Document ID: FDA-2010-D-0165-0004
Agency: fda
Document Type: Notice
Title: Guidance for Industry on Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Validation of Analytical Methods Used in Residue Depletion Studies
Posted Date: 2011-09-15T04:00Z

[Federal Register Volume 76, Number 179 (Thursday, September 15, 2011)]
[Notices]
[Pages 57058-57060]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23492]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0165]

International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products; 
Guidance for Industry on Studies To Evaluate the Metabolism and Residue 
Kinetics of Veterinary Drugs in Food-Producing Animals: Validation of 
Analytical Methods Used in Residue Depletion Studies; 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 guidance for industry (208) entitled 
``Guidance for Industry on Studies to Evaluate the Metabolism and 
Residue Kinetics of Veterinary Drugs in Food-Producing Animals: 
Validation of Analytical Methods Used in Residue Depletion Studies,'' 
(VICH GL49). 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 a general description of the 
criteria that have been found by the European Union, Japan, the United 
States, Australia, New Zealand, and Canada to be suitable for the 
validation of analytical methods used in veterinary drug residue 
depletion studies.

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.

[[Page 57059]]

    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: Julia Oriani, Center for Veterinary 
Medicine (HFV-151), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-276-8204, julia.oriani@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
(208) entitled ``Guidance for Industry on Studies to Evaluate 
the Metabolism and Residue Kinetics of Veterinary Drugs in Food-
Producing Animals: Validation of Analytical Methods Used in Residue 
Depletion Studies,'' (VICH GL49). 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 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. Guidance on the Validation of Analytical Methods Used in Residue 
Depletion Studies

    In the Federal Register of April 12, 2010 (75 FR 18505), FDA 
published a notice of availability for a draft guidance entitled 
``Draft Guidance for Industry on Guidances for the Validation of 
Analytical Methods Used in Residue Depletion Studies,'' (VICH GL49), 
which gave interested persons until May 12, 2010, to comment on the 
draft guidance. FDA received a few comments on the draft guidance and 
those comments, as well as those received by other VICH member 
regulatory agencies, were considered as the guidance was finalized. At 
a meeting held in February 2011, the VICH Steering Committee endorsed 
the final guidance for industry (VICH GL49). The guidance announced in 
this document finalizes the draft guidance dated April 12, 2010.
    This VICH guidance document is one of a series developed to 
facilitate the mutual acceptance by national/regional regulators of 
residue chemistry data for veterinary drugs used in food-producing 
animals. This guidance was prepared after consideration of the current 
national/regional requirements and recommendations for evaluating 
veterinary drug residues in the European Union, Japan, the United 
States, Australia, New Zealand, and Canada.
    During the veterinary drug development process, residue depletion 
studies are conducted to determine the concentration of the residue or 
residues present in the edible products (tissues, milk, eggs, or honey) 
of animals treated with veterinary drugs. This information is used in 
regulatory submissions around the world. Submission of regulatory 
methods (i.e., post approval control methods) and the validation 
requirements of the regulatory methods are usually well defined by 
various regulatory agencies worldwide and might even be defined by 
national or regional law. However, the residue depletion studies are 
generally conducted before the regulatory methods have been completed. 
Oftentimes the in-house validated residue methods provide the framework 
for the methods submitted for regulatory monitoring. Harmonization of 
the validation requirements for methodology used during residue 
depletion studies and submitted to the regulatory agencies in support 
of the maximum residue limits and withdrawal periods should be 
achievable. It is the intent of this document to describe a validation 
procedure that is acceptable to the regulatory bodies of the European 
Union, Japan, the United States, Australia, New Zealand, and Canada for 
use in the residue depletion studies. This validated method could 
continue on to become the ``regulatory method,'' but that phase of the 
process will not be addressed in any detail in this guidance. For 
purposes of this guidance, the term ``acceptable'' refers to the 
scientific evaluation of the analytical method in terms of the 
described validation criteria, not to acceptance of the analytical 
method as satisfying the applicable national/regional laws and 
regulations of any of the relevant regulatory bodies.

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

[[Page 57060]]

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

    Dated: September 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-23492 Filed 9-14-11; 8:45 am]
BILLING CODE 4160-01-P