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VA | RIN: 2900-AQ83 | Publication ID: Spring 2022 |
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. |
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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 |
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Timetable:
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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 |