[Federal Register: January 9, 2006 (Volume 71, Number 5)]
[Notices]
[Page 1434-1435]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09ja06-38]
[[Page 1434]]
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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.
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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 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://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
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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 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://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]
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