Newborn Screening Saves Lives Reauthorization Act of 2021

IIB 117TH CONGRESS 1ST SESSION H. R. 482 IN THE SENATE OF THE UNITED STATES JUNE 24, 2021 Received; read twice and referred to the Committee on Health, Education, Labor, and Pensions AN ACT To amend the Public Health Service Act to reauthorize cer- tain programs under part A of title XI of such Act relating to genetic diseases, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 VerDate Sep 11 2014 08:22 Jun 25, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H482.RFS H482 kjohnson on DSK79L0C42PROD with BILLS 2 HR 482 RFS SECTION 1. SHORT TITLE. 1 This Act may be cited as the ‘‘Newborn Screening 2 Saves Lives Reauthorization Act of 2021’’. 3 SEC. 2. IMPROVED NEWBORN AND CHILD SCREENING AND 4 FOLLOW-UP FOR HERITABLE DISORDERS. 5 (a) PURPOSES.—Section 1109(a) of the Public 6 Health Service Act (42 U.S.C. 300b–8(a)) is amended— 7 (1) in paragraph (1), by striking ‘‘enhance, im- 8 prove or’’ and inserting ‘‘facilitate, enhance, im- 9 prove, or’’; 10 (2) by amending paragraph (3) to read as fol- 11 lows: 12 ‘‘(3) to develop, and deliver to parents, families, 13 and patient advocacy and support groups, edu- 14 cational programs that— 15 ‘‘(A) address newborn screening coun- 16 seling, testing (including newborn screening 17 pilot studies), follow-up, treatment, specialty 18 services, and long-term care; 19 ‘‘(B) assess the target audience’s current 20 knowledge, incorporate health communications 21 strategies, and measure impact; and 22 ‘‘(C) are at appropriate literacy levels;’’; 23 and 24 (3) in paragraph (4)— 25 VerDate Sep 11 2014 08:22 Jun 25, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H482.RFS H482 kjohnson on DSK79L0C42PROD with BILLS 3 HR 482 RFS (A) by striking ‘‘followup’’ and inserting 1 ‘‘follow-up’’; and 2 (B) by inserting before the semicolon at 3 the end the following: ‘‘, including re-engaging 4 patients who have not received recommended 5 follow-up services and supports’’. 6 (b) APPROVAL FACTORS.—Section 1109(c) of the 7 Public Health Service Act (42 U.S.C. 300b–8(c)) is 8 amended— 9 (1) by striking ‘‘or will use’’ and inserting ‘‘will 10 use’’; and 11 (2) by inserting ‘‘, or will use amounts received 12 under such grant to enhance capacity and infra- 13 structure to facilitate the adoption of,’’ before ‘‘the 14 guidelines and recommendations’’. 15 SEC. 3. ADVISORY COMMITTEE ON HERITABLE DISORDERS 16 IN NEWBORNS AND CHILDREN. 17 Section 1111 of the Public Health Service Act (42 18 U.S.C. 300b–10) is amended— 19 (1) in subsection (b)— 20 (A) in paragraph (5), by inserting ‘‘and 21 adopt process improvements’’ after ‘‘take ap- 22 propriate steps’’; 23 (B) in paragraph (7) by striking ‘‘and’’ at 24 the end; 25 VerDate Sep 11 2014 08:22 Jun 25, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H482.RFS H482 kjohnson on DSK79L0C42PROD with BILLS 4 HR 482 RFS (C) by redesignating paragraph (8) as 1 paragraph (9); 2 (D) by inserting after paragraph (7) the 3 following: 4 ‘‘(8) develop, maintain, and publish on a pub- 5 licly accessible website consumer-friendly materials 6 detailing— 7 ‘‘(A) the uniform screening panel nomina- 8 tion process, including data requirements, 9 standards, and the use of international data in 10 nomination submissions; and 11 ‘‘(B) the process for obtaining technical as- 12 sistance for submitting nominations to the uni- 13 form screening panel and detailing the in- 14 stances in which the provision of technical as- 15 sistance would introduce a conflict of interest 16 for members of the Advisory Committee; and’’; 17 (E) in paragraph (9), as redesignated— 18 (i) by redesignating subparagraphs 19 (K) and (L) as subparagraphs (L) and 20 (M), respectively; and 21 (ii) by inserting after subparagraph 22 (J) the following: 23 ‘‘(K) the appropriate and recommended 24 use of safe and effective genetic testing by 25 VerDate Sep 11 2014 08:22 Jun 25, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H482.RFS H482 kjohnson on DSK79L0C42PROD with BILLS 5 HR 482 RFS health care professionals in newborns and chil- 1 dren with an initial diagnosis of a disease or 2 condition characterized by a variety of genetic 3 causes and manifestations;’’; and 4 (2) in subsection (g)— 5 (A) in paragraph (1) by striking ‘‘2019’’ 6 and inserting ‘‘2026’’; and 7 (B) in paragraph (2) by striking ‘‘2019’’ 8 and inserting ‘‘2026’’. 9 SEC. 4. CLEARINGHOUSE OF NEWBORN SCREENING INFOR- 10 MATION. 