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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 4739 Introduced in Senate (IS)]

<DOC>

118th CONGRESS
  2d Session
                                S. 4739

  To advance research to achieve medical breakthroughs in brain tumor 
treatment and improve awareness and adequacy of specialized cancer and 
                           brain tumor care.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                             July 23, 2024

 Mr. Blumenthal (for himself, Mr. Reed, Mr. Barrasso, and Mr. Rounds) 
introduced the following bill; which was read twice and referred to the 
          Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL

 
  To advance research to achieve medical breakthroughs in brain tumor 
treatment and improve awareness and adequacy of specialized cancer and 
                           brain tumor care.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Bolstering 
Research And Innovation Now Act'' or the ``BRAIN Act''.
    (b) Table of Contents.--The table of contents of this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Findings; purposes.
Sec. 3. Fostering transparency of biospecimen collections for brain 
                            cancer research.
Sec. 4. Glioblastoma Therapeutics Network; brain tumor CAR-T team 
                            science award.
Sec. 5. Clinical trials and biomarker testing national public awareness 
                            campaign.
Sec. 6. Pilot programs to develop, study, or evaluate approaches to 
                            monitoring and caring for brain tumor 
                            survivors.
Sec. 7. FDA guidance to ensure brain tumor patient access to clinical 
                            trials.

SEC. 2. FINDINGS; PURPOSES.

    (a) Findings.--Congress finds as follows:
            (1) According to the National Brain Tumor Society based on 
        data analyzed in 2024, more than 1,000,000 people in the United 
        States are living with a brain tumor and approximately 94,000 
        were estimated to be diagnosed with a primary brain tumor in 
        2023.
            (2) Brain tumors do not discriminate and can affect people 
        of all races, genders, and ages. Tragically, pediatric brain 
        tumors are the leading cause of cancer-related death among 
        children and young adults ages 19 and younger.
            (3) For malignant brain tumors, incidence and survival 
        rates have remained stagnant for 45 years, with an average 5-
        year relative survival rate of 35.7 percent and only 6.9 
        percent for glioblastoma, the most common primary malignant 
        brain tumor.
            (4) Most primary brain tumors are non-malignant, but many 
        still require surgery and radiation. The results of available 
        treatment options can vary from a successful return to normal 
        life to possible disability or a life-threatening condition.
            (5) Despite the statistics described in paragraphs (1) 
        through (4), there have been very few treatments ever approved 
        by the Food and Drug Administration to treat brain tumors, 
        thereby resulting in little change in mortality rates for 
        individuals with brain tumors.
            (6) As of the date of enactment of this Act, there is no 
        prevention and no early detection protocol for brain tumors.
            (7) All people in the United States have a stake in 
        reducing and eliminating brain tumors.
            (8) Patients living with a brain tumor and their families 
        want cures. Short of cures, they want safe and effective ways 
        to increase survival rates for such patients and improve the 
        quality of life for such patients.
    (b) Purposes.--The purposes of this Act are to--
            (1) strengthen research and treatment development regarding 
        brain tumors; and
            (2) improve the adequacy and awareness of and access to 
        specialized brain tumor health care.

SEC. 3. FOSTERING TRANSPARENCY OF BIOSPECIMEN COLLECTIONS FOR BRAIN 
              CANCER 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:

``SEC. 404P. REPORTING OF BRAIN TUMOR BIOSPECIMEN COLLECTIONS.

