International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 4B on Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms General Chapter; Availability, 15989-15990 [E9-7873]
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Federal Register / Vol. 74, No. 66 / Wednesday, April 8, 2009 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0398]
International Conference on
Harmonisation; Guidance on Q4B
Evaluation and Recommendation of
Pharmacopoeial Texts for Use in the
International Conference on
Harmonisation Regions; Annex 4B on
Microbiological Examination of
Nonsterile Products: Tests for
Specified Microorganisms General
Chapter; Availability
AGENCY:
Food and Drug Administration,
HHS.
rwilkins on PROD1PC63 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance entitled ‘‘Q4B
Evaluation and Recommendation of
Pharmacopoeial Texts for Use in the
ICH Regions; Annex 4B: Microbiological
Examination of Nonsterile Products:
Tests for Specified Microorganisms
General Chapter.’’ The guidance was
prepared under the auspices of the
International Conference on
Harmonisation of Technical
Requirements for Registration of
Pharmaceuticals for Human Use (ICH).
The guidance provides the results of the
ICH Q4B evaluation of the
Microbiological Examination of
Nonsterile Products: Tests for Specified
Microorganisms General Chapter
harmonized text from each of the three
pharmacopoeias (United States,
European, and Japanese) represented by
the Pharmacopoeial Discussion Group
(PDG). The guidance conveys
recognition of the three pharmacopoeial
methods by the three ICH regulatory
regions and provides specific
information regarding the recognition.
The 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. In the Federal Register of
February 21, 2008 (73 FR 9575), FDA
made available a guidance on the Q4B
process entitled ‘‘Q4B Evaluation and
Recommendation of Pharmacopoeial
Texts for Use in the ICH Regions.’’
DATES: Submit written or electronic
comments on agency guidance at any
time.
Submit written requests for
single copies of the guidance to the
Division of Drug Information , Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
ADDRESSES:
VerDate Nov<24>2008
17:05 Apr 07, 2009
Jkt 217001
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,
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 (CBER) at 1–800–835–4709 or
301–827–1800. Send two self-addressed
adhesive labels to assist the office in
processing your requests. Requests and
comments should be identified with the
docket number found in brackets in the
heading of this document. 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:
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
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
PO 00000
Frm 00077
Fmt 4703
Sfmt 4703
15989
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 the Federal Register of August 5,
2008 (73 FR 45465), FDA published a
notice announcing the availability of a
draft tripartite 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 notice gave
interested persons an opportunity to
submit comments by October 6, 2008.
After consideration of the comments
received and revisions to the guidance,
a final draft guidance entitled ‘‘Q4B
Evaluation and Recommendation of
Pharmacopoeial Texts for Use in the
ICH Regions; Annex 4B: Microbiological
Examination of Nonsterile Products:
Tests for Specified Microorganisms
General Chapter’’ was submitted to the
ICH Steering Committee and endorsed
by the three participating regulatory
agencies in November 2008.
The guidance provides the specific
evaluation outcome from the ICH Q4B
process for the Microbiological
Examination of Nonsterile Products:
Tests for Specified Microorganisms
General Chapter harmonization
proposal originating from the threeparty PDG. This guidance is in the form
of an annex to the core ICH Q4B
guidance. When implemented, the
annex will provide guidance for
industry and regulators on the use of the
specific pharmacopoeial texts evaluated
E:\FR\FM\08APN1.SGM
08APN1
15990
Federal Register / Vol. 74, No. 66 / Wednesday, April 8, 2009 / Notices
by the ICH Q4B process. Following
receipt of comments on the draft, no
substantive changes were made to the
annex.
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 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, at any time,
submit to the Division of Dockets
Management (see ADDRESSES) written
comments on the 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/cder/guidance/index.htm,
or https://www.fda.gov/cber/
guidelines.htm.
Dated: March 31, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–7873 Filed 4–7–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0370] (formerly
Docket No. 2007–D–0266)
International Conference on
Harmonisation; Guidance on Q10
Pharmaceutical Quality System;
Availability
AGENCY:
Food and Drug Administration,
HHS.
rwilkins on PROD1PC63 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance entitled ‘‘Q10
Pharmaceutical Quality System.’’ The
guidance was prepared under the
auspices of the International Conference
VerDate Nov<24>2008
17:05 Apr 07, 2009
Jkt 217001
on Harmonisation of Technical
Requirements for Registration of
Pharmaceuticals for Human Use (ICH).
The guidance describes a model for an
effective quality management system for
the pharmaceutical industry, referred to
as the Pharmaceutical Quality System.
