[Federal Register: May 27, 2005 (Volume 70, Number 102)]
[Notices]               
[Page 30763-30764]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27my05-83]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0200]

 
International Cooperation on Harmonization of Technical 
Requirements for Registration of Veterinary Medicinal Products (VICH); 
Draft Guidance for Industry on Specifications: Test Procedures and 
Acceptance Criteria for New Biotechnological/Biological Veterinary 
Medicinal Products; 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availability of a draft guidance document for industry (177) 
entitled ``Specifications: Test Procedures and Acceptance Criteria for 
New Biotechnological/Biological Veterinary Medicinal Products'' (VICH 
GL40). This draft guidance has been developed for veterinary use by the 
International Cooperation on Harmonization of Technical Requirements 
for Registration of Veterinary Medicinal Products (VICH). This draft 
VICH guidance document is intended to provide 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DATES: Submit written or electronic comments on the draft guidance by 
June 27, 2005, 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Communications Staff (HFV-12), Center for Veterinary 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 requests. 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for electronic access to the draft guidance document.
    Submit written comments on the draft guidance to the Division of 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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: Dennis Bensley, Center for Veterinary 
Medicine (HFV-143), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-6956, e-mail: dbensley@cvm.fda.gov.

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. 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; 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 Biotechnological/Biological Veterinary Medicinal 
Products

    The VICH Steering Committee held a meeting in August 2004 and 
agreed that the draft guidance document entitled ``Specifications: Test 
Procedures and Acceptance Criteria for New Biotechnological/Biological 
Veterinary Medicinal Products,'' (VICH GL40) should be made available 
for public comment. This draft 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.
    FDA and the VICH Safety Working Group will consider comments about 
the draft guidance document. Information collection is covered under 
OMB control number 0910-0032.

III. Significance of Guidance

    The draft 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 ``guideline.'' Because guidance documents are not binding, 
mandatory

[[Page 30764]]

words such as ``must,'' ``shall,'' and ``will'' in the original VICH 
document have been substituted with ``should.'' Similarly, words such 
as ``require'' or ``requirement'' have been replaced by ``recommend'' 
or ``recommendation'' as appropriate to the context.
    The draft VICH guidance (177) is consistent with the 
agency's current thinking on the subject matter. 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 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 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 are available for public examination 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 via the Internet at 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Once on this Internet site, 

select Docket No. 2005D-0200 entitled ``Specifications: Test Procedures 
and Acceptance Criteria for New Biotechnological/Biological Veterinary 
Medicinal Products'' (VICH GL40) and follow the directions.
    Copies of the draft 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 Center for Veterinary Medicine home page at 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cvm.


    Dated: May 23, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-10625 Filed 5-24-05; 11:50 am]

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