HHS regulations

FDA seeks 60 days of public comment on information collection requirements for Good Laboratory Practice standards in nonclinical laboratory studies.

The FDA determined that FENOGLIDE (fenofibrate) tablets at 40 mg and 120 mg strengths were not withdrawn for safety or effectiveness reasons, allowing continued approval of generic versions.

FDA classifies the laser-powered inferior vena cava filter retrieval catheter as a Class II medical device, requiring special controls to ensure safety and effectiveness for cardiovascular applications.

The FDA classifies radiation therapy marking devices as class II medical devices, requiring special controls to ensure safety and effectiveness while reducing regulatory burden for manufacturers.

NIH Office of Intramural Training & Education seeks public comment on proposed data collection for application, registration, and alumni systems; comment period closes 60 days from publication.

Center for Scientific Review will hold closed meetings to review grant applications and personnel matters on specified dates in accordance with federal sunshine laws.

The FDA proposes to withdraw approval of ChemoCentryx's TAVNEOS (avacopan) capsule based on lack of substantial evidence of effectiveness and untrue material statements in the application, with opportunity for hearing.

FDA determines that OZEMPIC semaglutide 2mg/1.5mL solution was not withdrawn for safety or effectiveness reasons, allowing continued approval of generic versions.

FDA seeks OMB approval for juice processors and importers to implement hazard analysis and critical control point procedures under the Paperwork Reduction Act of 1995.

Administration for Children and Families seeks one-year extension for NextGen Project's second follow-up survey data collection; OMB approval number 0970-0545 expires April 30, 2026.

HRSA publishes notice of petitions received under the National Vaccine Injury Compensation Program, which are reviewed by the U.S. Court of Federal Claims as required by the Public Health Service Act.

FDA seeks input on a pilot program to evaluate AI-enabled technologies for improving efficiency and decision-making in early-phase clinical trials while maintaining regulatory standards.

HRSA's Rural Hospital Provider Assistance Program distributes $25,000,000 in formula grants to eligible rural hospitals in fiscal year 2026; applications will be submitted through grants.gov.

HRSA's Ryan White HIV/AIDS Program expenditure reports collection (OMB No. 0915-0390) is under OMB review with a 30-day public comment period before approval.

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