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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6731 Introduced in House (IH)]
<DOC>
118th CONGRESS
1st Session
H. R. 6731
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
December 12, 2023
Mr. Schweikert (for himself, Mr. McCarthy, Mr. Valadao, Mr. LaMalfa,
Mr. Stanton, and Mr. Ciscomani) 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.
(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.
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 chapter 10 of part I of title 5,
United States Code (commonly referred to as the ``Federal Advisory
Committee Act'').
(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.''.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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