Center for Scientific Review; Notice of Closed Meetings, 57114-57115 [2014-22660]
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Federal Register / Vol. 79, No. 185 / Wednesday, September 24, 2014 / Notices
Submit written requests for
single copies of the guidance to the
Communications Staff (HFV–12), Center
for Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your request. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Marilyn Martinez, Center for Veterinary
Medicine (HFV–100), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–0635,
Marilyn.Martinez@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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ADDRESSES:
I. Background
FDA is announcing the availability of
a draft guidance for industry (GFI #224)
entitled ‘‘Draft Guidance for Industry,
Bioequivalence: Blood Level
Bioequivalence Study’’ (VICH GL52). In
recent years, many important initiatives
have been undertaken by regulatory
authorities and industry associations to
promote the international
harmonization of regulatory
requirements. FDA has participated in
efforts to enhance harmonization and
has expressed its commitment to seek
scientifically based harmonized
technical procedures for the
development of pharmaceutical
products. One of the goals of
harmonization is to identify and then
reduce differences in technical
requirements for drug development
among regulatory agencies in different
countries.
FDA has actively participated in the
International Conference on
Harmonisation of Technical
Requirements for Registration of
Pharmaceuticals for Human Use for
several years to develop harmonized
technical requirements for the approval
of human pharmaceutical and biological
products among the European Union,
Japan, and the United States. The VICH
is a parallel initiative for veterinary
medicinal products. The VICH is
concerned with developing harmonized
technical requirements for the approval
of veterinary medicinal products in the
European Union, Japan, and the United
States, and includes input from both
regulatory and industry representatives.
The VICH Steering Committee is
composed of member representatives
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from the European Commission;
European Medicines Evaluation Agency;
European Federation of Animal Health;
Committee on Veterinary Medicinal
Products; FDA; U.S. Department of
Agriculture; the Animal Health
Institute; the Japanese Veterinary
Pharmaceutical Association; the
Japanese Association of Veterinary
Biologics; and the Japanese Ministry of
Agriculture, Forestry, and Fisheries.
Six observers are eligible to
participate in the VICH Steering
Committee: One representative from the
government of Australia/New Zealand,
one representative from the industry in
Australia/New Zealand, one
representative from the government of
Canada, one representative from the
industry of Canada, one representative
from the government of South Africa,
and one representative from the
industry of South Africa. The VICH
Secretariat, which coordinates the
preparation of documentation, is
provided by the International
Federation for Animal Health (IFAH).
An IFAH representative also
participates in the VICH Steering
Committee meetings.
II. Draft Guidance on Bioequivalence:
Blood Level Bioequivalence Study
The VICH Steering Committee held a
meeting in November 2013 and agreed
that the draft guidance document
entitled ‘‘Draft Guidance for Industry,
Bioequivalence: Blood Level
Bioequivalence Study’’ (VICH GL52)
should be made available for public
comment. This draft VICH guidance
document is intended to harmonize the
data recommendations associated with
in vivo blood level BE for veterinary
pharmaceutical products. To meet this
objective, the draft guidance addresses
the following topics: A harmonized
definition of BE, factors/variables that
should be considered when developing
scientifically sound blood level BE
study designs, and information that
should be included in a blood level BE
study report.
FDA and the VICH Expert Working
Group will consider comments about
the draft guidance document.
III. Significance of Guidance
This draft guidance, developed under
the VICH process, has been revised to
conform to FDA’s good guidance
practices regulation (21 CFR 10.115).
For example, the document has been
designated ‘‘guidance’’ rather than
‘‘guideline.’’ In addition, guidance
documents must not include mandatory
language such as ‘‘shall,’’ ‘‘must,’’
‘‘require,’’ or ‘‘requirement,’’ unless
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FDA is using these words to describe a
statutory or regulatory requirement.
The draft guidance, when finalized,
will represent the Agency’s current
thinking on this topic. It does not create
or confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of applicable statutes and
regulations.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Action of
1995 (44 U.S.C. 3501–3520). The
collections of information in this draft
guidance have been approved under
OMB control numbers 0910–0032 and
0910–0669.
V. 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.
VI. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm or
https://www.regulations.gov.
Dated: September 18, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–22681 Filed 9–23–14; 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
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
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Federal Register / Vol. 79, No. 185 / Wednesday, September 24, 2014 / Notices
asabaliauskas on DSK5VPTVN1PROD with NOTICES
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 PAR 13–213:
Outcome Measures for Use in Treatment
Trials for Individuals with Intellectual and
Developmental Disabilities (R01).
Date: October 8, 2014.
Time: 1:30 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: Jane A. DoussardRoosevelt, Ph.D., Scientific Review Officer,
Center for Scientific Review, National
Institutes of Health, 6701 Rockledge Drive,
Room 3184, MSC 7848, Bethesda, MD 20892,
(301) 435–4445, doussarj@csr.nih.gov.
