IIB 
117TH CONGRESS 
1ST SESSION 
H. R. 482 
IN THE SENATE OF THE UNITED STATES 
JUNE 24, 2021 
Received; read twice and referred to the Committee on Health, Education, 
Labor, and Pensions 
AN ACT 
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, 
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SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Newborn Screening 
Saves Lives Reauthorization Act of 2021’’. 
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, im-
prove, 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 coun-
seling, testing (including newborn screening 
pilot studies), 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 
‘‘(C) are at appropriate literacy levels;’’; 
and 
(3) in paragraph (4)— 
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(A) by striking ‘‘followup’’ and inserting 
‘‘follow-up’’; and 
(B) by inserting before the semicolon at 
the end the following: ‘‘, including re-engaging 
patients who have not received recommended 
follow-up services and supports’’. 
(b) APPROVAL FACTORS.—Section 1109(c) of the 
Public 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 infra-
structure to facilitate the adoption of,’’ before ‘‘the 
guidelines 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 ap-
propriate steps’’; 
(B) in paragraph (7) by striking ‘‘and’’ at 
the end; 
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(C) by redesignating paragraph (8) as 
paragraph (9); 
(D) 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, 
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’’; 
(E) in paragraph (9), as redesignated— 
(i) by redesignating subparagraphs 
(K) and (L) as subparagraphs (L) and 
(M), respectively; and 
(ii) by inserting after subparagraph 
(J) the following: 
‘‘(K) the appropriate and recommended 
use of safe and effective genetic testing by 
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health care professionals in newborns and chil-
dren with an initial diagnosis of a disease or 
condition characterized by a variety of genetic 
causes and manifestations;’’; and 
(2) in subsection (g)— 
(A) in paragraph (1) by striking ‘‘2019’’ 
and inserting ‘‘2026’’; and 
(B) in paragraph (2) by striking ‘‘2019’’ 
and inserting ‘‘2026’’. 
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)— 
(i) by striking ‘‘performance evalua-
tion services,’’ and inserting ‘‘development 
of new screening tests,’’; and 
(ii) by striking ‘‘and’’ at the end; 
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(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— 
‘‘(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 
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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 
technologies are piloted 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 
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shall ensure that entities receiving funding through the 
program will provide assurances, as practicable, that such 
entities will work in consultation with State departments 
of health, as appropriate.’’. 
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 
‘‘2022’’; and 
(C) by striking ‘‘2019’’ and inserting 
‘‘2026’’; and 
(2) in paragraph (2)— 
(A) by striking ‘‘$8,000,000’’ and inserting 
‘‘$29,650,000’’; 
(B) by striking ‘‘2015’’ and inserting 
‘‘2022’’; and 
(C) by striking ‘‘2019’’ and inserting 
‘‘2026’’. 
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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 section 46.104(d)(4) of title 45, Code of Federal 
Regulations (or successor 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 
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 
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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 
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. 
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(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. 
(8) The impact on newborn morbidity and mor-
tality in States that adopt newborn screening tests 
included 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 top-
ics of such study. 
(c) 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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