,,ii #aahth ,,congress #b;d ,session ,s4 #dgci ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,july #bc1 #bjbd,mr4 ,blumenthal 7for himself1 ,mr4 ,reed1 ,mr4 ,barrasso1 and ,mr4 ,rounds7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to advance research to achieve medical breakthroughs in brain tumor treatment and improve awareness and adequacy of specialized cancer and brain tumor care4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,bolstering ,research ,and ,innovation ,now ,act or the ,,brain ,act4 7b7 ,table of contents ,the table of contents of this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4,sec4 #b4 ,findings2 purposes4,sec4 #c4 ,fostering transparency of biospecimen collections for brain cancer research4,sec4 #d4 ,glioblastoma ,therapeutics ,network2 brain tumor ,,car-,t team science award4,sec4 #e4 ,clinical trials and biomarker testing national public awareness campaign4,sec4 #f4 ,pilot programs to develop1 study1 or evaluate approaches to monitoring and caring for brain tumor survivors4,sec4 #g4 ,,fda guidance to ensure brain tumor patient access to clinical trials4 #b4 ,findings2 purposes 7a7 ,findings ,congress finds as follows3 7#a7 ,according to the ,national ,brain ,tumor ,society based on data analyzed in #bjbd1 more than #a1jjj1jjj people in the ,united ,states are living with a brain tumor and approximately #id1jjj were estimated to be diagnosed with a primary brain tumor in #bjbc4 7#b7 ,brain tumors do not discriminate and can affect people of all races1 genders1 and ages4 ,tragically1 pediatric brain tumors are the leading cause of cancer-related death among children and young adults ages #ai and younger4 7#c7 ,for malignant brain tumors1 incidence and survival rates have remained stagnant for #de years1 with an average #e-year relative survival rate of #ce4g percent and only #f4i percent for glioblastoma1 the most common primary malignant brain tumor4 7#d7 ,most primary brain tumors are non-malignant1 but many still require surgery and radiation4 ,the results of available treatment options can vary from a successful return to normal life to possible disability or a life-threatening condition4 7#e7 ,despite the statistics described in paragraphs 7#a7 through 7#d71 there have been very few treatments ever approved by the ,food and ,drug ,administration to treat brain tumors1 thereby resulting in little change in mortality rates for individuals with brain tumors4 7#f7 ,as of the date of enactment of this ,act1 there is no prevention and no early detection protocol for brain tumors4 7#g7 ,all people in the ,united ,states have a stake in reducing and eliminating brain tumors4 7#h7 ,patients living with a brain tumor and their families want cures4 ,short of cures1 they want safe and effective ways to increase survival rates for such patients and improve the quality of life for such patients4 7b7 ,purposes ,the purposes of this ,act are to-- 7#a7 strengthen research and treatment development regarding brain tumors2 and 7#b7 improve the adequacy and awareness of and access to specialized brain tumor health care4 #c4 ,fostering transparency of biospecimen collections for brain cancer research ,part ,a of title ,,iv of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bha et seq47 is amended by adding at the end the following3 #djd,p4 ,reporting of brain tumor biospecimen collections 7a7 ,definition of covered biospecimen collection 7#a7 ,in general ,in this section1 the term covered biospecimen collection means a biospecimen that was collected or acquired in whole or in part through funding from the ,national ,institutes of ,health4 7#b7 ,biospecimen ,for purposes of paragraph 7#a71 the term biospecimen means a brain tumor tissue1 cerebral spinal fluid1 or other specimen type listed by the ,specimen ,resource ,locator of the ,national ,cancer ,institute 7or a successor database74 7b7 ,establishment ,the ,secretary1 acting through the ,director of ,,nih1 may establish and maintain a searchable website1 or multiple websites1 which may include websites existing on the day before the date of enactment of this section1 for the purpose of making accessible to the public-- 7#a7 information on the existence and location of covered biospecimen collections2 7#b7 a description of such collections2 and 7#c7 contact information with respect to such collections4 7c7 ,reporting requirements 7#a7 ,existing collections ,any individual or entity that as of the date of enactment of this section maintains a covered biospecimen collection shall1 not later than #ahj days after such date of enactment1 submit a report to the ,director of ,,nih containing information with respect to such covered biospecimen collection as the ,director of ,,nih may specify1 including at a minimum the information the ,national ,cancer ,institute requires for the ,specimen ,resource ,locator 7or a successor database74 7#b7 ,new collections ,any individual or entity that collects or acquires a covered biospecimen collection on or after the date of enactment of this section shall1 not later than #fj days after the date of such collection or acquisition1 submit a report to the ,director of ,,nih containing the information required under paragraph 7#a74 7d7 ,oversight ,the ,secretary1 acting through the ,director of ,,nih1 shall establish and carry out an oversight mechanism1 which shall include withholding funding to individuals or entities that have committed a repeated or egregious violation of the requirements under subsection 7c74 4 #d4 ,glioblastoma ,therapeutics ,network2 brain