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 Massachu-
setts, 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 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-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Newborn Screening 
Saves Lives Reauthorization Act of 2019’’. 
SEC. 2. IMPROVED NEWBORN AND CHILD SCREENING AND 
FOLLOW-UP FOR HERITABLE DISORDERS. 
Section 1109(a)(3) of the Public Health Service Act 
(42 U.S.C. 300b–8(a)(3)) is amended to read as follows: 
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‘‘(3) to develop and deliver educational pro-
grams (at appropriate literacy levels) about newborn 
screening counseling, testing, follow-up, treatment, 
specialty services, and long-term care to parents, 
families, and patient advocacy and support groups 
that assess the target audience’s current knowledge, 
incorporate health communications strategies, and 
measure impact;’’. 
SEC. 3. ADVISORY COMMITTEE ON HERITABLE DISORDERS 
IN NEWBORNS AND CHILDREN. 
Section 1111 of the Public Health Service Act (42 
U.S.C. 300b–10) is amended— 
(1) in subsection (b)— 
(A) in paragraph (7) by striking ‘‘and’’ at 
the end; 
(B) by redesignating paragraph (8) as 
paragraph (9); and 
(C) by inserting after paragraph (7) the 
following: 
‘‘(8) develop, maintain, and publish on a pub-
licly accessible website consumer-friendly materials 
detailing— 
‘‘(A) the uniform screening panel nomina-
tion process, including data requirements, 
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standards, and the use of international data in 
nomination submissions; and 
‘‘(B) the process for obtaining technical as-
sistance for submitting nominations to the uni-
form screening panel and detailing the in-
stances in which the provision of technical as-
sistance would introduce a conflict of interest 
for members of the Advisory Committee; and’’; 
and 
(2) in subsection (g)— 
(A) in paragraph (1) by striking ‘‘2019’’ 
and inserting ‘‘2024’’; and 
(B) in paragraph (2) by striking ‘‘2019’’ 
and inserting ‘‘2024’’. 
SEC. 4. CLEARINGHOUSE OF NEWBORN SCREENING INFOR-
MATION. 
Section 1112(c) of the Public Health Service Act (42 
U.S.C. 300b–11(c)) is amended by striking ‘‘and supple-
ment, not supplant, existing information sharing efforts’’ 
and inserting ‘‘and complement other Federal newborn 
screening information sharing activities’’. 
SEC. 5. LABORATORY QUALITY AND SURVEILLANCE. 
Section 1113 of the Public Health Service Act (42 
U.S.C. 300b–12) is amended— 
(1) in subsection (a)— 
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(A) in paragraph (1)— 
(i) by striking ‘‘performance evalua-
tion services,’’ and inserting ‘‘development 
of new screening tests,’’; and 
(ii) by striking ‘‘and’’ at the end; 
(B) in paragraph (2)— 
(i) by striking ‘‘performance test ma-
terials’’ and inserting ‘‘test performance 
materials’’; and 
(ii) by striking the period at the end 
and inserting ‘‘; and’’; and 
(C) by adding at the end the following: 
‘‘(3) performance evaluation services to enhance 
disease detection, including the development of tools, 
resources, and infrastructure to improve data anal-
ysis, test result interpretation, data harmonization, 
and dissemination of laboratory best practices.’’; and 
(2) in subsection (b) to read as follows: 
‘‘(b) SURVEILLANCE ACTIVITIES.—The Secretary, 
acting through the Director of the Centers for Disease 
Control and Prevention, and taking into consideration the 
expertise of the Advisory Committee on Heritable Dis-
orders in Newborns and Children established under sec-
tion 1111, shall provide for the coordination of national 
surveillance activities, including— 
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‘‘(1) standardizing data collection and reporting 
through the use of electronic and other forms of 
health records to achieve real-time data for tracking 
and monitoring the newborn screening system, from 
the initial positive screen through diagnosis and 
long-term care management; and 
‘‘(2) by promoting data sharing linkages be-
tween State newborn screening programs and State- 
based birth defects and developmental disabilities 
surveillance programs to help families connect with 
services to assist in evaluating long-term outcomes.’’. 
SEC. 6. HUNTER KELLY RESEARCH PROGRAM. 
Section 1116 of the Public Health Service Act (42 
U.S.C. 300b–15) is amended— 
(1) in subsection (a)(1)— 
(A) by striking ‘‘may’’ and inserting 
‘‘shall’’; and 
(B) in subparagraph (D)— 
(i) by inserting ‘‘, or with a high prob-
ability of being recommended by,’’ after 
‘‘recommended by’’; and 
(ii) by striking ‘‘that screenings are 
ready for nationwide implementation’’ and 
inserting ‘‘that reliable newborn screening 
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technologies are evaluated and ready for 
use’’; and 
(2) in subsection (b) to read as follows: 
‘‘(b) FUNDING.—In carrying out the research pro-
gram under this section, the Secretary and the Director— 
‘‘(1) shall ensure that entities receiving funding 
through the program will provide assurances, as 
practicable, that such entities will work in consulta-
tion with the appropriate State departments of 
health; and 
‘‘(2) may accept, use, and dispose of donations 
and bequests from private for-profit and non-profit 
entities, in accordance with Federal law.’’. 
