Center for Scientific Review; Notice of Closed Meetings, 64007 [2015-26774]
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Federal Register / Vol. 80, No. 204 / Thursday, October 22, 2015 / Notices
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Selection of the Appropriate
Package Type Terms and
Recommendations for Labeling
Injectable Medical Products Packaged in
Multiple-Dose, Single-Dose, and SinglePatient-Use Containers for Human Use.’’
It does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
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II. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/default.htm or
https://www.regulations.gov.
III. The Paperwork Reduction Act of
1995
This guidance refers to previously
approved collections of information that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information discussed in this draft
guidance have been approved under
OMB under the following control
numbers: OMB control number 0910–
0001 for NDAs, ANDAs, supplements to
NDAs and ANDAs, and annual reports;
OMB control number 0910–0572 for
prescription drug product labeling;
OMB control number 0910–0338 for
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0120 for premarket notifications
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0231 for premarket approval
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number 0910–0485 for medical device
labeling; and OMB control number
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single-use devices. Relevant to this
collection of information, FDA
published its proposed rule on the
electronic distribution of prescribing
information for human prescription
drugs, including biological products in
the Federal Register of December 18,
2014 (79 FR 75506). In Section VII,
‘‘Paperwork Reduction Act of 1995,’’
FDA estimated the burden to design,
test, and produce the label for a drug
product’s immediate container and
outer container or package, as set forth
in 21 CFR part 201, including
§ 201.100(b) and other sections in
subpart A and subpart B.
VerDate Sep<11>2014
18:05 Oct 21, 2015
Jkt 238001
Dated: October 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–26849 Filed 10–21–15; 8:45 am]
BILLING CODE 4164–01–P
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; Program
Project: Molecular structure, dynamics, and
mechanism of key membrane transporters
and enzymes in cellular metabolism.
Date: November 17–18, 2015.
Time: 7:00 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: Kathryn M. Koeller, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4166,
MSC 7806, Bethesda, MD 20892, 301–435–
2681, koellerk@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR13–189:
Imaging and Biomarkers for Early Cancer
Detection.
Date: November 17, 2015.
Time: 10:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Chiayeng Wang, Ph.D.,
Scientific Review Officer. Center for
Scientific Review. 6701 Rockledge Drive,
Room 5213, MSC 7852, Bethesda, MD 20892,
301–435–2397, chiayeng.wang@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR–14–
092: Bioengineering Research Partnerships
(BRP).
Date: November 17, 2015.
Time: 11:00 a.m. to 5:00 p.m.
PO 00000
Frm 00051
Fmt 4703
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64007
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Mehrdad Mohseni, MD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5211,
MSC 7854, Bethesda, MD 20892, 301–435–
0484, mohsenim@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; AREA grant
applications: Toxicology and Digestive,
Kidney and Urological Systems.
Date: November 17, 2015.
Time: 11:30 a.m. to 2:00 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.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Skeletal Muscle.
Date: November 17, 2015.
Time: 1:00 p.m. to 4:00 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: Richard Ingraham, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4116,
MSC 7814, Bethesda, MD 20892, 301–496–
8551, ingrahamrh@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Program
Projects: New Modalities for the Treatment of
Pain and Drug Abuse.
Date: November 17, 2015.
Time: 1:00 p.m. to 4:00 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: Geoffrey G. Schofield,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4040–A,
MSC 7850, Bethesda, MD 20892, 301–435–
1235, geoffreys@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: October 16, 2015.
Anna Snouffer,
Deputy Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–26774 Filed 10–21–15; 8:45 am]
BILLING CODE 4140–01–P
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[Federal Register Volume 80, Number 204 (Thursday, October 22, 2015)]
[Notices]
[Page 64007]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-26774]
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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; Program Project: Molecular structure, dynamics, and mechanism
of key membrane transporters and enzymes in cellular metabolism.
Date: November 17-18, 2015.
Time: 7:00 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: Kathryn M. Koeller, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4166, MSC 7806, Bethesda, MD
20892, 301-435-2681, koellerk@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; PAR13-189: Imaging and Biomarkers for Early Cancer Detection.
Date: November 17, 2015.
Time: 10:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892, (Virtual Meeting).
Contact Person: Chiayeng Wang, Ph.D., Scientific Review Officer.
Center for Scientific Review. 6701 Rockledge Drive, Room 5213, MSC
7852, Bethesda, MD 20892, 301-435-2397, chiayeng.wang@nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; PAR-14-092: Bioengineering Research Partnerships (BRP).
Date: November 17, 2015.
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: Mehrdad Mohseni, MD, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 5211, MSC 7854, Bethesda, MD 20892, 301-435-
0484, mohsenim@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; AREA grant applications: Toxicology and Digestive, Kidney and
Urological Systems.
Date: November 17, 2015.
Time: 11:30 a.m. to 2:00 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.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Small Business: Skeletal Muscle.
Date: November 17, 2015.
Time: 1:00 p.m. to 4:00 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: Richard Ingraham, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4116, MSC 7814, Bethesda, MD
20892, 301-496-8551, ingrahamrh@mail.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Program Projects: New Modalities for the Treatment of Pain
and Drug Abuse.
Date: November 17, 2015.
Time: 1:00 p.m. to 4:00 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: Geoffrey G. Schofield, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4040-A, MSC 7850, Bethesda, MD
20892, 301-435-1235, geoffreys@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: October 16, 2015.
Anna Snouffer,
Deputy Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2015-26774 Filed 10-21-15; 8:45 am]
BILLING CODE 4140-01-P
