[Federal Register Volume 80, Number 104 (Monday, June 1, 2015)]
[Notices]
[Pages 31041-31042]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-13105]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-1804]


International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products; Studies 
To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: 
General Approach To Establish an Acute Reference Dose; Draft Guidance 
for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry (GFI) #232 entitled 
``Studies to Evaluate the Safety of Residues of Veterinary Drugs in 
Human Food: General Approach to Establish an Acute Reference Dose 
(ARfD)'' (VICH GL54). This draft guidance has been developed for 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 
address the nature and types of data that can be useful in determining 
an ARfD for residues of veterinary drugs, the studies that may generate 
such data, and how the ARfD may be calculated based on these data.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by July 31, 2015.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Policy and Regulations Staff (HFV-6), Center for 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INFORMATION section for electronic access to the draft guidance 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    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Tong Zhou, Center for Veterinary 
Medicine (HFV-153), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-0826, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
#232 entitled ``Studies to Evaluate the Safety of Residues of 
Veterinary Drugs in Human Food: General Approach to Establish an Acute 
Reference Dose (ARfD)'' (VICH GL54). 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 (ICH) 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

[[Page 31042]]

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. Draft Guidance on Studies To Evaluate the Safety of Residues of 
Veterinary Drugs in Human Food: General Approach To Establish an Acute 
Reference Dose (ARfD)

    The VICH Steering Committee held a meeting in February 2015 and 
agreed that the draft guidance document entitled ``Studies to Evaluate 
the Safety of Residues of Veterinary Drugs in Human Food: General 
Approach to Establish an Acute Reference Dose (ARfD)'' (VICH GL54) 
should be made available for public comment. This draft VICH guidance 
document is intended to address the nature and types of data that can 
be useful in determining an ARfD for residues of veterinary drugs, the 
studies that may generate such data, and how the ARfD may be calculated 
based on these data.
    FDA and the VICH Expert Working Group will consider comments about 
the draft guidance document.

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). The draft guidance, when finalized, will represent the current 
thinking of FDA on Studies to Evaluate the Safety of Residues of 
Veterinary Drugs in Human Food: General Approach to Establish an Acute 
Reference Dose (ARfD). 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 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 Action 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 draft guidance 
at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.

    Dated: May 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-13105 Filed 5-29-15; 8:45 am]
 BILLING CODE 4164-01-P