II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Bolstering Research And Innovation Now Act’’ or the 

6 ‘‘BRAIN Act’’. 

7 (b) TABLE OF CONTENTS.—The table of contents of 

8 this Act is as follows: 

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 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. 

1 SEC. 2. FINDINGS; PURPOSES. 

2 (a) FINDINGS.—Congress finds as follows: 

3 (1) According to the National Brain Tumor So4 ciety based on data analyzed in 2024, more than 

5 1,000,000 people in the United States are living 

6 with a brain tumor and approximately 94,000 were 

7 estimated to be diagnosed with a primary brain 

8 tumor in 2023. 

9 (2) Brain tumors do not discriminate and can 

10 affect people of all races, genders, and ages. Trag11 ically, pediatric brain tumors are the leading cause 

12 of cancer-related death among children and young 

13 adults ages 19 and younger. 

14 (3) For malignant brain tumors, incidence and 

15 survival rates have remained stagnant for 45 years, 

16 with an average 5-year relative survival rate of 35.7 

17 percent and only 6.9 percent for glioblastoma, the 

18 most common primary malignant brain tumor. 

19 (4) Most primary brain tumors are non-malig20 nant, but many still require surgery and radiation. 


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1 The results of available treatment options can vary 

2 from a successful return to normal life to possible 

3 disability or a life-threatening condition. 

4 (5) Despite the statistics described in para5 graphs (1) through (4), there have been very few 

6 treatments ever approved by the Food and Drug Ad7 ministration to treat brain tumors, thereby resulting 

8 in little change in mortality rates for individuals 

9 with brain tumors. 

10 (6) As of the date of enactment of this Act, 

11 there is no prevention and no early detection pro12 tocol for brain tumors. 

13 (7) All people in the United States have a stake 

14 in reducing and eliminating brain tumors. 

15 (8) Patients living with a brain tumor and their 

16 families want cures. Short of cures, they want safe 

17 and effective ways to increase survival rates for such 

18 patients and improve the quality of life for such pa19 tients. 

20 (b) PURPOSES.—The purposes of this Act are to— 

21 (1) strengthen research and treatment develop22 ment regarding brain tumors; and 

23 (2) improve the adequacy and awareness of and 

24 access to specialized brain tumor health care. 


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1 SEC. 3. FOSTERING TRANSPARENCY OF BIOSPECIMEN COL2 LECTIONS FOR BRAIN CANCER RESEARCH. 

3 Part A of title IV of the Public Health Service Act 

4 (42 U.S.C. 281 et seq.) is amended by adding at the end 

5 the following: 

6 ‘‘SEC. 404P. REPORTING OF BRAIN TUMOR BIOSPECIMEN 

7 COLLECTIONS. 

8 ‘‘(a) DEFINITION OF COVERED BIOSPECIMEN COL9 LECTION.— 

10 ‘‘(1) IN GENERAL.—In this section, the term 

11 ‘covered biospecimen collection’ means a biospecimen 

12 that was collected or acquired in whole or in part 

13 through funding from the National Institutes of 

14 Health. 

15 ‘‘(2) BIOSPECIMEN.—For purposes of para16 graph (1), the term ‘biospecimen’ means a brain 

17 tumor tissue, cerebral spinal fluid, or other specimen 

18 type listed by the Specimen Resource Locator of the 

19 National Cancer Institute (or a successor database). 

20 ‘‘(b) ESTABLISHMENT.—The Secretary, acting 

21 through the Director of NIH, may establish and maintain 

22 a searchable website, or multiple websites, which may in23 clude websites existing on the day before the date of enact24 ment of this section, for the purpose of making accessible 

25 to the public— 


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1 ‘‘(1) information on the existence and location 

2 of covered biospecimen collections; 

3 ‘‘(2) a description of such collections; and 

4 ‘‘(3) contact information with respect to such 

5 collections. 

6 ‘‘(c) REPORTING REQUIREMENTS.— 

7 ‘‘(1) EXISTING COLLECTIONS.—Any individual 

8 or entity that as of the date of enactment of this 

9 section maintains a covered biospecimen collection 

10 shall, not later than 180 days after such date of en11 actment, submit a report to the Director of NIH 

12 containing information with respect to such covered 

13 biospecimen collection as the Director of NIH may 

14 specify, including at a minimum the information the 

15 National Cancer Institute requires for the Specimen 

16 Resource Locator (or a successor database). 

17 ‘‘(2) NEW COLLECTIONS.—Any individual or 

18 entity that collects or acquires a covered biospecimen 

19 collection on or after the date of enactment of this 

20 section shall, not later than 60 days after the date 

21 of such collection or acquisition, submit a report to 

22 the Director of NIH containing the information re23 quired under paragraph (1). 

