II
119THCONGRESS
1
STSESSION S. 1330
To advance research to achieve medical breakthroughs in brain tumor treat-
ment and improve awareness and adequacy of specialized cancer and
brain tumor care.
IN THE SENATE OF THE UNITED STATES
APRIL8, 2025
Mr. B
LUMENTHAL(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 ade-
quacy of specialized cancer and brain tumor care.
Be it enacted by the Senate and House of Representa-1
tives of the United States of America in Congress assembled, 2
SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 3
(a) S
HORTTITLE.—This Act may be cited as the 4
‘‘Bolstering Research And Innovation Now Act’’ or the 5
‘‘BRAIN Act’’. 6
(b) T
ABLE OFCONTENTS.—The table of contents of 7
this Act is as follows: 8
Sec. 1. Short title; table of contents.
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Sec. 2. Findings; purposes.
Sec. 3. Fostering transparency of biospecimen collections for brain cancer re-
search.
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.
1
(a) F
INDINGS.—Congress finds as follows: 2
(1) According to the National Brain Tumor So-3
ciety, based on data analyzed in 2024, more than 4
1,000,000 people in the United States are living 5
with a brain tumor and approximately 94,000 were 6
estimated to be diagnosed with a primary brain 7
tumor in 2023. 8
(2) Brain tumors do not discriminate and can 9
affect people of all races, genders, and ages. Trag-10
ically, pediatric brain tumors are the leading cause 11
of cancer-related death among children and young 12
adults ages 19 and younger. 13
(3) For malignant brain tumors, incidence and 14
survival rates have remained stagnant for 45 years, 15
with an average 5-year relative survival rate of 35.7 16
percent and only 6.9 percent for glioblastoma, the 17
most common primary malignant brain tumor. 18
(4) Most primary brain tumors are non-malig-19
nant, but many still require surgery and radiation. 20
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The results of available treatment options can vary 1
from a successful return to normal life to possible 2
disability or a life-threatening condition. 3
(5) Despite the statistics described in para-4
graphs (1) through (4), there have been very few 5
treatments ever approved by the Food and Drug Ad-6
ministration to treat brain tumors, thereby resulting 7
in little change in mortality rates for individuals 8
with brain tumors. 9
(6) As of the date of enactment of this Act, 10
there is no prevention and no early detection pro-11
tocol for brain tumors. 12
(7) All people in the United States have a stake 13
in reducing and eliminating brain tumors. 14
(8) Patients living with a brain tumor and their 15
families want cures. Short of cures, they want safe 16
and effective ways to increase survival rates for such 17
patients and improve the quality of life for such pa-18
tients. 19
(b) P
URPOSES.—The purposes of this Act are to— 20
(1) strengthen research and treatment develop-21
ment regarding brain tumors; and 22
(2) improve the adequacy and awareness of and 23
access to specialized brain tumor and rare and recal-24
citrant cancer health care. 25
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SEC. 3. FOSTERING TRANSPARENCY OF BIOSPECIMEN COL-1
LECTIONS FOR BRAIN CANCER RESEARCH. 2
Part A of title IV of the Public Health Service Act 3
(42 U.S.C. 281 et seq.) is amended by adding at the end 4
the following: 5
‘‘SEC. 404P. REPORTING OF BRAIN TUMOR BIOSPECIMEN 6
COLLECTIONS. 7
‘‘(a) D
EFINITION OFCOVEREDBIOSPECIMENCOL-8
LECTION.— 9
‘‘(1) I
N GENERAL.—In this section, the term 10
‘covered biospecimen collection’ means a biospecimen 11
that was collected or acquired in whole or in part 12
through funding from the National Institutes of 13
Health. 14
‘‘(2) B
IOSPECIMEN.—For purposes of para-15
graph (1), the term ‘biospecimen’ means a brain 16
tumor tissue, cerebral spinal fluid, or other specimen 17
type listed by the Specimen Resource Locator of the 18
National Cancer Institute (or a successor database). 19
‘‘(b) E
STABLISHMENT.—The Secretary, acting 20
through the Director of NIH, may establish and maintain 21
a searchable website, or multiple websites, which may in-22
clude websites existing on the day before the date of enact-23
ment of this section, for the purpose of making accessible 24
to the public— 25
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‘‘(1) information on the existence and location 1
of covered biospecimen collections; 2
‘‘(2) a description of such collections; and 3
‘‘(3) contact information with respect to such 4
collections. 5
‘‘(c) R
EPORTINGREQUIREMENTS.— 6
‘‘(1) E
XISTING COLLECTIONS.—Any individual 7
or entity that as of the date of enactment of this 8
section maintains a covered biospecimen collection 9
