Center for Scientific Review; Notice of Closed Meetings, 13767-13768 [2010-6299]
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Federal Register / Vol. 75, No. 55 / Tuesday, March 23, 2010 / Notices
jlentini on DSKJ8SOYB1PROD with NOTICES
prescription drug and biological
products. This guidance is intended to
help applicants select information for
inclusion in the ‘‘Dosage and
Administration’’ section of labeling and
to help them organize that information.
DATES: Submit written or electronic
comments on agency guidances at any
time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002; or the
Office of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, suite 200N,
Rockville, MD 20852–1448. The
guidance may also be obtained by mail
by calling CBER at 1–800–835–4709 or
301–827–1800. Send two self-addressed
adhesive labels to assist the office in
processing your requests. Submit
written comments on the guidance to
the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Joseph P. Griffin, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 4204,
Silver Spring, MD 20993–0002, 301–
796–2270; or
Stephen Ripley, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled ‘‘Dosage
and Administration Section of Labeling
for Human Prescription Drug and
Biological Products—Content and
Format.’’ The guidance provides
recommendations on how to select
information for inclusion in the ‘‘Dosage
and Administration’’ section of labeling
and how to organize information within
the section. This guidance is one of a
series of guidances FDA is developing,
or has developed, to assist applicants
with the format and content of certain
sections of the labeling for prescription
drugs. In the Federal Register of January
VerDate Nov<24>2008
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24, 2006 (71 FR 3998), FDA issued final
guidances on the format and content of
the ‘‘Adverse Reactions’’ and ‘‘Clinical
Studies’’ sections of labeling and draft
guidances on implementing the new
labeling requirements for prescription
drugs and the format and content of the
‘‘Warnings and Precautions,’’
‘‘Contraindications,’’ and ‘‘Boxed
Warning’’ sections of labeling. In the
Federal Register of March 3, 2009 (74
FR 9250), FDA issued a draft guidance
on the format and content of the
‘‘Clinical Pharmacology’’ section of
labeling. The labeling requirements (71
FR 3922) and these guidances are
intended to make information in
prescription drug labeling easier for
health care practitioners to access, read,
and use.
On April 9, 2007, FDA issued a draft
of this guidance on the dosage and
administration section of labeling to
obtain public comment (72 FR 17561).
FDA received 10 comments—9 from the
pharmaceutical industry (individual
companies, a trade association, and a
consultant) and 1 from an academic
medical center. The comments offered
generally favorable impressions of the
guidance and its goals. The bulk of the
comments focused on clarifications and
further illustrations of issues discussed
in individual sections and subsections
of the guidance. FDA made an effort to
address as many of the identified
concerns as possible. A recurring
general concern in many industry
comments was that the guidance should
more clearly differentiate content that is
required when relevant to a given drug
from content that is recommended. FDA
has attempted to make the distinction as
clear as possible by using the word
‘‘must’’ and citing the relevant section of
the regulation whenever the guidance is
discussing required content and using
the word ‘‘should’’ when discussing
recommended content.
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 the content and
format of the ‘‘Dosage and
Administration’’ section of labeling for
human prescription drug and biological
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 to the
Division of Dockets Management (see
ADDRESSES) written or electronic
PO 00000
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13767
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified 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.
III. Paperwork Reduction Act of 1995
This 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 Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR 201.57 have been approved
under OMB control number 0910–0572.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at https://www.
fda.gov/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, https://www.fda.gov/
BiologicsBloodVaccines/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, or https://
www.regulations.gov.
Dated: March 18, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–6322 Filed 3–22–10; 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.
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; Small
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jlentini on DSKJ8SOYB1PROD with NOTICES
13768
Federal Register / Vol. 75, No. 55 / Tuesday, March 23, 2010 / Notices
Business: AIDS/HIV Small Business
Innovative Research Applications.
Date: April 1, 2010.
Time: 11:59 a.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Mark P. Rubert, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5218,
MSC 7852, Bethesda, MD 20892, 301–435–
1775, rubertm@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; Member
Conflict: Insulin Signaling and Diabetes.
