International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products; Final Guidance for Industry on Environmental Impact Assessments for Veterinary Medicinal Products-Phase II; Availability, 1434-1435 [E6-39]
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Federal Register / Vol. 71, No. 5 / Monday, January 9, 2006 / Notices
I. Background
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D–0156]
International Cooperation on
Harmonization of Technical
Requirements for Registration of
Veterinary Medicinal Products; Final
Guidance for Industry on
Environmental Impact Assessments
for Veterinary Medicinal Products—
Phase II; Availability
AGENCY:
Food and Drug Administration,
HHS.
cprice-sewell on PROD1PC66 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance document for
industry (#166) entitled ‘‘Environmental
Impact Assessments (EIA’s) for
Veterinary Medicinal Products
(VMP’s)—Phase II’’ (VICH GL38). This
guidance has been developed for
veterinary use by the International
Cooperation on Harmonization of
Technical Requirements for Registration
of Veterinary Medicinal Products
(VICH). This VICH guidance document
provides recommendations for
internationally harmonized test
methods used to generate environmental
fate and toxicity data.
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:
Charles E. Eirkson, Center for Veterinary
Medicine (HFV–145), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–6958, email: ceirkson@cvm.fda.gov.
SUPPLEMENTARY INFORMATION:
VerDate Aug<31>2005
15:31 Jan 06, 2006
Jkt 208001
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
Harmonization 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; 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.
The following 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.
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
II. Guidance on Environmental Impact
Assessments
In the Federal Register of April 21,
2004 (69 FR 21552), FDA published the
notice of availability of the VICH draft
guidance, giving interested persons
until May 21, 2004, 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 October 2004, the VICH Steering
Committee endorsed the final guidance
for industry (VICH GL38). The aim of
the guidance is to assess the potential
for VMPs to affect nontarget species in
the environment, including both aquatic
and terrestrial species. It is not possible
to evaluate the effects of VMPs on every
species in the environment that may be
exposed to the VMP following its
administration to the target species. The
species tested are intended to serve as
surrogates or indicators for the range of
species present in the environment.
This Phase II guidance contains
sections for each of the major branches:
(1) Aquaculture; (2) intensively reared
terrestrial animals; and (3) pasture
animals, each containing decision trees
pertaining to the branch. The document
also contains a section listing the
recommended tests for physical/
chemical properties, environmental fate
and environmental effects, as well as a
recommendation of how to determine
when tests may be relevant.
In the United States, the
environmental impact of VMPs is
determined under the requirements
established by the National
Environmental Policy Act (NEPA) (42
U.S.C. 4321 et seq.) and its
implementing regulations (40 CFR part
1500 and 21 CFR part 25) and under the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b(d)). Under NEPA, an
environmental assessment (EA) is
conducted to determine whether a VMP
may have a significant environmental
impact. A particular VMP may be
categorically excluded from the
requirement of an EA, or it may require
an EA, an environmental impact
statement, or both.
Information collection is covered
under Office of Management and Budget
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
E:\FR\FM\09JAN1.SGM
09JAN1
Federal Register / Vol. 71, No. 5 / Monday, January 9, 2006 / Notices
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.
This VICH guidance (#166) represents
the agency’s current thinking on the
conduct of environmental impact
assessments for veterinary medicinal
products proposed for marketing in the
European Union, Japan, and the United
States. This guidance does not create or
confer any rights for or on any person
and will not operate to bind FDA or the
public. You may use an alternative
method 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
cprice-sewell on PROD1PC66 with NOTICES
Copies of the guidance document
entitled ‘‘Environmental Impact
Assessments (EIA’s) for Veterinary
Medicinal Products (VMP’s)—Phase II’’
(VICH GL38) may be obtained on the
Internet from the CVM home page at
https://www.fda.gov/cvm.
Dated: December 23, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–39 Filed 1–6–06; 8:45 am]
BILLING CODE 4160–01–S
VerDate Aug<31>2005
16:48 Jan 06, 2006
Jkt 208001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Advisory Committee on Rural
Health and Human Services; Notice of
Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Public Law 92–463), notice is hereby
given that the following committee will
convene its fifty-second meeting.
Name: National Advisory Committee
on Rural Health and Human Services.
Dates and Times: January 29, 2006, 2
p.m.–5:15 p.m.; January 30, 2006, 8:45
a.m.–4:45 p.m.; January 31, 2006, 8:30
a.m.–11:15 a.m.
Place: Jurys Washington Hotel, 1500
New Hampshire Avenue, NW.,
Washington, DC 20036, Phone: 202–
483–6000.
Status: The meeting will be open to
the public.
Purpose: The National Advisory
Committee on Rural Health and Human
Services provides advice and
recommendations to the Secretary with
respect to the delivery, research,
development and administration of
health and human services in rural
areas.
Agenda: Sunday afternoon, January
29, at 2 p.m., the Chairperson, the
Honorable David Beasley, will open the
meeting and welcome the Committee.
The first session will open with a
discussion of the Committee business
and a review of the 2006 report to the
Secretary. This will be followed by a
session on the role of HHS in
connecting the three 2007 report topics
by Elizabeth M. Duke, Administrator of
the Health Resources and Services
Administration. Jack Kalavritinos, HHS
Office of Intergovernmental Affairs has
also been invited to speak on these three
topics. The three topics for the 2007
report are as follows: Medicare
Advantage, Substance Abuse and Head
Start. The final two sessions of the day
will be an overview of Medicare
Advantage in rural communities and an
overview of substance abuse in rural
communities. The Sunday meeting will
close at 5:15 p.m.
