[Federal Register Volume 78, Number 43 (Tuesday, March 5, 2013)]
[Notices]
[Pages 14306-14308]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-05014]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2000-D-0598]; (Formerly Docket No. 00D-1631)]


International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products; Draft 
Revised Guidance for Industry on ``Studies To Evaluate the Safety of 
Residues of Veterinary Drugs in Human Food: Genotoxicity Testing'' 
(VICH GL23(R)); 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 draft 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 draft revised guidance is a revision of a final guidance on the 
same topic for which a notice of availability was published in the 
Federal Register of January 4, 2002, and has been developed for 
veterinary use by the International Cooperation on Harmonisation of 
Technical Requirements for Registration of Veterinary Medicinal 
Products (VICH). In this draft revised VICH guidance the recommendation 
for a second test to evaluate the potential of a chemical to produce 
chromosomal effects is being revised. The draft revised guidance 
indicates that the potential of a chemical to produce chromosomal 
effects can be evaluated using one of the the following three tests: An 
in vitro chromosomal aberrations test using metaphase analysis, which 
detects both clastogenicity and aneugenicity; an in vitro mammalian 
cell micronucleus test, which detects the activity of

[[Page 14307]]

clastogenicity and aneugenicity; or a mouse lymphoma test, which, with 
modification, can detect both gene mutation and chromosomal damage. 
This draft 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: 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 revised guidance before it begins work on the final version of 
the revised guidance, submit either electronic or written comments on 
the draft revised guidance by May 6, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
revised 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 request. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft revised guidance 
document.
    Submit electronic comments on the draft 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 Pl., 
Rockville, MD 20855, 240-276-8120, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft 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)). 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 Approval 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 
International Cooperation on Harmonisation of Technical Requirements 
for Registration of Veterinary Medicinal Products (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; U.S. FDA; U.S. Department of Agriculture; 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 of 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 Revised Guidance on Genotoxicity Testing

    In December 2012, the VICH Steering Committee agreed that a draft 
revised guidance document entitled ``Studies to Evaluate the Safety of 
Residues of Veterinary Drugs in Human Food: Genotoxicity Testing'' 
(VICH GL23(R)) should be made available for public comment. This draft 
revised VICH guidance is a revision of a final guidance on the same 
topic for which a notice of availability was published in the Federal 
Register of January 4, 2002 (67 FR 603). In this draft revised guidance 
the recommendation for a second test to evaluate the potential of a 
chemical to produce chromosomal effects is being revised. The draft 
revised guidance indicates that the potential of a chemical to produce 
chromosomal effects can be evaluated using one of the 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 VICH draft revised 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 draft revised guidance is to ensure international harmonization of 
genotoxicity testing.
    The draft revised guidance is a product of the Safety Expert 
Working Group of the VICH. Comments about this draft revised guidance 
document will be considered by FDA and the VICH Safety Expert Working 
Group.

III. Paperwork Reduction Act of 1995

    This draft revised 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 revised guidance have 
been approved under OMB control number 0910-0032.

IV. Significance of Guidance

    This draft revised 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 revised 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

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such approach satisfies the requirements of the applicable statutes and 
regulations.

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

    Dated: February 27, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-05014 Filed 3-4-13; 8:45 am]
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