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HHS/FDA RIN: 0910-AF27 Publication ID: Spring 2008 
Title: Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements; Records and Reports 
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. On August 1, 2006, FDA reopened the comment period on selected topics. The comment period closed 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
Timetable:
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  12/00/2008   
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
Email: benson.silverman@fda.hhs.gov

 
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