[Federal Register Volume 71, Number 152 (Tuesday, August 8, 2006)]
[Notices]
[Pages 45059-45060]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-12807]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0297]


International Conference on Harmonisation; Draft Guidance on Q4B 
Regulatory Acceptance of Analytical Procedures and/or Acceptance 
Criteria; 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availability of a draft guidance entitled ``Q4B Regulatory Acceptance 
of Analytical Procedures and/or Acceptance Criteria.'' The draft 
guidance was prepared under the auspices of the International 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 The draft guidance describes a 
procedure to facilitate acceptance by regulatory authorities of 
pharmacopoeial test methods (referred to in the draft guidance as 
analytical procedures and/or acceptance criteria (APAC)) for use in the 
three ICH regions. The draft guidance is intended to facilitate 
regulatory acceptance of these proposed test methods and their 
interchangeability with test methods contained in the local regional 
pharmacopoeias, thus avoiding redundant testing and different 
acceptance criteria in favor of a common testing strategy in each ICH 
regulatory region. Elsewhere in this issue of theFederal Register, FDA 
is announcing the availability of a draft guidance entitled ``Q4B 
Regulatory Acceptance of Analytical Procedures and/or Acceptance 
Criteria; Annex 1: Residue on Ignition/Sulphated Ash General.''

DATES: Submit written or electronic comments on the draft guidance by 
October 10, 2006.

ADDRESSES: Submit written comments on the draft guidance to the 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.fda.gov/dockets/ecomments. 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requests for single copies of the draft guidance to the Division of 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, 5600 Fishers Lane, Rockville, MD 20857; 
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. 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

[[Page 45060]]

Evaluation and Research (HFD-003), Food and Drug Administration, 10993 
New Hampshire Ave., Bldg. 21, rm. 3542, Silver Spring, MD 20993-0002, 
301-796-1242; or
    Christopher Joneckis, Center for Biologics Evaluation and Research 
(HFM-20), Food and Drug Administration, 1401 Rockville Pike, Rockville, 
MD 20852, 301-435-5681.
    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 2006, the ICH Steering Committee agreed that a draft 
guidance entitled ``Q4B Regulatory Acceptance of Analytical Procedures 
and/or Acceptance Criteria'' should be made available for public 
comment. The draft guidance is the product of the Q4B Quality Expert 
Working Group of the ICH. Comments about this draft will be considered 
by FDA and the Q4B Quality Expert Working Group.
    The draft guidance provides information on a Q4B process for 
evaluating harmonization proposals for specific APAC topics originating 
principally from the three-party Pharmacopoeial Discussion Group (PDG). 
The PDG consists of representatives from the European Directorate for 
the Quality of Medicines in the Council of Europe; the Japanese 
Ministry of Health, Labour and Welfare, and the United States 
Pharmacopeial Convention, Inc. Once finalized, the Q4B guidance will 
describe the process for formally conveying the evaluation outcomes as 
topic-specific annexes to the core Q4B guidance. Each annex will be 
issued separately following the ICH step process, providing 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. The draft guidance and 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.fda.gov/ohrms/dockets/default.htm, http://www.fda.gov/cder/guidance/index.htm, or http://www.fda.gov/cber/publications.htm.

    Dated: July 31, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-12807 Filed 8-7-06; 8:45 am]
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