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HHS/FDA RIN: 0910-AJ25 Publication ID: 2026 
Title: ●Amendment of Regulations on Electronic Records and Electronic Signatures 
Abstract:

This rule would amend FDA's regulations on electronic records and signatures in 21 CFR Part 11 to streamline and modernize requirements for ensuring the reliability, authenticity, and integrity of electronic records and signatures.

 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Yes  Unfunded Mandates: No 
EO 14192 Designation: Deregulatory 
CFR Citation: 21 CFR 11   
Legal Authority: 21 U.S.C. 321 to 393    42 U.S.C. 262   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  09/00/2026 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Jean McCue
Senior Policy Analyst
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, WO Building 32, Room 4254,
Silver Spring, MD 20993
Phone:240 753-3297
Email: jean.mccue@fda.hhs.gov