International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex on Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter; Availability, 45463-45465 [E8-17862]
Download as PDF
<![CDATA[
Federal Register / Vol. 73, No. 151 / Tuesday, August 5, 2008 / Notices
dwashington3 on PRODPC61 with NOTICES
suite 200N, Rockville, MD 20852–1448.
The draft guidance may also be obtained
by mail by calling CBER 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Submit written comments on the draft
guidance to the Division of Dockets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electronic access to the draft guidance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Regarding the draft guidance: Ellis F.
Unger, Center for Drug Evaluation
and Research (HFD–110), Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 4170,
Silver Spring, MD 20993, 301–796–
2240; or
Peter F. Bross, Center for Biologics
Evaluation and Research (HFM–
755), Food and Drug
Administration, 1401 Rockville
Pike, Rockville, MD 20852, 301–
827–5102.
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
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
VerDate Aug<31>2005
14:19 Aug 04, 2008
Jkt 214001
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 2008, the ICH Steering
Committee agreed that a draft guidance
entitled ‘‘E2F Development Safety
Update Report’’ should be made
available for public comment. The draft
guidance is the product of the E2F
Expert Working Group of the ICH.
Comments about this draft will be
considered by FDA and the Efficacy
Expert Working Group.
The draft guidance describes the
format, content, and timing of a DSUR
for an investigational drug. The DSUR
would serve as a harmonized, annual
clinical trial safety report that would be
standard among the ICH regions. The
DSUR is patterned after the periodic
safety update report (PSUR) (used for
safety reporting in the postmarketing
environment) and could be submitted in
the United States in place of an annual
report for an IND. The harmonized
DSUR is intended to promote a
consistent approach to annual clinical
safety reporting among the ICH regions
and enhance efficiency by reducing the
number of reports generated for
submission to the regulatory authorities.
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
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
45463
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.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
III. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.regulations.gov, https://
www.fda.gov/cder/guidance/index.htm,
or https://www.fda.gov/cber/
guidelines.htm.
Dated: July 28, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–17861 Filed 8–4–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0396]
International Conference on
Harmonisation; Draft Guidance on Q4B
Evaluation and Recommendation of
Pharmacopoeial Texts for Use in the
International Conference on
Harmonisation Regions; Annex on
Microbiological Examination of NonSterile Products: Microbial
Enumeration Tests 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 4A: Microbiological
Examination of Non-Sterile Products:
Microbial Enumeration Tests 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
E:\FR\FM\05AUN1.SGM
05AUN1
dwashington3 on PRODPC61 with NOTICES
45464
Federal Register / Vol. 73, No. 151 / Tuesday, August 5, 2008 / Notices
of the ICH Q4B evaluation of the
Microbiological Examination of NonSterile Products: Microbial Enumeration
Tests 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 part A of
the fourth 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 6, 2008.
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, Training and
Manufacturers Assistance (HFM–40),
Center for Biologics Evaluation and
Research (CBER), Food and Drug
Administration, 1401 Rockville Pike,
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 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,
VerDate Aug<31>2005
14:19 Aug 04, 2008
Jkt 214001
301–796–1242; or
Christopher Joneckis, Center for
Biologics Evaluation and Research
(HFM–1), Food and Drug
Administration, 1401 Rockville
Pike, Rockville, MD 20852, 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
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 2008, the ICH Steering
Committee agreed that a draft guidance
entitled ‘‘Q4B Evaluation and
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
Recommendation of Pharmacopoeial
Texts for Use in the ICH Regions; Annex
4A: Microbiological Examination of
Non-Sterile Products: Microbial
Enumeration Tests 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 Microbiological
Examination of Non-Sterile Products:
Microbial Enumeration Tests 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.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
III. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.regulations.gov, https://
www.fda.gov/cder/guidance/index.htm,
E:\FR\FM\05AUN1.SGM
05AUN1
Federal Register / Vol. 73, No. 151 / Tuesday, August 5, 2008 / Notices
or https://www.fda.gov/cber/
guidelines.htm.
Dated: July 28, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–17862 Filed 8–4–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0398]
International Conference on
Harmonisation; Draft Guidance on Q4B
Evaluation and Recommendation of
Pharmacopoeial Texts for Use in the
International Conference on
Harmonisation Regions; Annex on
Microbiological Examination of NonSterile Products: Tests for Specified
Micro-organisms General Chapter;
Availability
AGENCY:
Food and Drug Administration,
HHS.
dwashington3 on PRODPC61 with NOTICES
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 4B: Microbiological
Examination of Non-Sterile Products:
Tests for Specified Micro-organisms
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
Microbiological Examination of NonSterile Products: Tests for Specified
Micro-organisms 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 part B of
the fourth annex to the core Q4B
guidance, which was made available in
VerDate Aug<31>2005
14:19 Aug 04, 2008
Jkt 214001
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 6, 2008.
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, Training and
Manufacturers Assistance (HFM–40),
Center for Biologics Evaluation and
Research (CBER), Food and Drug
Administration, 1401 Rockville Pike,
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 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–1), Food and Drug
Administration, 1401 Rockville
Pike, Rockville, MD 20852, 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
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
45465
requirements. FDA has participated in
many meetings designed to enhance
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 2008, the ICH Steering
Committee agreed that a draft guidance
entitled ‘‘Q4B Evaluation and
Recommendation of Pharmacopoeial
Texts for Use in the ICH Regions; Annex
4B: Microbiological Examination of
Non-Sterile Products: Tests for
Specified Micro-organisms 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 Microbiological
Examination of Non-Sterile Products:
Tests for Specified Micro-organisms
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
E:\FR\FM\05AUN1.SGM
05AUN1
]]>Agencies
[Federal Register Volume 73, Number 151 (Tuesday, August 5, 2008)]
[Notices]
[Pages 45463-45465]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-17862]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0396]
International Conference on Harmonisation; Draft Guidance on Q4B
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the
International Conference on Harmonisation Regions; Annex on
Microbiological Examination of Non-Sterile Products: Microbial
Enumeration Tests 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 4A: Microbiological Examination of Non-Sterile Products:
Microbial Enumeration Tests 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
[[Page 45464]]
of the ICH Q4B evaluation of the Microbiological Examination of Non-
Sterile Products: Microbial Enumeration Tests 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 part
A of the fourth 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 6, 2008.
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, Training and Manufacturers Assistance
(HFM-40), Center for Biologics Evaluation and Research (CBER), Food and
Drug Administration, 1401 Rockville Pike, 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
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-1), Food and Drug Administration, 1401 Rockville Pike, Rockville,
MD 20852, 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 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 2008, the ICH Steering Committee agreed that a draft
guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial
Texts for Use in the ICH Regions; Annex 4A: Microbiological Examination
of Non-Sterile Products: Microbial Enumeration Tests 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 Microbiological Examination of Non-Sterile
Products: Microbial Enumeration Tests 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.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at https://www.regulations.gov.
III. Electronic Access
Persons with access to the Internet may obtain the document at
https://www.regulations.gov, https://www.fda.gov/cder/guidance/index.htm,
[[Page 45465]]
or https://www.fda.gov/cber/guidelines.htm.
Dated: July 28, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-17862 Filed 8-4-08; 8:45 am]
BILLING CODE 4160-01-S
