. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/420
20 April 2001
(01-1983)
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 Approval of Veterinary Medicinal Products
(VICH); Final Guidances Entitled "Effectiveness of Anthelmintics: General
Recommendations" (VICH GL7), "Effectiveness of Anthelmintics: Specific
Recommendations for Bovine" (VICH GL12), "Effectiveness of Anthelmintics: Specific
Recommendations for Ovine" (VICH GL13), and "Effectiveness of Anthelmintics: Specific
Recommendations for Caprine" (VICH GL14);  Availability.  (3 pages plus guidances).
5. Description of content: The Food and Drug Administration (FDA) is announcing the
availability of four final guidances for industry (Nos. 90, 95, 96, and 97) entitled
"Effectiveness of Anthelmintics: General Recommendations" (EAGR) (VICH GL7),
"Effectiveness of Anthelmintics: Specific Recommendations for Bovine" (VICH GL12),
"Effectiveness of Anthelmintics: Specific Recommendations for Ovine" (VICH GL13), and
"Effectiveness of Anthelmintics: Specific Recommendations for Caprine" (VICH GL14).
These guidances have been adapted for veterinary use by the International Cooperation onHarmonisation of Technical Requirements for Approval of 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: [    ] 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 18257,
6 April 2001 (Available in English)
9. Proposed date of adoption:  This is a final guidance.G/SPS/N/USA/420
Page 2
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 is
the 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 BuildingStop 1027
1400 Independence Avenue, S.W.
Washington, D.C. 20250
Tel:  (202) 720-2239
Fax:  (202) 690-0677
E-mail:  ofsts@fas.usda.gov