[Federal Register: June 15, 2006 (Volume 71, Number 115)]
[Notices]
[Page 34623-34624]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15jn06-45]
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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://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 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: dennis.bensley@fda.hhs.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
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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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