Sec. 3. Pediatric Brain Tumor Real-World Data Registry Program
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Chapter X of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 391 et seq. ) is amended by adding at the end the following: The Secretary shall carry out a program, to be known as the Pediatric Brain Tumor Real-World Data Registry Program, to strengthen and expand activities related to the collection, sharing, and use of real-world data for children with brain tumors. In carrying out the program under this section, the Secretary shall— develop and maintain (or support the development and maintenance of) a registry of real-world data for children with atypical teratoid rhabdoid tumors; consider new and innovative approaches and technology for data collection, integration, and analysis; continue and expand activities, which may include existing data collection activities, to establish real-world database infrastructure; provide support for data integration, bioinformatics, and statistical analyses; and identify potential uses of real-world data registries as external control cohorts for pediatric brain tumor clinical trial design.
In carrying out the program under this section, the Secretary shall collaborate and consult, as appropriate, with public and private entities, including relevant departments and agencies, academic institutions, and industry. In carrying out the program under this section, the Secretary shall award grants, contracts, and cooperative agreements to academic institutions and other entities with relevant expertise in pediatric neuro-oncology or the collection, integration, and analysis of real-word data.
To seek an award under paragraph (1), an entity described in such paragraph shall submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require. An application under subparagraph
(A)shall include a description of how the applicant will partner, as applicable, with academic institutions or a consortium of academic institutions that have relevant expertise, such as expertise in pediatric neuro-oncology, clinical research, or the application of bioinformatics or statistics. For carrying out this section, there are authorized to be appropriated $2,000,000 for fiscal year 2025. .
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Sec. 3
Pediatric Brain Tumor Real-World Data Registry Program
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