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Replaces the existing text of 42 U.S.C. 289 (Section 12 of the Newborn Screening Saves Lives Reauthorization Act of 2014) with a provision that classifies research on nonidentified newborn dried blood spots as secondary research (per 45 C.F.R. 46.104(d)(4)) with nonidentified biospecimens for purposes of federally funded research under the Public Health Service Act.
Amends Section 1117, paragraph (1) of the Public Health Service Act by replacing an authorized amount of $1,900,000 with $883,000.
Amends section 1116 of the Public Health Service Act: (1) in subsection (a)(1), replaces 'may' with 'shall'; (2) in subparagraph (D) inserts text after ';' and replaces the phrase 'that screenings are ready for nationwide implementation' with 'that reliable newborn screening technologies are piloted and ready for use'; and (3) replaces subsection (b) to require that the Secretary and the Director ensure that entities receiving funding provide assurances, as practicable, that such entities will work in consultation with State departments of health, as appropriate.
Amends section 1113 of the Public Health Service Act (42 U.S.C. 300b-12) by modifying subsection (a) (striking and replacing specified phrases and adding a new paragraph (3) on performance evaluation services to enhance disease detection) and by replacing subsection (b) with a new 'Surveillance activities' provision directing the Secretary, acting through the Director of the CDC, to coordinate national surveillance activities including standardizing data collection and promoting data sharing linkages between State newborn screening programs and State-based birth defects and developmental disabilities surveillance programs.
Amends Section 1111 of the Public Health Service Act (42 U.S.C. 300b–10): (1) in subsection (b), inserts a new paragraph (8) requiring the development, maintenance, and publication on a publicly accessible website of 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 and instances in which providing technical assistance would introduce a conflict of interest for Advisory Committee members; (2) redesignates existing paragraph (8) as paragraph (9); (3) in the redesignated paragraph (9), redesignates subparagraphs (K) and (L) as (L) and (M), respectively, and inserts a new subparagraph (K) regarding the appropriate and recommended use of safe and effective genetic testing by health care professionals in newborns and children with an initial diagnosis of diseases or conditions characterized by a variety of genetic causes and manifestations; and (4) amends subsection (g) by striking and inserting text in paragraphs (1) and (2) (specific inserted text for subsection (g) not provided in this section).
Amends Section 1109 of the Public Health Service Act (42 U.S.C. 300b–8): modifies paragraph (1) wording to add 'facilitate,'; replaces paragraph (3) with new text requiring development and delivery of educational programs to parents, families, and patient advocacy and support groups with specified elements (subparagraphs (A)–(C)); corrects 'followup' to 'follow-up' in paragraph (4) and inserts text before the paragraph (4) semicolon; and amends subsection (c) to change wording by striking 'or will use' and inserting 'will use' and to insert text before a period (text as shown in the amendment).
Amends Section 1112(c) of the Public Health Service Act (42 U.S.C. 300b–11(c)) by removing language that required the clearinghouse to 'supplement, not supplant, existing information sharing efforts' and replacing it with language directing the clearinghouse to 'complement other Federal newborn screening information sharing activities'.
This bill renews and updates federal programs that help states screen newborns and some children for genetic and rare disorders. It puts more focus on clear parent education, stronger lab quality, and better data sharing so families can get faster answers and care .
Key points
Referred to the House Committee on Energy and Commerce.
Introduced July 23, 2025 by Kelly Morrison · Last progress July 23, 2025
Forwarded by Subcommittee to Full Committee by Voice Vote.
Subcommittee Consideration and Mark-up Session Held
Referred to the Subcommittee on Health.
Referred to the House Committee on Energy and Commerce.