International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Revised 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(R)); Request for Comments; Availability, 32218-32219 [2011-13821]
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Federal Register / Vol. 76, No. 107 / Friday, June 3, 2011 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Interviews/Surveys ...............................................................
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
(in hours) 2
Total hours
19,822
1
19,822
14/60
4,757
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 Burden estimates of less than 1 hour are expressed as a fraction of an hour in the format ‘‘[number of minutes per response]/60’’.
Annually, FDA projects about 45
communication studies using the
variety of test methods listed previously
in this document. FDA is requesting this
burden so as not to restrict the Agency’s
ability to gather information on public
sentiment for its proposals in its
regulatory and communications
programs.
Dated: May 18, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–13812 Filed 6–2–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2003–D–0433] (formerly
FDA–2003D–0474)
International Cooperation on
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products (VICH);
Draft Revised 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(R)); Request for Comments;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability for comments of a draft
revised guidance 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(R)). This draft revised guidance,
which updates a final guidance on the
same topic for which a notice of
availability was published in the
Federal Register of February 11, 2005,
has been developed for veterinary use
by the International Cooperation on
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products (VICH).
jlentini on DSK4TPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
15:49 Jun 02, 2011
Jkt 223001
This draft revised VICH guidance was
revised to include Appendix D—
Supplement to Section 2 Regarding the
Determination of the Fraction of Oral
Dose Available to Microorganisms. This
draft VICH guidance document is
intended to provide guidance for
assessing the human food safety of
residues from veterinary antimicrobial
drugs with regard to effects on the
human intestinal flora.
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
revised guidance before it begins work
on the final version of the revised
guidance, submit either electronic or
written comments on the draft revised
guidance by August 2, 2011.
ADDRESSES: Submit written requests for
single copies of the draft revised
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 revised
guidance document.
Submit electronic comments on the
draft revised 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:
Silvia A. Pineiro, Center for Veterinary
Medicine, (HFV–157), Food and Drug
Administration, 7500 Standish Place,
Rockville, MD 20855, 240–276–8227,
Silvia.Pineiro@fda.hhs.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
PO 00000
Frm 00084
Fmt 4703
Sfmt 4703
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 (ICH)
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
International Cooperation on
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products (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
E:\FR\FM\03JNN1.SGM
03JNN1
Federal Register / Vol. 76, No. 107 / Friday, June 3, 2011 / Notices
participates in the VICH Steering
Committee meetings.
jlentini on DSK4TPTVN1PROD with NOTICES
II. Guidance on Microbiological
Acceptable Daily Intake
In February 2011, the VICH Steering
Committee agreed that a draft revised
guidance entitled ‘‘Studies to Evaluate
the Safety of Residues of Veterinary
Drugs in Human Food: General
Approach to Establish a Microbiological
ADI (Revision)’’ (VICH GL36(R)) should
be made available for public comment.
This draft revised VICH guidance is a
revision of a final guidance on the same
topic for which a notice of availability
was published in the Federal Register of
February 11, 2005 (70 FR 7278). This
draft revised guidance was revised to
include Appendix D–Supplement to
Section 2 Regarding the Determination
of the Fraction of Oral Dose Available to
Microorganisms. 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
to: (1) Outline the recommended steps
in determining the need for establishing
a microbiological acceptable daily
intake (ADI); (2) 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) 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.
The draft revised guidance is a
product of the Quality Expert Working
Group of the VICH. Comments about
this draft will be considered by FDA
and the VICH Quality Expert Working
Group.
10.115). For example, the document has
been designated ‘‘guidance’’ rather than
‘‘guideline.’’ In addition, guidance
documents must not include mandatory
language such as ‘‘must,’’ ‘‘shall,’’
‘‘require’’ or ‘‘requirement’’ unless FDA is
using these words to describe a statutory
or regulatory requirement.
This draft revised VICH 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.
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 draft revised guidance at
either https://www.fda.gov/Animal
Veterinary/GuidanceCompliance
Enforcement/GuidanceforIndustry/
default.htm or https://
www.regulations.gov.
Dated: May 31, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–13821 Filed 6–2–11; 8:45 am]
BILLING CODE 4160–01–P
III. Paperwork Reduction Act of 1995
This draft revised guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in this revised guidance
have been approved under OMB control
number 0910–0032.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
IV. Significance of Guidance
This draft revised guidance,
developed under the VICH process, has
been revised to conform to FDA’s good
guidance practices regulation (21 CFR
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). At least one portion of the
meeting will be closed to the public.
VerDate Mar<15>2010
15:49 Jun 02, 2011
Jkt 223001
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Tobacco Products Scientific Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice.
Frm 00085
Fmt 4703
Sfmt 4703
32219
Name of Committee: Tobacco
Products Scientific Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on July 21, 2011, from 9 a.m. to 5
p.m., and on July 22, 2011, from 8 a.m.
to 5 p.m.