24 ‘‘(d) OVERSIGHT.—The Secretary, acting through the 

25 Director of NIH, shall establish and carry out an oversight 


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1 mechanism, which shall include withholding funding to in2 dividuals or entities that have committed a repeated or 

3 egregious violation of the requirements under subsection 

4 (c).’’. 

5 SEC. 4. GLIOBLASTOMA THERAPEUTICS NETWORK; BRAIN 

6 TUMOR CAR-T TEAM SCIENCE AWARD. 

7 (a) IN GENERAL.—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) IN GENERAL.—The Director of the Institute 

12 shall carry out a research program, known as the ‘Glio13 blastoma Therapeutics Network’, by awarding, on a com14 petitive basis, cooperative agreements, or other awards, 

15 through the U19 funding mechanism of the National In16 stitutes of Health for collaboration of institutions to im17 prove the treatment of glioblastoma by evaluating thera18 peutic agents from pre-clinical development studies 

19 through completion of early-phase clinical trials in hu20 mans. 

21 ‘‘(b) AUTHORIZATION 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 expended, to the Director of the Institute to carry out this 

25 section. 


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

2 ‘‘(a) IN GENERAL.—In order to take advantage of 

3 significant advancement in the development of chimeric 

4 antigen receptor-T (CAR-T) cell therapy approaches in 

5 cancer, including many such approaches previously funded 

6 by the National Institutes of Health, the Director of the 

7 Institute shall make awards, on a competitive basis, 

8 through a U series funding mechanism, to support the de9 velopment of a multi-institutional team science approach 

10 to using CAR-T treatment for adult and pediatric brain 

11 tumors. 

12 ‘‘(b) USE OF FUNDS.—Funds received through an 

13 award under this section shall be used— 

14 ‘‘(1) to support collaborative multi-institutional 

15 research activities, including pre-clinical and inves16 tigational new drug studies; and 

17 ‘‘(2) for the purpose of supporting clinical trials 

18 to evaluate CAR-T therapeutic approaches to treat19 ing brain tumors. 

20 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—There 

21 is authorized to be appropriated $10,000,000 for each of 

22 fiscal years 2026 through 2030, to remain available until 

23 expended, to the Director of the Institute to carry out this 

24 section.’’. 

25 (b) TRANSITION FOR THE GLIOBLASTOMA THERA26 PEUTICS NETWORK.—The Director of the National CanVerDate Sep 11 2014 18:21 Aug 29, 2024 Jkt 049200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S4739.IS S4739

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1 cer Institute shall take such steps as may be necessary 

2 for the orderly transition from the Glioblastoma Thera3 peutics Network carried out by the Director, as of the day 

4 before the date of enactment of this Act, to the research 

5 program authorized under section 417H of the Public 

6 Health Service Act, as added by subsection (a). In making 

7 such transition, the Director shall ensure that the pro8 gram authorized under such section 417H is based upon 

9 and consistent with the policies and procedures of the 

10 Glioblastoma Therapeutics Network carried out by the Di11 rector as of the day before the date of enactment of this 

12 Act. 

13 SEC. 5. CLINICAL TRIALS AND BIOMARKER TESTING NA14 TIONAL PUBLIC AWARENESS CAMPAIGN. 

15 Part P of title III of the Public Health Service Act 

16 (42 U.S.C. 280g et seq.) is amended by adding at the end 

17 the following: 

18 ‘‘SEC. 399V–8. CLINICAL TRIALS AND BIOMARKER TESTING 

19 NATIONAL PUBLIC AWARENESS CAMPAIGN. 

20 ‘‘(a) NATIONAL CAMPAIGN.— 

21 ‘‘(1) IN GENERAL.—The Secretary shall carry 

22 out a national campaign to increase the awareness 

23 and knowledge of health care providers and individ24 uals with respect to the importance of clinical trials 

25 in the treatment of cancer. 


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1 ‘‘(2) ACTIVITIES.— 

2 ‘‘(A) IN GENERAL.—Activities under such 

3 national campaign shall include each of the fol4 lowing: 

5 ‘‘(i) WRITTEN MATERIALS.—Main6 taining a supply of written and digital ma7 terials that provide information to the pub8 lic on clinical trials, and distributing such 

9 materials to members of the public upon 

10 request. 

