[Federal Register Volume 73, Number 35 (Thursday, February 21, 2008)]
[Notices]
[Pages 9576-9577]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-3187]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0083 (formerly Docket No. 2006D-0296)]


International Conference on Harmonisation; Guidance on Q4B 
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the 
ICH Regions; 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 guidance entitled ``Q4B Evaluation and Recommendation 
of Pharmacopoeial Texts for Use in the ICH Regions; Annex 1: Residue on 
Ignition/Sulphated Ash 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 Residue on Ignition/Sulphated Ash General Chapter harmonized 
text from each of the three pharmacopeias (United States, European, and 
Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The 
guidance conveys recognition of the three pharmacopeial methods by the 
three ICH regulatory regions and provides specific information 
regarding the recognition. The guidance is intended to recognize the 
interchangeability among these texts from the local regional 
pharmacopeias, thus avoiding redundant testing 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 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 (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),

[[Page 9577]]

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. 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. 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 20852-1448, 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 the Federal Register of August 8, 2006 (71 FR 45058), FDA 
published a notice 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 
Chapter.'' The notice gave interested persons an opportunity to submit 
comments by October 10, 2006.
    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 1: Residue on Ignition/Sulphated Ash General Chapter'' was 
submitted to the ICH Steering Committee and endorsed by the three 
participating regulatory agencies in November 2007.
    The 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 
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 pharmacopeial texts evaluated by 
the ICH Q4B process. Following receipt of comments on the draft, no 
substantive changes were made to the annex. The title of the core Q4B 
guidance was changed to more closely reflect the actual workings and 
process of the Q4B EWG.
    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, at any time, submit to the Division of 
Dockets Management (see ADDRESSES) written 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 
office above between 9 a.m. and 4 p.m., Monday through Friday.
    Please note that on January 15, 2008, the FDA Web site transitioned 
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will 
be accepted by FDA through FDMS only.

III. Electronic Access

    Persons with access to the Internet may obtain the document 
athttp://www.fda.gov/ohrms/dockets/default.htm, http://www.fda.gov/cder/guidance/index.htm, or http://www.fda.gov/cber/publications.htm.

    Dated: February 12, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-3187 Filed 2-20-08; 8:45 am]
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