[Federal Register Volume 73, Number 151 (Tuesday, August 5, 2008)]
[Notices]
[Pages 45467-45468]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-17865]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0400]


International Conference on Harmonisation; Draft Guidance on Q4B 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: Acceptance 
Criteria for Pharmaceutical Preparations and Substances for 
Pharmaceutical Use 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availability of a draft guidance entitled ``Q4B Evaluation and 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 4C: Microbiological Examination of Non-Sterile Products: 
Acceptance Criteria for Pharmaceutical Preparations and Substances for 
Pharmaceutical Use 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 The draft guidance was prepared 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 The draft guidance provides the results of the ICH Q4B 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 Non-Sterile Products: 
Acceptance Criteria for Pharmaceutical Preparations and Substances for 
Pharmaceutical Use 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 The draft 
guidance conveys recognition of the three pharmacopoeial methods by the 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 The draft guidance is intended to recognize 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 This draft guidance is part C of the fourth 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this draft guidance before it begins work on the final version of the 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, 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, 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.

[[Page 45468]]

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 20852-1448, 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 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 4C: Microbiological Examination 
of Non-Sterile Products: Acceptance Criteria for Pharmaceutical 
Preparations and Substances for Pharmaceutical Use 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: Acceptance Criteria for Pharmaceutical Preparations and 
Substances for Pharmaceutical Use 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 http://www.regulations.gov.

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: July 28, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-17865 Filed 8-4-08; 8:45 am]
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