IIB 

116TH CONGRESS 

1ST SESSION H. R. 2507 

IN THE SENATE OF THE UNITED STATES 

JULY 25, 2019 

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 certain programs under part A of title XI of such Act 

relating to genetic diseases, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Newborn Screening 

3 Saves Lives Reauthorization Act of 2019’’. 

4 SEC. 2. IMPROVED NEWBORN AND CHILD SCREENING AND 

5 FOLLOW-UP FOR HERITABLE DISORDERS. 

6 (a) PURPOSES.—Section 1109(a) of the Public 

7 Health Service Act (42 U.S.C. 300b–8(a)) is amended— 

8 (1) in paragraph (1), by striking ‘‘enhance, im9 prove or’’ and inserting ‘‘facilitate, enhance, im10 prove, or’’; 

11 (2) by amending paragraph (3) to read as fol12 lows: 

13 ‘‘(3) to develop, and deliver to parents, families, 

14 and patient advocacy and support groups, edu15 cational programs that— 

16 ‘‘(A) address newborn screening coun17 seling, testing (including newborn screening 

18 pilot studies), follow-up, treatment, specialty 

19 services, and long-term care; 

20 ‘‘(B) assess the target audience’s current 

21 knowledge, incorporate health communications 

22 strategies, and measure impact; and 

23 ‘‘(C) are at appropriate literacy levels;’’; 

24 and 

25 (3) in paragraph (4)— 


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1 (A) by striking ‘‘followup’’ and inserting 

2 ‘‘follow-up’’; and 

3 (B) by inserting before the semicolon at 

4 the end the following: ‘‘, including re-engaging 

5 patients who have not received recommended 

6 follow-up services and supports’’. 

7 (b) APPROVAL FACTORS.—Section 1109(c) of the 

8 Public Health Service Act (42 U.S.C. 300b–8(c)) is 

9 amended— 

10 (1) by striking ‘‘or will use’’ and inserting ‘‘will 

11 use’’; and 

12 (2) by inserting ‘‘, or will use amounts received 

13 under such grant to enhance capacity and infra14 structure to facilitate the adoption of,’’ before ‘‘the 

15 guidelines and recommendations’’. 

16 SEC. 3. ADVISORY COMMITTEE ON HERITABLE DISORDERS 

17 IN NEWBORNS AND CHILDREN. 

18 Section 1111 of the Public Health Service Act (42 

19 U.S.C. 300b–10) is amended— 

20 (1) in subsection (b)— 

21 (A) in paragraph (5), by inserting ‘‘and 

22 adopt process improvements’’ after ‘‘take ap23 propriate steps’’; 

24 (B) in paragraph (7) by striking ‘‘and’’ at 

25 the end; 


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1 (C) by redesignating paragraph (8) as 

2 paragraph (9); 

3 (D) by inserting after paragraph (7) the 

4 following: 

5 ‘‘(8) develop, maintain, and publish on a pub6 licly accessible website consumer-friendly materials 

7 detailing— 

8 ‘‘(A) the uniform screening panel nomina9 tion process, including data requirements, 

10 standards, and the use of international data in 

11 nomination submissions; and 

12 ‘‘(B) the process for obtaining technical as13 sistance for submitting nominations to the uni14 form screening panel and detailing the in15 stances in which the provision of technical as16 sistance would introduce a conflict of interest 

17 for members of the Advisory Committee; and’’; 

18 (E) in paragraph (9), as redesignated— 

19 (i) by redesignating subparagraphs 

20 (K) and (L) as subparagraphs (L) and 

21 (M), respectively; and 

22 (ii) by inserting after subparagraph 

23 (J) the following: 

24 ‘‘(K) the appropriate and recommended 

25 use of safe and effective genetic testing by 


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1 health care professionals in newborns and chil2 dren with an initial diagnosis of a disease or 

3 condition characterized by a variety of genetic 

4 causes and manifestations;’’; and 

5 (2) in subsection (g)— 

6 (A) in paragraph (1) by striking ‘‘2019’’ 

7 and inserting ‘‘2024’’; and 

8 (B) in paragraph (2) by striking ‘‘2019’’ 

9 and inserting ‘‘2024’’. 

