Document ID: FDA-2009-D-0013-0001
Agency: fda
Document Type: Notice
Title: International Conference on Harmonisation: Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts; Sterility Test, etc.
Posted Date: 2009-02-17T05:00Z

[Federal Register: February 17, 2009 (Volume 74, Number 30)]
[Notices]
[Page 7446-7447]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17fe09-87]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0013]

International Conference on Harmonisation; Draft Guidance on Q4B
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the
International Conference on Harmonisation Regions; Sterility Test
General Chapter; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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availability of a draft guidance entitled ``Q4B Evaluation and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 8: Sterility Test 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 The draft guidance was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 The draft guidance provides the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 Sterility Test 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 The draft guidance conveys recognition of the three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 The draft guidance is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 This draft guidance is the
eighth 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draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance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 April 20, 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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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,

[[Page 7447]]

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,
suite 200N, 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 http://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 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 November 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 8: Sterility Test 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 Sterility Test 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
http://www.regulations.gov, http://www.fda.gov/cder/guidance/index.htm,
or http://www.fda.gov/cber/guidelines.htm.

    Dated: February 6, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-3167 Filed 2-13-09; 8:45 am]

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