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 2016’’ 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. 
Sec. 2. Findings. 
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 Can-
cer Institute. 
Subtitle C—NIH Report on Childhood Cancer Activities 
Sec. 121. Reporting on childhood cancer research projects. 
TITLE II—MAXIMIZING DELIVERY: CARE, QUALITY OF LIFE, 
SURVIVORSHIP, AND CAREGIVER SUPPORT 
Subtitle A—Childhood Cancer Survivors’ Quality of Life Act 
Sec. 201. Cancer survivorship programs. 
Sec. 202. Grants to improve care for pediatric cancer survivors. 
Sec. 203. Comprehensive long-term follow-up services for pediatric cancer sur-
vivors. 
Sec. 204. Survivorship demonstration project. 
Subtitle B—Coverage and Payment of High Quality Care 
Sec. 211. Report by the Comptroller General. 
SEC. 2. FINDINGS. 
Congress makes the following findings:
(1) Each year in the United States there are an 
estimated 15,780 children between birth and the age 
of 19 diagnosed with cancer. Approximately 1 in 285 
children in the United States will be diagnosed with 
cancer before their 20th birthday. 
(2) In 1960, only 4 percent of children with 
cancer survived more than 5 years, but today, cure 
rates have increased to over 80 percent for children 
and adolescents under age 20. 
(3) While the cure rates for some childhood 
cancers are now over 80 percent, the survival rates 
for many types of cancers in children remain ex-
tremely low. 
(4) According to the Centers for Disease Con-
trol and Prevention, cancer continues to be the lead-
ing cause of death by disease in children and adoles-
cents under the age of 14. 
(5) By 2020, the population of childhood can-
cers survivors is expected to be 500,000 individuals. 
(6) As many as two-thirds of childhood cancer 
survivors are likely to experience at least one late ef-
fect of treatment, with as many as one-fourth expe-
riencing a late effect that is serious or life-threat-
ening. Common late effects of childhood cancer are 
neurocognitive, psychological, cardiopulmonary, en-
docrine, and musculoskeletal effects, secondary ma-
lignancies, and early death. 
(7) As a result of disparities in the delivery of 
cancer care, minority, low-income, and other medi-
cally underserved children are more likely to be diag-
nosed with late stage disease, experience poorer 
treatment outcomes, have shorter survival time with 
less quality of life, and experience a substantially 
greater likelihood of cancer death. 
(8) Collection of biospecimens, along with clin-
ical and outcome data, on children and adolescents 
with cancer in the United States is necessary to im-
prove childhood and adolescent cancer treatments 
and cures. Currently biospecimens, and clinical and 
outcome data, are collected for less than half of chil-
dren in the United States with cancer. 
(9) The late effects of cancer treatment may 
change as therapies evolve, which means that the 
monitoring and care of cancer survivors may need to 
be modified on a routine basis. 
(10) Despite the intense stress caused by child-
hood cancer, there is a lack of standardized and co-
ordinated psychosocial care for the children and 
their families, from the date of diagnosis through 
treatment and survivorship.
(11) The Institute of Medicine, in its report on 
cancer survivorship entitled ‘‘Childhood Cancer Sur-
vivorship: Improving Care and Quality of Life’’, 
states that an organized system of care and a meth-
od of care for pediatric cancer survivors is needed. 
(12) Focused and well-designed research and 
pilot health delivery programs can answer questions 
about the optimal ways to provide health care, fol-
low-up monitoring services, and survivorship care to 
those diagnosed with childhood cancer and con-
tribute to improvements in the quality of care and 
quality of life of those individuals through adult-
hood. 
(13) The National Institutes of Health, includ-
ing the National Cancer Institute, invest approxi-
mately half of their annual appropriations to support 
basic research that serves as the foundation for 
translational and clinical research for all diseases 
and conditions, with the potential to lead to break-
throughs for children with cancer. Virtually all 
progress against cancer—in both children and 
adults—has been founded in basic research, often in 
areas not directly related to the disease. 
(14) The National Cancer Institute supports a 
number of key research programs specifically to ad-
vance childhood cancer care, including precision 
medicine clinical trials for children with cancer, the 
Children’s Oncology Group (part of the National 
Clinical Trials Network of the National Cancer In-
stitute), the Pediatric Preclinical Testing Consor-
tium, the Pediatric Brain Tumor Consortium, the 
Childhood Cancer Survivor Study, the Therapeuti-
cally Applicable Research to Generate Effective 
Treatments program and related pediatric cancer 
genomics research (including the Pediatric MATCH 
Precision Medicine trial), and the Pediatric Oncology 
Branch (part of the intramural program of the Na-
tional Cancer Institute, whose mission is to develop 
new treatments for pediatric cancer). 
