[Federal Register Volume 74, Number 138 (Tuesday, July 21, 2009)]
[Notices]
[Pages 35875-35876]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-17251]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0309]


International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products (VICH); 
Draft Guidance for Industry on Bracketing and Matrixing Designs for 
Stability Testing of New Veterinary Drug Substances and Medicinal 
Products (VICH GL45); 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availability of a draft guidance for industry (198) entitled 
``Draft Guidance for Industry on Bracketing and Matrixing Designs For 
Stability Testing of New Veterinary Drug Substances and Medicinal 
Products,'' VICH GL45. This draft guidance has been developed for 
veterinary use by the International Cooperation on Harmonisation of 
Technical Requirements for Registration of Veterinary Medicinal 
Products (VICH). This draft guidance is an annex to a VICH guidance 
entitled ``Stability Testing of New Veterinary Drug Substances and 
Medicinal Products (Revision),'' VICH GL3(R), that published in the 
Federal Register of November 23, 2007 (72 FR 65751). This draft VICH 
guidance document is intended to provide guidance on the application of 
reduced designs (i.e., bracketing and matrixing) for stability studies 
conducted in accordance with the principles outlined in VICH GL3(R).

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draft guidance before it begins work on the final version of the 
guidance submit written or electronic comments on the draft guidance by 
August 20, 2009.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Communications Staff (HFV-12), Center for Veterinary 
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, 
MD 20855. Send one self-addressed adhesive label to assist that office 
in processing your request.
    Submit written comments on the draft guidance to the Division of 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.regulations.gov. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Dennis Bensley, Center for Veterinary 
Medicine (HFV-140), Food and Drug Administration, 7500 Standish Place, 
Rockville, MD 20855, 240-276-8268, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
(198) entitled ``Draft Guidance for Industry on Bracketing and 
Matrixing Designs for Stability Testing of New Veterinary Drug 
Substances and Medicinal Products,'' VICH GL45. In recent years, many 
important initiatives have been undertaken by regulatory authorities 
and industry associations to promote the international harmonization of 
regulatory requirements. FDA has participated in efforts to enhance 
harmonization and has expressed its commitment to seek scientifically 
based harmonized technical procedures for the development of 
pharmaceutical products. One of the goals of harmonization is to 
identify and then reduce differences in technical requirements for drug 
development among regulatory agencies in different countries.
    FDA has actively participated in the International Conference on 
Harmonisation of Technical Requirements for Approval of Pharmaceuticals 
for Human Use for several years to develop harmonized technical 
requirements for the approval of human pharmaceutical and biological 
products among the European Union, Japan, and the United States. The 
VICH is a parallel initiative for veterinary medicinal products. The 
VICH is concerned with developing harmonized technical requirements for 
the approval of veterinary medicinal products in the European Union, 
Japan, and the United States, and includes input from both regulatory 
and industry representatives.
    The VICH Steering Committee is composed of member representatives 
from: The European Commission, European Medicines Evaluation Agency, 
European Federation of Animal Health, Committee on Veterinary Medicinal 
Products, the U.S. FDA, the U.S. Department of Agriculture, the Animal 
Health Institute, the Japanese Veterinary Pharmaceutical Association, 
the Japanese Association of Veterinary Biologics, and the Japanese 
Ministry of Agriculture, Forestry, and Fisheries.
    Four observers are eligible to participate in the VICH Steering 
Committee: One representative from the government of Australia/New 
Zealand, one representative from the industry in Australia/New Zealand, 
one representative from the government of Canada, and one 
representative from the industry of Canada. The VICH Secretariat, which 
coordinates the preparation of documentation, is provided by the 
International Federation for Animal Health (IFAH). An IFAH 
representative also participates in the VICH Steering Committee 
meetings.

II. Draft Guidance on Bracketing and Matrixing Designs for Stability 
Testing

    The VICH Steering Committee held a meeting on February 11, 2008, 
and agreed that the draft guidance document entitled ``Draft Guidance 
for Industry on Bracketing and Matrixing Designs for Stability Testing 
of New Veterinary Drug Substances and Medicinal Products,'' VICH GL45 
should be made available for public comment. This draft VICH guidance 
document provides guidance on bracketing and matrixing study designs. 
Specific principles are defined in this guidance for situations in 
which bracketing or matrixing can be applied. This document is intended 
to address recommendations on the application of bracketing and 
matrixing to stability studies conducted in accordance with principles 
outlined in the VICH GL3(R), ``Stability Testing of New Veterinary Drug 
Substances and Medicinal Products (Revision).'' FDA and the VICH Expert 
Quality Working Group will consider comments about the draft guidance 
document.

III. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections

[[Page 35876]]

of information in sections 1-2 of this guidance have been approved 
under OMB Control No. 0910-0032.

IV. Significance of Guidance

    This draft guidance, developed under the VICH process, has been 
revised to conform to FDA's good guidance practices regulation (21 CFR 
10.115). For example, the document has been designated ``guidance'' 
rather than ``guideline.'' In addition, guidance documents must not 
include mandatory language such as ``shall,'' ``must,'' ``require,'' or 
``requirement,'' unless FDA is using these words to describe a 
statutory or regulatory requirement.
    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 applicable statutes and regulations.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
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.

VI. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/cvm or http://www.regulations.gov.

    Dated: July 10, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-17251 Filed 7-20-09; 8:45 am]
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