[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 292 Engrossed in Senate (ES)]

<DOC>
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
115th CONGRESS
  2d Session
                                 S. 292

_______________________________________________________________________

                                 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).

            Passed the Senate March 22, 2018.

            Attest:

                                                             Secretary.
115th CONGRESS

  2d Session

                                 S. 292

_______________________________________________________________________

                                 AN ACT

To maximize discovery, and accelerate development and availability, of 
     promising childhood cancer treatments, and for other purposes.