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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 
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1 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

2 (a) SHORT TITLE.—This Act may be cited as the 

3 ‘‘Childhood Cancer Survivorship, Treatment, Access, and 

4 Research Act of 2018’’ or the ‘‘Childhood Cancer STAR 

5 Act’’. 

6 (b) TABLE OF CONTENTS.—The table of contents for 

7 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. 
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1 TITLE I—MAXIMIZING RE2 SEARCH THROUGH DIS3 COVERY 

4 Subtitle A—Caroline Pryce Walker 

5 Conquer Childhood Cancer Re6 authorization Act 

7 SEC. 101. CHILDREN’S CANCER BIOREPOSITORIES AND BIO8 SPECIMEN RESEARCH. 

9 Section 417E of the Public Health Service Act (42 

10 U.S.C. 285a–11) is amended— 

11 (1) in the section heading, by striking ‘‘RE12 SEARCH AND AWARENESS’’ and inserting ‘‘RE13 SEARCH, AWARENESS, AND SURVIVORSHIP’’; 

14 (2) by striking subsection (a) and inserting the 

15 following: 

16 ‘‘(a) CHILDREN’S CANCER BIOREPOSITORIES.— 

17 ‘‘(1) AWARD.—The Secretary, acting through 

18 the Director of NIH, may make awards to an entity 

19 or entities described in paragraph (4) to build upon 

20 existing research efforts to collect biospecimens and 

21 clinical and demographic information of children, 

22 adolescents, and young adults with selected cancer 

23 subtypes (and their recurrences) for which current 

24 treatments are least effective, in order to achieve a 

25 better understanding of the causes of such cancer 
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1 subtypes (and their recurrences), and the effects and 

2 outcomes of treatments for such cancers. 

3 ‘‘(2) USE OF FUNDS.—Amounts received under 

4 an award under paragraph (1) may be used to carry 

5 out the following: 

6 ‘‘(A) Collect and store high-quality, do7 nated biospecimens and associated clinical and 

8 demographic information on children, adoles9 cents, and young adults diagnosed with cancer 

10 in the United States, focusing on children, ado11 lescents, and young adults with cancer enrolled 

12 in clinical trials for whom current treatments 

13 are least effective. Activities under this sub14 paragraph may include storage of biospecimens 

15 and associated clinical and demographic data at 

16 existing biorepositories supported by the Na17 tional Cancer Institute. 

18 ‘‘(B) Maintain an interoperable, secure, 

19 and searchable database on stored biospecimens 

20 and associated clinical and demographic data 

21 from children, adolescents, and young adults 

22 with cancer for the purposes of research by sci23 entists and qualified health care professionals. 

24 ‘‘(C) Establish and implement procedures 

25 for evaluating applications for access to such 
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1 biospecimens and clinical and demographic data 

2 from researchers and other qualified health care 

3 professionals. 

4 ‘‘(D) Provide access to biospecimens and 

5 clinical and demographic data from children, 

6 adolescents, and young adults with cancer to re7 searchers and qualified health care professionals 

8 for peer-reviewed research— 

9 ‘‘(i) consistent with the procedures es10 tablished pursuant to subparagraph (C); 

11 ‘‘(ii) only to the extent permitted by 

12 applicable Federal and State law; and 

13 ‘‘(iii) in a manner that protects per14 sonal privacy to the extent required by ap15 plicable Federal and State privacy law, at 

16 minimum. 

17 ‘‘(3) NO REQUIREMENT.—No child, adolescent, 

18 or young adult with cancer shall be required under 

19 this subsection to contribute a specimen to a bio20 repository or share clinical or demographic data. 

21 ‘‘(4) APPLICATION; CONSIDERATIONS.— 

22 ‘‘(A) APPLICATION.—To be eligible to re23 ceive an award under paragraph (1) an entity 

24 shall submit an application to the Secretary at 

25 such a time, in such manner, and containing 
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1 such information as the Secretary may reason2 ably require. 

3 ‘‘(B) CONSIDERATIONS.—In evaluating ap4 plications submitted under subparagraph (A), 

5 the Secretary shall consider the existing infra6 structure of the entity that would allow for the 

7 timely capture of biospecimens and related clin8 ical and demographic information for children, 

9 adolescents, and young adults with cancer for 

10 whom current treatments are least effective. 

