S. 292 

One Hundred Fifteenth Congress 

of the 

United States of America 

AT THE SECOND SESSION 

Begun and held at the City of Washington on Wednesday, 

the third day of January, two thousand and eighteen 

An Act 

To maximize discovery, and accelerate development and availability, of promising 

childhood cancer treatments, and for other purposes. 

Be it enacted by the Senate and House of Representatives of 

the United States of America in Congress assembled, 

SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

(a) SHORT TITLE.—This Act may be cited as the ‘‘Childhood 

Cancer Survivorship, Treatment, Access, and Research Act of 2018’’ 

or the ‘‘Childhood Cancer STAR Act’’. 

(b) TABLE OF CONTENTS.—The table of contents for this Act 

is as follows: 

Sec. 1. Short title; table of contents. 

TITLE I—MAXIMIZING RESEARCH THROUGH DISCOVERY 

Subtitle A—Caroline Pryce Walker Conquer Childhood Cancer Reauthorization Act 

Sec. 101. Children’s cancer biorepositories and biospecimen research. 

Sec. 102. Improving Childhood Cancer Surveillance. 

Subtitle B—Pediatric Expertise at NIH 

Sec. 111. Inclusion of at least one pediatric oncologist on the National Cancer Advisory Board. 

Sec. 112. Sense of Congress regarding pediatric expertise at the National Cancer 

Institute. 

Subtitle C—NIH Reporting on Childhood Cancer Activities 

Sec. 121. Reporting on childhood cancer research projects. 

TITLE II—MAXIMIZING DELIVERY: CARE, QUALITY OF LIFE, 

SURVIVORSHIP, AND CAREGIVER SUPPORT 

Sec. 201. Cancer survivorship programs. 

Sec. 202. Grants to improve care for pediatric cancer survivors. 

Sec. 203. Best practices for long-term follow-up services for pediatric cancer survivors. 

Sec. 204. Technical amendment. 
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TITLE I—MAXIMIZING RESEARCH 

THROUGH DISCOVERY 

Subtitle A—Caroline Pryce Walker Conquer Childhood Cancer Reauthorization 

Act 

SEC. 101. CHILDREN’S CANCER BIOREPOSITORIES AND BIOSPECIMEN 

RESEARCH. 

Section 417E of the Public Health Service Act (42 U.S.C. 285a– 

11) is amended— 

(1) in the section heading, by striking ‘‘RESEARCH AND

AWARENESS’’ and inserting ‘‘RESEARCH, AWARENESS, AND

SURVIVORSHIP’’; 

(2) by striking subsection (a) and inserting the following: 

‘‘(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. 

‘‘(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 
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‘‘(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 399E– 

1, 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 the date of 

enactment of the Childhood Cancer Survivorship, Treatment, 

Access, and Research Act of 2018, the Secretary shall submit 

to Congress a report on— 
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‘‘(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) 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.’’; and 

(3) in subsection (c), by striking ‘‘(42 U.S.C. 202 note)’’. 

SEC. 102. IMPROVING CHILDHOOD CANCER SURVEILLANCE. 

(a) IN GENERAL.—Section 399E–1 of the Public Health Service 

Act (42 U.S.C. 280e–3a) is amended— 

(1) in subsection (a)— 

(A) by striking ‘‘shall award a grant’’ and inserting 

‘‘may make awards to State cancer registries’’; and 

(B) by striking ‘‘track the epidemiology of pediatric 

cancer into a comprehensive nationwide registry of actual 

occurrences of pediatric cancer’’ and inserting ‘‘collect 

information to better understand the epidemiology of cancer 

in children, adolescents, and young adults’’; and 

(C) by striking the second sentence and inserting ‘‘Such 

registries may be updated to include each occurrence of 
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such cancers within a period of time designated by the 

Secretary.’’; 

(2) by redesignating subsection (b) as subsection (d); 

(3) by inserting after subsection (a) the following: 

‘‘(b) ACTIVITIES.—The grants described in subsection (a) may 

be used for— 

‘‘(1) identifying, recruiting, and training potential sources 

for reporting childhood, adolescent, and young adult cancer 

cases; 

‘‘(2) developing practices to ensure early inclusion of childhood, adolescent, and young adult cancer cases in State cancer 

registries through the use of electronic reporting; 

‘‘(3) collecting and submitting deidentified data to the Centers for Disease Control and Prevention for inclusion in a 

national database that includes information on childhood, 

adolescent, and young adult cancers; and 

‘‘(4) improving State cancer registries and the database 

described in paragraph (3), as appropriate, including to support 

the early inclusion of childhood, adolescent, and young adult 

cancer cases. 

