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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 3464 Introduced in Senate (IS)]

<DOC>

118th CONGRESS
  1st Session
                                S. 3464

To support endemic fungal disease research, incentivize fungal vaccine 
development, discover new antifungal therapies and diagnostics, and for 
                            other purposes.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                           December 12, 2023

 Mr. Kelly (for himself and Ms. Sinema) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL

 
To support endemic fungal disease research, incentivize fungal vaccine 
development, discover new antifungal therapies and diagnostics, 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; TABLE OF CONTENTS.

    (a) In General.--This Act may be cited as the ``Finding Orphan-
disease Remedies With Antifungal Research and Development Act of 2023'' 
or the ``FORWARD Act of 2023''.
    (b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Continuing support for research on endemic fungal diseases.
Sec. 3. Endemic fungal disease working group.
Sec. 4. Expanding tropical disease product priority review voucher 
                            program to encourage prevention and 
                            treatment of coccidioidomycosis.
Sec. 5. Combating antimicrobial resistance biopharmaceutical 
                            accelerator program.

SEC. 2. CONTINUING SUPPORT FOR RESEARCH ON ENDEMIC FUNGAL DISEASES.

    The Public Health Service Act is amended by inserting after section 
447D of such Act (42 U.S.C. 285f-5) the following new section:

``SEC. 447E. ENDEMIC FUNGAL DISEASES.

    ``(a) In General.--The Director of the Institute shall--
            ``(1) continue to conduct or support basic, translational, 
        and clinical research related to fungal diseases found in the 
        United States, including coccidioidomycosis (commonly known as 
        and referred to in this section as `Valley Fever'); and
            ``(2) subject to the availability of appropriations, make 
        grants to, or enter into contracts with, public or nonprofit 
        private entities to conduct such research.
    ``(b) Reports.--The Director of the Institute shall ensure that 
each triennial report under section 403 includes information on actions 
undertaken by the National Institutes of Health to carry out subsection 
(a) with respect to such fungal diseases, including coccidioidomycosis.
    ``(c) Authorization of Appropriations.--In addition to other 
amounts available for the purposes of carrying out this section, there 
is authorized to be appropriated to carry out this section $20,000,000 
for each of fiscal years 2024 through 2028 for such purpose.''.

SEC. 3. ENDEMIC FUNGAL DISEASE WORKING GROUP.

