
[Federal Register: April 12, 2010 (Volume 75, Number 69)]
[Notices]               
[Page 18505-18507]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12ap10-60]                         

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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Requirements for Registration of Veterinary Medicinal Products; Draft 
Guidance for Industry on Guidances for the Validation of Analytical 
Methods Used in Residue Depletion Studies (VICH GL49); 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availability of a draft guidance for industry (208) entitled 
``Draft Guidance for Industry on Guidances for the Validation of 
Analytical Methods Used in Residue Depletion Studies,'' (VICH GL49). 
This draft guidance has been developed for veterinary use by the 
International Cooperation on Harmonisation of Technical Requirements 
for Registration of Veterinary Medicinal Products (VICH). This draft 
VICH guidance document is intended to provide a general description of 
the criteria that has been found to be acceptable to the European Union 
(EU), Japan, the United States, Australia, New Zealand, and Canada for 
the validation of analytical methods used in veterinary drug residue 
studies.

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draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by May 12, 2010.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Communications Staff (HFV-12), Center for Veterinary 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 requests.
    Submit written comments on the draft guidance to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit

[[Page 18506]]

electronic comments to http://www.regulations.gov. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance document.

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, e-mail: julia.oriani@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
(208) entitled ``Draft Guidance for Industry on Guidances for 
the 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 EU, 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 EU, 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. Draft Guidance on the Validation of Analytical Methods Used in 
Residue Depletion Studies

    The VICH Steering Committee held a meeting on November 5, 2009, and 
agreed that the draft guidance document entitled ``Draft Guidances for 
the Validation of Analytical Methods Used in Residue Depletion 
Studies,'' (VICH GL49) should be made available for public comment. 
This draft VICH guidance document is one of a series developed to 
facilitate the mutual acceptance of residue chemistry data for 
veterinary drugs used in food-producing animals. This guidance was 
prepared after consideration of the current requirements for evaluating 
veterinary drug residues in the EU, 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 (postapproval control methods) and the validation requirements 
of the regulatory methods are usually well defined by various 
regulatory agencies worldwide and may even be defined by law. 
Consequently, it has been difficult to harmonize the procedures used 
for validation of these methods. However, the residue studies are 
generally conducted before the regulatory methods have been completed. 
Often 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 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 EU, Japan, the United States, Australia, 
New Zealand, and Canada for use in the residue depletion studies. This 
validated method may continue on to become the ``regulatory method'' 
but that phase of the process will not be addressed in any detail in 
these guidances.
    FDA and the VICH Expert Working Group will consider comments about 
the draft guidance document.

III. Significance of Guidance

    This draft 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.
    The draft 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.

IV. Paperwork Reduction Act of 1995

    This draft 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 sections 1-3 of this guidance have been 
approved under OMB control no. 0910-0032.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified 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 guidance 
at either http://www.fda.gov/AnimalVeterinary/

[[Page 18507]]

default.htm or http://www.regulations.gov.

    Dated: April 6, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-8230 Filed 4-9-10; 8:45 am]
BILLING CODE 4160-01-S

