§285a–11. Pediatric cancer research, awareness, and survivorship

(a) Children's cancer biorepositories

(1) Award

The Secretary, acting through the Director of NIH, may make awards to an entity or entities described in paragraph (4) to build upon existing research efforts to collect biospecimens and clinical and demographic information of children, adolescents, and young adults with selected cancer subtypes (and their recurrences) for which current treatments are least effective, in order to achieve a better understanding of the causes of such cancer subtypes (and their recurrences), and the effects and outcomes of treatments for such cancers.

(2) Use of funds

Amounts received under an award under paragraph (1) may be used to carry out the following:

(A) Collect and store high-quality, donated biospecimens and associated clinical and demographic information on children, adolescents, and young adults diagnosed with cancer in the United States, focusing on children, adolescents, and young adults with cancer enrolled in clinical trials for whom current treatments are least effective. Activities under this subparagraph may include storage of biospecimens and associated clinical and demographic data at existing biorepositories supported by the National Cancer Institute, such as collected samples of both solid tumor cancer and paired samples.

(B) Maintain an interoperable, secure, and searchable database on stored biospecimens and associated clinical and demographic data from children, adolescents, and young adults with cancer for the purposes of research by scientists and qualified health care professionals.

(C) Establish and implement procedures for evaluating applications for access to such biospecimens and clinical and demographic data from researchers and other qualified health care professionals.

(D) Provide access to biospecimens and clinical and demographic data from children, adolescents, and young adults with cancer to researchers and qualified health care professionals for peer-reviewed research-

(i) consistent with the procedures established pursuant to subparagraph (C);

(ii) only to the extent permitted by applicable Federal and State law; and

(iii) in a manner that protects personal privacy to the extent required by applicable Federal and State privacy law, at minimum.

(3) No requirement

No child, adolescent, or young adult with cancer shall be required under this subsection to contribute a specimen to a biorepository or share clinical or demographic data.

(4) Application; considerations

(A) Application

To be eligible to receive an award under paragraph (1) an entity shall submit an application to the Secretary at such a time, in such manner, and containing such information as the Secretary may reasonably require.

(B) Considerations

In evaluating applications submitted under subparagraph (A), the Secretary shall consider the existing infrastructure of the entity that would allow for the timely capture of biospecimens and related clinical and demographic information for children, adolescents, and young adults with cancer for whom current treatments are least effective.

(5) Privacy protections and informed consent

(A) In general

The Secretary may not make an award under paragraph (1) to an entity unless the Secretary ensures that such entity-

(i) collects biospecimens and associated clinical and demographic information only from participants who have given their informed consent in accordance with Federal and State law; and

(ii) protects personal privacy to the extent required by applicable Federal and State law, at minimum.

(B) Informed consent

The Secretary shall ensure biospecimens and associated clinical and demographic information are collected with informed consent, as described in subparagraph (A)(i).

(6) Guidelines and oversight

The Secretary shall develop and disseminate appropriate guidelines for the development and maintenance of the biorepositories supported under this subsection, including appropriate oversight, to facilitate further research on select cancer subtypes (and their recurrences) in children, adolescents, and young adults with such cancers (and their recurrences).

(7) Coordination

To encourage the greatest possible efficiency and effectiveness of federally supported efforts with respect to the activities described in this subsection, the Secretary shall ensure the appropriate coordination of programs supported under this section with existing federally supported cancer registry programs and the activities under section 280e–3a of this title, as appropriate.

(8) Supplement not supplant

Funds provided under this subsection shall be used to supplement, and not supplant, Federal and non-Federal funds available for carrying out the activities described in this subsection.

