Federal regulations

FDA classifies simple point-of-care SARS-CoV-2 detection devices as Class II medical devices, requiring special controls to ensure safety and effectiveness while reducing regulatory burden for manufacturers.

HHS seeks public comment on successful research, programs, and policies for addiction and mental illness prevention and treatment to inform future federal funding and policy decisions.

The Administration for Children and Families seeks OMB approval to extend its generic clearance for collecting participant information at agency gatherings through September 30, 2026, with updated burden estimates for the next three years.

Federal agency forms are under Paperwork Reduction Act review to reduce reporting burden on small businesses and other entities submitting required documentation.

CDC seeks public comment on a data collection for monitoring hantavirus-exposed cruise passengers and travelers in domestic and international settings under the Paperwork Reduction Act of 1995.

FDA amends sunscreen monograph M020 to add bemotrizinol at concentrations up to 6 percent as a generally recognized as safe and effective active ingredient for over-the-counter sunscreen products.

CDC seeks public comment on the National Death Index data collection system, which gathers mortality data for epidemiological research and authorized public health investigators under the Paperwork Reduction Act.

FDA classifies combined acoustic and electrical external stimulation devices for tinnitus relief as Class II medical devices, subject to special controls to ensure safety and effectiveness.

The Commission on Laboratory Accreditation (COLA) receives five-year deeming authority to accredit clinical laboratories in histocompatibility under the Clinical Laboratory Improvement Amendments of 1988.

CMS is seeking public comment for 60 days on proposed information collection activities under the Paperwork Reduction Act of 1995.