I 
116TH CONGRESS 
1ST SESSION H. R. 2858 
To support endemic fungal disease research, incentivize fungal vaccine devel-
opment, 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 En-
ergy 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 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 2019’’ or the ‘‘FOR-
WARD Act of 2019’’. 
(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 Federal-State match pilot program. 
Sec. 4. FDA guidance for industry on development of diagnostics and antifun-
gal 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 en-
demic 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 EN-
DEMIC FUNGAL DISEASES. 
The Public Health Service Act is amended by insert-
ing 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 re-
ferred to in this section as ‘Valley Fever’). 
‘‘(b) REPORTS.—The Secretary shall ensure that 
each triennial report under section 403 includes informa-
tion 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 es-
tablish a working group, to be known as the En-
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demic 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 dis-
ease; 
‘‘(B) to help ensure interagency coordina-
tion and minimize overlap with respect to such 
disease; and 
‘‘(C) to examine research priorities with re-
spect 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; 
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‘‘(ii) advances made pursuant to such 
research; 
‘‘(iii) Federal activities related to en-
demic fungal disease, including— 
‘‘(I) epidemiological activities re-
lated to endemic fungal disease; and 
‘‘(II) basic, clinical, and transla-
tional endemic fungal disease research 
related to the pathogenesis, preven-
tion, diagnosis, and treatment of en-
demic 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 Sec-
retary regarding any appropriate changes or 
improvements to such activities and research; 
and 
‘‘(C) solicit input from States, localities, 
and nongovernmental entities, including organi-
zations representing patients, health care pro-
viders, researchers, and industry regarding sci-
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entific advances, research questions, and sur-
veillance activities. 
‘‘(3) MEMBERSHIP.—The members of the 
Working Group shall represent a diversity of sci-
entific disciplines and views and shall be composed 
of the following members: 
‘‘(A) FEDERAL MEMBERS.—Seven Federal 
members, consisting of one or more representa-
tives of each of the following: 
‘‘(i) The Office of the Assistant Sec-
retary for Health. 
‘‘(ii) The Food and Drug Administra-
tion. 
‘‘(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 ap-
propriate. 
‘‘(B) NON-FEDERAL PUBLIC MEMBERS.— 
Seven non-Federal public members, consisting 
of representatives of the following categories: 
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‘‘(i) Physicians and other medical pro-
viders with experience in diagnosing and 
treating endemic fungal disease. 
‘‘(ii) Scientists or researchers with ex-
pertise. 
‘‘(iii) Patients and their family mem-
bers. 
‘‘(iv) Nonprofit organizations that ad-
vocate for patients with respect to endemic 
fungal disease. 
‘‘(v) Other individuals whose expertise 
is determined by the Secretary to be bene-
ficial 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 
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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 en-
actment of the FORWARD Act of 2019. 
‘‘(d) ENDEMIC FUNGAL DISEASE DEFINED.—In this 
section, the term ‘endemic fungal disease’ means blasto-
mycosis, coccidioidomycosis, histoplasmosis, and sporotri-
chosis.’’. 
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 appro-
priations, award grants through a competitive proc-
ess to eligible entities to conduct research with re-
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spect to endemic fungal diseases, including coccidioi-
domycosis. 
(2) PEER
REVIEW.—Any research supported 
under this section shall be subject to peer review in 
accordance with the requirements applicable to re-
search supported by the National Institutes of 
Health under section 492 of the Public Health Serv-
ice 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 organi-
zation that has been provided funds from State or local 
government sources for epidemiological, basic, translation-
al, 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. 
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(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 govern-
ment 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 blasto-
mycosis, coccidioidomycosis, histoplasmosis, and sporotri-
chosis. 
(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 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 
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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. 
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 blastomycosis, coc-
cidioidomycosis, histoplasmosis, or sporotrichosis, 
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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 
product under section 505E(d), or if the drug is a biologi-
cal product intended to treat blastomycosis, coccidioidomy-
cosis, 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— 
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(1) by redesignating subparagraph (S) as sub-
paragraph (T); and 
(2) by inserting after subparagraph (R) the fol-
lowing: 
‘‘(S) 
Blastomycosis, 
coccidioidomycosis, 
histoplasmosis, and sporotrichosis.’’. 
SEC. 7. ESTABLISHMENT OF ANTIFUNGAL RESISTANCE RE-
SEARCH PROGRAM MODELED ON THE CARB– 
X PROGRAM. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services, acting through the Director of the Bio-
medical Advanced Research and Development Authority, 
shall carry out a program, modeled on the Combating An-
tibiotic Resistant Bacteria Accelerator program of the De-
partment of Health and Human Services (commonly re-
ferred 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. 
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SEC. 8. BLOCKCHAIN PILOT PROGRAM FOR HOSPITAL 
DATA SECURITY FOR ENDEMIC FUNGAL DIS-
EASE 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 DIS-
EASE 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 in-
stall a blockchain on the servers of, or otherwise pro-
vide 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 que-
ries; 
‘‘(2) award a grant to an eligible entity— 
‘‘(A) to provide to not less than 3 qualified 
hospitals qualified software; and 
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‘‘(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 nec-
essary hardware in accordance with subsection (e); 
and 
‘‘(4) award grants to eligible entities to test the 
cybersecurity of such qualified hospitals by attempt-
ing to attack simulated data on the servers of such 
hospitals. 
‘‘(b) ELIGIBLE ENTITIES; APPLICATION.—The Di-
rector of NIH shall determine whether an entity is eligible 
to receive a grant under this section and shall select hos-
pitals to be qualified hospitals for purposes of this section. 
An entity seeking a grant under this section, and a hos-
pital seeking to be so selected, shall submit to the Director 
of NIH an application in such form and manner and con-
taining such information as the Director of NIH may 
specify. 
‘‘(c) DATA QUERIES.—The Director of NIH shall es-
tablish, 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; 
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‘‘(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 quali-
fied 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 quali-
fied hospital shall agree not to use the qualified soft-
ware 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 soft-
ware could not be extracted from the hospital’s serv-
ers. 
‘‘(f) DEFINITIONS.—In this section: 
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‘‘(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 pre-
vious 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 hos-
pital that is located in a region in which endemic 
fungal disease is endemic. 
‘‘(4) The term ‘qualified software’ means soft-
ware that uses secure multiparty encrypted com-
puting 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 
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parties can jointly compute a function of inputs 
while keeping those inputs private from each other, 
and from all other parties, such as multiparty homo-
morphic 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.’’. 
Æ 
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