11 ‘‘(5) PRIVACY PROTECTIONS AND INFORMED

12 CONSENT.— 

13 ‘‘(A) IN GENERAL.—The Secretary may 

14 not make an award under paragraph (1) to an 

15 entity unless the Secretary ensures that such 

16 entity— 

17 ‘‘(i) collects biospecimens and associ18 ated clinical and demographic information 

19 only from participants who have given 

20 their informed consent in accordance with 

21 Federal and State law; and 

22 ‘‘(ii) protects personal privacy to the 

23 extent required by applicable Federal and 

24 State law, at minimum. 
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1 ‘‘(B) INFORMED CONSENT.—The Secretary 

2 shall ensure biospecimens and associated clin3 ical and demographic information are collected 

4 with informed consent, as described in subpara5 graph (A)(i). 

6 ‘‘(6) GUIDELINES AND OVERSIGHT.—The Sec7 retary shall develop and disseminate appropriate 

8 guidelines for the development and maintenance of 

9 the biorepositories supported under this subsection, 

10 including appropriate oversight, to facilitate further 

11 research on select cancer subtypes (and their 

12 recurrences) in children, adolescents, and young 

13 adults with such cancers (and their recurrences). 

14 ‘‘(7) COORDINATION.—To encourage the great15 est possible efficiency and effectiveness of federally 

16 supported efforts with respect to the activities de17 scribed in this subsection, the Secretary shall ensure 

18 the appropriate coordination of programs supported 

19 under this section with existing federally supported 

20 cancer registry programs and the activities under 

21 section 399E–1, as appropriate. 

22 ‘‘(8) SUPPLEMENT NOT SUPPLANT.—Funds 

23 provided under this subsection shall be used to sup24 plement, and not supplant, Federal and non-Federal 
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1 funds available for carrying out the activities de2 scribed in this subsection. 

3 ‘‘(9) REPORT.—Not later than 4 years after the 

4 date of enactment of the Childhood Cancer Survivor5 ship, Treatment, Access, and Research Act of 2018, 

6 the Secretary shall submit to Congress a report on— 

7 ‘‘(A) the number of biospecimens and cor8 responding clinical demographic data collected 

9 through the biospecimen research efforts sup10 ported under paragraph (1); 

11 ‘‘(B) the number of biospecimens and cor12 responding clinical demographic data requested 

13 for use by researchers; 

14 ‘‘(C) barriers to the collection of biospeci15 mens and corresponding clinical demographic 

16 data; 

17 ‘‘(D) barriers experienced by researchers 

18 or health care professionals in accessing the 

19 biospecimens and corresponding clinical demo20 graphic data necessary for use in research; and 

21 ‘‘(E) recommendations with respect to im22 proving the biospecimen and biorepository re23 search efforts under this subsection. 

24 ‘‘(10) DEFINITIONS.—For purposes of this sub25 section: 
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1 ‘‘(A) AWARD.—The term ‘award’ includes 

2 a grant, contract, or cooperative agreement de3 termined by the Secretary. 

4 ‘‘(B) BIOSPECIMEN.—The term ‘biospeci5 men’ includes— 

6 ‘‘(i) solid tumor tissue or bone mar7 row; 

8 ‘‘(ii) normal or control tissue; 

9 ‘‘(iii) blood and plasma; 

10 ‘‘(iv) DNA and RNA extractions; 

11 ‘‘(v) familial DNA; and 

12 ‘‘(vi) any other sample relevant to 

13 cancer research, as required by the Sec14 retary. 

15 ‘‘(C) CLINICAL AND DEMOGRAPHIC INFOR16 MATION.—The term ‘clinical and demographic 

17 information’ includes— 

18 ‘‘(i) date of diagnosis; 

19 ‘‘(ii) age at diagnosis; 

20 ‘‘(iii) the patient’s sex, race, ethnicity, 

21 and environmental exposures; 

22 ‘‘(iv) extent of disease at enrollment; 

23 ‘‘(v) site of metastases; 

24 ‘‘(vi) location of primary tumor coded; 

25 ‘‘(vii) histologic diagnosis; 
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1 ‘‘(viii) tumor marker data when avail2 able; 

3 ‘‘(ix) treatment and outcome data; 

4 ‘‘(x) information related to specimen 

5 quality; and 

6 ‘‘(xi) any other applicable information 

7 required by the Secretary.’’; and 

8 (3) in subsection (c), by striking ‘‘(42 U.S.C. 

9 202 note)’’. 

