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HHS/FDA RIN: 0910-AF28 Publication ID: Fall 2007 
Title: Infant Formula Quality Factors 
Abstract: The Agency published a proposed rule on July 9, 1996, that would establish current good manufacturing practice regulations, quality control procedures, quality factors, notification requirements, and records and reports for the production of infant formula. This proposal was issued in response to the 1986 amendments to the Infant Formula Act of 1980. On April 28, 2003, FDA reopened the comment period to update comments on the proposal. The comment period was extended on June 27, 2003, to end on August 26, 2003. The comment period was reopened on August 1, 2006, to end on September 15, 2006. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 106    21 CFR 107   
Legal Authority: 21 USC 321    21 USC 350a    21 USC 371    ...   
Legal Deadline:  None
Action Date FR Cite
NPRM  07/09/1996  61 FR 36154   
NPRM Comment Period End  12/06/1996    
NPRM Comment Period Reopened  04/28/2003  68 FR 22341   
NPRM Comment Period Extended  06/27/2003  68 FR 38247   
NPRM Comment Period End  08/26/2003    
NPRM Comment Period Reopened  08/01/2006  71 FR 43392   
NPRM Comment Period End  09/15/2006    
Final Action  02/00/2008    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Related RINs: Split from 0910-AA04 
Agency Contact:
Benson Silverman
Staff Director, Infant Formula and Medical Foods
Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition (HFS-850), 5100 Paint Branch Parkway,
College Park, MD 20740
Phone:240 402-1459

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