    [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:
    ---------------------------------------------------------------------------

    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.