. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/424
24 April 2001
(01-2033)
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:  Food and Drug Administration - FDA
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); Final Guidance for Industry Entitled "Stability Testing of New
Biotechnological/Biological Veterinary Medicinal Products" (VICH GL17);  Availability
(2 pages plus guidances)
5. Description of content:  The Food and Drug Administration (FDA) is announcing the
availability of a final guidance for industry (No. 99) entitled "Stability Testing of NewBiotechnological/Biological Veterinary Medicinal Products" (VICH GL17).  FDA
published the VICH draft guidance in the Federal Register of 12 October 1999.  It was not
notified.  This final 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 VICHdocument 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 s ubmitted to the European Union, Japan, and the United States.
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           
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:  66 FR 19177,
13 April 2001 (Available in English)G/SPS/N/USA/424
Page 2
9. Proposed date of adoption:  This is a final guidance.
10. Proposed date of entry into force:  Same as above.
11. Final date for comments: You may submit written comments at anytime.  Comments
should be submitted through your own VICH representative.  For the United States that isthe Food and Drug Administration
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: The full text, including directions for submitting objections, 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 10271400 Independence Avenue, S.W.
Washington, D.C. 20250
Tel:  (202) 720-2239
Fax:  (202) 690-0677
E-mail:  ofsts@fas.usda.gov