| 1 | 1 | | II |
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| 2 | 2 | | 119THCONGRESS |
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| 3 | 3 | | 1 |
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| 4 | 4 | | STSESSION S. 1330 |
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| 5 | 5 | | To advance research to achieve medical breakthroughs in brain tumor treat- |
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| 6 | 6 | | ment and improve awareness and adequacy of specialized cancer and |
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| 7 | 7 | | brain tumor care. |
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| 8 | 8 | | IN THE SENATE OF THE UNITED STATES |
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| 9 | 9 | | APRIL8, 2025 |
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| 10 | 10 | | Mr. B |
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| 11 | 11 | | LUMENTHAL(for himself, Mr. ROUNDS, Mr. REED, and Mr. BARRASSO) |
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| 12 | 12 | | introduced the following bill; which was read twice and referred to the |
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| 13 | 13 | | Committee on Health, Education, Labor, and Pensions |
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| 14 | 14 | | A BILL |
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| 15 | 15 | | To advance research to achieve medical breakthroughs in |
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| 16 | 16 | | brain tumor treatment and improve awareness and ade- |
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| 17 | 17 | | quacy of specialized cancer and brain tumor care. |
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| 18 | 18 | | Be it enacted by the Senate and House of Representa-1 |
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| 19 | 19 | | tives of the United States of America in Congress assembled, 2 |
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| 20 | 20 | | SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 3 |
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| 21 | 21 | | (a) S |
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| 22 | 22 | | HORTTITLE.—This Act may be cited as the 4 |
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| 23 | 23 | | ‘‘Bolstering Research And Innovation Now Act’’ or the 5 |
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| 24 | 24 | | ‘‘BRAIN Act’’. 6 |
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| 25 | 25 | | (b) T |
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| 26 | 26 | | ABLE OFCONTENTS.—The table of contents of 7 |
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| 27 | 27 | | this Act is as follows: 8 |
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| 28 | 28 | | Sec. 1. Short title; table of contents. |
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| 32 | 32 | | Sec. 2. Findings; purposes. |
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| 33 | 33 | | Sec. 3. Fostering transparency of biospecimen collections for brain cancer re- |
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| 34 | 34 | | search. |
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| 35 | 35 | | Sec. 4. Glioblastoma Therapeutics Network; brain tumor related cellular |
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| 36 | 36 | | immunotherapy. |
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| 37 | 37 | | Sec. 5. Cancer clinical trials and biomarker testing national public awareness |
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| 38 | 38 | | campaign. |
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| 39 | 39 | | Sec. 6. Pilot programs to develop, study, or evaluate approaches to monitoring |
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| 40 | 40 | | and caring for brain tumor survivors. |
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| 41 | 41 | | Sec. 7. FDA guidance to ensure brain tumor patient access to clinical trials. |
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| 42 | 42 | | SEC. 2. FINDINGS; PURPOSES. |
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| 43 | 43 | | 1 |
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| 44 | 44 | | (a) F |
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| 45 | 45 | | INDINGS.—Congress finds as follows: 2 |
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| 46 | 46 | | (1) According to the National Brain Tumor So-3 |
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| 47 | 47 | | ciety, based on data analyzed in 2024, more than 4 |
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| 48 | 48 | | 1,000,000 people in the United States are living 5 |
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| 49 | 49 | | with a brain tumor and approximately 94,000 were 6 |
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| 50 | 50 | | estimated to be diagnosed with a primary brain 7 |
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| 51 | 51 | | tumor in 2023. 8 |
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| 52 | 52 | | (2) Brain tumors do not discriminate and can 9 |
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| 53 | 53 | | affect people of all races, genders, and ages. Trag-10 |
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| 54 | 54 | | ically, pediatric brain tumors are the leading cause 11 |
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| 55 | 55 | | of cancer-related death among children and young 12 |
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| 56 | 56 | | adults ages 19 and younger. 13 |
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| 57 | 57 | | (3) For malignant brain tumors, incidence and 14 |
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| 58 | 58 | | survival rates have remained stagnant for 45 years, 15 |
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| 59 | 59 | | with an average 5-year relative survival rate of 35.7 16 |