10 SEC. 102. IMPROVING CHILDHOOD CANCER SURVEIL11 LANCE. 

12 (a) IN GENERAL.—Section 399E–1 of the Public 

13 Health Service Act (42 U.S.C. 280e–3a) is amended— 

14 (1) in subsection (a)— 

15 (A) by striking ‘‘shall award a grant’’ and 

16 inserting ‘‘may make awards to State cancer 

17 registries’’; and 

18 (B) by striking ‘‘track the epidemiology of 

19 pediatric cancer into a comprehensive nation20 wide registry of actual occurrences of pediatric 

21 cancer’’ and inserting ‘‘collect information to 

22 better understand the epidemiology of cancer in 

23 children, adolescents, and young adults’’; and 

24 (C) by striking the second sentence and in25 serting ‘‘Such registries may be updated to in-
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1 clude each occurrence of such cancers within a 

2 period of time designated by the Secretary.’’; 

3 (2) by redesignating subsection (b) as sub4 section (d); 

5 (3) by inserting after subsection (a) the fol6 lowing: 

7 ‘‘(b) ACTIVITIES.—The grants described in sub8 section (a) may be used for— 

9 ‘‘(1) identifying, recruiting, and training poten10 tial sources for reporting childhood, adolescent, and 

11 young adult cancer cases; 

12 ‘‘(2) developing practices to ensure early inclu13 sion of childhood, adolescent, and young adult can14 cer cases in State cancer registries through the use 

15 of electronic reporting; 

16 ‘‘(3) collecting and submitting deidentified data 

17 to the Centers for Disease Control and Prevention 

18 for inclusion in a national database that includes in19 formation on childhood, adolescent, and young adult 

20 cancers; and 

21 ‘‘(4) improving State cancer registries and the 

22 database described in paragraph (3), as appropriate, 

23 including to support the early inclusion of childhood, 

24 adolescent, and young adult cancer cases. 
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1 ‘‘(c) COORDINATION.—To encourage the greatest 

2 possible efficiency and effectiveness of federally supported 

3 efforts with respect to the activities described in this sec4 tion, the Secretary shall ensure the appropriate coordina5 tion of programs supported under this section with other 

6 federally supported cancer registry programs and the ac7 tivities under section 417E(a), as appropriate.’’; and 

8 (4) in subsection (d), as so redesignated, by 

9 striking ‘‘registry established pursuant to subsection 

10 (a)’’ and inserting ‘‘activities described in this sec11 tion’’. 

12 (b) AUTHORIZATION OF APPROPRIATIONS.—Section 

13 417E(d) of the Public Health Service Act (42 U.S.C. 

14 285a–11(d)) is amended— 

15 (1) by striking ‘‘2009 through 2013’’ and in16 serting ‘‘2019 through 2023’’; and 

17 (2) by striking the second sentence. 

18 Subtitle B—Pediatric Expertise at 

19 NIH 

20 SEC. 111. INCLUSION OF AT LEAST ONE PEDIATRIC 

21 ONCOLOGIST ON THE NATIONAL CANCER AD22 VISORY BOARD. 

23 Clause (iii) of section 406(h)(2)(A) of the Public 

24 Health Service Act (42 U.S.C. 284a(h)(2)(A)) is amend25 ed— 
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1 (1) by striking ‘‘Board not less than five’’ and 

2 inserting ‘‘Board— 

3 ‘‘(I) not less than 5’’; 

4 (2) by inserting ‘‘and’’ after the semicolon; and 

5 (3) by adding at the end the following: 

6 ‘‘(II) not less than one member shall be an 

7 individual knowledgeable in pediatric oncol8 ogy;’’. 

9 SEC. 112. SENSE OF CONGRESS REGARDING PEDIATRIC EX10 PERTISE AT THE NATIONAL CANCER INSTI11 TUTE. 

12 It is the sense of Congress that the Director of the 

13 National Cancer Institute should ensure that all applicable 

14 study sections, committees, advisory groups, and panels 

15 at the National Cancer Institute include one or more 

16 qualified pediatric oncologists, as appropriate. 

