APHL collaborates with state newborn screening programs and legal counsels to monitor legal and legislative issues affecting state newborn screening programs. It conducts these activities through the Legal and Legislative Issues in Newborn Screening Workgroup. APHL also disseminates related policy resources.
Common Rule Update: One Year Implementation Delay
On January 18, the Department of Health and Human Services (HHS) and 15 other agencies issued the final rule on the body of regulations that protect human subjects involved in research, commonly known as the "Common Rule". At that time, the implementation date was set for January 2018.
On October 7, 2017, HHS formally requested a one year delay of the implementation date, pushing the effective date to early 2019 while still allowing the use of three burden reducing provisions during the delay year (regarding which APHL is securing additional details). The request by HHS is currently under review by the Office of Management and Budget. It is our understanding that the impact of this delay on public health laboratories is minimal. APHL's Public Policy Program will continue to provide updates as more information is gathered.
If you have any additional questions please contact Peter Kyriacopoulos.
Newborn Screening Saves Lives Reauthorization Act, 2014
The informed consent provisions included in the
Newborn Screening Saves Lives Reauthorization Act (NBSSLRA) went into effect on March 16, 2015. The law includes two significant changes to the human subjects regulations as they apply to research with newborn dried blood spots. First, the law requires that all research funded pursuant to the Public Health Service Act using newborn dried spots be considered human subjects research regardless of whether the specimens are identifiable. Second, the law eliminates the ability of the Institutional Review Board to approve alterations or waivers of informed consent under 45 CFR 46.116(c) and 116(d) for research involving newborn dried blood spots. The informed consent provisions of the NBSSLRA will remain in effect until January 19, 2018.
State Newborn Screening Bills
APHL monitors NBS legislation, such as additions to state NBS panels and fee increases, across the US. APHL's State Legislation Tracking site, allows users to click on highlighted states to view proposed and enacted legislation. Bill information is automatically updated as it becomes available. This tool is restricted to APHL staff, NBS program personnel, state laboratory directors and federal partners. To request access, please contact Funke Akinsola, associate specialist, Newborn Screening & Genetics, 240.485.2714.