National Institute on Aging; Notice of Closed Meeting, 27977 [2013-11209]
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Federal Register / Vol. 78, No. 92 / Monday, May 13, 2013 / Notices
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Nancy Lewis Ernst, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institutes of Health/NIAID, 6700B
Rockledge Drive, MSC 7616, Bethesda, MD
20892–7616, 301–451–7383,
nancy.ernst@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: May 7, 2013.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–11210 Filed 5–10–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meeting
tkelley on DSK3SPTVN1PROD 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 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 on
Aging Initial Review Group; Behavior and
Social Science of Aging Review Committee
NIA–S.
Date: June 12–13, 2013.
Time: 4:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Courtyard Long Beach Downtown,
500 East First Street, Long Beach, CA 90802.
Contact Person: Rebecca Jo Ferrell, Ph.D.,
Scientific Review Branch, National Institute
on Aging, Gateway Building, 7201 Wisconsin
Avenue, Suite 2C212, Bethesda, MD 20892,
301–402–7703, rebecca.ferrell@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
VerDate Mar<15>2010
16:13 May 10, 2013
Jkt 229001
Dated: May 6, 2013.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–11209 Filed 5–10–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of Biotechnology Activities;
Recombinant DNA Research:
Proposed Actions Under the NIH
Guidelines for Research Involving
Recombinant or Synthetic Nucleic Acid
Molecules (NIH Guidelines)
SUMMARY: The NIH Office of
Biotechnology Activities (NIH OBA)
proposes to revise the NIH Guidelines
for Research Involving Recombinant or
Synthetic Nucleic Acid Molecules (NIH
Guidelines) to streamline review of
certain human gene transfer trials that
present a low biosafety risk.
Specifically, the NIH OBA proposes to
remove the requirement that
institutional biosafety committees (IBCs)
review and approve certain human gene
transfer clinical trials that use plasmids
and certain attenuated, non-integrating
viral vectors, provided the clinical trial
follows an initial study in humans that
was previously approved by an IBC
registered with the OBA. This initial
trial will have established the safety of
the proposed dose of the gene transfer
product (vector and transgene) in a
comparable population (adults or
children). The initial study should have
been conducted in the same country as
the proposed study to control for
potential variability in infectious
disease backgrounds of the participants.
An initial IBC review is important to
evaluate the safety of the product and to
set standards for administration;
however, for well-characterized vectors,
in the absence of any unexpected
toxicities in the initial study,
subsequent biosafety assessments may
not provide any additional information.
While a single IBC review does not pose
an undue burden, as the gene transfer
field advances and more Phase II and
Phase III multisite trials are developed,
the time, effort and expense associated
with multiple IBC reviews can be
significant without adding
commensurate value in the form of
additional recommendations to protect
the health and safety of the subject,
health care worker, and community.
IBCs play a critical role in the
evaluation of new products and their
review can inform other oversight
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27977
bodies, such as Institutional Review
Boards. However, given the competing
demands on IBCs, this change will
provide IBCs with the option of focusing
their efforts on those clinical trials
where review will be most productive.
While IBCs will no longer be required to
review all clinical trials using the same
product, each institution can implement
its own policies regarding the need to
review such trials and the information
that a principal investigator (PI) should
submit regarding the safety of the
previous trial. For example, an
institution may designate the Biological
Safety Officer and the IBC Chair to
review data from the initial trial and
determine whether a subsequent trial
using the same agent meets the
exemption criteria outlined herein. The
institution may also set its own policies
regarding the need for the PI to inform
the IBC about enrollment, any relevant
new biosafety findings, and completion
of the trial.
This policy will only exempt human
gene transfer clinical trials from IBC
review under Section III–C–1. It does
not apply to basic, nonclinical research.
In addition, it does not create an
exemption from registration of the trial
with the NIH OBA or the Recombinant
DNA Advisory Committee (RAC) review
and reporting requirements. By
continuing to require registration and
reporting on these trials, the NIH OBA
will be able to continue to monitor
adverse events or incident reports of
accidental exposures by health care
workers delivering these agents and, if
necessary, provide information
regarding these events to investigators,
IBCs, and the public. The NIH OBA will
also be able to assess whether this
change in policy has any adverse impact
on the biosafety of gene transfer trials.
DATES: All comments should be
submitted by June 12, 2013.
ADDRESSES: Comments may be
submitted to the NIH OBA by email at
oba@od.nih.gov; by fax to 301–496–
9839; or by mail to the NIH Office of
Biotechnology Activities, National
Institutes of Health, 6705 Rockledge
Drive, Suite 750, Bethesda, MD 20892–
7985. All written comments received in
response to this notice will be available
for public inspection in the NIH Office
of Biotechnology Activities, 6705
Rockledge Drive, Suite 750, Bethesda,
Maryland, weekdays between the hours
of 8:30 a.m. and 5:00 p.m.
FOR FURTHER INFORMATION CONTACT: If
you have questions, or require
additional information about these
proposed changes, please contact the
NIH OBA by email at oba@od.nih.gov or
telephone at 301–496–9838. Comments
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[Federal Register Volume 78, Number 92 (Monday, May 13, 2013)]
[Notices]
[Page 27977]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-11209]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute on Aging; 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 on Aging Initial Review
Group; Behavior and Social Science of Aging Review Committee NIA-S.
Date: June 12-13, 2013.
Time: 4:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Courtyard Long Beach Downtown, 500 East First Street,
Long Beach, CA 90802.
Contact Person: Rebecca Jo Ferrell, Ph.D., Scientific Review
Branch, National Institute on Aging, Gateway Building, 7201
Wisconsin Avenue, Suite 2C212, Bethesda, MD 20892, 301-402-7703,
rebecca.ferrell@nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging
Research, National Institutes of Health, HHS)
Dated: May 6, 2013.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2013-11209 Filed 5-10-13; 8:45 am]
BILLING CODE 4140-01-P
