[Federal Register Volume 71, Number 84 (Tuesday, May 2, 2006)]
[Notices]
[Pages 25846-25848]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-6602]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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revised guidance, which updates a draft guidance on the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Federal Register of December 18, 2000 (the 2000 draft guidance), has 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://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: [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: 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

[[Page 25848]]

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://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://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]
BILLING CODE 4160-01-S