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HHS/FDA RIN: 0910-AF27 Publication ID: Spring 2004 
Title: Current Good Manufacutring 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. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Long-Term Actions 
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
Final Action  09/00/2005    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
Related RINs: Split from 0910-AA04 
Agency Contact:
Melissa Scales
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
HFS-800, HFS-024, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway,
College Park, MD 20740
Phone:301 436-1720

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