(9) Report

Not later than 4 years after January 5, 2023, the Secretary shall submit to Congress a report on-

(A) the number of biospecimens and corresponding clinical demographic data collected through the biospecimen research efforts supported under paragraph (1);

(B) the number of biospecimens and corresponding clinical demographic data requested for use by researchers;

(C) barriers to the collection of biospecimens and corresponding clinical demographic data;

(D) barriers experienced by researchers or health care professionals in accessing the biospecimens and corresponding clinical demographic data necessary for use in research; and

(E) recommendations with respect to improving the biospecimen and biorepository research efforts under this subsection.

(10) Report on researcher access to children's cancer biorepository samples

Not later than 2 years after January 5, 2023, the Director of NIH shall-

(A) conduct a review of the procedures established under paragraph (2)(C) and other policies or procedures related to researcher access to such biospecimens to identify any opportunities to reduce administrative burden, consistent with paragraph (2)(D), in a manner that protects personal privacy to the extent required by applicable Federal and State privacy law, at a minimum; and

(B) submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on the findings of the review under subparagraph (A) and whether the Director of NIH plans to make any changes to the policies or procedures considered in such review, based on such findings.

(11) Definitions

For purposes of this subsection:

(A) Award

The term "award" includes a grant, contract, or cooperative agreement determined by the Secretary.

(B) Biospecimen

The term "biospecimen" includes-

(i) solid tumor tissue or bone marrow;

(ii) normal or control tissue;

(iii) blood and plasma;

(iv) DNA and RNA extractions;

(v) familial DNA; and

(vi) any other sample relevant to cancer research, as required by the Secretary.

(C) Clinical and demographic information

The term "clinical and demographic information" includes-

(i) date of diagnosis;

(ii) age at diagnosis;

(iii) the patient's sex, race, ethnicity, and environmental exposures;

(iv) extent of disease at enrollment;

(v) site of metastases;

(vi) location of primary tumor coded;

(vii) histologic diagnosis;

(viii) tumor marker data when available;

(ix) treatment and outcome data;

(x) information related to specimen quality; and

(xi) any other applicable information required by the Secretary.

(b) Improving care for pediatric cancer survivors

(1) Research on pediatric cancer survivorship

The Director of NIH, in coordination with ongoing research activities, may continue to conduct or support pediatric cancer survivorship research including in any of the following areas:

(A) Outcomes of pediatric cancer survivors, including within minority or other medically underserved populations and with respect to health disparities of such outcomes.

(B) Barriers to follow-up care for pediatric cancer survivors, including within minority or other medically underserved populations.

(C) The impact of relevant factors, which may include familial, socioeconomic, and other environmental factors, on treatment outcomes and survivorship.

(D) The development of indicators used for long-term follow-up and analysis of the late effects of cancer treatment for pediatric cancer survivors.

(E) The identification of, as applicable-

(i) risk factors associated with the late effects of cancer treatment;

(ii) predictors of adverse neurocognitive and psychosocial outcomes; and

(iii) the molecular basis of long-term complications.

(F) The development of targeted interventions to reduce the burden of morbidity borne by cancer survivors in order to protect such cancer survivors from the late effects of cancer.

(2) Balanced approach

In conducting or supporting research under paragraph (1)(A)(i) on pediatric cancer survivors within minority or other medically underserved populations, the Director of NIH shall ensure that such research addresses both the physical and the psychological needs of such survivors, as appropriate.

(c) Rule of construction

Nothing in this section shall be construed as being inconsistent with the goals and purposes of the Minority Health and Health Disparities Research and Education Act of 2000.

(d) Authorization of appropriations

For purposes of carrying out this section and section 280e–3a of this title, there are authorized to be appropriated $30,000,000 for each of fiscal years 2024 through 2028. Funds appropriated under this subsection shall remain available until expended.

(July 1, 1944, ch. 373, title IV, §417E, as added Pub. L. 110–285, §4(a), July 29, 2008, 122 Stat. 2629 ; amended Pub. L. 115–180, title I, §§101, 102(b), title II, §202, June 5, 2018, 132 Stat. 1383 , 1386, 1389; Pub. L. 117–350, §2(a), Jan. 5, 2023, 136 Stat. 6262 .)

