G/SPS/N/USA/2502/Add.4  
 
20 November 2013  
(13-6389)  Page: 1/2  
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION 
Addendum 
The following communication, received on 19 November 2013, is being circulated at the request of 
the Delegation of the United States of America. 
 
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 Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for 
Human Food; Extension of Comment Periods 
The Food and Drug Administration (FDA) is ex tending the comment period for the notice of 
proposed rulemaking that appeared in the Federal Register of 16 January 2013 (78 FR 3646), entitled "Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive 
Controls for Human Food" and its information collection provisions. Submit either electronic or 
written comments on the notice of proposed rulemaking by 22 November 2013. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (the PRA) by 
22 November 2013 (see the "Paperwork Reduction Act of 1995" section). FDA is extending the 
comment period due to the inability of some commenters to submit comments through the http://www.regulations.gov  Website from 4 November 2013, through 14 November 2013, because 
of technical difficulties at that Website. 
http://members.wto.org/crnattachments/2013/sps/USA/13_4630_00_e.pdf  
This addendum concerns a: 
[X] 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 
[ ] 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) : 22 November 2013 G/SPS/N/USA/2502/Add.4 
 
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  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, identified by Docket No. FDA-2011-N-0920 and/or Regulatory 
Information Number (RIN) 0910-AG36, by any of th e following methods, except that comments on 
information collection issues under the PRA must be submitted to the Office of Information and Regulatory Affairs, Office of Management and Bu dget (OMB) (see the "Paperwork Reduction Act of 
1995" section). 
Electronic Submissions 
Submit electronic comments in the following way: Federal eRulemaking Portal: http://www.regulations.gov . Follow the instructions for submitting 
comments. 
Written Submissions 
Submit written submissions in the following ways: 
Mail/Hand delivery/Courier (for paper or CD-ROM submissions): 
Division of Dockets Management (HFA-305), Fo od and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. 
Instructions: 
All submissions received must include the Ag ency name and Docket No. FDA-2011-N-0920, and 
RIN 0910-AG36 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 "How to Submit Comments" heading of the 
SUPPLEMENTARY INFORMATION section of this document.  
Text 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 can also be found at the following URL: 
https://www.federalregister.gov/ articles/2013/11/20/ 2013-27783/current-g ood-manufacturing-
practice-and-hazard-analysis-and-risk-based-preventive-controls-for-human  
 
 
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