118 HR 4242 IH: To direct the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to issue guidance on considerations for conducting clinical trials for psychedelic assisted therapy. U.S. House of Representatives 2023-06-21 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

I118th CONGRESS1st SessionH. R. 4242IN THE HOUSE OF REPRESENTATIVESJune 21, 2023Mr. Crenshaw (for himself, Mrs. Miller-Meeks, and Mr. Khanna) introduced the following bill; which was referred to the Committee on Energy and CommerceA BILLTo direct the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to issue guidance on considerations for conducting clinical trials for psychedelic assisted therapy.

1.

Guidance on considerations for conducting clinical trials for psychedelic assisted therapy

The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall— (1)not later than 180 days after the date of enactment of this Act, issue for public comment draft guidance on considerations for conducting clinical trials for psychedelic assisted therapy, including how those seeking an investigational use exemption for such clinical trials should request interactive support by the Food and Drug Administration; and (2)not later than 180 days after issuing such draft guidance, finalize such guidance.