I 

116TH CONGRESS 

1ST SESSION H. R. 2507 

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. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 2, 2019 

Ms. ROYBAL-ALLARD (for herself, Mr. SIMPSON, Ms. CLARK of Massachusetts, and Ms. HERRERA BEUTLER) introduced the following bill; which 

was referred to the Committee on Energy and Commerce 

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 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, 

3 SECTION 1. SHORT TITLE. 

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

5 Saves Lives Reauthorization Act of 2019’’. 

6 SEC. 2. IMPROVED NEWBORN AND CHILD SCREENING AND 

7 FOLLOW-UP FOR HERITABLE DISORDERS. 

8 Section 1109(a)(3) of the Public Health Service Act 

9 (42 U.S.C. 300b–8(a)(3)) is amended to read as follows: 


kjohnson on DSK79L0C42 with BILLS
2 

•HR 2507 IH

1 ‘‘(3) to develop and deliver educational pro2 grams (at appropriate literacy levels) about newborn 

3 screening counseling, testing, follow-up, treatment, 

4 specialty services, and long-term care to parents, 

5 families, and patient advocacy and support groups 

6 that assess the target audience’s current knowledge, 

7 incorporate health communications strategies, and 

8 measure impact;’’. 

9 SEC. 3. ADVISORY COMMITTEE ON HERITABLE DISORDERS 

10 IN NEWBORNS AND CHILDREN. 

11 Section 1111 of the Public Health Service Act (42 

12 U.S.C. 300b–10) is amended— 

13 (1) in subsection (b)— 

14 (A) in paragraph (7) by striking ‘‘and’’ at 

15 the end; 

16 (B) by redesignating paragraph (8) as 

17 paragraph (9); and 

18 (C) by inserting after paragraph (7) the 

19 following: 

20 ‘‘(8) develop, maintain, and publish on a pub21 licly accessible website consumer-friendly materials 

22 detailing— 

23 ‘‘(A) the uniform screening panel nomina24 tion process, including data requirements, 


kjohnson on DSK79L0C42 with BILLS
3 

•HR 2507 IH

1 standards, and the use of international data in 

2 nomination submissions; and 

3 ‘‘(B) the process for obtaining technical as4 sistance for submitting nominations to the uni5 form screening panel and detailing the in6 stances in which the provision of technical as7 sistance would introduce a conflict of interest 

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

9 and 

10 (2) in subsection (g)— 

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

12 and inserting ‘‘2024’’; and 

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

14 and inserting ‘‘2024’’. 

15 SEC. 4. CLEARINGHOUSE OF NEWBORN SCREENING INFOR16 MATION. 

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

18 U.S.C. 300b–11(c)) is amended by striking ‘‘and supple19 ment, not supplant, existing information sharing efforts’’ 

20 and inserting ‘‘and complement other Federal newborn 

21 screening information sharing activities’’. 

22 SEC. 5. LABORATORY QUALITY AND SURVEILLANCE. 

23 Section 1113 of the Public Health Service Act (42 

24 U.S.C. 300b–12) is amended— 

25 (1) in subsection (a)— 


kjohnson on DSK79L0C42 with BILLS
4 

•HR 2507 IH

1 (A) in paragraph (1)— 

2 (i) by striking ‘‘performance evalua3 tion services,’’ and inserting ‘‘development 

4 of new screening tests,’’; and 

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

6 (B) in paragraph (2)— 

7 (i) by striking ‘‘performance test ma8 terials’’ and inserting ‘‘test performance 

9 materials’’; and 

10 (ii) by striking the period at the end 

11 and inserting ‘‘; and’’; and 

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

13 ‘‘(3) performance evaluation services to enhance 

14 disease detection, including the development of tools, 

15 resources, and infrastructure to improve data anal16 ysis, test result interpretation, data harmonization, 

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

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

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

20 acting through the Director of the Centers for Disease 

21 Control and Prevention, and taking into consideration the 

22 expertise of the Advisory Committee on Heritable Dis23 orders in Newborns and Children established under sec24 tion 1111, shall provide for the coordination of national 

25 surveillance activities, including— 


kjohnson on DSK79L0C42 with BILLS
5 

•HR 2507 IH

1 ‘‘(1) standardizing data collection and reporting 

2 through the use of electronic and other forms of 

3 health records to achieve real-time data for tracking 

4 and monitoring the newborn screening system, from 

5 the initial positive screen through diagnosis and 

6 long-term care management; and 

7 ‘‘(2) by promoting data sharing linkages be8 tween State newborn screening programs and State9 based birth defects and developmental disabilities 

10 surveillance programs to help families connect with 

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

12 SEC. 6. HUNTER KELLY RESEARCH PROGRAM. 

13 Section 1116 of the Public Health Service Act (42 

14 U.S.C. 300b–15) is amended— 

15 (1) in subsection (a)(1)— 

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

17 ‘‘shall’’; and 

18 (B) in subparagraph (D)— 

19 (i) by inserting ‘‘, or with a high prob20 ability of being recommended by,’’ after 