Date: April 6–7, 2010.
Time: 9 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Ann A. Jerkins, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6154,
MSC 7892, Bethesda, MD 20892, 301–435–
4514, jerkinsa@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; Member
Conflict: Exploratory Research in AIDS
Immunology and Pathogenesis.
Date: April 7, 2010.
Time: 2 p.m. to 4 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: Shiv A. Prasad, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5220,
MSC 7852, Bethesda, MD 20892, 301–443–
5779, prasads@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Molecular Signaling.
Date: April 13, 2010.
Time: 2 p.m. to 5 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: Russell T. Dowell, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4128,
MSC 7814, Bethesda, MD 20892, (301) 435–
1850, dowellr@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,
VerDate Nov<24>2008
16:31 Mar 22, 2010
Jkt 220001
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: March 16, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–6299 Filed 3–22–10; 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 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 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 Institute Special Emphasis Panel,
Conference Grants (R13’s).
Date: April 5–6, 2010.
Time: 11 a.m. to 10 a.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
(Virtual Meeting.)
Contact Person: Robert T. Su, Ph.D.,
Scientific Review Officer, Review Branch/
DERA, National Heart, Lung, and Blood
Institute, 6701 Rockledge Drive, Room 7202,
Bethesda, MD 20892–7924. 301–435–0297.
sur@mail.nih.gov.
(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)
Dated: March 16, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–6301 Filed 3–22–10; 8:45 am]
BILLING CODE 4140–01–P
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; 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 of
Neurological Disorders and Stroke Special
Emphasis Panel R25 Initiative.
Date: April 1, 2010.
Time: 11:15 a.m. to 12:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852.
Contact Person: Phillip F. Wiethorn,
Scientific Review Administrator, DHHS/NIH/
NINDS/DER/SRB, 6001 Executive Boulevard;
MSC 9529, Neuroscience Center; Room 3203,
Bethesda, MD 20892–9529, (301) 496–5388,
wiethorp@ninds.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: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel Udall Centers.
Date: April 20–21, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hotel Monaco Alexandria, 480 King
Street, Alexandria, VA 22314.
Contact Person: Ernest W Lyons, PhD.,
Scientific Review Administrator, Scientific
Review Branch, NINDS/NIH/DHHS,
Neuroscience Center, 6001 Executive Blvd.,
Suite 3208, MSC 9529,Bethesda, MD 20892–
9529, 301–496–4056, lyonse@ninds.nih.gov.
(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: March 15, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–6126 Filed 3–22–10; 8:45 am]
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]]>Agencies
[Federal Register Volume 75, Number 55 (Tuesday, March 23, 2010)]
[Notices]
[Pages 13767-13768]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-6299]
-----------------------------------------------------------------------
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; Small
[[Page 13768]]
Business: AIDS/HIV Small Business Innovative Research Applications.
Date: April 1, 2010.
Time: 11:59 a.m. to 3:30 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Mark P. Rubert, PhD, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 5218, MSC 7852, Bethesda, MD 20892, 301-435-
1775, rubertm@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; Member Conflict: Insulin Signaling and Diabetes.
Date: April 6-7, 2010.
Time: 9 a.m. to 6 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Ann A. Jerkins, PhD, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 6154, MSC 7892, Bethesda, MD 20892, 301-435-
4514, jerkinsa@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; Member Conflict: Exploratory Research in AIDS Immunology and
Pathogenesis.
Date: April 7, 2010.
Time: 2 p.m. to 4 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: Shiv A. Prasad, PhD, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 5220, MSC 7852, Bethesda, MD 20892, 301-443-
5779, prasads@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Molecular Signaling.
Date: April 13, 2010.
Time: 2 p.m. to 5 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: Russell T. Dowell, PhD, Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4128, MSC 7814, Bethesda, MD
20892, (301) 435-1850, dowellr@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: March 16, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2010-6299 Filed 3-22-10; 8:45 am]
BILLING CODE 4140-01-P
