,i #aacth ,,congress #ast ,session ,h4 ,r4 #bfjg ,,in ,,the ,,house ,,of ,,representatives ,june #bh1 #bjac ,mr4 ,van ,hollen 7for himself1 ,mr4 ,mc,caul1 ,mr4 ,upton1 ,ms4 ,speier1 ,mr4 ,reichert1 ,ms4 ,castor of ,florida1 ,mr4 ,king of ,new ,york1 ,mr4 ,waxman1 and ,mr4 ,harper7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to establish programs with respect to childhood1 adolescent1 and young adult cancer4 #a4 ,short title ,this ,act may be cited as the ,caroline ,pryce ,walker ,conquer ,childhood ,cancer ,reauthorization ,act4 #b4 ,findings ,congress finds as follows3 7#a7 ,every year1 #ac1ejj children in the ,united ,states are diagnosed with cancer4 7#b7 ,while the cure rates for some childhood cancers are now over #hj percent1 the survival rates for many types of cancers in children remain extremely low4 7#c7 ,according to the ,centers for ,disease ,control and ,prevention1 cancer continues to be the leading cause of death by disease in children and adolescents under the age of #ad4 7#d7 ,there are currently more than #cfj1jjj childhood cancer survivors living in the ,united ,states4 7#e7 ,as many as two-thirds of childhood cancer survivors experience at least one long-term health effect of their cancer treatment1 including secondary malignancies1 cardiopulmonary damage1 physical and intellectual developmental impairments1 endocrine disorders1 and others4 7#f7 ,collection of biospecimens and clinical and demographic data on the maximum possible number of children with cancer in the ,united ,states is necessary to improve childhood cancer treatments and cures4 ,currently biospecimens and some demographic data are collected for less than half of children with cancer4 #c4 ,comprehensive children's cancer biorepositories 7a7 ,in general ,section #dag;,e of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhe;a-#aa7 is amended-- 7#a7 by redesignating subsections 7c7 and 7d7 as subsections 7k7 and 7l71 respectively2 7#b7 by striking subsections 7a7 and 7b7 and inserting the following3 7a7 ,comprehensive children's cancer biorepositories ,the ,secretary1 acting through the ,director of ,,nih1 may make an award for a duration of at least #e years to an entity or entities described in subsection 7d7 to build upon existing initiatives to collect biospecimens and clinical and demographic information for at least #ij percent of all children1 adolescents1 and young adults with cancer in #a or more ,comprehensive ,children's ,cancer ,biorepositories to achieve a better understanding of the cause of such cancers and the effects of treatments for such cancers4 7b7 ,use of funds ,amounts received under the award under subsection 7a7 may be used to carry out the following3 7#a7 ,prospectively acquire1 preserve1 and store high-quality1 donated biospecimens and associated clinical and demographic information on children1 adolescents1 and young adults diagnosed with cancer in the ,united ,states4 7#b7 ,maintain a secure searchable database on stored biospecimens and associated clinical and demographic data from children1 adolescents1 and young adults with cancer for the conduct of research by scientists and qualified health care professionals4 7#c7 ,establish procedures for evaluating applications for access to such biospecimens and clinical and demographic data from researchers and other qualified health care professionals4 7#d7 ,make available and distribute 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 at a minimal cost4 7c7 ,no requirement ,no child1 adolescent1 or young adult with cancer shall be required to contribute a specimen to a ,biorepository or share clinical or demographic data4 7d7 ,application2 considerations 7#a7 ,application ,to be eligible to receive an award under subsection 7a7 an entity shall submit an application to the ,secretary at such a time1 in such a manner1 and containing such information as the ,secretary may reasonably require4 7#b7 ,considerations ,in evaluating the applications in paragraph 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 cancer4 7e7 ,privacy protections2 consent 7#a7 ,in general ,the ,secretary may not make an award under subsection 7a7 to an entity unless the ,secretary ensures that such entity-- 7,a7 collects biospecimens and associated clinical and demographic information from children with appropriate permission from parents or legal guardians in accordance with ,federal and ,state law2 and 7,b7 adheres to strict confidentiality to protect the identity and privacy of patients in accordance with ,federal and ,state law4 7#b7 ,consent ,the ,secretary shall establish an appropriate process for achieving consent from the patient1 parent1 or legal guardian4 7f7 ,single point of access2 standard data2 guidelines and oversight 7#a7 ,single point of access ,the ,secretary shall ensure that a ,biorepository established under subsection 7a7 has electronically searchable data for use by researchers and other qualified health care professionals in the manner and to the extent defined by the ,secretary4 7#b7 ,standard data ,the ,secretary shall require all recipients of an award under this section to make available a standard dataset for the purposes of paragraph 7#a7 in a standard electronic format that enables researchers and qualified health care professionals to search4 7#c7 ,guidelines and