[Federal Register Volume 80, Number 169 (Tuesday, September 1, 2015)]
[Notices]
[Pages 52756-52757]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21582]


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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; 
Electronic Exchange of Documents: Electronic File Format; Guidance for 
Industry; 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 #225) entitled 
``Electronic Exchange of Documents: Electronic File Format'' (VICH 
GL53). This guidance has been developed for veterinary use by the 
International Cooperation on Harmonisation of Technical Requirements 
for Registration of Veterinary Medicinal Products (VICH). This VICH 
guidance document is intended to cover the electronic file format 
specifications for individual documents and collections of multiple 
related documents that do not need subsequent modification during the 
regulatory procedure and are utilized for electronic exchange between 
industry and regulatory authorities in the context of regulatory 
approval of veterinary medicinal products.

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

ADDRESSES: Submit written requests for single copies of this guidance 
to the Policy and Regulations Staff (HFV-6), 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 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

    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 government 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 Electronic Exchange of Documents: Electronic File 
Format

    In the Federal Register of August 28, 2014 (79 FR 51342), FDA 
published a notice of availability for a draft guidance entitled 
``Electronic Exchange of Documents: Electronic File Format'' (VICH 
GL53) giving interested persons until October 27, 2014, to comment on 
the draft guidance. FDA received two comments on the draft 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 notice finalizes the draft guidance dated 
August 2014. The final guidance is a product of the Electronic File 
Format Expert Working Group of the VICH.
    This VICH guidance document provides 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 
guidance applies to communication or data exchanged as documents in the 
context of all regulatory procedures where regulatory authorities 
accept electronic transfer of such documents. This can include but is 
not limited to applications for initial marketing authorizations, 
related pre-submission or post-authorization

[[Page 52757]]

procedures, applications for maximum residue limits, clinical trial 
applications, drug/active substance master files, or requests for 
regulatory or scientific advice.

III. Significance of Guidance

    This guidance, developed under the VICH process, has been revised 
to conform with FDA's good guidance practices regulation (21 CFR 
10.115). For example, the document has been designated ``guidance'' 
rather ``guideline''. In addition, guidance documents must not include 
mandatory language such as ``shall'', ``must'', ``require'', or 
``requirements'', unless FDA is using these words to describe a 
statutory or regulatory requirement. The guidance represents the 
current thinking of FDA on electronic exchange of documents: Electronic 
file format. It does not establish any rights for any person and is not 
binding on FDA or the public. You can use an alternative approach if it 
satisfies the requirements of applicable statutes and regulations.

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 21 CFR part 514 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 guidance at 
either http://www.fda.gov/cvm or http://www.regulations.gov.

    Dated: August 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-21582 Filed 8-31-15; 8:45 am]
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