Monday morning, January 30, at 8:45
a.m. the meeting will begin with an
overview of Head Start in rural
communities. The next three sessions
will look at the three topics from a
research perspective. Speakers will
include Keith Mueller from the Rural
Policy Research Institute; Peggy Halpern
and Ann McCormick from ASPE
(Assistant Secretary for Planning and
PO 00000
Frm 00030
Fmt 4703
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1435
Evaluation, HHS); David Hartley with
Maine Rural Health Research Center;
and Maria Woolverton, Office of
Planning, Research and Evaluation at
the Administration for Children and
Families. The final two sessions of the
day will consist of an update on
Washington by the National Rural
Health Association and the appointment
of Subcommittees for the 2007 report.
The Monday meeting will close at 4:45
p.m.
The final session will be convened
Tuesday morning, January 31, at 8:30
a.m. The Committee will break into
Subcommittee format to discuss the
chapter outlines and timelines. The
meeting will conclude with a discussion
of the June meeting. The meeting will be
adjourned at 11:15 a.m.
FOR FURTHER INFORMATION CONTACT:
Anyone requiring information regarding
the Committee should contact Tom
Morris, M.P.A., Executive Secretary,
National Advisory Committee on Rural
Health and Human Services, Health
Resources and Services Administration,
Parklawn Building, Room 9A–55, 5600
Fishers Lane, Rockville, MD 20857,
telephone (301) 443–0835, Fax (301)
443–2803.
Persons interested in attending any
portion of the meeting should contact
Michele Pray-Gibson, Office of Rural
Health Policy (ORHP), telephone (301)
443–0835. The Committee meeting
agenda will be posted on ORHP’s Web
site https://www.ruralhealth.hrsa.gov.
Dated: December 29, 2005.
Tina M. Cheatham,
Director, Division of Policy Review and
Coordination.
[FR Doc. E6–43 Filed 1–6–06; 8:45 am]
BILLING CODE 4165–15–P
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
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
E:\FR\FM\09JAN1.SGM
09JAN1
]]>Agencies
[Federal Register Volume 71, Number 5 (Monday, January 9, 2006)]
[Notices]
[Pages 1434-1435]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-39]
[[Page 1434]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D-0156]
International Cooperation on Harmonization of Technical
Requirements for Registration of Veterinary Medicinal Products; Final
Guidance for Industry on Environmental Impact Assessments for
Veterinary Medicinal Products--Phase II; 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 (166)
entitled ``Environmental Impact Assessments (EIA's) for Veterinary
Medicinal Products (VMP's)--Phase II'' (VICH GL38). This guidance has
been developed for veterinary use by the International Cooperation on
Harmonization of Technical Requirements for Registration of Veterinary
Medicinal Products (VICH). This VICH guidance document provides
recommendations for internationally harmonized test methods used to
generate environmental fate and toxicity data.
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: Charles E. Eirkson, Center for
Veterinary Medicine (HFV-145), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-6958, e-mail:
ceirkson@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
Harmonization 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; 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.
The following 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 Environmental Impact Assessments
In the Federal Register of April 21, 2004 (69 FR 21552), FDA
published the notice of availability of the VICH draft guidance, giving
interested persons until May 21, 2004, 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 October 2004, the VICH Steering Committee endorsed
the final guidance for industry (VICH GL38). The aim of the guidance is
to assess the potential for VMPs to affect nontarget species in the
environment, including both aquatic and terrestrial species. It is not
possible to evaluate the effects of VMPs on every species in the
environment that may be exposed to the VMP following its administration
to the target species. The species tested are intended to serve as
surrogates or indicators for the range of species present in the
environment.
This Phase II guidance contains sections for each of the major
branches: (1) Aquaculture; (2) intensively reared terrestrial animals;
and (3) pasture animals, each containing decision trees pertaining to
the branch. The document also contains a section listing the
recommended tests for physical/chemical properties, environmental fate
and environmental effects, as well as a recommendation of how to
determine when tests may be relevant.
In the United States, the environmental impact of VMPs is
determined under the requirements established by the National
Environmental Policy Act (NEPA) (42 U.S.C. 4321 et seq.) and its
implementing regulations (40 CFR part 1500 and 21 CFR part 25) and
under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(d)).
Under NEPA, an environmental assessment (EA) is conducted to determine
whether a VMP may have a significant environmental impact. A particular
VMP may be categorically excluded from the requirement of an EA, or it
may require an EA, an environmental impact statement, or both.
Information collection is covered under Office of Management and
Budget 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
[[Page 1435]]
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.
This VICH guidance (166) represents the agency's current
thinking on the conduct of environmental impact assessments for
veterinary medicinal products proposed for marketing in the European
Union, Japan, and the United States. This guidance does not create or
confer any rights for or on any person and will not operate to bind FDA
or the public. You may use an alternative method 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 ``Environmental Impact
Assessments (EIA's) for Veterinary Medicinal Products (VMP's)--Phase
II'' (VICH GL38) may be obtained on the Internet from the CVM home page
at https://www.fda.gov/cvm.
Dated: December 23, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-39 Filed 1-6-06; 8:45 am]
BILLING CODE 4160-01-S
