[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2565 Introduced in House (IH)]

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117th CONGRESS
  1st Session
                                H. R. 2565

      To amend the Federal Food, Drug, and Cosmetic Act to allow 
manufacturers and sponsors of a drug to use alternative testing methods 
  to animal testing to investigate the safety and effectiveness of a 
                     drug, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             April 15, 2021

Mr. Buchanan (for himself, Mrs. Luria, Ms. Mace, Ms. Sherrill, and Mr. 
Brendan F. Boyle of Pennsylvania) introduced the following bill; which 
          was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
      To amend the Federal Food, Drug, and Cosmetic Act to allow 
manufacturers and sponsors of a drug to use alternative testing methods 
  to animal testing to investigate the safety and effectiveness of a 
                     drug, and for other purposes.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``FDA Modernization Act of 2021''.

SEC. 2. ANIMAL TESTING ALTERNATIVES.

    Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355) is amended--
            (1) in subsection (b)(5)(B)(i)(II), by striking ``animal'' 
        and inserting ``nonclinical tests or studies'';
            (2) in subsection (i)--
                    (A) in paragraph (1)(A), by striking ``(including 
                tests on animals)''; and
                    (B) in paragraph (2)(B), by striking ``animal or 
                human studies'' and inserting ``nonclinical tests or 
                studies''; and
            (3) after subsection (y), by inserting the following:
    ``(z) Nonclinical Test or Study Defined.--For purposes of this 
section, the term `nonclinical test or study' means a test or study 
that is most likely to predict human response based on scientific 
evidence and occurs before or during the clinical trial phase of the 
investigation of the safety and effectiveness of a drug. Such test or 
study may include the following:
            ``(1) Cell-based assays.
            ``(2) Organ chips and microphysiological systems.
            ``(3) Sophisticated computer modeling.
            ``(4) Other human biology-based test methods.
            ``(5) Animal tests.''.
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