[Federal Register Volume 64, Number 196 (Tuesday, October 12, 1999)]
[Notices]
[Pages 55294-55295]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-26502]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99D-4070]
International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products (VICH);
Draft Guidance on ``Quality of Biotechnological Products in the
Veterinary Field: Stability Testing of Biotechnological/Biological
Products'' (VICH GL17); 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availability for comment on the draft guidance for industry entitled
``Quality of Biotechnological Products in the Veterinary Field:
Stability Testing of Biotechnological/Biological Products'' (VICH
GL17). This guidance has been adapted for veterinary use by the
International Cooperation on Harmonisation of Technical Requirements
for Registration of Veterinary Medicinal Products (VICH) from a
guidance regarding pharmaceuticals for human use which was adopted by
the International Conference on Harmonisation of Technical Requirements
for Registration of Pharmaceuticals for Human Use (ICH). This draft
VICH document is intended to provide guidance to applicants regarding
the stability studies that should be conducted and the stability data
that should be provided in support of new animal drug applications
(NADA's) (referred to as marketing applications in the draft guidance)
for veterinary biotechnological/biological products that are regulated
by FDA.
DATES: Submit written comments by November 12, 1999.
ADDRESSES: Send 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of the draft guidance document and the docket number found in the
heading of this document.
Copies of the draft guidance document entitled ``Quality of
Biotechnological Products in the Veterinary Field: Stability Testing of
Biotechnological/Biological Products'' (VICH GL17) may be obtained on
the
[[Page 55295]]
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 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.
FOR FURTHER INFORMATION CONTACT:
Regarding VICH: Sharon R. Thompson, Center for Veterinary Medicine
(HFV-3), Food and Drug Administration, 7500 Standish Pl., Rockville, MD
20855, 301-594-1798, e-mail sthompso@cvm.fda.gov'', or
Robert C. Livingston, Center for Veterinary Medicine (HFV-1), Food
and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-
594-5903, e mail rlivings@cvm.fda.gov''.
Regarding the guidance document: William G. Marnane, Center for
Veterinary Medicine (HFV-140), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-6966, e-mail
wmarnane@cvm.fda.gov''.
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 seek 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 ICH 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 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; 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 Confederation Mondiale de L'Industrie
de la Sante Animale (COMISA). A COMISA representative participates in
the VICH Steering Committee meetings.
II. Guidance on Stability Testing of Biotechnological/Biological
Products
This draft guidance entitled ``Quality of Biotechnological Products
in the Veterinary Field: Stability Testing of Biotechnological/
Biological Products'' (VICH GL17), has been adapted for veterinary use
by the VICH from a guidance regarding pharmaceuticals for human use
which was adopted by the ICH and published in the Federal Register of
July 10, 1996 (61 FR 36466). At a meeting held on May 18 through 20,
1999, the VICH Steering Committee agreed that VICH GL17 should be made
available for public comment.
This draft guidance document is intended to provide guidance to
applicants regarding the stability studies that should be conducted and
the stability data that should be provided in support of NADA's for
veterinary biotechnological/biological products that are regulated by
FDA. It is intended to supplement the tripartite VICH GL3 guidance
entitled ``Stability Testing of New Veterinary Drug Substances and
Medicinal Products.'' Biotechnological/biological products have
distinguishing characteristics to which consideration should be given
in any well-defined testing program designed to confirm their stability
during the intended storage period. For such products, in which the
active components are typically proteins and/or polypeptides,
maintenance of molecular conformation and biological activity is
dependent on noncovalent as well as covalent forces. The products are
particularly sensitive to environmental factors such as temperature
changes, oxidation, light, ionic content, and shear. In order to ensure
maintenance of biological activity and to avoid degradation, stringent
conditions for their storage are usually necessary.
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.
This draft guidance document has been revised to conform to FDA's
good guidance practices (62 FR 8961, February 27, l997) . For example,
the document has been designated ``guidance'' rather than
``guideline.'' Because guidance documents are not binding, mandatory
words such as ``must,'' ``shall,'' and ``will'' in the original VICH
documents have been substituted with ``should.''
This draft guidance represents the agency's current thinking on
stability testing of veterinary biotechnological/biological products.
The document does not create or confer any rights for or on any person
and will not operate to bind FDA or the public. You may use alternate
methods as long as they satisfy the requirements of the applicable
statute and regulation.
III. Comments
General comments are welcome at any time, however, in order to
ensure consideration at the next meeting, interested persons should
submit written comments on or before November 12, 1999, to the Dockets
Management Branch (address above) 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.
Dated: September 30, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-26502 Filed 10-8-99; 8:45 am]
BILLING CODE 4160-01-F
