Center for Scientific Review; Notice of Closed Meetings, 51827 [2015-21153]
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Federal Register / Vol. 80, No. 165 / Wednesday, August 26, 2015 / Notices
51827
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
an increase in evidence-based data
about medications used in children.
National Institutes of Health
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Best Pharmaceuticals for Children Act
(BPCA) Priority List of Needs in
Pediatric Therapeutics
Update on BPCA Prioritization
The BPCA requires that the NIH, in
consultation with the Food and Drug
Administration and experts in pediatric
research, identify the drugs and
therapeutic areas of highest priority for
study in pediatric populations. The
NIH’s authority and responsibility
outlined in the BPCA legislation is to
establish a program for pediatric drug
testing and development and to publish
a list of information needs regarding
drugs used to treat children. The drug
development program consists of a
series of clinical trials in various
therapeutic areas, which may be based
on proposed pediatric study requests
(PPSRs) submitted to FDA and/or from
written requests (WR) received from the
FDA. The BPCA Priority List consists of
key therapeutic needs in the medical
treatment of children and adolescents
identified for further study; it is
organized by therapeutic area, which
can be a group of conditions, a subgroup
of the population, or a setting of care.
The first priority list of off-patent drugs
needing further study under the 2002
BPCA legislation was published in
January 2003 in the Federal Register
(FR Vol. 68, No. 13; Tuesday, January
21, 2003: 2789–2790). The most recent
priority list was published August 25,
2014; all Federal Register notices can be
found on the BPCA Web site: https://
bpca.nichd.nih.gov/prioritization/
status.cfm. The BPCA legislation
requires the NIH to update the priority
list every three years. This publication
serves as an update to the BPCA priority
list of needs in pediatric therapeutics.
The Obstetric and Pediatric
Pharmacology and Therapeutics Branch
of the Eunice Kennedy Shriver National
Institute of Child Health and Human
Development (NICHD), NIH, has
developed a prioritization process for
the determination of the needs in
pediatric therapeutics. There are two
main phases: Phase I of the
prioritization process entails identifying
therapeutic areas, which are general
categories of conditions, diseases,
settings of care, or populations with
multiple therapeutic needs. The NICHD
solicits input from experts in pediatric
research, general pediatric and
subspecialty care, organizations focused
on specific conditions, and professional
societies to determine these therapeutic
areas that need further study. Each year,
the NICHD revisits the current list of
needs in pediatric therapeutics,
prioritizes three therapeutic areas of
interests for that calendar year, and
develops working groups in the
rmajette on DSK7SPTVN1PROD 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 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
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel PAR14–262:
Weight and Sleep Outcomes After Bariatric
Surgery.
Date: September 17, 2015.
Time: 2:00 p.m. to 5:00 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: Ellen K Schwartz, EDD.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3144,
MSC 7770, Bethesda, MD 20892, 301–828–
6146, schwarel@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel PAR Panel:
Targeting Temporal Dynamics of the Brain
Activity for the Treatment of Cognitive
Deficits.
Date: September 29, 2015.
Time: 10:30 a.m. to 12:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Wei-Qin Zhao, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5181
MSC 7846, Bethesda, MD 20892–7846, 301–
435–1236, zhaow@csr.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)
Dated: August 21, 2015.
Carolyn Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–21153 Filed 8–25–15; 8:45 am]
BILLING CODE 4140–01–P
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National Institutes of Health,
The Eunice Kennedy Shriver National
Institute of Child Health and Human
Development (NICHD).
ACTION: Notice.
AGENCY:
The National Institutes of
Health (NIH) hereby announces the Best
Pharmaceuticals for Children Act
(BPCA) Priority List of Needs in
Pediatric Therapeutics for 2015. The
Best Pharmaceuticals for Children Act
(BPCA) seeks to improve the level of
information on the safe and effective use
of pharmaceuticals used to treat
children. The BPCA requires that the
NIH identify the drugs of highest
priority for study in pediatric
populations, and publish a list of drugs/
needs in pediatric therapeutics. This
notice fulfills the requirement to
publish that list.
ADDRESSES: All nominations of pediatric
therapeutics for future consideration by
NICHD should be submitted to Dr.
Perdita Taylor-Zapata at taylorpe@
mail.nih.gov.
SUMMARY:
Dr.
Perdita Taylor-Zapata via email at
taylorpe@mail.nih.gov; by phone at
301–496–9584; or by fax at 301–480–
2897.
FOR FURTHER INFORMATION CONTACT:
The
pediatric medical community, the
public health community, and
government agencies have long
recognized multiple gaps in knowledge
regarding the use of therapeutics in
children including the correct dosage,
appropriate indications, side effects,
and safety concerns of pharmaceuticals
in the short- and long term. These gaps
have frequently resulted in inadequate
labeling for pediatric use and in widespread off-label use of prescription
drugs in children. Off-label use of a drug
substantially limits the ability to gain
clinical information of the drug product
such as appropriate dosing of a drug,
changes in drug metabolism and
response during growth and
development, and important short- and
long-term effects.
The NICHD, the Food and Drug
Administration (FDA), other federal
agencies, and various non-profit and
commercial organizations are taking
steps to fill knowledge gaps that exist in
pediatric therapeutics and to promote
SUPPLEMENTARY INFORMATION:
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[Federal Register Volume 80, Number 165 (Wednesday, August 26, 2015)]
[Notices]
[Page 51827]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21153]
[[Page 51827]]
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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. 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 would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: Center for Scientific Review Special Emphasis
Panel PAR14-262: Weight and Sleep Outcomes After Bariatric Surgery.
Date: September 17, 2015.
Time: 2:00 p.m. to 5:00 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: Ellen K Schwartz, EDD., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3144, MSC 7770, Bethesda, MD
20892, 301-828-6146, schwarel@mail.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel PAR Panel: Targeting Temporal Dynamics of the Brain Activity
for the Treatment of Cognitive Deficits.
Date: September 29, 2015.
Time: 10:30 a.m. to 12:30 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892, (Virtual Meeting).
Contact Person: Wei-Qin Zhao, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 5181 MSC 7846, Bethesda, MD 20892-7846, 301-
435-1236, zhaow@csr.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)
Dated: August 21, 2015.
Carolyn Baum,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2015-21153 Filed 8-25-15; 8:45 am]
BILLING CODE 4140-01-P