shall, not later than 180 days after such date of en-10
actment, submit a report to the Director of NIH 11
containing information with respect to such covered 12
biospecimen collection as the Director of NIH may 13
specify, including at a minimum the information the 14
National Cancer Institute requires for the Specimen 15
Resource Locator (or a successor database). 16
‘‘(2) N
EW COLLECTIONS .—Any individual or 17
entity that collects or acquires a covered biospecimen 18
collection on or after the date of enactment of this 19
section shall, not later than 60 days after the date 20
of such collection or acquisition, submit a report to 21
the Director of NIH containing the information re-22
quired under paragraph (1). 23
‘‘(d) O
VERSIGHT.—The Secretary, acting through the 24
Director of NIH, shall establish and carry out an oversight 25
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mechanism, which shall include withholding funding to in-1
dividuals or entities that have committed a repeated or 2
egregious violation of the requirements under subsection 3
(c).’’. 4
SEC. 4. GLIOBLASTOMA THERAPEUTICS NETWORK; BRAIN 5
TUMOR RELATED CELLULAR 6
IMMUNOTHERAPY. 7
(a) I
NGENERAL.—Subpart 1 of part C of title IV 8
of the Public Health Service Act (42 U.S.C. 285 et seq.) 9
is amended by adding at the end the following: 10
‘‘SEC. 417H. GLIOBLASTOMA THERAPEUTICS NETWORK. 11
‘‘(a) I
NGENERAL.—The Director of the Institute 12
shall carry out a research program, known as the ‘Glio-13
blastoma Therapeutics Network’, by awarding, on a com-14
petitive basis, cooperative agreements, or other awards, 15
through the U19 funding mechanism of the National In-16
stitutes of Health for collaboration of institutions to im-17
prove the treatment of glioblastoma by evaluating thera-18
peutic agents from pre-clinical development studies 19
through completion of early-phase clinical trials in hu-20
mans. 21
‘‘(b) A
UTHORIZATION OF APPROPRIATIONS.—There 22
is authorized to be appropriated $50,000,000 for each of 23
fiscal years 2026 through 2030, to remain available until 24
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expended, to the Director of the Institute to carry out this 1
section. 2
‘‘SEC. 417I. BRAIN TUMOR RELATED CELLULAR 3
IMMUNOTHERAPY. 4
‘‘(a) I
NGENERAL.—In order to take advantage of 5
significant advancement in the development of brain 6
tumor related cellular immunotherapy, including chimeric 7
antigen receptor-T (CAR-T), which may include ap-8
proaches previously funded by the National Institutes of 9
Health, the Director of the Institute shall make awards, 10
on a competitive basis, through a U series funding mecha-11
nism, to support the development of a multi-institutional 12
team science approach to using brain tumor related cancer 13
cellular immunotherapy, including CAR-T treatment, for 14
adult and pediatric brain tumors. 15
‘‘(b) U
SE OFFUNDS.—Funds received through an 16
award under this section shall be used— 17
‘‘(1) to support collaborative multi-institutional 18
research activities, including pre-clinical and inves-19
tigational new drug studies; and 20
‘‘(2) for the purpose of supporting clinical trials 21
to evaluate brain tumor related cancer cellular 22
immunotherapy, including CAR-T. 23
‘‘(c) A
UTHORIZATION OF APPROPRIATIONS.—There 24
is authorized to be appropriated $10,000,000 for each of 25
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fiscal years 2026 through 2030, to remain available until 1
expended, to the Director of the Institute to carry out this 2
section.’’. 3
(b) T
RANSITION FOR THE GLIOBLASTOMATHERA-4
PEUTICSNETWORK.—The Director of the National Can-5
cer Institute shall take such steps as may be necessary 6
for the orderly transition from the Glioblastoma Thera-7
peutics Network carried out by the Director, as of the day 8
before the date of enactment of this Act, to the research 9
program authorized under section 417H of the Public 10
Health Service Act, as added by subsection (a). In making 11
such transition, the Director shall ensure that the pro-12
gram authorized under such section 417H is based upon 13
and consistent with the policies and procedures of the 14
Glioblastoma Therapeutics Network carried out by the Di-15
rector as of the day before the date of enactment of this 16
Act. 17
SEC. 5. CANCER CLINICAL TRIALS AND BIOMARKER TEST-18
ING NATIONAL PUBLIC AWARENESS CAM-19
PAIGN. 20
Part P of title III of the Public Health Service Act 21
(42 U.S.C. 280g et seq.) is amended by adding at the end 22
the following: 23
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‘‘SEC. 399V–8. CANCER CLINICAL TRIALS AND BIOMARKER 1
TESTING NATIONAL PUBLIC AWARENESS 2
CAMPAIGN. 3
‘‘(a) N
ATIONALCAMPAIGN.— 4
‘‘(1) I
N GENERAL.—The Secretary shall carry 5
