[Federal Register: May 2, 2006 (Volume 71, Number 84)]
[Notices]
[Page 25845-25846]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02my06-78]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D-0170]
International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products (VICH);
Draft Guidance for Industry on Pharmacovigilance of Veterinary
Medicinal Products; Data Elements for Submission of Adverse Event
Reports (VICH GL42); 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availability for comments of a draft guidance document for industry
(182) entitled ``Pharmacovigilance of Veterinary Medicinal
Products; Data Elements for Submission of Adverse Event Reports'' (VICH
GL42). This draft guidance has been developed for veterinary use by the
International Cooperation on Harmonisation of Technical Requirements
for Registration of Veterinary Medicinal Products (VICH). The objective
of this draft guidance document is to standardize the data for
submission of adverse events relating to veterinary medicinal products.
DATES: Submit written or electronic comments on the draft guidance by
June 1, 2006, 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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Communications Staff (HFV-12), Center for Veterinary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for electronic access to the draft guidance document.
Submit written comments on the draft guidance to the Division of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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Comments should be identified
with the full title of the draft guidance and the docket number found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
Harmonization of Technical Requirements for Approval of Pharmaceuticals
for Human Use for several years to develop harmonized technical
requirements for the approval
[[Page 25846]]
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
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. Draft Guidance on Pharmacovigilance of Veterinary Medicinal
Products
In November 2005, the VICH Steering Committee agreed that a draft
guidance entitled ``Pharmacovigilance of Veterinary Medicinal Products:
Data Elements for Submission of Adverse Event Reports'' (VICH GL42)
should be made available for public comment. Elements of this draft
guidance were previously published in 2000 as part of a draft guidance
entitled ``Pharmacovigilance of Veterinary Medicinal Products:
Management of Adverse Event Reports (AER's)'' (VICH GL24). The
objective of draft guidance VICH GL42 is to standardize the data for
submission of adverse events relating to VMPs. A consistent set of data
will contribute to a harmonized approach for the detection and
investigation of adverse effects of marketed VMPs and thus help to
increase public and animal health. The draft guidance is the product of
the Pharmacovigilance Expert Working Group of the VICH. Comments on
this draft will be considered by FDA and the Pharmacovigilance Expert
Working Group.
III. Paperwork Reduction Act of 1995
This draft guidance document refers to previously approved
collections of information found in FDA regulations. The collections of
information have been approved under OMB control number 0910-0284
(expiration date June 30, 2006). Prior to the finalization and
implementation of this guidance, FDA intends to add the new collection
of information to the related form for submitting adverse event reports
entitled ``Veterinary Adverse Drug Reaction, Lack of Effectiveness,
Product Defect Report'' (Form FDA 1932), and FDA will publish a
separate notice in the Federal Register requesting comment on any new
collection of information in the updated form.
IV. Significance of Guidance
Under 21 CFR 10.115(i)(3), when issuing draft guidance documents
that are the product of international negotiations, FDA need not apply
21 CFR 10.115(i)(2), which states that 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. However, any final guidance
document issued according to 21 CFR 10.115(i) must contain the elements
in 21 CFR 10.115(i)(2). In this draft guidance, any language that is
mandatory under U.S. laws and/or regulations is followed by a citation
to the appropriate statutory or regulatory provision. In accordance
with 21 CFR 10.115(i)(3), any mandatory language in this draft guidance
that does not describe a statutory or regulatory requirement will be
revised in the final guidance document to comply with 21 CFR
10.115(i)(2).
The draft VICH guidance 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 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
Comments may be submitted electronically on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
Once on this Internet site, select
Docket No. 2006D-0170, entitled draft guidance for industry on
``Pharmacovigilance of Veterinary Medicinal Products; Data Elements for
Submission of Adverse Event Reports'' (VICH GL42), and follow the
directions.
Copies of the draft guidance document entitled ``Draft Guidance for
Industry on ``Pharmacovigilance of Veterinary Medicinal Products; Data
Elements for Submission of Adverse Event Reports'' (VICH GL42), may be
obtained on the Internet from the Center for Veterinary Medicine home
page at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cvm.
Dated: April 26, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-6601 Filed 5-1-06; 8:45 am]
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