I 
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 Representa-
tives 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 Re-
search and Development Act of 2021’’ or the ‘‘FOR-
WARD Act of 2021’’. 
(b) TABLE OF CONTENTS.—The table of contents for 
this Act is as follows: 
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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 Val-
ley Fever. 
Sec. 7. Combating Antimicrobial Resistance Biopharmaceutical Accelerator Pro-
gram. 
SEC. 2. CONTINUING SUPPORT FOR RESEARCH ON EN-
DEMIC FUNGAL DISEASES. 
The Public Health Service Act is amended by insert-
ing 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 epidemio-
logical, basic, translational, and clinical research, 
such as vaccine development, related to endemic 
fungal diseases, including coccidioidomycosis (com-
monly known as and referred to in this section as 
‘Valley Fever’); and 
‘‘(2) subject to the availability of appropria-
tions, 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 in-
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cludes information on actions undertaken by the National 
Institutes of Health to carry out subsection (a) with re-
spect to endemic fungal diseases, including Valley Fever. 
‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—In ad-
dition to other amounts available for the purposes of car-
rying out this section, there is authorized to be appro-
priated 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 ‘‘Sec-
retary’’) 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 Serv-
ices 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— 
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(1) not later than 2 years after the date of en-
actment of this Act, develop or update a summary 
of— 
(A) ongoing endemic fungal disease re-
search, including research related to causes, 
prevention (such as vaccine development), treat-
ment, surveillance, diagnosis, diagnostics, dura-
tion of illness, and intervention for individuals 
with an endemic fungal disease; 
(B) advances made pursuant to such re-
search; 
(C) the impact of viral respiratory ill-
nesses, 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 vac-
cine development), diagnosis, and treat-
ment of endemic fungal disease; 
(E) gaps in endemic fungal disease re-
search described in subparagraph (D)(ii); 
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(F) the Working Group’s meetings re-
quired under subsection (d); and 
(G) the comments received by the Working 
Group; 
(2) make recommendations, including a pro-
posed strategy related to development of thera-
peutics and vaccines, to the Secretary regarding any 
appropriate changes or improvements related to ac-
tivities described in paragraph (1); and 
(3) in implementing this subsection, solicit 
input from States, localities, and nongovernmental 
entities, including organizations representing pa-
tients, health care providers, researchers, and indus-
try 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 mem-
bers: 
(1) FEDERAL MEMBERS.—Seven Federal mem-
bers, 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. 
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(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 represent-
atives of the following categories: 
(A) Physicians and other medical providers 
with experience in diagnosing and treating en-
demic fungal disease. 
(B) Scientists or researchers with exper-
tise. 
(C) Patients and their family members. 
(D) Nonprofit organizations that advocate 
for patients with respect to endemic fungal dis-
ease. 
(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 an-
nually. 
(e) REPORTING.—Not later than 2 years after the 
date of enactment of this Act, and every 2 years thereafter 
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until termination of the Working Group pursuant to sub-
section (g), the Working Group shall— 
(1) submit a report on its activities under sub-
section (b)(1) and any recommendations under sub-
section (b)(2) to the Secretary, the Committee on 
Energy and Commerce of the House of Representa-
tives, 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 blasto-
mycosis, 
coccidioidomycosis, 
histoplasmosis, 
and 
sporotrichosis. 
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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 Commis-
sioner of Food and Drugs, shall issue draft guidance for 
industry for the purposes of assisting entities seeking ap-
proval 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 Com-
missioner of Food and Drugs, shall finalize the draft guid-
ance. 
(c) WORKSHOPS; GOOD GUIDANCE PRACTICES.—In 
developing and issuing the guidance required by this sec-
tion, the Secretary of Health and Human Services shall 
hold at least 2 public workshops. 
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SEC. 5. PRIORITY REVIEW; FAST TRACK PRODUCT. 
(a) PRIORITY REVIEW.— 
(1) IN GENERAL.—Section 524A(a) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
360n–1(a)) is amended by striking ‘‘then the Sec-
retary shall give priority review to the first applica-
tion submitted for approval for such drug under sec-
tion 505(b)’’ and inserting ‘‘or if the drug is a bio-
logical 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 prod-
uct under section 505E(d)’’ and inserting ‘‘if the Sec-
retary designates the drug as a qualified infectious disease 
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product under section 505E(d), or if the drug is a biologi-
cal 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 sub-
paragraph (T); and 
(2) by inserting after subparagraph (R) the fol-
lowing: 
‘‘(S) Coccidioidomycosis.’’. 
SEC. 7. COMBATING ANTIMICROBIAL RESISTANCE BIO-
PHARMACEUTICAL 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 RESIST-
ANCE BIOPHARMACEUTICAL ACCELERATOR PRO-
GRAM.— 
‘‘(i) IN
GENERAL.—The Secretary, 
acting through the Director of BARDA, 
shall implement strategic initiatives, to be 
known as the Combating Antimicrobial Re-
sistance 
Biopharmaceutical 
Accelerator 
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Program, including by building on existing 
programs and by awarding contracts, 
grants, and cooperative agreements, or en-
tering into other transactions— 
‘‘(I) to optimize the use of 
antimicrobials in human and animal 
health settings; 
‘‘(II) to support innovative can-
didate products in preclinical and clin-
ical development that reduce anti-
microbial 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 other-
wise specified, any reference to the Com-
bating Antibiotic Resistant Bacteria Bio-
pharmaceutical 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. 
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‘‘(iii) AUTHORIZATION OF APPROPRIA-
TIONS.— 
‘‘(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.’’. 
Æ 
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