. /.  WORLD TRADE  
ORGANIZATION   
G/SPS/N/USA/2156/Add.3/Rev.1 
3 November 2011  
 (11-5573) 
Committee on Sanitary and Phytosanitary Measures Original:   English 
  
 
NOTIFICATION 
 
Revision 
  
The following communication, received on 28 Octo ber 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;  Extension of Comment Period 
 The Food and Drug Administration (FDA) is extending the comment period to 
30 November 2011, for the notice entitled, Burden  of Food and Drug Administration Food Safety 
Modernization Act Fee Amounts on Sm all Business;  Request for Comments that appeared in the 
Federal Register of 1 August 2011 (76 FR 45818).  In that document, FDA announced the 
establishment of a docket to obtain information that  would 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).  In par ticular, the Agency requested public comments on 
whether a reduction of fees or other consideration for small business was appropriate, and if so, what 
factors the Agency should consider for each.  In  addition, the Agency requested public comment on 
how small business should be defined or recognized.  The Agency is taking this action in response to 
requests for an extension to allow interested pers ons additional time to submit comments.  The notice 
can be found at:  http://www.gpo.gov/fdsys/pkg/FR -2011-10-18/pdf/2011-26815.pdf  or in the Federal 
Register of 18 October 2011 at Federal Regist er:  18 October 2011 (Volume 76, Number 201) 
Notices; Page 64354. 
This addendum concerns a: 
[ ] Modification of final date for comments 
[X] 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 
[ ] Other:    
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.)  G/SPS/N/USA/2156/Add.3/Rev.1 
Page 2  
 
  [ ] Sixty days from the date of circulation of the addendum to the notification and/or 
(dd/mm/yy) :  30 November 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: 
Alexis Nazario-Negron, Office of  Financial Management, Food a nd Drug Administration, 1350 
Piccard Dr., rm. 210E, Rockville, MD 20850, 301-79 6-7223,  Alexis.Nazar io-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  
 
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