G/SPS/N/USA/2658  
 
16 April 2014   
(14-2378) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION  
1. Notifying Member: UNITED STATES OF AME RICA 
If applicable, name of local government involved:   
2. Agency responsible: US Food and Drug Administration  
3. Products covered (provide tariff item number(s) as specif ied in national 
schedules deposited with the WTO; ICS numbers should be provided in 
addition, where applicable): Animal feeds  
4. Regions or countries likely to be affected, to the extent relevant or practicable : 
[X] All trading partners   
[ ] Specific reg ions or countries:   
5. Title of the notified document: New Animal Drugs for Use in Animal Feeds; 
Withdrawal of Approval of New Animal Drug Applications; Bambermycins; Hygromycin 
B; Lincomycin; Pyrantel; Tylosin; Tylosin and Sulfamethazine; Virginiamycin   
Language(s): English   Number of pages: 2 
http://www.gpo.gov/fdsys/pkg/FR -2014-04-10/pdf/2014 -08011.pdf  
6. Description of content: The Food and Drug Administration (FDA) is ame nding its 
animal drug regulations to reflect the withdrawal of approval of 19 new animal drug 
applications (NADAs) for certain Type A medicated articles and Type B medicated feeds. 
This action is being taken at the sponsors' request because these products are no longer 
manufactured or marketed.  
7. 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.   
8. Is there a releva nt international standard? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g.   title or serial number of Codex 
standard or related text)   
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, ch apter number)    
[ ] International Plant Protection Convention (e.g.  ISPM number)    
[X] None  
Does this proposed regulation conform to the relevant international standard?   
[ ] Yes   [ ] No  
If no, describe, whenever possible, how and why it deviates from th e 
international standard:   G/SPS/N/USA/26 58 
 
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  9. Other relevant documents and language(s) in which these are available: Draft 
Qualitative Risk Assessment of Risk of Activity/Animal Food Combinations for Activities 
(Outside the Farm Definition) Conducted in a  Facility Co -Located on a Farm;  
US Food, Drug, and Cosmetic Act,  
http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticAct
FDCA ct/default.htm   
(available in English ) 
10. Proposed date of adoption (dd/mm/yy) : 21 April 2014  
Proposed date of publication (dd/mm/yy) : 10 April 2014  
11. Proposed date of entry into force: [ ]  Six months from date of publication , 
and/or  (dd/mm/yy) : 21 April 2014  
[ ] Trade facilitating measure   
12. Final date for comments: [ ]  Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : Not applicable for notice of drug withdrawal.  
Agency or authority designated to handle comments: [ ]  National Notification 
Authority, [ ]  National Enquiry Point. Address, fax number and e -mail address 
(if available) of other body:  
FOR FURTHER INFORMATION CONTACT:  
John Bartkowiak, Center for Veterinary  
Medicine, Food and Drug  
Administration, 7519 Standi sh Pl.,  
Rockville, MD 20855,  
john.bartkowiak@fda.hhs.gov  
13. Texts available from: [X]  National Notification Authority, [ ]  National Enquiry 
Point. Address, fax number and e -mail address (if available) of other body:  
United States SPS National Notificati on Authority, USDA Foreign Agricultural Service, 
International Regulations and Standards Division (IRSD), Stop 1014, Washington D.C. 
20250; Tel: +(1 202) 720 1301; Fax: +(1 202) 720 0433; 
E-mail: us.spsenquirypoint@fas.usda.gov