[Federal Register Volume 65, Number 203 (Thursday, October 19, 2000)]
[Notices]
[Pages 62723-62724]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-26897]


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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); 
Draft 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; 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 three draft 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 These related draft guidance 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 guidances by December 18, 
2000, 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 guidances 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 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 Place, Rockville, MD 20855. Send one 
self-addressed adhesive label to assist that office in processing your 
requests.
    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 R. Thompson, Center for Veterinary 
Medicine (HFV-3), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1798, e-mail: [email protected], or 
Carole R. Andres, Center for Veterinary Medicine (HFV-1), Food and Drug 
Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6524, 
e-mail: [email protected].
    Regarding the draft guidance documents: 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 
requirements 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 
requirements for the approval of veterinary medicinal products in the

[[Page 62724]]

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; 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.
    The VICH Steering Committee held a meeting on November 16 through 
19, 1999, and agreed that the three draft guidances 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) should be made 
available for public comment.
    The three draft guidances: VICH GL15, VICH GL16, and VICH GL19, 
should be read in conjunction with the ``Efficacy of Anthelmintics: 
General Recommendations (EAGR)'' announced in the Federal Register of 
July 16, 1999 (64 FR 38445). The draft guidances for equine, porcine, 
and canine are part of the EAGR, and the aim of these three draft 
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. Comments about the draft guidances 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 guidances, 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 ``requirement'' or ``acceptable'' have been 
replaced by ``recommendation'' or ``recommended'' as appropriate to the 
context.
    These draft guidances represent current FDA thinking on 
effectiveness recommendations for certain veterinary anthelmintic 
medicinal products. These draft guidances 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.

II. Comments

    These draft guidances are being distributed for comment purposes 
only, and they are not intended for implementation at this time. 
Interested persons may submit to the Dockets Management Branch (address 
above) written comments regarding the draft guidance documents by 
December 18, 2000. 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 draft guidances and received comments may 
be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., 
Monday through Friday.

    Dated: October 6, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-26897 Filed 10-18-00; 8:45 am]
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