[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6562 Introduced in House (IH)]

<DOC>






115th CONGRESS
  2d Session
                                H. R. 6562

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 26, 2018

 Mr. McCarthy (for himself, Mr. Schweikert, Ms. Bass, Ms. Sinema, and 
 Ms. McSally) introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
 To support endemic orphan fungal disease research, incentivize Valley 
   Fever 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 2018'' 
or the ``FORWARD Act of 2018''.
    (b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Findings.
Sec. 3. Continuing support for research on endemic orphan fungal 
                            diseases.
Sec. 4. Endemic orphan fungal disease Federal-State match pilot 
                            program.
Sec. 5. FDA guidance for industry on development of diagnostics and 
                            antifungal drugs and vaccines for Valley 
                            Fever.
Sec. 6. Including antifungal biological products as qualified 
                            infectious disease products.
Sec. 7. Priority review to encourage treatments for endemic orphan 
                            fungal diseases.
Sec. 8. Including antifungal products in the CARB-X program.
Sec. 9. Blockchain pilot program for hospital data security for 
                            coccidioidomycosis research.

SEC. 2. FINDINGS.

    Congress finds the following:
            (1) Worldwide fungal infections, such as candidiasis, 
        cryptococcosis, and aspergillosis, often pose fatal 
        opportunistic threats to immunologically impaired persons.
            (2) Endemic fungal infections, such as histoplasmosis, 
        coccidioidomycosis, and blastomycosis, occur in certain 
        geographic regions worldwide, including in the United States, 
        and are acquired through exposure to the environment.
            (3) Because the endemic mycoses referred to in paragraph 
        (2) are regional, such endemic mycoses do not receive the same 
        amount of resources as mycoses of worldwide distribution, even 
        though within the regions in which they are endemic such 
        strains pose significant public health threats.
            (4) Coccidioidomycosis, also known as Valley Fever, is a 
        fungal infection acquired by the inhalation of spores of 
        certain fungi primarily found in the soil endemic to the 
        American Southwest, including in Arizona, California, Nevada, 
        New Mexico, Texas, Utah, and Washington.
            (5) According to the Morbidity and Mortality Weekly Report 
        issued by the Centers for Disease Control and Prevention and 
        dated August 11, 2017--
                    (A) 97 percent of the all reported cases of Valley 
                Fever occurred in California and Arizona;
                    (B) individuals at increased risk for severe Valley 
                Fever include persons of African or Filipino descent, 
                pregnant women, adults in older age groups, and other 
                individuals with weakened immune systems;
                    (C) the overall incident rate of Valley Fever 
                peaked in 2011 and again in 2016;
                    (D) in California, the Valley Fever incident rate 
                for 2016 was the highest recorded to date, with 42 
                percent of cases reported coming from Kern County; and
                    (E) the reason for increases in Valley Fever cases 
                reported in California in 2016 is not known.
            (6) Valley Fever illness ranges from influenza-like 
        symptoms to life-threatening when the infection spreads to 
        other parts of the body, including the brain.
            (7) The overall estimated impact of Valley Fever is less 
        than 200,000 people in the United States, with roughly 200 
        deaths each year and over 11,000 new cases identified in 2016. 
        The estimated economic impact to the United States is at least 
        $500,000,000 from hospital, outpatient, and lost productivity 
        costs.
            (8) In the past 60 years, only 4 classes of antifungal 
        compounds have been approved by the Food and Drug 
        Administration for treatment for all fungal infections.
            (9) Existing antifungal therapies often do not cure the 
        fungal infection involved because, similar to how bacteria have 
        become resistant to antibiotic therapies, some fungi no longer 
        respond to the current limited antifungal therapies that are 
        designed to treat them.
            (10) Coccidioides, the cause of Valley Fever, is not cured 
        by any available drug.
            (11) Although antibiotic-resistant bacterial infections are 
        a widely recognized public health threat, less is known about 
        the effects of antifungal resistance and the burden of drug-
        resistant fungal infections.
            (12) Fungal infections are a rising threat to public health 
        and the resistance to current antifungal therapies will only 
        complicate the Nation's response in the event of a public 
        health emergency.

SEC. 3. CONTINUING SUPPORT FOR RESEARCH ON ENDEMIC ORPHAN FUNGAL 
              DISEASES.

    (a) In General.--Subtitle F of title II of the 21st Century Cures 
Act (Public Law 114-255) is amended by inserting after section 2062 (42 
U.S.C. 284s) the following new section:

``SEC. 2062A. ENDEMIC ORPHAN FUNGAL DISEASES.

