,,ib ,union ,calendar ,no4 #ced #aacth ,,congress #b;d ,session ,h4 ,r4 #abha ,report ,no4 #aac-dgh ,,in ,,the ,,house ,,of ,,representatives ,march #bj1 #bjac ,ms4 ,roybal-,allard 7for herself and ,mr4 ,simpson7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,june #ai1 #bjad ,additional sponsors3 ,ms4 ,moore1 ,mr4 ,grijalva1 ,mr4 ,waxman1 ,mr4 ,rogers of ,kentucky1 ,mr4 ,higgins1 ,mr4 ,rangel1 ,ms4 ,lee of ,california1 ,ms4 ,speier1 ,mr4 ,mc,govern1 ,mrs4 ,capps1 ,ms4 ,jackson ,lee1 ,mr4 ,hastings of ,florida1 ,ms4 ,mc,collum1 ,mr4 ,david ,scott of ,georgia1 ,ms4 ,clarke of ,new ,york1 ,mr4 ,conyers1 ,mr4 ,dingell1 ,mr4 ,huffman1 ,ms4 ,de,lauro1 ,mr4 ,crowley1 ,mr4 ,cohen1 ,ms4 ,slaughter1 ,mr4 ,bishop of ,georgia1 ,ms4 ,castor of ,florida1 ,mr4 ,takano1 ,ms4 ,wilson of ,florida1 ,mr4 ,loebsack1 ,mr4 ,bera of ,california1 ,mr4 ,walden1 ,mr4 ,nadler1 ,mr4 ,gene ,green of ,texas1 ,mr4 ,delaney1 ,mr4 ,collins of ,new ,york1 ,mr4 ,pocan1 ,mr4 ,heck of ,washington1 ,mr4 ,farr1 ,mr4 ,matheson1 ,mrs4 ,beatty1 ,mrs4 ,kirkpatrick1 ,mr4 ,moran1 ,mr4 ,sires1 ,ms4 ,schakowsky1 ,mr4 ,costa1 ,ms4 ,loretta ,sanchez of ,california1 ,mr4 ,ruiz1 ,mrs4 ,negrete ,mc,leod1 ,mr4 ,castro of ,texas1 ,mr4 ,gallego1 ,mr4 ,becerra1 ,mr4 ,sablan1 ,ms4 ,michelle ,lujan ,grisham of ,new ,mexico1 ,mr4 ,crdenas1 ,mr4 ,gutirrez1 ,mr4 ,ryan of ,ohio1 ,mr4 ,ben ,ray ,lujn of ,new ,mexico1 ,mr4 ,garcia1 ,mr4 ,hinojosa1 ,mrs4 ,napolitano1 ,mr4 ,vargas1 ,mr4 ,serrano1 ,ms4 ,velzquez1 ,mr4 ,king of ,new ,york1 ,mrs4 ,capito1 ,mr4 ,calvert1 ,mr4 ,royce1 ,mr4 ,grayson1 ,ms4 ,esty1 ,mr4 ,gary ,g4 ,miller of ,california1 ,mr4 ,jones1 ,mr4 ,mc,keon1 ,mr4 ,pierluisi1 ,mr4 ,schiff1 ,mr4 ,neal1 ,mr4 ,langevin1 ,mr4 ,doyle1 ,mr4 ,tonko1 ,ms4 ,wasserman ,schultz1 ,ms4 ,de,gette1 ,ms4 ,eshoo1 ,mrs4 ,lowey1 ,mr4 ,barton1 ,mr4 ,danny ,k4 ,davis of ,illinois1 ,mr4 ,garamendi1 ,mr4 ,mc,dermott1 ,mr4 ,nunes1 ,mr4 ,courtney1 ,mr4 ,levin1 ,mr4 ,cicilline1 ,mr4 ,welch1 ,mr4 ,blumenauer1 ,ms4 ,titus1 ,mr4 ,lipinski1 ,mr4 ,tierney1 ,mr4 ,larson of ,connecticut1 ,ms4 ,matsui1 ,ms4 ,granger1 ,mr4 ,latham1 ,mrs4 ,christensen1 ,mr4 ,lance1 ,mr4 ,ellison1 ,mr4 ,honda1 ,ms4 ,shea-,porter1 ,ms4 ,brownley of ,california1 ,ms4 ,edwards1 ,mr4 ,meeks1 ,mr4 ,michaud1 ,ms4 ,eddie ,bernice ,johnson of ,texas1 ,mr4 ,payne1 ,mr4 ,pallone1 ,mr4 ,johnson of ,georgia1 ,mr4 ,lowenthal1 ,mr4 ,thompson of ,california1 ,mr4 ,clay1 ,mr4 ,cartwright1 ,ms4 ,schwartz1 ,mr4 ,pascrell1 ,mr4 ,burgess1 ,mrs4 ,mc,morris ,rodgers1 and ,mr4 ,israel ,june #ai1 #bjad ,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 ,march #bj1 #bjac ,a ,,bill ,to amend the ,public ,health ,service ,act to reauthorize programs under part ,a of title ,,xi of such ,act4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,newborn ,screening ,saves ,lives ,reauthorization ,act of #bjad4 7b7 ,table of contents ,the table of contents of this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4 ,sec4 #b4 ,improved newborn and child screening and followup for heritable disorders4 ,sec4 #c4 ,evaluating the effectiveness of newborn and child screening and followup programs4 ,sec4 #d4 ,advisory ,committee on ,heritable ,disorders in ,newborns and ,children4 ,sec4 #e4 ,clearinghouse of ,newborn ,screening ,information4 ,sec4 #f4 ,laboratory quality and surveillance4 ,sec4 #g4 ,interagency ,coordinating ,committee on ,newborn and ,child ,screening4 ,sec4 #h4 ,national contingency plan for newborn screening4 ,sec4 #i4 ,hunter ,kelly ,research ,program4 ,sec4 #aj4 ,authorization of appropriations4 ,sec4 #aa4 ,reports to ,congress4 #b4 ,improved newborn and child screening and followup for heritable disorders ,section #aaji of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;b-#h7 is amended-- 7#a7 in subsection 7a7-- 7,a7 in the matter preceding paragraph 7#a7-- 7i7 by striking subsection 7j7 and inserting section #aaag2 and 7ii7 by striking and in consultation with the ,advisory ,committee and inserting and taking into consideration the expertise of the ,advisory ,committee2 7,b7 by amending paragraph 7#b7 to read as follows3 7#b7 to assist in providing health care professionals and newborn screening laboratory personnel with education in newborn screening1 counseling1 