Title: FORWARD Act of 2019
Policy area: Health

Summary:
Finding Orphan-disease Remedies With Antifungal Research and Development Act of 2019 or the FORWARD Act of 2019  This bill establishes programs to support the research of endemic fungal diseases and the development of antifungal drugs. (Endemic fungal diseases are fungal infections, e.g., Valley fever, that tend to occur in specific geographic areas and affect particular at-risk populations, e.g., older adults.)  Specifically, the bill establishes the Endemic Fungal Disease Working Group to review, coordinate, and make recommendations about the Department of Health and Human Services' (HHS) efforts to address endemic fungal diseases. The working group is comprised of experts from both relevant federal agencies and the private sector. The bill requires HHS to award grants for fungal disease research to local hospitals, higher education institutions, public health agencies, and nonprofit organizations. HHS also must establish an accelerated research program modeled after its research program to combat antibiotic resistant bacteria.  The bill further requires the National Institutes of Health to develop a publicly-accessible server using blockchain technology to securely facilitate the sharing of fungal disease clinical research data. (Blockchain technology uses cryptography to create a digital ledger of transactions that can be simultaneously used and shared within a large, decentralized, and permanent network.)  Additionally, the Food and Drug Administration (FDA) must prioritize the review of drugs to treat endemic fungal diseases and fast track the approval of such drugs at the request of applicants. The FDA must issue draft and final guidance related to the approval of antifungal products and therapies, including those that diagnose, treat, or prevent Valley fever.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 1567 Introduced in Senate (IS)]

<DOC>






116th CONGRESS
  1st Session
                                S. 1567

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

                              May 21, 2019

Ms. McSally (for herself 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 2019'' 
or the ``FORWARD Act of 2019''.
    (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 Federal-State match pilot program.
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. Establishment of antifungal resistance research program modeled 
                            on the CARB-X program.
Sec. 8. Blockchain pilot program for hospital data security for endemic 
                            fungal disease research.

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

    The Public Health Service Act is amended by inserting after section 
320A of such Act (42 U.S.C. 247d-8) the following new section:

``SEC. 320B. ENDEMIC FUNGAL DISEASES.

    ``(a) In General.--The Secretary shall 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').
    ``(b) Reports.--The Secretary 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) Endemic Fungal Disease Working Group.--
            ``(1) Establishment.--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--
                    ``(A) to provide expertise and to review all 
                efforts within the Department of Health and Human 
                Services related to endemic fungal disease;
                    ``(B) to help ensure interagency coordination and 
                minimize overlap with respect to such disease; and
                    ``(C) to examine research priorities with respect 
                to such disease.
            ``(2) Responsibilities.--The Working Group shall--
                    ``(A) not later than 2 years after the date of 
                enactment of the FORWARD Act of 2019, develop or update 
                a summary of--
                            ``(i) 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;
                            ``(ii) advances made pursuant to such 
                        research;
                            ``(iii) 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;
                            ``(iv) gaps in endemic fungal disease 
                        research described in clause (iii)(II);
                            ``(v) the Working Group's meetings required 
                        under paragraph (4); and
                            ``(vi) the comments received by the Working 
                        Group;
                    ``(B) make recommendations to the Secretary 
                regarding any appropriate changes or improvements to 
                such activities and research; and
                    ``(C) 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.
            ``(3) Membership.--The members of the Working Group shall 
        represent a diversity of scientific disciplines and views and 
        shall be composed of the following members:
                    ``(A) Federal members.--Seven Federal members, 
                consisting of one or more representatives of each of 
                the following:
                            ``(i) The Office of the Assistant Secretary 
                        for Health.
                            ``(ii) The Food and Drug Administration.
                            ``(iii) The Centers for Disease Control and 
                        Prevention.
                            ``(iv) The National Institutes of Health.
                            ``(v) Such other agencies and offices of 
                        the Department of Health and Human Services as 
                        the Secretary determines appropriate.
                    ``(B) Non-federal public members.--Seven non-
                Federal public members, consisting of representatives 
                of the following categories:
                            ``(i) Physicians and other medical 
                        providers with experience in diagnosing and 
                        treating endemic fungal disease.
                            ``(ii) Scientists or researchers with 
                        expertise.
                            ``(iii) Patients and their family members.
                            ``(iv) Nonprofit organizations that 
                        advocate for patients with respect to endemic 
                        fungal disease.
                            ``(v) Other individuals whose expertise is 
                        determined by the Secretary to be beneficial to 
                        the functioning of the Working Group.
            ``(4) Meetings.--The Working Group shall meet annually.
            ``(5) Reporting.--Not later than 2 years after the date of 
        enactment of the FORWARD Act of 2019, and every 2 years 
        thereafter until termination of the Working Group pursuant to 
        paragraph (7), the Working Group shall--
                    ``(A) submit a report on its activities under 
                paragraph (2)(A) and any recommendations under 
                paragraph (2)(B) 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
                    ``(B) make such report publicly available on the 
                internet website of the Department of Health and Human 
                Services.
            ``(6) 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.).
            ``(7) Sunset.--The Working Group under this section shall 
        terminate 5 years after the date of enactment of the FORWARD 
        Act of 2019.
    ``(d) Endemic Fungal Disease Defined.--In this section, the term 
`endemic fungal disease' means blastomycosis, coccidioidomycosis, 
histoplasmosis, and sparotrichosis.''.

