[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 2188 Introduced in Senate (IS)]

<DOC>






114th CONGRESS
  1st Session
                                S. 2188

 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
                     humanitarian device exemption.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            October 21, 2015

  Mr. Gardner (for himself and Mr. Donnelly) 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 with respect to the 
                     humanitarian device exemption.

    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 ``Rare Disease Innovation Act''.

SEC. 2. HUMANITARIAN DEVICE EXEMPTION APPLICATION.

    (a) In General.--Section 520(m) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360j) is amended--
            (1) in paragraph (1) by striking ``fewer than 4,000'' and 
        inserting ``not more than 8,000'';
            (2) in paragraph (2)(A) by striking ``fewer than 4,000'' 
        and inserting ``not more than 8,000''; and
            (3) in paragraph (6)(A)(ii), by striking ``4,000'' and 
        inserting ``8,000''.
    (b) Guidance Document on Probable Benefit.--Not later than 18 
months after the date of enactment of this Act, the Secretary of Health 
and Human Services, acting through the Commissioner of Food and Drugs, 
shall publish a draft guidance document that defines the criteria for 
establishing ``probable benefit'' as that term is used in section 
520(m)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360j(m)(2)(C)).
    (c) Reports to Congress.--Five years after the date of enactment of 
this Act and every 5 years thereafter, the Secretary of Health and 
Human Services shall submit to Congress a report on the effect of the 
amendments made by subsection (a).
                                 <all>