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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7827 Introduced in House (IH)]

<DOC>

118th CONGRESS
  2d Session
                                H. R. 7827

  To amend the Federal Food, Drug, and Cosmetic Act to encourage the 
development of vaccines to prevent, treat, or mitigate opioid, cocaine, 
 methamphetamine, or alcohol use disorder, to establish an x-prize for 
       the development of such a vaccine, and for other purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                             March 26, 2024

Mr. Schweikert 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 encourage the 
development of vaccines to prevent, treat, or mitigate opioid, cocaine, 
 methamphetamine, or alcohol use disorder, to establish an x-prize for 
       the development of such a vaccine, 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. ENCOURAGING DEVELOPMENT OF VACCINES FOR OPIOID, COCAINE, 
              METHAMPHETAMINE, OR ALCOHOL USE DISORDER.

    (a) Breakthrough Therapies.--Section 506(a) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 356(a)) is amended by adding at the 
end the following:
            ``(4) Vaccines for opioid, cocaine, methamphetamine, or 
        alcohol use disorder.--
                    ``(A) In general.--If a request is submitted under 
                paragraph (1) for a vaccine to prevent, treat, or 
                mitigate an opioid use disorder (including such a 
                disorder related to fentanyl), a cocaine use disorder, 
                a methamphetamine use disorder, or an alcohol use 
                disorder, such vaccine is deemed to be a breakthrough 
                therapy.
                    ``(B) Sunset.--Subparagraph (A) shall cease to be 
                effective on the date that is 10 years after the date 
                of enactment of this paragraph.''.
    (b) Fast Track Products.--Section 506(b) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 356(b)) is amended by adding at the end the 
following:
            ``(4) Vaccines for opioid, cocaine, methamphetamine, or 
        alcohol use disorder.--
                    ``(A) In general.--If a request is submitted under 
                paragraph (1) for a vaccine to prevent, treat, or 
                mitigate an opioid use disorder (including such a 
                disorder related to fentanyl), a cocaine use disorder, 
                a methamphetamine use disorder, or an alcohol use 
                disorder, such vaccine is deemed to be a fast track 
                product.
                    ``(B) Sunset.--Subparagraph (A) shall cease to be 
                effective on the date that is 10 years after the date 
                of enactment of this paragraph.''.
    (c) Priority Review.--
            (1) In general.--The Secretary of Health and Human Services 
        shall give priority review to any application for a vaccine to 
        prevent, treat, or mitigate an opioid use disorder (including 
        such a disorder related to fentanyl), a cocaine use disorder, a 
        methamphetamine use disorder, or an alcohol use disorder that 
        is submitted under--
                    (A) section 505 of the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 355); or
                    (B) section 351 of the Public Health Service Act 
                (42 U.S.C. 262).
            (2) Sunset.--Paragraph (1) shall cease to be effective on 
        the date that is 10 years after the date of enactment of this 
        subsection.

SEC. 2. X-PRIZE FOR VACCINE FOR OPIOID, COCAINE, METHAMPHETAMINE, OR 
              ALCOHOL USE DISORDER.

    (a) Eligible New Drug Sponsor.--In this section, the term 
``eligible new drug sponsor'' means the sponsor of a vaccine to 
prevent, treat, or mitigate an opioid use disorder (including such a 
disorder related to fentanyl), a cocaine use disorder, a 
methamphetamine use disorder, or an alcohol use disorder that--
            (1) is approved under section 505 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 355) or is licensed under 
        section 351 of the Public Health Service Act (42 U.S.C. 262); 
        and
            (2) is mass-produced.
    (b) Application.--An eligible new drug sponsor may submit to the 
Secretary of Health and Human Services an application for an award, to 
be known as the Vaccine X-Prize.
    (c) Award.--Subject to subsection (d), if the Secretary of Health 
and Human Services determines that an eligible new drug sponsor has 
submitted an application under subsection (b), the Secretary shall, 
subject to the availability of appropriations, pay the eligible new 
drug sponsor $1,000,000,000.
    (d) Single Award.--The Secretary of Health and Human Services may 
not award more than 1 Vaccine X-Prize.
                                 <all>
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