    ``(a) Definition of Covered Biospecimen Collection.--
            ``(1) In general.--In this section, the term `covered 
        biospecimen collection' means a biospecimen that was collected 
        or acquired in whole or in part through funding from the 
        National Institutes of Health.
            ``(2) Biospecimen.--For purposes of paragraph (1), the term 
        `biospecimen' means a brain tumor tissue, cerebral spinal 
        fluid, or other specimen type listed by the Specimen Resource 
        Locator of the National Cancer Institute (or a successor 
        database).
    ``(b) Establishment.--The Secretary, acting through the Director of 
NIH, may establish and maintain a searchable website, or multiple 
websites, which may include websites existing on the day before the 
date of enactment of this section, for the purpose of making accessible 
to the public--
            ``(1) information on the existence and location of covered 
        biospecimen collections;
            ``(2) a description of such collections; and
            ``(3) contact information with respect to such collections.
    ``(c) Reporting Requirements.--
            ``(1) Existing collections.--Any individual or entity that 
        as of the date of enactment of this section maintains a covered 
        biospecimen collection shall, not later than 180 days after 
        such date of enactment, submit a report to the Director of NIH 
        containing information with respect to such covered biospecimen 
        collection as the Director of NIH may specify, including at a 
        minimum the information the National Cancer Institute requires 
        for the Specimen Resource Locator (or a successor database).
            ``(2) New collections.--Any individual or entity that 
        collects or acquires a covered biospecimen collection on or 
        after the date of enactment of this section shall, not later 
        than 60 days after the date of such collection or acquisition, 
        submit a report to the Director of NIH containing the 
        information required under paragraph (1).
    ``(d) Oversight.--The Secretary, acting through the Director of 
NIH, shall establish and carry out an oversight mechanism, which shall 
include withholding funding to individuals or entities that have 
committed a repeated or egregious violation of the requirements under 
subsection (c).''.

SEC. 4. GLIOBLASTOMA THERAPEUTICS NETWORK; BRAIN TUMOR CAR-T TEAM 
              SCIENCE AWARD.

    (a) In General.--Subpart 1 of part C of title IV of the Public 
Health Service Act (42 U.S.C. 285 et seq.) is amended by adding at the 
end the following:

``SEC. 417H. GLIOBLASTOMA THERAPEUTICS NETWORK.

    ``(a) In General.--The Director of the Institute shall carry out a 
research program, known as the `Glioblastoma Therapeutics Network', by 
awarding, on a competitive basis, cooperative agreements, or other 
awards, through the U19 funding mechanism of the National Institutes of 
Health for collaboration of institutions to improve the treatment of 
glioblastoma by evaluating therapeutic agents from pre-clinical 
development studies through completion of early-phase clinical trials 
in humans.
    ``(b) Authorization of Appropriations.--There is authorized to be 
appropriated $50,000,000 for each of fiscal years 2026 through 2030, to 
remain available until expended, to the Director of the Institute to 
carry out this section.

``SEC. 417I. BRAIN TUMOR CAR-T TEAM SCIENCE AWARD.

    ``(a) In General.--In order to take advantage of significant 
advancement in the development of chimeric antigen receptor-T (CAR-T) 
cell therapy approaches in cancer, including many such approaches 
previously funded by the National Institutes of Health, the Director of 
the Institute shall make awards, on a competitive basis, through a U 
series funding mechanism, to support the development of a multi-
institutional team science approach to using CAR-T treatment for adult 
and pediatric brain tumors.
    ``(b) Use of Funds.--Funds received through an award under this 
section shall be used--
            ``(1) to support collaborative multi-institutional research 
        activities, including pre-clinical and investigational new drug 
        studies; and
            ``(2) for the purpose of supporting clinical trials to 
        evaluate CAR-T therapeutic approaches to treating brain tumors.
    ``(c) Authorization of Appropriations.--There is authorized to be 
appropriated $10,000,000 for each of fiscal years 2026 through 2030, to 
remain available until expended, to the Director of the Institute to 
carry out this section.''.
    (b) Transition for the Glioblastoma Therapeutics Network.--The 
Director of the National Cancer Institute shall take such steps as may 
be necessary for the orderly transition from the Glioblastoma 
Therapeutics Network carried out by the Director, as of the day before 
the date of enactment of this Act, to the research program authorized 
under section 417H of the Public Health Service Act, as added by 
subsection (a). In making such transition, the Director shall ensure 
that the program authorized under such section 417H is based upon and 
consistent with the policies and procedures of the Glioblastoma 
Therapeutics Network carried out by the Director as of the day before 
the date of enactment of this Act.

SEC. 5. CLINICAL TRIALS AND BIOMARKER TESTING NATIONAL PUBLIC AWARENESS 
              CAMPAIGN.

    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. CLINICAL TRIALS AND BIOMARKER TESTING NATIONAL PUBLIC 
              AWARENESS CAMPAIGN.

