[Congressional Record Volume 164, Number 50 (Thursday, March 22, 2018)]
[Senate]
[Pages S1975-S1977]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                       CHILDHOOD CANCER STAR ACT

  Mr. McCONNELL. Mr. President, I ask unanimous consent that the Senate 
proceed to the immediate consideration of Calendar No. 342, S. 292.
  The PRESIDING OFFICER. The clerk will report the bill by title.
  The senior assistant legislative clerk read as follows:

       A bill (S. 292) to maximize discovery, and accelerate 
     development and availability, of promising childhood cancer 
     treatments, and for other purposes.

  There being no objection, the Senate proceeded to consider the bill, 
which had been reported from the Committee on Health, Education, Labor, 
and Pensions, with an amendment to strike all after the enacting clause 
and insert in lieu thereof the following:

     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

[[Page S1976]]

     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

[[Page S1977]]

     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).
  Mr. McCONNELL. Mr. President, I ask unanimous consent that the 
committee-reported substitute amendment be agreed to; that the bill, as 
amended, be considered read a third time and passed; and that the 
motion to reconsider be considered made and laid upon the table.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The committee-reported amendment in the nature of a substitute was 
agreed to.
  The bill (S. 292), as amended, was ordered to be engrossed for a 
third reading, was read the third time, and passed.

                          ____________________