IB 

Union Calendar No. 134 

116TH CONGRESS 

1ST SESSION H. R. 2507 

[Report No. 116–174] 

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 

JULY 23, 2019 

Additional sponsors: Mr. FITZPATRICK, Mrs. RODGERS of Washington, Ms. 

NORTON, Mr. RASKIN, Ms. CLARKE of New York, Mr. NEGUSE, Mr. 

WATKINS, Miss RICE of New York, Mr. STEWART, Mrs. DINGELL, Mr. 

CARTER of Texas, Mr. CASE, Mr. CALVERT, Mr. GALLEGO, Mr. COLE, 

Mr. PAPPAS, Mr. FLEISCHMANN, Ms. CASTOR of Florida, Mr. LAMBORN, 

Ms. SHALALA, Mr. COLLINS of New York, Ms. BLUNT ROCHESTER, Mr. 

GRIJALVA, Mr. KENNEDY, Mr. TED LIEU of California, Mr. HIMES, Mr. 

RUSH, Mr. HASTINGS, Mr. HIGGINS of New York, Mr. SOTO, Ms. 

KUSTER of New Hampshire, Ms. KELLY of Illinois, Mr. WELCH, Mrs. 

AXNE, Mr. COHEN, Mrs. BROOKS of Indiana, Mr. ROUDA, Ms. FUDGE, 

Mr. STIVERS, Ms. DEGETTE, Mrs. DAVIS of California, Mr. HAGEDORN, 

Mr. CASTEN of Illinois, Mr. GUTHRIE, Ms. SCANLON, Mr. YARMUTH, and 

Mr. DAVID SCOTT of Georgia 

JULY 23, 2019 

Reported with an amendment, committed to the Committee of the Whole 

House on the State of the Union, and ordered to be printed 

[Strike out all after the enacting clause and insert the part printed in italic] 

[For text of introduced bill, see copy of bill as introduced on May 2, 2019] 


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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. 


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

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

10 (1) in paragraph (1), by striking ‘‘enhance, im11 prove or’’ and inserting ‘‘facilitate, enhance, improve, 

12 or’’; 

13 (2) by amending paragraph (3) to read as fol14 lows: 

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

16 and patient advocacy and support groups, edu17 cational programs that— 

18 ‘‘(A) address newborn screening counseling, 

19 testing (including newborn screening pilot stud20 ies), follow-up, treatment, specialty services, and 

21 long-term care; 

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

23 knowledge, incorporate health communications 

24 strategies, and measure impact; and 


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

2 and 

3 (3) in paragraph (4)— 

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

5 ‘‘follow-up’’; and 

6 (B) by inserting before the semicolon at the 

7 end the following: ‘‘, including re-engaging pa8 tients who have not received recommended follow9 up services and supports’’. 

10 (b) APPROVAL FACTORS.—Section 1109(c) of the Pub11 lic Health Service Act (42 U.S.C. 300b–8(c)) is amended— 

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

13 use’’; and 

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

15 under such grant to enhance capacity and infrastruc16 ture to facilitate the adoption of,’’ before ‘‘the guide17 lines and recommendations’’. 

18 SEC. 3. ADVISORY COMMITTEE ON HERITABLE DISORDERS 

19 IN NEWBORNS AND CHILDREN. 

20 Section 1111 of the Public Health Service Act (42 

21 U.S.C. 300b–10) is amended— 

22 (1) in subsection (b)— 

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

24 adopt process improvements’’ after ‘‘take appro25 priate steps’’; 


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

2 the end; 

3 (C) by redesignating paragraph (8) as 

4 paragraph (9); 

5 (D) by inserting after paragraph (7) the fol6 lowing: 

7 ‘‘(8) develop, maintain, and publish on a pub8 licly accessible website consumer-friendly materials 

9 detailing— 

10 ‘‘(A) the uniform screening panel nomina11 tion process, including data requirements, stand12 ards, and the use of international data in nomi13 nation submissions; and 

14 ‘‘(B) the process for obtaining technical as15 sistance for submitting nominations to the uni16 form screening panel and detailing the instances 

