,,ib ,union ,calendar ,no4 #acd #aafth ,,congress #ast ,session ,h4 ,r4 #bejg ,report ,no4 #aaf-agd ,,in ,,the ,,house ,,of ,,representatives ,may #b1 #bjai ,ms4 ,roybal-,allard 7for herself1 ,mr4 ,simpson1 ,ms4 ,clark of ,massachusetts1 and ,ms4 ,herrera ,beutler7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,july #bc1 #bjai ,additional sponsors3 ,mr4 ,fitzpatrick1 ,mrs4 ,rodgers of ,washington1 ,ms4 ,norton1 ,mr4 ,raskin1 ,ms4 ,clarke of ,new ,york1 ,mr4 ,neguse1 ,mr4 ,watkins1 ,miss ,rice of ,new ,york1 ,mr4 ,stewart1 ,mrs4 ,dingell1 ,mr4 ,carter of ,texas1 ,mr4 ,case1 ,mr4 ,calvert1 ,mr4 ,gallego1 ,mr4 ,cole1 ,mr4 ,pappas1 ,mr4 ,fleischmann1 ,ms4 ,castor of ,florida1 ,mr4 ,lamborn1 ,ms4 ,shalala1 ,mr4 ,collins of ,new ,york1 ,ms4 ,blunt ,rochester1 ,mr4 ,grijalva1 ,mr4 ,kennedy1 ,mr4 ,ted ,lieu of ,california1 ,mr4 ,himes1 ,mr4 ,rush1 ,mr4 ,hastings1 ,mr4 ,higgins of ,new ,york1 ,mr4 ,soto1 ,ms4 ,kuster of ,new ,hampshire1 ,ms4 ,kelly of ,illinois1 ,mr4 ,welch1 ,mrs4 ,axne1 ,mr4 ,cohen1 ,mrs4 ,brooks of ,indiana1 ,mr4 ,rouda1 ,ms4 ,fudge1 ,mr4 ,stivers1 ,ms4 ,de,gette1 ,mrs4 ,davis of ,california1 ,mr4 ,hagedorn1 ,mr4 ,casten of ,illinois1 ,mr4 ,guthrie1 ,ms4 ,scanlon1 ,mr4 ,yarmuth1 and ,mr4 ,david ,scott of ,georgia ,july #bc1 #bjai ,reported with an amendment1 committed to the ,committee of the ,whole ,house on the ,state of the ,union1 and ordered to be printed ,strike out all after the enacting clause and insert the part printed in italic ,for text of introduced bill1 see copy of bill as introduced on ,may #b1 #bjai ,a ,,bill ,to amend the ,public ,health ,service ,act to reauthorize certain programs under part ,a of title ,,xi of such ,act relating to genetic diseases1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,newborn ,screening ,saves ,lives ,reauthorization ,act of #bjai4 #b4 ,improved newborn and child screening and follow-up for heritable disorders 7a7 ,purposes ,section #aaji7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;b-#h7;a77 is amended-- 7#a7 in paragraph 7#a71 by striking enhance1 improve or and inserting facilitate1 enhance1 improve1 or2 7#b7 by amending paragraph 7#c7 to read as follows3 7#c7 to develop1 and deliver to parents1 families1 and patient advocacy and support groups1 educational programs that-- 7,a7 address newborn screening counseling1 testing 7including newborn screening pilot studies71 follow-up1 treatment1 specialty services1 and long-term care2 7,b7 assess the target audience's current knowledge1 incorporate health communications strategies1 and measure impact2 and 7,c7 are at appropriate literacy levels2 2 and 7#c7 in paragraph 7#d7-- 7,a7 by striking followup and inserting follow-up2 and 7,b7 by inserting before the semicolon at the end the following3 1 including re-engaging patients who have not received recommended follow-up services and supports4 7b7 ,approval factors ,section #aaji7;c7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;b-#h7;c77 is amended-- 7#a7 by striking or will use and inserting will use2 and 7#b7 by inserting 1 or will use amounts received under such grant to enhance capacity and infrastructure to facilitate the adoption of1 before the guidelines and recommendations4 #c4 ,advisory committee on heritable disorders in newborns and children ,section #aaaa of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;b-#aj7 is amended-- 7#a7 in subsection 7b7-- 7,a7 in paragraph 7#e71 by inserting and adopt process improvements after take appropriate steps2 7,b7 in paragraph 7#g7 by striking and at the end2 7,c7 by redesignating paragraph 7#h7 as paragraph 7#i72 7,d7 by inserting after paragraph 7#g7 the following3 7#h7 develop1 maintain1 and publish on a publicly accessible website consumer-friendly materials detailing-- 7,a7 the uniform screening panel nomination process1 including data requirements1 standards1 and the use of international data in nomination submissions2 and 7,b7 the process for obtaining technical assistance for submitting nominations to the uniform screening panel and detailing the instances in which the provision of technical assistance would introduce a conflict of interest for