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HHS/FDA RIN: 0910-AI50 Publication ID: Spring 2021 
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, 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 
CFR Citation: 21 CFR 101.69    21 CFR 130.17    21 CFR 171.1    21 CFR 571.1    21 CFR 71.1    21 CFR 814.39    21 CFR 822.21    21 CFR 822.8    21 CFR 10.20    21 CFR 10.40    21 CFR 10.85    21 CFR 314.94    21 CFR 314.50   
Legal Authority: 21 U.S.C. 321    21 U.S.C. 331    21 U.S.C. 351    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. 360bbb-8b    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. 381    42 U.S.C. 262   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  12/00/2021 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Undetermined 
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