Center for Scientific Review; Notice of Closed Meetings, 37333-37334 [2014-15295]
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Federal Register / Vol. 79, No. 126 / Tuesday, July 1, 2014 / Notices
Commissioner, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 3238, Silver Spring,
MD 20993–0002, 301–796–4850.
Dated: June 26, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
SUPPLEMENTARY INFORMATION:
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I. Background
FDA is posting its draft Strategic
Priorities FY 2014–2018 document to
ensure that the public has an
opportunity to comment on this
document.
The purpose of this document is to
outline FDA’s strategic intentions and
plans for the next 4 years. This
document identifies five cross-cutting
strategic priorities and four core mission
goals that will guide efforts to achieve
FDA’s public health mission and to
fulfill its role in supporting the larger
mission and strategic goals of the
Department of Health and Human
Services. The five cross-cutting strategic
priorities are: (1) Regulatory science, (2)
globalization, (3) safety and quality, (4)
smart regulation, and (5) stewardship.
The four core mission goals are: (1)
Enhance oversight of FDA-regulated
products, (2) improve and safeguard
access to FDA-regulated products to
benefit health, (3) promote better
informed decisions about the use of
FDA-regulated products, and (4)
strengthen organizational excellence
and accountability.
For comparison purposes, the current
FDA Strategic Priorities FY 2011–2015
document can be viewed at https://
www.fda.gov/AboutFDA/
ReportsManualsForms/Reports/
ucm227527.htm.
The text of the draft Strategic
Priorities FY 2014–2018 document is
available in a downloadable portable
document format through FDA’s Web
site: https://www.fda.gov/AboutFDA/.
We look forward to receiving your
comments (see DATES).
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II. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). 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.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Library of Medicine; 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.
Name of Committee: National Library of
Medicine Special Emphasis Panel, Conflicts
R01/K99.
Date: July 17, 2014.
Time: 12:00 p.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Library of Medicine, 6705
Rockledge Drive, Suite 301Bethesda, MD
20817, (Telephone Conference Call).
Contact Person: Zoe E. Huang, MD,
Scientific Review Officer, Extramural
Programs, National Library of Medicine, NIH,
6705 Rockledge Drive, Suite 301, Bethesda,
MD 20892–7968, 301–594–4937, huangz@
mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program No. 93.879, Medical Library
Assistance, National Institutes of Health,
HHS).
Dated: June 24, 2014.
Michelle Trout,
Program Analyst, Office of the Federal
Advisory Committee Policy.
[FR Doc. 2014–15297 Filed 6–30–14; 8:45 am]
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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
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37333
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; Population
Sciences and Epidemiology.
Date: July 10, 2014.
Time: 11:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Julia Krushkal, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3148,
MSC 7770, Bethesda, MD 20892, 301–435–
1782, krushkalj@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.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; AREA:
Cardiovascular and Respiratory Sciences.
Date: July 21–22, 2014.
Time: 9:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 4136, 6701 Rockledge Drive,
Bethesda, MD 20892, (Virtual Meeting).
Contact Person: Sara Ahlgren, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Rm. 4136,
Bethesda, MD 20892, 301–435–0904,
sara.ahlgren@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Autoimmune Diseases, Regulatory
T-cells and Transplantation.
Date: July 21, 2014.
Time: 3:00 p.m. to 7:00 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: Betty Hayden, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4206,
MSC 7812, Bethesda, MD 20892, 301–435–
1223, haydenb@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Academic
Research Enhancement: Healthcare Delivery
and Methodologies.
Date: July 22, 2014.
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37334
Federal Register / Vol. 79, No. 126 / Tuesday, July 1, 2014 / Notices
Time: 10:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
Contact Person: Ping Wu, Ph.D., Scientific
Review Officer, HDM IRG, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3166,
Bethesda, MD 20892, 301–615–7401, wup4@
csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; HIV/AIDS
Innovative Research Applications.
Date: July 23–24, 2014.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Kenneth A. Roebuck,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5106,
MSC 7852, Bethesda, MD 20892, (301) 435–
1166, roebuckk@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflicts: Continuous Submissions:
Respiratory Diseases.
Date: July 24–25, 2014.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Yuanna Cheng, MD, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4138,
MSC 7814, Bethesda, MD 20892, (301) 435–
1195, Chengy5@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Urology and Nephrology.
Date: July 24, 2014.
Time: 1:00 p.m. to 3:00 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: Patricia Greenwel, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2178,
MSC 7818, Bethesda, MD 20892, 301–435–
1169, greenwep@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: June 23, 2014.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Amended Notice of
Meeting
Announcement of Workshops for the
Development of New Antibacterial
Products
Notice is hereby given of a change in
the meeting of the National Institute of
Child Health and Human Development
Special Emphasis Panel, June 17, 2014,
08:30 a.m. to June 17, 2014, 12:00 p.m.,
Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD,
20814 which was published in the
Federal Register on May 19, 2014, 79
FR 28740.
