Text: S.292 — 115th Congress (2017-2018)All Information (Except Text)

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Public Law No: 115-180 (06/05/2018)

 
[115th Congress Public Law 180]
[From the U.S. Government Publishing Office]



[[Page 1381]]

 CHILDHOOD CANCER SURVIVORSHIP, TREATMENT, ACCESS, AND RESEARCH ACT OF 
                                  2018

[[Page 132 STAT. 1382]]

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. <<NOTE: June 5, 2018 -  [S. 292]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, <<NOTE: Childhood Cancer 
Survivorship, Treatment, Access, and Research Act of 2018. 42 USC 201 
note.>> 
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 132 STAT. 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) <<NOTE: Procedures.>>  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 132 STAT. 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 132 STAT. 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) <<NOTE: Recommenda- tions.>>  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 132 STAT. 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 132 STAT. 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. <<NOTE: 42 USC 285a-11 note.>>  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 132 STAT. 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) <<NOTE: Deadline. Review.>>  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) <<NOTE: Assessment.>>  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) <<NOTE: Recommenda- tions.>>  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 132 STAT. 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) <<NOTE: Coordination.>>  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. <<NOTE: 42 USC 285a-11 note.>>  BEST PRACTICES FOR LONG-
                        TERM FOLLOW-UP SERVICES FOR PEDIATRIC 
                        CANCER SURVIVORS.

    The Secretary <<NOTE: Consultation.>>  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 132 STAT. 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) <<NOTE: 42 USC 285a-10.>>  is amended by striking ``section 419C'' 
and inserting ``section 417C''.

    (b) <<NOTE: 42 USC 285a-10 note.>>  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.

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