[Federal Register Volume 67, Number 124 (Thursday, June 27, 2002)]
[Notices]
[Pages 43332-43333]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-16292]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1532]


International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products (VICH); 
Final Guidances for Industry on ``Effectiveness of Anthelmintics: 
Specific Recommendations for Equine'' (VICH GL15), ``Effectiveness of 
Anthelmintics: Specific Recommendations for Porcine'' (VICH GL16), and 
``Effectiveness of Anthelmintics: Specific Recommendations for Canine'' 
(VICH GL19); 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 three final guidances for industry (Nos. 109, 110, and 
111 respectively) entitled ``Effectiveness of Anthelmintics: Specific 
Recommendations for Equine'' (VICH GL15), ``Effectiveness of 
Anthelmintics: Specific Recommendations for Porcine'' (VICH GL16), and 
``Effectiveness of Anthelmintics: Specific Recommendations for Canine'' 
(VICH GL19). These related guidance documents have been developed by 
the International Cooperation on Harmonisation of Technical 
Requirements for Registration 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: Submit written or electronic comments on the final guidance 
documents at any time.

ADDRESSES: Submit written requests for single copies of the final 
guidance documents 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. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the final guidance 
document.
    Submit written comments on the final guidance documents to the 
Dockets Management Branch (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 final guidance and the docket number found 
in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Thomas Letonja, Center for Veterinary 
Medicine (HFV-135), 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 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 the differences in 
technical requirements for drug development among regulatory agencies 
in different countries.
    FDA has actively participated in the International Conference on 
Harmonisation (ICH) of Technical Requirements for Registration 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 
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; Committee on Veterinary Medicinal 
Products; 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 Conf[eacute]deration Mondiale de 
L'Industrie de la Sant[eacute] Animale (COMISA). A COMISA 
representative also participates in the VICH Steering Committee 
meetings.

II. Final Guidance on Effectiveness of Anthelmintics

    In the Federal Register on October 19, 2000 (65 FR 62723), FDA 
published the notice of availability of these VICH draft guidances, 
giving interested persons until December 18, 2000, to submit comments. 
FDA received no comments. The final guidance was submitted to the VICH 
Steering Committee. At a meeting held on June 28, 2001, the VICH 
Steering Committee endorsed the three final guidances for industry, 
VICH GL15, VICH GL16, and VICH GL19.
    The three final guidances VICH GL15, VICH GL16, and VICH GL19 
should be read in conjunction with the ``Effectiveness of 
Anthelmintics: General Recommendations (EAGR)'' announced in the 
Federal Register on April 6, 2001 (66 FR 18257). The final

[[Page 43333]]

guidances for equine, porcine, and canine are part of the EAGR, and the 
aim of these three separate 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 between the EAGR and these 
documents.
    These final level 1 guidance documents, developed under the VICH 
process, are consistent with FDA's good guidance practices regulation 
(21 CFR 10.115). These documents do not create or confer any rights for 
or on any person and will 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. (Information collected is 
covered under OMB control number 0910-0032.)

III. Comments

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

IV. Electronic Access

    Copies of the final guidance documents entitled ``Effectiveness of 
Anthelmintics: Specific Recommendations for Equine'' (VICH GL15), 
``Effectiveness of Anthelmintics: Specific Recommendations for 
Porcine'' (VICH GL16), and ``Effectiveness of Anthelmintics: Specific 
Recommendations for Canine'' (VICH GL19) may be obtained on the 
Internet at http://www.fda.gov/cvm.

    Dated: June 17, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-16292 Filed 6-26-02; 8:45 am]
BILLING CODE 4160-01-S