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| 60 | 60 | | percent and only 6.9 percent for glioblastoma, the 17 |
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| 61 | 61 | | most common primary malignant brain tumor. 18 |
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| 62 | 62 | | (4) Most primary brain tumors are non-malig-19 |
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| 63 | 63 | | nant, but many still require surgery and radiation. 20 |
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| 67 | 67 | | The results of available treatment options can vary 1 |
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| 68 | 68 | | from a successful return to normal life to possible 2 |
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| 69 | 69 | | disability or a life-threatening condition. 3 |
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| 70 | 70 | | (5) Despite the statistics described in para-4 |
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| 71 | 71 | | graphs (1) through (4), there have been very few 5 |
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| 72 | 72 | | treatments ever approved by the Food and Drug Ad-6 |
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| 73 | 73 | | ministration to treat brain tumors, thereby resulting 7 |
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| 74 | 74 | | in little change in mortality rates for individuals 8 |
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| 75 | 75 | | with brain tumors. 9 |
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| 76 | 76 | | (6) As of the date of enactment of this Act, 10 |
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| 77 | 77 | | there is no prevention and no early detection pro-11 |
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| 78 | 78 | | tocol for brain tumors. 12 |
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| 79 | 79 | | (7) All people in the United States have a stake 13 |
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| 80 | 80 | | in reducing and eliminating brain tumors. 14 |
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| 81 | 81 | | (8) Patients living with a brain tumor and their 15 |
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| 82 | 82 | | families want cures. Short of cures, they want safe 16 |
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| 83 | 83 | | and effective ways to increase survival rates for such 17 |
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| 84 | 84 | | patients and improve the quality of life for such pa-18 |
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| 85 | 85 | | tients. 19 |
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| 86 | 86 | | (b) P |
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| 87 | 87 | | URPOSES.—The purposes of this Act are to— 20 |
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| 88 | 88 | | (1) strengthen research and treatment develop-21 |
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| 89 | 89 | | ment regarding brain tumors; and 22 |
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| 90 | 90 | | (2) improve the adequacy and awareness of and 23 |
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| 91 | 91 | | access to specialized brain tumor and rare and recal-24 |
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| 92 | 92 | | citrant cancer health care. 25 |
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| 95 | 95 | | •S 1330 IS |
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| 96 | 96 | | SEC. 3. FOSTERING TRANSPARENCY OF BIOSPECIMEN COL-1 |
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| 97 | 97 | | LECTIONS FOR BRAIN CANCER RESEARCH. 2 |
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| 98 | 98 | | Part A of title IV of the Public Health Service Act 3 |
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| 99 | 99 | | (42 U.S.C. 281 et seq.) is amended by adding at the end 4 |
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| 100 | 100 | | the following: 5 |
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| 101 | 101 | | ‘‘SEC. 404P. REPORTING OF BRAIN TUMOR BIOSPECIMEN 6 |
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| 102 | 102 | | COLLECTIONS. 7 |
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| 103 | 103 | | ‘‘(a) D |
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| 104 | 104 | | EFINITION OFCOVEREDBIOSPECIMENCOL-8 |
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| 105 | 105 | | LECTION.— 9 |
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| 106 | 106 | | ‘‘(1) I |
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| 107 | 107 | | N GENERAL.—In this section, the term 10 |
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| 108 | 108 | | ‘covered biospecimen collection’ means a biospecimen 11 |
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| 109 | 109 | | that was collected or acquired in whole or in part 12 |
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| 110 | 110 | | through funding from the National Institutes of 13 |
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| 111 | 111 | | Health. 14 |
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| 112 | 112 | | ‘‘(2) B |
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| 113 | 113 | | IOSPECIMEN.—For purposes of para-15 |
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| 114 | 114 | | graph (1), the term ‘biospecimen’ means a brain 16 |
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| 115 | 115 | | tumor tissue, cerebral spinal fluid, or other specimen 17 |
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| 116 | 116 | | type listed by the Specimen Resource Locator of the 18 |
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| 117 | 117 | | National Cancer Institute (or a successor database). 19 |
