[Federal Register Volume 64, Number 136 (Friday, July 16, 1999)]
[Notices]
[Pages 38445-38446]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 99-18166]


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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 Registration of Veterinary Medicinal Products (VICH); 
Draft Guidances on Efficacy of Anthelmintics: General Recommendations 
(#90), Efficacy of Anthelmintics: Specific Recommendations for Bovines 
(#95), Efficacy of Anthelmintics: Specific Recommendations for Ovines 
(#96), and Efficacy of Anthelmintics: Specific Recommendations for 
Caprines (#97); 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availability for comment of four draft guidance documents entitled: 
``Efficacy of Anthelmintics: General Recommendations (#90),'' 
``Efficacy of Anthelmintics: Specific Recommendations for Bovines 
(#95),'' ``Efficacy of Anthelmintics: Specific Recommendations for 
Ovines (#96),'' and ``Efficacy of Anthelmintics: Specific 
Recommendations for Caprines (#97).'' These related draft guidance 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 by August 16, 1999. FDA must receive 
comments before the deadline in order to ensure their consideration at 
the next VICH Committee.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm 1061, 
Rockville, MD 20852. Comments should be identified with the full title 
of the draft guidance documents and the docket number found in the 
heading of this document.
    Copies of the draft guidance documents entitled ``Efficacy of 
Anthelmintics: General Recommendations,'' ``Efficacy of Anthelmintics: 
Specific Recommendations for Bovines,'' ``Efficacy of Anthelmintics: 
Specific Recommendations for Ovines,'' and ``Efficacy of Anthelmintics: 
Specific Recommendations for Caprines'' 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.

FOR FURTHER INFORMATION CONTACT: 
    Regarding VICH: Sharon R. Thompson (HFV-3), Center for Veterinary 
Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, 
MD 20855, 301-594-1798, e-mail: ``sthompso@cvm.fda.gov''.
    Regarding the guidance documents: Thomas Letonja (HFV-130), Center 
for Veterinary Medicine, Food and Drug Administration, 7500 Standish 
Pl., Rockville, MD 20855, 301-827-7576, e-mail: 
``tletonja@cvm.fda.gov''.

SUPPLEMENTARY INFORMATION: 

[[Page 38446]]

I. Background

    In recent years, many important initiatives have been undertaken by 
regulatory authorities, industry associations, and individual sponsors 
to promote the international harmonization of regulatory requirements. 
FDA has participated in efforts to enhance harmonization and has 
expressed its commitment to seeking scientifically based harmonized 
technical requirements for the development of pharmaceutical products. 
One of the goals of harmonization is to identify and 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 registration of human pharmaceutical 
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 registration of veterinary medicinal products in the European 
Union, Japan, and the United States, and includes input from both 
regulatory and industry representatives.
    The VICH meetings are held under the auspices of the Office 
International des Epizooties (OIE). The VICH Steering Committee is 
composed of member representatives from the European Commission; the 
European Medicines Evaluation Agency; the European Federation of Animal 
Health; the Japanese Veterinary Pharmaceutical Association; the 
Japanese Ministry of Agriculture, Forestry and Fisheries; the U.S. 
Animal Health Institute; the U.S. FDA; and the U.S. Department of 
Agriculture.
    Four observers are eligible to participate in the VICH Steering 
Committee: One representative from the Government of Australia/ New 
Zealand, one representative from industry in Australia/ New Zealand, 
one representative from MERCOSUR (Argentina, Brazil, Uruguay and 
Paraguay), and one representative from Federacion Latino-Americana de 
la Industria para la Salud Animal. 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 participates in the VICH Steering Committee 
meetings.
    The VICH Steering Committee held meetings and agreed that the four 
draft guidance documents should be made available for public comment. 
On October 20 through 22, 1998, the Committee agreed to the draft 
guidance document entitled ``Efficacy of Anthelmintics: General 
Recommendations.'' On March 16 through 18, 1999, the Committee agreed 
on the three draft guidance documents entitled ``Efficacy of 
Anthelmintics: Specific Recommendations for Bovines,'' ``Efficacy of 
Anthelmintics: Specific Recommendations for Ovines,'' and ``Efficacy of 
Anthelmintics: Specific Recommendations for Caprines.''
    The draft guidance entitled ``Efficacy of Anthelmintics: General 
Recommendations'' 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, which will reduce the number of 
animals required for necessary studies. Likewise this will benefit the 
industry by reducing research and development costs. The three draft 
guidances entitled ``Efficacy of Anthelmintics: Specific 
Recommendations for Bovines,'' ``Efficacy of Anthelmintics: Specific 
Recommendations for Ovines,'' and ``Efficacy of Anthelmintics: Specific 
Recommendations for Caprines'' should be read in conjunction with the 
``Efficacy of Anthelmintics: General Recommendations (EAGR).'' The 
guidances for bovines, ovines, and caprines 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 efficacy data recommendations, 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 regulations (62 FR 
8961, February 27, l997). 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'' or phrases 
such as ``minimum standards'' or ``minimum needed'' have been replaced 
by ``recommendation'' or ``recommended'' as appropriate to the context. 
Additionally, the term(s) ``veterinary medicinal products'' and 
``veterinary pharmaceuticals products'' may require revision to be 
consistent with product terms used in other VICH guidance documents.
    These draft documents represent current FDA thinking on efficacy 
requirements for 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. Alternate approaches may be used if 
they satisfy the requirements of applicable statutes, regulations, or 
both.

II. Comments

    Interested persons should submit written comments on or before 
August 16, 1999 to the Dockets Management Branch (address above) 
regarding the guidance documents. 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 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, except for Federal 
Holidays.

    Dated: July 12, 1999.
Margaret M. Dotzel,
Acting Assoicate Commissioner for Policy Coordination.
[FR Doc. 99-18166 Filed 7-13-99; 12:06 pm]
BILLING CODE 4160-01-F