. /.  WORLD TRADE  
ORGANIZATION   
G/SPS/N/USA/2156/Add.2 
11 August 2011  
 (11-4015) 
Committee on Sanitary and Phytosanitary Measures Original:   English 
  
 
NOTIFICATION 
 
Addendum 
  
The following communication, received on 9 Augus t 2011, is being circulated at the request 
of the Delegation of the United States. 
 
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Food Safety Modernization Act Domestic and Fore ign Facility Reinspections, Recall, and Importer 
Reinspection User Fee Rates for Fiscal Year 2012 
 The US Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2012 fee 
rates for certain domestic and foreign facility reinspec tions, failure to comply with a recall order, and 
importer reinspections that are mandated in the Fe deral Food, Drug, and Cosmetic Act (the FD&C 
Act), amended by the FDA Food Safety Moderniz ation Act (FSMA).  These fees are effective on 
1 October 2011, and will remain in effect thr ough 30 September 2012.  Invoices for these fees for 
FY 2012 will be issued using the fee schedule est ablished in this document.  FDA is accepting 
comments to this document and intends to consider such comments in implementing these user fees in 
FY 2013.  The notice published in the Federal Re gister on 1 August 2011 76 FR 45820.  The notice 
can be found at:  http://www.gpo.gov/fdsys/pkg/FR -2011-08-01/pdf/2011-19331.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. 
 http://members.wto.org/crnattach ments/2011/sps/USA//11_2684_00_e.pdf  
 
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.2 
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 2011 
Agency or authority designated to handle comments:  [ ] National Notification Authority, 
[ ] National Enquiry Point.  Address, fax num ber 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.  Please indicate Docket No. FDA-2011-N-0528 with comment submission. 
For further information contact:  Amy Waltrip , 12420 Parklawn Dr., Rm. 2012, Rockville, MD 
20857, 1-301-796-8811, E-mail:  Amy.Waltrip@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 
Text available on the internet at:  http://www.gpo.gov/fdsys/pkg/FR -2011-08-01/pdf/2011-19331.pdf  
 
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