Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting, 69638-69639 [2012-28162]
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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]
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[FR Doc. 2012–28197 Filed 11–19–12; 8:45 am]
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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]
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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 / Vol. 77, No. 224 / Tuesday, November 20, 2012 / Notices
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 contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel; Contraceptive
Clinical Trail Network: Female Sites.
Date: December 10, 2012.
Time: 8:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: The Holiday Inn Express, 1775
Rockville Pike, Rockville, MD 20852.
Contact Person: David H. Weinberg, 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, Rockville, MD 20852,
301–435–6973, David.Weinberg@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 14, 2012.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–28162 Filed 11–19–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
wreier-aviles on DSK5TPTVN1PROD with
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meetings
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 meetings.
The meetings 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
VerDate Mar<15>2010
15:12 Nov 19, 2012
Jkt 229001
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would constitute a clearly unwarranted
invasion of personal privacy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Partnerships for
Interventions to Treat Chronic, Persistent and
Latent Infections J6.
Date: December 10, 2012.
Time: 10:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6700B
Rockledge Drive, Bethesda, MD 20817
(Telephone Conference Call).
Contact Person: Jane K. Battles, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institutes of Health/NIAID, 6700B
Rockledge Drive, Room 3128, Bethesda, MD
20892–7616, 301–451–2744,
battlesja@mail.nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Partnerships for
Interventions to Treat Chronic, Persistent and
Latent Infections J2.
Date: December 11, 2012.
Time: 10:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6700B
Rockledge Drive, Bethesda, MD 20817,
(Telephone Conference Call).
Contact Person: Jane K. Battles, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institutes of Health/NIAID, 6700B
Rockledge Drive, Room 3128, Bethesda, MD
20892–7616, 301–451–2744,
battlesja@mail.nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Partnerships for
Interventions to Treat Chronic, Persistent and
Latent Infections J4.
Date: December 13, 2012.
Time: 10:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health. 6700B
Rockledge Drive, Bethesda, MD 20817,
(Telephone Conference Call).
Contact Person: Jane K. Battles, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institutes of Health/NIAID, 6700B
Rockledge Drive, Room 3128, Bethesda, MD
20892–7616, 301–451–2744,
battlesja@mail.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)
National Institutes of Health
Dated: November 14, 2012.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
Dated: November 14, 2012.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–28164 Filed 11–19–12; 8:45 am]
[FR Doc. 2012–28166 Filed 11–19–12; 8:45 am]
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National Heart, Lung, and Blood
Institute; Notice of Closed Meetings
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 meetings.
The meetings 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 contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
PETAL Network Clinical Centers.
Date: December 10–11, 2012.
Time: 12:30 p.m. to 10:30 a.m.
Agenda: To review and evaluate contract
proposals.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: William J. Johnson, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7178, Bethesda, MD 20892–7924, 301–435–
0725, johnsonwj@nhlbi.nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
PETAL Network Clinical Coordinating
Center.
Date: December 11, 2012.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: William J Johnson, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7178, Bethesda, MD 20892–7924, 301–435–
0725, johnsonwj@nhlbi.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
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[Federal Register Volume 77, Number 224 (Tuesday, November 20, 2012)]
[Notices]
[Pages 69638-69639]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-28162]
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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
[[Page 69639]]
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 contract proposals and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the contract proposals, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Institute of Child Health and Human
Development Special Emphasis Panel; Contraceptive Clinical Trail
Network: Female Sites.
Date: December 10, 2012.
Time: 8:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate contract proposals.
Place: The Holiday Inn Express, 1775 Rockville Pike, Rockville,
MD 20852.
Contact Person: David H. Weinberg, 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, Rockville, MD 20852, 301-435-6973,
David.Weinberg@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 14, 2012.
Michelle Trout,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2012-28162 Filed 11-19-12; 8:45 am]
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