International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Guidance for Industry on Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Repeat-Dose (Chronic) Toxicity Testing (VICH GL-37); Availability, 6449-6450 [05-2266]
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Federal Register / Vol. 70, No. 24 / Monday, February 7, 2005 / Notices
representing consumers, animal feed
processors, animal producers, and State
and other Federal Government agencies.
Following the meeting, we placed a
number of documents in the FDA
Docket named at the beginning of this
notice. These documents included a
transcript of the meeting, summaries of
breakout discussion groups,
presentations of invited speakers, and a
summary of the meeting. We stated our
view that an AFSS should be
comprehensive and risk-based, and we
have since drafted definitions for these
terms and placed them in this Docket.
Likewise, we created and placed in the
Docket a listing of elements we felt
would be essential for process control
under an AFSS. After reviewing
comments to these items in the Docket,
we drafted the following framework for
the AFSS, including the four major
components we see as comprising the
AFSS:
• Component 1—Ingredients and the
approval process.
• Component 2—Limits for animal
feed contaminants.
• Component 3—Process control for
the production of feed ingredients and
mixed feed.
• Component 4—Regulatory
oversight.
This new document has been added
to our Web site and the Docket and will
be discussed at the meeting. We also
intend to discuss a draft risk-ranking
model under development by the
agency for determining the relative risks
of the numerous hazards that may be
present in animal feed. Your comments
on our proposed framework, including
Components 1 through 4, and any riskrelated topics would be most
appreciated. Please submit all
comments by March 4, 2005.
II. Meeting
We are holding the meeting in an
effort to further gather information from
you, our stakeholders, on the design of
an effective, comprehensive, preventive,
risk-based AFSS that is intended to help
minimize risks associated with animal
feeds.
Resources and costs are important
considerations in any such undertaking,
and we are receptive to suggestions
about how these can be controlled or
used most effectively while focusing
preventive efforts on important known
and emerging health risks associated
with animal feeds. We are particularly
interested in your thoughts on the
application of Hazard Analysis and
Critical Control Point (HACCP)
(mandatory or voluntary) to any or all
segments of the industry, development
of risk standards for contaminants,
VerDate jul<14>2003
21:04 Feb 04, 2005
Jkt 205001
revising existing good manufacturing
practices (GMPs) to make them more
risk-based, development of GMP-type
regulations and/or guidance for
producers of feed ingredients and
nonmedicated feeds, extending
regulatory control to users of feed, and
the role of State and first-party
inspections.
On the morning of the first day of the
meeting, we will summarize the
aforementioned documents placed in
our docket, followed by breakout
sessions in the afternoon to discuss each
topic. Additionally, one group will be
asked to discuss the perceived benefits
of the AFSS. The breakout group(s) on
risk analysis and risk-ranking is likely to
be of greatest interest to meeting
attendees who have a scientific
background. If you are interested in
participating in the breakout group on
risk analysis and risk-ranking, please
indicate this on your registration form.
We will do our best to accommodate
these requests.
Discussions will be summarized in
breakout group reports on the final day
of the meeting. The meeting will wrap
up with an open discussion and closing
remarks.
III. Comments
Interested persons may submit written
or electronic comments to the Division
of Dockets Management (see
ADDRESSES). Comments should be
identified with the full title and the
docket number found in brackets in the
heading of this document. A copy of the
received comments will be available for
public examination in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: January 28, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–2210 Filed 2–4–05; 8:45 am]
BILLING CODE 4160–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003D–0466]
International Cooperation on
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products (VICH);
Guidance for Industry on Studies to
Evaluate the Safety of Residues of
Veterinary Drugs in Human Food:
Repeat-Dose (Chronic) Toxicity
Testing (VICH GL–37); Availability
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
ACTION:
6449
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance document for
industry (#160) entitled ‘‘Studies to
Evaluate the Safety of Residues of
Veterinary Drugs in Human Food:
Repeat-Dose (Chronic) Toxicity Testing’’
(VICH GL–37). 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 establish recommendations
for internationally harmonized repeatdose chronic toxicity testing.
