[Federal Register Volume 79, Number 196 (Thursday, October 9, 2014)]
[Notices]
[Pages 61081-61082]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-24152]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2002-D-0268 (formerly Docket No. 2002D-0005)]


International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products (VICH 
GL30); Guidance for Industry on Pharmacovigilance of Veterinary 
Medicinal Products: Controlled List of Terms; 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 guidance for industry (GFI #143) entitled ``Guidance 
for Industry on Pharmacovigilance of Veterinary Medicinal Products: 
Controlled List of Terms'' (VICH GL30). This guidance has been 
developed for veterinary use by the International Cooperation on 
Harmonisation of Technical Requirements for Registration of Veterinary 
Medicinal Products (VICH). The purpose of this VICH guidance document 
is to describe the controlled lists of terms critical to completing the 
controlled data fields as identified in the guidance entitled ``Data 
Elements for Submission of Veterinary Adverse Event Reports to the 
Center for Veterinary Medicine'' (GFI #188), available on the FDA Web 
site at: http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/ucm042450.htm.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Communications Staff (HFV-12), Center for Veterinary Medicine, Food 
and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send 
one self-addressed adhesive label to assist that office in processing 
your request. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments on the guidance to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Margarita Brown, Center for Veterinary 
Medicine (HFV-240), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-276-9048, [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 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 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.
    Six observers are eligible to participate in the VICH Steering 
Committee: One representative from the governments of Australia/New 
Zealand, one representative from the industry in Australia/New Zealand, 
one representative from the government of Canada, one representative 
from the industry of Canada, one representative from the government of 
South Africa, and one representative from the industry of South Africa. 
The VICH Secretariat, which coordinates the preparation of 
documentation, is provided by the International Federation for Animal 
Health (IFAH). An IFAH representative also participates in the VICH 
Steering Committee meetings.

II. Guidance on Controlled Lists of Terms

    In the Federal Register of June 21, 2007 (72 FR 34261), FDA 
published a notice of availability for a revised draft guidance 
entitled ``Revised Draft Guidance for Industry on Pharmacovigilance of 
Veterinary Medicinal Products: Controlled List of Terms'' (VICH GL30). 
Interested persons were given until July 23, 2007, to comment on the 
revised draft guidance. FDA received a few comments on the draft 
revised guidance, and those comments, as well as those received by 
other VICH member regulatory agencies, were considered as the guidance 
was finalized. The guidance announced in this document finalizes the 
draft revised guidance dated June 20, 2007. The final guidance is a 
product of the Pharmacovigilance Expert Working Group of the VICH.
    This VICH guidance document describes the controlled lists of terms 
critical to completing the controlled data fields as indicated in FDA's 
``Guidance for Industry, Data Elements for Submission of Veterinary 
Adverse Event Reports to the Center for Veterinary Medicine'' (GFI 
#188). To assess the safety and efficacy of veterinary medicinal 
products, the use of controlled lists of terms is important in order to 
assure consistency, as well as to provide for comparison between 
products and across product classes. This guidance also includes an 
appropriate maintenance procedure to keep the lists of terms up to 
date.

III. Significance of Guidance

    This guidance, 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.'' In addition, guidance documents must not include 
mandatory language such as ``shall,'' ``must,'' ``require,'' or 
``requirement,'' unless FDA is using these words to describe a 
statutory or regulatory requirement.
    The guidance represents the Agency's current thinking on this 
topic. It does not create or confer any rights for or on any person and 
does not operate to bind FDA or the public. An alternative approach may 
be used if such approach satisfies the requirements of applicable 
statutes and regulations.

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IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in this guidance have been approved under 
OMB control numbers 0910-0284 and 0910-0645.

V. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

VI. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.

    Dated: October 6, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-24152 Filed 10-8-14; 8:45 am]
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