oversight ,the ,secretary shall develop and disseminate appropriate guidelines for the development and maintenance of the biorepositories authorized under this section1 including appropriate oversight4 7g7 ,definitions 7#a7 ,award ,the term award includes a grant1 contract1 cooperative agreement1 or other mechanism determined by the ,secretary4 7#b7 ,biospecimen ,the term biospecimen includes-- 7,a7 solid tumor tissue or bone marrow2 7,b7 normal or control tissue2 7,c7 blood_/plasma2 7,d7 ,,dna and ,,rna extractions2 7,e7 familial ,,dna2 and 7,f7 any other sample required by the ,secretary4 7#c7 ,clinical and demographic information ,the term clinical and demographic information shall include-- 7,a7 date of diagnosis2 7,b7 age at diagnosis2 7,c7 patient's gender1 race and ethnicity2 7,d7 extent of disease at enrollment2 7,e7 site of metastases2 7,f7 location of primary tumor coded2 7,g7 histologic diagnosis2 7,h7 tumor marker data when available2 7,i7 treatment and outcome data2 7,j7 information related to specimen quality2 and 7,k7 any other information required by the ,secretary4 7h7 ,coordination ,the ,secretary shall ensure that clinical and demographic information collected in accordance with this section is collected in coordination with the information collected under section #cii;,e-#a4 7i7 ,prohibition on use of funds ,funds made available under this section shall not be used to acquire1 preserve1 or maintain a biospecimen collected from a patient if such activity is already covered by funds available from the ,national ,cancer ,institute for such purpose4 7j7 ,report ,not later than #d years after the date of enactment of the ,caroline ,pryce ,walker ,conquer ,childhood ,cancer ,reauthorization ,act1 the ,secretary shall submit to ,congress a report on-- 7#a7 the number of biospecimens and corresponding clinical demographic data collected through the ,comprehensive ,children's ,cancer ,biorepositories established under subsection 7a72 7#b7 the number of biospecimens and corresponding clinical demographic data requested for use by researchers2 7#c7 any barriers to the collection of biospecimens and corresponding clinical demographic data2 7#d7 any 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 any recommendations with respect to improving the ,comprehensive ,children's ,cancer ,biorepository program under this section4 2 and 7#c7 in subsection 7l71 as so redesignated-- 7,a7 by striking #cj1jjj1jjj and inserting #aj1jjj1jjj2 and 7,b7 by striking #bjac and inserting #bjah4 7b7 ,improving ,childhood ,cancer ,surveillance ,section #cii;,e-#a of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhj;e-#c;a7 is amended-- 7#a7 by redesignating subsection 7b7 as subsection 7d72 and 7#b7 by striking subsection 7a7 and inserting the following3 7a7 ,in general ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall award grants to ,state cancer registries to enhance and expand infrastructure to track the epidemiology of cancer in children1 adolescents1 and young adults4 ,such registries shall be updated to include each occurrence of such cancers within a period of time designated by the ,secretary4 7b7 ,activities ,the grants described in subsection 7a7 may be used for-- 7#a7 identifying1 recruiting1 and training all potential sources for reporting childhood1 adolescent1 and young adult cancer cases2 7#b7 developing procedures to implement early inclusion of childhood1 adolescent1 and young adult cancer cases on ,state cancer registries through the use of electronic reporting2 7#c7 purchasing infrastructure to support the early inclusion of childhood1 adolescent1 and young adult cancer cases on such registries2 7#d7 submitting deidentified data to the ,centers for ,disease ,control and ,prevention for inclusion in a national database of childhood1 adolescent1 and young adult cancers2 and 7#e7 tracking the late effects of childhood1 adolescent1 and young adult cancers4 7c7 ,coordination ,the ,secretary shall ensure that information collected through ,state cancer registries under this section is collected in coordination with clinical and demographic information collected under section #dag;,e4 4 #d4 ,report to improve development of new drugs and biologic products to treat childhood cancers 7a7 ,in general ,not later than #b years after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall report to ,congress on barriers to studying oncologic therapies in pediatric populations under section #eje;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c74 7b7 ,content ,the report under subsection 7a7 shall include-- 7#a7 an assessment of the feasibility of requiring studies for a pediatric oncologic indication under section #eje;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7 if the therapeutic target of a drug or biologic product for an adult oncologic indication is highly relevant to any pediatric cancer to which it could apply2 7#b7 recommendations to overcome any barriers identified in the report on how to improve research1 development and access to new oncologic therapies for use in pediatric patients2 and 7#c7 an assessment of the potential impact of altering the exemption under subsection 7k7 of such section #eje;,b4 7c7 ,stakeholder ,input ,the report under subsection 7a7 shall be developed with input from relevant stakeholders4