    ``(a) National Campaign.--
            ``(1) In general.--The Secretary shall carry out a national 
        campaign to increase the awareness and knowledge of health care 
        providers and individuals with respect to the importance of 
        clinical trials in the treatment of cancer.
            ``(2) Activities.--
                    ``(A) In general.--Activities under such national 
                campaign shall include each of the following:
                            ``(i) Written materials.--Maintaining a 
                        supply of written and digital materials that 
                        provide information to the public on clinical 
                        trials, and distributing such materials to 
                        members of the public upon request.
                            ``(ii) Public service announcements; public 
                        engagement.--Providing public service 
                        announcements, in accordance with applicable 
                        law, including through publishing materials in 
                        digital or print form, and carrying out other 
                        public engagement initiatives. Such public 
                        service announcements and other public 
                        engagement initiatives shall include such 
                        announcements and initiatives intended to 
                        encourage individuals to discuss with their 
                        physicians--
                                    ``(I) what clinical trials are;
                                    ``(II) the importance of clinical 
                                trials in the treatment of cancer;
                                    ``(III) how to enroll in clinical 
                                trials;
                                    ``(IV) what biomarker testing is;
                                    ``(V) the importance of biomarker 
                                testing in the treatment of cancer; and
                                    ``(VI) how to access biomarker 
                                testing.
                    ``(B) Targeted populations.--The Secretary shall 
                ensure that the national campaign includes 
                communications, including public service announcements 
                and other public engagement initiatives under 
                subparagraph (A)(ii), that are--
                            ``(i) culturally and linguistically 
                        competent; and
                            ``(ii) targeted to--
                                    ``(I) specific populations that are 
                                at a higher risk of cancer, including 
                                such populations based on factors 
                                including race, ethnicity, level of 
                                acculturation, and family history;
                                    ``(II) rural communities; and
                                    ``(III) such other communities as 
                                the Secretary determines appropriate.
            ``(3) Consultation.--In carrying out the national campaign 
        under this subsection, the Secretary shall consult with--
                    ``(A) health care providers;
                    ``(B) nonprofit organizations;
                    ``(C) State and local public health departments; 
                and
                    ``(D) elementary and secondary schools and 
                institutions of higher education.
    ``(b) Demonstration Projects Regarding Outreach and Education 
Strategies for Cancer and Brain Tumor Patients.--
            ``(1) In general.--The Secretary shall carry out a program 
        to award grants or contracts to public or nonprofit private 
        entities for the purpose of carrying out demonstration projects 
        to test, compare, and evaluate different evidence-based 
        outreach and education strategies to increase the awareness and 
        knowledge of cancer, including brain tumor biomarker testing 
        and brain tumor clinical trials. Such projects shall focus on 
        the awareness and knowledge of patients (and the families of 
        patients), physicians, nurses, and other key health 
        professionals involved in brain tumor treatment.
            ``(2) Awards.--In making awards under paragraph (1), the 
        Secretary shall--
                    ``(A) ensure that information provided through 
                demonstration projects supported by such an award is 
                consistent with the best available medical information; 
                and
                    ``(B) give preference to--
                            ``(i) applicants with demonstrated 
                        expertise in--
                                    ``(I) biomarker testing and 
                                clinical trials in brain tumors and 
                                other recalcitrant cancers;
                                    ``(II) brain cancer and other 
                                recalcitrant cancer education or 
                                treatment;
                                    ``(III) working with groups of 
                                patients and caregivers; and
                                    ``(IV) reaching geographic areas 
                                that have historically low rates of 
                                participation in cancer clinical 
                                trials; and
                            ``(ii) applicants that demonstrate in their 
                        application submitted under paragraph (3) that 
                        the project for which they are seeking a grant 
                        or contract will involve and connect 
                        physicians, nurses, other key health 
                        professionals, health profession students, 
                        hospitals, and payers.
            ``(3) Applications.--To seek a grant or contract under this 
        subsection, an entity shall submit an application to the 
        Secretary in such form, in such manner, and containing such 
        agreements, assurances, and information as the Secretary may 
        reasonably require.
    ``(c) Authorization of Appropriations.--For the purpose of carrying 
out this section, there is authorized to be appropriated $10,000,000 
for the period of fiscal years 2026 through 2030.''.

