[Federal Register Volume 65, Number 243 (Monday, December 18, 2000)]
[Notices]
[Pages 79111-79113]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-32056]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1632]


International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products (VICH); 
Draft Guidance on ``Pharmacovigilance of Veterinary Medicinal Products: 
Management of Adverse Event Reports (AER's)'' (VICH GL24); 
Availability; Request for Comments

AGENCY: Food and Drug Administration, HHS.

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ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability for comment of a draft guidance for industry (#117) 
entitled ``Pharmacovigilance of Veterinary Medicinal Products: 
Management of Adverse Event Reports (AER's)'' (VICH GL24). This draft 
guidance has been developed by the International Cooperation on 
Harmonisation of Technical Requirements for Registration of Veterinary 
Medicinal Products (VICH). This draft guidance is intended to describe 
the reporting system for identification of possible adverse events 
following the use of marketed veterinary medicinal products (VMP's) 
submitted to the European Union, Japan, and the United States.

DATES: Submit written comments concerning the draft guidance to ensure 
their adequate consideration in preparation of the final document by 
January 17, 2001. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written comments concerning the draft guidance to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Identify comments with the 
full title of the draft guidance and the docket number found in 
brackets in the heading of this document.
    Copies of the draft guidance entitled ``Pharmacovigilance of 
Veterinary Medicinal Products: Management of Adverse Event Reports 
(AER's)'' (VICH GL24) may be obtained on the Internet from the CVM home 
page at http://www.fda.gov/cvm/fda/TOCs/guideline.html. Persons without 
Internet access may submit written requests for single copies of the 
draft guidance to the Communications Staff (HFV-12), Center for 
Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855. Send one self-addressed adhesive label to assist 
that office in processing your requests.

FOR FURTHER INFORMATION CONTACT:
    Regarding VICH: Sharon R. Thompson, Center for Veterinary Medicine 
(HFV-3), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 
20855, 301-594-1798, e-mail: [email protected], or Carole R. Andres, 
Center for Veterinary Medicine (HFV-1), Food and Drug Administration, 
7500 Standish Pl., Rockville, MD 20855, 301-827-6524, e-mail: 
[email protected].
    Regarding the guidance document: Neal Bataller, Center for 
Veterinary Medicine (HFV-214), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0163, 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 the differences in 
technical requirements for drug development among regulatory agencies.
    FDA has actively participated in the International Conference on 
Harmonisation of Technical Requirements for Registration 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. The VICH is a parallel initiative for veterinary pharmaceutical 
products. The VICH is concerned with developing harmonized technical 
requirements for the approval of VMP's 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; the European Medicines Evaluation Agency; 
the European Federation of Animal Health; the 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.
    Two observers are eligible to participate in the VICH Steering 
Committee: One representative from the Government of Australia/New 
Zealand, and one representative from the industry in Australia/New 
Zealand. The VICH Secretariat, which coordinates the preparation of 
documentation, is provided by the Confederation Mondiale de L'Industrie 
de la Sante Animale (COMISA). A COMISA representative also participates 
in the VICH Steering Committee meetings.

II. Draft Guidance on AER's

    The VICH Steering Committee held a meeting on June 15, 2000, and 
agreed that the draft guidance entitled ``Pharmacovigilance of 
Veterinary Medicinal Products: Management of Adverse Event Reports 
(AER's)'' (VICH GL24) should be made available for public comment.
    The draft guidance is intended to describe 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 guidance presents the terms and definitions 
intended to harmonize other previously used terms referring to similar 
pharmacovigilance concepts. The draft guidance describes the various 
components of information flow within the pharmacovigilance system. 
Finally, the draft guidance defines data elements that are sufficiently 
comprehensive to cover complex reports from most sources for the 
purpose of electronic transmission. (This information collected is 
authorized by OMB Control No. 0910-0012).

III. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices (65 FR 56468, September 19, 2000). For example, the 
documents have been designated ``guidance'' rather than ``guideline.'' 
Because guidance documents are not binding, unless specifically 
supported by statute or regulation, mandatory words such as ``must,'' 
``shall,'' and ``will'' in the original VICH documents have been 
substituted with ``should.'' Similarly, words such as ``requirement'' 
or ``acceptable'' or phrases such as ``minimum standards'' or ``minimum 
needed'' have been replaced by ``recommendation'' or ``recommended'' as 
appropriate to the context.
    The draft guidance represents the agency's current thinking on the 
management of AER's of approved new animal drugs. This draft 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.

IV. Comments

    This draft guidance is being distributed for comment purposes only 
and is not intended for implementation

[[Page 79113]]

at this time. Interested persons may submit to the Dockets Management 
Branch (address above) written comments regarding this draft guidance 
document. Submit written comments to ensure adequate consideration in 
preparation of the final guidance by January 17, 2001. Two copies of 
any comments are to be submitted, except that individuals may submit 
one 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 
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

    Dated: December 8, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-32056 Filed 12-15-00; 8:45 am]
BILLING CODE 4160-01-F