republic-os/legal/us/code/title-42/chapter-6a/section-300b-15.md

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LegalText	42 U.S.C. § 300b–15	Hunter Kelly Research Program	us	united_states_code	code_section	42	THE PUBLIC HEALTH AND WELFARE	6A	PUBLIC HEALTH SERVICE	300b–15	42 U.S.C. § 300b–15	current	119-100	2026-06-26	official	https://uscode.house.gov/download/releasepoints/us/pl/119/100/xml_usc42@119-100.zip	/us/usc/t42/s300b–15	data/legal/raw/us/code/title-42/usc42.xml	052e9726fb64fe4e418b00efdb4170411d3cd87936561022c375d9bfdc717286	644321055a08eb1f260a6a3e31ac157fa024756abf612a9fd6857e7e400cf24e	b0ae48cbde33dab3a5c40ffdf0ba98d8e2207110d4e40072b7b949fd6bcddfbd	2026-07-04	official	legal us-code

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

Text

(a) Newborn screening activities (1) In general The Secretary, in conjunction with the Director of the National Institutes of Health and taking into consideration the recommendations of the Advisory Committee, may continue carrying out, coordinating, and expanding research in newborn screening (to be known as “Hunter Kelly Newborn Screening Research Program”) including—

(A) identifying, developing, and testing the most promising new screening technologies, in order to improve already existing screening tests, increase the specificity of newborn screening, and expand the number of conditions for which screening tests are available;

(B) experimental treatments and disease management strategies for additional newborn conditions, and other genetic, metabolic, hormonal, or functional conditions that can be detected through newborn screening for which treatment is not yet available;

(C) providing research findings and data for newborn conditions under review by the Advisory Committee on Heritable Disorders in Newborns and Children to be added to the recommended uniform screening panel;

(D) conducting pilot studies on conditions recommended by the Advisory Committee on Heritable Disorders in Newborns and Children to ensure that screenings are ready for nationwide implementation; and

(E) other activities that would improve newborn screening, as identified by the Director.

(2) Additional newborn condition For purposes of this subsection, the term “additional newborn condition” means any condition that is not one of the core conditions recommended by the Advisory Committee and adopted by the Secretary.

(b) Funding 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 the appropriate State departments of health, and, as practicable, focus their research on screening technology not currently performed in the States in which the entities are located, and the conditions on the uniform screening panel (or the standard test existing on the uniform screening panel).

(c) Reports The Director is encouraged to include information about the activities carried out under this section in the biennial report required under section 283 of this title. If such information is included, the Director shall make such information available to be included on the Internet Clearinghouse established under section 300b–11 of this title.

(d) Nonduplication In carrying out programs under this section, the Secretary shall minimize duplication and supplement, not supplant, existing efforts of the type carried out under this section.

(e) Peer review Nothing in this section shall be construed to interfere with the scientific peer-review process at the National Institutes of Health.

(July 1, 1944, ch. 373, title XI, § 1116, as added Pub. L. 110–204, § 7, Apr. 24, 2008, 122 Stat. 711; amended Pub. L. 110–237, § 1(a)(7), May 27, 2008, 122 Stat. 1557; Pub. L. 113–240, § 9, Dec. 18, 2014, 128 Stat. 2855.)

Notes

Editorial Notes

Amendments2014—Subsec. (a)(1)(C) to (E). Pub. L. 113–240, § 9(1), added subpars. (C) and (D) and redesignated former subpar. (C) as (E). Subsec. (c). Pub. L. 113–240, § 9(2), substituted “section 283 of this title” for “section 403 of the National Institutes of Health Reform Act of 2006”. 2008—Subsec. (a)(1)(B). Pub. L. 110–237 substituted “, or” for “and or”.