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 Massachu-
setts, 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 cer-
tain programs under part A of title XI of such Act 
relating to genetic diseases, and for other purposes. 
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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. 
(a) PURPOSES.—Section 1109(a) of the Public Health 
Service Act (42 U.S.C. 300b–8(a)) is amended— 
(1) in paragraph (1), by striking ‘‘enhance, im-
prove or’’ and inserting ‘‘facilitate, enhance, improve, 
or’’; 
(2) by amending paragraph (3) to read as fol-
lows: 
‘‘(3) to develop, and deliver to parents, families, 
and patient advocacy and support groups, edu-
cational programs that— 
‘‘(A) address newborn screening counseling, 
testing (including newborn screening pilot stud-
ies), follow-up, treatment, specialty services, and 
long-term care; 
‘‘(B) assess the target audience’s current 
knowledge, incorporate health communications 
strategies, and measure impact; and 
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‘‘(C) are at appropriate literacy levels;’’; 
and 
(3) in paragraph (4)— 
(A) by striking ‘‘followup’’ and inserting 
‘‘follow-up’’; and 
(B) by inserting before the semicolon at the 
end the following: ‘‘, including re-engaging pa-
tients who have not received recommended follow- 
up services and supports’’. 
(b) APPROVAL FACTORS.—Section 1109(c) of the Pub-
lic Health Service Act (42 U.S.C. 300b–8(c)) is amended— 
(1) by striking ‘‘or will use’’ and inserting ‘‘will 
use’’; and 
(2) by inserting ‘‘, or will use amounts received 
under such grant to enhance capacity and infrastruc-
ture to facilitate the adoption of,’’ before ‘‘the guide-
lines and recommendations’’. 
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 (5), by inserting ‘‘and 
adopt process improvements’’ after ‘‘take appro-
priate steps’’; 
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(B) in paragraph (7) by striking ‘‘and’’ at 
the end; 
(C) by redesignating paragraph (8) as 
paragraph (9); 
(D) by inserting after paragraph (7) the fol-
lowing: 
‘‘(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, stand-
ards, and the use of international data in nomi-
nation submissions; and 
‘‘(B) the process for obtaining technical as-
sistance for submitting nominations to the uni-
form screening panel and detailing the instances 
in which the provision of technical assistance 
would introduce a conflict of interest for mem-
bers of the Advisory Committee; and’’; 
(E) in paragraph (9), as redesignated— 
(i) by redesignating subparagraphs (K) 
and (L) as subparagraphs (L) and (M), re-
spectively; and 
(ii) by inserting after subparagraph 
(J) the following: 
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‘‘(K) the appropriate and recommended use 
of safe and effective genetic testing by health care 
professionals in newborns and children with an 
initial diagnosis of a disease or condition char-
acterized by a variety of genetic causes and 
manifestations;’’; 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)— 
(A) in paragraph (1)— 
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(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 mate-
rials’’ and inserting ‘‘test performance ma-
terials’’; 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, act-
ing through the Director of the Centers for Disease Control 
and Prevention, and taking into consideration the expertise 
of the Advisory Committee on Heritable Disorders in 
Newborns and Children established under section 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 between 
State newborn screening programs and State-based 
birth defects and developmental disabilities surveil-
lance 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 program 
under this section, the Secretary and the Director— 
‘‘(1) shall ensure that entities receiving funding 
through the program will provide assurances, as prac-
ticable, that such entities will work in consultation 
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 inserting 
‘‘$31,000,000’’; 
(B) by striking ‘‘2015’’ and inserting 
‘‘2020’’; and 
(C) by striking ‘‘2019’’ and inserting 
‘‘2024’’; and 
(2) in paragraph (2)— 
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(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 amended 
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 de-
fined 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 Pub-
lic 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 with 
the National Academy of Medicine (in this section referred 
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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 rec-
ommendation processes to identify factors that impact 
decisions to add new conditions to the uniform screen-
ing panel, to describe challenges posed by newly nom-
inated conditions, including low-incidence diseases, 
late onset variants, and new treatments 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 recommenda-
tions for optimizing the capacity of this research, in-
cluding piloting multiple prospective conditions at 
once and addressing rare disease questions. 
(4) New and emerging technologies that would 
permit screening for new categories of disorders, or 
would make current screening more effective, more ef-
ficient, or less expensive. 
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(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 surveil-
lance. 
(6) Current and future communication and edu-
cational needs for priority stakeholders and the public 
to promote understanding and knowledge of a mod-
ernized newborn screening system with an emphasis 
on evolving communication channels and messaging. 
(7) The extent to which newborn screening yields 
better data on the disease prevalence for screened con-
ditions and improves long-term outcomes for those 
identified through newborn screening, including exist-
ing systems supporting such data collection and rec-
ommendations for systems that would allow for im-
proved data collection. 
(8) The impact on newborn morbidity and mor-
tality in States that adopt newborn screening tests in-
cluded on the uniform panel. 
(b) PUBLIC STAKEHOLDER MEETING.—In the course 
of completing the study described in subsection (a), NAM 
or such other appropriate entity shall hold not less than 
one public meeting to obtain stakeholder input on the topics 
of such study. 
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