#aaeth ,,congress #b;d ,session ,s4 #bib ,,an ,,act ,to maximize discovery1 and accelerate development and availability1 of promising childhood cancer treatments1 and for other purposes4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,childhood ,cancer ,survivorship1 ,treatment1 ,access1 and ,research ,act of #bjah or the ,childhood ,cancer ,,star ,act4 7b7 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4,,title ,i--,maximizing research through discovery,subtitle ,a--,caroline ,pryce ,walker ,conquer ,childhood ,cancer ,reauthorization ,act,sec4 #aja4 ,children's cancer biorepositories and biospecimen research4,sec4 #ajb4 ,improving ,childhood ,cancer ,surveillance4,subtitle ,b--,pediatric expertise at ,n,i,h,sec4 #aaa4 ,inclusion of at least one pediatric oncologist on the ,national ,cancer ,advisory ,board4,sec4 #aab4 ,sense of ,congress regarding pediatric expertise at the ,national ,cancer ,institute4,subtitle ,c--,,nih reporting on childhood cancer activities,sec4 #aba4 ,reporting on childhood cancer research projects4,,title ,,ii--,maximizing delivery3 care1 quality of life1 survivorship1 and caregiver support,sec4 #bja4 ,cancer survivorship programs4,sec4 #bjb4 ,grants to improve care for pediatric cancer survivors4,sec4 #bjc4 ,best practices for long-term follow-up services for pediatric cancer survivors4,sec4 #bjd4 ,technical amendment4 ,i ,maximizing research through discovery ,a ,caroline ,pryce ,walker ,conquer ,childhood ,cancer ,reauthorization ,act #aja4 ,children's cancer biorepositories and biospecimen research ,section #dag;,e of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhe;a-#aa7 is amended-- 7#a7 in the section heading1 by striking research and awareness and inserting research1 awareness1 and survivorship2 7#b7 by striking subsection 7a7 and inserting the following3 7a7 ,children's cancer biorepositories 7#a7 ,award ,the ,secretary1 acting through the ,director of ,,nih1 may make awards to an entity or entities described in paragraph 7#d7 to build upon existing research efforts to collect biospecimens and clinical and demographic information of children1 adolescents1 and young adults with selected cancer subtypes 7and their recurrences7 for which current treatments are least effective1 in order to achieve a better understanding of the causes of such cancer subtypes 7and their recurrences71 and the effects and outcomes of treatments for such cancers4 7#b7 ,use of funds ,amounts received under an award under paragraph 7#a7 may be used to carry out the following3 7,a7 ,collect and store high-quality1 donated biospecimens and associated clinical and demographic information on children1 adolescents1 and young adults diagnosed with cancer in the ,united ,states1 focusing on children1 adolescents1 and young adults with cancer enrolled in clinical trials for whom current treatments are least effective4 ,activities under this subparagraph may include storage of biospecimens and associated clinical and demographic data at existing biorepositories supported by the ,national ,cancer ,institute4 7,b7 ,maintain an interoperable1 secure1 and searchable database on stored biospecimens and associated clinical and demographic data from children1 adolescents1 and young adults with cancer for the purposes of research by scientists and qualified health care professionals4 7,c7 ,establish and implement procedures for evaluating applications for access to such biospecimens and clinical and demographic data from researchers and other qualified health care professionals4 7,d7 ,provide access to biospecimens and clinical and demographic data from children1 adolescents1 and young adults with cancer to researchers and qualified health care professionals for peer-reviewed research-- 7i7 consistent with the procedures established pursuant to subparagraph 7,c72 7ii7 only to the extent permitted by applicable ,federal and ,state law2 and 7iii7 in a manner that protects personal privacy to the extent required by applicable ,federal and ,state privacy law1 at minimum4 7#c7 ,no requirement ,no child1 adolescent1 or young adult with cancer shall be required under this subsection to contribute a specimen to a biorepository or share clinical or demographic data4 7#d7 ,application2 considerations 7,a7 ,application ,to be eligible to receive an award under paragraph 7#a7 an entity shall submit an application to the ,secretary at such a time1 in such manner1 and containing such information as the ,secretary may reasonably require4 7,b7 ,considerations ,in evaluating applications submitted