10 SEC. 4. CLEARINGHOUSE OF NEWBORN SCREENING INFOR11 MATION. 

12 Section 1112(c) of the Public Health Service Act (42 

13 U.S.C. 300b–11(c)) is amended by striking ‘‘and supple14 ment, not supplant, existing information sharing efforts’’ 

15 and inserting ‘‘and complement other Federal newborn 

16 screening information sharing activities’’. 

17 SEC. 5. LABORATORY QUALITY AND SURVEILLANCE. 

18 Section 1113 of the Public Health Service Act (42 

19 U.S.C. 300b–12) is amended— 

20 (1) in subsection (a)— 

21 (A) in paragraph (1)— 

22 (i) by striking ‘‘performance evalua23 tion services,’’ and inserting ‘‘development 

24 of new screening tests,’’; and 

25 (ii) by striking ‘‘and’’ at the end; 


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1 (B) in paragraph (2)— 

2 (i) by striking ‘‘performance test ma3 terials’’ and inserting ‘‘test performance 

4 materials’’; and 

5 (ii) by striking the period at the end 

6 and inserting ‘‘; and’’; and 

7 (C) by adding at the end the following: 

8 ‘‘(3) performance evaluation services to enhance 

9 disease detection, including the development of tools, 

10 resources, and infrastructure to improve data anal11 ysis, test result interpretation, data harmonization, 

12 and dissemination of laboratory best practices.’’; and 

13 (2) in subsection (b) to read as follows: 

14 ‘‘(b) SURVEILLANCE ACTIVITIES.—The Secretary, 

15 acting through the Director of the Centers for Disease 

16 Control and Prevention, and taking into consideration the 

17 expertise of the Advisory Committee on Heritable Dis18 orders in Newborns and Children established under sec19 tion 1111, shall provide for the coordination of national 

20 surveillance activities, including— 

21 ‘‘(1) standardizing data collection and reporting 

22 through the use of electronic and other forms of 

23 health records to achieve real-time data for tracking 

24 and monitoring the newborn screening system, from 


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1 the initial positive screen through diagnosis and 

2 long-term care management; and 

3 ‘‘(2) by promoting data sharing linkages be4 tween State newborn screening programs and State5 based birth defects and developmental disabilities 

6 surveillance programs to help families connect with 

7 services to assist in evaluating long-term outcomes.’’. 

8 SEC. 6. HUNTER KELLY RESEARCH PROGRAM. 

9 Section 1116 of the Public Health Service Act (42 

10 U.S.C. 300b–15) is amended— 

11 (1) in subsection (a)(1)— 

12 (A) by striking ‘‘may’’ and inserting 

13 ‘‘shall’’; and 

14 (B) in subparagraph (D)— 

15 (i) by inserting ‘‘, or with a high prob16 ability of being recommended by,’’ after 

17 ‘‘recommended by’’; and 

18 (ii) by striking ‘‘that screenings are 

19 ready for nationwide implementation’’ and 

20 inserting ‘‘that reliable newborn screening 

21 technologies are piloted and ready for 

22 use’’; and 

23 (2) in subsection (b) to read as follows: 

24 ‘‘(b) FUNDING.—In carrying out the research pro25 gram under this section, the Secretary and the Director 


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1 shall ensure that entities receiving funding through the 

2 program will provide assurances, as practicable, that such 

3 entities will work in consultation with State departments 

4 of health, as appropriate.’’. 

5 SEC. 7. AUTHORIZATION OF APPROPRIATIONS FOR NEW6 BORN SCREENING PROGRAMS AND ACTIVI7 TIES. 

8 Section 1117 of the Public Health Service Act (42 

9 U.S.C. 300b–16) is amended— 

10 (1) in paragraph (1)— 

11 (A) by striking ‘‘$11,900,000’’ and insert12 ing ‘‘$31,000,000’’; 

13 (B) by striking ‘‘2015’’ and inserting 

14 ‘‘2020’’; and 

15 (C) by striking ‘‘2019’’ and inserting 

16 ‘‘2024’’; and 

17 (2) in paragraph (2)— 

18 (A) by striking ‘‘$8,000,000’’ and inserting 

19 ‘‘$29,650,000’’; 

20 (B) by striking ‘‘2015’’ and inserting 

21 ‘‘2020’’; and 

22 (C) by striking ‘‘2019’’ and inserting 

23 ‘‘2024’’. 


