HR4709-119

1. Short title This Act may be cited as the Newborn Screening Saves Lives Reauthorization Act of 2025.

2. Improved newborn and child screening and follow-up for heritable disorders Section 1109(a) of the Public Health Service Act (42 U.S.C. 300b–8(a)) is amended— in paragraph (1), by striking enhance, improve or and inserting facilitate, enhance, improve, or; by amending paragraph (3) to read as follows: to develop, and deliver to parents, families, and patient advocacy and support groups, educational programs that— address newborn screening counseling, testing (including newborn screening pilot studies), follow-up, treatment, specialty services, and long-term care; assess the target audience’s current knowledge, incorporate health communications strategies, and measure impact; and are at appropriate literacy levels; in paragraph (4)— by striking followup and inserting follow-up; and by inserting before the semicolon at the end the following: , including re-engaging patients who have not received recommended follow-up services and supports. Section 1109(c) of the Public Health Service Act (42 U.S.C. 300b–8(c)) is amended— by striking or will use and inserting will use; and 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. (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. 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— in subsection (b)— in paragraph (5), by inserting and adopt process improvements after take appropriate steps; in paragraph (7) by striking and at the end; by redesignating paragraph (8) as paragraph (9); by inserting after paragraph (7) the following: develop, maintain, and publish on a publicly accessible website consumer-friendly materials detailing— the uniform screening panel nomination process, including data requirements, standards, and the use of international data in nomination submissions; and 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 in paragraph (9), as redesignated— by redesignating subparagraphs (K) and (L) as subparagraphs (L) and (M), respectively; and by inserting after subparagraph (J) the following: 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; in subsection (g)— in paragraph (1) by striking 2019 and inserting 2030; and in paragraph (2) by striking 2019 and inserting 2030. (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 (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

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.

5. Laboratory quality and surveillance Section 1113 of the Public Health Service Act (42 U.S.C. 300b–12) is amended— in subsection (a)— in paragraph (1)— by striking performance evaluation services, and inserting development of new screening tests,; and by striking and at the end; in paragraph (2)— by striking performance test materials and inserting test performance materials; and by striking the period at the end and inserting ; and; and by adding at the end the following: 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. in subsection (b) to read as follows: 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— 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 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. (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 (b)Surveillance activitiesThe 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..

6. Hunter Kelly research program Section 1116 of the Public Health Service Act (42 U.S.C. 300b–15) is amended— in subsection (a)(1)— by striking may and inserting shall; and in subparagraph (D)— by inserting , or with a high probability of being recommended by, after recommended by; and by striking that screenings are ready for nationwide implementation and inserting that reliable newborn screening technologies are piloted and ready for use; and in subsection (b) to read as follows: 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. (b)FundingIn 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..

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: 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.). 12.Institutional review boards; ethics guidance programResearch 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.)..

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.).