---
kind: "section"
citation: "42 U.S.C. § 300b–15"
title: "42"
title_heading: "The Public Health and Welfare"
number: "300b–15"
heading: "Hunter Kelly Research Program"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/42/300b-15"
units:
  - "Chapter 6A — Public Health Service"
  - "Subchapter IX — Genetic Diseases, Hemophilia Programs, and Sudden Infant Death Syndrome"
  - "Part A — Genetic Diseases"
---

# §300b–15. Hunter Kelly Research Program

- (a) **Newborn screening activities—**
  - (1) **In general—** The [Secretary](/usc/42/201.md?p=c), in conjunction with the [Director](/usc/42/11851.md?p=5) of the National Institutes of Health and taking into consideration the recommendations of the [Advisory Committee](/usc/42/17061.md?p=2), may continue carrying out, coordinating, and expanding research in newborn screening (to be known as “Hunter Kelly Newborn Screening Research [Program](/usc/42/274l–1.md?p=4)”) 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](/usc/42/11851.md?p=11) 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](/usc/42/11851.md?p=11) is not yet available;
    - (C) providing research findings and data for newborn conditions under review by the [Advisory Committee](/usc/42/17061.md?p=2) 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](/usc/42/17061.md?p=2) 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](/usc/42/11851.md?p=5).
  - (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](/usc/42/17061.md?p=2) and adopted by the [Secretary](/usc/42/201.md?p=c).
- (b) **Funding—** In carrying out the research [program](/usc/42/274l–1.md?p=4) under this section, the [Secretary](/usc/42/201.md?p=c) and the [Director](/usc/42/11851.md?p=5) shall ensure that entities receiving funding through the [program](/usc/42/274l–1.md?p=4) 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](/usc/42/201.md?p=f) 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](/usc/42/11851.md?p=5) is encouraged to include information about the activities carried out under this section in the biennial report required under [section 283 of this title](/usc/42/283.md). If such information is included, the [Director](/usc/42/11851.md?p=5) shall make such information available to be included on the Internet Clearinghouse established under [section 300b–11 of this title](/usc/42/300b–11.md).
- (d) **Nonduplication—** In carrying out [programs](/usc/42/274l–1.md?p=4) under this section, the [Secretary](/usc/42/201.md?p=c) 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.

## Source credit

(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

### Amendments

2014—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”.