[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]
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