. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/190
25 October 1999
(99-4617)
Committee on Sanitary and Phytosanitary Measures Original:  English
NOTIFICATION
1. Member to Agreement notifying:  UNITED STATES
If applicable, name of local government involved:           
2. Agency responsible:  US Food and Drug Administration
3. Products covered (provide tariff item number(s) as specified in national schedules
deposited with the WTO; ICS numbers may be provided in addition, whereapplicable).  Regions or countries likely to be affected, to the extent relevant or
practicable:  Veterinary medicinal products
4. Title and number of pages of the notified document: 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Products (VICH); Draft Guidance on "Quality of Biotechnological Products in the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 GL 17);
Availability; Request for Comments (2 pages, plus the guidance document).
5. Description of content: The Food and Drug Administration (FDA) is announcing the
availability for comment on the draft guidance for industry entitled "Quality ofBiotechnological Products in the Veterinary Field: Stability Testing of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 provideguidance 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(referred to as marketing applications in the draft guidance) for veterinary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. It is intended to assist in
developing new animal drug applications su bmitted to the European Union, Japan, and the
United States.
6. Objective and rationale: [  X ] food safety,  [  X ] animal health,  [    ] plant protection,
[    ] protect humans from animal/plant pest or disease, [    ] protect territory from
other damage from pests           
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:  64 FR 55294,
12 October 1999 (Available in English)G/SPS/N/USA/190
Page 2
9. Proposed date of adoption:  Will be published as future guidance.
10. Proposed date of entry into force:  Same as paragraph 9.
11. Final date for comments:  12 November 1999.
Agency or authority designated to handle comments:  [     ] National notification
authority, [     ] National enquiry point, or address, fax number and E-mail address (if
available) of other body: .  Food and Drug Administration
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: [  X ] National notification authority, [  X ] 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 1027
1400 Independence Avenue, S.W.Washington, D.C. 20250
Phone (202) 720-2239
Fax (202) 690-0677
E-mail Address: ofsts@fas.usda.gov