S. 1330 — BRAIN Act

This section cites the Act as the “Bolstering Research And Innovation Now Act” or the “BRAIN Act” and includes a table of contents.

This section sets forth congressional findings on brain tumors, including that more than 1,000,000 people in the United States are living with a brain tumor, approximately 94,000 new primary diagnoses occurred in 2023, pediatric brain tumors are the leading cause of cancer-related death for those 19 and younger, and five-year relative survival rates for malignant brain tumors have remained stagnant for 45 years at 35.7% overall and 6.9% for glioblastoma. The section declares the purposes of the Act to (1) strengthen research and treatment development regarding brain tumors and (2) improve the adequacy, awareness of, and access to specialized brain tumor and rare and recalcitrant cancer health care.

This section establishes reporting requirements for covered biospecimen collections—defined as brain tumor tissue, cerebral spinal fluid, or other specimen types listed in the National Cancer Institute's (NCI) Specimen Resource Locator (or successor database) that were collected or acquired with National Institutes of Health (NIH) funding. The NIH Director may establish and maintain a searchable public website providing information on the existence, location, description, and contact details for such collections. Entities maintaining existing collections must report specified details to NIH within 180 days of enactment, and those acquiring new collections must report within 60 days; NIH must implement oversight, including withholding funding for repeated or egregious violations.

This section establishes the Glioblastoma Therapeutics Network within the National Cancer Institute (NCI) to award, on a competitive basis, cooperative agreements or other awards through the U19 funding mechanism for multi-institutional collaboration evaluating glioblastoma therapeutics (i.e., for the most aggressive primary brain cancer) from pre-clinical development through early-phase clinical trials and authorizes $50 million for each of FY2026 through FY2030 (available until expended). This section further establishes an NCI program to award, on a competitive basis through a U series funding mechanism, multi-institutional team science research on brain tumor-related cellular immunotherapy—including chimeric antigen receptor T-cell (CAR-T) therapy—for adult and pediatric brain tumors, including for pre-clinical studies, investigational new drug applications, and clinical trials, and authorizes $10 million for each of FY2026 through FY2030 (available until expended). This section directs NCI to ensure an orderly transition from its existing Glioblastoma Therapeutics Network to the new statutory program, consistent with prior policies and procedures.

This section establishes a national public awareness campaign on the importance of cancer clinical trials and biomarker testing for health care providers, patients, and caregivers. Campaign activities include written and digital materials; public service announcements and public engagement initiatives encouraging discussions on clinical trials, biomarker testing, enrollment, and access; and culturally/linguistically competent communications targeted to high-risk populations (i.e., based on race, ethnicity, acculturation, family history), rural communities, and others, conducted in consultation with health care providers, nonprofits, public health departments, and educational institutions. The section also establishes a grant and contract program for demonstration projects testing, comparing, and evaluating outreach and education strategies on cancer and brain tumor clinical trials and biomarker testing, with award preferences for applicants demonstrating expertise in relevant areas (e.g., biomarker testing in brain tumors and recalcitrant cancers) and connections among physicians, nurses, health professionals, students, hospitals, and payers. For these purposes, $10 million is authorized for FY2026 through 2030.

This section directs the NIH Director to make awards to eligible entities—such as medical schools, children’s hospitals, cancer centers, community-based medical facilities, or other experienced entities (prioritizing small, medium, and large entities in rural and urban areas)—to establish pilot programs developing, studying, or evaluating approaches to monitoring and caring for adult and pediatric brain tumor survivors throughout their lifespan, including post-treatment transitions and care coordination. Awards must comply with peer review under section 492 of the Public Health Service Act, and funds may support (1) survivorship programs such as follow-up care and peer mentoring, (2) multidisciplinary care models, (3) dissemination of culturally appropriate follow-up information to providers, (4) psychosocial evaluations and support programs, (5) AI and machine learning tools for secure transfer of treatment summaries and follow-up plans, (6) care coordination initiatives among providers, and (7) broader dissemination of results. The section authorizes $5 million for each of FY2026 through FY2030.

This section directs the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to issue guidance within one year of enactment to identify ways to minimize the exclusion of brain tumor patients and patients with rare and recalcitrant cancers from clinical trials evaluating treatments for other indications.