2014-20482. International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Draft Guidance for Industry on Electronic Exchange of Documents: File Format Recommendations; Availability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.

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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (GFI #225) entitled “Draft Guidance for Industry, Electronic Exchange of Documents: File Format Recommendations” (VICH GL53). This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 27, 2014.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 See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

Submit electronic comments on the draft guidance to http://www.regulations.gov.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, [e-mail].

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FDA is announcing the availability of a draft guidance for industry (GFI #225) entitled “Draft Guidance for Industry, Electronic Exchange of Documents: File Format Recommendations” (VICH GL53).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