21 ‘‘recommended by’’; and 

22 (ii) by striking ‘‘that screenings are 

23 ready for nationwide implementation’’ and 

24 inserting ‘‘that reliable newborn screening 


kjohnson on DSK79L0C42 with BILLS
6 

•HR 2507 IH

1 technologies are evaluated and ready for 

2 use’’; and 

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

4 ‘‘(b) FUNDING.—In carrying out the research pro5 gram under this section, the Secretary and the Director— 

6 ‘‘(1) shall ensure that entities receiving funding 

7 through the program will provide assurances, as 

8 practicable, that such entities will work in consulta9 tion with the appropriate State departments of 

10 health; and 

11 ‘‘(2) may accept, use, and dispose of donations 

12 and bequests from private for-profit and non-profit 

13 entities, in accordance with Federal law.’’. 

14 SEC. 7. AUTHORIZATION OF APPROPRIATIONS FOR NEW15 BORN SCREENING PROGRAMS AND ACTIVI16 TIES. 

17 Section 1117 of the Public Health Service Act (42 

18 U.S.C. 300b–16) is amended— 

19 (1) in paragraph (1)— 

20 (A) by striking ‘‘$11,900,000’’ and insert21 ing ‘‘$31,000,000’’; 

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

23 ‘‘2020’’; and 

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

25 ‘‘2024’’; and 


kjohnson on DSK79L0C42 with BILLS
7 

•HR 2507 IH

1 (2) in paragraph (2)— 

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

3 ‘‘$29,650,000’’; 

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

5 ‘‘2020’’; and 

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

7 ‘‘2024’’. 

8 SEC. 8. INSTITUTIONAL REVIEW BOARDS; ETHICS GUID9 ANCE PROGRAM. 

10 Section 12 of the Newborn Screening Saves Lives Re11 authorization Act of 2014 (42 U.S.C. 289 note) is amend12 ed to read as follows: 

13 ‘‘SEC. 12. INSTITUTIONAL REVIEW BOARDS; ETHICS GUID14 ANCE PROGRAM. 

15 ‘‘Research on nonidentified newborn dried blood spots 

16 shall be considered secondary research (as that term is 

17 defined in part 4 of section 46.104 of title 45, Code of 

18 Federal Regulations) with nonidentified biospecimens for 

19 purposes of federally funded research conducted pursuant 

20 to the Public Health Service Act (42 U.S.C. 200 et seq.).’’. 

21 SEC. 9. NAM REPORT ON THE MODERNIZATION OF NEW22 BORN SCREENING. 

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

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

25 Human Services shall seek to enter into an agreement 


kjohnson on DSK79L0C42 with BILLS
8 

•HR 2507 IH

1 with the National Academy of Medicine (in this section 

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

3 such an agreement, another appropriate entity) under 

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

5 conduct a study on the following: 

6 (1) The uniform screening panel review and 

7 recommendation processes to identify factors that 

8 impact decisions to add new conditions to the uni9 form screening panel, to describe challenges posed 

10 by newly nominated conditions, including low-inci11 dence diseases, late onset variants, and new treat12 ments without long-term efficacy data. 

13 (2) The barriers that preclude States from add14 ing new uniform screening panel conditions to their 

15 State screening panels with recommendations on re16 sources needed to help States implement uniform 

17 screening panel recommendations. 

18 (3) The current state of federally and privately 

19 funded newborn screening research with rec20 ommendations for optimizing the capacity of this re21 search, including piloting multiple prospective condi22 tions at once and addressing rare disease questions. 

23 (4) New and emerging technologies that would 

24 permit screening for new categories of disorders, or 


kjohnson on DSK79L0C42 with BILLS
9 

•HR 2507 IH

1 would make current screening more effective, more 

2 efficient, or less expensive. 

3 (5) Technological and other infrastructure 

4 needs to improve timeliness of diagnosis and short5 and long-term follow-up for infants identified 

6 through newborn screening and improve public 

7 health surveillance. 

8 (6) Current and future communication and edu9 cational needs for priority stakeholders and the pub10 lic to promote understanding and knowledge of a 

11 modernized newborn screening system with an em12 phasis on evolving communication channels and mes13 saging. 

14 (7) The extent to which newborn screening 

15 yields better data on the disease prevalence for 

16 screened conditions and improves long-term out17 comes for those identified through newborn screen18 ing, including existing systems supporting such data 

19 collection and recommendations for systems that 

20 would allow for improved data collection. 

21 (b) REPORT.—Not later than 18 months after the ef22 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 


kjohnson on DSK79L0C42 with BILLS
10 

•HR 2507 IH

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 (c) 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. 

Æ 


kjohnson on DSK79L0C42 with BILLS