International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Draft Guidance for Industry on Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Marker Residue Depletion Studies to Establish Product Withdrawal Periods (VICH GL48); Availability, 18504-18505 [2010-8231]
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Federal Register / Vol. 75, No. 69 / Monday, April 12, 2010 / Notices
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Telephone Interview .......................................
Dated: April 6, 2010.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2010–8259 Filed 4–9–10; 8:45 am]
[Docket No. FDA–2010–D–0166]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
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Centers for Disease Control and
Prevention
Advisory Committee on Immunization
Practices: Notice of Charter Renewal
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This gives notice under the Federal
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463) of October 6, 1972, that the
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and Prevention, Department of Health
and Human Services, has been renewed
for a 2-year period through April 1,
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Dated: April 6, 2010.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2010–8254 Filed 4–9–10; 8:45 am]
BILLING CODE 4163–18–P
VerDate Nov<24>2008
17:58 Apr 09, 2010
Jkt 220001
Food and Drug Administration
International Cooperation on
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products; Draft
Guidance for Industry on Studies to
Evaluate the Metabolism and Residue
Kinetics of Veterinary Drugs in FoodProducing Animals: Marker Residue
Depletion Studies to Establish Product
Withdrawal Periods (VICH GL48);
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry (#207) entitled ‘‘Draft Guidance
for Industry on Studies to Evaluate the
Metabolism and Residue Kinetics of
Veterinary Drugs in Food-Producing
Animals: Marker Residue Depletion
Studies to Establish Product Withdrawal
Periods,’’ (VICH GL48). 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 study
design recommendations which will
facilitate the universal acceptance of the
generated residue depletion data to
fulfill this recommendation.
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 selfaddressed adhesive label to assist that
office in processing your requests.
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
37
Number of responses per
respondent
1
Average
burden per
response
(in hours)
1
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
electronic comments to https://
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, email: julia.oriani@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry (#207)
entitled ‘‘Draft Guidance for Industry on
Studies to Evaluate the Metabolism and
Residue Kinetics of Veterinary Drugs in
Food-Producing Animals: Marker
Residue Depletion Studies to Establish
Product Withdrawal Periods,’’ (VICH
GL48). 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
(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
E:\FR\FM\12APN1.SGM
12APN1
Federal Register / Vol. 75, No. 69 / Monday, April 12, 2010 / Notices
sroberts on DSKD5P82C1PROD with NOTICES
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 Study to Marker
Residue Depletion Studies to Establish
Product Withdrawal Periods
The VICH Steering Committee held a
meeting on November 5, 2009, and
agreed that the draft guidance document
entitled ‘‘Draft Guidance for Industry on
Studies to Evaluate the Metabolism and
Residue Kinetics of Veterinary Drugs in
Food-Producing Animals: Marker
Residue Depletion Studies to Establish
Product Withdrawal Periods,’’ VICH
GL48 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, United
States, Australia, New Zealand, and
Canada.
As part of the approval process for
veterinary medicinal products in foodproducing animals, regulatory
authorities recommend data from
marker residue depletion studies in
order to establish appropriate
withdrawal periods in edible products
including meat, milk, eggs, and honey.
The objective of this guidance is to
provide study design recommendations
which will facilitate the universal
VerDate Nov<24>2008
17:58 Apr 09, 2010
Jkt 220001
18505
acceptance of the generated residue
depletion data to fulfill this
recommendation.
FDA and the VICH Expert Working
Group will consider comments about
the draft guidance document.
Dated: April 6, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
III. Significance of Guidance
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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 1–2 of the
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
https://www.fda.gov/AnimalVeterinary/
default.htm or https://
www.regulations.gov.
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
[FR Doc. 2010–8231 Filed 4–9–10; 8:45 am]
BILLING CODE 4160–01–S
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.
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 selfaddressed 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
E:\FR\FM\12APN1.SGM
12APN1
]]>Agencies
[Federal Register Volume 75, Number 69 (Monday, April 12, 2010)]
[Notices]
[Pages 18504-18505]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-8231]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0166]
International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products; Draft
Guidance for Industry on Studies to Evaluate the Metabolism and Residue
Kinetics of Veterinary Drugs in Food-Producing Animals: Marker Residue
Depletion Studies to Establish Product Withdrawal Periods (VICH GL48);
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry (207) entitled
``Draft Guidance for Industry on Studies to Evaluate the Metabolism and
Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Marker
Residue Depletion Studies to Establish Product Withdrawal Periods,''
(VICH GL48). 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 study design
recommendations which will facilitate the universal acceptance of the
generated residue depletion data to fulfill this recommendation.
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 electronic comments
to https://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
(207) entitled ``Draft Guidance for Industry on Studies to
Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in
Food-Producing Animals: Marker Residue Depletion Studies to Establish
Product Withdrawal Periods,'' (VICH GL48). 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 (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
[[Page 18505]]
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 Study to Marker Residue Depletion Studies to
Establish Product Withdrawal Periods
The VICH Steering Committee held a meeting on November 5, 2009, and
agreed that the draft guidance document entitled ``Draft Guidance for
Industry on Studies to Evaluate the Metabolism and Residue Kinetics of
Veterinary Drugs in Food-Producing Animals: Marker Residue Depletion
Studies to Establish Product Withdrawal Periods,'' VICH GL48 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,
United States, Australia, New Zealand, and Canada.
As part of the approval process for veterinary medicinal products
in food-producing animals, regulatory authorities recommend data from
marker residue depletion studies in order to establish appropriate
withdrawal periods in edible products including meat, milk, eggs, and
honey. The objective of this guidance is to provide study design
recommendations which will facilitate the universal acceptance of the
generated residue depletion data to fulfill this recommendation.
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 1-2 of the 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 https://www.fda.gov/AnimalVeterinary/default.htm or https://www.regulations.gov.
Dated: April 6, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-8231 Filed 4-9-10; 8:45 am]
BILLING CODE 4160-01-S
