. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/346
23 October 2000
(00-4379)
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 Guidances for Industry on "Effectiveness of Anthelmintics:
Specific Recommendations for Equine'' (VICH GL15), "Effectiveness of Anthelmintics:
Specific Recommendations for Porcine'' (VICH GL16), and "Effectiveness of
Anthelmintics:  Specific Recommendations for Canine'' (VICH GL19); Availability;
Request for Comments (2 pages plus guidance documents)
5. Description of content:  The Food and Drug Administra tion (FDA) is announcing the
availability for comment of three draft guidances for industry (Nos.109, 110, and 111,
respectively) entitled: "Effectiveness of Anthelmintics: Specific Recommendations for
Equine'' (VICH GL15), "Effectiveness of Anthelmintics: Specific Recommendations for
Porcine'' (VICH GL16), and "Effectiveness of Anthelmintics: Specific Recommendations
for Canine'' (VICH GL19). These related draft guidance documents have been developed by
the International Cooperation on Harmonisation of Technical Requirements for Registrationof Veterinary Medicinal Products (VICH). They are intended to standardize and simplify
methods used in the evaluation of new anthelmintics submitted for approval 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: 65 FR 62723,
19 October 2000 (Available in English)
9. Proposed date of adoption:  Will be published as future guidance.G/SPS/N/USA/346
Page 2
10. Proposed date of entry into force:  Same as paragraph 9
11. Final date for comments:  18 December 2000
Agency or authority designated to handle comments:  Food and Drug Administration
[    ] 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: [  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
Phone (202) 720-2239
Fax (202) 690-0677
E-mail Address: ofsts@fas.usda.gov