    ``(a) In General.--The Secretary of Health and Human Services (in 
this section referred to as the `Secretary') shall continue to conduct 
or support epidemiological, basic, translational, and clinical research 
related to endemic orphan 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 of the Public Health Service Act (42 U.S.C. 
283) includes information on actions undertaken by the National 
Institutes of Health to carry out subsection (a) with respect to 
endemic orphan fungal diseases, including Valley Fever.
    ``(c) Valley Fever Working Group.--
            ``(1) Establishment.--The Secretary shall establish a 
        working group, to be known as the Valley Fever Working Group 
        (referred to in this section as the `Working Group'), comprised 
        of representatives of appropriate Federal agencies and other 
        non-Federal entities, to provide expertise and to review all 
        efforts within the Department of Health and Human Services 
        related to Valley Fever, to help ensure interagency 
        coordination and minimize overlap, and to examine research 
        priorities.
            ``(2) Responsibilities.--The Working Group shall--
                    ``(A) not later than 2 years after the date of 
                enactment of this Act, develop or update a summary of--
                            ``(i) ongoing Valley Fever research, 
                        including research related to causes, 
                        prevention, treatment, surveillance, diagnosis, 
                        diagnostics, duration of illness, and 
                        intervention for individuals with Valley Fever;
                            ``(ii) advances made pursuant to such 
                        research;
                            ``(iii) Federal activities related to 
                        Valley Fever, including--
                                    ``(I) epidemiological activities 
                                related to Valley Fever; and
                                    ``(II) basic, clinical, and 
                                translational Valley Fever research 
                                related to the pathogenesis, 
                                prevention, diagnosis, and treatment of 
                                Valley Fever;
                            ``(iv) gaps in Valley Fever 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 Valley Fever.
                            ``(ii) Scientists or researchers with 
                        expertise.
                            ``(iii) Patients and their family members.
                            ``(iv) Nonprofit organizations that 
                        advocate for patients with respect to Valley 
                        Fever.
                            ``(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 this Act, 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 this Act.
    ``(d) Endemic Orphan Fungal Disease Defined.--The term `endemic 
orphan fungal disease' has the meaning given such term in section 
529B(a) of the Federal Food, Drug, and Cosmetic Act.''.
    (b) Conforming Table of Contents Amendment.--Section 1(b) of the 
21st Century Cures Act (Public Law 114-255) is amended in the table of 
contents, by inserting after the item relating to section 2062 the 
following:

``Sec. 2062A. Endemic orphan fungal diseases.''.

SEC. 4. ENDEMIC ORPHAN FUNGAL DISEASE FEDERAL-STATE MATCH PILOT 
              PROGRAM.

    (a) In General.--For each of fiscal years 2019 through 2024, 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 orphan fungal diseases, including coccidioidomycosis.
    (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)), or a nonprofit organization that has been 
provided funds from State or local government sources for 
epidemiological, basic, translational, and clinical research on endemic 
orphan fungal diseases during the 3-year period ending on the date of 
the enactment of this Act.
    (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 Orphan Fungal Disease Defined.--The term ``endemic 
orphan fungal disease'' has the meaning given such term in section 529B 
of the Federal Food, Drug, and Cosmetic Act, as added by section 7.
    (f) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section $8,000,000 for each of fiscal 
years 2019 through 2024, to remain available until expended.
    (g) Sunset.--The Secretary may not award grants under this section 
on or after October 1, 2024.

SEC. 5. FDA GUIDANCE FOR INDUSTRY ON DEVELOPMENT OF DIAGNOSTICS AND 
              ANTIFUNGAL DRUGS AND VACCINES FOR VALLEY FEVER.

    (a) In General.--Not later than one year 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) Consultation.--In developing the draft guidance under 
subsection (a), the Secretary of Health and Human Services, acting 
through the Commissioner of Food and Drugs, shall consult with 
institutions of higher education (as defined in section 101 of the 
Higher Education Act of 1965 (20 U.S.C. 1001)), researchers, and other 
relevant stakeholders.
    (c) Final Guidance.--The Secretary of Health and Human Services, 
acting through the Commissioner of Food and Drugs, shall finalize the 
draft guidance issued under subsection (a) not later than 2 years after 
the date of the enactment of this Act.

SEC. 6. INCLUDING ANTIFUNGAL BIOLOGICAL PRODUCTS AS QUALIFIED 
              INFECTIOUS DISEASE PRODUCTS.