members of the ,advisory ,committee2 and 2 7,e7 in paragraph 7#i71 as redesignated-- 7i7 by redesignating subparagraphs 7,k7 and 7,l7 as subparagraphs 7,l7 and 7,m71 respectively2 and 7ii7 by inserting after subparagraph 7,j7 the following3 7,k7 the appropriate and recommended use of safe and effective genetic testing by health care professionals in newborns and children with an initial diagnosis of a disease or condition characterized by a variety of genetic causes and manifestations2 2 and 7#b7 in subsection 7g7-- 7,a7 in paragraph 7#a7 by striking #bjai and inserting #bjbd2 and 7,b7 in paragraph 7#b7 by striking #bjai and inserting #bjbd4 #d4 ,clearinghouse of newborn screening information ,section #aaab7;c7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;b-#aa7;c77 is amended by striking and supplement1 not supplant1 existing information sharing efforts and inserting and complement other ,federal newborn screening information sharing activities4 #e4 ,laboratory quality and surveillance ,section #aaac of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;b-#ab7 is amended-- 7#a7 in subsection 7a7-- 7,a7 in paragraph 7#a7-- 7i7 by striking performance evaluation services1 and inserting development of new screening tests12 and 7ii7 by striking and at the end2 7,b7 in paragraph 7#b7-- 7i7 by striking performance test materials and inserting test performance materials2 and 7ii7 by striking the period at the end and inserting 2 and2 and 7,c7 by adding at the end the following3 7#c7 performance evaluation services to enhance disease detection1 including the development of tools1 resources1 and infrastructure to improve data analysis1 test result interpretation1 data harmonization1 and dissemination of laboratory best practices4 2 and 7#b7 in subsection 7b7 to read as follows3 7b7 ,surveillance activities ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 and taking into consideration the expertise of the ,advisory ,committee on ,heritable ,disorders in ,newborns and ,children established under section #aaaa1 shall provide for the coordination of national surveillance activities1 including-- 7#a7 standardizing data collection and reporting through the use of electronic and other forms of health records to achieve real-time data for tracking and monitoring the newborn screening system1 from the initial positive screen through diagnosis and long-term care management2 and 7#b7 by promoting data sharing linkages between ,state newborn screening programs and ,state-based birth defects and developmental disabilities surveillance programs to help families connect with services to assist in evaluating long-term outcomes4 4 #f4 ,hunter ,kelly research program ,section #aaaf of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;b-#ae7 is amended-- 7#a7 in subsection 7a77#a7-- 7,a7 by striking may and inserting shall2 and 7,b7 in subparagraph 7,d7-- 7i7 by inserting 1 or with a high probability of being recommended by1 after recommended by2 and 7ii7 by striking that screenings are ready for nationwide implementation and inserting that reliable newborn screening technologies are evaluated and ready for use2 and 7#b7 in subsection 7b7 to read as follows3 7b7 ,funding ,in carrying out the research program under this section1 the ,secretary and the ,director-- 7#a7 shall ensure that entities receiving funding through the program will provide assurances1 as practicable1 that such entities will work in consultation with the appropriate ,state departments of health2 and 7#b7 may accept1 use1 and dispose of donations and bequests from private for-profit and non-profit entities1 in accordance with ,federal law4 4 #g4 ,authorization of appropriations for newborn screening programs and activities ,section #aaag of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;b-#af7 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 by striking #aa1ijj1jjj and inserting #ca1jjj1jjj2 7,b7 by striking #bjae and inserting #bjbj2 and 7,c7 by striking #bjai and inserting #bjbd2 and 7#b7 in paragraph 7#b7-- 7,a7 by striking #h1jjj1jjj and inserting #bi1fej1jjj2 7,b7 by striking #bjae and inserting #bjbj2 and 7,c7 by