[Federal Register Volume 64, Number 136 (Friday, July 16, 1999)]
[Notices]
[Pages 38445-38446]
From the Federal Register Online via the Government Publishing 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availability for comment of four draft guidance documents entitled: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 These related draft guidance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of the draft guidance documents and the docket number found in the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Copies of the draft guidance documents entitled ``Efficacy of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: ``[email protected]''.
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:
``[email protected]''.
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]
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