[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2858 Introduced in House (IH)]
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116th CONGRESS
1st Session
H. R. 2858
To support endemic fungal disease research, incentivize fungal vaccine
development, discover new antifungal therapies and diagnostics, and for
other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 21, 2019
Mr. McCarthy (for himself, Mr. Schweikert, Ms. Bass, and Mr. Stanton)
introduced the following bill; which was referred to the Committee on
Energy and Commerce
_______________________________________________________________________
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 sporotrichosis.''.
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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