Location: Center for Tobacco
Products, Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 1–877–287–1373.
Contact Person: Caryn Cohen, Center
for Tobacco Products, Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 1–877–287–1373
(choose option 4), e-mail: TPSAC@fda.
hhs.gov, or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area), and follow the prompts to the
desired center or product area. Please
call the Information Line for up-to-date
information on this meeting. A notice in
the Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site and call the
appropriate advisory committee hot
line/phone line to learn about possible
modifications before coming to the
meeting.
Agenda: On the morning of July 21,
2011, the committee will discuss
changes proposed by committee
members to the Tobacco Products
Scientific Advisory Committee (TPSAC)
Menthol Report submitted to the
Agency on March 18, 2011. The
committee will consider additional oral
and written comments from the public
on the Menthol Report and the proposed
changes to the report, as submitted
according to the instructions in the
Procedure portion of this document.
The committee will consider and
deliberate on proposed changes to the
report and adopt amendments that
constitute the advice of the committee.
Redacted versions of the document,
reflecting the changes to the report
proposed by the committee members,
will be made available on the FDA Web
site at https://www.fda.gov/
AdvisoryCommittees/
CommitteesMeetingMaterials/
TobaccoProductsScientificAdvisory
Committee/ucm237359.htm, no later
than June 22, 2011. On the afternoon of
July 21, 2011, and on July 22, 2011, the
TPSAC will initiate discussions on the
issue of the nature and impact of the use
of dissolvable tobacco products on the
E:\FR\FM\03JNN1.SGM
03JNN1
]]>Agencies
[Federal Register Volume 76, Number 107 (Friday, June 3, 2011)]
[Notices]
[Pages 32218-32219]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-13821]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2003-D-0433] (formerly FDA-2003D-0474)
International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products (VICH);
Draft Revised 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(R)); Request for
Comments; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability for comments of a draft revised guidance 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(R)). This draft revised guidance,
which updates a final guidance on the same topic for which a notice of
availability was published in the Federal Register of February 11,
2005, has been developed for veterinary use by the International
Cooperation on Harmonisation of Technical Requirements for Registration
of Veterinary Medicinal Products (VICH). This draft revised VICH
guidance was revised to include Appendix D--Supplement to Section 2
Regarding the Determination of the Fraction of Oral Dose Available to
Microorganisms. This draft VICH guidance document is intended to
provide guidance for assessing the human food safety of residues from
veterinary antimicrobial drugs with regard to effects on the human
intestinal flora.
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 revised guidance before it begins work on the final version of
the revised guidance, submit either electronic or written comments on
the draft revised guidance by August 2, 2011.
ADDRESSES: Submit written requests for single copies of the draft
revised 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 draft revised guidance
document.
Submit electronic comments on the draft revised 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: Silvia A. Pineiro, Center for
Veterinary Medicine, (HFV-157), Food and Drug Administration, 7500
Standish Place, Rockville, MD 20855, 240-276-8227,
Silvia.Pineiro@fda.hhs.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 (ICH) 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
International Cooperation on Harmonisation of Technical Requirements
for Registration of Veterinary Medicinal Products (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
[[Page 32219]]
participates in the VICH Steering Committee meetings.
II. Guidance on Microbiological Acceptable Daily Intake
In February 2011, the VICH Steering Committee agreed that a draft
revised guidance entitled ``Studies to Evaluate the Safety of Residues
of Veterinary Drugs in Human Food: General Approach to Establish a
Microbiological ADI (Revision)'' (VICH GL36(R)) should be made
available for public comment. This draft revised VICH guidance is a
revision of a final guidance on the same topic for which a notice of
availability was published in the Federal Register of February 11, 2005
(70 FR 7278). This draft revised guidance was revised to include
Appendix D-Supplement to Section 2 Regarding the Determination of the
Fraction of Oral Dose Available to Microorganisms. 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 to: (1) Outline
the recommended steps in determining the need for establishing a
microbiological acceptable daily intake (ADI); (2) 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) 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.
The draft revised guidance is a product of the Quality Expert
Working Group of the VICH. Comments about this draft will be considered
by FDA and the VICH Quality Expert Working Group.
III. Paperwork Reduction Act of 1995
This draft revised guidance refers to previously approved
collections of information found in FDA regulations. These collections
of information are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in this revised guidance have
been approved under OMB control number 0910-0032.
IV. Significance of Guidance
This draft revised 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 ``must,'' ``shall,'' ``require'' or
``requirement'' unless FDA is using these words to describe a statutory
or regulatory requirement.
This draft revised VICH 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.
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 draft revised
guidance at either https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or https://www.regulations.gov.
Dated: May 31, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-13821 Filed 6-2-11; 8:45 am]
BILLING CODE 4160-01-P