11 Section 1112(c) of the Public Health Service Act (42 12 U.S.C. 300b–11(c)) is amended by striking ‘‘and supple- 13 ment, not supplant, existing information sharing efforts’’ 14 and inserting ‘‘and complement other Federal newborn 15 screening information sharing activities’’. 16 SEC. 5. LABORATORY QUALITY AND SURVEILLANCE. 17 Section 1113 of the Public Health Service Act (42 18 U.S.C. 300b–12) is amended— 19 (1) in subsection (a)— 20 (A) in paragraph (1)— 21 (i) by striking ‘‘performance evalua- 22 tion services,’’ and inserting ‘‘development 23 of new screening tests,’’; and 24 (ii) by striking ‘‘and’’ at the end; 25 VerDate Sep 11 2014 08:22 Jun 25, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H482.RFS H482 kjohnson on DSK79L0C42PROD with BILLS 6 HR 482 RFS (B) in paragraph (2)— 1 (i) by striking ‘‘performance test ma- 2 terials’’ and inserting ‘‘test performance 3 materials’’; and 4 (ii) by striking the period at the end 5 and inserting ‘‘; and’’; and 6 (C) by adding at the end the following: 7 ‘‘(3) performance evaluation services to enhance 8 disease detection, including the development of tools, 9 resources, and infrastructure to improve data anal- 10 ysis, test result interpretation, data harmonization, 11 and dissemination of laboratory best practices.’’; and 12 (2) in subsection (b) to read as follows: 13 ‘‘(b) SURVEILLANCE ACTIVITIES.—The Secretary, 14 acting through the Director of the Centers for Disease 15 Control and Prevention, and taking into consideration the 16 expertise of the Advisory Committee on Heritable Dis- 17 orders in Newborns and Children established under sec- 18 tion 1111, shall provide for the coordination of national 19 surveillance activities, including— 20 ‘‘(1) standardizing data collection and reporting 21 through the use of electronic and other forms of 22 health records to achieve real-time data for tracking 23 and monitoring the newborn screening system, from 24 VerDate Sep 11 2014 08:22 Jun 25, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H482.RFS H482 kjohnson on DSK79L0C42PROD with BILLS 7 HR 482 RFS the initial positive screen through diagnosis and 1 long-term care management; and 2 ‘‘(2) by promoting data sharing linkages be- 3 tween State newborn screening programs and State- 4 based birth defects and developmental disabilities 5 surveillance programs to help families connect with 6 services to assist in evaluating long-term outcomes.’’. 7 SEC. 6. HUNTER KELLY RESEARCH PROGRAM. 8 Section 1116 of the Public Health Service Act (42 9 U.S.C. 300b–15) is amended— 10 (1) in subsection (a)(1)— 11 (A) by striking ‘‘may’’ and inserting 12 ‘‘shall’’; and 13 (B) in subparagraph (D)— 14 (i) by inserting ‘‘, or with a high prob- 15 ability of being recommended by,’’ after 16 ‘‘recommended by’’; and 17 (ii) by striking ‘‘that screenings are 18 ready for nationwide implementation’’ and 19 inserting ‘‘that reliable newborn screening 20 technologies are piloted and ready for 21 use’’; and 22 (2) in subsection (b) to read as follows: 23 ‘‘(b) FUNDING.—In carrying out the research pro- 24 gram under this section, the Secretary and the Director 25 VerDate Sep 11 2014 08:22 Jun 25, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H482.RFS H482 kjohnson on DSK79L0C42PROD with BILLS 8 HR 482 RFS shall ensure that entities receiving funding through the 1 program will provide assurances, as practicable, that such 2 entities will work in consultation with State departments 3 of health, as appropriate.’’. 4 SEC. 7. AUTHORIZATION OF APPROPRIATIONS FOR NEW- 5 BORN SCREENING PROGRAMS AND ACTIVI- 6 TIES. 7 Section 1117 of the Public Health Service Act (42 8 U.S.C. 300b–16) is amended— 9 (1) in paragraph (1)— 10 (A) by striking ‘‘$11,900,000’’ and insert- 11 ing ‘‘$31,000,000’’; 12 (B) by striking ‘‘2015’’ and inserting 13 ‘‘2022’’; and 14 (C) by striking ‘‘2019’’ and inserting 15 ‘‘2026’’; and 16 (2) in paragraph (2)— 17 (A) by striking ‘‘$8,000,000’’ and inserting 18 ‘‘$29,650,000’’; 19 (B) by striking ‘‘2015’’ and inserting 20 ‘‘2022’’; and 21 (C) by striking ‘‘2019’’ and inserting 22 ‘‘2026’’. 23 VerDate Sep 11 2014 08:22 Jun 25, 2021 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H482.RFS H482 kjohnson on DSK79L0C42PROD with BILLS 9 HR 482 RFS SEC. 8. INSTITUTIONAL REVIEW BOARDS; ETHICS GUID- 1 ANCE PROGRAM. 2 Section 12 of the Newborn Screening Saves Lives Re- 3 authorization Act of 2014 (42 U.S.C. 289 note) is amend- 4 ed to read as follows: 5 ‘‘SEC. 12. INSTITUTIONAL REVIEW BOARDS; ETHICS GUID- 6 ANCE PROGRAM. 