[Federal Register Volume 71, Number 115 (Thursday, June 15, 2006)]
[Notices]
[Pages 34623-34624]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-9324]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0200]


International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products; Final 
Guidance for Industry on ``Specifications: Test Procedures and 
Acceptance Criteria for New Biotechnological/Biological Veterinary 
Medicinal Products;'' Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance document for industry (177) 
entitled ``Specifications: Test Procedures and Acceptance Criteria for 
New Biotechnological/Biological Veterinary Medicinal Products'' (VICH 
GL40). This guidance has been developed for veterinary use by the 
International Cooperation on Harmonization of Technical Requirements 
for Registration of Veterinary Medicinal Products (VICH). This VICH 
guidance document provides general principles through recommendations 
on the setting and justification, to the extent possible, of a uniform 
set of international specifications for biotechnological and biological 
products to support new marketing applications.

DATES: Submit written or electronic comments 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 requests. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.

[[Page 34624]]

    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.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.
    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. Guidance on Biotechnological/Biological Veterinary Medicinal 
Products

    In the Federal Register of May 27, 2005 (70 FR 30763), FDA 
published the notice of availability of the VICH draft guidance, giving 
interested persons until June 27, 2005, to submit comments. No comments 
were received. At a meeting held on November 2005, the VICH Steering 
Committee endorsed the final guidance for industry, (VICH GL-40).
    This VICH guidance document provides general principles through 
recommendations on the setting and justification, to the extent 
possible, of a uniform set of international specifications for 
biotechnological and biological products to support new marketing 
applications. The recommendations in this document apply to products 
composed of well-characterized proteins and polypeptides, and their 
derivatives which are isolated from tissues, body fluids, cell 
cultures, or produced using recombinant deoxyribonucleic acid (r-DNA) 
technology. Thus, the document covers the generation and submission of 
specifications for products such as cytokines, growth hormones and 
growth factors, insulins, and monoclonal antibodies. This document does 
not cover antibiotics, heparins, vitamins, cell metabolites, DNA 
products, allergenic extracts, vaccines, cells, whole blood, and 
cellular blood components.

III. Paperwork Reduction Act of 1995

    This guidance document 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 21 CFR 514.1 have been approved under OMB 
Control No. 0910-0032 (expiration date 12/31/2007).

IV. Significance of Guidance

    This 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 VICH guidance (177) is consistent with the agency's 
current thinking on the Biotechnological/Biological Veterinary 
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

    As with all of FDA's guidances, the public is encouraged to submit 
written or electronic comments pertinent to this guidance. FDA will 
periodically review the comments in the docket and, where appropriate, 
will amend the guidance. The agency will notify the public of any such 
amendments through a notice in the Federal Register.
    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

    Copies of the guidance document entitled ``Specifications: Test 
Procedures and Acceptance Criteria for New Biotechnological/Biological 
Veterinary Medicinal Products'' (VICH GL40) may be obtained on the 
Internet from the CVM home page at http://www.fda.gov/cvm.

    Dated: June 6, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-9324 Filed 6-14-06; 8:45 am]
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