[Federal Register Volume 66, Number 67 (Friday, April 6, 2001)]
[Notices]
[Pages 18257-18259]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-8452]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D-2248]


International Cooperation on Harmonisation of Technical 
Requirements for Approval of Veterinary Medicinal Products (VICH); 
Final Guidances Entitled ``Effectiveness of Anthelmintics: General 
Recommendations'' (VICH GL7), ``Effectiveness of Anthelmintics: 
Specific Recommendations for Bovine'' (VICH GL12), ``Effectiveness of 
Anthelmintics: Specific Recommendations for Ovine'' (VICH GL13), and 
``Effectiveness of Anthelmintics: Specific Recommendations for 
Caprine'' (VICH GL14); 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 four final guidances for industry (Nos. 90, 95, 96, and 
97) entitled ``Effectiveness of Anthelmintics: General 
Recommendations'' (EAGR) (VICH GL7), ``Effectiveness of Anthelmintics: 
Specific Recommendations for Bovine'' (VICH GL12), ``Effectiveness of 
Anthelmintics: Specific

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Recommendations for Ovine'' (VICH GL13), and ``Effectiveness of 
Anthelmintics: Specific Recommendations for Caprine'' (VICH GL14). 
These guidances have been adapted for veterinary use by the 
International Cooperation on Harmonisation of Technical Requirements 
for Approval of Veterinary Medicinal Products (VICH). They are intended 
to standardize and simplify methods used in the evaluation of new 
anthelmintics submitted for approval to the European Union, Japan, and 
the United States.

DATES: You may submit written comments at anytime.

ADDRESSES: Copies of the final guidances entitled ``Effectiveness of 
Anthelmintics: General Recommendations'' (VICH GL7), ``Effectiveness of 
Anthelmintics: Specific Recommendations for Bovine'' (VICH GL12), 
``Effectiveness of Anthelmintics: Specific Recommendations for Ovine'' 
(VICH GL13), and ``Effectiveness of Anthelmintics: Specific 
Recommendations for Caprine'' (VICH GL14) may be obtained on the 
Internet from the CVM home page at http:\\www.fda.gov/cvm/guidance/guidance.html. Persons without Internet access may submit written 
requests for single copies of the final guidances 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 
requests.
    You may submit written comments any time 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: Thomas Letonja (HFV-135), Center for 
Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-7576, 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 veterinary medicinal 
products. The VICH is concerned with developing harmonized technical 
recommendations 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; the U.S. 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.
    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 Effectiveness of Anthelmintics

    These four guidances are entitled ``Effectiveness of Anthelmintics: 
General Recommendations'' (VICH GL7), ``Effectiveness of Anthelmintics: 
Specific Recommendations for Bovine'' (VICH GL12), ``Effectiveness of 
Anthelmintics: Specific Recommendations for Ovine'' (VICH GL13), and 
``Effectiveness of Anthelmintics: Specific Recommendations for 
Caprine'' (VICH GL14).
    In the Federal Register of July 16, 1999 (64 FR 38445), FDA 
published these VICH guidances in draft form, giving interested persons 
until August 16, 1999, to submit comments. FDA shared the comments with 
the appropriate VICH Expert Working Group and after considering the 
comments, the work group submitted the final guidance to the VICH 
Steering Committee. At a meeting held from November 16 to 19, 1999, the 
VICH Steering Committee endorsed the four final guidances for industry, 
VICH GL7, VICH GL12, VICH GL13, and VICH GL14.
    VICH GL7 is intended to standardize and simplify the methods used 
for the effectiveness evaluation of new anthelmintics and generic 
copies for use in domesticated animals. Animal welfare will benefit by 
the elimination of duplicate studies that will reduce the number of 
animals required for necessary studies. Likewise this will benefit the 
industry by reducing research and development costs. VICH GL12, VICH 
GL13, and VICH GL14 should be read in conjunction with the EAGR, VICH 
GL7. The guidances for bovine, ovine, and caprine are part of the EAGR, 
and the aim of these three final guidances is to: (1) Be more specific 
for certain issues not discussed in the general guidance; (2) highlight 
differences with the EAGR on effectiveness data recommendations; and 
(3) give explanations for disparities with the EAGR.
    This final level 1 guidance is being issued consistent with FDA's 
good guidance practices (21 CFR 10.115; 65 FR 56468, September 19, 
2000). These final guidances represent the agency's current thinking on 
effectiveness recommendations for anthelmintic medicinal products. 
These guidances do not create or confer any rights for or on any 
person, and do not operate to bind FDA or the public. An alternative 
method may be used as long as it satisfies the requirements of 
applicable statutes and regulations.

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 
these guidances. FDA will periodically review the comments in the 
docket and, where appropriate, will amend the guidances. 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 these guidances. 
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

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brackets in the heading of this document. A copy of the guidances 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 29, 2001.
Ann M. Witt,
Acting Associate Commissioner for Policy.
[FR Doc. 01-8452 Filed 4-5-01; 8:45 am]
BILLING CODE 4160-01-S