[Federal Register Volume 66, Number 49 (Tuesday, March 13, 2001)]
[Notices]
[Pages 14589-14590]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-6116]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D-2975]


International Cooperation on Harmonisation of Technical 
Requirements for Approval of Veterinary Medicinal Products (VICH); 
Final Guidance on ``Environmental Impact Assessments (EIA's) for 
Veterinary Medicinal Products (VMP's)-Phase I'' (VICH GL6); 
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 final guidance for industry (No. 89) entitled 
``Environmental Impact Assessments (EIA's) for Veterinary Medicinal 
Products (VMP's)-Phase I'' (VICH GL6). This final guidance document has 
been developed for veterinary use by the International Cooperation on 
Harmonisation of Technical Requirements for Approval of Veterinary 
Medicinal Products (VICH). It is intended to assist in developing 
harmonized guidance for conducting environmental assessments for VMP's 
in the European Union, Japan, and the United States.

DATES: Submit written comments at any time.

ADDRESSES: Copies of the final guidance documents entitled 
``Environmental Impact Assessments (EIA's) for Veterinary Medicinal 
Products (VMP's)-Phase I '' (VICH GL6) may be obtained on the Internet 
from the CVM home page at http://www.fda.gov/cvm/fda/mappgs/vich.html. 
Persons without Internet access may submit written requests for a 
single copy of the final guidance to the Communications Staff (HFV-12), 
Center for Veterinary Medicine, Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive 
label to assist that office in processing your request.
    Submit written comments on the final guidance to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Charles E. Eirkson (HFV-145), Center 
for Veterinary Medicine, 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 recommendations. FDA has 
participated in efforts to enhance harmonization and has expressed its 
commitment to seek scientifically based harmonized technical 
recommendations for the development of pharmaceutical products. One of 
the goals of harmonization is to identify and then reduce the 
differences in technical recommendations for drug development among 
regulatory agencies in different countries.
    FDA has actively participated in the International Conference on 
Harmonisation of Technical Requirements for Registration of 
Pharmaceuticals for Human Use for several years to develop harmonized 
technical recommendations 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 VMP's. The VICH is 
concerned with developing harmonized technical recommendations for the 
VMP's 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; U.S. FDA; U.S. Department of 
Agriculture; Animal Health Institute; Japanese Veterinary 
Pharmaceutical Association; Japanese Association of Veterinary 
Biologics; and the Japanese Ministry of Agriculture, Forestry, and 
Fisheries.
    Two observers are eligible to participate in the VICH Steering 
Committee: One representative from the Government of Australia/ New 
Zealand, and one representative from the industry in Australia/ New 
Zealand. The VICH Secretariat, which coordinates the preparation of 
documentation, is provided by the Confederation Mondiale de L'Industrie 
de la Sante Animale (COMISA). A COMISA representative also participates 
in the VICH Steering Committee meetings.

II. Guidance on Assessing Environmental Impacts of VMP's Other Than 
Veterinary Biological Products

    In the Federal Register of September 17, 1999 (64 FR 50519), FDA 
published the notice of availability of the VICH GL6 guidance entitled 
``Environmental Impact Assessments (EIA's) for Veterinary Medicinal 
Products (VMP's)-Phase I'' giving interested persons until October 18, 
1999, to submit comments. In response to the Federal Register notice, 
the agency received one comment that endorsed adoption of the Phase I 
document. The European Union and Japan also published this guidance in 
their respective countries and requested comments. The comments were 
evaluated at the November 12 through 16, 1999, VICH Ecotoxicity/
Environmental Impact Assessment Working Group meeting in Brussels, 
Belgium. In response to the comments from the European Union and Japan, 
the working group revised the wording in questions 2, 6, 7, 8, 11, 14, 
15, 16, and 17 to clarify the questions, the issues covered by 
questions or the information to be provided in response to questions. 
The working group also added questions 18 and 19 to the Phase I 
document. Questions 18 and 19 were added to account for regional laws 
that can alter environmental introductions of VMP's. Specifically in 
the European Union, certain member countries have legal requirements 
for a minimum manure storage period. Others have legal restrictions on 
the amount of manure that may be spread in a given area. These legal 
requirements will modify variables in the predicted

[[Page 14590]]

environmental concentration in soil PECsoil calculation and 
the resulting PECsoil, as described in question 17. 
Therefore, it is important to consider them in the Phase I EIA. At a 
meeting held June 14 through 16, 2000, the VICH Steering Committee 
endorsed the final VICH GL6 guidance that incorporates these changes.
    VICH GL6 offers guidance on how to assess the environmental impact 
of VMP's other than veterinary biological products.
    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 an EA, an environmental impact statement (EIS), or both.
    This final guidance document is intended to be consistent with the 
laws of the European Union, Japan, and the United States. In an effort 
to harmonize the different recommendations in each of these areas for 
assessing the environmental impact of VMP's, this final guidance 
document adopts the terminology ``Phase I EIA's'' and ``Phase II 
EIA's.'' Using the terminology of the final guidance document, a Phase 
I EIA is equivalent under NEPA to either a categorical exclusion or an 
EA that addresses only environmental exposures (40 CFR 1508.4 and 
1508.9). A Phase II EIA is equivalent to an EA with more extensive data 
than would be necessary under the U.S. equivalent of a Phase I EIA. A 
Phase II EIA may lead to a finding of no significant impact or 
preparation of an EIS under NEPA.
    This final Level 1 guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115; 65 FR 56468, 
September 19, 2000). This final guidance document represents a portion 
of FDA's current thinking on the conduct of ecological risk assessment 
for veterinary medicinal products proposed for marketing in the 
European Union, Japan, and the United States. It does not create or 
confer any rights for or on any person, and does not operate to bind 
FDA or the public. An alternate method may be used as long as it 
satisfies the requirements of applicable statutes and regulations.
    Information collected is covered under OMB control number 0910-
0332.

III. Comments

    As with all of FDA's guidances, the public is encouraged to submit 
written comments with new data or other new information pertinent to 
this final 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, at any time, submit written comments to the 
Dockets Management Branch (address above) regarding this guidance 
document. Two copies of any comments are to be submitted, except 
individuals may submit one copy. Comments should be identified with the 
docket number found in the brackets in the heading of this document. A 
copy of the document and received comments are available for public 
examination in the Dockets Management Branch between 9 a.m. and 4 p.m., 
Monday through Friday.

    Dated: March 5, 2001.
Ann M. Witt,
Acting Associate Commissioner for Policy.
[FR Doc. 01-6116 Filed 3-12-01; 8:45 am]
BILLING CODE 4160-01-S