striking #bjai and inserting #bjbd4 #h4 ,institutional review boards2 ethics guidance program ,section #ab of the ,newborn ,screening ,saves ,lives ,reauthorization ,act of #bjad 7#db ,u4,s4,c4 #bhi note7 is amended to read as follows3 #ab4 ,institutional review boards2 ethics guidance program ,research on nonidentified newborn dried blood spots shall be considered secondary research 7as that term is defined in part #d of section #df4ajd of title #de1 ,code of ,federal ,regulations7 with nonidentified biospecimens for purposes of federally funded research conducted pursuant to the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bjj et seq474 4 #i4 ,,nam report on the modernization of newborn screening 7a7 ,study ,not later than #fj days after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall seek to enter into an agreement with the ,national ,academy of ,medicine 7in this section referred to as ,,nam7 7or if ,,nam declines to enter into such an agreement1 another appropriate entity7 under which ,,nam1 or such other appropriate entity1 agrees to conduct a study on the following3 7#a7 ,the uniform screening panel review and recommendation processes to identify factors that impact decisions to add new conditions to the uniform screening panel1 to describe challenges posed by newly nominated conditions1 including low-incidence diseases1 late onset variants1 and new treatments without long-term efficacy data4 7#b7 ,the barriers that preclude ,states from adding new uniform screening panel conditions to their ,state screening panels with recommendations on resources needed to help ,states implement uniform screening panel recommendations4 7#c7 ,the current state of federally and privately funded newborn screening research with recommendations for optimizing the capacity of this research1 including piloting multiple prospective conditions at once and addressing rare disease questions4 7#d7 ,new and emerging technologies that would permit screening for new categories of disorders1 or would make current screening more effective1 more efficient1 or less expensive4 7#e7 ,technological and other infrastructure needs to improve timeliness of diagnosis and short- and long-term follow-up for infants identified through newborn screening and improve public health surveillance4 7#f7 ,current and future communication and educational needs for priority stakeholders and the public to promote understanding and knowledge of a modernized newborn screening system with an emphasis on evolving communication channels and messaging4 7#g7 ,the extent to which newborn screening yields better data on the disease prevalence for screened conditions and improves long-term outcomes for those identified through newborn screening1 including existing systems supporting such data collection and recommendations for systems that would allow for improved data collection4 7#h7 ,the impact on newborn morbidity and mortality in ,states that adopt newborn screening tests included on the uniform panel4 7b7 ,public stakeholder meeting ,in the course of completing the study described in subsection 7a71 ,,nam or such other appropriate entity shall hold not less than one public meeting to obtain stakeholder input on the topics of such study4 7c7 ,report ,not later than #ah months after the effective date of the agreement under subsection 7a71 such agreement shall require ,,nam1 or such other appropriate entity1 to submit to the ,secretary of ,health and ,human ,services and the appropriate committees of jurisdiction of ,congress a report containing-- 7#a7 the results of the study conducted under subsection 7a72 7#b7 recommendations to modernize the processes described in subsection 7a77#a72 and 7#c7 recommendations for such legislative and administrative action as ,,nam1 or such other appropriate entity1 determines appropriate4 7d7 ,authorization of appropriations ,there is authorized to be appropriated #b1jjj1jjj for the period of fiscal years #bjbj and #bjba to carry out this section4 ,july #bc1 #bjai ,reported with an amendment1 committed to the ,committee of the ,whole ,house on the ,state of the ,union1 and ordered to be printed