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| 118 | 118 | | ‘‘(b) E |
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| 119 | 119 | | STABLISHMENT.—The Secretary, acting 20 |
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| 120 | 120 | | through the Director of NIH, may establish and maintain 21 |
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| 121 | 121 | | a searchable website, or multiple websites, which may in-22 |
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| 122 | 122 | | clude websites existing on the day before the date of enact-23 |
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| 123 | 123 | | ment of this section, for the purpose of making accessible 24 |
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| 124 | 124 | | to the public— 25 |
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| 127 | 127 | | •S 1330 IS |
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| 128 | 128 | | ‘‘(1) information on the existence and location 1 |
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| 129 | 129 | | of covered biospecimen collections; 2 |
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| 130 | 130 | | ‘‘(2) a description of such collections; and 3 |
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| 131 | 131 | | ‘‘(3) contact information with respect to such 4 |
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| 132 | 132 | | collections. 5 |
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| 133 | 133 | | ‘‘(c) R |
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| 134 | 134 | | EPORTINGREQUIREMENTS.— 6 |
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| 135 | 135 | | ‘‘(1) E |
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| 136 | 136 | | XISTING COLLECTIONS.—Any individual 7 |
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| 137 | 137 | | or entity that as of the date of enactment of this 8 |
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| 138 | 138 | | section maintains a covered biospecimen collection 9 |
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| 139 | 139 | | shall, not later than 180 days after such date of en-10 |
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| 140 | 140 | | actment, submit a report to the Director of NIH 11 |
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| 141 | 141 | | containing information with respect to such covered 12 |
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| 142 | 142 | | biospecimen collection as the Director of NIH may 13 |
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| 143 | 143 | | specify, including at a minimum the information the 14 |
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| 144 | 144 | | National Cancer Institute requires for the Specimen 15 |
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| 145 | 145 | | Resource Locator (or a successor database). 16 |
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| 146 | 146 | | ‘‘(2) N |
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| 147 | 147 | | EW COLLECTIONS .—Any individual or 17 |
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| 148 | 148 | | entity that collects or acquires a covered biospecimen 18 |
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| 149 | 149 | | collection on or after the date of enactment of this 19 |
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| 150 | 150 | | section shall, not later than 60 days after the date 20 |
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| 151 | 151 | | of such collection or acquisition, submit a report to 21 |
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| 152 | 152 | | the Director of NIH containing the information re-22 |
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| 153 | 153 | | quired under paragraph (1). 23 |
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| 154 | 154 | | ‘‘(d) O |
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| 155 | 155 | | VERSIGHT.—The Secretary, acting through the 24 |
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| 156 | 156 | | Director of NIH, shall establish and carry out an oversight 25 |
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| 159 | 159 | | •S 1330 IS |
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| 160 | 160 | | mechanism, which shall include withholding funding to in-1 |
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| 161 | 161 | | dividuals or entities that have committed a repeated or 2 |
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| 162 | 162 | | egregious violation of the requirements under subsection 3 |
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| 163 | 163 | | (c).’’. 4 |
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| 164 | 164 | | SEC. 4. GLIOBLASTOMA THERAPEUTICS NETWORK; BRAIN 5 |
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| 165 | 165 | | TUMOR RELATED CELLULAR 6 |
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| 166 | 166 | | IMMUNOTHERAPY. 7 |
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| 167 | 167 | | (a) I |
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| 168 | 168 | | NGENERAL.—Subpart 1 of part C of title IV 8 |
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| 169 | 169 | | of the Public Health Service Act (42 U.S.C. 285 et seq.) 9 |
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| 170 | 170 | | is amended by adding at the end the following: 10 |
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| 171 | 171 | | ‘‘SEC. 417H. GLIOBLASTOMA THERAPEUTICS NETWORK. 11 |
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| 172 | 172 | | ‘‘(a) I |
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| 173 | 173 | | NGENERAL.—The Director of the Institute 12 |
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| 174 | 174 | | shall carry out a research program, known as the ‘Glio-13 |
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| 175 | 175 | | blastoma Therapeutics Network’, by awarding, on a com-14 |