DATES: Submit written or electronic
comments at any time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Communications Staff (HFV–12), Center
for Veterinary Medicine (CVM), Food
and Drug Administration, 7519 Standish
Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
Submit written comments on the
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.fda.gov/dockets/ecomments.
Comments should be identified with the
full title of the guidance and the docket
number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Louis T. Mulligan, Center for Veterinary
Medicine (HFV–153), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–6984, email: lmulliga@cvm.fda.gov.
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
E:\FR\FM\07FEN1.SGM
07FEN1
6450
Federal Register / Vol. 70, No. 24 / Monday, February 7, 2005 / Notices
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 Repeat-Dose Chronic
Toxicity Testing
In the Federal Register of October 23,
2003 (68 FR 60703), FDA published the
notice of availability of the VICH draft
guidance, giving interested persons
until November 24, 2003, to submit
comments. After consideration of
comments received, the draft guidance
was changed in response to the
comments and submitted to the VICH
Steering Committee. At a meeting held
on May 3, 2004, the VICH Steering
Committee endorsed the final guidance
for industry, VICH GL–37. This VICH
guidance is one of a series of guidances
developed to facilitate the mutual
acceptance of safety data necessary for
the determination of acceptable daily
VerDate jul<14>2003
21:04 Feb 04, 2005
Jkt 205001
intakes for veterinary drug residues in
human food. This guidance was
developed after consideration of the
current practices for evaluating
veterinary drug residues in human food
in the European Union, Japan, the
United States, Australia, New Zealand,
and Canada. It also took account of
available data from subchronic and
chronic toxicity studies.
Information collection is covered
under the Office of Management and
Budget (OMB) control number 0910–
0032.
III. Significance of Guidance
This document, 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.’’ Because guidance
documents are not binding, mandatory
words such as ‘‘must,’’ ‘‘shall,’’ and
‘‘will’’ in the original VICH document
have been substituted with ‘‘should.’’
Similarly, words such as ‘‘require’’ or
‘‘requirement’’ have been replaced by
‘‘recommend’’ or ‘‘recommendation’’ as
appropriate to the context.
The VICH guidance (#160) is
consistent with the agency’s current
thinking on the safety of residues of
veterinary drugs in human foods. This
guidance does not create or confer any
rights for or on any person and will not
operate to bind FDA or the public. An
alternative method may be used as long
as it satisfies the requirements of
applicable statutes and regulations.
IV. Comments
As with all of FDA’s guidances, the
public is encouraged to submit written
or electronic comments pertinent to this
guidance. FDA will periodically review
the comments in the docket and, where
appropriate, will amend the guidance.
The agency will notify the public of any
such amendments through a notice in
the Federal Register.
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.
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
V. Electronic Access
Copies of the guidance document
entitled ‘‘Studies to Evaluate the Safety
of Residues of Veterinary Drugs in
Human Food: Repeat-Dose (Chronic)
Toxicity Testing’’ (VICH GL–37) may be
obtained on the Internet from the CVM
home page at https://www.fda.gov/cvm.
Dated: January 25, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–2266 Filed 2–4–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
University of Arkansas/Food and Drug
Administration Food Labeling; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshops.
SUMMARY: The Food and Drug
Administration (FDA), Office of
Regulatory Affairs (ORA), Southwest
Regional Small Business Representative
Program (SWR SBR), in collaboration
with The University of Arkansas (UA),
is announcing a public workshop
entitled ‘‘UA/FDA Food Labeling
Workshop.’’ This public workshop is
intended to provide information about
FDA food labeling regulations and other
related subjects to the regulated
industry, particularly small businesses
and startups.
Date and Time: This public workshop
will be held on April 5, 2005, from 8
a.m. to 5 p.m., and on April 6, 2005,
from 8 a.m. to 3 p.m.
Location: The public workshop will
be held at the Continuing Education
Center in Fayetteville, AR, located
downtown (2 East Center St.).
Contact: Steven C. Seideman, 2650
North Young Ave., Institute of Food
Science & Engineering, University of
Arkansas, Fayetteville, AR 72704, 479–
575–4221, FAX: 479–575–2165, or email: seideman@uark.edu.
