[Federal Register Volume 76, Number 122 (Friday, June 24, 2011)]
[Notices]
[Pages 37129-37131]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-15814]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0012]


International Conference on Harmonisation; Guidance on Q4B 
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the 
International Conference on Harmonisation Regions; Annex 7(R2) on 
Dissolution Test 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

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availability of a guidance entitled ``Q4B Evaluation and Recommendation 
of Pharmacopoeial Texts for Use in the ICH Regions; Annex 7(R2): 
Dissolution Test General Chapter'' (Q4B Annex 7(R2)). 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 Q4B Annex 7(R2) is a revision 
of the previously published ICH guidance, ``Q4B Evaluation and 
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; 
Annex 7: Dissolution Test General Chapter'' (Q4B Annex 7). The revised 
guidance specifies additional dissolution apparatuses to which 
interchangeability applies in the three ICH regions, updates the 
considerations for implementation, and updates the references used for 
the Q4B evaluation. 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. The 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'' 
(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.

FOR FURTHER INFORMATION CONTACT:

Regarding the Guidance

    Robert H. King, Sr., Center for Drug Evaluation and Research, 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 (EU), 
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 
(MHLW); 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 April 5, 2010 (75 FR 17148), FDA 
published a notice announcing the availability of Q4B Annex 7. In 
September 2010, the April 2010 guidance was revised to add guidance on 
Health Canada consideration. This second revision, Q4B Annex 7(R2), 
specifies additional dissolution apparatuses to which 
interchangeability applies in the three ICH regions: The Basket 
Apparatus (Apparatus 1), the Paddle Apparatus (Apparatus 2), and the 
Flow-Through Cell. Q4B Annex 7(R2) also updates the considerations for 
implementation for FDA, EU, and MHLW. In addition, it updates the 
references used for the Q4B evaluation.
    Following changes made by the three pharmacopeias and after review 
of the changes by the ICH Q4B Expert Working Group, the ICH Steering 
Committee, with the endorsement of the three participating regulatory 
agencies, approved Q4B Annex 7(R2) in November 2010.
    The guidance provides specific evaluation outcomes from the ICH Q4B 
process for the Dissolution Test Chapter harmonization proposal 
originating from the three-party PDG. The 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.
    FDA is issuing Q4B Annex 7(R2) as Level 2 guidance under FDA's good 
guidance practices regulation (21 CFR 10.115). Consistent with FDA's 
good guidance practices regulation, the Agency will accept comments on 
the guidance at any time. 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

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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: June 20, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-15814 Filed 6-23-11; 8:45 am]
BILLING CODE 4160-01-P