeting will be posted when available. (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: November 4, 2011. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2011–29138 Filed 11–9–11; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR–5477–N–45] Federal Property Suitable as Facilities To Assist the Homeless Office of the Assistant Secretary for Community Planning and Development, HUD. ACTION: Notice. AGENCY: This Notice identifies unutilized, underutilized, excess, and surplus Federal property reviewed by HUD for suitability for possible use to assist the homeless. FOR FURTHER INFORMATION CONTACT: Juanita Perry, Department of Housing and Urban Development, 451 Seventh Street SW., Room 7262, Washington, DC 20410; telephone (202) 708–1234; TTY number for the hearing- and speechimpaired (202) 708–2565, (these telephone numbers are not toll-free), or call the toll-free Title V information line at (800) 927–7588. SUMMARY: E:\FR\FM\10NON1.SGM 10NON1

Agencies

[Federal Register Volume 76, Number 218 (Thursday, November 10, 2011)]
[Notices]
[Pages 70154-70155]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-29141]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Cancer Institute; 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 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 Cancer Institute Special Emphasis 
Panel, Small Grants Program for Cancer Epidemiology.
    Date: November 17-18, 2011.
    Time: 8:30 a.m. to 5 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Bethesda North Marriott Hotel & Conference Center, 5701 
Marinelli Road, Bethesda, MD 20852.
    Contact Person: Jeffrey E. DeClue, Ph.D., Scientific Review 
Officer, Special Review and Logistics Branch, Division of Extramural 
Activities, National Cancer Institute, NIH, 6116 Executive 
Boulevard, Room 8059, Bethesda, MD 20892-8329, (301) 496-7904, 
decluej@mail.nih.gov.
    This notice is being published less than 15 days prior to the 
meeting due to scheduling conflicts.
    Information is also available on the Institute's/Center's home 
page: https://deainfo.nci.nih.gov/advisory/sep/sep.htm, where an 
agenda and any additional information for the meeting will be posted 
when available.

(Catalogue of Federal Domestic Assistance Program Nos. 93.392, 
Cancer Construction;

[[Page 70155]]

93.393, Cancer Cause and Prevention Research; 93.394, Cancer 
Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 
93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 
93.398, Cancer Research Manpower; 93.399, Cancer Control, National 
Institutes of Health, HHS)

    Dated: November 4, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2011-29141 Filed 11-9-11; 8:45 am]
BILLING CODE 4140-01-P
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