[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Requirements for Registration of Veterinary Medicinal Products; Draft 
Guidance for Industry on Environmental Impact Assessments for 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availability for comments of a draft guidance document for industry 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draft guidance has been developed for veterinary use by the 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DATES: Submit written or electronic comments on the draft guidance by 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Communications Staff (HFV-12), Center for Veterinary 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INFORMATION section for electronic access to the draft guidance 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    Submit written comments on the draft guidance to the Division of 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with the full title of the draft guidance and the docket number found 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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