I 
118TH CONGRESS 
2D SESSION 
H. R. 9942 
To support the development, licensing, and initial manufacturing of a human 
vaccine for valley fever. 
IN THE HOUSE OF REPRESENTATIVES 
OCTOBER 8, 2024 
Mr. DUARTE (for himself, Mr. STANTON, Mr. SCHWEIKERT, Mr. COSTA, Mr. 
VALADAO, Ms. TOKUDA, and Mr. OBERNOLTE) introduced the following 
bill; which was referred to the Committee on Energy and Commerce 
A BILL 
To support the development, licensing, and initial 
manufacturing of a human vaccine for valley fever. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Valley Fever Aware-
ness and Vaccine Development and Manufacturing Act of 
2024’’. 
SEC. 2. VALLEY FEVER VACCINE NATIONAL STRATEGY. 
(a) WHOLE OF GOVERNMENT APPROACH.— 
(1) IN GENERAL.—The Secretary shall coordi-
nate with the relevant agency heads to support the 
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development, licensing, and initial manufacturing of 
a human vaccine for valley fever. 
(2) CONSULTATION.—In implementing para-
graph (1), the Secretary shall consult with expert 
stakeholders on valley fever and vaccine development 
and manufacturing. 
(3) VACCINE COORDINATOR.— 
(A) APPOINTMENT.—Not later than 60 
days after the date of the enactment of this sec-
tion, the Secretary shall appoint a Vaccine Co-
ordinator from among the officials at the Food 
and Drug Administration or the National Insti-
tutes of Health. 
(B) DUTIES.—The Vaccine Coordinator 
shall— 
(i) act as a single point of contact 
within the Federal Government on matters 
related to implementing this section; 
(ii) not later 180 days after the date 
of the enactment of this section, and every 
180 days thereafter, publish on the inter-
net website of the Department of Health 
and Human Services a report that de-
scribes all of the activities undertaken pur-
suant to this section; 
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(iii) not later than six months after 
the date of the enactment of this section, 
and every six months thereafter, convene a 
meeting with the relevant agency heads 
and expert stakeholders to advance the de-
velopment, approval, and manufacturing of 
a valley fever vaccine; and 
(iv) identify ways to— 
(I) expedite regulatory review 
and licensing of a safe and effective 
valley fever vaccine, consistent with 
applicable safety and other require-
ments; and 
(II) to advance the development, 
licensing, and manufacturing of such 
a vaccine. 
(b) VALLEY FEVER VACCINE DEVELOPMENT NA-
TIONAL STRATEGY.— 
(1) IN
GENERAL.—Not later than one year 
after the date of the enactment of this section, the 
Secretary, acting through the Vaccine Coordinator 
and in consultation with the relevant agency heads 
and expert stakeholders, shall develop and publish 
on the internet website of the Department of Health 
and Human Services a national strategy to develop, 
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license, and manufacture a valley fever vaccine by no 
later than January 1, 2034. 
(2) CONTENT.—The national strategy shall con-
tain— 
(A) a statement of science on valley fever, 
including current efforts to develop a valley 
fever vaccine; 
(B) an assessment of the status of valley 
fever vaccine development and manufacturing, 
including vaccine market viability; 
(C) an overview of Federal research fund-
ing made available over the 10 years preceding 
the date of the enactment of this section to sup-
port valley fever vaccine development, including 
pre-clinical and clinical work, licensing, and 
manufacturing; 
(D) identifiable and achievable benchmarks 
for vaccine development and manufacturing, in-
cluding a timeline for valley fever vaccine devel-
opment and manufacturing consistent with the 
timeline in paragraph (1); 
(E) Federal, State, and local funding pri-
orities and opportunities that actively support 
the development or manufacturing of a valley 
fever vaccine; 
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Register and provide an opportunity for public 
comment on such national strategy. 
(B) CONSIDERATION
OF
COMMENTS.—In 
finalizing the national strategy, the Secretary 
shall consider public comments received pursu-
ant to subparagraph (A). 
