[Federal Register Volume 72, Number 96 (Friday, May 18, 2007)]
[Notices]
[Pages 28058-28059]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-9592]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D-0166]


International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products (VICH); 
Draft Guidance for Industry on Target Animal Safety for Veterinary 
Pharmaceutical Products, VICH GL43, 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availability for comments of a draft guidance document for industry 
(185) entitled ``Draft Guidance for Industry on Target Animal 
Safety for Veterinary Pharmaceutical Products,''VICH GL43. This draft 
guidance has been developed for veterinary use by the International 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 VICH guidance 
document has been developed as a harmonized standard to aid in 
development of mutually acceptable target animal safety (TAS) studies 
for the relevant governmental regulatory bodies.

DATES: Submit written or electronic comments on the draft guidance by 
June 18, 2007, 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Communications Staff (HFV-12), Center for Veterinary 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, 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for electronic access to the draft guidance document.
    Submit written comments on the draft guidance to the Division of 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with the full title of the draft guidance and the docket number found 
in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Laura Hungerford, Center for 
Veterinary Medicine, (HFV-100), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-6439, 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

[[Page 28059]]

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. Draft Guidance on Target Animal Safety

    The VICH steering committee held a meeting in December 2006 and 
agreed that the draft guidance document entitled ``Draft Guidance for 
Industry on Target Animal Safety for Veterinary Pharmaceutical 
Products,''VICH GL43 should be made available for public comment. This 
draft VICH guidance document has been developed as a harmonized 
standard to aid in development of mutually acceptable TAS studies for 
the relevant governmental regulatory bodies. This draft guidance 
document is intended to cover TAS studies for any Investigational 
Veterinary Pharmaceutical Product used in the following species: 
Bovine, ovine, caprine, feline, canine, porcine, equine, and poultry 
(chickens and turkeys). Minor species and minor uses may be excluded 
from this guidance for local registration. The guidance does not 
provide information for the design of TAS studies in other species 
including aquatic animals. For other species, TAS studies should be 
designed following local guidance.
    FDA and the VICH Expert 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 of information in section 1-5 of the draft guidance have 
been approved under OMB Control No. 0910-0032.

IV. Significance of Guidance

    This draft 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 VICH guidance (GFI 185) is consistent with the 
agency's current thinking on this topic. 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.

IV. Comments

    This draft guidance document is being distributed for comment 
purposes only and is not intended for implementation at this time. 
Interested persons may submit written or electronic comments regarding 
this draft guidance document to the Division of Dockets Management (see 
ADDRESSES). 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 draft 
guidance and received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

V. Electronic Access

    Electronic comments may also be submitted electronically on the Web 
site at http://www.fda.gov/dockets/ecomments. Once on this Internet 
site, select Docket No. 2007D-0166 entitled ``Draft Guidance for 
Industry on Target Animal Safety for Veterinary Pharmaceutical 
Products,''VICH GL43 and follow the directions.
    Copies of the draft guidance document entitled ``Draft Guidance for 
Industry on Target Animal Safety for Veterinary Pharmaceutical 
Products,''VICH GL43 may be obtained on the Web site from the Center 
for Veterinary Medicine home page at http://www.fda.gov/cvm.

    Dated: May 10, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-9592 Filed 5-17-07; 8:45 am]
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