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[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.).''.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Subcommittee Consideration and Mark-up Session Held
Forwarded by Subcommittee to Full Committee by Voice Vote.
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