Adding Coccidioidomycosis to the FDA Priority Review Voucher Program Act of 2023

Adding Coccidioidomycosis to the FDA Priority Review Voucher Program Act of 2023

This bill expands the priority-review voucher program for tropical diseases to include coccidioidomycosis (also known as Valley fever). A voucher entitles the holder to have a future new drug or biological product application acted upon by the Food and Drug Administration within six months.

[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6227 Introduced in House (IH)]

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118th CONGRESS
  1st Session
                                H. R. 6227

    To amend the Federal Food, Drug, and Cosmetic Act to expand the 
 tropical disease product priority review voucher program to encourage 
            prevention and treatment of coccidioidomycosis.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            November 3, 2023

 Mr. Schweikert (for himself, Mr. McCarthy, Mr. Burgess, Mr. Self, Mr. 
  Ciscomani, Mr. Armstrong, Mr. Gallego, Ms. Caraveo, Mr. Costa, Mr. 
   Grijalva, Mrs. Steel, Mr. Levin, Ms. De La Cruz, and Mr. Valadao) 
 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 expand the 
 tropical disease product priority review voucher program to encourage 
            prevention and treatment of coccidioidomycosis.

    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 ``Adding Coccidioidomycosis to the FDA 
Priority Review Voucher Program Act of 2023''.

SEC. 2. EXPANDING TROPICAL DISEASE PRODUCT PRIORITY REVIEW VOUCHER 
              PROGRAM TO ENCOURAGE PREVENTION AND TREATMENT OF 
              COCCIDIOIDOMYCOSIS.

    Section 524(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360n(a)(3)) is amended--
            (1) by redesignating subparagraph (S) as subparagraph (T); 
        and
            (2) by inserting after subparagraph (R) the following:
                    ``(S) Coccidioidomycosis.''.
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