[Federal Register Volume 75, Number 171 (Friday, September 3, 2010)]
[Notices]
[Pages 54153-54154]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-21991]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0579]


International Conference on Harmonisation; Guidance on Q4B 
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the 
International Conference on Harmonisation Regions; Annex 11 on 
Capillary Electrophoresis 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 11: Capillary 
Electrophoresis 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 
Capillary Electrophoresis 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. This guidance is in the form of an annex to the 
core guidance on the Q4B process entitled ``Q4B Evaluation and 
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions'' 
(the core ICH Q4B guidance).

DATES:  Submit either electronic or written comments on agency 
guidances 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, 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. Send one self-addressed adhesive label to assist the office in 
processing your requests. The guidance may also be obtained by mail by 
calling CBER at 1-800-835-4709 or 301-827-1800. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

[[Page 54154]]


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 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 December 17, 2009 (74 FR 66981), 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 11: Capillary Electrophoresis 
General Chapter.'' The notice gave interested persons an opportunity to 
submit comments by February 16, 2010.
    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 11: Capillary Electrophoresis General Chapter'' was submitted to 
the ICH Steering Committee and endorsed by the three participating 
regulatory agencies in June 2010.
    The guidance provides the specific evaluation outcome from the ICH 
Q4B process for the Capillary Electrophoresis 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 made 
available in the Federal Register of February 21, 2008 (73 FR 9575). 
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) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments 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/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

    Dated: August 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-21991 Filed 9-2-10; 8:45 am]
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