(4) EXPERT CONSULTATION.—In developing the 
national strategy, the Secretary, acting through the 
Vaccine Coordinator, shall— 
(A) consult with the relevant agency heads 
and expert stakeholders; and 
(B) hold not less than two in-person meet-
ings with the relevant agency heads and expert 
stakeholders, of which one shall be conducted 
prior to receiving public comments on the na-
tional strategy and one shall be conducted after 
such public comments are received. 
SEC. 3. GUIDANCE ON DEVELOPMENT, MANUFACTURING, 
AND APPROVAL OF VALLEY FEVER VACCINE. 
The Director of the National Institutes of Health, the 
Commissioner of Food and Drugs, and the Director of the 
Centers for Disease Control and Prevention shall issue 
guidance on the development and manufacturing of a val-
ley fever vaccine and approval for use of such vaccine, as 
applicable. 
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SEC. 4. VACCINE DEVELOPMENT AND MANUFACTURING. 
(a) VACCINE DEVELOPMENT PROGRAM.— 
(1) 
IN
GENERAL.—The 
Secretary, 
acting 
through the Vaccine Coordinator and in consultation 
with the relevant agency heads, shall carry out a 
program of— 
(A) entering into contracts with eligible en-
tities to support and advance the development 
of a valley fever vaccine; or 
(B) awarding grants to eligible entities 
under paragraph (2). 
(2) GRANT PROGRAM.— 
(A) IN
GENERAL.—The Secretary may 
award grants pursuant to paragraph (1)(B) to 
support and advance the development of a val-
ley fever vaccine. 
(B) PRIORITY.—In awarding grants under 
subparagraph (A), the Secretary shall give pri-
ority to applicants that have commenced Phase 
1, 2, or 3 clinical trials on a valley fever vac-
cine. 
(C) AWARD AMOUNT.—The amount of a 
grant under this paragraph shall be not less 
than $500,000 and not more than $2,500,000. 
(3) COMMENCEMENT.—Not later than 180 days 
after the date of the enactment of this section, the 
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Secretary shall commence the program under para-
graph (1). 
(4) CONSULTATION
REQUIREMENT.—In car-
rying out this subsection, the Secretary shall consult 
with physicians, medical providers, scientists, re-
searchers, nonprofit entities, advocacy groups, and 
other individuals with expertise in valley fever re-
search and vaccine development. 
(b) VACCINE MANUFACTURING PROGRAM.— 
(1) 
IN
GENERAL.—The 
Secretary, 
acting 
through the Vaccine Coordinator and in consultation 
with the relevant agency heads, shall— 
(A) enter into contracts with eligible enti-
ties to support and advance the manufacturing 
of a valley fever vaccine; or 
(B) award grants to eligible entities under 
paragraph (2). 
(2) GRANT PROGRAM.— 
(A) IN
GENERAL.—The Secretary may 
award grants pursuant to paragraph (1)(B) to 
support and advance the manufacturing of a 
valley fever vaccine. 
(B) AWARD AMOUNT.—The amount of a 
grant under this paragraph shall be not less 
than $500,000 and not more than $5,000,000. 
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(3) COMMENCEMENT.—Not later than 180 days 
after the date of the enactment of this section, the 
Secretary shall commence the programs under para-
graph (1). 
(4) CONSULTATION
REQUIREMENT.—In car-
rying out this subsection, the Secretary shall consult 
with vaccine manufacturing experts and other indi-
viduals with expertise in valley fever research and 
vaccine manufacturing. 
SEC. 5. AUTHORIZATION OF APPROPRIATIONS. 
There are authorized to be appropriated to the Sec-
retary— 
(1) $1,000,000 for fiscal year 2026 to carry out 
section 2(b); 
(2) $25,000,000 for the period of fiscal years 
2025 through 2030 to carry out section 4(a); and 
(3) $25,000,000 for the period of fiscal years 
2025 through 2030 to carry out section 4(b). 
SEC. 6. NATIONAL VALLEY FEVER REGISTRY. 
Part P of title III of the Public Health Service Act 
(42 U.S.C. 280g et seq.) is amended by adding at the end 
the following: 
‘‘SEC. 399V–8. NATIONAL VALLEY FEVER REGISTRY. 
