International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 9 on Tablet Friability General Chapter; Availability, 41144-41145 [E9-19528]
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Federal Register / Vol. 74, No. 156 / Friday, August 14, 2009 / Notices
mstockstill on DSKH9S0YB1PROD with NOTICES
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Committee agreed that a draft guidance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
10: Polyacrylamide Gel Electrophoresis
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 The draft
guidance is the product of the Q4B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The draft guidance provides the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 Polyacrylamide Gel
Electrophoresis General Chapter
harmonization proposal originating
from the three-party 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 This draft
guidance is in the form of an annex to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This draft guidance is being issued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).
The draft guidance, when finalized, will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comments on the draft guidance.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
VerDate Nov<24>2008
16:27 Aug 13, 2009
Jkt 217001
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. E9–19522 Filed 8–13–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0343]
International Conference on
Harmonisation; Draft Guidance on Q4B
Evaluation and Recommendation of
Pharmacopoeial Texts for Use in the
International Conference on
Harmonisation Regions; Annex 9 on
Tablet Friability General Chapter;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance entitled
‘‘Q4B Evaluation and Recommendation
of Pharmacopoeial Texts for Use in the
ICH Regions; Annex 9: Tablet Friability
General Chapter.’’ The draft guidance
was prepared under the auspices of the
International Conference on
Harmonisation of Technical
Requirements for Registration of
Pharmaceuticals for Human Use (ICH).
The draft guidance provides the results
of the ICH Q4B evaluation of the Tablet
Friability General Chapter harmonized
text from each of the three
pharmacopoeias (United States,
European, and Japanese) represented by
the Pharmacopoeial Discussion Group
(PDG). The draft guidance conveys
recognition of the three pharmacopoeial
methods by the three ICH regulatory
regions and provides specific
information regarding the recognition.
The draft guidance is intended to
recognize the interchangeability
between the local regional
pharmacopoeias, thus avoiding
redundant testing in favor of a common
testing strategy in each regulatory
region. This draft guidance is the ninth
annex to the core Q4B guidance, which
was made available in the Federal
Register of February 21, 2008 (73 FR
9575).
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
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
written or electronic comments on the
draft guidance by October 13, 2009.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information (HFD–
240), 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 and Development,
Center for Biologics Evaluation and
Research, Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448.
The guidance may also be obtained by
mail by calling the Center for Biologics
Evaluation and Research at 1–800–835–
4709 or 301–827–1800. Send two selfaddressed adhesive labels to assist the
office in processing your requests.
Submit written comments on the draft
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 draft guidance
document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Robert H.
King, Sr., Center for Drug
Evaluation and Research (HFD–
003), Food and Drug
Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 4150,
Silver Spring, MD 20993–0002,
301–796–1242; or
Christopher Joneckis, Center for
Biologics Evaluation and Research
(HFM–25), Food and Drug
Administration, 1401 Rockville
Pike, suite 200N, Rockville, MD
20852–1448, 301–827–0373.
Regarding the ICH: Michelle Limoli,
Office of International Programs
(HFG–1), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–
4480.
SUPPLEMENTARY INFORMATION:
I. Background
In recent years, many important
initiatives have been undertaken by
regulatory authorities and industry
associations to promote international
harmonization of regulatory
requirements. FDA has participated in
many meetings designed to enhance
E:\FR\FM\14AUN1.SGM
14AUN1
mstockstill on DSKH9S0YB1PROD with NOTICES
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]
[Pages 41144-41145]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-19528]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-D-0343]
International Conference on Harmonisation; Draft Guidance on Q4B
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the
International Conference on Harmonisation Regions; Annex 9 on Tablet
Friability General Chapter; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``Q4B Evaluation and
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions;
Annex 9: Tablet Friability General Chapter.'' The draft guidance was
prepared under the auspices of the International Conference on
Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH). The draft guidance provides the
results of the ICH Q4B evaluation of the Tablet Friability General
Chapter harmonized text from each of the three pharmacopoeias (United
States, European, and Japanese) represented by the Pharmacopoeial
Discussion Group (PDG). The draft guidance conveys recognition of the
three pharmacopoeial methods by the three ICH regulatory regions and
provides specific information regarding the recognition. The draft
guidance is intended to recognize the interchangeability between the
local regional pharmacopoeias, thus avoiding redundant testing in favor
of a common testing strategy in each regulatory region. This draft
guidance is the ninth annex to the core Q4B guidance, which was made
available in the Federal Register of February 21, 2008 (73 FR 9575).
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 written or electronic comments on the draft guidance
by October 13, 2009.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), 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 and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 1401 Rockville
Pike, suite 200N, Rockville, MD 20852-1448. The guidance may also be
obtained by mail by calling the Center for Biologics Evaluation and
Research 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 draft 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 draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Robert H. King, Sr., Center for Drug
Evaluation and Research (HFD-003), Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 51, rm. 4150, Silver Spring, MD 20993-0002,
301-796-1242; or
Christopher Joneckis, Center for Biologics Evaluation and Research
(HFM-25), Food and Drug Administration, 1401 Rockville Pike, suite
200N, Rockville, MD 20852-1448, 301-827-0373.
Regarding the ICH: Michelle Limoli, Office of International
Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-4480.
SUPPLEMENTARY INFORMATION:
I. Background
In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote
international harmonization of regulatory requirements. FDA has
participated in many meetings designed to enhance
[[Page 41145]]
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 three-party 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). 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/GuidanceComplianceRegulatoryInformation/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
