View Rule

---

HHS/FDA

RIN: 0910-AF28

Publication ID: Spring 2008

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 (To search for a specific CFR, visit the Code of Federal Regulations.)
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 Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition (HFS-024), 5100 Paint Branch Parkway, College Park, MD 20740 Phone:301 436-1459 Email: benson.silverman@fda.hhs.gov