Editorial Notes

References in Text

The Minority Health and Health Disparities Research and Education Act of 2000, referred to in subsec. (c), is Pub. L. 106–525, Nov. 22, 2000, 114 Stat. 2495 . For complete classification of this Act to the Code, see Short Title of 2000 Amendments note set out under section 201 of this title and Tables.

Amendments

2023-Subsec. (a)(2)(A). Pub. L. 117–350, §2(a)(1)(A), inserted ", such as collected samples of both solid tumor cancer and paired samples" after "National Cancer Institute".

Subsec. (a)(9). Pub. L. 117–350, §2(a)(1)(B), substituted "January 5, 2023" for "June 5, 2018" in introductory provisions.

Subsec. (a)(10), (11). Pub. L. 117–350, §2(a)(1)(C), (D), added par. (10) and redesignated former par. (10) as (11).

Subsec. (d). Pub. L. 117–350, §2(a)(2), substituted "2024 through 2028" for "2019 through 2023".

2018-Pub. L. 115–180, §101(1), substituted "research, awareness, and survivorship" for "research and awareness" in section catchline.

Subsec. (a). Pub. L. 115–180, §101(2), added subsec. (a) and struck out former subsec. (a). Prior to amendment, text read as follows:

"(1) Programs of research excellence in pediatric cancer.-The Secretary, in collaboration with the Director of NIH and other Federal agencies with interest in prevention and treatment of pediatric cancer, shall continue to enhance, expand, and intensify pediatric cancer research and other activities related to pediatric cancer, including therapeutically applicable research to generate effective treatments, pediatric preclinical testing, and pediatric clinical trials through National Cancer Institute-supported pediatric cancer clinical trial groups and their member institutions. In enhancing, expanding, and intensifying such research and other activities, the Secretary is encouraged to take into consideration the application of such research and other activities for minority, health disparity, and medically underserved communities. For purposes of this section, the term 'pediatric cancer research' means research on the causes, prevention, diagnosis, recognition, treatment, and long-term effects of pediatric cancer.

"(2) Peer review requirements.-All grants awarded under this subsection shall be awarded in accordance with section 289a of this title."

Subsec. (b). Pub. L. 115–180, §202, added subsec. (b) and struck out former subsec. (b) which related to public awareness of pediatric cancers and available treatments and research.

Subsec. (c). Pub. L. 115–180, §101(3), struck out "(42 U.S.C. 202 note)" before period at end.

Subsec. (d). Pub. L. 115–180, §102(b), substituted "2019 through 2023" for "2009 through 2013" and struck out "Such authorization of appropriations is in addition to the authorization of appropriations established in section 282a of this title with respect to such purpose." before "Funds appropriated".

Statutory Notes and Related Subsidiaries

Reporting on Childhood Cancer Research Projects

Pub. L. 115–180, title I, §121, June 5, 2018, 132 Stat. 1387 , provided that: "The Director of the National Institutes of Health shall ensure that childhood cancer research projects conducted or supported by the National Institutes of Health are included in appropriate reports to Congress, which may include the Pediatric Research Initiative report."

Executive Documents

Ex. Ord. No. 14355. Unlocking Cures for Pediatric Cancer With Artificial Intelligence

Ex. Ord. No. 14355, Sept. 30, 2025, 90 F.R. 48153, provided:

By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered:

Section 1. Purpose and Policy. My Administration is committed to driving innovation to prevent and treat childhood diseases, including through the use of artificial intelligence (AI). Pediatric cancer remains the leading cause of disease-related death for children in the United States aged 1–19 years, and its incidence has increased by more than 40 percent since 1975.

As outlined in my joint address to the Congress in March, reversing this trend is one of the top priorities for the Make America Healthy Again (MAHA) Commission established in Executive Order 14212 of February 13, 2025 (Establishing the President's Make America Healthy Again Commission) [42 U.S.C. 201 note]. AI presents an opportunity to more quickly achieve this aim.