17 in which the provision of technical assistance 

18 would introduce a conflict of interest for mem19 bers of the Advisory Committee; and’’; 

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

21 (i) by redesignating subparagraphs (K) 

22 and (L) as subparagraphs (L) and (M), re23 spectively; and 

24 (ii) by inserting after subparagraph 

25 (J) the following: 


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1 ‘‘(K) the appropriate and recommended use 

2 of safe and effective genetic testing by health care 

3 professionals in newborns and children with an 

4 initial diagnosis of a disease or condition char5 acterized by a variety of genetic causes and 

6 manifestations;’’; and 

7 (2) in subsection (g)— 

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

9 and inserting ‘‘2024’’; and 

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

11 and inserting ‘‘2024’’. 

12 SEC. 4. CLEARINGHOUSE OF NEWBORN SCREENING INFOR13 MATION. 

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

15 U.S.C. 300b–11(c)) is amended by striking ‘‘and supple16 ment, not supplant, existing information sharing efforts’’ 

17 and inserting ‘‘and complement other Federal newborn 

18 screening information sharing activities’’. 

19 SEC. 5. LABORATORY QUALITY AND SURVEILLANCE. 

20 Section 1113 of the Public Health Service Act (42 

21 U.S.C. 300b–12) is amended— 

22 (1) in subsection (a)— 

23 (A) in paragraph (1)— 


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1 (i) by striking ‘‘performance evalua2 tion services,’’ and inserting ‘‘development 

3 of new screening tests,’’; and 

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

5 (B) in paragraph (2)— 

6 (i) by striking ‘‘performance test mate7 rials’’ and inserting ‘‘test performance ma8 terials’’; and 

9 (ii) by striking the period at the end 

10 and inserting ‘‘; and’’; and 

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

12 ‘‘(3) performance evaluation services to enhance 

13 disease detection, including the development of tools, 

14 resources, and infrastructure to improve data anal15 ysis, test result interpretation, data harmonization, 

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

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

18 ‘‘(b) SURVEILLANCE ACTIVITIES.—The Secretary, act19 ing through the Director of the Centers for Disease Control 

20 and Prevention, and taking into consideration the expertise 

21 of the Advisory Committee on Heritable Disorders in 

22 Newborns and Children established under section 1111, 

23 shall provide for the coordination of national surveillance 

24 activities, including— 


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1 ‘‘(1) standardizing data collection and reporting 

2 through the use of electronic and other forms of health 

3 records to achieve real-time data for tracking and 

4 monitoring the newborn screening system, from the 

5 initial positive screen through diagnosis and long6 term care management; and 

7 ‘‘(2) by promoting data sharing linkages between 

8 State newborn screening programs and State-based 

9 birth defects and developmental disabilities surveil10 lance programs to help families connect with services 

11 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 


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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 program 

5 under this section, the Secretary and the Director— 

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

7 through the program will provide assurances, as prac8 ticable, that such entities will work in consultation 

9 with the appropriate State departments of health; and 

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

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

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

13 SEC. 7. AUTHORIZATION OF APPROPRIATIONS FOR NEW14 BORN SCREENING PROGRAMS AND ACTIVI15 TIES. 

16 Section 1117 of the Public Health Service Act (42 

17 U.S.C. 300b–16) is amended— 

18 (1) in paragraph (1)— 

19 (A) by striking ‘‘$11,900,000’’ and inserting 

20 ‘‘$31,000,000’’; 

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

22 ‘‘2020’’; and 

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

24 ‘‘2024’’; and 

25 (2) in paragraph (2)— 


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

2 ‘‘$29,650,000’’; 

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

4 ‘‘2020’’; and 

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

6 ‘‘2024’’. 

7 SEC. 8. INSTITUTIONAL REVIEW BOARDS; ETHICS GUID8 ANCE PROGRAM. 

9 Section 12 of the Newborn Screening Saves Lives Re10 authorization Act of 2014 (42 U.S.C. 289 note) is amended 

11 to read as follows: 

12 ‘‘SEC. 12. INSTITUTIONAL REVIEW BOARDS; ETHICS GUID13 ANCE PROGRAM. 

