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[Federal Register Volume 80, Number 45 (Monday, March 9, 2015)]
[Notices]
[Pages 12490-12491]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-05346]

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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; Studies 
To Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in 
Food-Producing Animals: Validation of Analytical Methods Used in 
Residue Depletion Studies; 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 #208) entitled 
``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(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, 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 document is intended to provide a general description of 
the criteria that have been found by the European Union, Japan, 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.
    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: 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.
    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

[[Page 12491]]

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: Validation of 
Analytical Methods Used in Residue Depletion Studies

    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: 
Validation of Analytical Methods Used in Residue Depletion Studies'' 
(VICH GL49(R)) should be made available to the public. This 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 makes minor 
changes such as correcting a typographical error in table 2 (Annex 3). 
Also, the explanatory text for table 2 (Annex 3) was revised to correct 
a description of the statistical model and to provide an explanation of 
the procedure used to generate the data in the table. This revised 
guidance is a product of the Metabolism and Residue Kinetics Expert 
Working Group of the VICH.
    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., postapproval 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 VICH 
regions 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

    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. 2015-05346 Filed 3-6-15; 8:45 am]
 BILLING CODE 4164-01-P
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