[Federal Register Volume 79, Number 167 (Thursday, August 28, 2014)]
[Notices]
[Pages 51342-51343]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-20482]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1177]


International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products; Draft 
Guidance for Industry on Electronic Exchange of Documents: File Format 
Recommendations; 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availability of a draft guidance for industry (GFI #225) 
entitled ``Draft Guidance for Industry, Electronic Exchange of 
Documents: File Format Recommendations'' (VICH GL53). This draft 
guidance has been developed for veterinary use by the International 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 is 
intended to provide recommendations to industry on electronic file 
format specifications for individual documents and collections of 
multiple related documents that need no subsequent editing and are 
utilized for electronic exchange between industry and regulators in the 
context of regulatory approval of veterinary medicinal products.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by October 27, 2014.

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 requests. 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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 to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Scott Fontana, Center for Veterinary 
Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-0656, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
(GFI #225) entitled ``Draft Guidance for Industry, Electronic 
Exchange of Documents: File Format Recommendations'' (VICH GL53). 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;

[[Page 51343]]

European Medicines Evaluation Agency; European Federation of Animal 
Health; Committee on Veterinary Medicinal Products; FDA; U.S. 
Department of Agriculture; the Animal Health Institute; Japanese 
Veterinary Pharmaceutical Association; Japanese Association of 
Veterinary Biologics; and 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 in 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 Exchange of Documents: File Format 
Recommendations

    In November 2013, the VICH Steering Committee agreed that a draft 
guidance document entitled ``Draft Guidance for Industry, Electronic 
Exchange of Documents: File Format Recommendations'' (VICH GL53) should 
be made available for public comment. This draft VICH guidance document 
is intended to provide recommendations to industry regarding electronic 
file format specifications (e.g., file format, file size, file 
security, and cross referencing) for individual documents and 
collections of multiple related documents for the transfer of 
electronic regulatory information in support of applications for the 
approval of veterinary medicinal products. This draft guidance applies 
to communication or data exchanged as documents in the context of all 
regulatory procedures where regulators accept electronic transfer of 
such documents. This may include, but is not limited to, applications 
for initial marketing authorizations, related presubmission or post-
authorization procedures, applications for maximum residue limits, 
clinical trial applications, drug/active substance master files, or 
requests for regulatory or scientific advice.
    This draft guidance is a product of the Electronic File Format 
Expert Working Group of the VICH. Comments about this draft guidance 
document will be considered by FDA and the VICH Electronic File Format 
Expert Working Group.

III. 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 ``must,'' ``shall,'' ``require,'' or 
``requirement'' unless FDA is using these words to describe a statutory 
or regulatory requirement.
    This draft VICH 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 the applicable statutes and regulations.

IV. 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 number 0910-0032.

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 draft guidance 
at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.

    Dated: August 22, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-20482 Filed 8-27-14; 8:45 am]
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