[Federal Register Volume 72, Number 225 (Friday, November 23, 2007)]
[Notices]
[Pages 65753-65754]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-22902]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1999D-2215]


International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products; Revised 
Guidance for Industry on Impurities in New Veterinary Drug Substances 
(Revision); Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a revised guidance for industry (92) entitled 
``Impurities in New Veterinary Drug Substances (Revision)'' VICH 
GL10(R). This revised guidance has been developed for veterinary use by 
the International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products (VICH). 
The 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 on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of the 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 request. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.
    Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Comments should be identified with the full title 
of the guidance and the docket number found in brackets in the heading 
of this document. Submit electronic comments on the guidance via the 
Internet at http://www.fda.gov/dockets/ecomments or http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Dennis Bensley, Center for Veterinary 
Medicine (HFV-140), 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 for several years in the 
International Conference on Harmonisation of Technical Requirements for 
Approval of Pharmaceuticals for Human Use 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

[[Page 65754]]

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. Revised Guidance on Impurities in New Veterinary Drug Substances

    In the Federal Register of January 4, 2006 (71 FR 351), FDA 
published a notice of availability for a draft revised guidance 
entitled ``Impurities in New Veterinary Drug Substances (Revision)'' 
VICH GL10(R) giving interested persons until February 3, 2006, to 
comment on the draft revised guidance. No comments were received. The 
revised guidance announced in this document finalizes the draft revised 
guidance announced on January 4, 2006. The revised guidance has been 
amended to add to the glossary a definition for the term ``Degradation 
Products''.
    The document is intended to provide guidance for new animal drug 
applicants (referred to in the guidance as registration applicants) on 
the content and qualification of impurities in new veterinary drug 
substances intended to be used for new veterinary medicinal products 
produced by chemical synthesis and not previously registered in a 
country, region, or member state. The revised guidance is the product 
of the Quality Expert Working Group of the VICH.

III. Paperwork Reduction Act of 1995

    This guidance 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 sections 2 through 7 of the guidance have 
been approved under OMB Control Number 0910-0032.

IV. Significance of Guidance

    This 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 revised VICH guidance (guidance for industry 92) is 
consistent with the agency's current thinking on impurities in new 
veterinary drug substances. 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

    Interested persons may, at any time, submit written or electronic 
comments regarding the revised guidance document to the Division of 
Dockets Management (see ADDRESSES). Submit a single copy of electronic 
comments or two copies of written comments, except that individuals may 
submit one copy. Comments are to be identified with the docket number 
found in brackets in the heading of this document. A copy of the 
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.

VI. Electronic Access

    Persons with access to the Internet may obtain the guidance from 
either the CVM home page (http://www.fda.gov/cvm) or the Division of 
Dockets Management Web site (http://www.fda.gov/ohrms/dockets/default.htm).

    Dated: November 12, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-22902 Filed 11-21-07; 8:45 am]
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