OMB.report

Federal forms, ICRs, and supporting documents

OMB control number

Electronic Records: Electronic Signatures

OMB 0910-0303 ยท 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 is listed under ICR 202312-0910-007.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
DocumentType
0303 Elec Sigs 21 CFR part 11 SSA 2023 REV.docxSupporting Statement A
General Requirements - 11.100 Information collection
Controls for Identification Codes/Passwords - 11.300 Information collection
Signature Manifestation - 11.50 Information collection
Closed for Open Systems - 11.30 Information collection
Controls for Closed Systems - 11.10 Information collection

All Historical Document Collections

Historical document collections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

OMB Details

General Requirements - 11.100

Federal Enterprise Architecture: Health - Public Health Monitoring