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HHS/FDA RIN: 0910-AI50 Publication ID: Spring 2025 
Title: Amending Regulations That Require Multiple Copies Submissions  
Abstract:

This proposed rule would amend FDA’s regulations to remove requirements for submission of multiple copies and replace them with the requirement for a single submission in electronic format. This action is being undertaken to revise regulations that required paper submission in duplicate, triplicate, etc.

 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
EO 14192 Designation: Deregulatory 
CFR Citation: 21 CFR 101.69    21 CFR 130.17    21 CFR 171.1    21 CFR 571.1    21 CFR 71.1    21 CFR 10.20    21 CFR 10.40    21 CFR 10.85    21 CFR 314.94    21 CFR 314.50   
Legal Authority: 5 U.S.C. 551 to 558    5 U.S.C. 701 to 706    15 U.S.C. 1453    15 U.S.C. 1454    15 U.S.C. 1455    21 U.S.C. 141 to 149    21 U.S.C. 321    21 U.S.C. 331    21 U.S.C. 336    21 U.S.C. 341    21 U.S.C. 342    21 U.S.C. 343    21 U.S.C. 348    21 U.S.C. 351    21 U.S.C. 352    21 U.S.C. 353    21 U.S.C. 355    21 U.S.C. 360    21 U.S.C. 360c    21 U.S.C. 360j    21 U.S.C. 360l    21 U.S.C. 360aa    21 U.S.C. 360aaa-6    21 U.S.C. 360b-360f    21 U.S.C. 360bbb-8b    21 U.S.C. 360h to 360i    21 U.S.C. 361    21 U.S.C. 371    21 U.S.C. 372    21 U.S.C. 373    21 U.S.C. 374    21 U.S.C. 375    21 U.S.C. 379    21 U.S.C. 379e    21 U.S.C. 379k-1    21 U.S.C. 381    21 U.S.C. 467f    21 U.S.C. 679    21 U.S.C. 821    21 U.S.C. 1034    28 U.S.C. 2112    42 U.S.C. 201    42 U.S.C. 216    42 U.S.C. 241    42 U.S.C. 243    42 U.S.C. 262    42 U.S.C. 263b    42 U.S.C. 264    42 U.S.C. 271    ...   
Legal Deadline:
Action Source Description Date
NPRM  Statutory    09/30/2022 
Timetable:
Action Date FR Cite
NPRM  03/00/2026 
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 
Agency Contact:
Shena Arellano
Policy Analyst
Department of Health and Human Services
Food and Drug Administration
Office of the Commissioner, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-8353
Email: shena.arellano@fda.hhs.gov