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HHS/FDA

RIN: 0910-AA04

Publication ID: Fall 2003

Title: Infant Formula: Requirements Pertaining to Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Notification Requirements, and 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: 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

Child RIN List:

RIN	Title
0910-AD81	Current Good Mfg. Practices; Qual. Control Proc.; Quality Factors
0910-AD80	Infant Form Cons Comp, Micro Test & Recd Retention Req
0910-AD77	Infant Formula Quality Factors

Regulatory Flexibility Analysis Required: No	Government Levels Affected: None
Small Entities Affected: No	Federalism: No
Included in the Regulatory Plan: No
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 Email: melissa.scales@fda.hhs.gov