42 U.S.C. § 300b–15: Hunter Kelly Research…

Summary

The Secretary of Health, working with the NIH Director and using advice from the Advisory Committee, may keep running and growing a newborn screening research program called the Hunter Kelly Newborn Screening Research Program. The program can develop and test better screening tools, study experimental treatments and care for conditions found by newborn screening (including genetic, metabolic, hormonal, or functional conditions that do not yet have treatments), supply research needed when the Advisory Committee reviews conditions for the recommended uniform screening panel, run pilot studies so new screenings are ready for nationwide use, and do other Director‑identified activities. "Additional newborn condition" means a condition that is not one of the core conditions recommended by the Advisory Committee and adopted by the Secretary. Funded projects must, as practical, work with state health departments and focus on tests not already used in their state and on conditions on the uniform screening panel. The Director is encouraged to include program information in the biennial report under section 283 and make it available to the Internet Clearinghouse under section 300b–11. The program must avoid duplicating existing efforts and must not interfere with NIH scientific peer review.

Title 42, §300b–15

The Public Health and Welfare, Source: USLM XML via OLRC

(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.

Notes & Related Subsidiaries

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”.

§300b–15 Hunter Kelly Research Program

Summary

Title 42, §300b–15

Notes & Related Subsidiaries

Editorial Notes

Amendments

Citations & Metadata