out a national campaign to increase the awareness 6
and knowledge of health care providers and individ-7
uals, including patients and caregivers, with respect 8
to the importance of clinical trials in the treatment 9
of cancer. 10
‘‘(2) A
CTIVITIES.— 11
‘‘(A) I
N GENERAL.—Activities under such 12
national campaign shall include each of the fol-13
lowing: 14
‘‘(i) W
RITTEN MATERIALS .—Main-15
taining a supply of written and digital ma-16
terials that provide information to the pub-17
lic on clinical trials, and distributing such 18
materials to members of the public upon 19
request. 20
‘‘(ii) P
UBLIC SERVICE ANNOUNCE -21
MENTS; PUBLIC ENGAGEMENT .—Providing 22
public service announcements, in accord-23
ance with applicable law, including through 24
publishing materials in digital or print 25
form, and carrying out other public en-26
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gagement initiatives. Such public service 1
announcements and other public engage-2
ment initiatives shall include such an-3
nouncements and initiatives intended to 4
encourage individuals to discuss with their 5
physicians— 6
‘‘(I) what cancer clinical trials 7
are; 8
‘‘(II) the importance of clinical 9
trials in the treatment of cancer; 10
‘‘(III) how to enroll in cancer 11
clinical trials; 12
‘‘(IV) what cancer biomarker 13
testing is; 14
‘‘(V) the importance of biomarker 15
testing in the diagnosis and treatment 16
of cancer; and 17
‘‘(VI) how to access cancer bio-18
marker testing. 19
‘‘(B) T
ARGETED POPULATIONS .—The Sec-20
retary shall ensure that the national campaign 21
includes communications, including public serv-22
ice announcements and other public engage-23
ment initiatives under subparagraph (A)(ii), 24
that are— 25
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‘‘(i) culturally and linguistically com-1
petent; and 2
‘‘(ii) targeted to— 3
‘‘(I) specific populations that are 4
at a higher risk of cancer, including 5
such populations based on factors in-6
cluding race, ethnicity, level of accul-7
turation, and family history; 8
‘‘(II) rural communities; and 9
‘‘(III) such other communities as 10
the Secretary determines appropriate. 11
‘‘(3) C
ONSULTATION.—In carrying out the na-12
tional campaign under this subsection, the Secretary 13
shall consult with— 14
‘‘(A) health care providers; 15
‘‘(B) nonprofit organizations; 16
‘‘(C) State and local public health depart-17
ments; and 18
‘‘(D) elementary and secondary schools 19
and institutions of higher education. 20
‘‘(b) D
EMONSTRATION PROJECTSREGARDINGOUT-21
REACH ANDEDUCATIONSTRATEGIES FORCANCER AND 22
B
RAINTUMORPATIENTS.— 23
‘‘(1) I
N GENERAL.—The Secretary shall carry 24
out a program to award grants or contracts to pub-25
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lic or nonprofit private entities for the purpose of 1
carrying out demonstration projects to test, com-2
pare, and evaluate different evidence-based outreach 3
and education strategies to increase the awareness 4
and knowledge of cancer and brain tumor clinical 5
trials and biomarker testing. Such projects shall 6
focus on the awareness and knowledge of patients 7
(and the families of patients), physicians, nurses, 8
and other key health professionals involved in brain 9
tumor treatment. 10
‘‘(2) A
WARDS.—In making awards under para-11
graph (1), the Secretary shall— 12
‘‘(A) ensure that information provided 13
through demonstration projects supported by 14
such an award is consistent with the best avail-15
able medical information; and 16
‘‘(B) give preference to— 17
‘‘(i) applicants with demonstrated ex-18
pertise in— 19
‘‘(I) biomarker testing and clin-20
ical trials in brain tumors and other 21
recalcitrant cancers; 22
‘‘(II) brain cancer and other re-23
calcitrant cancer education or treat-24
ment; 25
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‘‘(III) working with groups of pa-1
tients and caregivers; and 2
‘‘(IV) reaching geographic areas 3
that have historically low rates of par-4
ticipation in cancer clinical trials; and 5
‘‘(ii) applicants that demonstrate in 6
their application submitted under para-7
graph (3) that the project for which they 8
are seeking a grant or contract will involve 9
and connect physicians, nurses, other key 10
health professionals, health profession stu-11
dents, hospitals, and payers. 12
‘‘(3) A
PPLICATIONS.—To seek a grant or con-13
tract under this subsection, an entity shall submit 14
an application to the Secretary in such form, in such 15
manner, and containing such agreements, assur-16
ances, and information as the Secretary may reason-17
ably require. 18
‘‘(c) A
UTHORIZATION OFAPPROPRIATIONS.—For the 19
purpose of carrying out this section, there is authorized 20
to be appropriated $10,000,000 for the period of fiscal 21