tumor ,,car-,t team science award 7a7 ,in general ,subpart #a of part ,c of title ,,iv of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhe et seq47 is amended by adding at the end the following3 #dag;,h4 ,glioblastoma ,therapeutics ,network 7a7 ,in general ,the ,director of the ,institute shall carry out a research program1 known as the ,glioblastoma ,therapeutics ,network1 by awarding1 on a competitive basis1 cooperative agreements1 or other awards1 through the ,u#ai funding mechanism of the ,national ,institutes of ,health for collaboration of institutions to improve the treatment of glioblastoma by evaluating therapeutic agents from pre-clinical development studies through completion of early-phase clinical trials in humans4 7b7 ,authorization of appropriations ,there is authorized to be appropriated #ej1jjj1jjj for each of fiscal years #bjbf through #bjcj1 to remain available until expended1 to the ,director of the ,institute to carry out this section4 #dag;,i4 ,brain tumor ,,car-,t team science award 7a7 ,in general ,in order to take advantage of significant advancement in the development of chimeric antigen receptor-,t 7,,car-,t7 cell therapy approaches in cancer1 including many such approaches previously funded by the ,national ,institutes of ,health1 the ,director of the ,institute shall make awards1 on a competitive basis1 through a ,u series funding mechanism1 to support the development of a multi-institutional team science approach to using ,,car-,t treatment for adult and pediatric brain tumors4 7b7 ,use of funds ,funds received through an award under this section shall be used-- 7#a7 to support collaborative multi-institutional research activities1 including pre-clinical and investigational new drug studies2 and 7#b7 for the purpose of supporting clinical trials to evaluate ,,car-,t therapeutic approaches to treating brain tumors4 7c7 ,authorization of appropriations ,there is authorized to be appropriated #aj1jjj1jjj for each of fiscal years #bjbf through #bjcj1 to remain available until expended1 to the ,director of the ,institute to carry out this section4 4 7b7 ,transition for the ,glioblastoma ,therapeutics ,network ,the ,director of the ,national ,cancer ,institute shall take such steps as may be necessary for the orderly transition from the ,glioblastoma ,therapeutics ,network carried out by the ,director1 as of the day before the date of enactment of this ,act1 to the research program authorized under section #dag;,h of the ,public ,health ,service ,act1 as added by subsection 7a74 ,in making such transition1 the ,director shall ensure that the program authorized under such section #dag;,h is based upon and consistent with the policies and procedures of the ,glioblastoma ,therapeutics ,network carried out by the ,director as of the day before the date of enactment of this ,act4 #e4 ,clinical trials and biomarker testing national public awareness campaign ,part ,p of title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhj;g et seq47 is amended by adding at the end the following3 #cii,v-#h4 ,clinical trials and biomarker testing national public awareness campaign 7a7 ,national campaign 7#a7 ,in general ,the ,secretary shall carry out a national campaign to increase the awareness and knowledge of health care providers and individuals with respect to the importance of clinical trials in the treatment of cancer4 7#b7 ,activities 7,a7 ,in general ,activities under such national campaign shall include each of the following3 7i7 ,written materials ,maintaining a supply of written and digital materials that provide information to the public on clinical trials1 and distributing such materials to members of the public upon request4 7ii7 ,public service announcements2 public engagement ,providing public service announcements1 in accordance with applicable law1 including through publishing materials in digital or print form1 and carrying out other public engagement initiatives4 ,such public service announcements and other public engagement initiatives shall include such announcements and initiatives intended to encourage individuals to discuss with their physicians-- 7,i7 what clinical trials are2 7,,ii7 the importance of clinical trials in the treatment of cancer2 7,,iii7 how to enroll in clinical trials2 7,,iv7 what biomarker testing is2 7,v7 the importance of biomarker testing in the treatment of cancer2 and 7,,vi7 how to access biomarker testing4 7,b7 ,targeted populations ,the ,secretary shall ensure that the national campaign includes communications1 including public service announcements and other public engagement initiatives under subparagraph 7,a77ii71 that are-- 7i7 culturally and linguistically competent2 and 7ii7 targeted to-- 7,i7 specific populations that are at a higher risk of cancer1 including such populations based on factors including race1 ethnicity1 level of acculturation1 and family history2 7,,ii7 rural communities2 and 7,,iii7 such other communities as the ,secretary determines appropriate4 7#c7 ,consultation ,in carrying out the national campaign under this subsection1 the ,secretary shall consult with-- 7,a7 health care providers2 7,b7 nonprofit organizations2 7,c7 ,state and local public health departments2 and 7,d7 elementary and secondary schools and institutions of higher education4 7b7 ,demonstration projects regarding outreach and education strategies for cancer and brain tumor patients 7#a7 ,in general ,the ,secretary shall carry out a program to award grants or contracts to public or nonprofit private entities for the purpose of