. /.  WORLD TRADE  
ORGANIZATION   
G/SPS/N/USA/2156/Add.4 
7 August 2012  
 (12-4343) 
Committee on Sanitary and Phytosanitary Measures Original:   English 
  
 
NOTIFICATION 
 
Addendum 
  
The following communication, received on 3 Augus t 2012, is being circulated at the request 
of the Delegation of the United States of America. 
 
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Food Safety Modernization Act Domestic and Fore ign Facility Reinspections, Recall, and Importer 
Reinspection User Fee Rates for Fiscal Year 2013; Notice 
 The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2013 fee rates 
for certain domestic and foreign facility reinspectio ns, failures to comply with a recall order, and 
importer reinspections that are authorized by the Federal Food, Drug, and Co smetic Act (the FD&C 
Act), as amended by the FDA Food Safety Modern ization Act (FSMA). These fees are effective on 
1 October 2012, and will remain in effect through 30 September 2013. 
 FDA is accepting comments to this document a nd intends to consider such comments in its 
continued implementation of these fees.  The noti ce published in the Federal Register on 1 August 
2012 at 77 FR 45636.  The notice can be found at:  " http://www.gpo.gov/fdsys/pkg/FR-2012-08-
01/pdf/2012-18678.pdf ". 
 FDA recognizes that there is significant international interest in how we are implementing the 
Food Safety Modernization Act of 2010, and as a result has elected to is notify this action to give US 
trading partners an opportunity to submit comments on the burden of fee amounts on small business, even though this notification is not an obligation under Article 7, Annex B.   
This addendum concerns a: 
[ ] Modification of final date for comments 
[ ] Notification of adoption, publication or entry into force of regulation 
[ ] Modification of content and/or scope of previously notified draft regulation 
[ ] Withdrawal of proposed regulation 
[ ] Change in proposed date of adoption, publication or date of entry into force 
[X] Other:   Notice for public comment on fee burdens under the FDA Food Safety 
Modernization Act (FSMA) G/SPS/N/USA/2156/Add.4 
Page 2  
 
  Comment period:  (If the addendum extends the scope of th e previously notified measure in terms 
of products and/or potentially affected Members, a new deadline for receipt of comments should be 
provided, normally of at least 60 calendar days.  Under other circumstances, such as extension of 
originally announced final date for comments, th e comment period provided in the addendum may 
vary.)  
[ ] Sixty days from the date of circulation of the addendum to the notification and/or 
(dd/mm/yy) :  31 October 2012 
Agency or authority designated to handle commen ts:  [ ] National Notification Authority, [ ] 
National Enquiry Point.  Address, fax number and e-mail address (if available) of other body: 
Submit electronic comments to http://www.regulations.gov .  Submit written comments to the Division 
of Dockets Management (HFA 305), Food and Dr ug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Comments should be s ubmitted under Docket No. FDA-2012-N-0799. 
For information contact Erin Caines, Office of R esource Management, Office of Regulatory Affairs, 
12420 Parklawn Dr., rm. 2010, Rockville, MD 20857, 301-796-2900, E-mail: Erin.Caines@fda.hhs.gov.  
Text available from:  [X] National Notification Au thority, [ ] National Enquiry Point.  Address, 
fax number and e-mail address (if available) of other body: 
United States SPS National Notification Authority, US DA Foreign Agricultural Service, International 
Regulations and Standards Division (IRSD), Stop 10 14, Washington D.C. 20250;  Tel:  +(1 202) 720 
1301;  Fax:  +(1 202) 720 0433;  E-mail :  us.spsenquirypoint@fas.usda.gov 
  
 
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