42 U.S.C. § 285a–11 — Pediatric cancer research, awareness, and survivorship

(a) Children's cancer biorepositories. The Secretary, acting through the Director of NIH, may give awards — grants, contracts, or cooperative agreements — to eligible entities so they can build on existing efforts to collect biospecimens (like tumor tissue, bone marrow, normal tissue, blood, plasma, DNA, RNA, and other cancer-relevant samples) and clinical and demographic information (like date and age of diagnosis, sex, race, ethnicity, environmental exposures, disease extent, tumor location, treatment and outcome data, and more) from children, adolescents, and young adults with cancer subtypes that current treatments handle worst. The goal is to better understand what causes these cancers and how treatments affect them. Award money can be used to: collect and store high-quality donated biospecimens and data, focusing on patients in clinical trials with the least effective treatments, including storage at existing National Cancer Institute biorepositories; build and maintain a secure, searchable database of this material for researchers and qualified health professionals; create procedures for evaluating requests to access the biospecimens and data; and give researchers and health professionals access to the material for peer-reviewed research, but only following those access procedures, only to the extent federal and state law allows, and in a way that protects personal privacy under federal and state privacy law at a minimum. No child, adolescent, or young adult with cancer can be forced to give a specimen or share their data. To get an award, an entity must apply to the Secretary in the time, manner, and with the information the Secretary reasonably requires. When judging applications, the Secretary must consider whether the entity already has the infrastructure to quickly capture biospecimens and related data from patients whose current treatments work least well. The Secretary cannot make an award unless the entity collects biospecimens and data only from people who gave informed consent under federal and state law, and unless the entity protects personal privacy to at least the level federal and state law requires. The Secretary must make sure informed consent is actually obtained. The Secretary must write and share guidelines — including oversight rules — for building and running these biorepositories, to support further research on these cancer subtypes in children, adolescents, and young adults. The Secretary must coordinate these programs with existing federally supported cancer registries and with the activities under section 280e–3a, to make federal efforts as efficient and effective as possible. Money for this program must add to existing federal and non-federal funding, not replace it. Within 4 years of January 5, 2023, the Secretary must report to Congress on: how many biospecimens and related data have been collected; how many have been requested by researchers; barriers to collecting them; barriers researchers and health professionals face in accessing them; and recommendations for improving the biospecimen and biorepository research effort. Within 2 years of January 5, 2023, the Director of NIH must review the access-evaluation procedures and related policies to find ways to cut administrative burden — while still protecting privacy at least as much as federal and state law requires — and must report the review's findings, and any planned policy changes, to the Senate HELP Committee and the House Energy and Commerce Committee. This subsection defines "award" to include a grant, contract, or cooperative agreement; "biospecimen" to include solid tumor tissue, bone marrow, normal or control tissue, blood, plasma, DNA and RNA extractions, familial DNA, and any other sample the Secretary requires; and "clinical and demographic information" to include date and age of diagnosis, sex, race, ethnicity, environmental exposures, disease extent at enrollment, site of any spread, tumor location, histologic diagnosis, tumor marker data, treatment and outcome data, specimen-quality information, and anything else the Secretary requires. (b) Improving care for pediatric cancer survivors. The Director of NIH may keep conducting or supporting research on pediatric cancer survivorship, including: outcomes for survivors, including in minority and medically underserved groups and disparities in those outcomes; barriers to follow-up care, including for those same groups; how family, economic, and other environmental factors affect treatment outcomes and survivorship; ways to track and analyze the late effects of cancer treatment over the long term; identifying risk factors for late effects, predictors of neurocognitive and psychosocial problems, and the molecular basis of long-term complications; and developing targeted ways to reduce the health burden survivors carry from these late effects. When this research looks at survivors in minority or underserved groups, the Director of NIH must make sure it addresses both their physical and psychological needs. (c) Rule of construction. Nothing in this section conflicts with the goals of the Minority Health and Health Disparities Research and Education Act of 2000. (d) Authorization of appropriations. Congress authorizes $30,000,000 for each fiscal year from 2024 through 2028 to carry out this section and section 280e–3a. This money stays available until it is spent, with no yearly deadline.