Name of Committee: Immunology
Integrated Review Group, Innate Immunity
and Inflammation Study Section.
Date: October 21–22, 2014.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Salt Lake Marriott Downtown at City
Creek, 75 South West Temple, Salt Lake, UT
84101.
Contact Person: Tina McIntyre, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4202,
MSC 7812, Bethesda, MD 20892, 301–594–
6375, mcintyrt@csr.nih.gov.
Name of Committee: Biological Chemistry
and Macromolecular Biophysics Integrated
Review Group, Macromolecular Structure
and Function A Study Section.
Date: October 21–22, 2014.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Renaissance Washington, DC Hotel,
999 Ninth Street NW., Washington, DC
20001–4427.
Contact Person: Nitsa Rosenzweig, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4152,
MSC 7760, Bethesda, MD 20892, (301) 404–
7419, rosenzweign@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel
Macromolecular Structure and Function.
Date: October 21, 2014.
Time: 1:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Renaissance Washington, DC Hotel,
999 Ninth Street NW., Washington, DC
20001–4427.
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Contact Person: James W. Mack, Ph.D.,
Scientific Review Administrator, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4154,
MSC 7806, Bethesda, MD 20892, (301) 435–
2037, mackj2@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: September 17, 2014.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–22660 Filed 9–23–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the Sickle
Cell Disease Advisory Committee.
The meeting will be open to the
public, with attendance limited to space
available. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
Name of Committee: Sickle Cell Disease
Advisory Committee.
Date: October 17, 2014,
Time: 8:00 a.m. to 5:00 p.m.,
Agenda: Discussion of Programs.
Place: National Institutes of Health, 6701
Rockledge Drive, Room 9100/9104, Bethesda,
MD 20892.
Contact Person: W. Keith Hoots, MD,
Director, Division of Blood Diseases and
Resources, National Heart, Lung, and Blood
Institute, 6701 Rockledge Drive, Suite 9030,
Bethesda, MD 20892, 301–435–0080,
hootswk@nhlbi.nih.gov.
Information is also available on the
Institute’s/Center’s home page:
www.nhlbi.nih.gov/meetings/index.htm,
where an agenda and any additional
information for the meeting will be
posted when available.
(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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57115
Dated: September 17, 2014.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–22655 Filed 9–23–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Heart, Lung, and Blood
Advisory Council.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the 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 Heart, Lung,
and Blood Advisory Council.
Date: October 22, 2014.
Open: 8:00 a.m. to 1:00 p.m.
Agenda: To discuss program policies and
issues.
Place: National Institutes of Health,
Building 31, Room 10, 31 Center Drive,
Bethesda, MD 20892.
Closed: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Building 31, Room 10, 31 Center Drive,
Bethesda, MD 20892.
Contact Person: Stephen C. Mockrin, Ph.D.,
Director, Division of Extramural Research
Activities, National Heart, Lung, and Blood
Institute, National Institutes of Health, 6701
Rockledge Drive, Room 7100, Bethesda, MD
20892, (301) 435–0260, mockrins@
nhlbi.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
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]]>Agencies
[Federal Register Volume 79, Number 185 (Wednesday, September 24, 2014)]
[Notices]
[Pages 57114-57115]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22660]
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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.
[[Page 57115]]
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 PAR 13-213: Outcome Measures for Use in Treatment Trials for
Individuals with Intellectual and Developmental Disabilities (R01).
Date: October 8, 2014.
Time: 1:30 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: Jane A. Doussard-Roosevelt, Ph.D., Scientific
Review Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3184, MSC 7848, Bethesda, MD
20892, (301) 435-4445, doussarj@csr.nih.gov.
Name of Committee: Immunology Integrated Review Group, Innate
Immunity and Inflammation Study Section.
Date: October 21-22, 2014.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Salt Lake Marriott Downtown at City Creek, 75 South West
Temple, Salt Lake, UT 84101.
Contact Person: Tina McIntyre, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 4202, MSC 7812, Bethesda, MD 20892, 301-594-
6375, mcintyrt@csr.nih.gov.
Name of Committee: Biological Chemistry and Macromolecular
Biophysics Integrated Review Group, Macromolecular Structure and
Function A Study Section.
Date: October 21-22, 2014.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Renaissance Washington, DC Hotel, 999 Ninth Street NW.,
Washington, DC 20001-4427.
Contact Person: Nitsa Rosenzweig, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4152, MSC 7760, Bethesda, MD
20892, (301) 404-7419, rosenzweign@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel Macromolecular Structure and Function.
Date: October 21, 2014.
Time: 1:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Renaissance Washington, DC Hotel, 999 Ninth Street NW.,
Washington, DC 20001-4427.
Contact Person: James W. Mack, Ph.D., Scientific Review
Administrator, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4154, MSC 7806, Bethesda, MD
20892, (301) 435-2037, mackj2@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: September 17, 2014.
David Clary,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2014-22660 Filed 9-23-14; 8:45 am]
BILLING CODE 4140-01-P