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| 176 | 176 | | petitive basis, cooperative agreements, or other awards, 15 |
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| 177 | 177 | | through the U19 funding mechanism of the National In-16 |
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| 178 | 178 | | stitutes of Health for collaboration of institutions to im-17 |
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| 179 | 179 | | prove the treatment of glioblastoma by evaluating thera-18 |
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| 180 | 180 | | peutic agents from pre-clinical development studies 19 |
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| 181 | 181 | | through completion of early-phase clinical trials in hu-20 |
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| 182 | 182 | | mans. 21 |
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| 183 | 183 | | ‘‘(b) A |
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| 184 | 184 | | UTHORIZATION OF APPROPRIATIONS.—There 22 |
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| 185 | 185 | | is authorized to be appropriated $50,000,000 for each of 23 |
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| 186 | 186 | | fiscal years 2026 through 2030, to remain available until 24 |
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| 190 | 190 | | expended, to the Director of the Institute to carry out this 1 |
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| 191 | 191 | | section. 2 |
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| 192 | 192 | | ‘‘SEC. 417I. BRAIN TUMOR RELATED CELLULAR 3 |
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| 193 | 193 | | IMMUNOTHERAPY. 4 |
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| 194 | 194 | | ‘‘(a) I |
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| 195 | 195 | | NGENERAL.—In order to take advantage of 5 |
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| 196 | 196 | | significant advancement in the development of brain 6 |
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| 197 | 197 | | tumor related cellular immunotherapy, including chimeric 7 |
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| 198 | 198 | | antigen receptor-T (CAR-T), which may include ap-8 |
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| 199 | 199 | | proaches previously funded by the National Institutes of 9 |
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| 200 | 200 | | Health, the Director of the Institute shall make awards, 10 |
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| 201 | 201 | | on a competitive basis, through a U series funding mecha-11 |
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| 202 | 202 | | nism, to support the development of a multi-institutional 12 |
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| 203 | 203 | | team science approach to using brain tumor related cancer 13 |
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| 204 | 204 | | cellular immunotherapy, including CAR-T treatment, for 14 |
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| 205 | 205 | | adult and pediatric brain tumors. 15 |
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| 206 | 206 | | ‘‘(b) U |
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| 207 | 207 | | SE OFFUNDS.—Funds received through an 16 |
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| 208 | 208 | | award under this section shall be used— 17 |
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| 209 | 209 | | ‘‘(1) to support collaborative multi-institutional 18 |
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| 210 | 210 | | research activities, including pre-clinical and inves-19 |
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| 211 | 211 | | tigational new drug studies; and 20 |
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| 212 | 212 | | ‘‘(2) for the purpose of supporting clinical trials 21 |
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| 213 | 213 | | to evaluate brain tumor related cancer cellular 22 |
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| 214 | 214 | | immunotherapy, including CAR-T. 23 |
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| 215 | 215 | | ‘‘(c) A |
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| 216 | 216 | | UTHORIZATION OF APPROPRIATIONS.—There 24 |
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| 217 | 217 | | is authorized to be appropriated $10,000,000 for each of 25 |
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| 221 | 221 | | fiscal years 2026 through 2030, to remain available until 1 |
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| 222 | 222 | | expended, to the Director of the Institute to carry out this 2 |
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| 223 | 223 | | section.’’. 3 |
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| 224 | 224 | | (b) T |
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| 225 | 225 | | RANSITION FOR THE GLIOBLASTOMATHERA-4 |
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| 226 | 226 | | PEUTICSNETWORK.—The Director of the National Can-5 |
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| 227 | 227 | | cer Institute shall take such steps as may be necessary 6 |
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| 228 | 228 | | for the orderly transition from the Glioblastoma Thera-7 |
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| 229 | 229 | | peutics Network carried out by the Director, as of the day 8 |
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| 230 | 230 | | before the date of enactment of this Act, to the research 9 |
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| 231 | 231 | | program authorized under section 417H of the Public 10 |
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| 232 | 232 | | Health Service Act, as added by subsection (a). In making 11 |
