[Federal Register Volume 67, Number 25 (Wednesday, February 6, 2002)]
[Notices]
[Pages 5605-5606]
From the Federal Register Online via the Government Publishing 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Draft Guidance for Industry on ``Pharmacovigilance of Veterinary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availability of a draft guidance for industry (#143) entitled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 This draft guidance has been developed by the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 This draft
guidance addresses the process for developing a controlled list of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 This draft guidance is limited to developing a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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Communications Staff (HFV-12), Center for Veterinary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INFORMATION section for electronic access to the draft guidance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Submit written comments on the draft guidance to the Dockets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:
[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
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]
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