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Title 42, The Public Health and WelfareRelease 119-110

§300b–12 Laboratory Quality and Surveillance

Title 42 › CHAPTER 6A — PUBLIC HEALTH SERVICE › SUBCHAPTER IX — GENETIC DISEASES, HEMOPHILIA PROGRAMS, AND SUDDEN INFANT DEATH SYNDROME › Part A — Genetic Diseases › § 300b–12

Last updated Sep 22, 2026|Official source

Summary

The Secretary must make sure the CDC Director, with advice from the Advisory Committee on Heritable Disorders in Newborns and Children, runs quality programs for labs that screen newborns and children. That means checking that tests are accurate and done quickly, giving labs training and help, running evaluations, and providing materials to test new screening tools. The Secretary may also help coordinate monitoring of newborn screening. This can include standard data collection and use of electronic health records, and encouraging data sharing with State birth defects and developmental disabilities programs.

Full Legal Text

Title 42, §300b–12

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

(a)In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention and taking into consideration the expertise of the Advisory Committee on Heritable Disorders in Newborns and Children established under section 300b–10 of this title, shall provide for— (1)
(2)appropriate quality control and other performance test materials to evaluate the performance of new screening tools.
(b)Surveillance activities
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, and taking into consideration the expertise of the Advisory Committee on Heritable Disorders in Newborns and Children established under section 300b–10 of this title, may provide, as appropriate, for the coordination of surveillance activities, including—
(1)through standardized data collection and reporting, as well as the use of electronic health records; and
(2)by promoting data sharing regarding newborn screening with State-based birth defects and developmental disabilities monitoring programs.

Legislative History

Notes & Related Subsidiaries

Editorial Notes

Amendments

2014—Pub. L. 113–240, § 6(1), inserted “and surveillance” after “quality” in section catchline. Subsec. (a). Pub. L. 113–240, § 6(2)(A), substituted “and taking into consideration the expertise of the Advisory Committee” for “and in consultation with the Advisory Committee” in introductory provisions. Subsec. (a)(1). Pub. L. 113–240, § 6(2)(B), inserted “timeliness for processing such tests,” after “newborn-screening tests,”. Subsec. (b). Pub. L. 113–240, § 6(3), added subsec. (b) and struck out former subsec. (b). Prior to amendment, text read as follows: “For the purpose of carrying out this section, there are authorized to be appropriated $5,000,000 for fiscal year 2009, $5,062,500 for fiscal year 2010, $5,125,000 for fiscal year 2011, $5,187,500 for fiscal year 2012, and $5,250,000 for fiscal year 2013.” 2008—Subsec. (b). Pub. L. 110–237 substituted “2009, $5,062,500 for fiscal year 2010, $5,125,000 for fiscal year 2011, $5,187,500 for fiscal year 2012, and $5,250,000 for fiscal year 2013.” for “2008, $5,062,500 for fiscal year 2009, $5,125,000 for fiscal year 2010, $5,187,500 for fiscal year 2011, and $5,250,000 for fiscal year 2012.”

Reference

Citations & Metadata

Citation

42 U.S.C. § 300b–12

Title 42, The Public Health and Welfare

Last Updated

Sep 22, 2026

Release point: 119-110