    (a) Establishment.--The Secretary of Health and Human Services 
(referred to in this section as the ``Secretary'') shall establish a 
working group, to be known as the Endemic Fungal Disease Working Group 
(referred to in this section as the ``Working Group''), comprised of 
representatives of appropriate Federal agencies and other non-Federal 
entities--
            (1) to provide expertise and to review all efforts within 
        the Department of Health and Human Services related to fungal 
        disease in the United States;
            (2) to help ensure interagency coordination and minimize 
        overlap with respect to such disease; and
            (3) to examine research priorities with respect to such 
        disease.
    (b) Duties.--The Working Group shall--
            (1) make recommendations to the Secretary, including an 
        updated strategy related to development of therapeutics and 
        vaccines for endemic fungal diseases, that shall--
                    (A) take into account ongoing fungal disease 
                research, including for animals, that may be adapted 
                for human use;
                    (B) identify gaps in endemic fungal disease 
                research, including basic, clinical, and translational 
                research related to the pathogenesis, prevention, 
                diagnosis, and treatment of such diseases; and
                    (C) include recommendations for congressional 
                action to spur additional research and product 
                development for fungal diseases; and
            (2) in implementing this subsection, solicit input from 
        States, Tribes, localities, and nongovernmental entities, 
        including organizations representing patients, health care 
        providers, researchers, and industry regarding scientific 
        advances, research questions, and surveillance activities.
    (c) Membership.--The members of the Working Group shall represent a 
diversity of scientific disciplines and shall be composed of the 
following members:
            (1) Federal members.--Seven Federal members, consisting of 
        one or more representatives of each of the following:
                    (A) The Office of the Assistant Secretary for 
                Health, who shall serve as Chair.
                    (B) The Food and Drug Administration.
                    (C) The Centers for Disease Control and Prevention.
                    (D) The National Institutes of Health, who shall 
                serve as Vice Chair.
                    (E) Such other agencies and offices of the 
                Department of Health and Human Services as the 
                Secretary determines appropriate.
            (2) Non-federal public members.--Seven non-Federal public 
        members, consisting of representatives of the following 
        categories:
                    (A) Physicians, veterinarians, and other medical 
                providers with experience in diagnosing and treating 
                endemic fungal disease.
                    (B) Scientists or researchers with expertise in 
                endemic fungal disease.
                    (C) Patients who have been diagnosed with an 
                endemic fungal disease and family members or caregivers 
                of such patients, as applicable.
                    (D) Nonprofit organizations that advocate for 
                patients with respect to endemic fungal disease.
                    (E) Other individuals whose expertise is determined 
                by the Secretary to be beneficial to the functioning of 
                the Working Group.
    (d) Meetings.--The Working Group shall meet not less frequently 
than annually.
    (e) Reporting.--Not later than 1 year after the date of enactment 
of this Act, and annually thereafter until termination of the Working 
Group pursuant to subsection (g), the Secretary shall--
            (1) submit a report on recommendations received under 
        subsection (b)(1) to the Committee on Health, Education, Labor, 
        and Pensions of the Senate and the Committee on Energy and 
        Commerce of the House of Representatives; and
            (2) make such report publicly available on the website of 
        the Department of Health and Human Services.
    (f) Applicability of FACA.--The Working Group shall be treated as 
an advisory committee subject to the Federal Advisory Committee Act (5 
U.S.C. App.).
    (g) Sunset.--The Working Group under this section shall terminate 5 
years after the date of enactment of this Act.
    (h) Endemic Fungal Disease Defined.--In this section, the term 
``endemic fungal disease'' means blastomycosis, coccidioidomycosis, 
histoplasmosis, and sparotrichosis.

SEC. 4. 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.''.

SEC. 5. COMBATING ANTIMICROBIAL RESISTANCE BIOPHARMACEUTICAL 
              ACCELERATOR PROGRAM.

    Paragraph (4) of section 319L(c) of the Public Health Service Act 
(42 U.S.C. 247d-7e(c)) is amended by adding at the end the following:
                    ``(H) Combating antimicrobial resistance 
                biopharmaceutical accelerator program.--
                            ``(i) In general.--The Secretary, acting 
                        through the Director of BARDA, shall implement 
                        strategic initiatives, to be known as the 
                        Combating Antimicrobial Resistance 
                        Biopharmaceutical Accelerator Program, 
                        including by building on existing programs and 
                        by awarding contracts, grants, and cooperative 
                        agreements, or entering into other 
                        transactions--
                                    ``(I) to optimize the use of 
                                antimicrobials in human health 
                                settings;
                                    ``(II) to support innovative 
                                candidate products in preclinical and 
                                clinical development that reduce 
                                antimicrobial resistance; and
                                    ``(III) to support research with 
                                respect to infection prevention and 
                                control to slow the spread of resistant 
                                bacteria, fungi, and viruses.
                            ``(ii) References.--Except as otherwise 
                        specified, any reference to the Combating 
                        Antibiotic Resistant Bacteria Biopharmaceutical 
                        Accelerator or the CARB-X program in any 
                        statute, Executive order, rule, regulation, 
                        directive, or other Federal document is deemed 
                        to be a reference to the Combating 
                        Antimicrobial Resistance Biopharmaceutical 
                        Accelerator Program under this subparagraph.
                            ``(iii) Authorization of appropriations.--
                                    ``(I) In general.--To carry out the 
                                program under clause (i), there is 
                                authorized to be appropriated 
                                $500,000,000 for the period of fiscal 
                                years 2024 through 2028, to remain 
                                available until expended.
                                    ``(II) Requirement.--Of the amounts 
                                made available to carry out the program 
                                under clause (i) for the period of 
                                fiscal years 2024 through 2028, not 
                                less than 20 percent shall be used to 
                                support antifungal product 
                                development.''.
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