The meeting notice is amended to
change the date of the ZHD1 Special
Emphasis Panel meeting from June 17,
2014 to July 8, 2014. The meeting will
now be a telephone conference call and
will be closed to the public.
Dated: June 25, 2014.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–15299 Filed 6–30–14; 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; Cancellation of Meeting
Notice is hereby given of the
cancellation of the National Children’s
Study Advisory Committee, July 11,
2014, 9:00 a.m. to July 11, 2014, 4:45
p.m., National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 which
was published in the Federal Register
on June 16, 2014, 79 FR 34332.
The meeting of the National
Children’s Study Advisory Committee is
cancelled for July 11, 2014, 9:00 a.m. to
4:45 p.m.
Dated: June 24, 2014.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–15296 Filed 6–30–14; 8:45 am]
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National Institutes of Health,
Department of Health and Human
Services.
ACTION: Notice of Public Workshop.
AGENCY:
The National Institutes of
Health (NIH), Office of the Director,
Office of Science Policy, and the Food
and Drug Administration (FDA), Office
of the Commissioner, are announcing a
public workshop titled ‘‘The
Development of New Antibacterial
Products: Charting a Course for the
Future.’’ The workshop is being held to:
(1) Examine key issues and challenges
related to antibacterial product
development, (2) discuss regulatory
pathways for bringing new antibacterial
drugs to market, (3) identify strategies
for promoting clinical trials for
antibacterial drugs, and (4) encourage
partnerships to accelerate the
development of new antibacterial drugs.
The workshop is open to the public and
is free of charge.
DATES: The workshop will be held on
July 30 and 31, 2014, from 8:00 a.m. to
5:15 p.m. and from 8:00 a.m. to 1:00
p.m., respectively. The registration
deadline is July 14, 2014.
ADDRESSES: The workshop will be held
at the Bethesda North Marriott Hotel
and Conference Center, 5701 Marinelli
Road, North Bethesda, Maryland 20852.
FOR FURTHER INFORMATION CONTACT:
Kelly Fennington, NIH, Office of
Science Policy, 6705 Rockledge Drive,
Room 750, Bethesda, MD 20892–7985;
301–496–9838; email: FenningK@
mail.nih.gov.
SUMMARY:
Specific
issues to be discussed at this workshop
include: (1) Priorities and strategic
approaches to conducting clinical trials
for antibacterial drugs; (2) regulatory
pathways, including streamlined
programs for the development of
antibacterial drugs for patients with
limited or no treatment options; (3)
clinical trial design, including the
development of a common clinical
protocol, use of common control groups,
statistical design, data sharing across
trial, clinical trial endpoints, and
lessons learned from other therapeutic
areas; and (4) the role of public-private
partnerships in advancing the
development of antibacterial drugs.
Participants will include individuals
SUPPLEMENTARY INFORMATION:
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Agencies
[Federal Register Volume 79, Number 126 (Tuesday, July 1, 2014)]
[Notices]
[Pages 37333-37334]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-15295]
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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; Population Sciences and Epidemiology.
Date: July 10, 2014.
Time: 11:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892, (Virtual Meeting).
Contact Person: Julia Krushkal, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3148, MSC 7770, Bethesda, MD
20892, 301-435-1782, krushkalj@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.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; AREA: Cardiovascular and Respiratory Sciences.
Date: July 21-22, 2014.
Time: 9:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 4136, 6701
Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting).
Contact Person: Sara Ahlgren, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Rm. 4136, Bethesda, MD 20892, 301-435-0904,
sara.ahlgren@nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Autoimmune Diseases, Regulatory T-cells and
Transplantation.
Date: July 21, 2014.
Time: 3:00 p.m. to 7:00 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: Betty Hayden, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 4206, MSC 7812, Bethesda, MD 20892, 301-435-
1223, haydenb@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Academic Research Enhancement: Healthcare Delivery and
Methodologies.
Date: July 22, 2014.
[[Page 37334]]
Time: 10:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892.
Contact Person: Ping Wu, Ph.D., Scientific Review Officer, HDM
IRG, Center for Scientific Review, National Institutes of Health,
6701 Rockledge Drive, Room 3166, Bethesda, MD 20892, 301-615-7401,
wup4@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; HIV/AIDS Innovative Research Applications.
Date: July 23-24, 2014.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892, (Virtual Meeting).
Contact Person: Kenneth A. Roebuck, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5106, MSC 7852, Bethesda, MD
20892, (301) 435-1166, roebuckk@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflicts: Continuous Submissions: Respiratory
Diseases.
Date: July 24-25, 2014.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892, (Virtual Meeting).
Contact Person: Yuanna Cheng, MD, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4138, MSC 7814, Bethesda, MD
20892, (301) 435-1195, Chengy5@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Urology and Nephrology.
Date: July 24, 2014.
Time: 1:00 p.m. to 3:00 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: Patricia Greenwel, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2178, MSC 7818, Bethesda, MD
20892, 301-435-1169, greenwep@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: June 23, 2014.
Michelle Trout,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2014-15295 Filed 6-30-14; 8:45 am]
BILLING CODE 4140-01-P