[Federal Register Volume 72, Number 119 (Thursday, June 21, 2007)]
[Notices]
[Pages 34261-34262]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-11996]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2002D-0005 (formerly 02D-0005)]


International Cooperation on Harmonisation of Technical 
Requirements for Approval of Veterinary Medicinal Products (VICH); 
Revised Draft Guidance for Industry on Pharmacovigilance of Veterinary 
Medicinal Products: Controlled List of Terms (VICH GL30); 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availability for comments of a revised draft guidance for industry 
(143) entitled ``Revised Draft Guidance for Industry on 
Pharmacovigilance of Veterinary Medicinal Products: Controlled List of 
Terms'' (VICH GL30). This revised draft guidance, which updates a draft 
guidance on the same topic for which a notice of availability was 
published in the Federal Register of February 6, 2002 (the 2002 
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 VICH guidance 
document describes the specific data elements to be used for the 
submission and exchange of spontaneous adverse event reports (AERs) 
between marketing authorization holders (MAHs) and regulatory 
authorities (RAs).

DATES: Submit written or electronic comments on the revised draft 
guidance by July 23, 2007, to ensure their adequate consideration in 
preparation of the final document. General comments on agency guidance 
documents are welcome at any time.

ADDRESSES: Submit written requests for single copies of the revised 
draft guidance to the Communications Staff (HFV-12), Center for 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 requests. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the revised draft guidance 
document.
    Submit written comments on the revised draft guidance to the 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. Comments should be 
identified with the full title of the revised draft guidance and the 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Lynn Post, Center for Veterinary 
Medicine, (HFV-210), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-276-9062, 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 
Harmonisation 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. Revised Draft Guidance on Controlled Lists of Terms

    In June 2006, the VICH steering committee agreed that a revised 
draft guidance entitled ``Pharmacovigilance of Veterinary Medicinal 
Products: Controlled List of Terms'' (VICH GL30), should be made 
available for public comment. The draft guidance is a revision of a 
guidance on the same topic for which a notice of availability was 
published in the Federal Register of February 6, 2002 (67 FR 5605). 
This revised draft guidance clarifies the 2002 guidance, adding 
information, and providing consistency with more recently published 
VICH guidances.
    This draft VICH guidance document describes the specific data 
elements to be used for the submission and exchange of spontaneous AERs 
between MAHs and RAs. Although the revised draft guidance includes, as 
Appendix A, a proposed list of terms, FDA prefers the list of terms 
maintained by the National Cancer Institute's NCI Thesaurus and would 
like to refer to the NCI Thesaurus in the final guidance. FDA invites 
comments regarding which list of terms (Appendix A or the NCI 
Thesaurus) would be the best choice to further the goals set forth in 
this revised draft guidance. Since Appendix A was included in the 
revised draft guidance for discussion purposes only, it has not yet 
been formally considered within the VICH process. FDA expects that the 
list of terms included in Appendix A will be discussed by a task force 
chosen from the members of the VICH pharmacovigilance expert working 
group.

III. Paperwork Reduction Act of 1995

    This revised draft 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 section III of the revised 
draft guidance have been

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approved under OMB Control No. 0910-0284.

IV. Significance of Guidance

    This draft 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 VICH guidance (143) is consistent with the 
agency's current thinking on this topic. 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

    This draft guidance document is being distributed for comment 
purposes only and is not intended for implementation at this time. 
Interested persons may submit written or electronic comments regarding 
this draft guidance document to the Division of Dockets Management (see 
ADDRESSES). 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 
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 electronically on the Web 
site http://www.fda.gov/dockets/ecomments. Once on this Internet site, 
select Docket No. 2002D-0005 entitled ``Revised Draft Guidance for 
Industry on Pharmacovigilance of Veterinary Medicinal Products: 
Controlled List of Terms'' (VICH GL30), and follow the directions.
    Copies of the draft guidance document entitled ``Revised Draft 
Guidance for Industry on Pharmacovigilance of Veterinary Medicinal 
Products: Controlled List of Terms'' (VICH GL30) may be obtained on the 
Internet from the Center for Veterinary Medicine home page at http://www.fda.gov/cvm.

    Dated: June 13, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-11996 Filed 6-20-07; 8:45 am]
BILLING CODE 4160-01-S