Center for Scientific Review; Notice of Closed Meeting, 77039 [E8-29882]
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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 https://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 https://
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 https://
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
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77039
(https://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 (https://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:
https://www.hhs.gov/faq/research/
stemcell/r-0006.html and https://
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]
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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.
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[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
