II 

116TH CONGRESS 

1ST SESSION S. 2158 

To improve certain programs of the Department of Health and Human 

Services with respect to heritable disorders. 

IN THE SENATE OF THE UNITED STATES 

JULY 18, 2019 

Ms. HASSAN (for herself and Mr. GARDNER) introduced the following bill; 

which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To improve certain programs of the Department of Health 

and Human Services with respect to heritable disorders. 

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 ‘‘The Newborn Screen5 ing Saves Lives Reauthorization Act of 2019’’. 

6 SEC. 2. AMENDMENTS. 

7 (a) IMPROVED NEWBORN AND CHILD SCREENING

8 FOR HERITABLE DISORDERS.—Section 1109(a)(3) of the 

9 Public Health Service Act (42 U.S.C. 300b–8(a)(3)) is 

10 amended— 


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1 (1) by striking ‘‘develop and deliver educational 

2 programs (at appropriate literacy levels)’’ and in3 serting ‘‘develop, deliver, and assess the impact of 

4 educational programs (with varying levels of infor5 mation and at appropriate literacy levels)’’; and 

6 (2) by striking ‘‘and specialty services’’ and in7 serting ‘‘specialty services, research-related pilot 

8 studies, and long-term care’’. 

9 (b) EXTENSION OF ADVISORY COMMITTEE ON HERI10 TABLE DISORDERS IN NEWBORNS AND CHILDREN.—Sec11 tion 1111(g) of the Public Health Service Act (42 U.S.C. 

12 300b–10(g)) is amended by striking ‘‘2019’’ each place 

13 it appears and inserting ‘‘2024’’. 

14 (c) TECHNICAL AMENDMENTS.—Title XI of the Pub15 lic Health Service Act (42 U.S.C. 300b–1 et seq.) is 

16 amended— 

17 (1) in the section heading of section 1110, by 

18 striking ‘‘FOLLOWUP’’ and inserting ‘‘FOLLOW19 UP’’; 

20 (2) in sections 1109, 1110, and 1111, by strik21 ing ‘‘followup’’ each place such term appears and in22 serting ‘‘follow-up’’; and 

23 (3) in paragraphs (1) and (2) of section 

24 1110(b), by inserting ‘‘(including long-term follow25 up)’’ before ‘‘, or specialty’’. 


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1 (d) CLEARINGHOUSE OF NEWBORN SCREENING IN2 FORMATION.—Subsection (c) of section 1112 of the Public 

3 Health Service Act (42 U.S.C. 300b–11) is amended to 

4 read as follows: 

5 ‘‘(c) NONDUPLICATION.—In carrying out activities 

6 under this section, the Secretary shall ensure that such 

7 activities minimize duplication and complement other ex8 isting Federal newborn screening-related information9 sharing activities.’’. 

10 (e) LABORATORY QUALITY AND SURVEILLANCE.— 

11 Section 1113 of the Public Health Service Act (42 U.S.C. 

12 300b–12) is amended— 

13 (1) in subsection (a)— 

14 (A) in paragraph (1)— 

15 (i) by striking ‘‘performance evalua16 tion services’’ and inserting ‘‘development 

17 of new screening tests’’; and 

18 (ii) by striking ‘‘; and’’ and inserting 

19 a semicolon; 

20 (B) in paragraph (2)— 

21 (i) by striking ‘‘performance test ma22 terials’’ and inserting ‘‘test performance 

23 materials’’; and 

24 (ii) by striking the period and insert25 ing ‘‘; and’’; and 


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

2 ‘‘(3) performance evaluation services to enhance 

3 disease detection, including the development of tools 

4 and resources to improve data analysis, interpreta5 tion of test results, and dissemination of laboratory 

6 best practices.’’; and 

7 (2) in subsection (b)— 

8 (A) in paragraph (1), by striking ‘‘; and’’ 

9 and inserting a semicolon; 

10 (B) in paragraph (2), by striking the pe11 riod and inserting ‘‘; and’’; and 

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

13 ‘‘(3) by assisting States, as appropriate, in as14 sessing and conducting long-term follow-up and as15 sessing long-term outcomes.’’. 

16 (f) HUNTER KELLY RESEARCH PROGRAM.—Section 

17 1116(a)(1)(D) of the Public Health Service Act (42 

18 U.S.C. 300b–15(a)(1)(D)) is amended— 

19 (1) by inserting ‘‘, or with a high probability of 

20 being recommend by,’’ after ‘‘recommended by’’; and 

21 (2) by striking ‘‘to ensure that screenings are 

22 ready for nationwide implementation’’ and inserting 

23 ‘‘, which may include those conditions that have 

24 been nominated pursuant to section 1111, to ensure 


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1 that screening technologies are piloted and ready for 

2 implementation’’. 

3 (g) AUTHORIZATION OF APPROPRIATIONS.—Section 

4 1117 of the Public Health Service Act (42 U.S.C. 300b– 

5 16) is amended— 

6 (1) in paragraph (1), by striking ‘‘$11,900,000 

7 for each of fiscal years 2015 through 2019’’ and in8 serting ‘‘$16,383,000 for each of fiscal years 2020 

9 through 2024’’; and 

10 (2) in paragraph (2), by striking ‘‘$8,000,000 

11 for each of fiscal years 2015 through 2019’’ and in12 serting ‘‘$17,250,000 for each of fiscal years 2020 

13 through 2024’’. 

14 (h) TECHNICAL ASSISTANCE.—The Secretary shall 

15 publish on the internet website of the Department of 

16 Health and Human Services, information regarding the 

17 process for obtaining technical assistance for submitting 

18 nominations to the recommended uniform screening panel. 

19 (i) REPORT ON THE MODERNIZATION OF NEWBORN

20 SCREENING.— 

21 (1) IN GENERAL.—The Secretary of Health and 

22 Human Services shall, directly or through a con23 tract, conduct an assessment of each of the fol24 lowing: 


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1 (A) The uniform screening panel review 

2 and recommendation processes, including an as3 sessment of factors that impact decisions to add 

4 new conditions to the uniform screening panel 

5 and challenges associated with newly nominated 

6 conditions, including rare diseases with late 

7 onset variants. 

8 (B) Strategies to support implementation 

9 of uniform screening panel recommendations. 

10 (C) Opportunities to improve newborn 

11 screening research, such as piloting the screen12 ing of multiple conditions in a single test and 

13 optimizing the capacity for such research. 

14 (D) Technologies that would improve 

15 screening, including technologies that identify 

16 multiple, related disorders in a single test. 

17 (E) Methods to improve public health sur18 veillance, timeliness of diagnosis, and short- and 

19 long-term follow-up for infants identified 

20 through newborn screening. 

21 (F) Strategies to improve communication 

22 with the public and stakeholders in order to 

23 promote understanding and knowledge of the 

24 newborn screening system. 


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1 (G) The quality of data on disease preva2 lence for screened conditions. 

3 (H) The effect of newborn screening on the 

4 outcomes of those identified as newborns 

5 through such screenings. 

6 (2) REPORT.—Not later than 2 years after the 

7 date of enactment of this Act, the Secretary of 

8 Health and Human Services shall submit, to the 

9 Committee on Health, Education, Labor, and Pen10 sions of the Senate and the Committee on Energy 

11 and Commerce of the House of Representatives, a 

12 report containing the results of the assessment and 

13 recommendations to improve processes described in 

14 paragraph (1). 

Æ 


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