under subparagraph 7,a71 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 children1 adolescents1 and young adults with cancer for whom current treatments are least effective4 7#e7 ,privacy protections and informed consent 7,a7 ,in general ,the ,secretary may not make an award under paragraph 7#a7 to an entity unless the ,secretary ensures that such entity-- 7i7 collects biospecimens and associated clinical and demographic information only from participants who have given their informed consent in accordance with ,federal and ,state law2 and 7ii7 protects personal privacy to the extent required by applicable ,federal and ,state law1 at minimum4 7,b7 ,informed consent ,the ,secretary shall ensure biospecimens and associated clinical and demographic information are collected with informed consent1 as described in subparagraph 7,a77i74 7#f7 ,guidelines and oversight ,the ,secretary shall develop and disseminate appropriate guidelines for the development and maintenance of the biorepositories supported under this subsection1 including appropriate oversight1 to facilitate further research on select cancer subtypes 7and their recurrences7 in children1 adolescents1 and young adults with such cancers 7and their recurrences74 7#g7 ,coordination ,to encourage the greatest possible efficiency and effectiveness of federally supported efforts with respect to the activities described in this subsection1 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 #cii;,e-#a1 as appropriate4 7#h7 ,supplement not supplant ,funds provided under this subsection shall be used to supplement1 and not supplant1 ,federal and non-,federal funds available for carrying out the activities described in this subsection4 7#i7 ,report ,not later than #d years after the date of enactment of the ,childhood ,cancer ,survivorship1 ,treatment1 ,access1 and ,research ,act of #bjah1 the ,secretary shall submit to ,congress a report on-- 7,a7 the number of biospecimens and corresponding clinical demographic data collected through the biospecimen research efforts supported under paragraph 7#a72 7,b7 the number of biospecimens and corresponding clinical demographic data requested for use by researchers2 7,c7 barriers to the collection of biospecimens and corresponding clinical demographic data2 7,d7 barriers experienced by researchers or health care professionals in accessing the biospecimens and corresponding clinical demographic data necessary for use in research2 and 7,e7 recommendations with respect to improving the biospecimen and biorepository research efforts under this subsection4 7#aj7 ,definitions ,for purposes of this subsection3 7,a7 ,award ,the term award includes a grant1 contract1 or cooperative agreement determined by the ,secretary4 7,b7 ,biospecimen ,the term biospecimen includes-- 7i7 solid tumor tissue or bone marrow2 7ii7 normal or control tissue2 7iii7 blood and plasma2 7iv7 ,,dna and ,,rna extractions2 7v7 familial ,,dna2 and 7vi7 any other sample relevant to cancer research1 as required by the ,secretary4 7,c7 ,clinical and demographic information ,the term clinical and demographic information includes-- 7i7 date of diagnosis2 7ii7 age at diagnosis2 7iii7 the patient's sex1 race1 ethnicity1 and environmental exposures2 7iv7 extent of disease at enrollment2 7v7 site of metastases2 7vi7 location of primary tumor coded2 7vii7 histologic diagnosis2 7viii7 tumor marker data when available2 7ix7 treatment and outcome data2 7x7 information related to specimen quality2 and 7xi7 any other applicable information required by the ,secretary4 2 and 7#c7 in subsection 7c71 by striking 7#db ,u4,s4,c4 #bjb note74 #ajb4 ,improving ,childhood ,cancer ,surveillance 7a7 ,in general ,section #cii;,e-#a of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhj;e-#c;a7 is amended-- 7#a7 in subsection 7a7-- 7,a7 by striking shall award a grant and inserting may make awards to ,state cancer registries2 and 7,b7 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 children1 adolescents1 and young adults2 and 7,c7 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 ,secretary42 7#b7 by redesignating subsection 7b7 as subsection 7d72 7#c7 by inserting after subsection 7a7 the following3 7b7 ,activities ,the grants described in subsection 7a7 may be used for-- 7#a7 identifying1 recruiting1 and training potential sources for reporting childhood1 adolescent1 and young adult cancer cases2 7#b7 developing practices to ensure early inclusion of childhood1 adolescent1 and young adult cancer cases in ,state cancer registries through the use of