[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 2952 Introduced in Senate (IS)]

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117th CONGRESS
  1st Session
                                S. 2952

      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 SENATE OF THE UNITED STATES

                            October 7, 2021

  Mr. Paul (for himself, Mr. Booker, Mr. Braun, Mr. Kennedy, and Mr. 
Lujan) introduced the following bill; which was read twice and referred 
       to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 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. NEW APPROACH METHODOLOGIES.

    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 ``preclinical 
                tests (including tests on animals)'' and inserting 
                ``nonclinical tests''; and
                    (B) in paragraph (2)(B), by striking ``animal'' 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 
conducted in vitro, in silico, in chemico, or in vivo that occurs 
before or during the clinical trial phase of the investigation of the 
safety and effectiveness of a drug, and may include the following:
            ``(1) Cell-based assays.
            ``(2) Organ chips and microphysiological systems.
            ``(3) Computer models.
            ``(4) Other non-animal or human biology-based test methods.
            ``(5) Animal tests.''.
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