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| 233 | 233 | | such transition, the Director shall ensure that the pro-12 |
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| 234 | 234 | | gram authorized under such section 417H is based upon 13 |
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| 235 | 235 | | and consistent with the policies and procedures of the 14 |
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| 236 | 236 | | Glioblastoma Therapeutics Network carried out by the Di-15 |
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| 237 | 237 | | rector as of the day before the date of enactment of this 16 |
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| 238 | 238 | | Act. 17 |
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| 239 | 239 | | SEC. 5. CANCER CLINICAL TRIALS AND BIOMARKER TEST-18 |
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| 240 | 240 | | ING NATIONAL PUBLIC AWARENESS CAM-19 |
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| 241 | 241 | | PAIGN. 20 |
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| 242 | 242 | | Part P of title III of the Public Health Service Act 21 |
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| 243 | 243 | | (42 U.S.C. 280g et seq.) is amended by adding at the end 22 |
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| 244 | 244 | | the following: 23 |
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| 248 | 248 | | ‘‘SEC. 399V–8. CANCER CLINICAL TRIALS AND BIOMARKER 1 |
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| 249 | 249 | | TESTING NATIONAL PUBLIC AWARENESS 2 |
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| 250 | 250 | | CAMPAIGN. 3 |
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| 251 | 251 | | ‘‘(a) N |
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| 252 | 252 | | ATIONALCAMPAIGN.— 4 |
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| 253 | 253 | | ‘‘(1) I |
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| 254 | 254 | | N GENERAL.—The Secretary shall carry 5 |
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| 255 | 255 | | out a national campaign to increase the awareness 6 |
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| 256 | 256 | | and knowledge of health care providers and individ-7 |
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| 257 | 257 | | uals, including patients and caregivers, with respect 8 |
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| 258 | 258 | | to the importance of clinical trials in the treatment 9 |
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| 259 | 259 | | of cancer. 10 |
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| 260 | 260 | | ‘‘(2) A |
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| 261 | 261 | | CTIVITIES.— 11 |
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| 262 | 262 | | ‘‘(A) I |
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| 263 | 263 | | N GENERAL.—Activities under such 12 |
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| 264 | 264 | | national campaign shall include each of the fol-13 |
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| 265 | 265 | | lowing: 14 |
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| 266 | 266 | | ‘‘(i) W |
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| 267 | 267 | | RITTEN MATERIALS .—Main-15 |
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| 268 | 268 | | taining a supply of written and digital ma-16 |
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| 269 | 269 | | terials that provide information to the pub-17 |
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| 270 | 270 | | lic on clinical trials, and distributing such 18 |
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| 271 | 271 | | materials to members of the public upon 19 |
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| 272 | 272 | | request. 20 |
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| 273 | 273 | | ‘‘(ii) P |
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| 274 | 274 | | UBLIC SERVICE ANNOUNCE -21 |
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| 275 | 275 | | MENTS; PUBLIC ENGAGEMENT .—Providing 22 |
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| 276 | 276 | | public service announcements, in accord-23 |
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| 277 | 277 | | ance with applicable law, including through 24 |
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| 278 | 278 | | publishing materials in digital or print 25 |
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| 279 | 279 | | form, and carrying out other public en-26 |
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| 283 | 283 | | gagement initiatives. Such public service 1 |
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| 284 | 284 | | announcements and other public engage-2 |
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| 285 | 285 | | ment initiatives shall include such an-3 |
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| 286 | 286 | | nouncements and initiatives intended to 4 |
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| 287 | 287 | | encourage individuals to discuss with their 5 |
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| 288 | 288 | | physicians— 6 |
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| 289 | 289 | | ‘‘(I) what cancer clinical trials 7 |
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| 290 | 290 | | are; 8 |
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| 291 | 291 | | ‘‘(II) the importance of clinical 9 |
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| 292 | 292 | | trials in the treatment of cancer; 10 |
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| 293 | 293 | | ‘‘(III) how to enroll in cancer 11 |
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| 294 | 294 | | clinical trials; 12 |
