G/SPS/N/USA/2682  
 
17 July 2014  
(14-4158)  Page: 1/2  
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION 
1. Notifying Member: UNITED STATES OF AMERICA 
If applicable, name of local government involved:   
2. Agency responsible: US Food and Drug Administration (FDA) 
3. Products covered (provide tariff item  number(s) as specified in national 
schedules deposited with the WTO; IC S numbers should be provided in 
addition, where applicable): Certain types of medicated animal feed 
4. Regions or countries likely to be affected , to the extent relevant or practicable: 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document: Withdrawal of Approval of Part of a New Animal Drug 
Application; Procaine Penicillin  Language(s): English  Number of pages: 2 
6. Description of content: The Food and Drug Administration (FDA) is withdrawing 
approval of those parts of a new animal drug application (NADA) for a three-way, fixed-ratio, combination drug Type A medicated article that pertain to use of the procaine penicillin component for growth promotion indications in swine. This action is being 
taken at the sponsor's request because the three-way Type A medicated article is no 
longer manufactured. 
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 relevant international st andard? 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, chapter 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 the 
international standard:   G/SPS/N/USA/2682 
 
- 2 - 
 
  9. Other relevant documents and language (s) in which these are available: 
FDA Guidance for Industry #209: "The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals" 
http://www.fda.gov/downloads/AnimalVeterina ry/GuidanceComplianceEnforcement/Guid
anceforIndustry/UCM216936.pdf  (available in English) 
10. Proposed date of adoption (dd/mm/yy) : 2 July 2014 
Proposed date of publication (dd/mm/yy) : 2 July 2014 
11. Proposed date of entry into force: [ ] Six months from date of publication , 
and/or  (dd/mm/yy) : 2 July 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 withdrawal of approval for 
animal drug. 
Agency or authority designated to hand le comments: [X] National Notification 
Authority, [ ] National Enquiry Point.  Address, fax number and e-mail address 
(if available) of other body:  
United States SPS National Notification Auth ority, 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 
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 Notification Auth ority, 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