[Federal Register: December 18, 2000 (Volume 65, Number 243)]
[Notices]
[Page 79113-79114]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18de00-102]
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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These related draft guidance documents have been developed by the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DATES: Submit written comments on the draft guidance documents by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ADDRESSES: Copies of the draft guidance documents entitled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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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: sthompso@cvm.fda.gov, 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:
candres1@cvm.fda.gov.
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: tletonja@cvm.fda.gov.
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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