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HHS/FDA | RIN: 0910-AI50 | Publication ID: Fall 2020 |
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. This action is being undertaken as part of HHS’s omnibus effort to review of existing regulations, which identified opportunities to revise regulations that required paper submission in duplicate, triplicate, etc. |
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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 13771 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 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 |
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Timetable:
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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 |