Department of Health and Human Services June 29, 2020 – Federal Register Recent Federal Regulation Documents

The Health Information Technology Advisory Committee (HITAC) was established in accordance with section 4003(e) of the 21st Century Cures Act and the Federal Advisory Committee Act. The HITAC, among other things, identifies priorities for standards adoption and makes recommendations to the National Coordinator for Health Information Technology (National Coordinator). The HITAC will hold public meetings throughout 2020. See list of public meetings below.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Review and Update of Device Establishment Inspection Processes and Standards.'' FDA is issuing this guidance to comply with changes to the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the FDA Reauthorization Act of 2017 (FDARA), which requires that FDA review and update, as needed, the processes and standards applicable to inspections (other than for- cause) of domestic and foreign medical device establishments in place as of August 18, 2017. This guidance describes how FDA will implement uniform inspection processes and standards. The guidance also describes standardized methods of communication during the inspection process and identifies practices for investigators and device establishments to facilitate the continuity of inspections of such establishments.

The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) seeks approval for a one- time study to examine familial outcomes 8 or more years after a child's adoption from the child welfare system. The primary objective of this study is to estimate the prevalence of instability events that occur in families who have adopted children who have exited the foster care system. The second objective is to understand risk and protective factors associated with post adoption instability.

The Administration for Community Living (ACL) is announcing the award of single-source supplement for the National Paralysis Resource Center (PRC) that was included in the 2020 Congressional budget appropriations.