FORWARD Act of 2022
Bill: S.3498 | Sponsor: Sen. Kelly, Mark (D-AZ)
Policy area: Health

Summary:
Finding Orphan-disease Remedies With Antifungal Research and Development Act of 2022 or the FORWARD Act of 2022
This bill establishes programs to support research on endemic fungal diseases and the development of antifungal drugs, with a particular focus on Valley Fever. Endemic fungal diseases are fungal infections that tend to occur in specific geographic areas and affect older adults and other at-risk populations.
Specifically, the bill establishes the Endemic Fungal Disease Working Group to review, coordinate, and make recommendations about the Department of Health and Human Services' efforts to address endemic fungal diseases. The working group is comprised of experts from both relevant federal agencies and the private sector.
In addition, the National Institutes of Health must continue its support for research on endemic fungal diseases.
Furthermore, the Food and Drug Administration must issue guidance for entities seeking approval for therapies, diagnostics, and vaccines to prevent and treat Valley Fever. Additionally, the bill provides for the use of priority reviews and other fast-track procedures to incentivize and expedite development and approval of these medical products.
The bill also requires the Biomedical Advanced Research and Development Authority to implement the Combating Antimicrobial Resistance Biopharmaceutical Accelerator Program to reduce and prevent antimicrobial resistance.

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.

    (a) In General.--This Act may be cited as the ``Finding Orphan-
disease Remedies With Antifungal Research and Development Act of 2022'' 
or the ``FORWARD Act of 2022''.
    (b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title.
Sec. 2. Continuing support for research on endemic fungal diseases.
Sec. 3. Endemic fungal disease working group.
Sec. 4. FDA guidance for industry on development of diagnostics and 
                            antifungal drugs and vaccines for Valley 
                            Fever.
Sec. 5. Priority review; fast track product.
Sec. 6. Priority review vouchers for products for prevention or 
                            treatment of endemic fungal diseases.
Sec. 7. 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 
447C of such Act (42 U.S.C. 285f-4) the following new section:

``SEC. 447D. ENDEMIC FUNGAL DISEASES.

    ``(a) In General.--The Director of the Institute shall--
            ``(1) continue to conduct or support epidemiological, 
        basic, translational, and clinical research related to endemic 
        fungal diseases, 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 endemic fungal diseases, including Valley Fever.
    ``(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 2022 through 2026 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 endemic 
        fungal disease;
            (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) Responsibilities.--The Working Group shall--
            (1) not later than 2 years after the date of enactment of 
        this Act, develop or update a summary of--
                    (A) ongoing endemic fungal disease research, 
                including research related to causes, prevention, 
                treatment, surveillance, diagnosis, diagnostics, 
                duration of illness, and intervention for individuals 
                with an endemic fungal disease;
                    (B) advances made pursuant to such research;
                    (C) the impact of viral respiratory illnesses, 
                including COVID-19, and fungal lung diseases and 
                pneumonias;
                    (D) Federal activities related to endemic fungal 
                disease, including--
                            (i) epidemiological activities related to 
                        endemic fungal disease; and
                            (ii) basic, clinical, and translational 
                        endemic fungal disease research related to the 
                        pathogenesis, prevention, diagnosis, and 
                        treatment of endemic fungal disease;
                    (E) gaps in endemic fungal disease research 
                described in subparagraph (D)(ii);
                    (F) the Working Group's meetings required under 
                subsection (d); and
                    (G) the comments received by the Working Group;
            (2) make recommendations to the Secretary, including a 
        proposed strategy related to development of therapeutics and 
        vaccines, regarding any appropriate changes or improvements to 
        such activities described in paragraph (1); and
            (3) in implementing this subsection, solicit input from 
        States, 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 views 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.
                    (B) The Food and Drug Administration.
                    (C) The Centers for Disease Control and Prevention.
                    (D) The National Institutes of Health.
                    (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 and other medical providers with 
                experience in diagnosing and treating endemic fungal 
                disease.
                    (B) Scientists or researchers with expertise.
                    (C) Patients and their family members.
                    (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 annually.
    (e) Reporting.--Not later than 2 years after the date of enactment 
of this Act, and every 2 years thereafter until termination of the 
Working Group pursuant to subsection (g), the Working Group shall--
            (1) submit a report on its activities under subsection 
        (b)(1) and any recommendations under paragraph (b)(2) to the 
        Secretary, the Committee on Energy and Commerce of the House of 
        Representatives, and the Committee on Health, Education, Labor, 
        and Pensions of the Senate; 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. FDA GUIDANCE FOR INDUSTRY ON DEVELOPMENT OF DIAGNOSTICS AND 
              ANTIFUNGAL DRUGS AND VACCINES FOR VALLEY FEVER.

    (a) Draft Guidance.--Not later than 2 years after the date of 
enactment of this Act, the Secretary of Health and Human Services, 
acting through the Commissioner of Food and Drugs, shall issue draft 
guidance for industry for the purposes of assisting entities seeking 
approval under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 
et seq.) or licensure under section 351 of the Public Health Service 
Act (42 U.S.C. 262) of antifungal therapies, diagnostics, or vaccines, 
specifically therapies, diagnostics, and vaccines designed to diagnose, 
treat, or prevent coccidioidomycosis (commonly known as Valley Fever).
    (b) Final Guidance.--Not later than 18 months after the close of 
the public comment period on the draft guidance issued pursuant to 
subsection (a), the Secretary of Health and Human Services, acting 
through the Commissioner of Food and Drugs, shall finalize the draft 
guidance.
    (c) Workshops; Good Guidance Practices.--In developing and issuing 
the guidance required by this section, the Secretary of Health and 
Human Services shall hold at least 2 public workshops.

SEC. 5. PRIORITY REVIEW; FAST TRACK PRODUCT.

    (a) Priority Review.--
            (1) In general.--Section 524A(a) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 360n-1(a)) is amended by striking 
        ``then the Secretary shall give priority review to the first 
        application submitted for approval for such drug under section 
        505(b)'' and inserting ``or if the drug is a biological product 
        intended to treat coccidioidomycosis, then the Secretary shall 
        give priority review to the first application submitted for 
        approval for such drug under section 505(b) of this Act or 
        section 351(a) of the Public Health Service Act''.
            (2) Applicability.--The amendment made by paragraph (1) 
        applies only to any application submitted under section 351(a) 
        of the Public Health Service Act (42 U.S.C. 262(a)) on or after 
        the date of enactment of this Act.
    (b) Fast Track Product.--Section 506(b)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 356(b)(1)) is amended by striking 
``or if the Secretary designates the drug as a qualified infectious 
disease product under section 505E(d)'' and inserting ``, if the 
Secretary designates the drug as a qualified infectious disease product 
under section 505E(d), or if the drug is a biological product intended 
to treat coccidioidomycosis''.

SEC. 6. PRIORITY REVIEW VOUCHERS FOR PRODUCTS FOR PREVENTION OR 
              TREATMENT OF ENDEMIC FUNGAL DISEASES.

    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. 7. 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:
                    ``(G) 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 and animal 
                                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 2022 through 2026, 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 2022 through 2026, not 
                                less than 10 percent shall be used to 
                                support antifungal product 
                                development.''.
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