and training in-- 7,a7 relevant and new technologies in newborn screening and congenital1 genetic1 and metabolic disorders2 7,b7 the importance of the timeliness of collection1 delivery1 receipt1 and screening of specimens2 and 7,c7 sharing of medical and diagnostic information with providers and families2 2 7,c7 in paragraph 7#c71 by striking and at the end2 7,d7 in paragraph 7#d7-- 7i7 by striking treatment and inserting followup and treatment2 and 7ii7 by striking the period and inserting 2 and2 and 7,e7 by adding at the end the following3 7#e7 to improve the timeliness of-- 7,a7 the collection1 delivery1 receipt1 and screening of specimens2 and 7,b7 the diagnosis of heritable disorders in newborns4 2 7#b7 in subsection 7c71 by striking application submitted for a grant under subsection 7a77#a7 and inserting application for a grant under this section2 7#c7 in subsection 7h71 by striking application submitted under subsection 7c77#b7 each place it appears and inserting application for a grant under this section2 and 7#d7 by striking subsection 7j7 7relating to authorization of appropriations74 #c4 ,evaluating the effectiveness of newborn and child screening and followup programs ,section #aaaj of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;b-#i7 is amended-- 7#a7 in the section heading1 by inserting and followup after child screening2 7#b7 in subsection 7a71 by striking of screening1 and inserting 1 including with respect to timeliness1 of screening1 followup12 7#c7 in subsection 7b7-- 7,a7 in paragraph 7#a7-- 7i7 by striking counseling1 testing and inserting treatment1 counseling1 testing1 followup12 and 7ii7 by inserting before the semicolon the following3 1 including1 as appropriate1 through the assessment of health and development outcomes for such children through adolescence2 7,b7 in paragraph 7#b7-- 7i7 by striking counseling1 testing and inserting treatment1 counseling1 testing1 followup12 7ii7 by inserting in a timely manner after in newborns and children2 and 7iii7 by striking or at the end2 7,c7 in paragraph 7#c71 by striking the period at the end and inserting a semicolon2 and 7,d7 by adding at the end the following3 7#d7 methods that may be identified to improve quality in the diagnosis1 treatment1 and disease management of heritable disorders based on gaps in services or care2 or 7#e7 methods or best practices by which the eligible entities described in section #aaji can achieve in a timely manner-- 7,a7 collection1 delivery1 receipt1 and screening of newborn screening specimens2 and 7,b7 diagnosis of heritable disorders in newborns4 2 and 7#d7 by striking subsection 7d7 7relating to authorization of appropriations74 #d4 ,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 by redesignating paragraphs 7#d7 through 7#f7 as paragraphs 7#f7 through 7#h71 respectively2 7,b7 by inserting after paragraph 7#c71 the following3 7#d7 provide technical assistance1 as appropriate1 to individuals and organizations regarding the submission of nominations to the uniform screening panel1 including prior to the submission of such nominations2 7#e7 take appropriate steps1 at its discretion1 to prepare for the review of nominations prior to their submission1 including for conditions for which a screening method has been validated but other nomination criteria are not yet met1 in order to facilitate timely action by the ,advisory ,committee once such submission has been received by the ,committee2 2 7,c7 in paragraph 7#f7 7as so redesignated71 by inserting 1 including the cost after public health impact2 and 7,d7 in paragraph 7#h7 7as so redesignated7-- 7i7 in subparagraph 7,a71 by striking achieve rapid diagnosis and inserting achieve best practices in rapid diagnosis and appropriate treatment2 7ii7 in subparagraph 7,d71 by inserting before the semicolon 1 including information on cost and incidence2 7iii7 in subparagraph 7,j71 by striking and at the end2 7iv7 in subparagraph 7,k71 by striking the period and inserting 2 and2 and 7v7 by adding at the end the following3 7,l7 the timeliness of collection1 delivery1 receipt1 and screening of specimens to be tested for heritable disorders in newborns in order to ensure rapid diagnosis and followup4 2 7#b7 in