. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/USA/41/Add.1 
8 August 2006 
 (06-3817) 
Committee on Technical Barriers to Trade Original:   English 
  
 
NOTIFICATION 
 
Addendum
 
  
 The following communication, dated 3 August 2006 has been received from the United 
States . 
 
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Current Good Manufacturing Practice, Quality Cont rol Procedures, Quality Factors, Notification 
Requirements, and Records and Reports for the Pr oduction of Infant Formula; Reopening of the 
Comment Period (71 FR 43392)  
  The U.S. Food and Drug Administration (F DA) is reopening until 15 September 2006, the 
comment period for the proposed rule, publishe d in the Federal Register of 9 July 1996 
(61 FR 36154), to revise its infant formula regul ations in 21 CFR parts 106 and 107.  The proposal 
would establish requirements for current good manuf acturing practice (CGMP) and audits, establish 
requirements for quality factors, and amend its qualit y control procedures, notification, and records 
and reports requirements for infant formula.  FD A previously reopened the comment period to update 
comments and to receive any new information on  28 April 2003.  The purpose of the current 
reopening of the comment period is to obtain comment only on the following issues:    
1. Whether FDA should require a microbiological standard for E. sakazakii
 for 
powdered infant formula of negative in 30 x 10 gram (g) samples;  
 
2. whether FDA should not require microbiological standards for aerobic plate count, 
coliforms, fecal coliforms, Listeria monocytogenes,  Staphylococcus aureus, and 
Bacillus cereus ;  
 
3. whether FDA should require measuremen ts of healthy growth beyond the two 
proposed quality factors of normal physical growth (as measured by body weight, recumbent length, head circumference, a nd average daily weight increment) and 
protein quality;  
 
4. whether FDA should require a measure for body composition as an indicator of 
normal physical growth, and if so, what measure; and  
 
5. whether FDA should require that the duration fo r a clinical study, if required, be no 
less than 15 weeks, and commence when infant s are no older than 2 weeks of age.   
  Full text of this addendum is online at: 
 
http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-12268.htm G/TBT/N/USA/41/Add.1 
Page 2  
 
   Relevant documents in add ition to the notified document: 
 
• Notice of Proposed Rulemaking; reopeni ng of the comment period published in the 
Federal Register at 68 FR 22341-22343 (available in English) 
(http://www.fda.gov/OHRMS/DOCKETS/98fr/03-10301.pdf) 
 
• Notice of Proposed Rulemaking; extension of the comment period published in the 
Federal Register  at 61 FR  38247 (available in English) 
(http://www.fda.gov/OHRMS/DOCKETS/98fr/03-16357.pdf.)  
• Notice of Proposed Rulemaking published in the Federal Register  at 61 FR 36154 
(available in English) (http://www.cfsan.fda.gov/~lrd/fr960709.html) 
 
• 21 CFR Part 106 – Infant Formula Quality Control Procedures (available in English) 
(http://www.access.gpo.gov/nara/cfr/ waisidx_02/21cfr106_02.html) 
 
• 21 CFR Part 107 – Infant Formula (available in English) 
(http://www.access.gpo.gov/nara/cfr/ waisidx_02/21cfr107_02.html). 
 
 Submit written or electronic comments by 15 September 2006.  Comments may be 
submitted by any of the following methods, id entified by Docket No. 1995N-0309 and RIN 0910-
AA04: 
 
Electronic Submissions (follow submitting instructions)  Federal eRulemaking Porta l: http://www.regulations.gov 
 Agency Web site:  http ://fda.gov/dockets/ecomments 
 Written Submissions 
 Submit written submissions in the following ways: 
 Fax: (+1) 301-827-6870  
Mail/Hand delivery/Courier [For paper,  disk, or CD-ROM submissions]: 
Division of Dockets Management (HFA-305) Food and Drug Administration, 
5630 Fishers Lane, rm. 1061 
Rockville, MD 20852 
 
For further information contact: 
 Benson Silverman U.S. Food and Drug Administration 
5100 Paint Branch Parkway 
College Park Maryland  Tel: (+1 207) 40 301 436 1459 email: Benson.Silverman@fda.hhs.gov 
 
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