SEC. 7. AUTHORIZATION OF APPROPRIATIONS FOR NEW-
BORN SCREENING PROGRAMS AND ACTIVI-
TIES. 
Section 1117 of the Public Health Service Act (42 
U.S.C. 300b–16) is amended— 
(1) in paragraph (1)— 
(A) by striking ‘‘$11,900,000’’ and insert-
ing ‘‘$31,000,000’’; 
(B) by striking ‘‘2015’’ and inserting 
‘‘2020’’; and 
(C) by striking ‘‘2019’’ and inserting 
‘‘2024’’; and 
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(2) in paragraph (2)— 
(A) by striking ‘‘$8,000,000’’ and inserting 
‘‘$29,650,000’’; 
(B) by striking ‘‘2015’’ and inserting 
‘‘2020’’; and 
(C) by striking ‘‘2019’’ and inserting 
‘‘2024’’. 
SEC. 8. INSTITUTIONAL REVIEW BOARDS; ETHICS GUID-
ANCE PROGRAM. 
Section 12 of the Newborn Screening Saves Lives Re-
authorization Act of 2014 (42 U.S.C. 289 note) is amend-
ed to read as follows: 
‘‘SEC. 12. INSTITUTIONAL REVIEW BOARDS; ETHICS GUID-
ANCE PROGRAM. 
‘‘Research on nonidentified newborn dried blood spots 
shall be considered secondary research (as that term is 
defined in part 4 of section 46.104 of title 45, Code of 
Federal Regulations) with nonidentified biospecimens for 
purposes of federally funded research conducted pursuant 
to the Public Health Service Act (42 U.S.C. 200 et seq.).’’. 
SEC. 9. NAM REPORT ON THE MODERNIZATION OF NEW-
BORN SCREENING. 
(a) STUDY.—Not later than 60 days after the date 
of the enactment of this Act, the Secretary of Health and 
Human Services shall seek to enter into an agreement 
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with the National Academy of Medicine (in this section 
referred to as ‘‘NAM’’) (or if NAM declines to enter into 
such an agreement, another appropriate entity) under 
which NAM, or such other appropriate entity, agrees to 
conduct a study on the following: 
(1) The uniform screening panel review and 
recommendation processes to identify factors that 
impact decisions to add new conditions to the uni-
form screening panel, to describe challenges posed 
by newly nominated conditions, including low-inci-
dence diseases, late onset variants, and new treat-
ments without long-term efficacy data. 
(2) The barriers that preclude States from add-
ing new uniform screening panel conditions to their 
State screening panels with recommendations on re-
sources needed to help States implement uniform 
screening panel recommendations. 
(3) The current state of federally and privately 
funded newborn screening research with rec-
ommendations for optimizing the capacity of this re-
search, including piloting multiple prospective condi-
tions at once and addressing rare disease questions. 
(4) New and emerging technologies that would 
permit screening for new categories of disorders, or 
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would make current screening more effective, more 
efficient, or less expensive. 
(5) Technological and other infrastructure 
needs to improve timeliness of diagnosis and short- 
and long-term follow-up for infants identified 
through newborn screening and improve public 
health surveillance. 
(6) Current and future communication and edu-
cational needs for priority stakeholders and the pub-
lic to promote understanding and knowledge of a 
modernized newborn screening system with an em-
phasis on evolving communication channels and mes-
saging. 
(7) The extent to which newborn screening 
yields better data on the disease prevalence for 
screened conditions and improves long-term out-
comes for those identified through newborn screen-
ing, including existing systems supporting such data 
collection and recommendations for systems that 
would allow for improved data collection. 
(b) REPORT.—Not later than 18 months after the ef-
fective date of the agreement under subsection (a), such 
agreement shall require NAM, or such other appropriate 
entity, to submit to the Secretary of Health and Human 
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Services and the appropriate committees of jurisdiction of 
Congress a report containing— 
(1) the results of the study conducted under 
subsection (a); 
(2) recommendations to modernize the proc-
esses described in subsection (a)(1); and 
(3) recommendations for such legislative and 
administrative action as NAM, or such other appro-
priate entity, determines appropriate. 
(c) AUTHORIZATION OF APPROPRIATIONS.—There is 
authorized to be appropriated $2,000,000 for the period 
of fiscal years 2020 and 2021 to carry out this section. 
Æ 
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