subsection 7d7-- 7,a7 in paragraph 7#a7-- 7i7 by striking #ahj and inserting #abj2 and 7ii7 by adding at the end the following3 ,if the ,secretary is unable to make a determination to adopt or reject such recommendation within such #abj-;day period1 the ,secretary shall notify the ,advisory ,committee and the appropriate committees of ,congress of such determination together with an explanation for why the ,secretary was unable to comply within such #abj-;day period1 as well as a plan of action for consideration of such pending recommendation42 7,b7 by striking paragraph 7#b72 7,c7 by redesignating paragraph 7#c7 as paragraph 7#b72 and 7,d7 by adding at the end the following3 7#c7 ,deadline for review ,for each condition nominated to be added to the recommended uniform screening panel in accordance with the requirements of this section1 the ,advisory ,committee shall review and vote on the nominated condition within #i months of the date on which the ,advisory ,committee referred the nominated condition to the condition review workgroup4 2 7#c7 by redesignating subsections 7f7 and 7g7 as subsections 7g7 and 7h71 respectively2 7#d7 by inserting after subsection 7e7 the following new subsection3 7f7 ,meetings ,the ,advisory ,committee shall meet at least #d times each calendar year1 or at the discretion of the ,designated ,federal ,officer in consultation with the ,chair4 2 7#e7 by amending subsection 7g7 7as so redesignated7 to read as follows3 7g7 ,continuation of operation of committee 7#a7 ,in general ,notwithstanding section #ad of the ,federal ,advisory ,committee ,act1 the ,advisory ,committee shall continue to operate through the end of fiscal year #bjai4 7#b7 ,continuation if not reauthorized ,if at the end of fiscal year #bjai the duration of the ,advisory ,committee has not been extended by statute1 the ,advisory ,committee may be deemed1 for purposes of the ,federal ,advisory ,committee ,act1 an advisory committee established by the ,president or an officer of the ,federal ,government under section #i7;a7 of such ,act4 2 and 7#f7 by striking subsection 7h7 7relating to authorization of appropriations71 as redesignated by paragraph 7#c74 #e4 ,clearinghouse of ,newborn ,screening ,information ,section #aaab of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;b-#aa7 is amended-- 7#a7 in subsection 7a7-- 7,a7 in paragraph 7#b71 by striking and at the end2 7,b7 in paragraph 7#c7-- 7i7 by striking data and inserting information2 and 7ii7 by striking the period at the end and inserting a semicolon2 and 7,c7 by adding at the end the following new paragraphs3 7#d7 maintain current information on the number of conditions for which screening is conducted in each ,state2 and 7#e7 disseminate available evidence-based guidelines related to diagnosis1 counseling1 and treatment with respect to conditions detected by newborn screening4 2 7#b7 in subsection 7b77#d77;,d71 by striking ,newborn ,screening ,saves ,lives ,act of #bjjh and inserting ,newborn ,screening ,saves ,lives ,reauthorization ,act of #bjad2 7#c7 in subsection 7c7-- 7,a7 by striking developing the clearinghouse and inserting carrying out activities2 and 7,b7 by striking clearinghouse minimizes duplication and supplements1 not supplants and inserting activities minimize duplication and supplement1 not supplant2 and 7#d7 by striking subsection 7d7 7relating to authorization of appropriations74 #f4 ,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 the section heading1 by inserting and surveillance before the period2 7#b7 in subsection 7a7-- 7,a7 in the matter preceding paragraph 7#a71 by striking and in consultation with the ,advisory ,committee and inserting and taking into consideration the expertise of the ,advisory ,committee2 and 7,b7 in paragraph 7#a71 by inserting timeliness for processing such tests1 after newborn-screening tests12 and 7#c7 by striking subsection 7b7 7relating to authorization of appropriations7 and inserting the following3 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 may provide1 as appropriate1 for the coordination of surveillance activities1 including-- 7#a7 through standardized data collection and reporting1 as well as the use of electronic health records2 and 7#b7 