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[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 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 applicable statutes and regulations 
                and in a manner that protects privacy consistent with 
                applicable privacy statutes and regulations.
            ``(2) Coordination with the national institutes of 
        health.--Consistent with applicable privacy statutes and 
        regulations, the Secretary may ensure that epidemiological and 
        other types of information obtained under subsection (a) is 
        made available to the Director of the National Institutes of 
        Health.
    ``(e) National and Voluntary Health Associations Defined.--In this 
section, the term `national and voluntary health associations' means a 
national nonprofit organization with chapters or other affiliated 
organizations in States throughout the United States that have--
            ``(1) experience serving the population of individuals with 
        valley fever; and
            ``(2) have demonstrated experience in valley fever 
        research, care, and patient services.''.

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 academic 
        institutions, advocacy groups, clinicians, patient groups, 
        researchers, public health officials, scientists, and vaccine 
        manufactures with expertise in valley fever, vaccine 
        development, or vaccine manufacturing;
            (3) the term ``relevant agency heads'' means--
                    (A) the Director of the National Institutes of 
                Health;
                    (B) the Director of the Biomedical Advanced 
                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;
            (5) the term ``valley fever'' means coccidioidomycosis; and
            (6) the term ``Vaccine Coordinator'' means the valley fever 
        vaccine development coordinator appointed under section 
        2(a)(3).
                                 <all>
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