‘‘(c) COORDINATION.—To encourage the greatest possible efficiency and effectiveness of federally supported efforts with respect 

to the activities described in this section, the Secretary shall ensure 

the appropriate coordination of programs supported under this section with other federally supported cancer registry programs and 

the activities under section 417E(a), as appropriate.’’; and 

(4) in subsection (d), as so redesignated, by striking ‘‘registry established pursuant to subsection (a)’’ and inserting 

‘‘activities described in this section’’. 

(b) AUTHORIZATION OF APPROPRIATIONS.—Section 417E(d) of the 

Public Health Service Act (42 U.S.C. 285a–11(d)) is amended— 

(1) by striking ‘‘2009 through 2013’’ and inserting ‘‘2019 

through 2023’’; and 

(2) by striking the second sentence. 

Subtitle B—Pediatric Expertise at NIH 

SEC. 111. INCLUSION OF AT LEAST ONE PEDIATRIC ONCOLOGIST ON 

THE NATIONAL CANCER ADVISORY BOARD. 

Clause (iii) of section 406(h)(2)(A) of the Public Health Service 

Act (42 U.S.C. 284a(h)(2)(A)) is amended— 

(1) by striking ‘‘Board not less than five’’ and inserting 

‘‘Board— 

‘‘(I) not less than 5’’; 

(2) by inserting ‘‘and’’ after the semicolon; and 

(3) by adding at the end the following: 

‘‘(II) not less than one member shall be an individual 

knowledgeable in pediatric oncology;’’. 

SEC. 112. SENSE OF CONGRESS REGARDING PEDIATRIC EXPERTISE 

AT THE NATIONAL CANCER INSTITUTE. 

It is the sense of Congress that the Director of the National 

Cancer Institute should ensure that all applicable study sections, 

committees, advisory groups, and panels at the National Cancer 

Institute include one or more qualified pediatric oncologists, as 

appropriate. 
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Subtitle C—NIH Reporting on Childhood 

Cancer Activities 

SEC. 121. REPORTING ON CHILDHOOD CANCER RESEARCH PROJECTS. 

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. 

TITLE II—MAXIMIZING DELIVERY: 

CARE, QUALITY OF LIFE, SURVIVORSHIP, AND CAREGIVER SUPPORT 

SEC. 201. CANCER SURVIVORSHIP PROGRAMS. 

(a) PILOT PROGRAMS TO EXPLORE MODEL SYSTEMS OF CARE

FOR PEDIATRIC CANCER SURVIVORS.— 

(1) IN GENERAL.—The Secretary of Health and Human 

Services (referred to in this section as the ‘‘Secretary’’) may 

make awards to eligible entities to establish pilot programs 

to develop, study, or evaluate model systems for monitoring 

and caring for childhood cancer survivors throughout their lifespan, including evaluation of models for transition to adult 

care and care coordination. 

(2) AWARDS.— 

(A) TYPES OF ENTITIES.—In making awards under this 

subsection, the Secretary shall, to the extent practicable, 

include— 

(i) small, medium, and large-sized eligible entities; 

and 

(ii) sites located in different geographic areas, 

including rural and urban areas. 

(B) ELIGIBLE ENTITIES.—In this subsection, the term 

‘‘eligible entity’’ means— 

(i) a medical school; 

(ii) a children’s hospital; 

(iii) a cancer center; 

(iv) a community-based medical facility; or 

(v) any other entity with significant experience 

and expertise in treating survivors of childhood cancers. 

