International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Draft Guidance for Industry on Electronic Exchange of Documents: File Format Recommendations; Availability, 51342-51343 [2014-20482]

Download as PDF 51342 Federal Register / Vol. 79, No. 167 / Thursday, August 28, 2014 / Notices donations based on screening tests for syphilis. The recommendations described in the document are for blood establishments that use either nontreponemal or treponemal screening assays to test donors for serological evidence of syphilis infection. In the Federal Register of February 26, 2013 (78 FR 13069), FDA announced the availability of the 2013 draft guidance. FDA received several comments on the 2013 draft guidance and those comments were considered as the guidance was finalized. In summary, FDA modified the recommendations provided in the 2013 draft guidance concerning the use of an FDA-cleared nontreponemal donor screening assay to test donations from reentered donors. In addition, FDA made editorial changes to recommendations in the guidance to improve clarity. The guidance announced in this notice finalizes the 2013 draft guidance. The guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents FDA’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 requirement of the applicable statutes and regulations. II. 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 601.12 have been approved under OMB control number 0910–0338; and 21 CFR 606.121, 606.160, 610.40, 630.6, 640.3, 640.65, and 640.71 have been approved under OMB control number 0910–0116. pmangrum on DSK3VPTVN1PROD with NOTICES III. Comments Interested persons may submit either electronic comments regarding this document to https://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 https:// www.regulations.gov. VerDate Mar<15>2010 14:14 Aug 27, 2014 Jkt 232001 IV. Electronic Access Persons with access to the Internet may obtain the guidance at either https://www.fda.gov/Biologics BloodVaccines/GuidanceCompliance RegulatoryInformation/Guidances/ default.htm or https:// www.regulations.gov. Dated: August 25, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–20483 Filed 8–27–14; 8:45 am] BILLING CODE 4164–01–P 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. 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. SUMMARY: 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. DATES: Submit written requests for single copies of the guidance to the ADDRESSES: PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 Communications Staff (HFV–12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one selfaddressed 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 https:// 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, Scott.Fontana@fda.hhs.gov. 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; E:\FR\FM\28AUN1.SGM 28AUN1 Federal Register / Vol. 79, No. 167 / Thursday, August 28, 2014 / Notices pmangrum on DSK3VPTVN1PROD with NOTICES 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. III. Significance of Guidance 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. 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. VerDate Mar<15>2010 14:14 Aug 27, 2014 Jkt 232001 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 V. Comments Interested persons may submit either electronic comments regarding this document to https://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 https:// www.regulations.gov. VI. Electronic Access Persons with access to the Internet may obtain the draft guidance at either https://www.fda.gov/AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/default.htm or https://www.regulations.gov. Dated: August 22, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–20482 Filed 8–27–14; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 51343 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0001] Risk Communications Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Risk Communications Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on November 3 and 4, 2014, from 9 a.m. to 5 p.m. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993–0002. Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/ AdvisoryCommittees/default.htm; under the heading ‘‘Resources for You,’’ click on ‘‘Public Meetings at the FDA White Oak Campus.’’ Please note that visitors to the White Oak Campus must enter through Building 1. Contact Person: Luis G. Bravo, Office of Planning, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3274, Silver Spring, MD 20993–0002, 240–402–5274, FAX: 301–847–8609, email: RCAC@ fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site at https:// www.fda.gov/AdvisoryCommittees/ default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. If you are unable to join us in person, we encourage you to watch the free Webcast. Visit the Risk Communication Advisory Committee Web site at https:// E:\FR\FM\28AUN1.SGM 28AUN1

Agencies

[Federal Register Volume 79, Number 167 (Thursday, August 28, 2014)]
[Notices]
[Pages 51342-51343]
From the Federal Register Online via the Government Printing 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.

-----------------------------------------------------------------------

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 https://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, Scott.Fontana@fda.hhs.gov.

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 https://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 https://www.regulations.gov.

VI. Electronic Access

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

Dated: August 22, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-20482 Filed 8-27-14; 8:45 am]
BILLING CODE 4164-01-P

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