[Federal Register Volume 80, Number 45 (Monday, March 9, 2015)]
[Notices]
[Pages 12501-12502]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-05345]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0166]


International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products; Studies 
To Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in 
Food-Producing Animals: Marker Residue Depletion Studies To Establish 
Product Withdrawal Periods; Revised Guidance for Industry; 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 #207) entitled 
``Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary 
Drugs in Food-Producing Animals: Marker Residue Depletion Studies to 
Establish Product Withdrawal Periods'' (VICH GL48(R)). This revised 
guidance, which provides minor updates to a final guidance on the same 
topic for which a notice of availability was published in the Federal 
Register of September 15, 2011 (2011 guidance), has been developed for 
veterinary use by the International Cooperation on Harmonisation of 
Technical Requirements for Registration of Veterinary Medicinal 
Products (VICH). This revised VICH guidance is intended to provide 
study design recommendations that will facilitate the universal 
acceptance of the generated residue depletion data to fulfill the 
national/regional requirements.

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 revised guidance to http://www.regulations.gov. Submit written comments on the guidance to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Julia Oriani, Center for Veterinary 
Medicine (HFV-151), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-0788, [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.

[[Page 12502]]

    FDA has actively participated in the International Conference on 
Harmonisation of Technical Requirements for Registration 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, FDA, U.S. Department of Agriculture, the Animal Health 
Institute, Japanese Veterinary Pharmaceutical Association, Japanese 
Association of Veterinary Biologics, and 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.

II. Revised Guidance on Studies To Evaluate the Metabolism and Residue 
Kinetics of Veterinary Drugs in Food-Producing Animals: Marker Residue 
Depletion Studies To Establish Product Withdrawal Periods

    In June 2014, the VICH Steering Committee agreed that a revised 
guidance document entitled ``Studies to Evaluate the Metabolism and 
Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Marker 
Residue Depletion Studies to Establish Product Withdrawal Periods'' 
(VICH GL48(R)) should be made available to the public. The 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 
September 15, 2011 (76 FR 57056). The revised guidance includes minor 
changes that clarify recommendations for conducting a single timepoint 
study for products proposed for a 0-day withdrawal period or a 0-day 
milk discard time. In addition, the design for a 0-day milk discard 
timestudy was described, and a definition for preruminant was added. 
This revised guidance is a product of the Metabolism and Residue 
Kinetics Expert Working Group of the VICH.
    As part of the approval process for veterinary medicinal products 
in food-producing animals, national/regional regulatory authorities 
require data from marker residue depletion studies in order to 
establish appropriate withdrawal periods in edible tissues, including 
meat, milk, and eggs. The objective of this guidance is to provide 
study design recommendations that will facilitate the universal 
acceptance of the generated residue depletion data to fulfill the 
national/regional requirements.

III. Significance of Guidance

    As a result of Level 2 revisions, this VICH revised guidance is 
being issued in final, consistent with FDA's good guidance practice 
(GGP) regulations at 21 CFR 10.115(g)(4). This guidance, developed 
under the VICH process, has been revised to conform to FDA's GGP 
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 VICH 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 applicable 
statutes and regulations.

IV. Paperwork Reduction Act of 1995

    This 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 21 CFR part 514 have been approved under 
OMB control number 0910-0032.

V. Comments

    Interested persons may submit either electronic comments regarding 
this document to 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 guidance at 
either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.

    Dated: March 3, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05345 Filed 3-6-15; 8:45 am]
 BILLING CODE 4164-01-P