[Federal Register Volume 66, Number 240 (Thursday, December 13, 2001)]
[Notices]
[Pages 64450-64451]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-30766]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 01D-0501]
International Cooperation on Harmonisation of Technical
Requirements for Approval of Veterinary Medicinal Products (VICH);
Draft Guidance for Industry on ``Pharmacovigilance of Veterinary
Medicinal Products: Management of Periodic Summary Update Reports
(PSUs)'' (VICH GL29); Request for Comments; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry (#142) entitled
``Pharmacovigilance of Veterinary Medicinal Products: Management of
Periodic Summary Update Reports (PSUs)'' (VICH GL29). This draft
guidance has been developed by the International Cooperation on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 This draft guidance is intended to describe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 submitted
to the European Union, Japan, and the United States.
DATES: Submit written or electronic comments on the draft guidance by
January 14, 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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Communications Staff (HFV-12), Center for Veterinary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INFORMATION section for electronic access to the draft guidance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Submit written comments on the draft guidance to the Dockets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with the full title of the draft guidance and the docket number found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 veterinary medicinal products. 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; 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
[[Page 64451]]
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 Management of Periodic Summary Update Reports
The VICH Steering Committee held a meeting on June 28, 2001, and
agreed that the draft guidance document entitled ``Pharmacovigilance of
Veterinary Medicinal Products: Management of Periodic Summary Update
Reports (PSUs)'' should be made available for public comment.
This draft guidance should be read in conjunction with the VICH
guidance document entitled ``Pharmacovigilance of Veterinary Medicinal
Products: Management of Adverse Event Reports (AERs)'' (VICH GL24) that
defines the PSU.
The draft guidance describes harmonized submission timing and
submission content for PSU reports. 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.
FDA and the VICH Safety Working Group 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.
(Information collection is covered under OMB control number 0910-
0012.)
III. Significance of Guidance
This draft document, developed under the VICH process, has been
revised to be consistent with 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, 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
management of PSUs of approved new animal drugs. 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 January 14, 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 electronically on the Internet
at http://www.fda.gov/dockets/ecomments. Once on this Internet site,
select [Docket No. 01D-0501] ``Pharmacovigilance of Veterinary
Medicinal Products: Management of Periodic Summary Update Reports
(PSUs)'' (VICH GL29) and follow the directions.
Copies of the draft guidance entitled ``Pharmacovigilance of
Veterinary Medicinal Products: Management of Periodic Summary Update
Reports (PSUs)'' (VICH GL29) may be obtained on the Internet from the
CVM home page at http://www.fda.gov/cvm.
Dated: December 3, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-30766 Filed 12-12-01; 8:45 am]
BILLING CODE 4160-01-S