[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 292 Enrolled Bill (ENR)]

        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.

             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
                ``(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--
            ``(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 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.

        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;
                (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).
    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
        (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.