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HHS/HRSA RIN: 0906-AB25 Publication ID: Spring 2021 
Title: Rescission of the Final Rule "Implementation of Executive Order on Access to Affordable Life-Saving Medications" 
Abstract:

This final rule will provide access to life-saving medications by low-income individuals who do not have access to affordable insulin and injectable epinephrine due to either lack of insurance or high cost sharing requirements.  Based on comments in response to both the proposed rule published at 85 FR 60748 (September 28, 2020) and the proposed rule published at 86 FR 13872 (March 11, 2021), which indicated concerns that administrative costs and related burdens required by health centers to comply with the rule and the loss of 340B savings that would result from the rule taking effect would reduce resources available to support critical services for patients, HHS is considering a proposed rulemaking to rescind the final rule of December 23, 2020.

 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 42 CFR 51c     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: sec. 330 of the PHS Act, 89 Stat. 342, (42 U.S.C. 254c)    sec. 215 of the PHS Act, 58 Stat. 690, (42 U.S.C. 216)   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  09/28/2020  85 FR 60748   
NPRM Comment Period End  10/28/2020 
Final Action  12/23/2020  85 FR 83822   
Final Action Effective  03/22/2021 
Final Action  01/26/2021  86 FR 7059   
Final Action Effective  03/22/2021 
Second NPRM  03/11/2021  86 FR 13872   
Second NPRM Comment Period End  03/14/2021 
Final Action  03/23/2021  86 FR 15423   
Final Action Effective  07/20/2021 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: No 
Agency Contact:
Jennifer Joseph
Director
Department of Health and Human Services
Health Resources and Services Administration
5600 Fishers Lane, 16N21,
Rockville, MD 20857
Phone:301 443-7355
Email: jjoseph@hrsa.gov