View Rule

View EO 12866 Meetings Printer-Friendly Version     Download RIN Data in XML
HHS/FDA RIN: 0910-AF27 Publication ID: Spring 2013 
Title: Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements; Records and Reports; and Quality Factors 
Abstract: The Food and Drug Administration (FDA) is revising its infant formula regulations in 21 CFR parts 106 and 107 to establish requirements for current good manufacturing practices (CGMP), including audits; to establish requirements for quality factors; and to amend FDA'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. 
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 and 107   
Legal Authority: 21 USC 321    21 USC 342    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 Rule  07/00/2013 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
RIN Data Printed in the FR: Yes 
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