For information on accommodation
options, contact Steven C. Seideman
(see Contact).
Registration: Registration by March
21, 2005, is encouraged. The University
of Arkansas has a $75 registration fee to
cover the cost of facilities, materials,
speakers, and breaks. Seats are limited,
please submit your registration as soon
as possible. Course space will be filled
in order of receipt of registration. Those
accepted into the course will receive
confirmation. Registration will close
E:\FR\FM\07FEN1.SGM
07FEN1
]]>Agencies
[Federal Register Volume 70, Number 24 (Monday, February 7, 2005)]
[Notices]
[Pages 6449-6450]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-2266]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003D-0466]
International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products (VICH);
Guidance for Industry on Studies to Evaluate the Safety of Residues of
Veterinary Drugs in Human Food: Repeat-Dose (Chronic) Toxicity Testing
(VICH GL-37); Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance document for industry (160)
entitled ``Studies to Evaluate the Safety of Residues of Veterinary
Drugs in Human Food: Repeat-Dose (Chronic) Toxicity Testing'' (VICH GL-
37). 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 establish recommendations for
internationally harmonized repeat-dose chronic toxicity testing.
DATES: Submit written or electronic comments at any time.
ADDRESSES: Submit written requests for single copies of the guidance to
the Communications Staff (HFV-12), Center for Veterinary Medicine
(CVM), Food and Drug Administration, 7519 Standish Pl., Rockville, MD
20855. Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.
Submit written comments on the 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.fda.gov/dockets/ecomments. Comments should be identified with the
full title of the guidance and the docket number found in brackets in
the heading of this document.
FOR FURTHER INFORMATION CONTACT: Louis T. Mulligan, Center for
Veterinary Medicine (HFV-153), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-6984, e-mail:
lmulliga@cvm.fda.gov.
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
[[Page 6450]]
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 Repeat-Dose Chronic Toxicity Testing
In the Federal Register of October 23, 2003 (68 FR 60703), FDA
published the notice of availability of the VICH draft guidance, giving
interested persons until November 24, 2003, to submit comments. After
consideration of comments received, the draft guidance was changed in
response to the comments and submitted to the VICH Steering Committee.
At a meeting held on May 3, 2004, the VICH Steering Committee endorsed
the final guidance for industry, VICH GL-37. This VICH guidance is one
of a series of guidances developed to facilitate the mutual acceptance
of safety data necessary for the determination of acceptable daily
intakes for veterinary drug residues in human food. This guidance was
developed after consideration of the current practices for evaluating
veterinary drug residues in human food in the European Union, Japan,
the United States, Australia, New Zealand, and Canada. It also took
account of available data from subchronic and chronic toxicity studies.
Information collection is covered under the Office of Management
and Budget (OMB) control number 0910-0032.
III. Significance of Guidance
This document, 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.'' Because guidance documents are not binding, mandatory
words such as ``must,'' ``shall,'' and ``will'' in the original VICH
document have been substituted with ``should.'' Similarly, words such
as ``require'' or ``requirement'' have been replaced by ``recommend''
or ``recommendation'' as appropriate to the context.
The VICH guidance (160) is consistent with the agency's
current thinking on the safety of residues of veterinary drugs in human
foods. This guidance does not create or confer any rights for or on any
person and will not operate to bind FDA or the public. An alternative
method may be used as long as it satisfies the requirements of
applicable statutes and regulations.
IV. Comments
As with all of FDA's guidances, the public is encouraged to submit
written or electronic comments pertinent to this guidance. FDA will
periodically review the comments in the docket and, where appropriate,
will amend the guidance. The agency will notify the public of any such
amendments through a notice in the Federal Register.
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.
V. Electronic Access
Copies of the guidance document entitled ``Studies to Evaluate the
Safety of Residues of Veterinary Drugs in Human Food: Repeat-Dose
(Chronic) Toxicity Testing'' (VICH GL-37) may be obtained on the
Internet from the CVM home page at https://www.fda.gov/cvm.
Dated: January 25, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-2266 Filed 2-4-05; 8:45 am]
BILLING CODE 4160-01-S
