[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]
-----------------------------------------------------------------------
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Draft Guidance for Industry on Specifications: Test Procedures and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.
-----------------------------------------------------------------------
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availability of a draft guidance document for industry (177)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 This draft guidance has been developed for veterinary use by the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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Communications Staff (HFV-12), Center for Veterinary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for electronic access to the draft guidance document.
Submit written comments on the draft guidance to the Division of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://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://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://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]
BILLING CODE 4160-01-S