‘‘(a) DATA COLLECTION AND REGISTRY.— 
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‘‘(1) IN
GENERAL.—The Secretary, acting 
through the Director of the Centers for Disease 
Control and Prevention, if scientifically advisable, 
may— 
‘‘(A) carry out a system to collect non-per-
sonally identifiable voluntary data on coccidioi-
domycosis (referred to in this section as ‘valley 
fever’) and other fungal diseases that can be 
confused with valley fever or misdiagnosed as 
valley fever, including information with respect 
to the incidence and prevalence of such diseases 
in the United States; and 
‘‘(B) maintain a national registry (referred 
to in this section as the ‘National Valley Fever 
Registry’) for the collection and storage of the 
data collected pursuant to subparagraph (A) to 
develop a population-based registry of cases in 
the United States of valley fever and other 
fungal diseases that can be confused with valley 
fever or misdiagnosed as valley fever. 
‘‘(2) REQUIRED COMMENCEMENT TIMING.—The 
authority to commence activities under paragraph 
(1) shall terminate on the date that is one year after 
the receipt of the report described in subsection 
(b)(4). 
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‘‘(b) ADVISORY COMMITTEE.— 
‘‘(1) ESTABLISHMENT.—Not later than 180 
days after the date of the enactment of this section, 
the Secretary, acting through the Director of the 
Centers for Disease Control and Prevention, shall 
establish the Advisory Committee on the National 
Valley Fever Registry (referred to in this section as 
the ‘Advisory Committee’). 
‘‘(2) MEMBERSHIP.—The Advisory Committee 
shall be composed of not more than 27 members to 
be appointed by the Secretary, acting through the 
Director of Centers for Disease Control and Preven-
tion, of which— 
‘‘(A) two-thirds of the members of the Ad-
visory Committee shall represent Federal agen-
cies, including at least— 
‘‘(i) two members representing the 
National Institutes of Health, to include, 
upon the recommendation of the Director 
of the National Institutes of Health, one 
such member representing the National In-
stitute of Allergy and Infectious Diseases; 
‘‘(ii) one member representing the De-
partment of Defense; 
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‘‘(iii) one member representing the 
Centers for Disease Control and Preven-
tion; 
‘‘(iv) one member who is a clinician 
with expertise on valley fever and related 
diseases; 
‘‘(v) one member who is an epi-
demiologist with experience in data reg-
istries; 
‘‘(vi) one member who is a statisti-
cian; 
‘‘(vii) one member who is an ethicist; 
and 
‘‘(viii) one member who is an expert 
in privacy regulations under the Health In-
surance Portability and Accountability Act 
of 1996 (42 U.S.C. 1320d–6); and 
‘‘(B) one-third of the members of the Advi-
sory Committee shall be members of the public, 
including at least— 
‘‘(i) one member representing national 
and voluntary health associations; 
‘‘(ii) one member representing pa-
tients with valley fever or their family 
members; 
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‘‘(iii) one member representing clini-
cians with expertise on valley fever and re-
lated diseases; 
‘‘(iv) one member representing epi-
demiologists with expertise in data reg-
istries; and 
‘‘(v) one member representing individ-
uals with an interest in developing and 
maintaining the National Valley Fever 
Registry. 
‘‘(3) 
DUTIES.—The 
Advisory 
Committee 
shall— 
‘‘(A) review information and make rec-
ommendations to the Secretary concerning— 
‘‘(i) the development and maintenance 
of the National Valley Fever Registry; 
‘‘(ii) the type of information to be col-
lected and stored in the National Valley 
Fever Registry; 
‘‘(iii) the manner in which such data 
is to be collected; 
‘‘(iv) the use and availability of such 
data including guidelines for such use; and 
‘‘(v) the collection of information 
about diseases and disorders that primarily 
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affect motor neurons that are considered 
essential to furthering the study and cure 
of valley fever; and 
‘‘(B) oversee the National Valley Fever 
Registry, if the Secretary establishes the Na-
tional Valley Fever Registry. 