14 ‘‘Research on nonidentified newborn dried blood spots 

15 shall be considered secondary research (as that term is de16 fined in part 4 of section 46.104 of title 45, Code of Federal 

17 Regulations) with nonidentified biospecimens for purposes 

18 of federally funded research conducted pursuant to the Pub19 lic Health Service Act (42 U.S.C. 200 et seq.).’’. 

20 SEC. 9. NAM REPORT ON THE MODERNIZATION OF NEW21 BORN SCREENING. 

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

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

24 Human Services shall seek to enter into an agreement with 

25 the National Academy of Medicine (in this section referred 


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1 to as ‘‘NAM’’) (or if NAM declines to enter into such an 

2 agreement, another appropriate entity) under which NAM, 

3 or such other appropriate entity, agrees to conduct a study 

4 on the following: 

5 (1) The uniform screening panel review and rec6 ommendation processes to identify factors that impact 

7 decisions to add new conditions to the uniform screen8 ing panel, to describe challenges posed by newly nom9 inated conditions, including low-incidence diseases, 

10 late onset variants, and new treatments without long11 term efficacy data. 

12 (2) The barriers that preclude States from add13 ing new uniform screening panel conditions to their 

14 State screening panels with recommendations on re15 sources needed to help States implement uniform 

16 screening panel recommendations. 

17 (3) The current state of federally and privately 

18 funded newborn screening research with recommenda19 tions for optimizing the capacity of this research, in20 cluding piloting multiple prospective conditions at 

21 once and addressing rare disease questions. 

22 (4) New and emerging technologies that would 

23 permit screening for new categories of disorders, or 

24 would make current screening more effective, more ef25 ficient, or less expensive. 


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1 (5) Technological and other infrastructure needs 

2 to improve timeliness of diagnosis and short- and 

3 long-term follow-up for infants identified through 

4 newborn screening and improve public health surveil5 lance. 

6 (6) Current and future communication and edu7 cational needs for priority stakeholders and the public 

8 to promote understanding and knowledge of a mod9 ernized newborn screening system with an emphasis 

10 on evolving communication channels and messaging. 

11 (7) The extent to which newborn screening yields 

12 better data on the disease prevalence for screened con13 ditions and improves long-term outcomes for those 

14 identified through newborn screening, including exist15 ing systems supporting such data collection and rec16 ommendations for systems that would allow for im17 proved data collection. 

18 (8) The impact on newborn morbidity and mor19 tality in States that adopt newborn screening tests in20 cluded on the uniform panel. 

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

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

23 or such other appropriate entity shall hold not less than 

24 one public meeting to obtain stakeholder input on the topics 

25 of such study. 


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1 (c) REPORT.—Not later than 18 months after the effec2 tive date of the agreement under subsection (a), such agree3 ment shall require NAM, or such other appropriate entity, 

4 to submit to the Secretary of Health and Human Services 

5 and the appropriate committees of jurisdiction of Congress 

6 a report containing— 

7 (1) the results of the study conducted under sub8 section (a); 

9 (2) recommendations to modernize the processes 

10 described in subsection (a)(1); and 

11 (3) recommendations for such legislative and ad12 ministrative action as NAM, or such other appro13 priate entity, determines appropriate. 

14 (d) AUTHORIZATION OF APPROPRIATIONS.—There is 

15 authorized to be appropriated $2,000,000 for the period of 

16 fiscal years 2020 and 2021 to carry out this section. 


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Union Calendar No. 134 

116TH CONGRESS 

1ST SESSION H. R. 2507 

[Report No. 116–174] 

A BILL 

To amend the Public Health Service Act to reauother purposes. of such Act relating to genetic diseases, and for thorize certain programs under part A of title XI 

JULY 23, 2019 

Reported with an amendment, committed to the Comand ordered to be printed mittee of the Whole House on the State of the Union, 


kjohnson on DSK79L0C42 with BILLS