View Rule

View EO 12866 Meetings Printer-Friendly Version     Download RIN Data in XML

VA RIN: 2900-AQ83 Publication ID: Fall 2021 
Title: Right to Try 
Abstract:

The Department of Veterans Affairs (VA) proposes to revise its medical benefits package regulation on the use of drugs, biologicals, and medical devices not approved by the Food and Drug Administration (FDA). The Right to Try Act of 2017 has changed how VA may utilize unapproved investigational drugs for eligible patients. This proposed rule aligns VA’s regulations with the Right to Try Act of 2017, FDA regulations concerning expanded access to drugs, biologicals, and medical devices not approved by the FDA, FDA’s regulations for investigational use of marketed drugs, biologics, and medical devices, and VA’s current practice to prescribe certain unapproved marketed drugs.

 
Agency: Department of Veterans Affairs(VA)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 38 CFR 17.38   
Legal Authority: 38 U.S.C. 501   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  12/00/2021 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Information URL: www.regulations.gov  
RIN Data Printed in the FR: No 
Agency Contact:
Karen C. Jeans
Director of Regulatory Affairs, Office of Research Development
Department of Veterans Affairs
810 Vermont Avenue NW,
Washington, DC 20420
Phone:202 443-5712
Email: c.karen.jeans@va.gov