(3) USE OF FUNDS.—Funds awarded under this subsection 

may be used— 

(A) to develop, study, or evaluate one or more models 

for monitoring and caring for cancer survivors; and 

(B) in developing, studying, and evaluating such 

models, to give special emphasis to— 

(i) design of models of follow-up care, monitoring, 

and other survivorship programs (including peer support and mentoring programs); 

(ii) development of models for providing multidisciplinary care; 
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(iii) dissemination of information to health care 

providers about culturally and linguistically appropriate follow-up care for cancer survivors and their 

families, as appropriate and practicable; 

(iv) development of psychosocial and support programs to improve the quality of life of cancer survivors 

and their families, which may include peer support 

and mentoring programs; 

(v) design of systems for the effective transfer of 

treatment information and care summaries from cancer 

care providers to other health care providers (including 

risk factors and a plan for recommended follow-up 

care); 

(vi) dissemination of the information and programs 

described in clauses (i) through (v) to other health 

care providers (including primary care physicians and 

internists) and to cancer survivors and their families, 

where appropriate and in accordance with Federal and 

State law; and 

(vii) development of initiatives that promote the 

coordination and effective transition of care between 

cancer care providers, primary care physicians, mental 

health professionals, and other health care professionals, as appropriate, including models that use a 

team-based or multi-disciplinary approach to care. 

(b) WORKFORCE DEVELOPMENT FOR HEALTH CARE PROVIDERS

ON MEDICAL AND PSYCHOSOCIAL CARE FOR CHILDHOOD CANCER

SURVIVORS.— 

(1) IN GENERAL.—The Secretary shall, not later than 1 

year after the date of enactment of this Act, conduct a review 

of the activities of the Department of Health and Human Services related to workforce development for health care providers 

who treat pediatric cancer patients and survivors. Such review 

shall include— 

(A) an assessment of the effectiveness of supportive 

psychosocial care services for pediatric cancer patients and 

survivors, including pediatric cancer survivorship care 

patient navigators and peer support programs; 

(B) identification of existing models relevant to providing medical and psychosocial services to individuals surviving pediatric cancers, and programs related to training 

for health professionals who provide such services to 

individuals surviving pediatric cancers; and 

(C) recommendations for improving the provision of 

psychosocial care for pediatric cancer survivors and 

patients. 

(2) REPORT.—Not later than 2 years after the date of enactment of this Act, the Secretary shall submit to the Committee 

on Health, Education, Labor, and Pensions of the Senate and 

Committee on Energy and Commerce of the House of Representatives, a report concerning the findings and recommendations 

from the review conducted under paragraph (1). 
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SEC. 202. GRANTS TO IMPROVE CARE FOR PEDIATRIC CANCER SURVIVORS. 

(a) IN GENERAL.—Section 417E of the Public Health Service 

Act (42 U.S.C. 285a–11), as amended by section 101, is further 

amended by striking subsection (b) and inserting the following: 

‘‘(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.’’. 

SEC. 203. BEST PRACTICES FOR LONG-TERM FOLLOW-UP SERVICES 

FOR PEDIATRIC CANCER SURVIVORS. 

The Secretary of Health and Human Services may facilitate 

the identification of best practices for childhood and adolescent 

cancer survivorship care, and, as appropriate, may consult with 

individuals who have expertise in late effects of disease and treatment of childhood and adolescent cancers, which may include— 

(1) oncologists, which may include pediatric oncologists; 

(2) primary care providers engaged in survivorship care; 

(3) survivors of childhood and adolescent cancer; 

(4) parents of children and adolescents who have been 

diagnosed with and treated for cancer and parents of longterm survivors; 

(5) nurses and social workers; 

(6) mental health professionals; 

(7) allied health professionals, including physical therapists 

and occupational therapists; and 
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(8) others, as the Secretary determines appropriate. 

SEC. 204. TECHNICAL AMENDMENT. 

(a) IN GENERAL.—Section 3 of the Hematological Cancer 

Research Investment and Education Act of 2002 (Public Law 107– 

172; 116 Stat. 541) is amended by striking ‘‘section 419C’’ and 

inserting ‘‘section 417C’’. 

(b) EFFECTIVE DATE.—The amendment made by subsection (a) 

shall take effect as if included in section 3 of the Hematological 

Cancer Research Investment and Education Act of 2002 (Public 

Law 107–172; 116 Stat. 541). 

Speaker of the House of Representatives. 

Vice President of the United States and

President of the Senate.