by promoting data sharing regarding newborn screening with ,state-based birth defects and developmental disabilities monitoring programs4 4 #g4 ,interagency ,coordinating ,committee on ,newborn and ,child ,screening ,section #aaad of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;b-#ac7 is amended-- 7#a7 in subsection 7c71 by striking the ,administrator1 the ,director of the ,agency for ,healthcare ,research and ,quality1 and inserting the ,administrator of the ,health ,resources and ,services ,administration1 the ,director of the ,agency for ,healthcare ,research and ,quality1 the ,commissioner of ,food and ,drugs12 and 7#b7 by striking subsection 7e7 7relating to authorization of appropriations74 #h4 ,national contingency plan for newborn screening ,section #aaae7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;b-#ad7;a77 is amended-- 7#a7 by striking consortia and inserting consortium2 and 7#b7 by adding at the end the following3 ,the plan shall be updated as needed and at least every five years44 #i4 ,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 in subparagraph 7,b71 by striking 2 and and inserting a semicolon2 7,b7 by redesignating subparagraph 7,c7 as subparagraph 7,e72 and 7,c7 by inserting after subparagraph 7,b7 the following3 7,c7 providing research findings and data for newborn conditions under review by the ,advisory ,committee on ,heritable ,disorders in ,newborns and ,children to be added to the recommended uniform screening panel2 7,d7 conducting pilot studies on conditions recommended by the ,advisory ,committee on ,heritable ,disorders in ,newborns and ,children to ensure that screenings are ready for nationwide implementation2 and 2 and 7#b7 in subsection 7c71 by striking of the ,national ,institutes of ,health ,reform ,act of #bjjf4 #aj4 ,authorization of appropriations ,part ,a of title ,,xi of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;b-#a et seq47 is amended by adding at the end1 the following3 #aaag4 ,authorization of appropriations for newborn screening programs and activities ,there are authorized to be appropriated-- 7#a7 to carry out sections #aaji1 #aaaj1 #aaaa1 and #aaab1 #aa1ijj1jjj for each of fiscal years #bjae through #bjai2 and 7#b7 to carry out section #aaac1 #h1jjj1jjj for each of fiscal years #bjae through #bjai4 4 #aa4 ,reports to ,congress 7a7 ,,gao report on timeliness of newborn screening 7#a7 ,in general ,not later than #b years after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall submit a report to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives concerning the timeliness of screening for heritable disorders in newborns4 7#b7 ,contents ,the report submitted under paragraph 7#a7 shall include the following3 7,a7 ,an analysis of information regarding the timeliness of newborn screening1 which may include the time elapsed from birth to specimen collection1 specimen collection to receipt by laboratory1 specimen receipt to reporting1 reporting to followup testing1 and followup testing to confirmed diagnosis4 7,b7 ,a summary of any guidelines1 recommendations1 or best practices available to ,states and health care providers intended to support a timely newborn screening system4 7,c7 ,an analysis of any barriers to maintaining a timely newborn screening system which may exist and recommendations for addressing such barriers4 7b7 ,report by ,secretary 7#a7 ,in general ,the ,secretary of ,health and ,human ,services shall-- 7,a7 not later than #a year after the date of enactment of this ,act1 submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report on activities related to-- 7i7 newborn screening2 and 7ii7 screening children who have or are at risk for heritable disorders2 and 7,b7 not less than every #b years1 submit to such committees an updated version of such report4 7#b7 ,contents ,the report submitted under this subsection shall contain a description of-- 7,a7 the ongoing activities under sections #aaji1 #aaaj1 and #aaab through #aaae of the ,public ,health ,service ,act2 and 7,b7 the amounts expended on such activities4 ,june #ai1 #bjad ,reported with an amendment1 committed to the ,committee of the ,whole ,house on the ,state of the ,union1 and ordered to be printed