SEC. 6. PILOT PROGRAMS TO DEVELOP, STUDY, OR EVALUATE APPROACHES TO 
              MONITORING AND CARING FOR BRAIN TUMOR SURVIVORS.

    Part B of title IV of the Public Health Service Act (42 U.S.C. 284 
et seq.) is amended by adding at the end the following:

``SEC. 409K. PILOT PROGRAMS TO DEVELOP, STUDY, OR EVALUATE APPROACHES 
              TO MONITORING AND CARING FOR BRAIN TUMOR SURVIVORS.

    ``(a) In General.--The Director of NIH may, as appropriate, make 
awards to eligible entities to establish pilot programs to develop, 
study, or evaluate approaches, including primary care, for monitoring 
and caring for adult and pediatric brain tumor survivors throughout 
their lifespan, including evaluating models for transition to post-
treatment care and care coordination.
    ``(b) Awards.--
            ``(1) Eligible entities.--
                    ``(A) In general.--For purposes of this section, an 
                eligible entity is--
                            ``(i) a medical school;
                            ``(ii) a children's hospital;
                            ``(iii) a cancer center;
                            ``(iv) a community-based medical facility; 
                        or
                            ``(v) any other entity with significant 
                        experience and expertise in carrying out the 
                        activities described in subsection (a).
                    ``(B) Types of entities.--Awards under this section 
                shall be made, to the extent practical, to--
                            ``(i) small, medium, and large-sized 
                        eligible entities; and
                            ``(ii) sites located in different 
                        geographic areas, including rural and urban 
                        areas.
            ``(2) Peer review.--In making awards under this section, 
        the Director of NIH shall comply with the peer review 
        requirements in section 492.
            ``(3) Use of funds.--Funds from awards under this section 
        may be used to develop, study, or evaluate one or more models 
        for monitoring and caring for brain tumor survivors, which may 
        include--
                    ``(A) evaluating follow-up care, educational 
                accommodations, monitoring, and other survivorship 
                programs (including peer support and mentoring 
                programs);
                    ``(B) developing and evaluating models for 
                providing multidisciplinary care;
                    ``(C) disseminating information to health care 
                providers about culturally and linguistically 
                appropriate follow-up care for brain tumor survivors 
                and their families, as appropriate and practicable;
                    ``(D) developing and evaluating existing 
                psychosocial evaluations, counseling, and support 
                programs to improve the quality of life of brain tumor 
                survivors and their families, which may include peer 
                support and mentoring programs;
                    ``(E) designing and evaluating tools to support the 
                secure electronic transfer of treatment information and 
                care summaries from brain tumor care providers to other 
                health care providers (including primary care 
                providers), which information and care summaries shall 
                include risk factors and a plan for recommended follow-
                up care;
                    ``(F) developing and evaluating initiatives that 
                promote the coordination and effective transition of 
                care between brain tumor care providers, primary care 
                providers, mental health professionals, and other 
                health care professionals, as appropriate, including 
                models that use a team-based or multi-disciplinary 
                approach to care; and
                    ``(G) disseminating information described in 
                subparagraphs (A) through (F), including with respect 
                to models, evaluations, programs, systems, and 
                initiatives described in such subparagraphs, to other 
                health care providers (including primary care 
                providers) and to pediatric brain tumor survivors and 
                their families, where appropriate and in accordance 
                with Federal and State law.
    ``(c) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section $5,000,000 for each of fiscal 
years 2026 through 2030.''.

SEC. 7. FDA GUIDANCE TO ENSURE BRAIN TUMOR PATIENT ACCESS TO CLINICAL 
              TRIALS.

    Not later than 1 year after the date of enactment of this Act, the 
Secretary of Health and Human Services, acting through the Commissioner 
of Food and Drugs, shall issue guidance to help identify ways to 
minimize the potential for the exclusion of brain tumor patients and 
patients with rare and recalcitrant cancers from clinical trials 
evaluating treatments for other indications.
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