119-hr2767

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2767 Introduced in House

    (IH) ]

<DOC>

119th CONGRESS
 1st Session
 H. R. 2767

 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 HOUSE OF REPRESENTATIVES

 April 9, 2025

 Mr. Fitzpatrick (for himself, Mrs. Trahan, Mr. Joyce of Pennsylvania, 
 and Ms. Schrier) introduced the following bill; which was referred to 
 the Committee on Energy and Commerce

_______________________________________________________________________

 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 related cellular 
 immunotherapy (including CAR-T) team 
 science award.

Sec. 5. Cancer 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, and rare and recalcitrant cancer, 
 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 RELATED CELLULAR 
 IMMUNOTHERAPY (INCLUDING 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 RELATED CELLULAR IMMUNOTHERAPY (INCLUDING CAR-
 T) TEAM SCIENCE AWARD.

 ``

    (a) In General.--In order to take advantage of the significant 
advancement in the development of brain tumor related cellular 
immunotherapy, including chimeric antigen receptor-T (in this section 
referred to as `CAR-T'), 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 brain tumor related cancer cellular 
immunotherapy, including 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 brain tumor related cancer cellular immunotherapy, 
 including CAR-T.
 ``
            (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. CANCER 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. CANCER 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, including patients and caregivers, 
 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 cancer clinical trials 
 are;
 ``
            (II) the importance of clinical 
 trials in the treatment of cancer;
 ``
            (III) how to enroll in cancer 
 clinical trials;
 ``
            (IV) what cancer biomarker 
 testing is;
 ``
            (V) the importance of biomarker 
 testing in the diagnosis and treatment 
 of cancer; and
 ``
            (VI) how to access cancer 
 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 and brain tumor clinical trials and 
 biomarker testing. 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 and specialty 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, which may 
 include tools generated by artificial intelligence and 
 machine learning, to support the secure electronic 
 transfer of treatment information and care summaries 
 from brain tumor care providers to other health care 
 providers (including primary and specialty 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 and 
 specialty 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 and specialty 
 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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