Center for Scientific Review; Notice of Closed Meeting, 77039 [E8-29882]

Download as PDF Federal Register / Vol. 73, No. 244 / Thursday, December 18, 2008 / Notices 8. Healthy People 2010 PHS is committed to achieving the health promotion and disease prevention objectives of ‘‘Healthy People 2010,’’ a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of ‘‘Healthy People 2010’’ at http://www.health.gov/healthypeople. 9. Smoke-Free Workplace PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103–227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. mstockstill on PROD1PC66 with NOTICES 10. Authority and Regulation This program is not subject to the intergovernmental review requirements of Executive Order 12372. FDA’s research program is described in the Catalog of Federal Domestic Assistance (CFDA), No. 93.103 http:// www.cfda.gov/. FDA will support the clinical studies covered by this notice under the authority of section 301 of the PHS Act as amended (42 U.S.C. 241) and under applicable regulations at 42 CFR part 52 and 45 CFR parts 74 and 92. All grant awards are subject to applicable requirements for clinical investigations imposed by sections 505, 512, and 515 of the Federal Food, Drug, and Cosmetic Act or safety, purity, and potency for licensing under section 351 of the PHS Act, including regulations issued under any of these sections. All human subject research regulated by FDA is also subject to FDA’s regulations regarding the protection of human subjects (21 CFR parts 50 and 56). Applicants are encouraged to review the regulations, guidance, and information sheets on human subject protection and Good Clinical Practice available on the Internet at http:// www.fda.gov/oc/gcp/. The applicant is referred to HHS regulations at 45 CFR 46.116 and 21 CFR 50.25 for details regarding the required elements of informed consent. All awards will be subject to all policies and requirements that govern the research grant programs of the PHS as incorporated in the HHS Grants Policy Statement, dated January 1, 2007, VerDate Aug<31>2005 17:51 Dec 17, 2008 Jkt 217001 77039 (http://www.hhs.gov/grantsnet/adminis/ gpd/index.htm). DEPARTMENT OF HEALTH AND HUMAN SERVICES 11. Human Subjects Protection National Institutes of Health Federal regulations (45 CFR part 46) require that applications and proposals involving human subjects must be evaluated with reference to: (1) The risks to the subjects, (2) the adequacy of protection against these risks, (3) the potential benefits of the research to the subjects and others, and (4) the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/ humansubjects/guidance/45cfr46.htm). Center for Scientific Review; Notice of Closed Meeting 12. Human Embryonic Stem Cell Research and Cloning Section 498 of the PHS Act places certain restrictions on human fetal research.In addition, under currently applicable executive orders, HHS funds may not be used to support human embryo research under any extramural award instrument. HHS funds may not be used for the creation of a human embryo for research purposes or for research in which a human embryo is destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.204 and 46.207 and subsection 498(b) of the PHS Act (42 U.S.C. 289g(b)). The term ‘‘human embryo’’ includes any organism not protected as a human subject under 45 CFR part 46, as of the date of enactment of the governing appropriations act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells. In addition, HHS is prohibited, by a March 4, 1997, Presidential memorandum, from using Federal funds for cloning human beings. In implementing this program, FDA will comply with all applicable statutes, regulations, presidential memoranda and Executive orders. Criteria for Federal funding of research on hESCs can be found at: http://www.hhs.gov/faq/research/ stemcell/r-0006.html and http:// stemcells.nih.gov/research/registry/ eligibilityCriteria.asp. Dated: December 9, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–30061 Filed 12–17–08; 8:45 am] Frm 00040 Fmt 4703 Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Behavior and Health. Date: December 19, 2008. Time: 10 a.m. to 12 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: Gayle M. Boyd, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3141, MSC 7808, Bethesda, MD 20892, 301–451– 9956, gboyd@mail.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. (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: December 9, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E8–29882 Filed 12–17–08; 8:45 am] BILLING CODE 4140–01–M 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 BILLING CODE 4160–01–S PO 00000 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. Sfmt 4703 E:\FR\FM\18DEN1.SGM 18DEN1

Agencies

[Federal Register Volume 73, Number 244 (Thursday, December 18, 2008)]
[Notices]
[Page 77039]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-29882]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Center for Scientific Review; 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: Center for Scientific Review Special Emphasis 
Panel; Member Conflict: Behavior and Health.
    Date: December 19, 2008.
    Time: 10 a.m. to 12 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: Gayle M. Boyd, PhD, Scientific Review Officer, 
Center for Scientific Review, National Institutes of Health, 6701 
Rockledge Drive, Room 3141, MSC 7808, Bethesda, MD 20892, 301-451-
9956, gboyd@mail.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.

(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: December 9, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. E8-29882 Filed 12-17-08; 8:45 am]
BILLING CODE 4140-01-M