[Federal Register: December 18, 2000 (Volume 65, Number 243)]
[Notices]
[Page 79111-79113]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18de00-101]
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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Draft Guidance on ``Pharmacovigilance of Veterinary Medicinal Products: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.
[[Page 79112]]
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availability for comment of a draft guidance for industry (#117)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 This draft
guidance has been developed by the International Cooperation on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 This draft guidance is intended to describe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DATES: Submit written comments concerning the draft guidance to ensure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ADDRESSES: Submit written comments concerning the draft guidance to the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full title of the draft guidance and the docket number found in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Copies of the draft guidance entitled ``Pharmacovigilance of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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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draft guidance to the Communications Staff (HFV-12), Center for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: sthompso@cvm.fda.gov, 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:
candres1@cvm.fda.gov.
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:
nbatalle@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 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]
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