. /.  WORLD TRADE  
ORGANIZATION   
G/SPS/N/USA/2156/Add.3 
11 August 2011  
 (11-4016) 
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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Burden of Food and Drug Administration Food Safety Modernization Act Fee Amounts on Small 
Business; Request for Comments 
 The Food and Drug Administration (FDA) seeks comments to obtain information that will be 
used to formulate a proposed set of guidelines in consideration of the burden of fee amounts on small 
business, as set forth in the FDA Food Safety Modernization Act (FSMA).  FSMA provides the Agency with authority under the Federal Food, Drug,  and Cosmetic Act (the FD&C Act) to assess and 
collect user fees, including tho se for costs associated with certain domestic and foreign facility 
reinspections, failure to comply with a recall or der, and importer reinspections.  FDA is seeking 
public comment on what burdens these fees impose on  small business, and whether and how the FDA 
should alleviate such burdens. In particular, the FDA is seeking public  comments on whether a 
reduction of fees or other consideration for small bus iness is appropriate, and if so, what factors FDA 
should consider for each.  In addition, FDA is seeking public comment on  how small business should 
be defined or recognized.  FDA is establishing th is docket in order to provide an opportunity for 
interested parties to provide data and share views th at will inform future FDA actions with respect to 
these matters.  The notice published in the Federal Register on 1 August 2011 76 FR 45818.  The 
notice can be found at:  http://www.gpo.gov/fdsys/pkg/FR-2011-08-01/pdf/2011-19333.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_2685_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.3 
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) :  17 October 2011 
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.  Please indicate Docket No. FDA-2011-N-0529 with comment submission. 
For further information contact:  Alexis Nazario-N egron, Office of Financial Management, Food and 
Drug Administration, 1350 Piccard Dr., rm. 210E,Rockville, MD 20 850, 301-796-7223, 
Alexis.Nazario-Negron@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/2011-19333.pdf   
 
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