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1 SEC. 8. INSTITUTIONAL REVIEW BOARDS; ETHICS GUID2 ANCE PROGRAM. 

3 Section 12 of the Newborn Screening Saves Lives Re4 authorization Act of 2014 (42 U.S.C. 289 note) is amend5 ed to read as follows: 

6 ‘‘SEC. 12. INSTITUTIONAL REVIEW BOARDS; ETHICS GUID7 ANCE PROGRAM. 

8 ‘‘Research on nonidentified newborn dried blood spots 

9 shall be considered secondary research (as that term is 

10 defined in section 46.104(d)(4) of title 45, Code of Federal 

11 Regulations (or successor regulations)) with nonidentified 

12 biospecimens for purposes of federally funded research 

13 conducted pursuant to the Public Health Service Act (42 

14 U.S.C. 200 et seq.).’’. 

15 SEC. 9. NAM REPORT ON THE MODERNIZATION OF NEW16 BORN SCREENING. 

17 (a) STUDY.—Not later than 60 days after the date 

18 of the enactment of this Act, the Secretary of Health and 

19 Human Services shall seek to enter into an agreement 

20 with the National Academy of Medicine (in this section 

21 referred to as ‘‘NAM’’) (or if NAM declines to enter into 

22 such an agreement, another appropriate entity) under 

23 which NAM, or such other appropriate entity, agrees to 

24 conduct a study on the following: 

25 (1) The uniform screening panel review and 

26 recommendation processes to identify factors that 


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1 impact decisions to add new conditions to the uni2 form screening panel, to describe challenges posed 

3 by newly nominated conditions, including low-inci4 dence diseases, late onset variants, and new treat5 ments without long-term efficacy data. 

6 (2) The barriers that preclude States from add7 ing new uniform screening panel conditions to their 

8 State screening panels with recommendations on re9 sources needed to help States implement uniform 

10 screening panel recommendations. 

11 (3) The current state of federally and privately 

12 funded newborn screening research with rec13 ommendations for optimizing the capacity of this re14 search, including piloting multiple prospective condi15 tions at once and addressing rare disease questions. 

16 (4) New and emerging technologies that would 

17 permit screening for new categories of disorders, or 

18 would make current screening more effective, more 

19 efficient, or less expensive. 

20 (5) Technological and other infrastructure 

21 needs to improve timeliness of diagnosis and short22 and long-term follow-up for infants identified 

23 through newborn screening and improve public 

24 health surveillance. 


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1 (6) Current and future communication and edu2 cational needs for priority stakeholders and the pub3 lic to promote understanding and knowledge of a 

4 modernized newborn screening system with an em5 phasis on evolving communication channels and mes6 saging. 

7 (7) The extent to which newborn screening 

8 yields better data on the disease prevalence for 

9 screened conditions and improves long-term out10 comes for those identified through newborn screen11 ing, including existing systems supporting such data 

12 collection and recommendations for systems that 

13 would allow for improved data collection. 

14 (8) The impact on newborn morbidity and mor15 tality in States that adopt newborn screening tests 

16 included on the uniform panel. 

17 (b) PUBLIC STAKEHOLDER MEETING.—In the course 

18 of completing the study described in subsection (a), NAM 

19 or such other appropriate entity shall hold not less than 

20 one public meeting to obtain stakeholder input on the top21 ics of such study. 

22 (c) REPORT.—Not later than 18 months after the ef23 fective date of the agreement under subsection (a), such 

24 agreement shall require NAM, or such other appropriate 

25 entity, to submit to the Secretary of Health and Human 


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1 Services and the appropriate committees of jurisdiction of 

2 Congress a report containing— 

3 (1) the results of the study conducted under 

4 subsection (a); 

5 (2) recommendations to modernize the proc6 esses described in subsection (a)(1); and 

7 (3) recommendations for such legislative and 

8 administrative action as NAM, or such other appro9 priate entity, determines appropriate. 

10 (d) AUTHORIZATION OF APPROPRIATIONS.—There is 

11 authorized to be appropriated $2,000,000 for the period 

12 of fiscal years 2020 and 2021 to carry out this section. 

Passed the House of Representatives July 24, 2019. 

Attest: CHERYL L. JOHNSON, 

Clerk. 


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