[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 9942 Introduced in House (IH)]
<DOC>
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 Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Valley Fever Awareness 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 coordinate with the
relevant agency heads to support the development, licensing,
and initial manufacturing of a human vaccine for valley fever.
(2) Consultation.--In implementing paragraph (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 section, the Secretary
shall appoint a Vaccine Coordinator from among the
officials at the Food and Drug Administration or the
National Institutes 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 internet
website of the Department of Health and Human
Services a report that describes all of the
activities undertaken pursuant to this section;
(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 development,
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
requirements; and
(II) to advance the development,
licensing, and manufacturing of such a
vaccine.
(b) Valley Fever Vaccine Development National 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, license, and
manufacture a valley fever vaccine by no later than January 1,
2034.
(2) Content.--The national strategy shall contain--
(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 funding made
available over the 10 years preceding the date of the
enactment of this section to support valley fever
vaccine development, including pre-clinical and
clinical work, licensing, and manufacturing;
(D) identifiable and achievable benchmarks for
vaccine development and manufacturing, including a
timeline for valley fever vaccine development and
manufacturing consistent with the timeline in paragraph
(1);
(E) Federal, State, and local funding priorities
and opportunities that actively support the development
or manufacturing of a valley fever vaccine;
(F) recommendations for coordination between
Federal agencies and departments to reduce any overlap
with respect to valley fever vaccine development and
manufacturing reviews, permits, and licensing;
(G) recommendations on actions Federal agencies and
departments may take to expedite the development or
manufacturing of a valley fever vaccine that do not
require congressional authorization;
(H) recommendations on actions that Congress may
take to expedite the development and manufacturing of a
valley fever vaccine; and
(I) an assessment of--
(i) the prevalence of valley fever in the
United States;
(ii) the cost associated with treating
valley fever in the United States; and
(iii) the economic impact of valley fever
in the United States.
(3) Public comment.--
(A) In general.--Not later than six months after
the date of the enactment of this section, the
Secretary shall publish a proposed draft of the
national strategy in the Federal 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 pursuant 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 meetings with
the relevant agency heads and expert stakeholders, of
which one shall be conducted prior to receiving public
comments on the national 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 valley fever vaccine and approval for use of such
vaccine, as applicable.
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 entities
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 valley fever vaccine.
(B) Priority.--In awarding grants under
subparagraph (A), the Secretary shall give priority to
applicants that have commenced Phase 1, 2, or 3
clinical trials on a valley fever vaccine.
(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 Secretary shall commence
the program under paragraph (1).
(4) Consultation requirement.--In carrying out this
subsection, the Secretary shall consult with physicians,
medical providers, scientists, researchers, nonprofit entities,
advocacy groups, and other individuals with expertise in valley
fever research 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 entities 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.
(3) Commencement.--Not later than 180 days after the date
of the enactment of this section, the Secretary shall commence
the programs under paragraph (1).
(4) Consultation requirement.--In carrying out this
subsection, the Secretary shall consult with vaccine
manufacturing experts and other individuals with expertise in
valley fever research and vaccine manufacturing.
SEC. 5. AUTHORIZATION OF APPROPRIATIONS.
There are authorized to be appropriated to the Secretary--
(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.--
``(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-personally
identifiable voluntary data on coccidioidomycosis
(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).
``(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
Prevention, of which--
``(A) two-thirds of the members of the Advisory
Committee shall represent Federal agencies, 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 Institute of Allergy
and Infectious Diseases;
``(ii) one member representing the
Department of Defense;
``(iii) one member representing the Centers
for Disease Control and Prevention;
``(iv) one member who is a clinician with
expertise on valley fever and related diseases;
``(v) one member who is an epidemiologist
with experience in data registries;
``(vi) one member who is a statistician;
``(vii) one member who is an ethicist; and
``(viii) one member who is an expert in
privacy regulations under the Health Insurance
Portability and Accountability Act of 1996 (42
U.S.C. 1320d-6); and
``(B) one-third of the members of the Advisory
Committee shall be members of the public, including at
least--
``(i) one member representing national and
voluntary health associations;
``(ii) one member representing patients
with valley fever or their family members;
``(iii) one member representing clinicians
with expertise on valley fever and related
diseases;
``(iv) one member representing
epidemiologists with expertise in data
registries; and
``(v) one member representing individuals
with an interest in developing and maintaining
the National Valley Fever Registry.
``(3) Duties.--The Advisory Committee shall--
``(A) review information and make recommendations
to the Secretary concerning--
``(i) the development and maintenance of
the National Valley Fever Registry;
``(ii) the type of information to be
collected 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 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 National Valley Fever
Registry.
``(4) Report.--Not later than 270 days after the date on
which the Advisory Committee is established, 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 paragraph (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
collection, analysis, and reporting of data on valley fever and
other fungal diseases that can be confused with valley fever or
misdiagnosed as valley fever.
``(2) Commencement.--After receiving the report 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 National Valley
Fever Registry, the Secretary, acting through the Director of
the Centers for Disease Control and Prevention, may--
``(A) identify, build upon, expand, and coordinate
among existing data, surveys, registries, and other
Federal public health and environmental infrastructure
wherever possible, which may include--
``(i) any registry previously supported by
the Centers for Disease Control and Prevention;
``(ii) State-based valley fever registries;
``(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 information
on each fun