electronic reporting2 7#c7 collecting and submitting deidentified data to the ,centers for ,disease ,control and ,prevention for inclusion in a national database that includes information on childhood1 adolescent1 and young adult cancers2 and 7#d7 improving ,state cancer registries and the database described in paragraph 7#c71 as appropriate1 including to support the early inclusion of childhood1 adolescent1 and young adult cancer cases4 7c7 ,coordination ,to encourage the greatest possible efficiency and effectiveness of federally supported efforts with respect to the activities described in this section1 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 #dag;,e7a71 as appropriate4 2 and 7#d7 in subsection 7d71 as so redesignated1 by striking registry established pursuant to subsection 7a7 and inserting activities described in this section4 7b7 ,authorization of appropriations ,section #dag;,e7d7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhe;a-#aa7;d77 is amended-- 7#a7 by striking #bjji through #bjac and inserting #bjai through #bjbc2 and 7#b7 by striking the second sentence4 ,b ,pediatric expertise at ,,nih #aaa4 ,inclusion of at least one pediatric oncologist on the ,national ,cancer ,advisory ,board ,clause 7iii7 of section #djf7;h77#b77;,a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhd;a7h77#b77;,a77 is amended-- 7#a7 by striking ,board not less than five and inserting 8,board-- 7,i7 not less than #e 2 7#b7 by inserting and after the semicolon2 and 7#c7 by adding at the end the following3 7,,ii7 not less than one member shall be an individual knowledgeable in pediatric oncology2 4 #aab4 ,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 sections1 committees1 advisory groups1 and panels at the ,national ,cancer ,institute include one or more qualified pediatric oncologists1 as appropriate4 ,c ,,nih reporting on childhood cancer activities #aba4 ,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 ,congress1 which may include the ,pediatric ,research ,initiative report4 ,,ii ,maximizing delivery3 care1 quality of life1 survivorship1 and caregiver support #bja4 ,cancer survivorship programs 7a7 ,pilot programs ,to explore model systems of care for pediatric cancer survivors 7#a7 ,in general ,the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 may make awards to eligible entities to establish pilot programs to develop1 study1 or evaluate model systems for monitoring and caring for childhood cancer survivors throughout their lifespan1 including evaluation of models for transition to adult care and care coordination4 7#b7 ,awards 7,a7 ,types of entities ,in making awards under this subsection1 the ,secretary shall1 to the extent practicable1 include-- 7i7 small1 medium1 and large-sized eligible entities2 and 7ii7 sites located in different geographic areas1 including rural and urban areas4 7,b7 ,eligible entities ,in this subsection1 the term eligible entity means-- 7i7 a medical school2 7ii7 a children's hospital2 7iii7 a cancer center2 7iv7 a community-based medical facility2 or 7v7 any other entity with significant experience and expertise in treating survivors of childhood cancers4 7#c7 ,use of funds ,funds awarded under this subsection may be used-- 7,a7 to develop1 study1 or evaluate one or more models for monitoring and caring for cancer survivors2 and 7,b7 in developing1 studying1 and evaluating such models1 to give special emphasis to-- 7i7 design of models of follow-up care1 monitoring1 and other survivorship programs 7including peer support and mentoring programs72 7ii7 development of models for providing multidisciplinary care2 7iii7 dissemination of information to health care providers about culturally and linguistically appropriate follow-up care for cancer survivors and their families1 as appropriate and practicable2 7iv7 development of psychosocial and support programs to improve the quality of life of cancer survivors and their families1 which may include peer support and mentoring programs2 7v7 design of systems for the effective transfer of treatment information and care summaries from cancer care providers to other health care providers 7including risk factors and a plan for recommended follow-up care72 7vi7 dissemination of the information and programs described in clauses 7i7 through 7v7 to other health care providers 7including primary care physicians and internists7 and to cancer survivors and their families1 where appropriate and in accordance with ,federal and ,state law2 and 7vii7 development of initiatives that promote the coordination