7 ‘‘Research on nonidentified newborn dried blood spots 8 shall be considered secondary research (as that term is 9 defined in section 46.104(d)(4) of title 45, Code of Federal 10 Regulations (or successor regulations)) with nonidentified 11 biospecimens for purposes of federally funded research 12 conducted pursuant to the Public Health Service Act (42 13 U.S.C. 200 et seq.).’’. 14 SEC. 9. NAM REPORT ON THE MODERNIZATION OF NEW- 15 BORN SCREENING. 16 (a) STUDY.—Not later than 60 days after the date 17 of the enactment of this Act, the Secretary of Health and 18 Human Services shall seek to enter into an agreement 19 with the National Academy of Medicine (in this section 20 referred to as ‘‘NAM’’) (or if NAM declines to enter into 21 such an agreement, another appropriate entity) under 22 which NAM, or such other appropriate entity, agrees to 23 conduct a study on the following: 24 (1) The uniform screening panel review and 25 recommendation processes to identify factors that 26 VerDate Sep 11 2014 08:22 Jun 25, 2021 Jkt 019200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H482.RFS H482 kjohnson on DSK79L0C42PROD with BILLS 10 HR 482 RFS impact decisions to add new conditions to the uni- 1 form screening panel, to describe challenges posed 2 by newly nominated conditions, including low-inci- 3 dence diseases, late onset variants, and new treat- 4 ments without long-term efficacy data. 5 (2) The barriers that preclude States from add- 6 ing new uniform screening panel conditions to their 7 State screening panels with recommendations on re- 8 sources needed to help States implement uniform 9 screening panel recommendations. 10 (3) The current state of federally and privately 11 funded newborn screening research with rec- 12 ommendations for optimizing the capacity of this re- 13 search, including piloting multiple prospective condi- 14 tions at once and addressing rare disease questions. 15 (4) New and emerging technologies that would 16 permit screening for new categories of disorders, or 17 would make current screening more effective, more 18 efficient, or less expensive. 19 (5) Technological and other infrastructure 20 needs to improve timeliness of diagnosis and short- 21 and long-term follow-up for infants identified 22 through newborn screening and improve public 23 health surveillance. 24 VerDate Sep 11 2014 08:22 Jun 25, 2021 Jkt 019200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H482.RFS H482 kjohnson on DSK79L0C42PROD with BILLS 11 HR 482 RFS (6) Current and future communication and edu- 1 cational needs for priority stakeholders and the pub- 2 lic to promote understanding and knowledge of a 3 modernized newborn screening system with an em- 4 phasis on evolving communication channels and mes- 5 saging. 6 (7) The extent to which newborn screening 7 yields better data on the disease prevalence for 8 screened conditions and improves long-term out- 9 comes for those identified through newborn screen- 10 ing, including existing systems supporting such data 11 collection and recommendations for systems that 12 would allow for improved data collection. 13 (8) The impact on newborn morbidity and mor- 14 tality in States that adopt newborn screening tests 15 included on the uniform panel. 16 (b) PUBLIC STAKEHOLDER MEETING.—In the course 17 of completing the study described in subsection (a), NAM 18 or such other appropriate entity shall hold not less than 19 one public meeting to obtain stakeholder input on the top- 20 ics of such study. 21 (c) REPORT.—Not later than 18 months after the ef- 22 fective date of the agreement under subsection (a), such 23 agreement shall require NAM, or such other appropriate 24 entity, to submit to the Secretary of Health and Human 25 VerDate Sep 11 2014 08:22 Jun 25, 2021 Jkt 019200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H482.RFS H482 kjohnson on DSK79L0C42PROD with BILLS 12 HR 482 RFS Services and the appropriate committees of jurisdiction of 1 Congress a report containing— 2 (1) the results of the study conducted under 3 subsection (a); 4 (2) recommendations to modernize the proc- 5 esses described in subsection (a)(1); and 6 (3) recommendations for such legislative and 7 administrative action as NAM, or such other appro- 8 priate entity, determines appropriate. 9 (d) AUTHORIZATION OF APPROPRIATIONS.—There is 10 authorized to be appropriated $2,000,000 for the period 11 of fiscal years 2022 and 2023 to carry out this section. 12 Passed the House of Representatives June 23, 2021. Attest: CHERYL L. JOHNSON, Clerk. VerDate Sep 11 2014 08:22 Jun 25, 2021 Jkt 019200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\H482.RFS H482 kjohnson on DSK79L0C42PROD with BILLS