    (a) In General.--Section 505E of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355f) is amended--
            (1) in subsection (a)--
                    (A) by inserting ``(or, pursuant to section 351 of 
                the Public Health Service Act, in the case of an 
                antifungal biological product)'' after ``pursuant to 
                section 505 for a drug''; and
                    (B) by striking ``or the 7-year period described in 
                section 527,'' and inserting ``the 7-year period 
                described in section 527, or, in the case of an 
                antifungal biological product, the 12-year period under 
                section 351(k) of the Public Health Service Act,'';
            (2) in subsection (c)--
                    (A) in paragraph (1), by inserting ``or, in the 
                case of an antifungal biological product, section 
                351(a) of the Public Health Service Act'' after 
                ``505(b)''; and
                    (B) in paragraph (2), by inserting ``or, in the 
                case of an antifungal biological product, section 351 
                of the Public Health Service Act'' after ``505'';
            (3) in subsection (d)(1) by inserting ``or, in the case of 
        an antifungal biological product, section 351(a) of the Public 
        Health Service Act'' after ``505(b)''; and
            (4) in subsection (g), in the matter preceding paragraph 
        (1)--
                    (A) by inserting ``(including antifungal biological 
                products)'' after ``antifungal drug''; and
                    (B) by inserting ``or prevent'' after ``treat''.
    (b) Effective Date.--The amendments made by subsection (a) shall 
apply with respect to applications for the approval of biological 
products under section 351 of the Public Health Service Act (42 U.S.C. 
262) submitted on or after the date of the enactment of this Act.
    (c) Updated Guidance.--Not later than one year 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 update 
``Qualified Infectious Disease Product Designation Questions and 
Answers Guidance for Industry'' issued in January 2018, to implement 
the amendments made by subsection (a).

SEC. 7. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR ENDEMIC ORPHAN 
              FUNGAL DISEASES.

    Subchapter B of chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360aa et seq.) is amended by adding at the end the 
following new section:

``SEC. 529B. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR ENDEMIC ORPHAN 
              FUNGAL DISEASES.

    ``(a) Definitions.--In this section:
            ``(1) Endemic orphan fungal disease.--The term `endemic 
        orphan fungal disease' means a disease, such as 
        coccidioidomycosis, that--
                    ``(A) is caused by a fungus;
                    ``(B) primarily occurs in certain limited 
                geographic regions; and
                    ``(C) is a rare disease or condition (as that term 
                is defined in section 526(a)(2) of the Federal Food, 
                Drug, and Cosmetic Act (21 U.S.C. 360bb(a)(2))).
            ``(2) Endemic orphan fungal disease drug application.--The 
        term `endemic orphan fungal disease drug application' means an 
        application that--
                    ``(A) is a human drug application for a drug 
                intended for use--
                            ``(i) to prevent or treat harm from an 
                        endemic orphan fungal disease; or
                            ``(ii) to cure an endemic orphan fungal 
                        disease;
                    ``(B) the Secretary determines eligible for 
                priority review;
                    ``(C) is approved after the date of enactment of 
                this section; and
                    ``(D) is for a human drug, no active ingredient 
                (including any ester or salt of the active ingredient) 
                of which has been approved in any other application 
                under section 505(b)(1) or section 351(a) of the Public 
                Health Service Act.
            ``(3) Human drug application.--The term `human drug 
        application' has the meaning given such term in section 735(1).
            ``(4) Priority review.--The term `priority review', with 
        respect to a human drug application, means review and action by 
        the Secretary on such application not later than 6 months after 
        receipt by the Secretary of such application, as described in 
        the Manual of Policies and Procedures in the Food and Drug 
        Administration and goals identified in the letters described in 
        section 101(b) of the Food and Drug Administration Safety and 
        Innovation Act.
            ``(5) Priority review voucher.--The term `priority review 
        voucher' means a voucher issued by the Secretary to the sponsor 
        of an endemic orphan fungal disease drug application that 
        entitles the holder of such voucher to priority review of a 
        single human drug application submitted under section 505(b)(1) 
        or section 351(a) of the Public Health Service Act after the 
        date of approval of the endemic orphan fungal disease drug 
        application.
    ``(b) Priority Review Voucher.--
            ``(1) In general.--The Secretary shall award a priority 
        review voucher to the sponsor of an endemic orphan fungal 
        disease drug application upon approval by the Secretary of such 
        endemic orphan fungal disease drug application.
            ``(2) Transferability.--The sponsor of a endemic orphan 
        fungal disease drug application that receives a priority review 
        voucher under this section may transfer (including by sale) the 
        entitlement to such voucher to a sponsor of a human drug for 
        which an application under section 505(b)(1) or section 351(a) 
        of the Public Health Service Act will be submitted after the 
        date of the approval of the endemic orphan fungal disease drug 
        application. There is no limit on the number of times a 
        priority review voucher may be transferred before such voucher 
        is used.
            ``(3) Notification.--
                    ``(A) In general.--The sponsor of a human drug 
                application shall notify the Secretary not later than 
                90 calendar days prior to submission of the human drug 
                application that is the subject of a priority review 
                voucher of an intent to submit the human drug 
                application, including the date on which the sponsor 
                intends to submit the application. Such notification 
                shall be a legally binding commitment to pay for the 
                user fee to be assessed in accordance with this 
                section.
                    ``(B) Transfer after notice.--The sponsor of a 
                human drug application that provides notification of 
                the intent of such sponsor to use the voucher for the 
                human drug application under subparagraph (A) may 
                transfer the voucher after such notification is 
                provided, if such sponsor has not yet submitted the 
                human drug application described in the notification.
    ``(c) Priority Review User Fee.--
            ``(1) In general.--The Secretary shall establish a user fee 
        program under which a sponsor of a human drug application that 
        is the subject of a priority review voucher shall pay to the 
        Secretary a fee determined under paragraph (2). Such fee shall 
        be in addition to any fee required to be submitted by the 
        sponsor under chapter VII.
            ``(2) Fee amount.--The amount of the priority review user 
        fee shall be determined each fiscal year by the Secretary and 
        based on the average cost incurred by the agency in the review 
        of a human drug application subject to priority review in the 
        previous fiscal year.
            ``(3) Annual fee setting.--The Secretary shall establish, 
        before the beginning of each fiscal year beginning after 
        September 30, 2019, for that fiscal year, the amount of the 
        priority review user fee.
            ``(4) Payment.--
                    ``(A) In general.--The priority review user fee 
                required by this subsection shall be due upon the 
                submission of a human drug application under section 
                505(b)(1) or section 351(a) of the Public Health 
                Service Act for which the priority review voucher is 
                used.
                    ``(B) Complete application.--An application 
                described under subparagraph (A) for which the sponsor 
                requests the use of a priority review voucher shall be 
                considered incomplete if the fee required by this 
                subsection and all other applicable user fees are not 
                paid in accordance with the Secretary's procedures for 
                paying such fees.
                    ``(C) No waivers, exemptions, reductions, or 
                refunds.--The Secretary may not grant a waiver, 
                exemption, reduction, or refund of any fees due and 
                payable under this section.
            ``(5) Offsetting collections.--Fees collected pursuant to 
        this subsection for any fiscal year--
                    ``(A) shall be deposited and credited as offsetting 
                collections to the account providing appropriations to 
                the Food and Drug Administration; and
                    ``(B) shall not be collected for any fiscal year 
                except to the extent provided in advance in 
                appropriation Acts.
    ``(d) Notice of Issuance of Voucher and Approval of Products Under 
Voucher.--The Secretary shall publish a notice in the Federal Register 
and on the Internet website of the Food and Drug Administration not 
later than 30 calendar days after the occurrence of each of the 
following:
            ``(1) The Secretary issues a priority review voucher under 
        this section.
            ``(2) The Secretary approves a drug pursuant to an 
        application submitted under section 505(b) of this Act or 
        section 351(a) of the Public Health Service Act for which the 
        sponsor of the application used a priority review voucher 
        issued under this section.
    ``(e) Eligibility for Other Programs.--Nothing in this section 
precludes a sponsor who seeks a priority review voucher under this 
section from participating in any other incentive program, including 
under this Act, except that no sponsor of a material threat medical 
countermeasure application may receive more than one priority review 
voucher issued under any section of this Act with respect to such drug.
    ``(f) Relation to Other Provisions.--The provisions of this section 
shall supplement, not supplant, any other provisions of this Act or the 
Public Health Service Act that encourage the development of medical 
countermeasures.
    ``(g) Sunset.--The Secretary may not award any priority review 
vouchers under subsection (b) after October 1, 2024.''.

