[United States Statutes at Large, Volume 132, 115th Congress, 2nd Session]
[From the U.S. Government Publishing Office, www.gpo.gov]
Public Law 115-180
115th Congress
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.
[[Page 1383]]
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
[[Page 1384]]
``(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--
[[Page 1385]]
``(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
[[Page 1386]]
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.
[[Page 1387]]
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;
[[Page 1388]]
(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).
[[Page 1389]]
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 long-term
survivors;
(5) nurses and social workers;
(6) mental health professionals;
(7) allied health professionals, including physical
therapists and occupational therapists; and
[[Page 1390]]
(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).
Approved June 5, 2018.
LEGISLATIVE HISTORY--S. 292:
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CONGRESSIONAL RECORD, Vol. 164 (2018):
Mar. 22, considered and passed Senate.
May 22, considered and passed House.
DAILY COMPILATION OF PRESIDENTIAL DOCUMENTS (2018):
June 5, Presidential remarks.