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HHS/OS RIN: 0991-AC21 Publication ID: Spring 2020 
Title: ●CY 2021 Civil Monetary Penalties Inflation Adjustment 

Annually, the Department of Health and Human Services is directed by OMB, to update its regulations to reflect required annual inflation-related increases to the civil monetary penalties in its regulations, pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, and to make changes to reflect an amendment to the Federal Food, Drug, and Cosmetic Act by the Further Consolidated Appropriations Act, 2020 (effective January 1, 2020).

Agency: Department of Health and Human Services(HHS)  Priority: Routine and Frequent 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Not subject to, not significant 
CFR Citation: CFR 45 102     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, Pub. L. No. 114-74, sec. 70l(b)(l)(A), 129 Stat. 599 (codified as amended at 28 U.S.C. sec. 2461 note)   
Legal Deadline:
Action Source Description Date
Final  Statutory  OMB M-20-05 memo mandates this deadline.   01/15/2020 
Action Date FR Cite
Interim Final Rule  01/00/2021 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: Businesses, Organizations  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Tiffani Redding
Program Analyst
Department of Health and Human Services
Office of the Secretary
200 Independence Avenue SW,
Washington, DC 20201
Phone:202 205-4321