11 ‘‘(ii) PUBLIC SERVICE ANNOUNCE12 MENTS; PUBLIC ENGAGEMENT.—Providing 

13 public service announcements, in accord14 ance with applicable law, including through 

15 publishing materials in digital or print 

16 form, and carrying out other public en17 gagement initiatives. Such public service 

18 announcements and other public engage19 ment initiatives shall include such an20 nouncements and initiatives intended to 

21 encourage individuals to discuss with their 

22 physicians— 

23 ‘‘(I) what clinical trials are; 

24 ‘‘(II) the importance of clinical 

25 trials in the treatment of cancer; 


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1 ‘‘(III) how to enroll in clinical 

2 trials; 

3 ‘‘(IV) what biomarker testing is; 

4 ‘‘(V) the importance of biomarker 

5 testing in the treatment of cancer; 

6 and 

7 ‘‘(VI) how to access biomarker 

8 testing. 

9 ‘‘(B) TARGETED POPULATIONS.—The Sec10 retary shall ensure that the national campaign 

11 includes communications, including public serv12 ice announcements and other public engage13 ment initiatives under subparagraph (A)(ii), 

14 that are— 

15 ‘‘(i) culturally and linguistically com16 petent; and 

17 ‘‘(ii) targeted to— 

18 ‘‘(I) specific populations that are 

19 at a higher risk of cancer, including 

20 such populations based on factors in21 cluding race, ethnicity, level of accul22 turation, and family history; 

23 ‘‘(II) rural communities; and 

24 ‘‘(III) such other communities as 

25 the Secretary determines appropriate. 


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1 ‘‘(3) CONSULTATION.—In carrying out the na2 tional campaign under this subsection, the Secretary 

3 shall consult with— 

4 ‘‘(A) health care providers; 

5 ‘‘(B) nonprofit organizations; 

6 ‘‘(C) State and local public health depart7 ments; and 

8 ‘‘(D) elementary and secondary schools 

9 and institutions of higher education. 

10 ‘‘(b) DEMONSTRATION PROJECTS REGARDING OUT11 REACH AND EDUCATION STRATEGIES FOR CANCER AND

12 BRAIN TUMOR PATIENTS.— 

13 ‘‘(1) IN GENERAL.—The Secretary shall carry 

14 out a program to award grants or contracts to pub15 lic or nonprofit private entities for the purpose of 

16 carrying out demonstration projects to test, com17 pare, and evaluate different evidence-based outreach 

18 and education strategies to increase the awareness 

19 and knowledge of cancer, including brain tumor bio20 marker testing and brain tumor clinical trials. Such 

21 projects shall focus on the awareness and knowledge 

22 of patients (and the families of patients), physicians, 

23 nurses, and other key health professionals involved 

24 in brain tumor treatment. 


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1 ‘‘(2) AWARDS.—In making awards under para2 graph (1), the Secretary shall— 

3 ‘‘(A) ensure that information provided 

4 through demonstration projects supported by 

5 such an award is consistent with the best avail6 able medical information; and 

7 ‘‘(B) give preference to— 

8 ‘‘(i) applicants with demonstrated ex9 pertise in— 

10 ‘‘(I) biomarker testing and clin11 ical trials in brain tumors and other 

12 recalcitrant cancers; 

13 ‘‘(II) brain cancer and other re14 calcitrant cancer education or treat15 ment; 

16 ‘‘(III) working with groups of pa17 tients and caregivers; and 

18 ‘‘(IV) reaching geographic areas 

19 that have historically low rates of par20 ticipation in cancer clinical trials; and 

21 ‘‘(ii) applicants that demonstrate in 

22 their application submitted under para23 graph (3) that the project for which they 

24 are seeking a grant or contract will involve 

25 and connect physicians, nurses, other key 


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1 health professionals, health profession stu2 dents, hospitals, and payers. 

3 ‘‘(3) APPLICATIONS.—To seek a grant or con4 tract under this subsection, an entity shall submit 

5 an application to the Secretary in such form, in such 

6 manner, and containing such agreements, assur7 ances, and information as the Secretary may reason8 ably require. 

9 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—For the 

10 purpose of carrying out this section, there is authorized 

11 to be appropriated $10,000,000 for the period of fiscal 

12 years 2026 through 2030.’’. 

13 SEC. 6. PILOT PROGRAMS TO DEVELOP, STUDY, OR EVALU14 ATE APPROACHES TO MONITORING AND CAR15 ING FOR BRAIN TUMOR SURVIVORS. 

