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[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 1330 Introduced in Senate (IS)]
<DOC>
119th CONGRESS
1st Session
S. 1330
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
April 8, 2025
Mr. Blumenthal (for himself, Mr. Rounds, Mr. Reed, and Mr. Barrasso)
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 related cellular
immunotherapy.
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.
(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.
``(a) In General.--In order to take advantage of significant
advancement in the development of brain tumor related cellular
immunotherapy, including chimeric antigen receptor-T (CAR-T), which may
include 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.
<all>
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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