[Federal Register Volume 65, Number 243 (Monday, December 18, 2000)]
[Notices]
[Pages 79113-79114]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-32057]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1629]


International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products (VICH); 
Draft Guidances for Industry on ``Effectiveness of Anthelmintics: 
Specific Recommendations for Feline'' (VICH GL20) and ``Effectiveness 
of Anthelmintics: Specific Recommendations for Poultry'' (VICH GL21); 
Availability; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability for comment of two draft guidances for industry (Nos. 113 
and 114, respectively) entitled ``Effectiveness of Anthelmintics: 
Specific Recommendations for Feline'' (VICH GL20) and ``Effectiveness 
of Anthelmintics: Specific Recommendations for Poultry'' (VICH GL21). 
These related draft guidance documents have been developed by the 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DATES: Submit written comments on the draft guidance documents by 
January 17, 2001, to ensure their adequate consideration in preparation 
of the final guidance document. General comments on agency guidance 
documents are welcome at any time.

ADDRESSES: Copies of the draft guidance documents entitled 
``Effectiveness of Anthelmintics: Specific Recommendations Feline'' 
(VICH GL20) and ``Effectiveness of Anthelmintics: Specific 
Recommendations for Poultry'' (VICH GL21) may be obtained on the 
Internet from the CVM home page at http://www.fda.gov/cvm/fda/TOCs/guideline.html. Persons without Internet access may submit written 
requests for single copies of the draft 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 to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:
    Regarding the VICH: Sharon Thompson, Center for Veterinary Medicine 
(HFV-3), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 
20855, 301-827-4514, e-mail: [email protected], or Carole R. Andres, 
Center for Veterinary Medicine (HFV-3), Food and Drug Administration, 
7519 Standish Pl., Rockville, MD 20855, 301-827-2977, e-mail: 
[email protected].
    Regarding the guidance documents: 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 differences 
in technical recommendations 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 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; U.S. FDA; U.S. Department of 
Agriculture; Animal Health Institute; Japanese Veterinary 
Pharmaceutical Association; Japanese Association of Veterinary 
Biologics; and 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 Anthelmintics

    The VICH Steering Committee held a meeting from June 14 through 16, 
2000, and agreed that the two draft guidance documents entitled 
``Effectiveness of Anthelmintics: Specific Recommendations for Feline'' 
(VICH GL20) and ``Effectiveness of Anthelmintics: Specific 
Recommendations for Poultry'' (VICH GL21) should be made available for 
public comment.
    The two draft guidances, VICH GL20 and VICH GL21, should be read in 
conjunction with the ``Effectiveness of Anthelmintics: General 
Recommendations (EAGR)'' (64 FR 38445, July 16, 1999). The guidances 
for feline and poultry are part of the EAGR, and the aim of these two 
draft guidances is to: (1) Be more specific for certain issues not 
discussed in the general

[[Page 79114]]

guidance, (2) highlight differences with the EAGR on effectiveness data 
recommendation, and (3) give explanations for disparities with the 
EAGR. Comments about the draft guidance documents will be considered by 
the FDA and the VICH Anthelmintic Working Group. Ultimately, FDA 
intends to adopt the VICH Steering Committee's final guidances and 
publish them as future guidances.
    These draft documents, developed under the VICH process, have been 
revised to conform to FDA's good guidance practices (65 FR 56468, 
September 19, 2000). For example, the documents have been designated 
``guidance'' rather than ``guideline.'' Because guidance documents are 
not binding, unless specifically supported by statute or regulation, 
mandatory words such as ``must,'' ``shall,'' and ``will'' in the 
original VICH documents have been substituted with ``should.'' 
Similarly, words such as ``require'' or ``requirement'' have been 
replaced by ``recommendation'' or ``recommended'' as appropriate to the 
context.
    These draft documents represent current FDA thinking on 
effectiveness recommendations for certain veterinary anthelmintic 
medicinal products. 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 
alternate method may be used as long as it satisfies the requirements 
of applicable statutes and regulations.

III. Comments

    These draft guidance documents are being distributed for comment 
purposes only and are not intended for implementation at this time. 
Interested persons should submit to the Dockets Management Branch 
(address above) written comments regarding the draft guidance documents 
by January 17, 2001. Two copies of any comments are to be submitted, 
except that individuals may submit one copy. Comments should be 
identified with the docket number found in brackets in the heading of 
this document. A copy of the draft 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.

    Dated: December 8, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-32057 Filed 12-15-00; 8:45 am]
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