. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/690/Add.9 
30 April 2009  
 (09-2093) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
NOTIFICATION  
 
Addendum
 
  
The following communication, received on 28 April 2009, is being circulated at the request of 
the Delegation of the United States
. 
 
_______________  
  
Small Entity Compliance Guide on Prior Notice of Imported Food;  Availability
 
 
On 24 April 2009, the US Food and Drug Admi nistration (FDA) published in the Federal 
Register a notice announcing the availability of a sm all entity compliance guide for the final rule on 
prior notice of imported food.  The Prior Notice of  Imported Food Shipments Final Rule issued under 
the Public Health Security and Bioterrorism Pr eparedness and Response Act of 2002 (Bioterrorism 
Act) and it was published in the Federal Register  of 7 November 2008 (73 FR 66294).  The small 
entity compliance guide is entitled "What you Need to Know About Prior Notice of Imported Food 
Shipments—A Small Entity Compliance Guide", and it is intended to help all entities, especially 
small businesses, better understand the prior notice re gulation.  The guidance document can be found 
at http://www.cfsan.fda.gov/guidance.html .  The complete text of the notice contained in the Federal 
Register (FR), 74 FR 18736 (available in English) can be found on the Internet at:  http://www.fda.gov/OHRMS/DOCKETS/98fr/E9-9358.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 sc ope of previously notified draft regulation 
 [   ] Withdrawal of proposed regulation  [   ] Change in proposed date of adoptio n, publication or date of entry into force 
 [ X ] Other:  Notice of availability for a guidance document 
 
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) :  Comments will be accepted at any time. 
 G/SPS/N/USA/690/Add.9 
Page 2  
 
  Agency or authority designated to handle comments:  [   ] National Notification Authority, [   ] 
National Enquiry Point.  Address, fax number and E-mail address (if available) of other body
: 
 
Submit written comments concerning the guidance do cument to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fi shers Lane, rm. 1061, Rockville, MD 20852.  
Submit electronic comments on the guidance document to http://www.regulations.gov . 
 
Text 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 Authority, US DA Foreign Agricultural Service, International 
Regulations and Standards Division (IRSD), Stop 10 27, 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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