TITLE 
I—MAXIMIZING 
RE-
SEARCH 
THROUGH 
DIS-
COVERY 
Subtitle A—Caroline Pryce Walker 
Conquer Childhood Cancer Re-
authorization Act 
SEC. 101. CHILDREN’S CANCER BIOREPOSITORIES AND BIO-
SPECIMEN RESEARCH. 
Section 417E of the Public Health Service Act (42 
U.S.C. 285a–11) is amended—
(1) 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 initiatives to collect biospecimens and clin-
ical and demographic information with a goal of col-
lection for the vast majority of all children, adoles-
cents, and young adults with selected cancer 
subtypes (and their recurrences) for which current 
treatments are least effective, through one or more 
biospecimen research efforts designed to achieve a 
better understanding of the cause of such cancers 
(and their recurrences) and the effects 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) Acquire, preserve, and store high- 
quality, donated biospecimens and associated 
clinical and demographic information on chil-
dren, adolescents, and young adults diagnosed 
with cancer in the United States, focusing on 
children and adolescents enrolled in clinical
trials for whom current treatments are least ef-
fective. Activities under this subparagraph may 
include storage of biospecimens and associated 
clinical and demographic data at biorepositories 
supported by the National Cancer Institute, 
such as the Children’s Oncology Group Bio-
repository 
and 
the 
Pediatric 
Cooperative 
Human Tissue Network as well as through bio-
repositories established as appropriate to sup-
port the scientific needs of future research ef-
forts. 
‘‘(B) Make such information publicly avail-
able, including the repositories described in sub-
paragraph (A). 
‘‘(C) Maintain a secure searchable data-
base on stored biospecimens and associated 
clinical and demographic data from children, 
adolescents, and young adults with cancer for 
the conduct of research by scientists and quali-
fied health care professionals. 
‘‘(D) Establish procedures for evaluating 
applications for access to such biospecimens 
and clinical and demographic data from re-
searchers and other qualified health care pro-
fessionals.
‘‘(E) Make available and distribute bio-
specimens and clinical and demographic data 
from children, adolescents, and young adults 
with cancer to researchers and qualified health 
care professionals for peer-reviewed research at 
a minimal cost. 
‘‘(3) NO REQUIREMENT.—No child, adolescent, 
or young adult with cancer shall be required under 
this subsection to contribute a specimen to a bio-
repository or share clinical or demographic data. 
‘‘(4) APPLICATION; CONSIDERATIONS.— 
‘‘(A) APPLICATION.—To be eligible to re-
ceive 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 reason-
ably require. 
‘‘(B) CONSIDERATIONS.—In evaluating the 
applications in 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 demo-
graphic information for children, adolescents, 
and young adults with cancer. 
‘‘(5) PRIVACY PROTECTIONS; 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 associ-
ated clinical and demographic information 
from children and adolescents with appro-
priate permission from parents or legal 
guardians in accordance with Federal and 
State law; and 
‘‘(ii) adheres to strict confidentiality 
to protect the identity and privacy of pa-
tients in accordance with Federal and 
State law. 
‘‘(B) CONSENT.—The Secretary shall es-
tablish an appropriate process for achieving 
consent from the patient, parent, or legal 
guardian. 
‘‘(6) SINGLE
POINT
OF
ACCESS; STANDARD 
DATA; GUIDELINES AND OVERSIGHT.— 
‘‘(A) SINGLE POINT OF ACCESS.—The Sec-
retary shall ensure that each biorepository sup-
ported under paragraph (1) has electronically 
searchable data for use by researchers and 
other qualified health care professionals in the
manner and to the extent defined by the Sec-
retary. 
‘‘(B) STANDARD
DATA.—The Secretary 
shall require all recipients of an award under 
this section to make available a standard 
dataset for the purposes of subparagraph (A) in 
a standard electronic format that enables re-
searchers and qualified health care professionals 
to search. 
‘‘(C) GUIDELINES AND OVERSIGHT.—The 
Secretary shall develop and disseminate appro-
priate guidelines for the development and main-
tenance of the biorepositories supported under 
this section, including appropriate oversight. 
