[Federal Register: April 21, 2004 (Volume 69, Number 77)]
[Notices]
[Page 21552-21553]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21ap04-71]
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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Requirements for Registration of Veterinary Medicinal Products; Draft
Guidance for Industry on Environmental Impact Assessments for
Veterinary Medicinal Products--Phase II; Request for Comments;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability for comments of a draft guidance document for industry
([numsign]166) entitled ``Environmental Impact Assessments (EIA's) for
Veterinary Medicinal Products (VMP's)--Phase II'' (VICH GL38). This
draft guidance has been developed for veterinary use by the
International Cooperation on Harmonization of Technical Requirements
for Registration of Veterinary Medicinal Products (VICH). This draft
VICH guidance document provides recommendations for internationally
harmonized test methods used to generate environmental fate and
toxicity data.
DATES: Submit written or electronic comments on the draft guidance by
May 21, 2004, to ensure their adequate consideration in preparation of
the final guidance document. General comments on agency guidance
documents are welcome at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Communications Staff (HFV-12), Center for Veterinary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INFORMATION section for electronic access to the draft guidance
document.
Submit written comments on the draft guidance to the Division of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with the full title of the draft guidance and the docket number found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.
Four observers are eligible to participate in the VICH Steering
Committee as follows: 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. Draft Guidance on Environmental Impact Assessments
The VICH Steering Committee held a meeting in October 2003 and
agreed that the draft guidance document entitled ``Environmental Impact
Assessments (EIA'S) For Veterinary Medicinal Products (VMP's)--Phase
II'' (VICH GL38) should be made available for public comment. The aim
of the guidance is to assess the potential for VMP's to affect
nontarget species in the environment, including both aquatic and
terrestrial species. It is not possible to evaluate the effects of
VMP's 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 VMP's 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
[[Page 21553]]
an EA, an environmental impact statement (EIS), or both.
FDA and the VICH Ecotoxicity/Environmental Impact Assessment
Working Group will consider comments about the draft guidance document.
Information collection is covered under the Office of Management and
Budget control number 0910-0032.
III. Significance of Guidance
This draft 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 draft VICH guidance ([numsign]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
This draft guidance document is being distributed for comment
purposes only and is not intended for implementation at this time.
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this draft
guidance 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. A copy of the draft
guidance and 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
Electronic comments may also be submitted electronically on the
Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Once on this Internet
site, select [docket number] entitled ``Environmental Impact
Assessments (EIA's) for Veterinary Medicinal Products (VMP's)--Phase
II'' (VICH GL38) and follow the directions.
Copies of the draft 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: April 13, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-9071 Filed 4-20-04; 8:45 am]
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