[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4242 Introduced in House (IH)]

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118th CONGRESS
  1st Session
                                H. R. 4242

 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.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             June 21, 2023

     Mr. Crenshaw (for himself, Mrs. Miller-Meeks, and Mr. Khanna) 
 introduced the following bill; which was referred to the Committee on 
                          Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
 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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 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        this Act, issue for public comment draft guidance on 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            (2) not later than 180 days after issuing such draft 
        guidance, finalize such guidance.
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