[Federal Register: January 4, 2006 (Volume 71, Number 2)]
[Notices]
[Page 351-352]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04ja06-67]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 1999D-2215] (formerly 99D-2215)
International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products; Draft
Revised Guidance for Industry on Impurities in New Veterinary Drug
Substances (Revision); 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
(92) entitled ``Impurities in New Veterinary Drug Substances
(Revision)'' VICH GL10(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). The draft revised document is
intended to provide guidance for registration applicants on the content
and qualification of impurities in new veterinary drug substances
produced by chemical syntheses and not previously registered in a
country, region, or member state.
DATES: Submit written or electronic comments by February 3, 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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Communications Staff (HFV-12), Center for Veterinary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 request. 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, 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.
[[Page 352]]
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: 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 Drug
Substances
In May 2005, the VICH steering committee agreed that a draft
revised guidance entitled ``Impurities in New Veterinary Drug
Substances (Revision)'' VICH GL10(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 42020). The
draft revised guidance clarifies the 2000 guidance, adds information,
and provides consistency with more recently published VICH guidances.
The draft revised guidance is the 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
registration 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 revised guidance includes revised text on recommended
threshold limits and revised text on recommended specification limits
for impurities. Additions to the glossary include definitions for the
terms ``identification threshold'' and ``qualification threshold.''
References to validated limits of quantitation were removed. In
addition, 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
provisions 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,'' ``required,''
or ``requirement,'' unless FDA is using these words to describe a
statutory or regulatory requirement.
The draft revised VICH guidance represents the agency's current
thinking on impurities in new veterinary drug substances. 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://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. 1999D-2215, entitled ``Draft Revised Guidance for Industry
on Impurities in New Veterinary Drug Substances (Revision)'' VICH
GL10(R), and follow the directions.
Copies of the draft guidance document entitled ``Draft Revised
Guidance for Industry on Impurities in New Veterinary Drug Substances
(Revision)'' VICH GL10(R), 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: December 21, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E5-8222 Filed 1-3-06; 8:45 am]
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