‘‘(7) COORDINATION.—The Secretary shall en-
sure that clinical and demographic information col-
lected in accordance with this section is collected in 
coordination with the information collected under 
section 399E–1. 
‘‘(8) PROHIBITION ON USE OF FUNDS.—Funds 
made available to carry out this subsection shall not 
be used to acquire, preserve, or maintain a biospeci-
men collected from a patient if such activity is al-
ready covered by funds available from the National 
Cancer Institute for such purpose.
‘‘(9) REPORT.—Not later than 4 years after the 
date of enactment of the Childhood Cancer Survivor-
ship, Treatment, Access, and Research Act of 2016, 
the Secretary shall submit to Congress a report on— 
‘‘(A) the number of biospecimens and cor-
responding clinical demographic data collected 
through the biospecimen research efforts sup-
ported under paragraph (1); 
‘‘(B) the number of biospecimens and cor-
responding clinical demographic data requested 
for use by researchers; 
‘‘(C) any barriers to the collection of bio-
specimens and corresponding clinical demo-
graphic data; 
‘‘(D) any barriers experienced by research-
ers or health care professionals in accessing the 
biospecimens and corresponding clinical demo-
graphic data necessary for use in research; and 
‘‘(E) any recommendations with respect to 
improving the biospecimen and biorepository re-
search efforts under this subsection. 
‘‘(10) DEFINITIONS.—For purposes of this sub-
section:
‘‘(A) AWARD.—The term ‘award’ includes 
a grant, contract, cooperative agreement, or 
other transaction determined by the Secretary. 
‘‘(B) BIOSPECIMEN.—The term ‘biospeci-
men’ includes— 
‘‘(i) solid tumor tissue or bone mar-
row; 
‘‘(ii) normal or control tissue; 
‘‘(iii) blood and plasma; 
‘‘(iv) DNA and RNA extractions; 
‘‘(v) familial DNA; and 
‘‘(vi) any other sample required by the 
Secretary. 
‘‘(C) CLINICAL AND DEMOGRAPHIC INFOR-
MATION.—The term ‘clinical and demographic 
information’ includes— 
‘‘(i) date of diagnosis; 
‘‘(ii) age at diagnosis; 
‘‘(iii) the patient’s gender, race, eth-
nicity, 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 avail-
able; 
‘‘(ix) treatment and outcome data; 
‘‘(x) information related to specimen 
quality; and 
‘‘(xi) any other information required 
by the Secretary.’’; and 
(2) in subsection (d)— 
(A) by striking ‘‘and section 399E–1’’ and 
inserting ‘‘and sections 317U, 399E–1, 417H, 
and 417H–1’’; 
(B) by striking ‘‘2009 through 2013’’ and 
inserting ‘‘2017 through 2021’’; and 
(C) by striking ‘‘such purpose’’ and insert-
ing ‘‘such purposes’’. 
SEC. 102. IMPROVING CHILDHOOD CANCER SURVEIL-
LANCE. 
Section 399E–1 of the Public Health Service Act (42 
U.S.C. 280e–3a) is amended— 
(1) by redesignating subsection (b) as sub-
section (d); and 
(2) by striking subsection (a) and inserting the 
following: 
‘‘(a) IN GENERAL.—The Secretary, acting through 
the Director of the Centers for Disease Control and Pre-
vention, may make awards to State cancer registries to 
enhance and expand infrastructure to track the epidemi-
ology of cancer in children, adolescents, and young adults. 
Such registries may be updated to include each occurrence 
of such cancers within a period of time designated by the 
Secretary. 
‘‘(b) ACTIVITIES.—The grants described in sub-
section (a) may be used for— 
‘‘(1) identifying, recruiting, and training all po-
tential sources for reporting childhood, adolescent, 
and young adult cancer cases; 
‘‘(2) developing procedures to implement early 
inclusion of childhood, adolescent, and young adult 
cancer cases on State cancer registries through the 
use of electronic reporting; 
‘‘(3) purchasing infrastructure to support the 
early inclusion of childhood, adolescent, and young 
adult cancer cases on such registries; 
‘‘(4) submitting deidentified data to the Centers 
for Disease Control and Prevention for inclusion in 
a national database of childhood, adolescent, and 
young adult cancers; and 
‘‘(5) tracking the late effects of childhood, ado-
lescent, and young adult cancers.
