[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]


-----------------------------------------------------------------------

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Draft Guidance on ``Quality of Biotechnological Products in the 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.

-----------------------------------------------------------------------

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availability for comment on the draft guidance for industry entitled 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(NADA's) (referred to as marketing applications in the draft guidance) 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of the draft guidance document and the docket number found in the 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    Copies of the draft guidance document entitled ``Quality of 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 ``[email protected]'', 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 ``[email protected]''.
    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 
``[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 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