[Federal Register Volume 76, Number 179 (Thursday, September 15, 2011)]
[Notices]
[Pages 57060-57061]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-23605]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0588]


International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products; Draft 
Guidance for Industry on Pharmacovigilance of Veterinary Medicinal 
Products: Electronic Standards for Transfer of Data; 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availability of a draft guidance for industry (214) entitled 
``Draft Guidance for Industry, Pharmacovigilance of Veterinary 
Medicinal Products: Electronic Standards for Transfer of Data'' (VICH 
GL35). This draft guidance has been developed for veterinary use by the 
International Cooperation on Harmonisation of Technical Requirements 
for Registration of Veterinary Medicinal Products (VICH). This draft 
VICH guidance document is intended to provide recommended standards to 
construct a single electronic message to transmit data elements for 
submission of adverse event reports (AERs) to all member regions.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by November 14, 2011.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Communications Staff (HFV-12), Center for Veterinary 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for electronic access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to 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 Place, 
Rockville, MD 20855, 240-276-9048, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
(214) entitled ``Draft Guidance for Industry, 
Pharmacovigilance of Veterinary Medicinal Products: Electronic 
Standards for Transfer of Data (VICH GL35).'' 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, U.S. FDA, 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.
    Four observers are eligible to participate in the VICH Steering 
Committee: One representative from the government of Australia/New 
Zealand, one representative from the industry in Australia/New Zealand, 
one representative from the government of Canada, and one 
representative from the industry of Canada. 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. Draft Guidance on Electronic Standards for Transfer of Data

    The VICH Steering Committee held a meeting in June 2010, and agreed 
that the draft guidance document entitled ``Draft Guidance for Industry 
on Pharmacovigilance of Veterinary Medicinal Products: Electronic 
Standards for Transfer of Data'' (VICH GL35) should be made available 
for public comment. This draft VICH guidance document is intended to 
provide recommended standards to construct a single electronic message 
to transmit data elements for submission of AERs to all member regions.
    The need to transfer and disseminate information quickly, 
accurately and easily between Regulatory Authorities (RA) and Marketing 
Authorization Holders (MAH) on a worldwide scope is especially 
pertinent to the notification and assimilation of information for 
pharmacovigilance. Whereas the recommended definition of the 
pharmacovigilance information has

[[Page 57061]]

been set forth within the draft guidances entitled, ``Pharmacovigilance 
of Veterinary Medicinal Products: Management of Adverse Event Reports 
(AER's)'' (VICH GL24), ``Pharmacovigilance of Veterinary Medicinal 
Products: Controlled Lists of Terms'' (VICH GL30) and 
``Pharmacovigilance of Veterinary Medicinal Products: Data Elements for 
Submission of Adverse Event Reports'' (VICH GL42), this draft guidance 
defines recommended electronic standards for transfer of data.
    In order to allow for electronic exchange of this information 
between stakeholders, further specification of the field descriptors 
and their relationships, including agreement on format of the 
electronic message is essential.
    FDA and the VICH Expert Working Group will consider comments about 
the draft guidance document.

III. Paperwork Reduction Act of 1995

    This draft 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 No. 0910-0284.

IV. Significance of Guidance

    This draft 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 draft guidance, when finalized, will represent 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.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
It is only necessary to send one set of comments. It is no longer 
necessary to send two copies of mailed 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.

VI. Electronic Access

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

    Dated: September 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-23605 Filed 9-14-11; 8:45 am]
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