Reports and guidance documents; availability, etc.: Pharmacovigilance veterinary medicinal products; controlled list of terms, 34261-34262 [E7-11996]

Agencies

• Food and Drug Administration

[Federal Register: June 21, 2007 (Volume 72, Number 119)]
[Notices]
[Page 34261-34262]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21jn07-50]


[[Page 34261]]

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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Revised Draft Guidance for Industry on Pharmacovigilance of Veterinary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availability for comments of a revised draft guidance for industry
(143) entitled ``Revised Draft Guidance for Industry on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 This revised draft guidance, which updates a draft
guidance on the same topic for which a notice of availability was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DATES: Submit written or electronic comments on the revised draft
guidance by July 23, 2007, to ensure their adequate consideration in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draft guidance to the Communications Staff (HFV-12), Center for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 https://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: lynn.post@fda.hhs.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
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

[[Page 34262]]

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 https://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 https://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]

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