National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting, 54584 [2012-21751]
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54584
Federal Register / Vol. 77, No. 172 / Wednesday, September 5, 2012 / Notices
MSC 7806, Bethesda, MD 20892, (301) 435–
2037, mackj2@csr.nih.gov.
Name of Committee: Endocrinology,
Metabolism, Nutrition and Reproductive
Sciences, Integrated Review Group,
Molecular and Cellular Endocrinology Study
Section.
Date: October 9, 2012.
Time: 8 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road NW.,
Washington, DC 20015.
Contact Person: John Bleasdale, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6170
MSC 7892, Bethesda, MD 20892, 301–435–
4514, bleasdaleje@csr.nih.gov.
Name of Committee: Integrative,
Functional and Cognitive Neuroscience
Integrated Review Group, Auditory System
Study Section.
Date: October 9, 2012.
Time: 8 a.m. to 6:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: Melrose Hotel, 2430 Pennsylvania
Avenue NW., Washington, DC 20037.
Contact Person: Lynn E Luethke, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5166,
MSC 7844, Bethesda, MD 20892, (301) 806–
3323, luethkel@csr.nih.gov.
Name of Committee: Digestive, Kidney and
Urological Systems Integrated Review Group,
Pathobiology of Kidney Disease Study
Section.
Date: October 9–10, 2012.
Time: 8 a.m. to 6 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: Atul Sahai, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2188,
MSC 7818, Bethesda, MD 20892, 301–435–
1198, sahaia@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Member
Conflict: Cell Biology.
Date: October 9, 2012.
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: Wallace Ip, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5128,
MSC 7840, Bethesda, MD 20892, 301–435–
1191, ipws@mail.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)
VerDate Mar<15>2010
19:14 Sep 04, 2012
Jkt 226001
Dated: August 29, 2012.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–21753 Filed 9–4–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Biomedical
Imaging and Bioengineering; 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 Institute of
Biomedical Imaging and Bioengineering
Special Emphasis Panel, ZEB1 OSR–D(J2) P
Tissue Engineering Resource Center (P41).
Date: November 7–9, 2012.
Time: 6 p.m. to 12 p.m.
Agenda: To review and evaluate grant
applications.
Place: Best Western Hotel III Tria, 220
Alewife Brook Parkway, Cambridge, MA
02138.
Contact Person: John K. Hayes, Ph.D.,
Scientific Review Officer, National Institute
of Biomedical Imaging and Bioengineering,
National Institutes of Health, 6707
Democracy Boulevard, Room 959, Bethesda,
MD 20892, 301–451–3398,
hayesj@mail.nih.gov.
Dated: August 29, 2012.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–21751 Filed 9–4–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Final Action Under the NIH Guidelines
for Research Involving Recombinant
DNA Molecules (NIH Guidelines)
On March 4, 2009, the
National Institutes of Health (NIH)
SUMMARY:
PO 00000
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Fmt 4703
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Office of Biotechnology Activities,
Office of Science Policy (NIH/OBA)
published a proposal in the Federal
Register (74 FR 9411) to revise the NIH
Guidelines in two regards. The first was
to address biosafety considerations for
research with synthetic nucleic acids.
The proposal modified the scope of the
NIH Guidelines specifically to cover
certain basic and clinical research with
nucleic acid molecules created solely by
synthetic means. The second proposed
revision was to modify the criteria for
determining whether an experiment to
introduce drug resistance into a
microorganism must be reviewed by the
Recombinant DNA Advisory Committee
(RAC) and approved by the NIH Director
(as a Major Action under Section III–A–
1–a of the NIH Guidelines). Comments
submitted were discussed at the ‘‘NIH
Public Consultation on Proposed
Changes to the NIH Guidelines for
Synthetic Nucleic Acids’’ on June 23,
2009 (https://oba.od.nih.gov/rdna_rac/
rac_pub_con.html’’.
This notice sets forth final changes to
the NIH Guidelines regarding those two
proposals. The scope of the NIH
Guidelines is being modified to cover
certain classes of basic and clinical
research with synthetic nucleic acids
while exempting others. As discussed
herein, the majority of research with
synthetic nucleic acids that are not
designed to replicate does not raise
significant biosafety concerns that
warrant oversight under the NIH
Guidelines. Because of the modification
of the scope of the NIH Guidelines, the
title of the NIH Guidelines will be
revised from NIH Guidelines for
Research Involving Recombinant DNA
Molecules to NIH Guidelines for
Research Involving Recombinant or
Synthetic Nucleic Acids Molecules.
These changes also clarify the criteria
for determining whether an experiment
to introduce drug resistance into a
microorganism raises sufficient public
health issues to warrant the experiment
being reviewed by the RAC and
approved by the NIH Director under
Section III–A–1–a of the NIH
Guidelines. While the current criteria
for determining whether an experiment
requires review under Section III–A–1–
a are being retained, additional language
is being added regarding the assessment
of whether a drug is therapeutically
useful. In addition, NIH/OBA has
clarified that Institutional Biosafety
Committees (IBCs) can consult with
NIH/OBA regarding a specific
experiment that does not meet the
criteria for review under Section III–A–
1–a but nonetheless raises important
public health issues. Finally, a section
is added to give NIH/OBA the authority
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Agencies
[Federal Register Volume 77, Number 172 (Wednesday, September 5, 2012)]
[Notices]
[Page 54584]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-21751]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering;
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 Institute of Biomedical Imaging and
Bioengineering Special Emphasis Panel, ZEB1 OSR-D(J2) P Tissue
Engineering Resource Center (P41).
Date: November 7-9, 2012.
Time: 6 p.m. to 12 p.m.
Agenda: To review and evaluate grant applications.
Place: Best Western Hotel III Tria, 220 Alewife Brook Parkway,
Cambridge, MA 02138.
Contact Person: John K. Hayes, Ph.D., Scientific Review Officer,
National Institute of Biomedical Imaging and Bioengineering,
National Institutes of Health, 6707 Democracy Boulevard, Room 959,
Bethesda, MD 20892, 301-451-3398, hayesj@mail.nih.gov.
Dated: August 29, 2012.
David Clary,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2012-21751 Filed 9-4-12; 8:45 am]
BILLING CODE 4140-01-P