FDA classifies infant supine sleep systems as Class II medical devices, requiring special controls to ensure safety and effectiveness while reducing regulatory burden for manufacturers.
FDA extends the effective date of its estrogen-androgen fixed-combination drug product withdrawal notice from June 26, 2026, to September 24, 2026, to allow time for consideration of interested party comments.
Centers for Medicare & Medicaid Services seeks public comment on proposed information collection activities under the Paperwork Reduction Act; interested parties may submit feedback on burden estimates and collection methodology.
FDA revokes Emergency Use Authorizations for three COVID-19 diagnostic devices from Becton Dickinson, InBios International, and Roche Diagnostics upon manufacturer request.
HHS proposed rule updates sponsor assessment requirements for unaccompanied children placement to include identity proof, income verification, and enhanced background checks under the Trafficking Victims Protection Reauthorization Act.
FDA determines prednisolone tablets 5mg were not withdrawn for safety or effectiveness reasons, allowing continued approval of generic versions meeting regulatory requirements.
ATSDR seeks public comment on the APPLETREE Performance Measures data collection to support its Partnership to Promote Local Efforts to Reduce Environmental Exposures cooperative agreement program under the Paperwork Reduction Act.
SAMHSA seeks public comment on developing an independent accreditation system for Certified Community Behavioral Health Clinic Expansion grant recipients to establish oversight and national quality standards.
ACF's TANF Contingency Fund Application collects data for state requests of provisional payments to support temporary assistance for needy families during economic hardship.
SAMHSA requests public comment by [insert Federal Register publication date] on continued approval and updates to the Protection and Advocacy for Individuals With Mental Illness annual performance report collection (OMB No. 0930-0169).
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