. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/228
22 February 2000
(00-0655)
Committee on Sanitary and Phytosanitary Measures
NOTIFICATION
1. Member to Agreement notifying:  UNITED STATES
If applicable, name of local government involved:           
2. Agency responsible:  Department of Agriculture, Animal and Plant Health Inspection
Service - APHIS
3. Products covered (provide tariff item number(s) as specified in national schedules
deposited with the WTO; ICS numbers may be provided in addition, where
applicable).  Regions or countries likely to be affected, to the extent relevant or
practicable:  Biotechnological/Biological Veterinary Medicinal Products
4. Title and number of pages of the notified document: Draft Guidelines on Stability
Testing of Biotechnological/ Biological Veterinary Medicinal Products, VICH Topic GL17
(2 pages plus related draft paper).
5.Description of content:
A draft guideline titled "Stability Testing of Biotechnological/Biological Veterinary
Medicinal Products'' has been developed by the International Cooperation on Harmonization
of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). The
guideline contains proposed international standards for the generation and submission ofstability data for products such as cytokines (interferons, interleukins, colony-stimulating
factors, tumor necrosis factors), monoclonal antibodies, and vaccines consisting of well-
characterized proteins or polypeptides, including some conventional vaccines. Because the
draft guidelines pertain to veterinary biological products regulated by the Animal and Plant
Health Inspection Service under the Virus-Serum-Toxin Act, we are requesting comments
on its provisions so that we may include any relevant public input on the draft in the
Agency's comments to the VICH Steering Committee.
Ultimately, APHIS intends to consider the VICH Steering Committee's final guidance
document for use by U.S. veterinary biologics licensees, permittees, and applicants. In
addition, APHIS will consider its use as a basis for the approval of stability studies
conducted to establish and extend expiration dates for applicable veterinary biological
products under 9 CFR 114.13 and 114.14. APHIS may also use the final guidance documentas the basis for proposed additions or amendments to its regulations in 9 CFR chapter I,
subchapter E (Viruses, Serums, Toxins, and Analogous Products; Organisms and Vectors).
Because we anticipate that applicable provisions of the final version of ``Stability Testing of
Biotechnological/Biological Veterinary Medicinal Products'' may be introduced into
APHIS' veterinary biologics regulatory program in the future, we encourage your commentson the draft version
6. Objective and rationale: [     ] food safety,  [  X ] animal health,  [     ] plant protection,
[    ] protect humans from animal/plant pest or disease,
[    ] protect territory from other damage from pests           G/SPS/N/USA/228
Page 2
7. An international standard, guideline or recommendation does not exist [  X ].
If an international standard, guideline or recommendation exists, give the appropriate
reference and briefly identify deviations:           
8. Relevant documents and language(s) in which these are available: 65 FR 5305,
3 February 2000;  Available in English.
9. Proposed date of adoption: To be determined.
10. Proposed date of entry into force: To be determined.          
11.Final date for comments: 3 April 2000
Agency or authority designated to handle comments: Animal and Plant Health
Inspection Service.  [    ] National notification authority, [     ] National enquiry point, or
address, fax number and E-mail address (if available) of other body: Detailed
instruction on where and how to send comments is in the body of the full text - which will
be sent upon request to the address in paragraph 12.
12. Texts available from: [     ] National notification authority, [     ] National enquiry point
or address, fax number and E-mail address (if available) of other body:
United States SPS Enquiry Point/Notification Authority
USDA/FAS/FSTSD
ATTN: Carolyn F. Wilson
Room 5545 South Agriculture Building
Stop 10271400 Independence Avenue, S.W.
Washington, D.C. 20250
Phone (202) 720-2239
Fax (202) 690-0677
E-mail Address: ofsts@fas.usda.gov