[Federal Register Volume 71, Number 2 (Wednesday, January 4, 2006)]
[Notices]
[Pages 351-352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E5-8222]


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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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Communications Staff (HFV-12), Center for Veterinary 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://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: [email protected].

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://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://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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