[Federal Register Volume 76, Number 107 (Friday, June 3, 2011)]
[Notices]
[Pages 32218-32219]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-13821]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2003-D-0433] (formerly FDA-2003D-0474)


International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products (VICH); 
Draft Revised Guidance for Industry on ``Studies To Evaluate the Safety 
of Residues of Veterinary Drugs in Human Food: General Approach To 
Establish a Microbiological ADI'' (VICH GL-36(R)); Request for 
Comments; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability for comments of a draft revised guidance for industry 
(159) entitled ``Studies to Evaluate the Safety of Residues of 
Veterinary Drugs in Human Food: General Approach to Establish a 
Microbiological ADI'' (VICH GL36(R)). This draft revised guidance, 
which updates a final guidance on the same topic for which a notice of 
availability was published in the Federal Register of February 11, 
2005, has been developed for veterinary use by the International 
Cooperation on Harmonisation of Technical Requirements for Registration 
of Veterinary Medicinal Products (VICH). This draft revised VICH 
guidance was revised to include Appendix D--Supplement to Section 2 
Regarding the Determination of the Fraction of Oral Dose Available to 
Microorganisms. This draft VICH guidance document is intended to 
provide guidance for assessing the human food safety of residues from 
veterinary antimicrobial drugs with regard to effects on the human 
intestinal flora.

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 August 2, 2011.

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: Silvia A. Pineiro, Center for 
Veterinary Medicine, (HFV-157), Food and Drug Administration, 7500 
Standish Place, Rockville, MD 20855, 240-276-8227, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    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, the U.S. 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.
    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

[[Page 32219]]

participates in the VICH Steering Committee meetings.

II. Guidance on Microbiological Acceptable Daily Intake

    In February 2011, the VICH Steering Committee agreed that a draft 
revised guidance entitled ``Studies to Evaluate the Safety of Residues 
of Veterinary Drugs in Human Food: General Approach to Establish a 
Microbiological ADI (Revision)'' (VICH GL36(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 February 11, 2005 
(70 FR 7278). This draft revised guidance was revised to include 
Appendix D-Supplement to Section 2 Regarding the Determination of the 
Fraction of Oral Dose Available to Microorganisms. This VICH guidance 
provides guidance for assessing the human food safety of residues from 
veterinary antimicrobial drugs with regard to effects on the human 
intestinal flora. The objectives of this guidance are to: (1) Outline 
the recommended steps in determining the need for establishing a 
microbiological acceptable daily intake (ADI); (2) recommend test 
systems and methods for determining no-observable adverse effect 
concentrations (NOAECs) and no-observable adverse effect levels 
(NOAELs) for the endpoints of health concern; and (3) recommend a 
procedure to derive a microbiological ADI. It is recognized that 
different tests may be useful. The experience gained with the 
recommended tests may result in future modifications to this guidance 
and its recommendations.
    The draft revised guidance is a product of the Quality Expert 
Working Group of the VICH. Comments about this draft will be considered 
by FDA and the VICH Quality 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 such approach satisfies 
the requirements of applicable statutes and regulations.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed 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.

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: May 31, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-13821 Filed 6-2-11; 8:45 am]
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