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Adds a new section (designated 399V–8) to Part P of title III of the Public Health Service Act establishing a national campaign on cancer clinical trials and biomarker testing, a grants/contracts demonstration project program for outreach and education for cancer and brain tumor patients, and an authorization of appropriations.
Adds new sections 417H (Glioblastoma Therapeutics Network) and 417I (Brain tumor related cellular immunotherapy (including CAR–T) team science award) to Subpart 1 of part C of title IV of the Public Health Service Act, authorizing NIH awards and appropriations to carry out those programs.
Adds a new section (section 409K) to Part B of title IV of the Public Health Service Act authorizing the Director of the NIH to make awards to eligible entities to establish pilot programs to develop, study, or evaluate approaches for monitoring and caring for adult and pediatric brain tumor survivors.
Adds a new section (designated 404P) to Part A of title IV of the Public Health Service Act establishing reporting requirements and a searchable public website for NIH-funded brain tumor biospecimen collections, and an oversight mechanism including withholding of funding for repeated or egregious violations.
Requires NIH-funded brain tumor biospecimen collections to be reported and publicly listed, creates new NIH research programs focused on glioblastoma and brain tumor cellular immunotherapy, funds a national outreach campaign to increase awareness of clinical trials and biomarker testing, establishes pilot grants to improve lifelong survivorship care, and directs the FDA to issue guidance to reduce exclusion of brain tumor and other rare-cancer patients from clinical trials. The law authorizes multi-year funding for the research networks and awards, sets reporting and oversight requirements for biospecimen repositories, and provides grants and demonstration project funding to improve patient outreach and care coordination.
Referred to the House Committee on Energy and Commerce.
Introduced April 9, 2025 by Brian K. Fitzpatrick · Last progress April 9, 2025
BRAIN Act