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| 295 | 295 | | ‘‘(IV) what cancer biomarker 13 |
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| 296 | 296 | | testing is; 14 |
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| 297 | 297 | | ‘‘(V) the importance of biomarker 15 |
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| 298 | 298 | | testing in the diagnosis and treatment 16 |
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| 299 | 299 | | of cancer; and 17 |
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| 300 | 300 | | ‘‘(VI) how to access cancer bio-18 |
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| 301 | 301 | | marker testing. 19 |
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| 302 | 302 | | ‘‘(B) T |
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| 303 | 303 | | ARGETED POPULATIONS .—The Sec-20 |
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| 304 | 304 | | retary shall ensure that the national campaign 21 |
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| 305 | 305 | | includes communications, including public serv-22 |
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| 306 | 306 | | ice announcements and other public engage-23 |
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| 307 | 307 | | ment initiatives under subparagraph (A)(ii), 24 |
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| 308 | 308 | | that are— 25 |
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| 312 | 312 | | ‘‘(i) culturally and linguistically com-1 |
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| 313 | 313 | | petent; and 2 |
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| 314 | 314 | | ‘‘(ii) targeted to— 3 |
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| 315 | 315 | | ‘‘(I) specific populations that are 4 |
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| 316 | 316 | | at a higher risk of cancer, including 5 |
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| 317 | 317 | | such populations based on factors in-6 |
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| 318 | 318 | | cluding race, ethnicity, level of accul-7 |
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| 319 | 319 | | turation, and family history; 8 |
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| 320 | 320 | | ‘‘(II) rural communities; and 9 |
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| 321 | 321 | | ‘‘(III) such other communities as 10 |
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| 322 | 322 | | the Secretary determines appropriate. 11 |
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| 323 | 323 | | ‘‘(3) C |
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| 324 | 324 | | ONSULTATION.—In carrying out the na-12 |
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| 325 | 325 | | tional campaign under this subsection, the Secretary 13 |
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| 326 | 326 | | shall consult with— 14 |
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| 327 | 327 | | ‘‘(A) health care providers; 15 |
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| 328 | 328 | | ‘‘(B) nonprofit organizations; 16 |
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| 329 | 329 | | ‘‘(C) State and local public health depart-17 |
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| 330 | 330 | | ments; and 18 |
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| 331 | 331 | | ‘‘(D) elementary and secondary schools 19 |
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| 332 | 332 | | and institutions of higher education. 20 |
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| 333 | 333 | | ‘‘(b) D |
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| 334 | 334 | | EMONSTRATION PROJECTSREGARDINGOUT-21 |
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| 335 | 335 | | REACH ANDEDUCATIONSTRATEGIES FORCANCER AND 22 |
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| 336 | 336 | | B |
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| 337 | 337 | | RAINTUMORPATIENTS.— 23 |
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| 338 | 338 | | ‘‘(1) I |
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| 339 | 339 | | N GENERAL.—The Secretary shall carry 24 |
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| 340 | 340 | | out a program to award grants or contracts to pub-25 |
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| 343 | 343 | | •S 1330 IS |
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| 344 | 344 | | lic or nonprofit private entities for the purpose of 1 |
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| 345 | 345 | | carrying out demonstration projects to test, com-2 |
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| 346 | 346 | | pare, and evaluate different evidence-based outreach 3 |
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| 347 | 347 | | and education strategies to increase the awareness 4 |
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| 348 | 348 | | and knowledge of cancer and brain tumor clinical 5 |
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| 349 | 349 | | trials and biomarker testing. Such projects shall 6 |
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| 350 | 350 | | focus on the awareness and knowledge of patients 7 |
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| 351 | 351 | | (and the families of patients), physicians, nurses, 8 |
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| 352 | 352 | | and other key health professionals involved in brain 9 |
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| 353 | 353 | | tumor treatment. 10 |
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| 354 | 354 | | ‘‘(2) A |
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| 355 | 355 | | WARDS.—In making awards under para-11 |
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| 356 | 356 | | graph (1), the Secretary shall— 12 |
