H.R. 4709 — Newborn Screening Saves Lives Reauthorization Act of 2025

This section revises the purposes of grants under Section 1109 of the Public Health Service Act (42 U.S.C. 300b–8)—which supports state newborn and child screening programs for heritable disorders, including follow-up, treatment, and specialty services—as follows: (1) expands eligible activities in paragraph (1) to include facilitating (in addition to enhancing or improving) screening, follow-up, and treatment; (2) requires educational programs under paragraph (3) to address counseling, testing (including pilot studies), follow-up, treatment, specialty services, and long-term care; assess target audience knowledge, incorporate health communications strategies, and measure impact; and be at appropriate literacy levels; and (3) expands follow-up under paragraph (4) to include re-engaging patients who have not received recommended services and supports. The section also modifies grant approval criteria under subsection (c) to require applicants to use grant funds (previously, to use or will use) to enhance capacity and infrastructure to facilitate adoption of recommended uniform screening guidelines (in addition to implementing such guidelines).

This section revises duties of the Advisory Committee on Heritable Disorders in Newborns and Children—which advises the Secretary of HHS on newborn screening for heritable disorders, including the Recommended Uniform Screening Panel—and reauthorizes the committee through 2030 (from 2019). It (1) requires the committee to adopt process improvements in carrying out its functions; (2) directs the committee to develop, maintain, and publish consumer-friendly materials on its website detailing the uniform screening panel nomination process (including data requirements, standards, and use of international data) and the process for obtaining technical assistance (including conflict-of-interest limitations); and (3) requires the committee to provide guidance on the appropriate use of safe and effective genetic testing by health care professionals for newborns and children with an initial diagnosis of a disease or condition with varied genetic causes and manifestations.

This section revises the newborn screening information clearinghouse established under Section 1112 of the Public Health Service Act (42 U.S.C. 300b-11) by replacing the requirement to "supplement, not supplant, existing information sharing efforts" with a requirement to "complement other Federal newborn screening information sharing activities." (As background, the clearinghouse coordinates and disseminates data and best practices to support state newborn screening programs, which test infants for treatable genetic, metabolic, and congenital disorders.)

This section revises laboratory quality assurance and surveillance provisions under Section 1113 of the Public Health Service Act (42 U.S.C. 300b–12), which supports state newborn screening programs for heritable disorders (i.e., testing infants shortly after birth for treatable conditions to enable early intervention). Specifically, in subsection (a), it (1) replaces "performance evaluation services" with "development of new screening tests" in paragraph (1); (2) replaces "performance test materials" with "test performance materials" in paragraph (2); and (3) adds paragraph (3) requiring performance evaluation services to enhance disease detection, including tools and infrastructure for data analysis, test interpretation, data harmonization, and laboratory best practices dissemination. It also replaces subsection (b) to direct the Secretary, acting through the CDC Director and considering the Advisory Committee on Heritable Disorders in Newborns and Children, to coordinate national surveillance activities by (1) standardizing data collection and reporting through electronic health records for real-time tracking from initial screening through diagnosis and long-term care; and (2) promoting data-sharing linkages between state newborn screening programs and state birth defects and developmental disabilities surveillance programs to connect families with services for evaluating long-term outcomes.

This section revises the Hunter Kelly Prenatal and Newborn Infant Research Program (42 U.S.C. 300b-15)—which supports research to develop and validate screening tests for heritable disorders recommended by the Advisory Committee on Heritable Disorders in Newborns and Children—by (1) requiring the Secretary to conduct specified research activities (changing "may" to "shall" in subsection (a)(1)); (2) in subsection (a)(1)(D), expanding eligibility to conditions with a high probability of being recommended by the committee and to reliable newborn screening technologies that are piloted and ready for use (from readiness for nationwide implementation); and (3) requiring the Secretary and Director, in subsection (b), to ensure that funded entities consult with state departments of health, as practicable and appropriate.

This section revises authorizations of appropriations under Section 1117 of the Public Health Service Act for newborn screening programs and activities—which support grants to states and other entities to screen newborns for heritable disorders (e.g., phenylketonuria) and coordinate follow-up testing, treatment, and education—by (1) in paragraph (1), increasing the amount to $20,883,000 for FY2026 (from $11,900,000 for FY2015) and extending the authorization through FY2030 (from FY2019); and (2) in paragraph (2), increasing the amount to $22,250,000 for FY2026 (from $8,000,000 for FY2015) and extending the authorization through FY2030 (from FY2019).

This section revises Section 12 of the Newborn Screening Saves Lives Reauthorization Act of 2014 (42 U.S.C. 289 note)—previously concerning institutional review boards and an ethics guidance program for newborn screening research—to classify research on nonidentified newborn dried blood spots as secondary research with nonidentified biospecimens (as defined in 45 CFR 46.104(d)(4) or successor regulations) for purposes of federally funded research under the Public Health Service Act. (Thus, such research is not human subjects research requiring institutional review board oversight under the Common Rule.)