[Federal Register Volume 74, Number 79 (Monday, April 27, 2009)]
[Notices]
[Pages 19096-19097]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-9521]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0430] (formerly Docket No. 2007D-0166)


International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products (VICH); 
Guidance for Industry on ``Target Animal Safety for Veterinary 
Pharmaceutical Products,'' VICH GL43; 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 guidance for industry (185) entitled 
``Target Animal Safety for Veterinary Pharmaceutical Products,'' VICH 
GL43. The purpose of this harmonized guidance is to provide 
recommendations regarding target animal safety (TAS) evaluation for 
regulatory submission of an Investigational Veterinary Pharmaceutical 
Product (IVPP), which is appropriate for determining the safety of an 
IVPP in the target animal. The guidance includes recommendations on 
including identification of target organs, where possible, and 
confirmation of margin of safety, using the minimum number of animals 
appropriate for the studies.

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, Food 
and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send 
one self-addressed adhesive label to assist that office in processing 
your requests.
    Submit written comments on the 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 guidance document.

FOR FURTHER INFORMATION CONTACT: Steven Vaughn, Center for Veterinary 
Medicine, (HFV-100), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-276-8300, 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 (VICH) 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. Guidance on Target Animal Safety for Veterinary Pharmaceutical 
Products

    In the Federal Register of May 18, 2007 (72 FR 28058), FDA 
published the notice of availability for a draft guidance entitled 
``Draft Guidance for Industry on Target Animal Safety for Veterinary 
Pharmaceutical Products,'' which gave interested persons until June 18, 
2007, to comment on the draft guidance. FDA received a few comments on 
the draft guidance and those comments as well as those received by 
other VICH member regulatory agencies were considered as the guidance 
was finalized. Based on the comments received, the VICH Expert Working 
Group on Target Animal Safety clarified the guidance's recommendations 
regarding the development and conduct of TAS studies. In particular, 
the Expert Working Group revised the sections addressing necropsy and 
histopathology examinations and mammary gland studies to clarify the 
recommendations regarding these topics. At a meeting held in July 2008, 
the VICH Steering Committee endorsed the final guidance for industry, 
(VICH GL43). The guidance announced in this notice finalizes the draft 
guidance dated May 18, 2007.
    This guidance document is intended to cover TAS evaluation for any 
IVPP used in the following species: Bovine, ovine, caprine, feline, 
canine, porcine, equine, and poultry (chickens and turkeys). The 
recommendations in this guidance may not be appropriate for 
registration by national or regional authorities of products for use in 
minor species or minor uses. The guidance does not provide information 
for the design of TAS studies in other species, including aquatic 
animals. For other species and for minor uses, TAS studies should be 
designed following national or regional guidance.

III. Significance of Guidance

    This guidance 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

[[Page 19097]]

``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 guidance represents agency's 
current thinking on the 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.

IV. 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 sections 1-5 of the guidance have been 
approved under OMB control no. 0910-0032 (expiration date April 30, 
2010).

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 guidance at 
either http://www.fda.gov/cvm or http://www.regulations.gov.

    Dated: April 20, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-9521 Filed 4-24-09; 8:45 am]
BILLING CODE 4160-01-S