[Federal Register Volume 71, Number 5 (Monday, January 9, 2006)]
[Notices]
[Pages 1434-1435]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-39]



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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://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: 
[email protected].

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://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