[Federal Register: January 10, 2006 (Volume 71, Number 6)]
[Notices]
[Page 1543-1544]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10ja06-38]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 1999D-2145] (formerly 99D-2145)
International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products; Draft
Revised Guidance for Industry on Impurities in New Veterinary Medicinal
Products (Revised); 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 for comments of a draft revised guidance for industry
(93) entitled ``Impurities in New Veterinary Medicinal
Products (Revised)'' VICH GL11(R). This draft revised guidance, which
updates a final guidance on the same topic for which a notice of
availability was published in the Federal Register of July 7, 2000 (the
2000 guidance), has been developed for veterinary use by the
International Cooperation on Harmonisation of Technical Requirements
for Registration of Veterinary Medicinal Products (VICH). This draft
revised document is intended to assist in developing registration
applications for approval of veterinary medicinal products submitted to
the European Union, Japan, and the United States. The revised guidance
addresses only those impurities in new veterinary medicinal drug
products classified as degradation products.
DATES: Submit written or electronic comments by February 9, 2006, to
ensure their adequate consideration in preparation of the final
guidance 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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Communications Staff (HFV-12), Center for Veterinary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 (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 draft revised guidance
document.
Submit written comments on the draft revised guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Room 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 revised 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
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. VICH
is a parallel initiative for veterinary medicinal products. 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 as follows: 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 Revised Guidance on Impurities in New Veterinary Medicinal
Products
In May 2005, the VICH steering committee agreed that a draft
revised guidance entitled ``Impurities in New Veterinary Medicinal
Products (Revised)'' VICH GL11(R) should be made available for public
comment. The draft revised guidance is a revision of a final guidance
on the same topic for which a notice of availability was published in
the Federal Register of July 7, 2000 (65 FR 42019). The draft revised
guidance clarifies the 2000 guidance, adds information, and provides
consistency with more recently published VICH guidances. The draft
revised guidance is a product of the Quality Expert Working Group of
VICH. Comments about this draft will be considered by FDA and the
Quality Expert Working Group.
This draft revised document is intended to provide guidance for new
animal drug applications on the content and qualification of impurities
in new veterinary drug substances intended to be used for new
veterinary medicinal products, produced by chemical syntheses and not
previously registered in a country, region, or member state.
The draft guidance has been revised to add information to certain
sections and to provide clarification to other sections of the previous
guidance. The
[[Page 1544]]
revisions include changes in the following ways: (1) The text on the
recommended reporting, identification, and qualification thresholds;
(2) the recommended deletion of the exception to conventional rounding
practice; (3) modification of the decision tree in Attachment 2, which
sets out a recommended approach to identifying and qualifying
degradation products; and (4) additions and revisions to the previous
glossary including definitions for the terms ``unspecified degradation
product,'' ``reporting threshold,'' and ``identification threshold.''
In addition, the guidance was updated to reference, where
appropriate, other more recently published VICH guidances relevant to
this topic. Finally, minor editorial changes were made to improve the
clarity and consistency of the document.
III. Paperwork Reduction Act of 1995
This draft revised guidance contains information collection
previsions that 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 this draft revised guidance
have been approved under OMB control number 0910-0032.
IV. Significance of Guidance
This draft revised 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 draft revised VICH guidance (93) represents the
agency's current thinking on impurities in new veterinary drug
medicinal products. This draft revised 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
This draft revised 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 revised 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 revised guidance and 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
Electronic comments may also be submitted on the Internet at http://www.fda.gov/dockets/ecomments.
Once on this Internet site, select
Docket No. 1999D-2245, entitled ``Draft Revised Guidance for Industry
on Impurities in New Veterinary Medicinal Products (Revised)'' (VICH
GL11(R)) and follow the directions.
Copies of the draft guidance document entitled ``Draft Revised
Guidance for Industry on Impurities in New Veterinary Medicinal
Products (Revised)'' VICH GL11(R) may be obtained on the Internet from
the CVM home page at http://www.fda.gov/cvm.
Dated: December 30, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-90 Filed 1-9-06; 8:45 am]
BILLING CODE 4160-01-S