II 
114TH CONGRESS 
2D SESSION 
H. R. 3381 
IN THE SENATE OF THE UNITED STATES 
DECEMBER 7, 2016 
Received 
AN ACT 
To maximize discovery, and accelerate development and avail-
ability, of promising childhood cancer treatments, and 
for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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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: 
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(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-
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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. 
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(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-
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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— 
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(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 
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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. 
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‘‘(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.— 
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