17 Subtitle C—NIH Reporting on 

18 Childhood Cancer Activities 

19 SEC. 121. REPORTING ON CHILDHOOD CANCER RESEARCH 

20 PROJECTS. 

21 The Director of the National Institutes of Health 

22 shall ensure that childhood cancer research projects con23 ducted or supported by the National Institutes of Health 

24 are included in appropriate reports to Congress, which 

25 may include the Pediatric Research Initiative report. 
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1 TITLE II—MAXIMIZING DELIV2 ERY: CARE, QUALITY OF LIFE, 

3 SURVIVORSHIP, AND CARE4 GIVER SUPPORT 

5 SEC. 201. CANCER SURVIVORSHIP PROGRAMS. 

6 (a) PILOT PROGRAMS TO EXPLORE MODEL SYSTEMS

7 OF CARE FOR PEDIATRIC CANCER SURVIVORS.— 

8 (1) IN GENERAL.—The Secretary of Health and 

9 Human Services (referred to in this section as the 

10 ‘‘Secretary’’) may make awards to eligible entities to 

11 establish pilot programs to develop, study, or evalu12 ate model systems for monitoring and caring for 

13 childhood cancer survivors throughout their lifespan, 

14 including evaluation of models for transition to adult 

15 care and care coordination. 

16 (2) AWARDS.— 

17 (A) TYPES OF ENTITIES.—In making 

18 awards under this subsection, the Secretary 

19 shall, to the extent practicable, include— 

20 (i) small, medium, and large-sized eli21 gible entities; and 

22 (ii) sites located in different geo23 graphic areas, including rural and urban 

24 areas. 
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1 (B) ELIGIBLE ENTITIES.—In this sub2 section, the term ‘‘eligible entity’’ means— 

3 (i) a medical school; 

4 (ii) a children’s hospital; 

5 (iii) a cancer center; 

6 (iv) a community-based medical facil7 ity; or 

8 (v) any other entity with significant 

9 experience and expertise in treating sur10 vivors of childhood cancers. 

11 (3) USE OF FUNDS.—Funds awarded under 

12 this subsection may be used— 

13 (A) to develop, study, or evaluate one or 

14 more models for monitoring and caring for can15 cer survivors; and 

16 (B) in developing, studying, and evaluating 

17 such models, to give special emphasis to— 

18 (i) design of models of follow-up care, 

19 monitoring, and other survivorship pro20 grams (including peer support and men21 toring programs); 

22 (ii) development of models for pro23 viding multidisciplinary care; 

24 (iii) dissemination of information to 

25 health care providers about culturally and 
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1 linguistically appropriate follow-up care for 

2 cancer survivors and their families, as ap3 propriate and practicable; 

4 (iv) development of psychosocial and 

5 support programs to improve the quality of 

6 life of cancer survivors and their families, 

7 which may include peer support and men8 toring programs; 

9 (v) design of systems for the effective 

10 transfer of treatment information and care 

11 summaries from cancer care providers to 

12 other health care providers (including risk 

13 factors and a plan for recommended follow14 up care); 

15 (vi) dissemination of the information 

16 and programs described in clauses (i) 

17 through (v) to other health care providers 

18 (including primary care physicians and in19 ternists) and to cancer survivors and their 

20 families, where appropriate and in accord21 ance with Federal and State law; and 

22 (vii) development of initiatives that 

23 promote the coordination and effective 

24 transition of care between cancer care pro25 viders, primary care physicians, mental 
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1 health professionals, and other health care 

2 professionals, as appropriate, including 

3 models that use a team-based or multi-dis4 ciplinary approach to care. 

5 (b) WORKFORCE DEVELOPMENT FOR HEALTH CARE

6 PROVIDERS ON MEDICAL AND PSYCHOSOCIAL CARE FOR

7 CHILDHOOD CANCER SURVIVORS.— 

8 (1) IN GENERAL.—The Secretary shall, not 

9 later than 1 year after the date of enactment of this 

10 Act, conduct a review of the activities of the Depart11 ment of Health and Human Services related to 

12 workforce development for health care providers who 

13 treat pediatric cancer patients and survivors. Such 

14 review shall include— 

15 (A) an assessment of the effectiveness of 

16 supportive psychosocial care services for pedi17 atric cancer patients and survivors, including 

18 pediatric cancer survivorship care patient navi19 gators and peer support programs; 

20 (B) identification of existing models rel21 evant to providing medical and psychosocial 

22 services to individuals surviving pediatric can23 cers, and programs related to training for 

24 health professionals who provide such services 

25 to individuals surviving pediatric cancers; and 
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1 (C) recommendations for improving the 

2 provision of psychosocial care for pediatric can3 cer survivors and patients. 

