42 U.S.C. § 300b–15 — Hunter Kelly Research Program

(a) Newborn screening activities: (1) In general — the Secretary, working with the NIH Director and considering the Advisory Committee's recommendations, may keep running, coordinating, and expanding a research program called the "Hunter Kelly Newborn Screening Research Program," covering: (A) finding, developing, and testing the most promising new screening technologies to improve existing tests, make screening more precise, and expand the number of conditions screened for; (B) experimental treatments and disease-management strategies for additional newborn conditions — genetic, metabolic, hormonal, or functional conditions screening can detect, but that don't have a treatment yet; (C) providing research findings and data on newborn conditions the Advisory Committee is reviewing for the uniform screening panel; (D) running pilot studies on conditions the Advisory Committee recommends, to make sure screening is ready to roll out nationwide; and (E) any other activities the Director identifies that would improve newborn screening. (2) Additional newborn condition — this term means any condition that isn't one of the core conditions the Advisory Committee recommended and the Secretary adopted. (b) Funding: While running this research program, the Secretary and Director must make sure funded organizations agree, as much as practical, to work with the right state health departments, and to focus their research on screening technology not already used in their state, and on conditions on (or the standard test for) the uniform screening panel. (c) Reports: The Director is encouraged to include information about this program's activities in the biennial report required under section 283. If included, the Director must also make that information available on the internet clearinghouse (section 300b–11). (d) Nonduplication: In running this program, the Secretary must avoid duplicating, and instead add to, existing similar efforts. (e) Peer review: Nothing in this section can interfere with NIH's normal scientific peer-review process.