. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/1412 
31 August 2006 
 (06-4141) 
Committee on Sanitary a nd 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 should be provided in addition, where 
applicable):  Animal drugs  
4. Regions or countries likely to be affected , to the extent relevant or practicable:  
US trading partners  
5. Title, language and number of p ages of the notified document:  Index of Legally 
Marketed Unapproved New Animal Drugs for Mi nor Species (Available in English, 24 pages)  
6. Description of content:  FDA issued proposed regulations to implement section 572 of the 
Federal Food Drug and Cosmetic Act entitled "Index of Lega lly Marketed Unapproved New 
Animal Drugs for Minor Species."  These regul ations propose administrative procedures and 
criteria for index listing a new animal drug for us e in a minor animal species.  Such indexing 
provides a basis for legally marketing an unappr oved new animal drug intended for use in a 
minor animal species in the United States.  
7. 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   
8. International standard, guideline or recommendation: 
[   ] Codex Alimentarius Commission,  [   ] World Organization for Animal Health 
(OIE), [   ] International Plant Protection Convention,  [ X ] None 
If an international standard, guideline or recommendation exists, give the appropriate 
reference and briefly identify deviations:   
9. Relevant documents and language(s) in which these are available:  Proposed rule 
published in the Federal Register at 71 FR 48840 (available in English).  The notice can be 
found at:  http://www.fda.gov/OHRM S/DOCKETS/98fr/06-7070.pdf  
10. Proposed date of adoption:  Proposed rule;  date not yet established  
11. Proposed date of entry into force:  Proposed rule;  date not yet established  G/SPS/N/USA/1412 
Page 2  
 
  12. Final date for comments:  20 November 2006  
Agency or authority designated to handle comments:  [   ] National notification 
authority, [ X ] National enquiry point, or address, fax number and E-mail address (if 
available) of other body:   
You may submit comments, identified by [Docket No. 2006N–0067 and/RIN number 0910–
AF67], by any of the following methods: 
Electronic Submissions
:  Submit electronic comments in the following ways: 
• Federal eRulemaking Portal:  http://www.regulations.gov .  Follow the instructions for 
submitting comments. 
• Agency Web site:  http://www.fda.gov/dockets/ecomments .  Follow the instructions for 
submitting comments on the agency Web site. 
Written Submissions :  Submit written submissions in the following ways: 
• FAX:  301–827–6870. • Mail/Hand delivery/Courier [For paper, di sk, or CD–ROM submissions]:  Division of 
Dockets Management (HFA–305), Food and Dr ug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852. 
To ensure more timely processing of comment s, FDA is no longer accepting comments 
submitted to the agency by e-mail.  FDA encour ages you to continue to submit electronic 
comments by using the Federal eRulemaking Portal or the agency Web site, as described in 
the Electronic Submissions por tion of this paragraph. 
Instructions
:  All submissions received must include the agency name and Docket No(s). and 
Regulatory Information Number (RIN) for this  rulemaking.  All comments received may be 
posted without change to http://www.fda.gov/ohrms/dockets/default.htm , including any 
personal information provided.  
13. Texts available from:  [   ] National notification authority, [ X ] National enquiry point, 
or address, fax number and E-mail address (if available) of other body:   
U.S. Enquiry Point, U.S. Department of Agriculture, Stop 1027, Washington, DC 20250.  
TEL (202) 720-1301, FAX (202) 690-0677, fstsd@usda.gov .  Complete text can be also be 
found on the Internet at http://www.fda.gov/OHRMS/ DOCKETS/98fr/06-7070.htm .  For 
access to the docket to read background documents or commen ts received, go to 
http://www.fda.gov/ohrms /dockets/default.htm  and insert the Docket No. 2006N-0067 into 
the "Search" box and follow the prompts.