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| 357 | 357 | | ‘‘(A) ensure that information provided 13 |
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| 358 | 358 | | through demonstration projects supported by 14 |
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| 359 | 359 | | such an award is consistent with the best avail-15 |
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| 360 | 360 | | able medical information; and 16 |
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| 361 | 361 | | ‘‘(B) give preference to— 17 |
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| 362 | 362 | | ‘‘(i) applicants with demonstrated ex-18 |
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| 363 | 363 | | pertise in— 19 |
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| 364 | 364 | | ‘‘(I) biomarker testing and clin-20 |
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| 365 | 365 | | ical trials in brain tumors and other 21 |
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| 366 | 366 | | recalcitrant cancers; 22 |
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| 367 | 367 | | ‘‘(II) brain cancer and other re-23 |
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| 368 | 368 | | calcitrant cancer education or treat-24 |
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| 369 | 369 | | ment; 25 |
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| 372 | 372 | | •S 1330 IS |
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| 373 | 373 | | ‘‘(III) working with groups of pa-1 |
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| 374 | 374 | | tients and caregivers; and 2 |
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| 375 | 375 | | ‘‘(IV) reaching geographic areas 3 |
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| 376 | 376 | | that have historically low rates of par-4 |
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| 377 | 377 | | ticipation in cancer clinical trials; and 5 |
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| 378 | 378 | | ‘‘(ii) applicants that demonstrate in 6 |
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| 379 | 379 | | their application submitted under para-7 |
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| 380 | 380 | | graph (3) that the project for which they 8 |
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| 381 | 381 | | are seeking a grant or contract will involve 9 |
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| 382 | 382 | | and connect physicians, nurses, other key 10 |
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| 383 | 383 | | health professionals, health profession stu-11 |
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| 384 | 384 | | dents, hospitals, and payers. 12 |
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| 385 | 385 | | ‘‘(3) A |
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| 386 | 386 | | PPLICATIONS.—To seek a grant or con-13 |
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| 387 | 387 | | tract under this subsection, an entity shall submit 14 |
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| 388 | 388 | | an application to the Secretary in such form, in such 15 |
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| 389 | 389 | | manner, and containing such agreements, assur-16 |
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| 390 | 390 | | ances, and information as the Secretary may reason-17 |
|---|
| 391 | 391 | | ably require. 18 |
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| 392 | 392 | | ‘‘(c) A |
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| 393 | 393 | | UTHORIZATION OFAPPROPRIATIONS.—For the 19 |
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| 394 | 394 | | purpose of carrying out this section, there is authorized 20 |
|---|
| 395 | 395 | | to be appropriated $10,000,000 for the period of fiscal 21 |
|---|
| 396 | 396 | | years 2026 through 2030.’’. 22 |
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| 400 | 400 | | SEC. 6. PILOT PROGRAMS TO DEVELOP, STUDY, OR EVALU-1 |
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| 401 | 401 | | ATE APPROACHES TO MONITORING AND CAR-2 |
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| 402 | 402 | | ING FOR BRAIN TUMOR SURVIVORS. 3 |
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| 403 | 403 | | Part B of title IV of the Public Health Service Act 4 |
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| 404 | 404 | | (42 U.S.C. 284 et seq.) is amended by adding at the end 5 |
|---|
| 405 | 405 | | the following: 6 |
|---|
| 406 | 406 | | ‘‘SEC. 409K. PILOT PROGRAMS TO DEVELOP, STUDY, OR 7 |
|---|
| 407 | 407 | | EVALUATE APPROACHES TO MONITORING 8 |
|---|
| 408 | 408 | | AND CARING FOR BRAIN TUMOR SURVIVORS. 9 |
|---|
| 409 | 409 | | ‘‘(a) I |
|---|
| 410 | 410 | | NGENERAL.—The Director of NIH may, as 10 |
|---|
| 411 | 411 | | appropriate, make awards to eligible entities to establish 11 |
|---|
| 412 | 412 | | pilot programs to develop, study, or evaluate approaches, 12 |
|---|
| 413 | 413 | | including primary and specialty care, for monitoring and 13 |
|---|
| 414 | 414 | | caring for adult and pediatric brain tumor survivors 14 |
|---|
| 415 | 415 | | throughout their lifespan, including evaluating models for 15 |
|---|
| 416 | 416 | | transition to post-treatment care and care coordination. 16 |
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| 417 | 417 | | ‘‘(b) A |
|---|
| 418 | 418 | | WARDS.— 17 |
|---|
| 419 | 419 | | ‘‘(1) E |
|---|
| 420 | 420 | | LIGIBLE ENTITIES.— 18 |
|---|
| 421 | 421 | | ‘‘(A) I |
|---|
| 422 | 422 | | N GENERAL.—For purposes of this 19 |
|---|
| 423 | 423 | | section, an eligible entity is— 20 |
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| 424 | 424 | | ‘‘(i) a medical school; 21 |
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| 425 | 425 | | ‘‘(ii) a children’s hospital; 22 |
|---|