years 2026 through 2030.’’. 22
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SEC. 6. PILOT PROGRAMS TO DEVELOP, STUDY, OR EVALU-1
ATE APPROACHES TO MONITORING AND CAR-2
ING FOR BRAIN TUMOR SURVIVORS. 3
Part B of title IV of the Public Health Service Act 4
(42 U.S.C. 284 et seq.) is amended by adding at the end 5
the following: 6
‘‘SEC. 409K. PILOT PROGRAMS TO DEVELOP, STUDY, OR 7
EVALUATE APPROACHES TO MONITORING 8
AND CARING FOR BRAIN TUMOR SURVIVORS. 9
‘‘(a) I
NGENERAL.—The Director of NIH may, as 10
appropriate, make awards to eligible entities to establish 11
pilot programs to develop, study, or evaluate approaches, 12
including primary and specialty care, for monitoring and 13
caring for adult and pediatric brain tumor survivors 14
throughout their lifespan, including evaluating models for 15
transition to post-treatment care and care coordination. 16
‘‘(b) A
WARDS.— 17
‘‘(1) E
LIGIBLE ENTITIES.— 18
‘‘(A) I
N GENERAL.—For purposes of this 19
section, an eligible entity is— 20
‘‘(i) a medical school; 21
‘‘(ii) a children’s hospital; 22
‘‘(iii) a cancer center; 23
‘‘(iv) a community-based medical facil-24
ity; or 25
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‘‘(v) any other entity with significant 1
experience and expertise in carrying out 2
the activities described in subsection (a). 3
‘‘(B) T
YPES OF ENTITIES.—Awards under 4
this section shall be made, to the extent prac-5
tical, to— 6
‘‘(i) small, medium, and large-sized el-7
igible entities; and 8
‘‘(ii) sites located in different geo-9
graphic areas, including rural and urban 10
areas. 11
‘‘(2) P
EER REVIEW.—In making awards under 12
this section, the Director of NIH shall comply with 13
the peer review requirements in section 492. 14
‘‘(3) U
SE OF FUNDS .—Funds from awards 15
under this section may be used to develop, study, or 16
evaluate one or more models for monitoring and car-17
ing for brain tumor survivors, which may include— 18
‘‘(A) evaluating follow-up care, educational 19
accommodations, monitoring, and other survi-20
vorship programs (including peer support and 21
mentoring programs); 22
‘‘(B) developing and evaluating models for 23
providing multidisciplinary care; 24
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‘‘(C) disseminating information to health 1
care providers about culturally and linguistically 2
appropriate follow-up care for brain tumor sur-3
vivors and their families, as appropriate and 4
practicable; 5
‘‘(D) developing and evaluating existing 6
psychosocial evaluations, counseling, and sup-7
port programs to improve the quality of life of 8
brain tumor survivors and their families, which 9
may include peer support and mentoring pro-10
grams; 11
‘‘(E) designing and evaluating tools, which 12
may include tools generated by artificial intel-13
ligence and machine learning, to support the se-14
cure electronic transfer of treatment informa-15
tion and care summaries from brain tumor care 16
providers to other health care providers (includ-17
ing primary and specialty care providers), which 18
information and care summaries shall include 19
risk factors and a plan for recommended follow- 20
up care; 21
‘‘(F) developing and evaluating initiatives 22
that promote the coordination and effective 23
transition of care between brain tumor care 24
providers, primary and specialty care providers, 25
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mental health professionals, and other health 1
care professionals, as appropriate, including 2
models that use a team-based or multi-discipli-3
nary approach to care; and 4
‘‘(G) disseminating information described 5
in subparagraphs (A) through (F), including 6
with respect to models, evaluations, programs, 7
systems, and initiatives described in such sub-8
paragraphs, to other health care providers (in-9
cluding primary and specialty care providers) 10
and to pediatric brain tumor survivors and their 11
families, where appropriate and in accordance 12
with Federal and State law. 13
‘‘(c) A
UTHORIZATION OF APPROPRIATIONS.—There 14
are authorized to be appropriated to carry out this section 15
$5,000,000 for each of fiscal years 2026 through 2030.’’. 16
SEC. 7. FDA GUIDANCE TO ENSURE BRAIN TUMOR PATIENT 17
ACCESS TO CLINICAL TRIALS. 18
Not later than 1 year after the date of enactment 19
of this Act, the Secretary of Health and Human Services, 20
acting through the Commissioner of Food and Drugs, 21
shall issue guidance to help identify ways to minimize the 22
potential for the exclusion of brain tumor patients and pa-23
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tients with rare and recalcitrant cancers from clinical 1
trials evaluating treatments for other indications. 2
Æ
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