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Bill
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H.R. 2507 — what changed

Newborn Screening Saves Lives Reauthorization Act of 2019

From Reported in House to Engrossed in House. 2 sections amended between Reported in House and Engrossed in House.

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)
changed by striking “that screenings are ready for nationwide implementation” and inserting “that reliable newborn screening technologies are evaluated piloted and ready for use”; and
(2)
in subsection (b) to read as follows:

changed “(b) Funding—In carrying out the research program under this section, the Secretary and the Director—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.”

removed “(1) shall ensure that entities receiving funding through the program will provide assurances, as practicable, that such entities will work in consultation with the appropriate State departments of health; and

removed “(2) may accept, use, and dispose of donations and bequests from private for-profit and non-profit entities, in accordance with Federal law.”

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:

“12. Institutional review boards; ethics guidance program

changed “Research on nonidentified newborn dried blood spots shall be considered secondary research (as that term is defined in part 4 of section 46.104 46.104(d)(4) of title 45, Code of Federal Regulations) 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.).”