G/SPS/N/USA/2570/Add.2
4 August 2015 
(15-4011)  Page: 1/2
Committee on Sanitary and Phytosanitary Measures  Original: English
 
  NOTIFICATION 
Addendum 
The following communication, received on 3 August 2015, is being circulated at the request of the 
Delegation of the United States of America. 
 
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 User Fee Program To Provide for Accreditation of  Third-Party Auditors/Certification Bodies To 
Conduct Food Safety Audits and To Issue Certifications 
The Food and Drug Administration (FDA, the Agency, or we) is issuing this proposed rule to amend 
the proposed rule, ''Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications'' (Accreditation of Third-Party Auditors proposed rule) and 
to propose to establish a reimbursement (user fee) program to assess fees and require 
reimbursement for the work performed to establish and administer the system for the Accreditation of Third-Party Auditors under th e FDA Food Safety Modernization Act (FSMA). 
http://members.wto.org/crnattachments/2015/SPS/USA/15_3039_00_e.pdf  
This addendum concerns a: 
[ ] Modification of final date for comments 
[ ] Notification of adoption, publication or entry into force of regulation 
[X] 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 the previously notified 
measure in terms of products and/or potent ially affected Members, a new deadline for 
receipt of comments should be provided, norm ally of at least 60 calendar days. Under 
other circumstances, such as extension of or iginally announced final date for comments, 
the 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) : 7 October 2015 
Agency or authority designated to handle co mments: [ ] National Notification Authority, 
[ ] National Enquiry Point. Address, fax nu mber and e-mail address (if available) of 
other body: 
You may submit comments by any of the following methods: Electronic Submissions 
Submit electronic comments in the following way: 
Federal eRulemaking Portal: http://www.regulations.gov . Follow the instructions for submitting 
comments. G/SPS/N/USA/2570/Add.2 
 
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  Written Submissions 
Submit written submissions in the following ways: Mail/Hand delivery/Courier (for paper submission s): Division of Dockets Management (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 
Instructions: All submissions received must include the Docket No. FDA-2011-N-0146 for this 
rulemaking. All comments received may be posted without change to http://www.regulations.gov , 
including any personal information provided. For additional information on submitting comments, 
see the ''Comments'' heading of the SUPPLEMENTARY INFORMATION section of this document.  
Text(s) available from: [X] National Notificati on Authority, [ ] National Enquiry Point. 
Address, fax number and e-mail addre ss (if available) of other body: 
United States SPS National Notification Authority, USDA Foreign Agricultural Service, International 
Regulations and Standards Division (IRSD), Stop 1014, Washington D.C. 20250; Tel: +(1 202) 
720 1301; Fax: +(1 202) 720 0433; E-mail: us.spsenquirypoint@fas.usda.gov 
The text is available in the Federal Register Vol. 80 No. 142 at Page 43987 or at: 
http://www.gpo.gov/fdsys/pkg/FR- 2015-07-24/pdf/ 2015-18141.pdf .  
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