[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]
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