[Federal Register Volume 64, Number 140 (Thursday, July 22, 1999)]
[Notices]
[Pages 39515-39516]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-18692]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99D-2249]
International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products (VICH);
Draft Guidance on Stability Testing for Medicated Premixes;
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availability for comment on the following draft guidance for industry
document entitled ``Stability Testing for Medicated Premixes.'' This
draft guidance document has been developed for veterinary use by the
International Cooperation on Harmonisation of Technical Requirements
for Registration of Veterinary Medicinal Products (VICH). This draft
guidance document is an annex to the parent guidance VICH GL3 entitled
``Stability Testing of New Drug Substances and Products in the
Veterinary Field.'' This draft guidance document is the annex and
addresses the recommendations for stability testing of veterinary
medicinal Type A medicated articles (referred to as medicated premix
drug products in the draft guidance) intended for submission for
approval to the European Union, Japan, and the United States.
DATES: Written comments should be submitted by August 23, 1999. NOTE:
FDA will accept comments after the deadline, but to assure
consideration, we must receive them by August 23, 1999.
ADDRESSES: Submit written comments on the draft guidance to the Dockets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the full title of the draft guidance document and the docket number
found in the heading of this document. Submit written requests for
single copies of the draft guidance to the Communications Staff (HFV-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 of this document for electronic
access to the draft guidance.
FOR FURTHER INFORMATION CONTACT:
Regarding VICH: Sharon 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 document: William G. Marnane (HFV-140),
Center for Veterinary Medicine, Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-6966, e-mail
``[email protected]''.
SUPPLEMENTARY INFORMATION:
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 of Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH) 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 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 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 U.S. Food and Drug Administration; the U.S. Department of
Agriculture; the Animal Health Institute; the Japanese Veterinary
Pharmaceutical Association; and the Japanese Ministry of Agriculture,
Forestry and Fisheries.
Four observers are eligible to participate in the VICH Steering
Committee: One representative from the Government of Australia/New
Zealand, one representative from the 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.
At a meeting held on October 20-22, 1998, the VICH Steering
Committee agreed that the draft guidance document entitled ``Stability
Testing for Medicated Premixes'' should be made available for public
comment.
This draft guidance addresses the generation of acceptable
stability information for submission in new animal drug applications
(referred to as registration applications in the draft guidance) for
Type A medicated articles containing new molecular entities. Comments
about this draft guidance document will be considered by the FDA and
the VICH Quality Working Group. Ultimately, FDA intends to adopt the
VICH Steering Committee's final guidance and publish it as future
guidance.
[[Page 39516]]
This draft guidance has been revised to conform to FDA's good
guidance practices (62 FR 8961, February 27, l997) . For example, the
documents have been designated ``guidance'' rather than ``guideline.''
Because guidance documents are not binding, mandatory words such as
``must'' and ``shall,'' and ``will'' in the original VICH documents
have been substituted with ``should.'' Additionally, the term(s)
``veterinary medicinal products'' and ``veterinary pharmaceutical
products'' may require revision to be consistent with product terms
used in other VICH guidance documents.
This draft guidance document represents the FDA's current thinking
on acceptable stability testing of Type A medicated articles. The
document does 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 may, on or before August 23, 1999, submit to the
Dockets Management Branch (address above) written comments regarding
this draft guidance document. 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 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.
III. Electronic Access
Copies of the draft guidance document entitled ``Stability Testing
for Medicated Premixes'' may be obtained on the internet within the CVM
home page at ``http://www.fda.gov/cvm/fda/TOCs/guideline.html''.
Dated: July 15, 1999
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-18692 Filed 7-21-99; 8:45 am]
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