[Federal Register Volume 71, Number 72 (Friday, April 14, 2006)]
[Notices]
[Pages 19525-19526]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-5525]


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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; Draft 
Revised Guidance for Industry on Stability Testing of New Veterinary 
Drug Substances and Medicinal Products (Revision); Request for 
Comments; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability for comment of a draft revised guidance for industry 
(73) entitled ``Stability Testing of New Veterinary Drug 
Substances and Medicinal Products (Revision)'' VICH GL3(R). This draft 
revised guidance, which updates a guidance on the same topic for which 
a notice of availability was published in the Federal Register of 
October 12, 1999 (64 FR 55293) (the 1999 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 revised document is intended to provide 
guidance regarding the development of stability testing data 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 by May 15, 2006 to ensure 
their adequate consideration in preparation of the final document. 
General comments on agency guidance documents are welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Communications Staff (HFV-12), Center for Veterinary 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 requests. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.
    Submit written comments on the draft guidance to the Division of 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. Comments should be identified 
with the full title of the guidance and the docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Dennis Bensley, Center for Veterinary 
Medicine, (HFV-143), 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.

[[Page 19526]]

    FDA has actively participated in the International Conference on 
Harmonization 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 Revised Guidance on Stability Testing of New Veterinary Drug 
Substances and Medicinal Products

    The draft revised guidance is entitled ``Stability Testing of New 
Veterinary Drug Substances and Medicinal Products (Revision)'' VICH 
GL3(R). It has been adapted for veterinary use by the VICH from 
guidances regarding pharmaceuticals for human use which were adopted by 
the ICH and for which notices of availability were published in the 
Federal Register of November 7, 2001 (66 FR 56332), June 14, 2002 (67 
FR 40951), and November 21, 2003 (68 FR 65717).
    In October 2005, the VICH steering committee agreed that a draft 
revised guidance entitled ``Stability Testing of New Veterinary Drug 
Substances and Medicinal Products (Revision)'' VICH GL3(R) should be 
made available for public comment. The draft revised guidance is a 
revision of a guidance on the same topic for which a notice of 
availability was published in the Federal Register of October 12, 1999. 
The draft revised guidance clarifies the 1999 guidance, adds 
information, and provides consistency with more recently published VICH 
guidances. The draft revised guidance seeks to exemplify the core 
stability data package to be included in registration applications for 
new veterinary drug substances and medicinal products. The draft 
revised guidance is the product of the Quality Expert Working Group of 
the VICH. Comments about this draft will be considered by FDA and the 
Quality Expert Working Group.

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 number 0910-0032.

IV. Significance of Guidance

    This draft 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 draft 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 draft revised 
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

    This draft revised guidance document is being distributed for 
comment purposes only and is not intended for implementation at this 
time. Interested persons may submit to the Division of Dockets 
Management (see ADDRESSES) written or electronic comments regarding 
this draft guidance document. Submit a single copy of electronic 
comments or two paper copies of written 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 draft revised 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

    Electronic comments may also be submitted on the Internet at http://www.fda.gov/dockets/ecomments. Once on this Internet site, select 
Docket No. 1999D-2215, entitled ``Draft Revised Guidance for Industry 
on Stability Testing of New Veterinary Drug Substances and Medicinal 
Products (Revision)'' VICH GL3(R) and follow the directions.
    Copies of the draft guidance document entitled ``Draft Revised 
Guidance for Industry on Stability Testing of New Veterinary Drug 
Substances and Medicinal Products (Revision)'' VICH GL3(R) may be 
obtained on the Internet from the CVM home page at http://www.fda.gov/cvm.

    Dated: April 6, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-5525 Filed 4-13-06; 8:45 am]
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