. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/1933/Add.2 
18 September 2009  
 (09-4396) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
NOTIFICATION  
 
Addendum
 
  
The following communication, received on 14 Se ptember 2009, is being circulated at the 
request of the Delegation of United States
. 
 
_______________  
  
Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as 
Established by the Food and Drug Admi nistration Amendments Act of 2007  
 
The Food and Drug Administration (FDA) announces the availability of a guidance document 
entitled "Questions and Answers Re garding the Reportable Food Registry as Established by the Food 
and Drug Administration Amendments Act of 2007".  The document provides guidance to the 
industry in complying with the Reportable Food Registry requirements prescribed by the Food and Drug Administration Amendments Act of 2007 (FDAAA).  
The notice published in the Federal Regist er, 74 FR 46434-46435 on 9 September 2009 can 
be found at http://edocket.access.gpo.go v/2009/pdf/E9-21713.pdf
. 
 The guidance can be found at:  http://www.fda.gov/Food/GuidanceComplianceRegul atoryInformation/GuidanceDocuments/FoodSaf
ety/ucm180761.htm  
 
The Reportable Food Registry can be found at: 
http://www.fda.gov/Food/FoodSafety/FoodSafetyPrograms/RFR/default.htm  
 Questions and Answers can be found at: http://www.fda.gov/Food/FoodSafety/FoodSafetyPrograms/RFR/ucm180889.htm
 
 
Instructions can be found at: http://www.fda.gov/Food/GuidanceComplianceRegul atoryInformation/GuidanceDocuments/FoodSaf
ety/ucm180872.htm  
 
In the Federal Register of 11 June 2009 (74 FR 27803), FDA announced the availability of a 
draft guidance entitled "Questions and Answers Regarding the Reportable Food Registry as 
Established by the Food and Drug Administration Amendments Act of 2007" and gave interested 
parties an opportunity to submit comments by 27 July 2009.  The agency reviewed and evaluated these comments and has modified the guidance where appropriate.  The guidance contains questions 
and answers intended to assist those parties res ponsible for complying with the Reportable Food 
Registry requirements prescribed by the Food  and Drug Administration Amendments Act of 2007 
(Public Law 110–085), including: (1) How, when, and where to submit reports to FDA; (2) who is G/SPS/N/USA/1933/Add.2 
Page 2  
 
  required to submit reports to FDA; (3) what is requi red to be submitted to FDA; and (4) what may be 
required when providing notifications to other persons in the supply chain of an article of food.  FDA 
is issuing this guidance as level 1 guidance consis tent with FDA’s good guidance practices regulation 
(21 CFR 10.115). The guidance represents the agency’s  current thinking on this topic. It does not 
create or confer any rights for or on any person and does not operate to bind FDA or the public. 
 
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:  See above. 
 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 can be submitted at any time. 
 
Agency or authority designated to handle comments:  [   ] National Notification Authority, [ X ] 
National Enquiry Point.  Address, fax number and E-mail address (if available) of other body
: 
 Written or electronic comments can be submitted on the guidance to the Division of Dockets 
Management (HFA–305), Food and Dr ug Administration, 5630 Fishers Lane, Room 1061, Rockville, 
MD 20852. Submit electronic commen ts on the guidance to http://www .regulations.gov , please note 
Docket No. FDA–2009–D–0260 in submission.   
Text available from:  [ X ] National Notification Authority, [   ] National Enquiry Point.  Address, 
fax number and E-mail address (if available) of other body
: 
 
For further information contact: Faye Feldstein, Center for Food Safety and Applied Nutrition (HFS–
005), Food and Drug Administration, 5100 Paint Br anch Pkwy., College Park, MD 20740, 1–888–
Safefood. 
 
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  
 
__________