In 2019, my Administration created the Childhood Cancer Data Initiative (CCDI), a Federal investment in childhood cancer research of $50 million in funding every year for 10 years to address the critical need to collect, generate, and analyze childhood cancer data. The CCDI is building a foundational data infrastructure, aggregating and generating new data, and using this data to make new discoveries.

AI can be used to build upon this data initiative to produce meaningful solutions to pediatric, adolescent, and young adulthood cancer. This application of AI has the potential to transform the Nation's current care and research approach for pediatric cancer-as well as our healthcare and research infrastructure more broadly-through use of the rich and multimodal data, secured with appropriate individual privacy protections, to develop early and superior diagnostics, identify cures and optimize treatments, and advance medicine that will save lives.

For too long, we have watched our children and their families battle cancer and its long-term chronic effects while healthcare systems often rely on outdated technologies and can be slow to adopt certain innovations. We must prioritize investment in AI-enabled science, build world-class scientific datasets, and empower researchers and clinicians with the tools needed to translate data and AI capabilities into improved care.

Sec. 2. Harnessing American AI Innovation. The MAHA Commission, in coordination with the Secretary of Health and Human Services (Secretary), the Assistant to the President for Science and Technology (APST), and the Special Advisor for AI and Crypto, and in alignment with the implementation of America's AI Action Plan, shall work to develop innovative ways to utilize advanced technologies such as AI to unlock improved diagnoses, treatments, cures, and prevention strategies for pediatric cancer. The initial focus shall be on identifying opportunities to accelerate the progress of AI-driven solutions at the CCDI, including by making data platforms and tools available as part of the CCDI Data Ecosystem and funding research projects at National Cancer Institute-Designated Cancer Centers that prioritize:

(a) improving data infrastructure by consolidating data from multiple sources for AI-ready analysis and utilizing AI to better select participants for clinical trials;

(b) enhancing data analysis of complex biologic systems with AI tools to radically improve predictive modeling of patient response, disease progression, and treatment toxicity and to turn multi-omics data and imaging data into novel diagnostic, prognostic, and therapeutic biomarkers; and

(c) improving clinical trial design, access, and outcomes for patients by incorporating multimodal data and using AI approaches to maximize utilization of the information from clinical trials and improve accessibility, recruitment, administration, conduct, and interpretation of clinical trial results.

Sec. 3. Increasing Investment and Engagement in Pediatric Cancer Research and Care Infrastructure. The MAHA Commission, in coordination with the Secretary, the Director of the Office of Management and Budget, the Director of the National Institutes of Health, and the APST, shall prioritize expanding pediatric cancer research and advancements in care by identifying and implementing strategies for:

(a) increasing investment from existing Federal funds for the CCDI and other Federal Government initiatives that address pediatric cancer; and

(b) encouraging the private sector to make use of the most advanced technologies to unlock cures for pediatric cancer, including those based on AI, to the maximum possible extent.

Sec. 4. Improving Data Sharing and Empowering Patients. The Secretary, in consultation with the APST, shall work to ensure that AI innovation is appropriately integrated into current work on interoperability to maximize the potential for electronic health record and claims data to inform private sector and academic research and clinical trial design, while ensuring that patients and parents control their health information. In addition, the Secretary shall work to finalize interoperability standards for patient data to be used with AI that appropriately account for structured and unstructured data and enable safe and privacy-compliant exchanges of data.

Sec. 5. Definition. For the purposes of this order, "artificial intelligence" or "AI" has the meaning set forth in 15 U.S.C. 9401(3).

Sec. 6. General Provisions. (a) Nothing in this order shall be construed to impair or otherwise affect:

(i) the authority granted by law to an executive department or agency, or the head thereof; or

(ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.

(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.

(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.

(d) The costs for publication of this order shall be borne by the Department of Health and Human Services.

Donald J. Trump.