SEC. 8. INCLUDING ANTIFUNGAL PRODUCTS IN THE CARB-X PROGRAM.

    (a) In General.--The Secretary of Health and Human Services shall, 
in carrying out the Combating Antibiotic Resistant Bacteria Accelerator 
program of the Department of Health and Human Services (commonly 
referred to as ``CARB-X''), conduct research with respect to antifungal 
resistance, including therapies, diagnostics, and vaccines, including 
for coccidioidomycosis.
    (b) Authorization of Appropriations.--There are authorized to be 
appropriated to the Biodefense Medical Countermeasure Development Fund 
established under section 319L(d) of the Public Health Service Act (42 
U.S.C. 247d-7e(d)) to carry out subsection (a) $10,000,000 for each of 
fiscal years 2019 through 2024, to remain available until expended.

SEC. 9. BLOCKCHAIN PILOT PROGRAM FOR HOSPITAL DATA SECURITY FOR 
              COCCIDIOIDOMYCOSIS 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 
              COCCIDIOIDOMYCOSIS RESEARCH.

    ``(a) In General.--The Director of NIH shall carry out a pilot 
program to conduct, support, and facilitate auditable research on 
coccidioidomycosis (commonly referred to as `Valley Fever'). In 
carrying out such program, the Director 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 `qualified hospital' means a hospital that 
        is located in a region in which coccidioidomycosis is endemic.
            ``(3) 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.
            ``(4) 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 are authorized to be 
appropriated to carry out this section $5,000,000 for fiscal year 2020, 
to remain available until expended.''.
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