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S. 350: Newborn Screening Saves Lives Reauthorization Act of 2021


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The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress, and was published on Feb 22, 2021.


Newborn Screening Saves Lives Reauthorization Act of 2021

This bill reauthorizes through FY2026 and revises several programs and activities relating to newborn screening for certain conditions and genetic, endocrine, and metabolic diseases.

Among its changes, the bill reauthorizes and makes mandatory

the Hunter Kelly Research Program at the National Institutes of Health, and national surveillance activities conducted by the Centers for Disease Control and Prevention. The bill also aligns statutory requirements for research on non-identified newborn blood spots with federal regulations governing research on human subjects. These blood spots are collected as part of newborn screening programs, and some states make them available for biomedical and public health research. Under current regulations, research on non-identified bio-specimens such as blood spots is not considered to be research on human subjects, to which additional protections apply.