[Federal Register Volume 71, Number 152 (Tuesday, August 8, 2006)]
[Notices]
[Pages 45058-45059]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-12806]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0296]


International Conference on Harmonisation; Draft Guidance on Q4B 
Regulatory Acceptance of Analytical Procedures and/or Acceptance 
Criteria; Annex on Residue on Ignition/Sulphated Ash 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availability of a draft guidance entitled ``Q4B Regulatory Acceptance 
of Analytical Procedures and/or Acceptance Criteria; Annex 1: Residue 
on Ignition/Sulphated Ash General.'' The draft guidance was prepared 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 The draft guidance provides the outcome of the ICH Q4B 
evaluation of the Residue on Ignition/Sulphated Ash 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 The draft guidance conveys acceptance of the three 
pharmacopoeial methods by the three ICH regulatory regions and provides 
specific information regarding the acceptance. The draft guidance is 
intended to recognize the interchangeability between the local regional 
pharmacopoeias, thus avoiding redundant testing and different 
acceptance criteria in favor of a common testing strategy in each 
regulatory region. Elsewhere in this issue of the Federal Register, FDA 
is announcing the availability of a draft guidance entitled ``Q4B 
Regulatory Acceptance of Analytical Procedures and/or Acceptance 
Criteria.''

DATES: Submit written or electronic comments on the draft guidance by 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

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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, 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. 
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. 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, 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:

[[Page 45059]]

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; Annex 1: Residue on Ignition/Sulfated Ash 
General Chapter'' 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 the specific evaluation outcome from 
the ICH Q4B process for the Residue on Ignition/Sulphated Ash 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. 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. E6-12806 Filed 8-7-06; 8:45 am]
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