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, 57058-57060 [2011-23492]
Download as PDF
<![CDATA[
57058
Federal Register / Vol. 76, No. 179 / Thursday, September 15, 2011 / Notices
wreier-aviles on DSKGBLS3C1PROD with NOTICES
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 Comparative
Metabolism Studies in Laboratory
Animals
In the Federal Register of April 12,
2010 (75 FR 18507), FDA published a
notice of availability for a draft guidance
entitled ‘‘Draft Guidance for Industry on
Studies to Evaluate the Metabolism and
Residue Kinetics of Veterinary Drugs in
Food-Producing Animals: Comparative
Metabolism Studies in Laboratory
Animals (VICH GL47),’’ 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to comment on the draft guidance.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received a few comments on the draft
guidance and those comments as well as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 GL47). The
guidance announced in this notice
finalizes the draft guidance dated April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.
The objective of this guidance is to
provide recommendations for
internationally harmonized procedures
to identify the metabolites of veterinary
drugs produced by laboratory animals.
The purpose of the comparative
metabolism studies is to compare the
metabolites of the animals used for
toxicological testing to the residues of
the veterinary drugs in edible tissues of
food-producing animals in order to
determine if the laboratory animals used
for toxicological testing have been
exposed to the metabolites that humans
can be exposed to as residues in
products of food-producing animal
origin.
The human food safety evaluation of
veterinary drug residues helps ensure
that food derived from treated foodproducing animals is safe for human
VerDate Mar<15>2010
15:07 Sep 14, 2011
Jkt 223001
consumption. As part of the data
collection process, studies should be
conducted to characterize the
metabolites to which laboratory animals
are auto-exposed during the
toxicological testing of the veterinary
drug. The purpose of these studies is to
determine whether the metabolites that
people will consume from tissues of
target food-producing animals are also
produced by metabolism in the
laboratory animals used for the safety
testing.
III. Significance of Guidance
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
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
https://www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
Frm 00042
Fmt 4703
Sfmt 4703
Dated: September 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–23490 Filed 9–14–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0165]
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.
PO 00000
GuidanceforIndustry/default.htm or
https://www.regulations.gov.
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 FoodProducing Animals: Validation of
Analytical Methods Used in Residue
Depletion Studies; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 selfaddressed adhesive label to assist that
office in processing your request. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
SUMMARY:
E:\FR\FM\15SEN1.SGM
15SEN1
Federal Register / Vol. 76, No. 179 / Thursday, September 15, 2011 / Notices
wreier-aviles on DSKGBLS3C1PROD with NOTICES
Submit electronic comments on the
guidance to https://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 FoodProducing 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
VerDate Mar<15>2010
15:07 Sep 14, 2011
Jkt 223001
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
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
57059
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
E:\FR\FM\15SEN1.SGM
15SEN1
57060
Federal Register / Vol. 76, No. 179 / Thursday, September 15, 2011 / Notices
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
https://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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0588]
International Cooperation on
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products; Draft
Guidance for Industry on
Pharmacovigilance of Veterinary
Medicinal Products: Electronic
Standards for Transfer of Data;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry (#214) entitled ‘‘Draft Guidance
for Industry, Pharmacovigilance of
Veterinary Medicinal Products:
Electronic Standards for Transfer of
Data’’ (VICH GL35). 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 recommended
standards to construct a single
electronic message to transmit data
wreier-aviles on DSKGBLS3C1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:38 Sep 14, 2011
Jkt 223001
elements for submission of adverse
event reports (AERs) to all member
regions.
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 November 14, 2011.
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 selfaddressed adhesive label to assist that
office in processing your request. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. 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.
FOR FURTHER INFORMATION CONTACT:
Margarita Brown, Center for Veterinary
Medicine (HFV–240), Food and Drug
Administration, 7519 Standish Place,
Rockville, MD 20855, 240–276–9048,
e-mail: margarita.brown@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry (#214)
entitled ‘‘Draft Guidance for Industry,
Pharmacovigilance of Veterinary
Medicinal Products: Electronic
Standards for Transfer of Data (VICH
GL35).’’ 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
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
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, U.S. FDA, 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 Electronic
Standards for Transfer of Data
The VICH Steering Committee held a
meeting in June 2010, and agreed that
the draft guidance document entitled
‘‘Draft Guidance for Industry on
Pharmacovigilance of Veterinary
Medicinal Products: Electronic
Standards for Transfer of Data’’ (VICH
GL35) should be made available for
public comment. This draft VICH
guidance document is intended to
provide recommended standards to
construct a single electronic message to
transmit data elements for submission of
AERs to all member regions.
The need to transfer and disseminate
information quickly, accurately and
easily between Regulatory Authorities
(RA) and Marketing Authorization
Holders (MAH) on a worldwide scope is
especially pertinent to the notification
and assimilation of information for
pharmacovigilance. Whereas the
recommended definition of the
pharmacovigilance information has
E:\FR\FM\15SEN1.SGM
15SEN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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 https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or https://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
