Center for Scientific Review; Notice of Closed Meeting, 18229-18230 [2011-7818]
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Federal Register / Vol. 76, No. 63 / Friday, April 1, 2011 / Notices
over the last year in refining the
prioritization process. These include the
need for more preliminary information
on candidate drugs (for example,
information on frequency of use and
frequency of condition) as well as expert
input, a better approach for mass
outreach, enhancement of NIH
interagency collaborations, and
improvement in the overall
prioritization process.
The revised process includes:
• A Well-defined process, using a
systematic approach with clear
objectives and outcomes;
• Well-defined objective criteria that
are mutually exclusive and of a
manageable number;
• A dynamic process, including
transparency, stakeholder input, and
leadership; and
• Expert involvement to inform and
contribute to the process.
For 2010, NIH solicited nominations
for the BPCA Priority List of Needs in
Pediatric Therapeutics through a
‘‘Request for Information’’ (RFI)
announcement as part of NIH’s
authority and responsibility to establish
the program for pediatric drug testing
and development outlined in the BPCA
legislation. The BPCA Priority List
consists of key therapeutic needs in the
medical treatment of children and
adolescents. The list is organized by
Therapeutic Area, which can be a group
of conditions, a subgroup of the
population, or a setting of care. Each
calendar year, a few Therapeutic Areas
are selected for discussion and further
prioritization. Below is a summary of
the revised BPCA prioritization process:
• In early 2010, the RFI was issued to
solicit nominations for future studies of
pediatric therapeutics under the BPCA.
• The Obstetric and Pediatric
Pharmacology Branch of the NICHD
received 107 nominations, 67 of which
met the criteria for review.
• All nominations were reviewed and
evaluated on six key criteria, as follows:
• Relevance to BPCA Mission and
Goals
• No disqualifying ethical concerns
• Evidence: consideration of the level
of evidence available and current gaps
• Impact: potential effect on children,
society, and delivery of care
• Population: consideration of the
different populations that may benefit
from the research
• Feasibility: consideration of the
resources available to conduct the study
• Twenty-two volunteer health
professional evaluators scored the 67
nominations according to evidence,
impact, and the pediatric population
affected. Each nomination was reviewed
by a panel of three evaluators.
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• Therapeutic Area working groups
(several Therapeutic Areas are
determined annually) were developed
and met through the 2010 year to
discuss the gaps in knowledge in the
therapeutic approaches to diseases in
gastroenterology, endocrinology, and
neurology.
• Minutes of all working group
meetings conducted under the BPCA
can be found on the BPCA Web site,
https://bpca.nichd.nih.gov.
• As a final step in the process, the
NICHD, with input from the FDA,
ranked the nominations based on the
evaluators’ scores, quality and quantity
of existing studies, and feasibility of the
proposed study. The result was a tiered
list of nominations considered for
listing. Tier One represents the highest
percentage of scores: nominations of
interest to the NICHD for prioritization.
Tier Two represents the average
percentage of scores: nominations of
possible interest to the NICHD at a later
time. Tier Three represents the lowest
percentage of scores: Nominations of
least interest to the NICHD at this time
for prioritization.
The NICHD sponsored the annual
BPCA prioritization meeting, held
November 9–10, 2010, with
stakeholders from the NIH, the FDA, the
American Academy of Pediatrics, other
pediatric organizations and societies,
and patient advocates. The meeting
allowed the NICHD to review the
present progress from ongoing research
and to discuss the proposed Therapeutic
Areas from the 2010 nominations to be
prioritized for future study under the
BPCA and added to the existing BPCA
priority list.
Below is an updated list of
Therapeutic Areas and drugs that have
been prioritized for study since the
inception of the BPCA. It includes new
areas of prioritization from Tier One
nominations of the 2010 outreach and a
summary of the NICHD’s plans and
progress in all these areas.
