National Institute on Aging; Notice of Closed Meetings, 37232 [2013-14647]
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Federal Register / Vol. 78, No. 119 / Thursday, June 20, 2013 / Notices
That letter stated that OGD would
accept ANDAs with the ICH
recommended long-term room
temperature conditions for stability
studies, 25 ± 2° C, 60 ± 5 percent RH.
On September 25, 2012 (77 FR 58999),
FDA announced the availability of draft
guidance for industry on ‘‘ANDAs:
Stability Testing of Drug Substances and
Products.’’ The public comment period
closed on December 24, 2012. We are
finalizing the guidance with minor
changes and intend to publish a draft
guidance to address the public
comments in a question-and-answer
format in the near future.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking on this stability testing
for generic drug substances and
products. 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 the applicable statutes
and regulations.
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.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.regulations.gov or https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm.
TKELLEY on DSK3SPTVN1PROD with NOTICES
Dated: June 14, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–14674 Filed 6–19–13; 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; 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 the following meeting.
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: National Institute of
Child Health and Human Development
Special Emphasis Panel; Cardio-metabolic
risk and epigenetic differences among
children conceives by infertility.
Date: July 1, 2013.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To provide concept review.
Place: National Institutes of Health, 6100
Executive Boulevard, Rockville, MD 20852
(Telephone Conference Call).
Contact Person: Sathasiva B. Kandasamy,
Ph.D., Scientific Review Officer, Division of
Scientific Review, National Institute of Child
Health and Human Development, 6100
Executive Boulevard, Rockville, MD 20892–
9304, (301) 435–6680,
skandasa@mail.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. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Dated: June 14, 2013.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–14649 Filed 6–19–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; 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
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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 on
Aging Special Emphasis Panel; NIA DBSR
DATASETS.
Date: July 11–12, 2013.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel &
Conference Center, 5701 Marinelli Road,
Bethesda, MD 20852.
Contact Person: Alfonso Latoni, Ph.D.,
Scientific Review Branch, National Institute
on Aging, Gateway Building, 7201 Wisconsin
Avenue, Suite 2C212, Bethesda, MD 20892,
301–402–7702, Alfonso.Latoni@nih.gov.
Name of Committee: National Institute on
Aging Special Emphasis Panel;
Osteoimmunology.
Date: July 11, 2013.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
Suite 2C212, Bethesda, MD 20814,
(Telephone Conference Call).
Contact Person: Elaine Lewis, Ph.D.,
Scientific Review Branch, National Institute
on Aging, Gateway Building, 7201 Wisconsin
Avenue, Suite 2C212, Bethesda, MD 20892,
301–402–7707, elainelewis@nia.nih.gov.
Name of Committee: National Institute on
Aging Special Emphasis Panel; Treatment of
Obesity in Older Adults.
Date: July 18, 2013.
Time: 12:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
Suite 2C212, Bethesda, MD 20814,
(Telephone Conference Call).
Contact Person: Elaine Lewis, Ph.D.,
Scientific Review Branch, National Institute
on Aging, Gateway Building, 7201 Wisconsin
Avenue, Suite 2C212, Bethesda, MD 20892,
301–402–7707, elainelewis@nia.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: June 14, 2013.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–14647 Filed 6–19–13; 8:45 am]
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[Federal Register Volume 78, Number 119 (Thursday, June 20, 2013)]
[Notices]
[Page 37232]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-14647]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute on Aging; 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: National Institute on Aging Special Emphasis
Panel; NIA DBSR DATASETS.
Date: July 11-12, 2013.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Bethesda North Marriott Hotel & Conference Center, 5701
Marinelli Road, Bethesda, MD 20852.
Contact Person: Alfonso Latoni, Ph.D., Scientific Review Branch,
National Institute on Aging, Gateway Building, 7201 Wisconsin
Avenue, Suite 2C212, Bethesda, MD 20892, 301-402-7702,
Alfonso.Latoni@nih.gov.
Name of Committee: National Institute on Aging Special Emphasis
Panel; Osteoimmunology.
Date: July 11, 2013.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institute on Aging, Gateway Building, 7201
Wisconsin Avenue, Suite 2C212, Bethesda, MD 20814, (Telephone
Conference Call).
Contact Person: Elaine Lewis, Ph.D., Scientific Review Branch,
National Institute on Aging, Gateway Building, 7201 Wisconsin
Avenue, Suite 2C212, Bethesda, MD 20892, 301-402-7707,
elainelewis@nia.nih.gov.
Name of Committee: National Institute on Aging Special Emphasis
Panel; Treatment of Obesity in Older Adults.
Date: July 18, 2013.
Time: 12:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institute on Aging, Gateway Building, 7201
Wisconsin Avenue, Suite 2C212, Bethesda, MD 20814, (Telephone
Conference Call).
Contact Person: Elaine Lewis, Ph.D., Scientific Review Branch,
National Institute on Aging, Gateway Building, 7201 Wisconsin
Avenue, Suite 2C212, Bethesda, MD 20892, 301-402-7707,
elainelewis@nia.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging
Research, National Institutes of Health, HHS)
Dated: June 14, 2013.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2013-14647 Filed 6-19-13; 8:45 am]
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