Finding Orphan-disease Remedies With Antifungal Research and Development Act of 2021 or the FORWARD Act of 2021
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.
[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5566 Introduced in House (IH)]
<DOC>
117th CONGRESS
1st Session
H. R. 5566
To support fungal disease research, incentivize fungal vaccine
development, discover new antifungal therapies and diagnostics, and for
other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
October 12, 2021
Mr. McCarthy (for himself, Mr. Schweikert, Ms. Bass, and Mr.
O'Halleran) introduced the following bill; which was referred to the
Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To support 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 2021''
or the ``FORWARD Act of 2021''.
(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 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 to encourage treatments and vaccines
for Valley Fever.
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, such as vaccine
development, 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 (in
this section referred to 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 (such
as vaccine development), 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 (such as vaccine
development), 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, including a proposed strategy
related to development of therapeutics and vaccines, to the
Secretary regarding any appropriate changes or improvements
related to 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 subsection (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 internet
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 sporotrichosis.
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 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 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 coccidioidomycosis''.
SEC. 6. PRIORITY REVIEW VOUCHERS TO ENCOURAGE TREATMENTS AND VACCINES
FOR VALLEY FEVER.
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.''.
<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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