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HHS/FDA RIN: 0910-AI36 Publication ID: Spring 2019 
Title: ●Annual Summary Reporting Requirements Under the Right to Try Act 

To facilitate implementation of the reporting requirements of the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right toTry Act of 2017 (Right to Try Act), the FDA is proposing to establish requirements for the deadline and contents of submission of an annual summary. This action, if finalized, will create a new requirement outlining a due date and the annual summary requirements for sponsors and manufacturers who provide an eligible investigational drug for use by an eligible patient under the provisions of the Right to Try Act. The Act requires FDA to specify by regulation the due date for the annual summary. This regulation will fulfill that requirement. Because the Act states regulation is required, FDA is not considering any alternatives to address the problem. The economic impact of this requirement is expected to be low.


Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: Undetermined 
EO 13771 Designation: Regulatory 
CFR Citation: 21 CFR 312.34   
Legal Authority: Pub. L. 115-176   
Legal Deadline:  None
Action Date FR Cite
NPRM  09/00/2019 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Undetermined 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Kathleen Davies
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, HFD-45, Building 32, Room 3121,
Silver Spring, MD 20993
Phone:301 796-2205