. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/179
29 July 1999
(99-3203)
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, where applicable).
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:  New Animal Drug Applications;
Sheep as a Minor Species (3 pages)
5. Description of content: The Food and Drug Administration (FDA) is proposing to amend its
regulations to reclassify sheep as a minor species for all data collection purposes.  This
would allow sponsors of supplemental ne w animal drug applications (NADA’s) to
extrapolate human food safety data from a major species such as cattle to sheep.  Inparticular, this will allow the extrapolation of the tolerances for residues of new animal
drugs in cattle to sheep.
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, guidelin e 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 40321,
26 July 1999;  21 CFR Part 514 (Available in English)
9. Proposed date of adoption:  To be determined.
10. Proposed date of entry into force:  The date of adoption and entry into force will be
announced when the final rule is published in the Federal Register.G/SPS/N/USA/179
Page 2
11. Final date for comments:  25 October 1999
Agency or authority designated to handle comme nts:  [  ] 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 commen ts 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:
US 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
Tel:  (202) 720 2239
Fax::  (202) 690 0677
E-mail address:  ofsts@fas.usda.gov