OMB control number

Electronic Records: Electronic Signatures

OMB 0910-0303 · HHS/FDA.

OMB 0910-0303

This information collection supports Food and Drug Administration (FDA) regulations. Specifically, the regulations found at 21 CFR Part 11: Electronic Records; Electronic Signatures provide criteria for acceptance of electronic records, electronic signatures, and handwritten signatures serving to legally bind subsequent electronic submissions and verify electronic records. Under the regulations, records and reports may be submitted to FDA electronically, with certain provisions.

The latest form for Electronic Records: Electronic Signatures expires 2027-03-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
0303 Elec Sigs 21 CFR part 11 SSA 2023 REV.docx Supporting Statement A
General Requirements - 11.100
Controls for Identification Codes/Passwords - 11.300
Signature Manifestation - 11.50
Closed for Open Systems - 11.30
Controls for Closed Systems - 11.10

All Historical Document Collections

202312-0910-007 Approved without change	Revision of a currently approved collection	2024-01-22
202011-0910-011 Approved without change	Extension without change of a currently approved collection	2021-01-12
201711-0910-010 Approved without change	Extension without change of a currently approved collection	2017-11-29
201409-0910-018 Approved with change	Extension without change of a currently approved collection	2014-10-15
201107-0910-009 Approved with change	Revision of a currently approved collection	2011-07-19
200807-0910-002 Approved without change	Extension without change of a currently approved collection	2008-07-15
200505-0910-002 Approved without change	Extension without change of a currently approved collection	2005-05-12
200307-0910-005 Approved without change	Extension without change of a currently approved collection	2003-07-25
200004-0910-001 Approved without change	Extension without change of a currently approved collection	2000-04-05
199706-0910-002 Approved without change	Revision of a currently approved collection	1997-06-23
199410-0910-002 Approved without change	New collection (Request for a new OMB Control Number)	1994-10-18

OMB Details

General Requirements - 11.100

Federal Enterprise Architecture: Health - Public Health Monitoring