[Federal Register Volume 66, Number 72 (Friday, April 13, 2001)]
[Notices]
[Pages 19177-19178]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-9259]


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

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); 
Final Guidance for Industry Entitled ``Stability Testing of New 
Biotechnological/Biological Veterinary Medicinal Products'' (VICH 
GL17); Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a final guidance for industry (No. 99) entitled 
``Stability Testing of New Biotechnological/Biological Veterinary 
Medicinal 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 (VICH) 
from similarly titled 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 final 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 final guidance) for veterinary biotechnological/biological products 
that are regulated by FDA and for which the NADA's are submitted to the 
European Union, Japan, and the United States.

DATES: Submit written comments at any time.

ADDRESSES: Submit written requests for a single copy of the final 
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 
for electronic access to the final guidance document.
    Submit written comments on the final guidance to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: 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 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 
requirements 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 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 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. 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 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 Stability Testing of New Biotechnological/
Biological Veterinary Medicinal Products

    This final guidance entitled ``Stability Testing of New 
Biotechnological/

[[Page 19178]]

Biological Veterinary Medicinal 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).
    In the Federal Register of October 12, 1999 (64 FR 55294), FDA 
published the VICH draft guidance, giving interested persons until 
November 12, 1999, to submit comments. FDA shared the comments it 
received with the appropriate VICH Expert Working Group and after 
considering the comments, the work group submitted the final guidance 
to the VICH Steering Committee. No changes were made in response to the 
comments. At a meeting held on June 14 through 16, 2000, the VICH 
Steering Committee endorsed the final guidance for industry, VICH GL17.
    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. The evaluation of 
stability may require complex analytical methodologies. With these 
concerns in mind, applicants should develop proper supporting stability 
data for new products of this type.
    This final guidance document is intended to provide guidance to 
applicants regarding the type of 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'' (a copy of this final guidance document may be 
obtained on the Internet from the CVM home page at www.fda.gov/cvm).
    This Level 1 final guidance is being issued consistent with FDA's 
good guidance practices (21 CFR 10.115; 65 FR 56468, September 19, 
2000). It does not create or confer any rights for or on any person and 
does not operate to bind FDA or the public. An alternative approach may 
be used if such approach satisfies the requirements of the applicable 
statutes and regulations.
    Information collected is covered under OMB control number 0910-
0117.

III. Electronic Access

    Copies of the final guidance document entitled ``Stability Testing 
of New Biotechnological/Biological Veterinary Medicinal Products'' 
(VICH GL17) may be obtained on the Internet from the CVM home page at 
http://www.fda.gov/cvm.

IV. Comments

    As with all of FDA's guidances, the public is encouraged to submit 
written comments with new data or other new information pertinent to 
this final guidance. FDA will periodically review the comments in the 
docket and, where appropriate, will amend this final guidance. 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 
(address above) written comments regarding this final guidance document 
at any time. Two copies of any comments are to be submitted, except 
individuals may submit one copy. Comments should be identified with the 
docket number found in the brackets in the heading of this document. A 
copy of the final 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: April 6, 2001.
Ann M. Witt,
Acting Associate Commissioner for Policy.
[FR Doc. 01-9259 Filed 4-12-01; 8:45 am]
BILLING CODE 4160-01-S