| 426 | 426 | | ‘‘(iii) a cancer center; 23 |
|---|
| 427 | 427 | | ‘‘(iv) a community-based medical facil-24 |
|---|
| 428 | 428 | | ity; or 25 |
|---|
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| 432 | 432 | | ‘‘(v) any other entity with significant 1 |
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| 433 | 433 | | experience and expertise in carrying out 2 |
|---|
| 434 | 434 | | the activities described in subsection (a). 3 |
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| 435 | 435 | | ‘‘(B) T |
|---|
| 436 | 436 | | YPES OF ENTITIES.—Awards under 4 |
|---|
| 437 | 437 | | this section shall be made, to the extent prac-5 |
|---|
| 438 | 438 | | tical, to— 6 |
|---|
| 439 | 439 | | ‘‘(i) small, medium, and large-sized el-7 |
|---|
| 440 | 440 | | igible entities; and 8 |
|---|
| 441 | 441 | | ‘‘(ii) sites located in different geo-9 |
|---|
| 442 | 442 | | graphic areas, including rural and urban 10 |
|---|
| 443 | 443 | | areas. 11 |
|---|
| 444 | 444 | | ‘‘(2) P |
|---|
| 445 | 445 | | EER REVIEW.—In making awards under 12 |
|---|
| 446 | 446 | | this section, the Director of NIH shall comply with 13 |
|---|
| 447 | 447 | | the peer review requirements in section 492. 14 |
|---|
| 448 | 448 | | ‘‘(3) U |
|---|
| 449 | 449 | | SE OF FUNDS .—Funds from awards 15 |
|---|
| 450 | 450 | | under this section may be used to develop, study, or 16 |
|---|
| 451 | 451 | | evaluate one or more models for monitoring and car-17 |
|---|
| 452 | 452 | | ing for brain tumor survivors, which may include— 18 |
|---|
| 453 | 453 | | ‘‘(A) evaluating follow-up care, educational 19 |
|---|
| 454 | 454 | | accommodations, monitoring, and other survi-20 |
|---|
| 455 | 455 | | vorship programs (including peer support and 21 |
|---|
| 456 | 456 | | mentoring programs); 22 |
|---|
| 457 | 457 | | ‘‘(B) developing and evaluating models for 23 |
|---|
| 458 | 458 | | providing multidisciplinary care; 24 |
|---|
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| 462 | 462 | | ‘‘(C) disseminating information to health 1 |
|---|
| 463 | 463 | | care providers about culturally and linguistically 2 |
|---|
| 464 | 464 | | appropriate follow-up care for brain tumor sur-3 |
|---|
| 465 | 465 | | vivors and their families, as appropriate and 4 |
|---|
| 466 | 466 | | practicable; 5 |
|---|
| 467 | 467 | | ‘‘(D) developing and evaluating existing 6 |
|---|
| 468 | 468 | | psychosocial evaluations, counseling, and sup-7 |
|---|
| 469 | 469 | | port programs to improve the quality of life of 8 |
|---|
| 470 | 470 | | brain tumor survivors and their families, which 9 |
|---|
| 471 | 471 | | may include peer support and mentoring pro-10 |
|---|
| 472 | 472 | | grams; 11 |
|---|
| 473 | 473 | | ‘‘(E) designing and evaluating tools, which 12 |
|---|
| 474 | 474 | | may include tools generated by artificial intel-13 |
|---|
| 475 | 475 | | ligence and machine learning, to support the se-14 |
|---|
| 476 | 476 | | cure electronic transfer of treatment informa-15 |
|---|
| 477 | 477 | | tion and care summaries from brain tumor care 16 |
|---|
| 478 | 478 | | providers to other health care providers (includ-17 |
|---|
| 479 | 479 | | ing primary and specialty care providers), which 18 |
|---|
| 480 | 480 | | information and care summaries shall include 19 |
|---|
| 481 | 481 | | risk factors and a plan for recommended follow- 20 |
|---|
| 482 | 482 | | up care; 21 |
|---|
| 483 | 483 | | ‘‘(F) developing and evaluating initiatives 22 |
|---|
| 484 | 484 | | that promote the coordination and effective 23 |
|---|
| 485 | 485 | | transition of care between brain tumor care 24 |
|---|
| 486 | 486 | | providers, primary and specialty care providers, 25 |
|---|
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| 489 | 489 | | •S 1330 IS |
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| 490 | 490 | | mental health professionals, and other health 1 |
|---|
| 491 | 491 | | care professionals, as appropriate, including 2 |
|---|
| 492 | 492 | | models that use a team-based or multi-discipli-3 |
|---|
| 493 | 493 | | nary approach to care; and 4 |
|---|
| 494 | 494 | | ‘‘(G) disseminating information described 5 |
|---|
| 495 | 495 | | in subparagraphs (A) through (F), including 6 |
|---|
| 496 | 496 | | with respect to models, evaluations, programs, 7 |
|---|
| 497 | 497 | | systems, and initiatives described in such sub-8 |
|---|
| 498 | 498 | | paragraphs, to other health care providers (in-9 |
|---|
| 499 | 499 | | cluding primary and specialty care providers) 10 |
|---|
| 500 | 500 | | and to pediatric brain tumor survivors and their 11 |
|---|
| 501 | 501 | | families, where appropriate and in accordance 12 |
|---|
| 502 | 502 | | with Federal and State law. 13 |
|---|
| 503 | 503 | | ‘‘(c) A |
|---|
| 504 | 504 | | UTHORIZATION OF APPROPRIATIONS.—There 14 |
|---|
| 505 | 505 | | are authorized to be appropriated to carry out this section 15 |
|---|
| 506 | 506 | | $5,000,000 for each of fiscal years 2026 through 2030.’’. 16 |
|---|
| 507 | 507 | | SEC. 7. FDA GUIDANCE TO ENSURE BRAIN TUMOR PATIENT 17 |
|---|
| 508 | 508 | | ACCESS TO CLINICAL TRIALS. 18 |
|---|
| 509 | 509 | | Not later than 1 year after the date of enactment 19 |
|---|
| 510 | 510 | | of this Act, the Secretary of Health and Human Services, 20 |
|---|
| 511 | 511 | | acting through the Commissioner of Food and Drugs, 21 |
|---|
| 512 | 512 | | shall issue guidance to help identify ways to minimize the 22 |
|---|
| 513 | 513 | | potential for the exclusion of brain tumor patients and pa-23 |
|---|
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| 516 | 516 | | •S 1330 IS |
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| 517 | 517 | | tients with rare and recalcitrant cancers from clinical 1 |
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| 518 | 518 | | trials evaluating treatments for other indications. 2 |
|---|
| 519 | 519 | | Æ |
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