4 (2) REPORT.—Not later than 2 years after the 

5 date of enactment of this Act, the Secretary shall 

6 submit to the Committee on Health, Education, 

7 Labor, and Pensions of the Senate and Committee 

8 on Energy and Commerce of the House of Rep9 resentatives, a report concerning the findings and 

10 recommendations from the review conducted under 

11 paragraph (1). 

12 SEC. 202. GRANTS TO IMPROVE CARE FOR PEDIATRIC CAN13 CER SURVIVORS. 

14 (a) IN GENERAL.—Section 417E of the Public 

15 Health Service Act (42 U.S.C. 285a–11), as amended by 

16 section 101, is further amended by striking subsection (b) 

17 and inserting the following: 

18 ‘‘(b) IMPROVING CARE FOR PEDIATRIC CANCER SUR19 VIVORS.— 

20 ‘‘(1) RESEARCH ON PEDIATRIC CANCER SURVI21 VORSHIP.—The Director of NIH, in coordination 

22 with ongoing research activities, may continue to 

23 conduct or support pediatric cancer survivorship re24 search including in any of the following areas: 
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1 ‘‘(A) Outcomes of pediatric cancer sur2 vivors, including within minority or other medi3 cally underserved populations and with respect 

4 to health disparities of such outcomes. 

5 ‘‘(B) Barriers to follow-up care for pedi6 atric cancer survivors, including within minority 

7 or other medically underserved populations. 

8 ‘‘(C) The impact of relevant factors, which 

9 may include familial, socioeconomic, and other 

10 environmental factors, on treatment outcomes 

11 and survivorship. 

12 ‘‘(D) The development of indicators used 

13 for long-term follow-up and analysis of the late 

14 effects of cancer treatment for pediatric cancer 

15 survivors. 

16 ‘‘(E) The identification of, as applicable— 

17 ‘‘(i) risk factors associated with the 

18 late effects of cancer treatment; 

19 ‘‘(ii) predictors of adverse 

20 neurocognitive and psychosocial outcomes; 

21 and 

22 ‘‘(iii) the molecular basis of long-term 

23 complications. 

24 ‘‘(F) The development of targeted inter25 ventions to reduce the burden of morbidity 
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1 borne by cancer survivors in order to protect 

2 such cancer survivors from the late effects of 

3 cancer. 

4 ‘‘(2) BALANCED APPROACH.—In conducting or 

5 supporting research under paragraph (1)(A)(i) on 

6 pediatric cancer survivors within minority or other 

7 medically underserved populations, the Director of 

8 NIH shall ensure that such research addresses both 

9 the physical and the psychological needs of such sur10 vivors, as appropriate.’’. 

11 SEC. 203. BEST PRACTICES FOR LONG-TERM FOLLOW-UP 

12 SERVICES FOR PEDIATRIC CANCER SUR13 VIVORS. 

14 The Secretary of Health and Human Services may 

15 facilitate the identification of best practices for childhood 

16 and adolescent cancer survivorship care, and, as appro17 priate, may consult with individuals who have expertise in 

18 late effects of disease and treatment of childhood and ado19 lescent cancers, which may include— 

20 (1) oncologists, which may include pediatric 

21 oncologists; 

22 (2) primary care providers engaged in survivor23 ship care; 

24 (3) survivors of childhood and adolescent can25 cer; 
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1 (4) parents of children and adolescents who 

2 have been diagnosed with and treated for cancer and 

3 parents of long-term survivors; 

4 (5) nurses and social workers; 

5 (6) mental health professionals; 

6 (7) allied health professionals, including phys7 ical therapists and occupational therapists; and 

8 (8) others, as the Secretary determines appro9 priate. 

10 SEC. 204. TECHNICAL AMENDMENT. 

11 (a) IN GENERAL.—Section 3 of the Hematological 

12 Cancer Research Investment and Education Act of 2002 

13 (Public Law 107–172; 116 Stat. 541) is amended by strik14 ing ‘‘section 419C’’ and inserting ‘‘section 417C’’. 

15 (b) EFFECTIVE DATE.—The amendment made by 

16 subsection (a) shall take effect as if included in section 

17 3 of the Hematological Cancer Research Investment and 

18 Education Act of 2002 (Public Law 107–172; 116 Stat. 

19 541). 

Passed the Senate March 22, 2018. 

Attest: 

Secretary. 
115TH CONGRESS 

2D SESSION S. 292 

AN ACT 

To maximize discovery, and accelerate development 

treatments, and for other purposes. and availability, of promising childhood cancer