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HHS/FDA

RIN: 0910-AI50

Publication ID: Spring 2022

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: 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	03/00/2023

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