SEC. 3. ENDEMIC FUNGAL DISEASE FEDERAL-STATE MATCH PILOT PROGRAM.

    (a) In General.--
            (1) Grants.--For each of fiscal years 2021 through 2025, 
        the Secretary of Health and Human Services shall, subject to 
        the availability of appropriations, award grants through a 
        competitive process to eligible entities to conduct research 
        with respect to endemic fungal diseases, including 
        coccidioidomycosis.
            (2) Peer review.--Any research supported under this section 
        shall be subject to peer review in accordance with the 
        requirements applicable to research supported by the National 
        Institutes of Health under section 492 of the Public Health 
        Service Act (42 U.S.C. 289a).
    (b) Eligibility.--An entity eligible to receive a grant under this 
section is a State or local public hospital, an institution of higher 
education (as defined in section 101 of the Higher Education Act of 
1965 (20 U.S.C. 1001)), a public health department, or a nonprofit 
organization that has been provided funds from State or local 
government sources for epidemiological, basic, translational, and 
clinical research on endemic fungal diseases.
    (c) Application.--An entity seeking a grant under this section 
shall submit an application to the Secretary--
            (1) in such form and manner as the Secretary shall 
        prescribe;
            (2) that contains a certification that the entity has 
        received the funds described in subsection (b) and that 
        specifies the amount of such funds; and
            (3) that contains such other information as the Secretary 
        may require.
    (d) Amount of Grant.--The amount of a grant under this section 
shall equal (to the extent practicable) the amount of funds received 
from State or local government sources for the research that is the 
subject of the grant.
    (e) Endemic Fungal Disease Defined.--In this section, the term 
``endemic fungal disease'' means blastomycosis, coccidioidomycosis, 
histoplasmosis, and sporotrichosis.
    (f) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section $8,000,000 for each of fiscal 
years 2021 through 2025, to remain available until expended.
    (g) Sunset.--The Secretary may not award grants under this section 
on or after October 1, 2025.

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 the 
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 blastomycosis, coccidioidomycosis, 
        histoplasmosis, or sporotrichosis, 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 to an application submitted under section 351(a) of the 
        Public Health Service Act (42 U.S.C. 262(a)) only if such 
        application is submitted 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 blastomycosis, coccidioidomycosis, histoplasmosis, or 
sporotrichosis''.

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) Blastomycosis, coccidioidomycosis, 
                histoplasmosis, and sporotrichosis.''.

SEC. 7. ESTABLISHMENT OF ANTIFUNGAL RESISTANCE RESEARCH PROGRAM MODELED 
              ON THE CARB-X PROGRAM.

    (a) In General.--The Secretary of Health and Human Services, acting 
through the Director of the Biomedical Advanced Research and 
Development Authority, shall carry out a program, modeled on the 
Combating Antibiotic Resistant Bacteria Accelerator program of the 
Department of Health and Human Services (commonly referred to as 
``CARB-X''), for research with respect to antifungal resistance, 
including therapies, diagnostics, and vaccines, including for 
coccidioidomycosis.
    (b) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out subsection (a) $10,000,000 for each of fiscal 
years 2021 through 2025, to remain available until expended.

SEC. 8. BLOCKCHAIN PILOT PROGRAM FOR HOSPITAL DATA SECURITY FOR ENDEMIC 
              FUNGAL DISEASE RESEARCH.

