Advisory Committee Renewals, 7871 [2015-02909]
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Federal Register / Vol. 80, No. 29 / Thursday, February 12, 2015 / Notices
the extent to which progress has been made
toward eliminating tuberculosis.
Matters for Discussion: Agenda items
include the following topics: (1) Update on
Global TB Coordination Activities; (2) Profile
of Foreign-Born TB cases; (3) Impact of
funding cuts on TB programs in the field; and
(4) other tuberculosis-related issues.
Agenda items are subject to change as
priorities dictate. Contact Person for More
Information: Margie Scott-Cseh, Centers for
Disease Control and Prevention, 1600 Clifton
Road NE., M/S E–07, Atlanta, Georgia 30333,
telephone (404) 639–8317; Email:
zkr7@cdc.gov
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register Notices
pertaining to announcements of meetings and
other committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Catherine Ramadei,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. 2015–02887 Filed 2–11–15; 8:45 am]
Name of committee
Date of
expiration
Oncologic Drugs Advisory
Committee.
Anti-Infective Drugs Advisory
Committee.
Dermatologic and Ophthalmic
Drugs Advisory Committee.
Cellular, Tissue, and Gene
Therapies Advisory Committee.
Technical Electronic Product
Radiation Safety Standards
Committee.
September 1,
2016.
October 7,
2016.
October 7,
2016.
October 28,
2016.
December 24,
2016.
FOR FURTHER INFORMATION CONTACT:
Michael Ortwerth, Director, Advisory
Committee Oversight and Management
Staff, Food and Drug Administration,
10903 New Hampshire Ave., Silver
Spring, MD 20993–0002, 301–443–0572
or 1–800–741–8138. For further
information related to FDA advisory
committees, please visit us at https://
www.fda.gov/AdvisoryCommittees/
default.htm.
Dated: February 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2015–02909 Filed 2–11–15; 8:45 am]
BILLING CODE 4164–01–P
Food and Drug Administration
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2015–N–0001]
Advisory Committee Renewals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
renewal of certain FDA advisory
committees by the Commissioner of
Food and Drugs (the Commissioner).
The Commissioner has determined that
it is in the public interest to renew the
charters of the committees listed in the
following table for an additional 2 years
beyond charter expiration date. The new
charters will be in effect until the dates
of expiration listed in the following
table. This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app.).
DATES: Authority for these committees
will expire on the dates indicated in the
following table unless the
Commissioner formally determines that
renewal is in the public interest.
Rmajette on DSK2VPTVN1PROD with NOTICES
SUMMARY:
Name of committee
Cardio and Renal Drugs Advisory Committee.
Endocrinologic and Metabolic
Drugs Advisory Committee.
VerDate Sep<11>2014
13:54 Feb 11, 2015
Date of
expiration
August 27,
2016.
August 27,
2016.
Jkt 235001
Food and Drug Administration
[Docket No. FDA–2015–D–0152]
Alcoholism: Developing Drugs for
Treatment; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Alcoholism:
Developing Drugs for Treatment.’’ The
purpose of this guidance is to assist
sponsors in the development of drugs
for the treatment of alcoholism.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by April 13, 2015.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
SUMMARY:
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
7871
Hampshire Ave., Hillandale Bldg., 4th
Floor, Silver Spring, MD 20993. Send
one self-addressed adhesive label to
assist that office in processing your
requests. 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:
Rachel Skeete, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 3191,
Silver Spring, MD 20993–0002, 301–
796–2280.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Alcoholism: Developing Drugs for
Treatment.’’ There is a need for
additional pharmacologic treatments for
alcoholism. Traditionally, alcoholism
treatments have been assessed based on
the number of patients who refrain from
drinking altogether. Patients who attain
and sustain complete abstinence from
alcohol may be assumed to accrue
clinical benefit. However, other patterns
of drinking also may be valid surrogates
for clinical benefit. This guidance
provides supporting information for
endpoints based on patterns of drinking
that may be considered appropriate
measures of clinical benefit.
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 Agency’s current thinking
on the development of drugs for the
treatment of alcoholism and appropriate
endpoints for clinical trials of drugs to
treat alcoholism. 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. 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 in 21 CFR parts 312 and
314 have been approved under OMB
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]]>Agencies
[Federal Register Volume 80, Number 29 (Thursday, February 12, 2015)]
[Notices]
[Page 7871]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-02909]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0001]
Advisory Committee Renewals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of certain FDA advisory committees by the Commissioner of Food
and Drugs (the Commissioner). The Commissioner has determined that it
is in the public interest to renew the charters of the committees
listed in the following table for an additional 2 years beyond charter
expiration date. The new charters will be in effect until the dates of
expiration listed in the following table. This notice is issued under
the Federal Advisory Committee Act (5 U.S.C. app.).
DATES: Authority for these committees will expire on the dates
indicated in the following table unless the Commissioner formally
determines that renewal is in the public interest.
------------------------------------------------------------------------
Name of committee Date of expiration
------------------------------------------------------------------------
Cardio and Renal Drugs Advisory Committee. August 27, 2016.
Endocrinologic and Metabolic Drugs August 27, 2016.
Advisory Committee.
Oncologic Drugs Advisory Committee........ September 1, 2016.
Anti-Infective Drugs Advisory Committee... October 7, 2016.
Dermatologic and Ophthalmic Drugs Advisory October 7, 2016.
Committee.
Cellular, Tissue, and Gene Therapies October 28, 2016.
Advisory Committee.
Technical Electronic Product Radiation December 24, 2016.
Safety Standards Committee.
------------------------------------------------------------------------
FOR FURTHER INFORMATION CONTACT: Michael Ortwerth, Director, Advisory
Committee Oversight and Management Staff, Food and Drug Administration,
10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-443-0572 or
1-800-741-8138. For further information related to FDA advisory
committees, please visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.
Dated: February 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-02909 Filed 2-11-15; 8:45 am]
BILLING CODE 4164-01-P