Priority List of Needs in Pediatric
Therapeutics 2011
In accordance with the BPCA
legislation, the list outlines priority
needs in pediatric therapeutics for
multiple Therapeutic Areas listed
below. The priority list can be found on
the BPCA Web site at the following
address: https://bpca.nichd.nih.gov
• Table 1: Infectious Disease
Priorities
• Table 2: Cardiovascular Disease
Priorities
• Table 3: Respiratory Disease
Priorities
• Table 4: Intensive Care Priorities
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18229
• Table 5: Bio-defense Research
Priorities
• Table 6: Pediatric Cancer Priorities
• Table 7: Psychiatric Disorder
Priorities
• Table 8: Neurological Disease
Priorities
• Table 9: Neonatal Research
Priorities
• Table 10: Adolescent Research
Priorities
• Table 11: Hematologic Disease
Priorities
• Table 12: Endocrine Disease
Priorities and Diseases with Limited
Alternative Therapies
• Table 13: Dermatologic Disease
Priorities
• Table 14: Gastrointestinal Disease
Priorities
• Table 15: Renal Disease Priorities
• Table 16: Rheumatologic Disease
Priorities
• Table 17: Special Considerations
FOR FURTHER INFORMATION CONTACT: Dr.
Perdita Taylor-Zapata via e-mail at
taylorpe@mail.nih.gov or by telephone
at 301–496–9584 (not a toll-free
number).
Dated: March 24, 2011.
Francis S. Collins,
Director, National Institutes of Health.
[FR Doc. 2011–7673 Filed 3–31–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; 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: Center for Scientific
Review Special Emphasis Panel; Cell
Signaling and Guidance.
Date: April 7–11, 2011.
Time: 10 a.m. to 11 a.m.
Agenda: To review and evaluate grant
applications.
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18230
Federal Register / Vol. 76, No. 63 / Friday, April 1, 2011 / Notices
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Joanne T Fujii, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4184,
MSC 7850, Bethesda, MD 20892, (301) 435–
1178, fujiij@csr.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. 93.306, 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: March 28, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–7818 Filed 3–31–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meetings
mstockstill on DSKH9S0YB1PROD 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: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Loan Repayment Program.
Date: April 25–29, 2011.
Time: 8 a.m. to 5 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: Nancy Lewis Ernst, PhD,
Scientific Review Official, 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.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
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Emphasis Panel; Targeted Clinical Research
to Address Select Viral Infections.
Date: April 25–26, 2011.
Time: 8 p.m. to 6 p.m.
Agenda: To review and evaluate contract
proposals.
Place: Crowne Plaza Hotel—Silver Spring,
8777 Georgia Avenue, Silver Spring, MD
20910.
Contact Person: Eleazar Cohen, PhD,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institutes of Health, NIAID, 6700 B
Rockledge Drive, Room 3129, Bethesda, MD
20892, 301–435–3564, ec17w@nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Immune Response to
Infection Meeting I.
Date: April 25–26, 2011.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel &
Conference Center, 5701 Marinelli Road,
Bethesda, MD 20852.
Contact Person: Quirijn Vos, PhD,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
NIH/NIAID/DHHS, 6700B Rockledge Drive,
MSC 7616, Bethesda, MD 20892, 301–451–
2666, qvos@niaid.nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Immune Response to
Infection Meeting II.
Date: April 26, 2011.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel &
Conference Center, 5701 Marinelli Road,
Bethesda, MD 20852.
Contact Person: Quirijn Vos, PhD,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
NIH/NIAID/DHHS, 6700B Rockledge Drive,
MSC 7616, Bethesda, MD 20892, 301–451–
2666, qvos@niaid.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: March 28, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–7817 Filed 3–31–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
PO 00000
Frm 00087
Fmt 4703
Sfmt 4703
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
Allergy and Infectious Diseases Special
Emphasis Panel; ‘‘HIV Vaccine Design’’.
Date: April 27, 2011.
Time: 1 p.m. to 4 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: Raymond R. Schleef, PhD,
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) 451–3679,
schleefrr@niaid.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: March 28, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–7816 Filed 3–31–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; 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 materials,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
E:\FR\FM\01APN1.SGM
01APN1
]]>Agencies
[Federal Register Volume 76, Number 63 (Friday, April 1, 2011)]
[Notices]
[Pages 18229-18230]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-7818]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; 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: Center for Scientific Review Special Emphasis
Panel; Cell Signaling and Guidance.
Date: April 7-11, 2011.
Time: 10 a.m. to 11 a.m.
Agenda: To review and evaluate grant applications.
[[Page 18230]]
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Joanne T Fujii, PhD, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 4184, MSC 7850, Bethesda, MD 20892, (301) 435-
1178, fujiij@csr.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. 93.306,
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: March 28, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2011-7818 Filed 3-31-11; 8:45 am]
BILLING CODE 4140-01-P
