National Institute of General Medical Sciences; Notice of Closed Meeting, 69638 [2012-28157]
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Federal Register / Vol. 77, No. 224 / Tuesday, November 20, 2012 / Notices
disease and domain-specific therapeutic
area data standards.
On July 9, 2012, President Obama
signed into law the Food and Drug
Administration Safety and Innovation
Act of 2012, which includes the
reauthorization of the Prescription Drug
User Fee Act (PDUFA V). Under section
XII of the PDUFA V performance goals,
FDA agreed to create a plan for distinct
therapeutic area data standards and to
prioritize and develop the data
standards in collaboration with CDISC
and other open standards organizations.
FDA is seeking public comment on the
roadmap and will consider the
comments as the Agency develops its
proposed project plan which is due to
be issued for review and comment by
June 30, 2013. In addition, FDA will
publish notices soliciting input on, and
engagement in, standards development
activities, and will periodically issue
guidances specifying the completed data
standards, formats, and terminologies
that sponsors should use to submit data
in applications.
II. Comments
Interested persons may submit either
written comments regarding the
roadmap, as well as recommendations
on how the therapeutic area data
standards development effort could be
accomplished more rapidly, to the
Division of Dockets Management (see
ADDRESSES) or electronic comments to
https://www.regulations.gov. It is only
necessary to send one set of comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
III. Electronic Access
wreier-aviles on DSK5TPTVN1PROD with
Persons with access to the Internet
may obtain the roadmap at https://
www.fda.gov/Drugs/Development
ApprovalProcess/FormsSubmission
Requirements/ElectronicSubmissions/
ucm287408.htm, https://www.fda.gov/
BiologicsBloodVaccines/
GuidanceCompliance
RegulatoryInformation/default.htm, or
https://www.regulations.gov.
Dated: November 15, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
National Institute of General Medical
Sciences; Notice of Closed Meeting
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; 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
General Medical Sciences Special Emphasis
Panel, Review of Minority Biomedical
Research Support Behavioral Applications.
Date: November 28, 2012.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Natcher Building, 45 Center Drive, Room
3An.18, Bethesda, MD 20892, (Telephone
Conference Call).
Contact Person: Rebecca H. Johnson, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health, 45
Center Drive, Room 3An18C, Bethesda, MD
20892, 301–594–2771,
johnsonrh@nigms.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. 93.375, Minority Biomedical
Research Support; 93.821, Cell Biology and
Biophysics Research; 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.862, Genetics and
Developmental Biology Research; 93.88,
Minority Access to Research Careers; 93.96,
Special Minority Initiatives, National
Institutes of Health, HHS)
Dated: November 14, 2012.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–28157 Filed 11–19–12; 8:45 am]
BILLING CODE 4140–01–P
[FR Doc. 2012–28197 Filed 11–19–12; 8:45 am]
15:12 Nov 19, 2012
Jkt 229001
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel; ‘‘NIH Summer
Research Experience Programs (R25)’’.
Date: December 7, 2012.
Time: 1:30 p.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6100
Executive Boulevard, Rockville, MD 20852,
(Telephone Conference).
Contact Person: Anne Krey, Ph.D.,
Scientific Review Officer, Division of
Scientific Review, Eunice Kennedy Shriver
National Institute of Child Health and
Human Development, NIH, 6100 Executive
Blvd., Room 5B01, Bethesda, MD 20892,
301–435–6908, ak41o@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Dated: November 13, 2012.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–28160 Filed 11–19–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
BILLING CODE 4160–01–P
VerDate Mar<15>2010
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.
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[Federal Register Volume 77, Number 224 (Tuesday, November 20, 2012)]
[Notices]
[Page 69638]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-28157]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of General Medical Sciences; 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 General Medical
Sciences Special Emphasis Panel, Review of Minority Biomedical
Research Support Behavioral Applications.
Date: November 28, 2012.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Natcher Building, 45
Center Drive, Room 3An.18, Bethesda, MD 20892, (Telephone Conference
Call).
Contact Person: Rebecca H. Johnson, Ph.D., Scientific Review
Officer, Office of Scientific Review, National Institute of General
Medical Sciences, National Institutes of Health, 45 Center Drive,
Room 3An18C, Bethesda, MD 20892, 301-594-2771,
johnsonrh@nigms.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. 93.375,
Minority Biomedical Research Support; 93.821, Cell Biology and
Biophysics Research; 93.859, Pharmacology, Physiology, and
Biological Chemistry Research; 93.862, Genetics and Developmental
Biology Research; 93.88, Minority Access to Research Careers; 93.96,
Special Minority Initiatives, National Institutes of Health, HHS)
Dated: November 14, 2012.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2012-28157 Filed 11-19-12; 8:45 am]
BILLING CODE 4140-01-P
