[Federal Register Volume 74, Number 66 (Wednesday, April 8, 2009)]
[Notices]
[Pages 15991-15992]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-7902]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0396]


International Conference on Harmonisation; Guidance on Q4B 
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the 
International Conference on Harmonisation Regions; Annex 4A on 
Microbiological Examination of Nonsterile Products: Microbial 
Enumeration Tests 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 guidance entitled ``Q4B Evaluation and Recommendation 
of Pharmacopoeial Texts for Use in the ICH Regions; Annex 4A: 
Microbiological Examination of Nonsterile Products: Microbial 
Enumeration Tests 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: 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 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 (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. 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 http://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

[[Page 15992]]

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 45463), 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 4A: Microbiological Examination 
of Non-Sterile Products: Microbial Enumeration Tests 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 4A: Microbiological Examination of Nonsterile Products: Microbial 
Enumeration Tests 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: 
Microbial Enumeration Tests 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 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 submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic 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 
http://www.regulations.gov, http://www.fda.gov/cder/guidance/index.htm, 
or http://www.fda.gov/cber/guidelines.htm.

    Dated: March 31, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-7902 Filed 4-7-09; 8:45 am]
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