International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Final Guidance for Industry on Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological ADI (VICH GL-36); Availability, 7278-7279 [05-2643]
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Federal Register / Vol. 70, No. 28 / Friday, February 11, 2005 / Notices
memo #K91–1)’’ and for the document
entitled ‘‘FDA Policy for The Regulation
of Computer Products; Draft.’’ These
two guidance documents were listed in
error as both current and withdrawn.
These guidances have been withdrawn
by the agency.
2. On page 894, in the list, under the
heading ‘‘Guidance Documents Issued
by CFSAN,’’ the entire entry is removed
for the document entitled
‘‘Investigations Operations Manual’’ and
for the document entitled ‘‘Regulatory
Procedures Manual.’’ These two
guidance documents were listed as
being issued by the Center for Food
Safety and Applied Nutrition in error.
They can be found in the list of
guidance documents issued by the
Office of Regulatory Affairs.
Dated: February 3, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–2642 Filed 2–10–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
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:
DATES:
[Docket No. 2003D–0474]
International Cooperation on
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products (VICH);
Final Guidance for Industry on Studies
to Evaluate the Safety of Residues of
Veterinary Drugs in Human Food:
General Approach to Establish a
Microbiological ADI (VICH GL–36);
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 (#159) entitled ‘‘Studies to
Evaluate the Safety of Residues of
Veterinary Drugs in Human Food:
General Approach to Establish a
Microbiological ADI’’ (VICH GL36). 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
provides guidance for assessing the
human food safety of residues from
veterinary antimicrobial drugs with
regard to effects on the human intestinal
flora.
VerDate jul<14>2003
17:18 Feb 10, 2005
Jkt 205001
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 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
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
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 Microbiological
Acceptable Daily Intake
In the Federal Register of November
13, 2003 (68 FR 64354), FDA published
the notice of availability of the VICH
draft guidance, giving interested persons
until December 15, 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–36). This VICH
guidance provides guidance for
assessing the human food safety of
residues from veterinary antimicrobial
drugs with regard to effects on the
human intestinal flora. The objectives of
this guidance are: (1) To outline the
recommended steps in determining the
need for establishing a microbiological
acceptable daily intake (ADI); (2) to
recommend test systems and methods
for determining no-observable adverse
effect concentrations (NOAECs) and noobservable adverse effect levels
(NOAELs) for the endpoints of health
concern; and (3) to recommend a
procedure to derive a microbiological
ADI. It is recognized that different tests
may be useful. The experience gained
with the recommended tests may result
in future modifications to this guidance
and its recommendations. Information
collection is covered under Office of
E:\FR\FM\11FEN1.SGM
11FEN1
Federal Register / Vol. 70, No. 28 / Friday, February 11, 2005 / Notices
Management and Budget (OMB) control
number 0910–0032.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
III. Significance of Guidance
National Institutes of Health
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 (#159) is
consistent with the agency’s current
thinking on the subject matter. 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: General Approach to
Establish a Microbiological ADI’’ (VICH
GL–36) may be obtained on the Internet
from the CVM home page at https://
www.fda.gov/cvm.
Dated: February 3, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–2643 Filed 2–10–05; 8:45 am]
BILLING CODE 4160–01–S
VerDate jul<14>2003
17:18 Feb 10, 2005
Jkt 205001
National Cancer Institute; Notice of
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of a meeting of the
Board of Scientific Counselors, National
Cancer Institute.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended
for the review, discussion, and
evaluation of individual intramural
programs and projects conducted by the
National Cancer Institute, including
consideration of personnel
qualifications and performance, and the
competence of individual investigators,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Board of Scientific
Counselors, National Cancer Institute,
Subcommittee 1—Clinical Sciences and
Epidemiology.
Date: March 7–8, 2005.
Open: March 7, 2005, 8:30 a.m. to 10:45
a.m.
Agenda: Joint Session of NCI, Board of
Scientific Advisors and BSC Subcommittees.
Place: National Institutes of Health,
National Cancer Institute, 9000 Rockville
Pike, Building 31, Conference Room 10,
Bethesda, MD 20892.
Closed: March 7, 2005, 10:45 a.m. to 4:30
p.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institutes of Health,
National Cancer Institute, 9000 Rockville
Pike, Building 31, Conference Room 6,
Bethesda, MD 20892.
Closed: March 8, 2005, 8 a.m. to 12:45 p.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: Holiday Inn Bethesda, Versailles IV,
8120 Wisconsin Avenue, Bethesda, MD
20814.
Contact Person: Brian E. Wojcik, PhD,
Senior Review Administrator, Institute
Review Office, Office of the Director,
National Cancer Institute, 6116 Executive
Boulevard, Room 2114, Bethesda, MD 20892,
(301) 496–7628, wojcikb@mail.nih.gov.
PO 00000
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7279
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
instituted stringent procedures for entrance
into the building by non-government
employees. Persons without a government
I.D. will need to show a photo I.D. and signin at the security desk upon entering the
building.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: February 4, 2005.
LaVerne Y. Stringfield,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 05–2645 Filed 2–10–05; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications
and/or contract proposals and the
discussions could disclose confidential
trade secrets or commercial property
such as patentable material, and
personal information concerning
individuals associated with the grant
applications and/or contract proposals,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Cancer
Institute Special Emphasis Panel; CA05–018:
CISNET.
Date: March 4, 2005.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Marriott Bethesda North, 5701
Marinelli Road, North Bethesda, MD 20852.
Contact Person: C. Michael Kerwin, PhD,
MPH, Scientific Review Administrator,
Special Review and Logistics Branch,
E:\FR\FM\11FEN1.SGM
11FEN1
]]>Agencies
[Federal Register Volume 70, Number 28 (Friday, February 11, 2005)]
[Notices]
[Pages 7278-7279]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-2643]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003D-0474]
International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products (VICH);
Final Guidance for Industry on Studies to Evaluate the Safety of
Residues of Veterinary Drugs in Human Food: General Approach to
Establish a Microbiological ADI (VICH GL-36); 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 (159)
entitled ``Studies to Evaluate the Safety of Residues of Veterinary
Drugs in Human Food: General Approach to Establish a Microbiological
ADI'' (VICH GL36). 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 provides guidance for assessing the human
food safety of residues from veterinary antimicrobial drugs with regard
to effects on the human intestinal flora.
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 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 Microbiological Acceptable Daily Intake
In the Federal Register of November 13, 2003 (68 FR 64354), FDA
published the notice of availability of the VICH draft guidance, giving
interested persons until December 15, 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-36). This VICH guidance
provides guidance for assessing the human food safety of residues from
veterinary antimicrobial drugs with regard to effects on the human
intestinal flora. The objectives of this guidance are: (1) To outline
the recommended steps in determining the need for establishing a
microbiological acceptable daily intake (ADI); (2) to recommend test
systems and methods for determining no-observable adverse effect
concentrations (NOAECs) and no-observable adverse effect levels
(NOAELs) for the endpoints of health concern; and (3) to recommend a
procedure to derive a microbiological ADI. It is recognized that
different tests may be useful. The experience gained with the
recommended tests may result in future modifications to this guidance
and its recommendations. Information collection is covered under Office
of
[[Page 7279]]
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 (159) is consistent with the agency's
current thinking on the subject matter. 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: General Approach
to Establish a Microbiological ADI'' (VICH GL-36) may be obtained on
the Internet from the CVM home page at https://www.fda.gov/cvm.
Dated: February 3, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-2643 Filed 2-10-05; 8:45 am]
BILLING CODE 4160-01-S