16 Part B of title IV of the Public Health Service Act 

17 (42 U.S.C. 284 et seq.) is amended by adding at the end 

18 the following: 

19 ‘‘SEC. 409K. PILOT PROGRAMS TO DEVELOP, STUDY, OR 

20 EVALUATE APPROACHES TO MONITORING 

21 AND CARING FOR BRAIN TUMOR SURVIVORS. 

22 ‘‘(a) IN GENERAL.—The Director of NIH may, as 

23 appropriate, make awards to eligible entities to establish 

24 pilot programs to develop, study, or evaluate approaches, 

25 including primary care, for monitoring and caring for 


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1 adult and pediatric brain tumor survivors throughout their 

2 lifespan, including evaluating models for transition to 

3 post-treatment care and care coordination. 

4 ‘‘(b) AWARDS.— 

5 ‘‘(1) ELIGIBLE ENTITIES.— 

6 ‘‘(A) IN GENERAL.—For purposes of this 

7 section, an eligible entity is— 

8 ‘‘(i) a medical school; 

9 ‘‘(ii) a children’s hospital; 

10 ‘‘(iii) a cancer center; 

11 ‘‘(iv) a community-based medical facil12 ity; or 

13 ‘‘(v) any other entity with significant 

14 experience and expertise in carrying out 

15 the activities described in subsection (a). 

16 ‘‘(B) TYPES OF ENTITIES.—Awards under 

17 this section shall be made, to the extent prac18 tical, to— 

19 ‘‘(i) small, medium, and large-sized el20 igible entities; and 

21 ‘‘(ii) sites located in different geo22 graphic areas, including rural and urban 

23 areas. 


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1 ‘‘(2) PEER REVIEW.—In making awards under 

2 this section, the Director of NIH shall comply with 

3 the peer review requirements in section 492. 

4 ‘‘(3) USE OF FUNDS.—Funds from awards 

5 under this section may be used to develop, study, or 

6 evaluate one or more models for monitoring and car7 ing for brain tumor survivors, which may include— 

8 ‘‘(A) evaluating follow-up care, educational 

9 accommodations, monitoring, and other survi10 vorship programs (including peer support and 

11 mentoring programs); 

12 ‘‘(B) developing and evaluating models for 

13 providing multidisciplinary care; 

14 ‘‘(C) disseminating information to health 

15 care providers about culturally and linguistically 

16 appropriate follow-up care for brain tumor sur17 vivors and their families, as appropriate and 

18 practicable; 

19 ‘‘(D) developing and evaluating existing 

20 psychosocial evaluations, counseling, and sup21 port programs to improve the quality of life of 

22 brain tumor survivors and their families, which 

23 may include peer support and mentoring pro24 grams; 


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1 ‘‘(E) designing and evaluating tools to sup2 port the secure electronic transfer of treatment 

3 information and care summaries from brain 

4 tumor care providers to other health care pro5 viders (including primary care providers), which 

6 information and care summaries shall include 

7 risk factors and a plan for recommended follow8 up care; 

9 ‘‘(F) developing and evaluating initiatives 

10 that promote the coordination and effective 

11 transition of care between brain tumor care 

12 providers, primary care providers, mental health 

13 professionals, and other health care profes14 sionals, as appropriate, including models that 

15 use a team-based or multi-disciplinary approach 

16 to care; and 

17 ‘‘(G) disseminating information described 

18 in subparagraphs (A) through (F), including 

19 with respect to models, evaluations, programs, 

20 systems, and initiatives described in such sub21 paragraphs, to other health care providers (in22 cluding primary care providers) and to pediatric 

23 brain tumor survivors and their families, where 

24 appropriate and in accordance with Federal and 

25 State law. 


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1 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—There 

2 are authorized to be appropriated to carry out this section 

3 $5,000,000 for each of fiscal years 2026 through 2030.’’. 

4 SEC. 7. FDA GUIDANCE TO ENSURE BRAIN TUMOR PATIENT 

5 ACCESS TO CLINICAL TRIALS. 

6 Not later than 1 year after the date of enactment 

7 of this Act, the Secretary of Health and Human Services, 

8 acting through the Commissioner of Food and Drugs, 

9 shall issue guidance to help identify ways to minimize the 

10 potential for the exclusion of brain tumor patients and pa11 tients with rare and recalcitrant cancers from clinical 

12 trials evaluating treatments for other indications. 

Æ 


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