National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting, 35987 [2012-14605]
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Federal Register / Vol. 77, No. 116 / Friday, June 15, 2012 / Notices
SUPPLEMENTARY INFORMATION:
srobinson on DSK4SPTVN1PROD with NOTICES
I. Background
FDA is announcing the availability of
a guidance for small business entities
entitled ‘‘Toll-Free Number Labeling
and Related Requirements for Over-theCounter and Prescription Drugs
Marketed With Approved Applications;
Small Entity Compliance Guide.’’
This guidance summarizes the final
rule published in the Federal Register
of October 28, 2008 (73 FR 63886),
which requires the labeling of each
human drug product for which an
application is approved under section
505 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) to include: (1)
The toll-free number maintained by
FDA for the purpose of receiving reports
of adverse events regarding drugs and
(2) a statement that the number is to be
used for reporting purposes only, and
not to receive medical advice. The final
rule requires that the toll-free number
and reporting information be:
• Included in all FDA-approved
Medication Guides for products
approved under section 505,
• Provided to patients by authorized
dispensers or pharmacies with each
prescription drug product approved
under section 505, and
• Included in the labeling of certain
over-the-counter drugs approved under
section 505.
FDA has previously issued a guidance
for industry entitled ‘‘Medication
Guides—Adding a Toll-Free Number for
Reporting Adverse Events’’ (June 2009)
to assist new drug application holders
with revising FDA-approved Medication
Guides to comply with the first of these
requirements. This guidance is intended
to assist small businesses and others
with implementing the two other
requirements in the final rule:
Distribution of the toll-free number
information to patients with each
prescription (or refill) and adding the
toll-free number information to the
labeling of certain OTC drugs.
FDA is issuing this small entity
compliance guide as level 2 guidance
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking on side effects
statement requirements as set forth in
the final rule. 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.
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17:05 Jun 14, 2012
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II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed 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.
35987
This notice is being published less than 15
days prior to the meeting due to the timing
and limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.853, Clinical Research
Related to Neurological Disorders; 93.854,
Biological Basis Research in the
Neurosciences, National Institutes of Health,
HHS)
Dated: June 8, 2012.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–14605 Filed 6–14–12; 8:45 am]
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
BILLING CODE 4140–01–P
Dated: June 11, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
Center for Scientific Review; Notice of
Closed Meetings
[FR Doc. 2012–14632 Filed 6–14–12; 8:45 am]
BILLING CODE 4160–01–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.
Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel; Center Core Grants.
Date: June 28, 2012.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Churchill Hotel, 1914 Connecticut
Avenue NW., Washington, DC 20009.
Contact Person: Richard D. Crosland,
Ph.D., Scientific Review Officer, Scientific
Review Branch, Division of Extramural
Research, NINDS/NIH, NSC, 6001 Executive
Blvd., Suite 3208, MSC 9529, Bethesda, MD
20892, 301–594–0635, Rc218u@nih.gov.
PO 00000
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
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: AIDS and Related
Research Integrated Review Group; AIDSassociated Opportunistic Infections and
Cancer Study Section.
Date: July 10, 2012.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
Contact Person: Eduardo A Montalvo,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5108,
MSC 7852, Bethesda, MD 20892, (301) 435–
1168, montalve@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Oral Biology and Craniofacial
Development.
Date: July 10, 2012.
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: Rajiv Kumar, Ph.D., Chief,
MOSS IRG, Center for Scientific Review,
E:\FR\FM\15JNN1.SGM
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]]>Agencies
[Federal Register Volume 77, Number 116 (Friday, June 15, 2012)]
[Notices]
[Page 35987]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14605]
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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.
Name of Committee: National Institute of Neurological Disorders
and Stroke Special Emphasis Panel; Center Core Grants.
Date: June 28, 2012.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Churchill Hotel, 1914 Connecticut Avenue NW., Washington,
DC 20009.
Contact Person: Richard D. Crosland, Ph.D., Scientific Review
Officer, Scientific Review Branch, Division of Extramural Research,
NINDS/NIH, NSC, 6001 Executive Blvd., Suite 3208, MSC 9529,
Bethesda, MD 20892, 301-594-0635, Rc218u@nih.gov.
This notice is being published less than 15 days prior to the
meeting due to the timing and limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance Program Nos. 93.853,
Clinical Research Related to Neurological Disorders; 93.854,
Biological Basis Research in the Neurosciences, National Institutes
of Health, HHS)
Dated: June 8, 2012.
Jennifer S. Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2012-14605 Filed 6-14-12; 8:45 am]
BILLING CODE 4140-01-P