    Part A of title IV of the Public Health Service Act (42 U.S.C. 281 
et seq.) is amended by adding at the end the following new section:

``SEC. 404O. BLOCKCHAIN PILOT PROGRAM FOR HOSPITAL DATA SECURITY FOR 
              ENDEMIC FUNGAL DISEASE RESEARCH.

    ``(a) In General.--The Director of NIH shall carry out a pilot 
program to conduct, support, and facilitate auditable research on 
endemic fungal disease. In carrying out such program, the Director of 
NIH shall--
            ``(1) award a grant to an eligible entity to install a 
        blockchain on the servers of, or otherwise provide blockchain 
        services to, the National Institutes of Health, and provide 
        support with respect to such a blockchain, which shall contain 
        public, unalterable data which includes every query made 
        through the procedure established under subsection (c), as well 
        as the identity of the individual who asked such a question, 
        without disclosing the results of such queries;
            ``(2) award a grant to an eligible entity--
                    ``(A) to provide to not less than 3 qualified 
                hospitals qualified software; and
                    ``(B) to provide customer service to each such 
                hospital with respect to such qualified software or any 
                associated service;
            ``(3) provide to such qualified hospitals any necessary 
        hardware in accordance with subsection (e); and
            ``(4) award grants to eligible entities to test the 
        cybersecurity of such qualified hospitals by attempting to 
        attack simulated data on the servers of such hospitals.
    ``(b) Eligible Entities; Application.--The Director of NIH shall 
determine whether an entity is eligible to receive a grant under this 
section and shall select hospitals to be qualified hospitals for 
purposes of this section. An entity seeking a grant under this section, 
and a hospital seeking to be so selected, shall submit to the Director 
of NIH an application in such form and manner and containing such 
information as the Director of NIH may specify.
    ``(c) Data Queries.--The Director of NIH shall establish, for 
purposes of allowing researchers to process data from a qualified 
hospital's servers pursuant to this section, a procedure to determine--
            ``(1) who can ask queries of the servers;
            ``(2) which data the hospital must include on such servers; 
        and
            ``(3) which questions may be asked of such servers, and 
        what form of de-identification of the servers' data is required 
        to ensure privacy.
    ``(d) Request for Proposals.--Not later than 90 days after the date 
of the enactment of this section, the Director of NIH shall publish in 
the Federal Register a request for proposals for grants under 
paragraphs (1), (2), and (4) of subsection (a).
    ``(e) Provision of Servers.--
            ``(1) In general.--The Director of NIH shall, in carrying 
        out subsection (a)(3), provide to qualified hospitals hardware, 
        including computer servers, sufficient to support qualified 
        software.
            ``(2) Condition.--As a condition on the receipt of a 
        computer server under paragraph (1), a qualified hospital shall 
        agree not to use the qualified software on the server to store 
        data from patients of the hospital until the Director of NIH 
        determines that testing performed pursuant to subsection (a)(4) 
        has determined that simulated data used in such software could 
        not be extracted from the hospital's servers.
    ``(f) Definitions.--In this section:
            ``(1) The term `blockchain' means software that uses a 
        distributed digital ledger of cryptographically signed 
        transactions that are grouped into blocks, each of which--
                    ``(A) is cryptographically linked to the previous 
                block after validation and undergoing a consensus 
                decision; and
                    ``(B) when added as a new block, makes any older 
                blocks more difficult to modify and is replicated 
                across all copies of the ledger within the relevant 
                network, with any conflicts in such blocks resolved 
                automatically using established rules.
            ``(2) The term `endemic fungal disease' means 
        blastomycosis, coccidioidomycosis, histoplasmosis, and 
        sporotrichosis.
            ``(3) The term `qualified hospital' means a hospital that 
        is located in a region in which endemic fungal disease is 
        endemic.
            ``(4) The term `qualified software' means software that 
        uses secure multiparty encrypted computing to allow researchers 
        to perform computations on encrypted data supplied by qualified 
        hospitals.
            ``(5) The term `secure multiparty encrypted computing' 
        means a form of cryptography in which parties can jointly 
        compute a function of inputs while keeping those inputs private 
        from each other, and from all other parties, such as multiparty 
        homomorphic encryption, threshold encryption, and secure 
        multiparty computation.
    ``(g) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section $5,000,000 for fiscal year 2021, 
to remain available until expended.''.
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