‘‘(c) COORDINATION.—The Secretary shall ensure 
that information collected through State cancer registries 
under this section is collected in coordination with clinical 
and demographic information collected under section 
417E(a) as appropriate.’’. 
Subtitle B—Pediatric Expertise at 
NIH 
SEC. 111. INCLUSION OF AT LEAST ONE PEDIATRIC 
ONCOLOGIST ON THE NATIONAL CANCER AD-
VISORY BOARD. 
Clause (iii) of section 406(h)(2)(A) of the Public 
Health and Service Act (42 U.S.C. 284a(h)(2)(A)) is 
amended to read as follows: 
‘‘(iii) of the members appointed to the Board— 
‘‘(I) not less than five members shall be in-
dividuals knowledgeable in environmental car-
cinogenesis (including carcinogenesis involving 
occupational and dietary factors); and 
‘‘(II) not less than one member shall be an 
individual knowledgeable in pediatric oncol-
ogy;’’.
SEC. 112. SENSE OF CONGRESS REGARDING PEDIATRIC EX-
PERTISE AT THE NATIONAL CANCER INSTI-
TUTE. 
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. 
Subtitle C—NIH Report on 
Childhood Cancer Activities 
SEC. 121. REPORTING ON CHILDHOOD CANCER RESEARCH 
PROJECTS. 
Section 409D(c)(3) of the Public Health Service Act 
(42 U.S.C. 284h(c)(3)) is amended by— 
(1) striking ‘‘public on’’ and inserting ‘‘public 
on— 
‘‘(A)’’; 
(2) striking the period at the end and inserting 
‘‘; and’’; and 
(3) inserting at the end the following: 
‘‘(B) childhood cancer research projects 
conducted or supported by the National Insti-
tutes of Health.’’.
TITLE 
II—MAXIMIZING 
DELIV-
ERY: CARE, QUALITY OF LIFE, 
SURVIVORSHIP, 
AND 
CARE-
GIVER SUPPORT 
Subtitle A—Childhood Cancer 
Survivors’ Quality of Life Act 
SEC. 201. CANCER SURVIVORSHIP PROGRAMS. 
(a) CANCER SURVIVORSHIP PROGRAMS.—The Public 
Health Service Act is amended by inserting after section 
399N of such Act (42 U.S.C. 280g–2) the following: 
‘‘SEC. 399N–1. PILOT PROGRAMS TO EXPLORE MODEL SYS-
TEMS OF CARE FOR PEDIATRIC CANCER SUR-
VIVORS. 
‘‘(a) IN GENERAL.—Not later than 1 year after the 
date of enactment of this section, 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 shared care and medical 
home and clinic based models for transition to adult care. 
‘‘(b) ELIGIBLE ENTITIES.—In this section, the term 
‘eligible entity’ means— 
‘‘(1) a medical school; 
‘‘(2) a children’s hospital; 
‘‘(3) a cancer center;
‘‘(4) a community-based medical facility; or 
‘‘(5) any other entity with significant experience 
and expertise in treating survivors of childhood can-
cers. 
‘‘(c) USE OF FUNDS.—The Secretary may make an 
award under this section to an eligible entity only if the 
entity agrees— 
‘‘(1) to use the award to establish a pilot pro-
gram to develop, study, or evaluate one or more 
model systems for monitoring and caring for cancer 
survivors; and 
‘‘(2) in developing, studying, and evaluating 
such systems, to give special emphasis to the fol-
lowing: 
‘‘(A) Design of protocols for different mod-
els of follow-up care, monitoring, and other sur-
vivorship programs (including peer support and 
mentoring programs). 
‘‘(B) Development of various models for 
providing multidisciplinary care. 
‘‘(C) Dissemination of information and the 
provision of training to health care providers 
about how to provide linguistically and cul-
turally competent follow-up care and monitoring 
to cancer survivors and their families.
‘‘(D) Development of psychosocial inter-
ventions and support programs to improve the 
quality of life of cancer survivors and their fam-
ilies. 
‘‘(E) 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). 
‘‘(F) Dissemination of the information and 
programs described in subparagraphs (A) 
through (E) to other health care providers (in-
cluding primary care physicians and internists) 
and to cancer survivors and their families, 
where appropriate. 
‘‘(G) Development of initiatives that pro-
mote the coordination and effective transition of 
care between cancer care providers, primary 
care physicians, and mental health profes-
sionals. 
