[Federal Register Volume 78, Number 43 (Tuesday, March 5, 2013)]
[Notices]
[Pages 14308-14309]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-05016]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2003-D-0433]


International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products; Revised 
Guidance for Industry on ``Studies To Evaluate the Safety of Residues 
of Veterinary Drugs in Human Food: General Approach To Establish a 
Microbiological Acceptable Daily Intake (ADI)'' (VICH GL36(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 revised guidance for industry (GFI 159) 
entitled ``Studies to Evaluate the Safety of Residues of Veterinary 
Drugs in Human Food: General Approach to Establish a Microbiological 
Acceptable Daily Intake (ADI),'' (VICH GL36(R)). This guidance has been 
developed for veterinary use by the International Cooperation on 
Harmonisation of Technical Requirements for Registration of Veterinary 
Medicinal Products (VICH). This 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: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of the 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 guidance document.
    Submit electronic comments on the 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 Pl., Rockville, MD 20855, 240-276-8227, 
Silvia.Pineiro@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
revised guidance for industry (GFI 159) entitled ``Studies to 
Evaluate the Safety of Residues of Veterinary Drugs in Human Food: 
General Approach to Establish a Microbiological Acceptable Daily Intake 
(ADI),'' (VICH GL36(R)).

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 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, 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 governments of Australia/New 
Zealand, one representative from 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. Revised Guidance on Microbiological ADI

    In the Federal Register of June 3, 2011 (76 FR 32218), FDA 
published a notice of availability for 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'' (VICH GL36(R)). Interested persons were given until August 2, 
2011, to comment on the draft revised guidance. FDA received two 
comments on the draft, and those comments, as well as those received by 
other VICH member regulatory agencies, were considered as the guidance 
was finalized. No substantive changes were made in finalizing this 
guidance document. The revised guidance announced in this document 
finalizes the draft revised guidance dated June 2, 2011. The final 
revised guidance is a product of the Microbiological ADI Expert Working 
Group of the VICH.
    This document provides guidance for assessing the human food safety 
of

[[Page 14309]]

residues from veterinary antimicrobial drugs with regard to effects on 
the human intestinal flora. The objectives of this guidance are to: (1) 
Outline the 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.

III. Significance of Guidance

    This 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 ``shall,'' ``must,'' ``require,'' or 
``requirement,'' unless FDA is using these words to describe a 
statutory or regulatory requirement.
    This guidance represents 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 the applicable 
statutes and regulations.

IV. 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 this guidance have been approved under 
OMB control number 0910-0032.

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. 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 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. 2013-05016 Filed 3-4-13; 8:45 am]
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