#aacth ,,congress #b;d ,session ,s4 #adag ,,an ,,act ,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 #bjac4 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 follow-up for heritable disorders4,sec4 #c4 ,evaluating the effectiveness of newborn and child screening and follow-up 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 ,congress #b4 ,improved newborn and child screening and follow-up 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 in paragraph 7#b71 by striking screening and training and inserting screening1 counseling1 and training2 7,c7 in paragraph 7#c71 by striking and at the end2 7,d7 in paragraph 7#d7-- 7i7 by striking treatment and inserting follow-up 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 timely collection1 delivery1 receipt1 and screening of specimens1 and the timely diagnosis of heritable disorders in newborns4 2 7#b7 in subsection 7h71 by striking subsection 7c77#b7 each place that such appears and inserting subsection 7c72 and 7#c7 by striking subsection 7j7 7relating to authorization of appropriations74 #c4 ,evaluating the effectiveness of newborn and child screening and follow-up 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 follow-up after child screening2 7#b7 in subsection 7a71 by striking of screening1 and inserting 1 including with respect to timeliness1 of screening1 follow-up12 7#c7 in subsection 7b7-- 7,a7 in paragraph 7#a7-- 7i7 by striking counseling1 testing and inserting treatment1 counseling1 testing1 follow-up12 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 follow-up12 and 7ii7 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 the timely collection1 delivery1 receipt1 and screening of newborn screening specimens1 and the timely 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#e7 through 7#g71 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 2 7,c7 in paragraph 7#e7 7as so redesignated71 by inserting 1 including the cost after public health impact2 and 7,d7 in paragraph 7#g7 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 timely collection1 delivery1 receipt1 and screening of specimens to be tested for heritable disorders in newborns in order to ensure rapid diagnosis and follow-up4 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 recommendations42 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 nomination to the recommended uniform screening panel1 the ,advisory ,committee on ,heritable ,disorders in ,newborns and ,children shall review and vote on the nominated condition within #i months of the date on which the ,advisory ,committee referred the nomination 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 as subject to the discretion of the ,designated ,federal ,officer in consultation with the ,chair4 2 7#e7 in subsection 7g7 7as so redesignated71 by striking ,newborn ,screening ,saves ,lives ,act of #bjjh and inserting ,newborn ,screening ,saves ,lives ,reauthorization ,act of #bjac2 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 2 and and inserting a semicolon2 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 #bjac2 7#c7 in subsection 7c7-- 7,a7 by striking developing the clearinghouse and inserting carrying out activities2 and 7,b7 by striking clearinghouse minimizes and inserting activities minimize2 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 by striking the subsection enumerator and heading2 7,b7 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 7,c7 in paragraph 7#a7-- 7i7 by inserting timeliness for processing such tests1 after newborn screening tests2 and 7ii7 by striking and at the end2 and 7,d7 in paragraph 7#b71 by striking the period and inserting 2 and2 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 ,quality 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 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 #aaaf7;a77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;b-#ae7;a77#a77 is amended-- 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 by 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 4 #aj4 ,authorization of appropriations ,part ,a of title ,,xi of the ,public ,health ,service ,act 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 #ah1ccd1jjj for each of fiscal years #bjad through #bjah2 and 7#b7 to carry out section #aaac1 #g1ejj1jjj for each of fiscal years #bjad through #bjah4 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 ,labor 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 follow-up testing1 and follow-up 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 the ,newborn ,screening ,saves ,lives ,reauthorization ,act of #bjac1 submit to the ,committee on ,health1 ,education1 ,labor 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 shall 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 ,passed the ,senate ,january #bi1 #bjad4,secretary