G/SPS/N/USA/701/Add.2  
 
12 February 2014  
(14-0853)  Page: 1/2  
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION 
Addendum 
The following communication, received on 12 Februa ry 2014, is being circulated at the request of 
the Delegation of the United States of America. 
 
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 Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification 
Requirements, and Records and Reports, for Infant Formula 
The Food and Drug Administration is revising our infant formula regulations to establish requirements for current good manufacturing practices (CGMP), including audits; to establish requirements for quality factors; and to amend FD A's quality control procedures, notification, and 
record and reporting requirements for infant formula. FDA is taking this action to improve the 
protection of infants who consume infant formula products. 
This interim final rule is effective 10 July 2014. 
Text is available at http://www.gpo.gov/fdsys/pkg/F R-2014-02-10/pdf/ 2014-02148.pdf . 
Other relevant documents: 
 Draft Guidance for Industry: Demonstration of the Quality Factor Requirements for ''Eligible'' 
Infant Formulas; Availability (available in English) ( http://www.gpo.gov/fdsys/pkg/FR-2014-
02-10/pdf/2014-02731.pdf ) 
 Draft Guidance for Industry: Exempt Infant Formula Production: Current Good Manufacturing 
Practices, Quality Control Procedures, Conduct of Audits, and Records and Reports; Availability 
(available in English) ( http://www.gpo.gov/fdsys/pkg/FR- 2014-02-10/pdf/2 014-02732.pdf ) 
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 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) : 27 March 2014 G/SPS/N/USA/701/Add.2 
 
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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: 
Submit either electronic or written comments on the interim final rule to the addresses in this 
ADDRESSES section. To ensure that  comments on information collection are received, the Office of 
Information and Regulatory Affairs, Office of  Management and Budget (OMB) recommends that 
written comments be faxed to the Office of Info rmation and Regulatory Affairs, OMB, Attn: FDA 
Desk Officer, FAX: 202-395-5806. All comments received must include the Agency name, Docket 
No. FDA-1995-N-0036, and RIN number 0910-AF27 for this rulemaking. You may submit comments, identified by Docket No. FDA-1995-N-0036 (formerly 95N-0309) and/or RIN number RIN 0910-AF27, 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. 
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 Agency name and Docket No. FDA-1995-N-
0036 (formerly 95N-0309) and RIN 0910-AF27 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 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  
Text available in the Federal Register, Vol. 79, No. 27, at page 7934 or at 
http://www.gpo.gov/fdsys/pkg/FR- 2014-02-10/pdf/ 2014-02148.pdf  
 
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