. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/361
15 December 2000
(00-5489)
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:  Animal drugs
4. Title and number of pages of the notified document:  Implantation or Injectable Dosage
Form New Animal Drugs; Trenbolone and Estradiol (2 pages)
5. Description of content:  The Food and Drug Administ ration (FDA) is announcing an
amendment to the animal drug regulations to reflect approval of a supplemental abbreviated
new animal drug application (ANADA).  The supplemental ANADA provides for adding
tylosin tartrate as a local antibacterial to an approved subcutaneous cattle ear implant
containing trenbolone and estradiol used in pasture cattle for increased rate of weight gain.
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 70662,
27 November 2000 (Available in English)
9. Proposed date of adoption:  27 November 2000
10. Proposed date of entry into force:  27 November 2000
11. Final date for comments:
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 of this announcement will be sent upon request to
the address in paragraph 12.G/SPS/N/USA/361
Page 2
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. WilsonRoom 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