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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.