carrying out demonstration projects to test1 compare1 and evaluate different evidence-based outreach and education strategies to increase the awareness and knowledge of cancer1 including brain tumor biomarker testing and brain tumor clinical trials4 ,such projects shall focus on the awareness and knowledge of patients 7and the families of patients71 physicians1 nurses1 and other key health professionals involved in brain tumor treatment4 7#b7 ,awards ,in making awards under paragraph 7#a71 the ,secretary shall-- 7,a7 ensure that information provided through demonstration projects supported by such an award is consistent with the best available medical information2 and 7,b7 give preference to-- 7i7 applicants with demonstrated expertise in-- 7,i7 biomarker testing and clinical trials in brain tumors and other recalcitrant cancers2 7,,ii7 brain cancer and other recalcitrant cancer education or treatment2 7,,iii7 working with groups of patients and caregivers2 and 7,,iv7 reaching geographic areas that have historically low rates of participation in cancer clinical trials2 and 7ii7 applicants that demonstrate in their application submitted under paragraph 7#c7 that the project for which they are seeking a grant or contract will involve and connect physicians1 nurses1 other key health professionals1 health profession students1 hospitals1 and payers4 7#c7 ,applications ,to seek a grant or contract under this subsection1 an entity shall submit an application to the ,secretary in such form1 in such manner1 and containing such agreements1 assurances1 and information as the ,secretary may reasonably require4 7c7 ,authorization of appropriations ,for the purpose of carrying out this section1 there is authorized to be appropriated #aj1jjj1jjj for the period of fiscal years #bjbf through #bjcj4 4 #f4 ,pilot programs to develop1 study1 or evaluate approaches to monitoring and caring for brain tumor survivors ,part ,b of title ,,iv of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhd et seq47 is amended by adding at the end the following3 #dji,k4 ,pilot programs to develop1 study1 or evaluate approaches to monitoring and caring for brain tumor survivors 7a7 ,in general ,the ,director of ,,nih may1 as appropriate1 make awards to eligible entities to establish pilot programs to develop1 study1 or evaluate approaches1 including primary care1 for monitoring and caring for adult and pediatric brain tumor survivors throughout their lifespan1 including evaluating models for transition to post-treatment care and care coordination4 7b7 ,awards 7#a7 ,eligible entities 7,a7 ,in general ,for purposes of this section1 an eligible entity is-- 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 carrying out the activities described in subsection 7a74 7,b7 ,types of entities ,awards under this section shall be made1 to the extent practical1 to-- 7i7 small1 medium1 and large-sized eligible entities2 and 7ii7 sites located in different geographic areas1 including rural and urban areas4 7#b7 ,peer review ,in making awards under this section1 the ,director of ,,nih shall comply with the peer review requirements in section #dib4 7#c7 ,use of funds ,funds from awards under this section may be used to develop1 study1 or evaluate one or more models for monitoring and caring for brain tumor survivors1 which may include-- 7,a7 evaluating follow-up care1 educational accommodations1 monitoring1 and other survivorship programs 7including peer support and mentoring programs72 7,b7 developing and evaluating models for providing multidisciplinary care2 7,c7 disseminating information to health care providers about culturally and linguistically appropriate follow-up care for brain tumor survivors and their families1 as appropriate and practicable2 7,d7 developing and evaluating existing psychosocial evaluations1 counseling1 and support programs to improve the quality of life of brain tumor survivors and their families1 which may include peer support and mentoring programs2 7,e7 designing and evaluating tools to support the secure electronic transfer of treatment information and care summaries from brain tumor care providers to other health care providers 7including primary care providers71 which information and care summaries shall include risk factors and a plan for recommended follow-up care2 7,f7 developing and evaluating initiatives that promote the coordination and effective transition of care between brain tumor care providers1 primary care providers1 mental health professionals1 and other health care professionals1 as appropriate1 including models that use a team-based or multi-disciplinary approach to care2 and 7,g7 disseminating information described in subparagraphs 7,a7 through 7,f71 including with respect to models1 evaluations1 programs1 systems1 and initiatives described in such subparagraphs1 to other health care providers 7including primary care providers7 and to pediatric brain tumor survivors and their families1 where appropriate and in accordance with ,federal and ,state law4 7c7 ,authorization of appropriations ,there are authorized to be appropriated to carry out this section #e1jjj1jjj for each of fiscal years #bjbf through #bjcj4 4 #g4 ,,fda guidance to ensure brain tumor patient access to clinical trials ,not later than #a year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall issue guidance to help identify ways to minimize the potential for the exclusion of brain tumor patients and patients with rare and recalcitrant cancers from clinical trials evaluating treatments for other indications4