‘‘SEC. 
399N–2. 
WORKFORCE 
DEVELOPMENT 
COLLABO-
RATIVE ON MEDICAL AND PSYCHOSOCIAL 
CARE FOR CHILDHOOD CANCER SURVIVORS. 
‘‘(a) IN GENERAL.—The Secretary shall, not later 
than 1 year after the date of enactment of this Act, con-
vene a Workforce Development Collaborative on Medical 
and Psychosocial Care for Pediatric Cancer Survivors (re-
ferred to in this paragraph as the ‘Collaborative’). The 
Collaborative shall be a cross-specialty, multidisciplinary 
group composed of educators, consumer and family advo-
cates, and providers of psychosocial and biomedical health 
services. 
‘‘(b) GOALS AND REPORTS.—The Collaborative shall 
submit to the Secretary a report establishing a plan to 
meet the following objectives for medical and psychosocial 
care workforce development: 
‘‘(1) Identifying, refining, and broadly dissemi-
nating to health care educators information about 
workforce competencies, models, and curricula rel-
evant to providing medical and psychosocial services 
to persons surviving pediatric cancers. 
‘‘(2) Adapting curricula for continuing edu-
cation of the existing workforce using efficient work-
place-based learning approaches. 
‘‘(3) Developing the skills of faculty and other 
trainers in teaching psychosocial health care using 
evidence-based teaching strategies. 
‘‘(4) Strengthening the emphasis on psycho-
social health care in educational accreditation stand-
ards and professional licensing and certification
exams by recommending revisions to the relevant 
oversight organizations. 
‘‘(5) Evaluating the effectiveness of patient 
navigators in pediatric cancer survivorship care. 
‘‘(6) Evaluating the effectiveness of peer sup-
port programs in the psychosocial care of pediatric 
cancer patients and survivors.’’. 
(b) TECHNICAL AMENDMENT.— 
(1) 
IN
GENERAL.—Section 
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’’. 
(2) EFFECTIVE DATE.—The amendment made 
by paragraph (1) shall take effect as if included in 
section 3 of the Hematological Cancer Research In-
vestment and Education Act of 2002 (Public Law 
107–172; 116 Stat. 541). 
SEC. 202. GRANTS TO IMPROVE CARE FOR PEDIATRIC CAN-
CER 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— 
(1) in the section heading, by striking ‘‘RE-
SEARCH AND AWARENESS’’ and inserting ‘‘RE-
SEARCH, AWARENESS, AND
SURVIVORSHIP’’; 
and 
(2) by striking subsection (b) and inserting the 
following: 
‘‘(b) IMPROVING CARE FOR PEDIATRIC CANCER SUR-
VIVORS.— 
‘‘(1) RESEARCH ON CAUSES OF HEALTH DIS-
PARITIES IN PEDIATRIC CANCER SURVIVORSHIP.— 
‘‘(A) RESEARCH
AWARDS.—The Director 
of NIH, in coordination with ongoing research 
activities, may conduct or support pediatric 
cancer survivorship research including any of 
the following areas: 
‘‘(i) Needs and outcomes of pediatric 
cancer survivors within minority or other 
medically underserved populations. 
‘‘(ii) Health disparities in pediatric 
cancer survivorship outcomes within minor-
ity or other medically underserved popu-
lations. 
‘‘(iii) Barriers that pediatric cancer 
survivors within minority or other medi-
cally underserved populations face in re-
ceiving follow-up care.
‘‘(iv) Familial, socioeconomic, and 
other environmental factors and the impact 
of such factors on treatment outcomes and 
survivorship. 
‘‘(B) 
BALANCED
APPROACH.—In 
sup-
porting research under subparagraph (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 psycho-
logical needs of such survivors, as appropriate. 
‘‘(2) RESEARCH ON LATE EFFECTS AND FOL-
LOW-UP
CARE
FOR
PEDIATRIC
CANCER
SUR-
VIVORS.—The Director of NIH, in coordination with 
ongoing research activities, may conduct or support 
research on follow-up care for pediatric cancer sur-
vivors, including any of the following areas: 
‘‘(A) The development of indicators used 
for long-term patient tracking and analysis of 
the late effects of cancer treatment for pediatric 
cancer survivors. 
‘‘(B) The identification of risk factors as-
sociated with the late effects of cancer treat-
ment.