Infant Formula Recall Regulations

OMB 0910-0188

This collection request supports agency regulations requiring information from manufacturers of infant formula that allows FDA to conduct effective recalls of infant formula should it become necessary.

The latest form for Infant Formula Recall Regulations expires 2023-12-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
0188 Infant Formula Recalls SSA 2020 Ext.docx Supporting Statement A
Reporting: Requirements for Written Recall Strategy Furnished to Appropriate FDA District Office By Recalling Firm
Third- Party Disclosure- Additional Notification Requirements When Implementation of Recall Strategy is Determined Deficient
Third- Party Disclosure- Notification and Posting Requirements of Recall by Recalling Firm
Reporting: Requirements For Additional Effectiveness Checks when Recall Implementation Is Determined Deficient
Reporting: Recommendation Requirements for Terminating a Recall by Recalling Firm
Reporting: Notification , Written Reports & Status Update Requirements for Recalling Firms or Establishments

All Historical Document Collections

202010-0910-012 Approved without change	Extension without change of a currently approved collection	2020-11-27
201710-0910-010 Approved without change	Extension without change of a currently approved collection	2017-11-09
201410-0910-010 Approved without change	Extension without change of a currently approved collection	2014-10-27
201108-0910-013 Approved without change	Extension without change of a currently approved collection	2011-08-30
200807-0910-005 Approved without change	Extension without change of a currently approved collection	2008-07-17
200505-0910-007 Approved without change	Extension without change of a currently approved collection	2005-05-27
200206-0910-001 Approved without change	Extension without change of a currently approved collection	2002-06-07
199905-0910-010 Approved without change	Extension without change of a currently approved collection	1999-05-21
199611-0910-002 Approved without change	Reinstatement without change of a previously approved collection	1996-11-20
199509-0910-017 Approved without change	No material or nonsubstantive change to a currently approved collection	1995-09-30
199212-0910-004 Approved without change	Revision of a currently approved collection	1992-12-28
198910-0910-003 Approved without change	Reinstatement with change of a previously approved collection	1989-10-16
198710-0910-002 Approved without change	Reinstatement with change of a previously approved collection	1987-10-01
198402-0910-003 Approved without change	New collection (Request for a new OMB Control Number)	1984-02-27

OMB Details

Reporting: Requirements for Written Recall Strategy Furnished to Appropriate FDA District Office By Recalling Firm

Federal Enterprise Architecture: Health - Consumer Health and Safety