[Federal Register Volume 80, Number 92 (Wednesday, May 13, 2015)]
[Notices]
[Pages 27322-27323]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-11527]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2000-D-0598 (Formerly 2000D-1631)]


International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products (VICH 
GL23(R)); Studies To Evaluate the Safety of Residues of Veterinary 
Drugs in Human Food: Genotoxicity Testing; Revised 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 revised guidance for industry (GFI) #116 entitled 
``Studies to Evaluate the Safety of Residues of Veterinary Drugs in 
Human Food: Genotoxicity Testing'' (VICH GL23(R)). This revised 
guidance has been developed for veterinary use by the International 
Cooperation on Harmonisation of Technical Requirements for Registration 
of Veterinary Medicinal Products (VICH). In this VICH guidance, the 
recommendation for a second test to evaluate the potential of a 
chemical to produce chromosomal effects is revised. The revised 
guidance indicates that the potential of a chemical to produce 
chromosomal effects can be evaluated using one of the following three 
tests: (1) An in vitro chromosomal aberrations test using metaphase 
analysis, which detects both clastogenicity and aneugenicity; (2) an in 
vitro mammalian cell micronucleus test, which detects the activity of 
clastogenicity and aneugenicity; or (3) a mouse lymphoma test, which, 
with modification, can detect both gene mutation and chromosomal 
damage. This revised VICH guidance document is intended to facilitate 
the mutual acceptance of safety data necessary for the establishment of 
acceptable daily intakes for veterinary drug residues in human food by 
the relevant regulatory authorities.

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

ADDRESSES: Submit written requests for single copies of the revised 
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 revised guidance 
document.
    Submit electronic comments on the revised 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 Place, 
Rockville, MD 20855, 240-402-0826, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, many important initiatives have been undertaken by 
regulatory authorities and industry associations to promote the

[[Page 27323]]

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 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.
    In the Federal Register of March 5, 2013 (78 FR 14306), FDA 
published a notice of availability for a draft revised guidance 
document entitled ``Studies to Evaluate the Safety of Residues of 
Veterinary Drugs in Human Food: Genotoxicity Testing'' (VICH GL23(R)) 
giving interested persons until May 6, 2013, to comment on the draft 
revised guidance. FDA received one comment on the draft revised 
guidance, and that comment, as well as those received by other VICH 
member regulatory agencies, were considered as the guidance was 
finalized. The guidance announced in this document finalizes the draft 
revised guidance dated March 5, 2013. The revised guidance is a product 
of the Safety Expert Working Group of the VICH.
    This revised VICH guidance document recommends a second test to 
evaluate the potential of a chemical to produce chromosomal effects. 
The revised VICH guidance indicates that the potential of a chemical to 
produce chromosomal effects can be evaluated using one of the following 
three tests: (1) An in vitro chromosomal aberrations test using 
metaphase analysis, which detects both clastogenicity and aneugenicity; 
(2) an in vitro mammalian cell micronucleus test, which detects the 
activity of clastogenicity and aneugenicity; or (3) a mouse lymphoma 
test, which, with modification, can detect both gene mutation and 
chromosomal damage. This revised VICH guidance is intended to 
facilitate the mutual acceptance of safety data necessary for the 
establishment of acceptable daily intakes for veterinary drug residues 
in human food by the relevant regulatory authorities. The objective of 
this revised VICH guidance is to ensure international harmonization of 
genotoxicity testing.

II. Significance of Guidance

    This guidance, developed under the VICH process, is being issued 
consistent with FDA's good guidance practices regulation (21 CFR 
10.115). This guidance represents the current thinking of FDA on this 
topic. 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.

III. 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.

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

    Dated: May 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-11527 Filed 5-12-15; 8:45 am]
 BILLING CODE 4164-01-P