[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]


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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Draft Guidance for Industry on ``Pharmacovigilance of Veterinary 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.

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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availability of a draft guidance for industry (#142) entitled 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 This draft 
guidance has been developed by the International Cooperation on 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 This draft guidance is intended to describe 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DATES:  Submit written or electronic comments on the draft guidance by 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Communications Staff (HFV-12), Center for Veterinary 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INFORMATION section for electronic access to the draft guidance 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    Submit written comments on the draft guidance to the Dockets 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with the full title of the draft guidance and the docket number found 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