[Federal Register Volume 72, Number 225 (Friday, November 23, 2007)]
[Notices]
[Pages 65751-65752]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-22900]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0139]


International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products; Revised 
Guidance for Industry on Stability Testing of New Veterinary Drug 
Substances and Medicinal Products (Revision); 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 revised guidance for industry (73) entitled 
``Stability Testing of New Veterinary Drug Substances and Medicinal 
Products (Revision) VICH GL3(R).'' This revised guidance has been 
developed for veterinary use by the International Cooperation on 
Harmonisation of Technical Requirements for Registration of Veterinary 
Medicinal Products (VICH). This revised document is intended to provide 
guidance regarding the development of stability testing data for new 
animal drug applications (referred to as registration applications in 
the guidance) submitted to the European Union (EU), Japan, and United 
States.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Communications Staff (HFV-12), Center for Veterinary Medicine 
(CVM), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 
20855. Send one self-addressed adhesive label to assist that office in 
processing your request. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.
    Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Comments should be identified with the full title 
of the guidance and the docket number found in brackets in the heading 
of this document. Submit electronic comments on the guidance via the 
Internet at http://www.fda.gov/dockets/ecomments or http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Dennis Bensley, Center for Veterinary 
Medicine (HFV-140), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-6956, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    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. VICH 
is a parallel initiative for veterinary medicinal products. 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; 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. Revised Guidance on Stability Testing of New Veterinary Drug 
Substances and Medicinal Products

    In the Federal Register of April 14, 2006 (71 FR 19525), FDA 
published a notice of availability for a draft revised guidance 
entitled ``Stability Testing of New Veterinary Drug Substances and 
Medicinal Products (Revision)'', VICH GL3(R) giving interested persons 
until May 15, 2006, to comment on the draft revised guidance. No 
comments were received. The revised guidance announced in this notice 
finalizes the draft revised guidance announced on April 14, 2006. The 
revised guidance is a product of the quality expert working group of 
the VICH. The revised guidance seeks to exemplify the core stability 
data package to be included in registration applications for new 
veterinary drug substances and medicinal products.

[[Page 65752]]

III. Paperwork Reduction Act of 1995

    This 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 of information in section 2 of the guidance have been 
approved under OMB Control No. 0910-0032.

IV. Significance of Guidance

    This revised document, 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 revised VICH guidance (GFI 73) is consistent with the 
agency's current thinking on the stability testing of new veterinary 
drug substances and medicinal products. This guidance does not create 
or confer any rights for or on any person and will not operate to bind 
FDA or the public. An alternative method may be used as long as it 
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 revised 
guidance 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. A copy of the 
guidance and 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 guidance at 
CVM's home page (http://www.fda.gov/cvm) and from the Division of 
Dockets Management Web site (http://www.fda.gov/ohrms/dockets/default.htm).

    Dated: November 12, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-22900 Filed 11-21-07; 8:45 am]
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