Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Health Promotion and Disease Prevention Research Centers, Special Interest Project Competitive Supplements (SIPS) (U48 Panels N-P), RFA-DP09-101SUPP09, Initial Review, 41145 [E9-19501]
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Federal Register / Vol. 74, No. 156 / Friday, August 14, 2009 / Notices
harmonization and is committed to
seeking scientifically based harmonized
technical procedures for pharmaceutical
development. One of the goals of
harmonization is to identify and then
reduce differences in technical
requirements for drug development
among regulatory agencies.
ICH was organized to provide an
opportunity for tripartite harmonization
initiatives to be developed with input
from both regulatory and industry
representatives. FDA also seeks input
from consumer representatives and
others. ICH is concerned with
harmonization of technical
requirements for the registration of
pharmaceutical products among three
regions: The European Union, Japan,
and the United States. The six ICH
sponsors are the European Commission;
the European Federation of
Pharmaceutical Industries Associations;
the Japanese Ministry of Health, Labour,
and Welfare; the Japanese
Pharmaceutical Manufacturers
Association; the Centers for Drug
Evaluation and Research and Biologics
Evaluation and Research, FDA; and the
Pharmaceutical Research and
Manufacturers of America. The ICH
Secretariat, which coordinates the
preparation of documentation, is
provided by the International
Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
The ICH Steering Committee includes
representatives from each of the ICH
sponsors and the IFPMA, as well as
observers from the World Health
Organization, Health Canada, and the
European Free Trade Area.
In June 2009, the ICH Steering
Committee agreed that a draft guidance
entitled ‘‘Q4B Evaluation and
Recommendation of Pharmacopoeial
Texts for Use in the ICH Regions; Annex
9: Tablet Friability General Chapter’’
should be made available for public
comment. The draft guidance is the
product of the Q4B Expert Working
Group of the ICH. Comments about this
draft will be considered by FDA and the
Q4B Expert Working Group.
The draft guidance provides the
specific evaluation results from the ICH
Q4B process for the Tablet Friability
General Chapter harmonization
proposal originating from the threeparty PDG. This draft guidance is in the
form of an annex to the core ICH Q4B
guidance. Once finalized, the annex will
provide guidance to assist industry and
regulators in the implementation of the
specific topic evaluated by the ICH Q4B
process.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
VerDate Nov<24>2008
16:27 Aug 13, 2009
Jkt 217001
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 the applicable statutes
and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments on the draft guidance. 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. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.regulations.gov, https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, or https://
www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm.
Dated: July 31, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–19528 Filed 8–13–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention (CDC)
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Health
Promotion and Disease Prevention
Research Centers, Special Interest
Project Competitive Supplements
(SIPS) (U48 Panels N–P), RFA–DP09–
101SUPP09, Initial Review
Cancellation: The notice was
originally published in the Federal
Register on July 21, 2009 (Volume 74,
Number 138] [page 35877]. The
following panels are cancelled: N, O and
P.
Contact Person for More Information:
Brenda Colley-Gilbert, Ph.D., Director,
Extramural Research Program Office,
CCCH, 4770 Buford Highway, MS K–92,
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
41145
Atlanta, GA 30341, Telephone (770)
488–6295.
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 CDC
and the Agency for Toxic Substances
and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E9–19501 Filed 8–13–09; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2008–0333]
Delaware River and Bay Oil Spill
Advisory Committee; Meeting
Coast Guard, DHS.
Notice of meeting.
AGENCY:
ACTION:
SUMMARY: The Delaware River and Bay
Oil Spill Advisory Committee
(DRBOSAC) will meet in Lewes, DE to
discuss various issues to improve oil
spill prevention and response strategies
for the Delaware River and Bay. This
meeting will be open to the public.
DATES: The Committee will meet on
Wednesday, September 9, 2009, from 2
p.m. to 4 p.m. This meeting may close
early if all business is finished. Written
material, requests to make oral
presentations, and requests to have a
copy of your material distributed to
each member of the committee should
reach the Coast Guard on or before
September 2, 2009.
ADDRESSES: The Committee will meet at
Virden Retreat Center, University of
Delaware (the Harbor Room), 700
Pilottown Road, Lewes, DE 19958. Send
written material and requests to make
oral presentations to Gerald Conrad,
Liaison to the Designated Federal
Officer (DFO) of the DRBOSAC, Coast
Guard Sector Delaware Bay, 1
Washington Ave., Philadelphia, PA
19147. This notice and any documents
identified in the Supplementary
Information section as being available in
the docket may be viewed online, at
https://www.regulations.gov, using
docket number USCG–2008–0333.
FOR FURTHER INFORMATION CONTACT:
Gerald Conrad, Liaison to the DFO of
the DRBOSAC, telephone 215–271–
4824.
E:\FR\FM\14AUN1.SGM
14AUN1
Agencies
[Federal Register Volume 74, Number 156 (Friday, August 14, 2009)]
[Notices]
[Page 41145]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-19501]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention (CDC)
Disease, Disability, and Injury Prevention and Control Special
Emphasis Panel (SEP): Health Promotion and Disease Prevention Research
Centers, Special Interest Project Competitive Supplements (SIPS) (U48
Panels N-P), RFA-DP09-101SUPP09, Initial Review
Cancellation: The notice was originally published in the Federal
Register on July 21, 2009 (Volume 74, Number 138] [page 35877]. The
following panels are cancelled: N, O and P.
Contact Person for More Information: Brenda Colley-Gilbert, Ph.D.,
Director, Extramural Research Program Office, CCCH, 4770 Buford
Highway, MS K-92, Atlanta, GA 30341, Telephone (770) 488-6295.
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 CDC and the Agency for Toxic Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services Office, Centers for Disease
Control and Prevention.
[FR Doc. E9-19501 Filed 8-13-09; 8:45 am]
BILLING CODE 4163-18-P