Regulatory Counsel

0910-AI36 201904 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS 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.

]]> Substantive, Nonsignificant First Time Published in The Unified Agenda Proposed Rule Stage Undetermined Undetermined Regulatory 21 CFR 312.34 Pub. L. 115-176 No NPRM 09/00/2019 No No Undetermined No No No No Kathleen Davies Regulatory Counsel 0910 Food and Drug Administration FDA 301 796-2205 kathleen.davies@fda.hhs.gov 10903 New Hampshire Avenue, HFD-45, Building 32, Room 3121, Silver Spring MD 20993