[Federal Register: May 2, 2006 (Volume 71, Number 84)]
[Notices]
[Page 25846-25848]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02my06-79]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2000D-1632 (formerly 00D-1632)]
International Cooperation on Harmonisation of Technical
Requirements for Approval of Veterinary Medicinal Products; Draft
Revised Guidance for Industry on Pharmacovigilance of Veterinary
Medicinal Products: Management of Adverse Event Reports; 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 of draft revised guidance for industry (117)
entitled ``Pharmacovigilance of Veterinary Medicinal Products:
Management of Adverse Event Reports (AER's)'' VICH GL24. This draft
revised guidance, which updates a draft guidance on the
[[Page 25847]]
same topic for which a notice of availability was published in the
Federal Register of December 18, 2000 (the 2000 draft guidance), has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 guidance is intended to
describe the reporting system for identification of possible adverse
events following the use of marketed veterinary medicinal products
(VMPs) submitted to the European Union, Japan, and the United States.
DATES: Submit written comments on the draft revised guidance by June 1,
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
revised 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 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, 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 revised 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 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. Draft Guidance on Adverse Event Reports
In November 2005, the VICH steering committee held a meeting and
agreed that the draft guidance document entitled ``Pharmacovigilance of
Veterinary Medicinal Products: Management of Adverse Event Reports
(AER's)'' VICH GL24, should be revised and made available for a second
public comment period. This draft revised guidance updates the draft
guidance on the same topic for which a notice of availability was
published in the Federal Register of December 18, 2000 (65 FR 79111).
The draft revised guidance clarifies the 2000 draft guidance, adds
information, and provides consistency with more recently published VICH
guidances. The draft revised guidance is the product of the
Pharmacovigilance Expert Working Group of VICH. Comments on this draft
will be considered by FDA and the Pharmacovigilance Expert Working
Group.
The draft revised guidance describes the harmonized and common
systems, common definitions, and standardized terminology within
pharmacovigilance. Harmonization of those elements between the VICH
regions facilitates the reporting responsibilities for the marketing
authorities or drug sponsors, many with worldwide activities. More
specifically, the draft revised guidance presents the terms and
definitions intended to harmonize other previously used terms referring
to similar pharmacovigilance concepts. This draft revised guidance
describes a system for the management of adverse drug event reports
following the use of marketed veterinary medicinal products.
This draft revised guidance includes revised text on the definition
of a veterinary medicinal product, definition of international birth
date, and third country reporting. Data elements for the submission of
AERs were removed from this draft revised guidance, but are addressed
in a separate VICH draft guidance document entitled ``Pharmacovigilance
of Veterinary Medicinal Products: Data Elements for Submission of
Adverse Event Reports'' VICH GL42. The notice of availability for VICH
GL42 is published elsewhere in this issue of the Federal Register.
III. Paperwork Reduction Act of 1995
This draft revised 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 21 CFR 514.80 have been
approved under OMB control number 0910-0284 (expiration date 06/30/
2006).
IV. Significance of Guidance
Under part 10 (21 CFR part 10), specifically Sec. 10.115(i)(3),
when issuing draft guidance documents that are the product of
international negotiations, FDA need not apply Sec. 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
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regulatory requirement. However, any final guidance document issued
according to Sec. 10.115(i) must contain the elements in Sec.
10.115(i)(2). In this draft revised 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 Sec. 10.115(i)(3), any mandatory language in this draft revised
guidance that does not describe a statutory or regulatory requirement
will be revised in the final guidance document to comply with Sec.
10.115(i)(2).
The draft revised VICH guidance represents the agency's current
thinking on the management of AERs of approved new animal drugs. 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 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. 2000D-1632, entitled ``Draft Guidance for
Industry on Pharmacovigilance of Veterinary Medicinal Products:
Management of Adverse Event Reports (AER's)'' VICH GL24 and follow the
directions.
Copies of the draft revised guidance document entitled
``Pharmacovigilance of Veterinary Medicinal Products: Management of
Adverse Event Reports (AER's)'' VICH GL24 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. E6-6602 Filed 5-1-06; 8:45 am]
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