and effective transition of care between cancer care providers1 primary care physicians1 mental health professionals1 and other health care professionals1 as appropriate1 including models that use a team-based or multi-disciplinary approach to care4 7b7 ,workforce development for health care providers on medical and psychosocial care for childhood cancer survivors 7#a7 ,in general ,the ,secretary shall1 not later than #a year after the date of enactment of this ,act1 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 survivors4 ,such review shall include-- 7,a7 an assessment of the effectiveness of supportive psychosocial care services for pediatric cancer patients and survivors1 including pediatric cancer survivorship care patient navigators and peer support programs2 7,b7 identification of existing models relevant to providing medical and psychosocial services to individuals surviving pediatric cancers1 and programs related to training for health professionals who provide such services to individuals surviving pediatric cancers2 and 7,c7 recommendations for improving the provision of psychosocial care for pediatric cancer survivors and patients4 7#b7 ,report ,not later than #b years after the date of enactment of this ,act1 the ,secretary shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and ,committee on ,energy and ,commerce of the ,house of ,representatives1 a report concerning the findings and recommendations from the review conducted under paragraph 7#a74 #bjb4 ,grants to improve care for pediatric cancer survivors 7a7 ,in general ,section #dag;,e of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhe;a-#aa71 as amended by section #aja1 is further amended by striking subsection 7b7 and inserting the following3 7b7 ,improving care for pediatric cancer survivors 7#a7 ,research on pediatric cancer survivorship ,the ,director of ,,nih1 in coordination with ongoing research activities1 may continue to conduct or support pediatric cancer survivorship research including in any of the following areas3 7,a7 ,outcomes of pediatric cancer survivors1 including within minority or other medically underserved populations and with respect to health disparities of such outcomes4 7,b7 ,barriers to follow-up care for pediatric cancer survivors1 including within minority or other medically underserved populations4 7,c7 ,the impact of relevant factors1 which may include familial1 socioeconomic1 and other environmental factors1 on treatment outcomes and survivorship4 7,d7 ,the development of indicators used for long-term follow-up and analysis of the late effects of cancer treatment for pediatric cancer survivors4 7,e7 ,the identification of1 as applicable-- 7i7 risk factors associated with the late effects of cancer treatment2 7ii7 predictors of adverse neurocognitive and psychosocial outcomes2 and 7iii7 the molecular basis of long-term complications4 7,f7 ,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 cancer4 7#b7 ,balanced approach ,in conducting or supporting research under paragraph 7#a77;,a77i7 on pediatric cancer survivors within minority or other medically underserved populations1 the ,director of ,,nih shall ensure that such research addresses both the physical and the psychological needs of such survivors1 as appropriate4 4 #bjc4 ,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 care1 and1 as appropriate1 may consult with individuals who have expertise in late effects of disease and treatment of childhood and adolescent cancers1 which may include-- 7#a7 oncologists1 which may include pediatric oncologists2 7#b7 primary care providers engaged in survivorship care2 7#c7 survivors of childhood and adolescent cancer2 7#d7 parents of children and adolescents who have been diagnosed with and treated for cancer and parents of long-term survivors2 7#e7 nurses and social workers2 7#f7 mental health professionals2 7#g7 allied health professionals1 including physical therapists and occupational therapists2 and 7#h7 others1 as the ,secretary determines appropriate4 #bjd4 ,technical amendment 7a7 ,in general ,section #c of the ,hematological ,cancer ,research ,investment and ,education ,act of #bjjb 7,public ,law #ajg-agb2 #aaf ,stat4 #eda7 is amended by striking section #dai;,c and inserting section #dag;,c4 7b7 ,effective date ,the amendment made by subsection 7a7 shall take effect as if included in section #c of the ,hematological ,cancer ,research ,investment and ,education ,act of #bjjb 7,public ,law #ajg-agb2 #aaf ,stat4 #eda74 ,passed the ,senate ,march #bb1 #bjah4,secretary