Title 42 — The Public Health and WelfareRelease 119-73
§285a–11 Pediatric cancer research, awareness, and survivorship
Title 42 › Chapter CHAPTER 6A— - PUBLIC HEALTH SERVICE › Subchapter SUBCHAPTER III— - NATIONAL RESEARCH INSTITUTES › Part Part C— - Specific Provisions Respecting National Research Institutes › Subpart subpart 1— - national cancer institute › § 285a–11
Summary
The Secretary of Health, through the NIH Director, can give grants or contracts to groups to collect and store samples and health information from children, teens, and young adults who have cancer types that are hardest to treat. Money can be used to gather high-quality donated samples, keep them safely in biobanks, build a secure searchable database, set clear rules for how researchers can ask for and use the samples and data, and then share those materials with qualified researchers in ways that follow Federal and State law and protect privacy. No patient must give a sample or data if they do not want to. Applicants for awards must show they can quickly collect samples and data and must get informed consent and follow privacy rules. The Secretary must publish guidelines, coordinate with existing cancer registries and related programs, and make sure federal funds add to (not replace) other funding. The NIH Director must review access procedures within 2 years after January 5, 2023, and the Secretary must report to Congress within 4 years after January 5, 2023, on how many samples and data were collected and requested, what obstacles existed, and suggestions to improve the work. Up to $30,000,000 is authorized each year for fiscal years 2024 through 2028, available until spent. The NIH Director may also continue or support research on survivorship. That includes studying survivor health outcomes (including in minority and underserved groups), barriers to follow-up care, how family and social factors affect recovery, ways to track late effects of treatment, risks and causes of long-term problems, and testing targeted ways to reduce survivor illness. Research on underserved populations must look at both physical and mental health needs. Defined terms: “award” means grants, contracts, or cooperative agreements; “biospecimen” means samples like tumor tissue, blood, DNA, and other relevant materials; “clinical and demographic information” means things like diagnosis date and age, sex, race, tumor and treatment details, outcomes, and related data.
Full Legal Text
Title 42, §285a–11
The Public Health and Welfare — Source: USLM XML via OLRC
(a)(1)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)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 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)(A)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)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)(A)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)The Secretary shall ensure biospecimens and associated clinical and demographic information are collected with informed consent, as described in subparagraph (A)(i).
(6)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)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)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)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)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)For purposes of this subsection:
(A)The term “award” includes a grant, contract, or cooperative agreement determined by the Secretary.
(B)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)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)(1)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)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)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)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.
Legislative History
Notes & Related Subsidiaries
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.”
Reference
Citations & Metadata
Citation
42 U.S.C. § 285a–11
Title 42 — The Public Health and Welfare
Last Updated
Apr 6, 2026
Release point: 119-73