‘‘(4) REPORT.—Not later than 270 days after 
the date on which the Advisory Committee is estab-
lished, the Advisory Committee shall submit a report 
to the Secretary containing the information reviewed 
and each recommendation made under paragraph 
(3)(A). 
‘‘(5) TERMINATION.—The Advisory Committee 
shall terminate on the date that is seven years after 
the date on which the report required under para-
graph (4) is submitted. 
‘‘(c) GRANTS.— 
‘‘(1) IN
GENERAL.—The Secretary, acting 
through the Director of the Centers for Disease 
Control and Prevention, may award grants to, and 
enter into contracts and cooperative agreements 
with, public or private nonprofit entities for the col-
lection, analysis, and reporting of data on valley 
fever and other fungal diseases that can be confused 
with valley fever or misdiagnosed as valley fever. 
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‘‘(2) COMMENCEMENT.—After receiving the re-
port under subsection (b)(4), the Secretary may 
commence making awards under paragraph (1). 
‘‘(d) COORDINATION WITH FEDERAL, STATE, AND 
LOCAL REGISTRIES.— 
‘‘(1) IN
GENERAL.—In establishing the Na-
tional Valley Fever Registry, the Secretary, acting 
through the Director of the Centers for Disease 
Control and Prevention, may— 
‘‘(A) identify, build upon, expand, and co-
ordinate among existing data, surveys, reg-
istries, and other Federal public health and en-
vironmental infrastructure wherever possible, 
which may include— 
‘‘(i) any registry previously supported 
by the Centers for Disease Control and 
Prevention; 
‘‘(ii) State-based valley fever reg-
istries; 
‘‘(iii) the National Vital Statistics 
System of the National Center for Health 
Statistics; and 
‘‘(iv) any other existing or relevant 
databases that collect or maintain informa-
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tion on each fungal disease recommended 
by the Advisory Committee; and 
‘‘(B) provide for research access to valley 
fever data, as recommended by the Advisory 
Committee, to the extent permitted by applica-
ble statutes and regulations and in a manner 
that protects privacy consistent with applicable 
privacy statutes and regulations. 
‘‘(2) COORDINATION WITH THE NATIONAL IN-
STITUTES OF HEALTH.—Consistent with applicable 
privacy statutes and regulations, the Secretary may 
ensure that epidemiological and other types of infor-
mation obtained under subsection (a) is made avail-
able to the Director of the National Institutes of 
Health. 
‘‘(e) NATIONAL AND VOLUNTARY HEALTH ASSOCIA-
TIONS DEFINED.—In this section, the term ‘national and 
voluntary health associations’ means a national nonprofit 
organization with chapters or other affiliated organiza-
tions in States throughout the United States that have— 
‘‘(1) experience serving the population of indi-
viduals with valley fever; and 
‘‘(2) have demonstrated experience in valley 
fever research, care, and patient services.’’. 
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SEC. 7. DEFINITIONS. 
In this Act— 
(1) the term ‘‘eligible entity’’ means— 
(A) an academic institution; 
(B) a nonprofit organization; 
(C) a State or local government; and 
(D) a private entity; 
(2) the term ‘‘expert stakeholders’’ means aca-
demic institutions, advocacy groups, clinicians, pa-
tient groups, researchers, public health officials, sci-
entists, and vaccine manufactures with expertise in 
valley fever, vaccine development, or vaccine manu-
facturing; 
(3) the term ‘‘relevant agency heads’’ means— 
(A) the Director of the National Institutes 
of Health; 
(B) the Director of the Biomedical Ad-
vanced Research and Development Authority; 
(C) the Commissioner of Food and Drugs; 
and 
(D) such other heads of Federal agencies 
and departments as the Secretary determines 
relevant; 
(4) the term ‘‘Secretary’’ means the Secretary 
of Health and Human Services; 
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(5) the term ‘‘valley fever’’ means coccidioi-
domycosis; and 
(6) the term ‘‘Vaccine Coordinator’’ means the 
valley fever vaccine development coordinator ap-
pointed under section 2(a)(3). 
Æ 
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