(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)— 
(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’’. 
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(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; 
(C) by redesignating paragraph (8) as 
paragraph (9); 
(D) by inserting after paragraph (7) the 
following: 
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‘‘(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’’; 
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 
health care professionals in newborns and chil-
dren with an initial diagnosis of a disease or 
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condition characterized by a variety of genetic 
causes and manifestations;’’; and 
(2) in subsection (g)— 
(A) in paragraph (1) by striking ‘‘2019’’ 
and inserting ‘‘2030’’; and 
(B) in paragraph (2) by striking ‘‘2019’’ 
and inserting ‘‘2030’’. 
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; 
(B) in paragraph (2)— 
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(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 
the initial positive screen through diagnosis and 
long-term care management; and 
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‘‘(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 
shall ensure that entities receiving funding through the 
program will provide assurances, as practicable, that such 
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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 ‘‘$20,883,000’’; 
(B) by striking ‘‘2015’’ and inserting 
‘‘2026’’; and 
(C) by striking ‘‘2019’’ and inserting 
‘‘2030’’; and 
(2) in paragraph (2)— 
(A) by striking ‘‘$8,000,000’’ and inserting 
‘‘$22,250,000’’; 
(B) by striking ‘‘2015’’ and inserting 
‘‘2026’’; and 
(C) by striking ‘‘2019’’ and inserting 
‘‘2030’’. 
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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.).’’. 
Æ 
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