[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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