119-hr4709

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4709 Introduced in House

    (IH) ]

<DOC>

119th CONGRESS
 1st Session
 H. R. 4709

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

 July 23, 2025

 Ms. Morrison (for herself, Mr. Simpson, Ms. Schrier, and Mr. 
 Langworthy) 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 certain 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 Representatives 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 2025''.

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, improve or'' 
 and inserting ``facilitate, enhance, improve, or'';

    (2) by amending paragraph

    (3) to read as follows:
 ``

    (3) to develop, and deliver to parents, families, and 
 patient advocacy and support groups, educational programs 
 that--
 ``
        (A) address newborn screening counseling, 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''.

    (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 infrastructure 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 appropriate 
 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:
 ``

    (8) develop, maintain, and publish on a publicly 
 accessible website consumer-friendly materials detailing--
 ``
        (A) the uniform screening panel nomination 
 process, including data requirements, standards, and 
 the use of international data in nomination 
 submissions; and
 ``
        (B) the process for obtaining technical 
 assistance for submitting nominations to the uniform 
 screening panel and detailing the instances in which 
 the provision of technical assistance 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 children 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 ``2030''; and
        (B) in paragraph

    (2) by striking ``2019'' and 
 inserting ``2030''.

SEC. 4. CLEARINGHOUSE OF NEWBORN SCREENING INFORMATION.

 

Section 1112
            (c) of the Public Health Service Act (42 U.S.C. 300b-
11
            (c) ) is amended by striking ``and supplement, 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 evaluation 
 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 
 materials'' 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 analysis, 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 
Disorders in Newborns and Children established under 

section 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
 ``

    (2) by promoting data sharing linkages between 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 
 probability 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 program under this 
section, the Secretary and the Director 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 NEWBORN SCREENING PROGRAMS 
 AND ACTIVITIES.

 

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 
 ``$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''.

SEC. 8. INSTITUTIONAL REVIEW BOARDS; ETHICS GUIDANCE PROGRAM.

 

Section 12 of the Newborn Screening Saves Lives Reauthorization Act 
of 2014 (42 U.S.C. 289 note) is amended to read as follows:

``

SEC. 12. INSTITUTIONAL REVIEW BOARDS; ETHICS GUIDANCE 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.).''.
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