[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 2443 Introduced in Senate (IS)]

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114th CONGRESS
  1st Session
                                S. 2443

   To support the establishment of a Standards Coordinating Body in 
             Regenerative Medicine and Advanced Therapies.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            January 12, 2016

  Ms. Baldwin introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
   To support the establishment of a Standards Coordinating Body in 
             Regenerative Medicine and Advanced Therapies.

    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 ``Advancing Standards in Regenerative 
Medicine Act''.

SEC. 2. SUPPORT FOR THE ESTABLISHMENT OF A STANDARDS COORDINATING BODY 
              IN REGENERATIVE MEDICINE AND ADVANCED THERAPIES.

    Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by inserting after section 506F 
the following:

``SEC. 506G. COORDINATING BODY IN REGENERATIVE MEDICINE AND ADVANCED 
              THERAPIES.

    ``(a) In General.--The Secretary, in consultation with 
stakeholders, including regenerative medicine product manufacturers and 
clinical trial sponsors, contract manufacturers, academic institutions, 
standard setting organizations, the National Institute of Standards and 
Technology, and other relevant Federal agencies, as appropriate, shall 
facilitate establishment of a public-private Standards Coordinating 
Body in Regenerative Medicine and Advanced Therapies.
    ``(b) Function of Standards Coordinating Body.--Upon establishment 
of the Standards Coordinating Body in Regenerative Medicine and 
Advanced Therapies under subsection (a), the Secretary shall--
            ``(1) identify opportunities for the development of 
        laboratory regulatory science research and documentary 
        standards that the Secretary determines would support the 
        development, evaluation, and review of regenerative medicine 
        products; and
            ``(2) work with such Standards Coordinating Body, as 
        appropriate, in the development of standards described in 
        paragraph (1).
    ``(c) Guidance.--The Secretary shall issue guidance, as 
appropriate, on how standards may be used in regulatory review for 
regenerative medicine and advanced therapies.
    ``(d) Definition.--For purposes of this section, the term 
`regenerative medicine and advanced therapies' includes cell therapy, 
gene therapy, gene-modified cell therapy, therapeutic tissue 
engineering products, and human cell and tissue products, and 
combination products using any such therapies or products.
    ``(e) No Additional Funds.--The Secretary shall carry out this 
section using funds otherwise made available to the Food and Drug 
Administration. No additional funds are authorized to be appropriated 
to carry out this section.''.
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