. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/180
18 August 1999
(99-3474)
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: U.S. 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Products (VICH); Draft Guidance on VICH GL9 Good Clinical Practices; Request for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availability for comment of the following draft guidance document entitled: VICH GL9
"Good Clinical Practices". This draft guidance document was developed by the InternationalCooperation on Harmonisation of Technical Requirements for Registration of Veterinary
Medicinal Products (VICH). It is intended to provide a unified standard for designing,
conducting, monitoring, recording, and reporting studies used in registration applications for
approval of veterinary products submitted 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 42135,
3 August 1999; Available in English
9. Proposed date of adoption: Will be published as future guidance.
10. Proposed date of entry into force: Will be published as future guidance.G/SPS/N/USA/180
Page 2
11. Final date for comments: 2 September 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/FSTD
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 ofsts@fas.usda.gov