[Federal Register Volume 67, Number 25 (Wednesday, February 6, 2002)]
[Notices]
[Pages 5605-5606]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 02-2881]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0005 ]


International Cooperation on Harmonisation of Technical 
Requirements for Approval of Veterinary Medicinal Products (VICH); 
Draft Guidance for Industry on ``Pharmacovigilance of Veterinary 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.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry (#143) entitled 
``Pharmacovigilance of Veterinary Medicinal Products: Controlled List 
of Terms'' (VICH GL30). This draft guidance has been developed by the 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 This draft 
guidance addresses the process for developing a controlled list of 
terms in order to assure that terms are used consistently in adverse 
event reports, and to allow comparison between products and across 
product classes. This draft guidance is limited to developing a 
controlled list of terms describing veterinary medicinal products 
(VMPs), animals, clinical signs, and associated body systems and organs 
for reporting an adverse event associated with the use of a VMP.

DATES: Submit written or electronic comments on the draft guidance by 
March 8, 2002, 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Communications Staff (HFV-12), Center for Veterinary 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 (CVM), Food and Drug Administration, 7500 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INFORMATION section for electronic access to the draft guidance 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    Submit written comments on the draft guidance to the Dockets 
Management Branch (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 guidance and the docket number found 
in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: William C. Keller, Center for 
Veterinary Medicine (HFV-210), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-6642, e-mail: 
wkeller@cvm.fda.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. The 
VICH is a parallel initiative for VMPs. 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; U.S. FDA; U.S. Department of Agriculture; Animal Health 
Institute; Japanese Veterinary Pharmaceutical Association; Japanese 
Association of Veterinary Biologics; and 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 Controlled List of Terms

    The VICH Steering Committee held a meeting on June 28, 2001, and 
agreed that the draft guidance document entitled ``Pharmacovigilance of 
Veterinary Medicinal Products: Controlled List of Terms'' (VICH GL30) 
should be made available for public comment.
    A controlled list of terminology is essential to ensure consistent 
evaluation of adverse event reports and electronic submission of these 
reports on a national and international basis. This draft guidance 
provides recommendations for adopting and managing a controlled list of 
terminology used to describe veterinary medicinal products, animals, 
clinical signs, and associated body systems and organs in adverse event 
reports. Components of the recommendations are directed at regulatory 
authorities and should be implemented by these agencies as well as by 
regulated industry.
    The VICH closely followed the progress of its human counterpart, 
ICH (International Conference on Harmonisation of Technical 
Requirements for Registration of Pharmaceuticals for Human Use), in 
implementing a standardized controlled terminology and believes that 
with appropriate modification the same approach will be viable for the 
VICH. Thus, the approach outlined in the guidance document is based on 
identification of similar technical terminology needs and an approach 
for meeting those needs used by ICH to develop MedDRA (Medical 
Dictionary for Drug Regulatory Activities), the international 
terminology for reports to regulatory authorities describing human 
adverse events.
    These recommendations include that government and industry partner 
together in development,

[[Page 5606]]

implementation, and ongoing maintenance necessary to keep an adverse 
event terminology updated and distributed to users. It recommends 
adopting VEDDRA (Veterinary Medicinal Dictionary for Drug Regulatory 
Authorities) as the controlled list of terminology for adverse event 
reports. Specific recommendations include an independent joint industry 
and government oversight board as well as a funding model that will 
allow use by all regulatory agencies and even the smallest companies in 
industry. The two background paragraphs provide insight into the 
deliberations, recommendations, and comments from the Expert Working 
Group charged by VICH to the VICH Steering Committee on this issue.
    FDA and the VICH will consider comments about the draft guidance 
document. Ultimately, FDA intends to adopt the VICH Steering 
Committee's final guidance and publish it as a final guidance.

III. 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.'' 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 ``require'' or ``requirement'' have been replaced by 
``recommendation'' or ``recommended'' as appropriate to the context.
    The draft guidance represents the agency's current thinking on 
developing a controlled list of terms for reporting an adverse event 
associated with the use of an approved new animal drug. 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.

IV. 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. Written or electronic comments should be 
submitted to the Dockets Management Branch (address above). Submit 
written or electronic comments by March 8, 2002, to ensure adequate 
consideration in preparation of the final guidance. 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.

V. Electronic Access

    Electronic comments may be submitted on the Internet at http://
www.fda.gov/dockets/ecomments. Once on this Internet site, select 
``02D-0005 Pharmacovigilance of Veterinary Medicinal Products: 
Controlled List of Terms (VICH GL30)'' and follow the directions.
    Copies of the draft guidance entitled ``Pharmacovigilance of 
Veterinary Medicinal Products: Controlled List of Terms'' (VICH GL30) 
may be obtained on the Internet from the CVM home page at http://
www.fda.gov/cvm. The draft guidance is also available at http://
www.fda.gov/ohrms/dockets/default.htm.

    Dated: January 30, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-2881 Filed 2-5-02; 8:45 am]
BILLING CODE 4160-01-S