[Federal Register Volume 71, Number 6 (Tuesday, January 10, 2006)]
[Notices]
[Pages 1543-1544]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-90]


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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Communications Staff (HFV-12), Center for Veterinary 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