The guidance is intended to provide a
comprehensive approach to an effective
pharmaceutical quality system that is
based on International Organization for
Standardization (ISO) concepts,
includes applicable good manufacturing
practice (GMP) regulations and
complements ICH guidances on ‘‘Q8
Pharmaceutical Development’’ and ‘‘Q9
Quality Risk Management.’’
DATES: Submit written or electronic
comments on agency guidance at any
time.
ADDRESSES: Submit written requests for
single copies of the 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, Outreach and
Development (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 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:
Regarding the guidance: Joseph C.
Famulare, Center for Drug
Evaluation and Research (HFD–
300), Food and Drug
Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 5266,
Silver Spring, MD 20993–0002,
301–796–3100;
Christopher Joneckis, Center for
Biologics Evaluation and Research
(HFM–25), Food and Drug
Administration, 1401 Rockville
Pike, suite 200, Rockville, MD
20852, 301–827–0373; or
Diana Amador-Toro, Office of
Regulatory Affairs (HFR-CE350),
Food and Drug Administration, 10
Waterview Blvd., Parsippany, NJ
07054, 973–331–4915.
PO 00000
Frm 00078
Fmt 4703
Sfmt 4703
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 the Federal Register of July 13,
2007 (72 FR 38604), FDA published a
notice announcing the availability of a
draft guidance entitled ‘‘Q10
Pharmaceutical Quality System.’’ The
notice gave interested persons an
opportunity to submit comments by
October 11, 2007.
After consideration of the comments
received and revisions to the guidance,
E:\FR\FM\08APN1.SGM
08APN1
]]>Agencies
[Federal Register Volume 74, Number 66 (Wednesday, April 8, 2009)]
[Notices]
[Pages 15989-15990]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-7873]
[[Page 15989]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0398]
International Conference on Harmonisation; Guidance on Q4B
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the
International Conference on Harmonisation Regions; Annex 4B on
Microbiological Examination of Nonsterile Products: Tests for Specified
Microorganisms General Chapter; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance entitled ``Q4B Evaluation and Recommendation
of Pharmacopoeial Texts for Use in the ICH Regions; Annex 4B:
Microbiological Examination of Nonsterile Products: Tests for Specified
Microorganisms General Chapter.'' The guidance was prepared under the
auspices of the International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use (ICH).
The guidance provides the results of the ICH Q4B evaluation of the
Microbiological Examination of Nonsterile Products: Tests for Specified
Microorganisms General Chapter harmonized text from each of the three
pharmacopoeias (United States, European, and Japanese) represented by
the Pharmacopoeial Discussion Group (PDG). The guidance conveys
recognition of the three pharmacopoeial methods by the three ICH
regulatory regions and provides specific information regarding the
recognition. The 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. In the Federal Register of February 21, 2008
(73 FR 9575), FDA made available a guidance on the Q4B process entitled
``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in
the ICH Regions.''
DATES: Submit written or electronic comments on agency guidance at any
time.
ADDRESSES: Submit written requests for single copies of the 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, 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 (CBER) at 1-800-835-4709 or 301-827-1800. Send two self-
addressed adhesive labels to assist the office in processing your
requests. Requests and comments should be identified with the docket
number found in brackets in the heading of this document. 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:
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 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 the Federal Register of August 5, 2008 (73 FR 45465), FDA
published a notice announcing the availability of a draft tripartite
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 notice gave interested persons an opportunity to submit
comments by October 6, 2008.
After consideration of the comments received and revisions to the
guidance, a final draft guidance entitled ``Q4B Evaluation and
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions;
Annex 4B: Microbiological Examination of Nonsterile Products: Tests for
Specified Microorganisms General Chapter'' was submitted to the ICH
Steering Committee and endorsed by the three participating regulatory
agencies in November 2008.
The guidance provides the specific evaluation outcome from the ICH
Q4B process for the Microbiological Examination of Nonsterile Products:
Tests for Specified Microorganisms General Chapter harmonization
proposal originating from the three-party PDG. This guidance is in the
form of an annex to the core ICH Q4B guidance. When implemented, the
annex will provide guidance for industry and regulators on the use of
the specific pharmacopoeial texts evaluated
[[Page 15990]]
by the ICH Q4B process. Following receipt of comments on the draft, no
substantive changes were made to the annex.
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 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, at any time, submit to the Division of
Dockets Management (see ADDRESSES) written comments on the 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/cder/guidance/index.htm,
or https://www.fda.gov/cber/guidelines.htm.
Dated: March 31, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-7873 Filed 4-7-09; 8:45 am]
BILLING CODE 4160-01-S
