[Federal Register Volume 72, Number 241 (Monday, December 17, 2007)]
[Notices]
[Pages 71417-71418]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-24434]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D-0458]


International Conference on Harmonisation; Draft Guidance on Q4B 
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the 
International Conference on Harmonisation Regions; Annex 2 on Test for 
Extractable Volume of Parenteral Preparations 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availability of a draft guidance entitled ``Q4B Evaluation and 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 2: Test for Extractable Volume of Parenteral Preparations 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 The draft guidance was prepared under the auspices of the 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 The draft guidance 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 Test for 
Extractable Volume of Parenteral Preparations 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 The draft guidance conveys recognition of the three 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 The draft guidance is 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 is the second annex to 
the core Q4B guidance, which was made available in draft in August 2006 
(71 FR 45059, August 8, 2006).

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this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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 February 15, 2008.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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

[[Page 71418]]

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 November 2007, the ICH Steering Committee agreed that a draft 
guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial 
Texts for Use in the ICH Regions; Annex 2: Test for Extractable Volume 
of Parenteral Preparations 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 Test for Extractable Volume of Parenteral 
Preparations 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 in January 2008, the FDA Web site is expected to 
transition to the Federal Dockets Management System (FDMS). FDMS is a 
Government-wide, electronic docket management system. After the 
transition date, electronic submissions will be accepted by FDA through 
the FDMS only. When the exact date of the transition to FDMS is known, 
FDA will publish a Federal Register notice announcing that date.

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: December 7, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-24434 Filed 12-14-07; 8:45 am]
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