CMS Plan Benefit Package (PBP) and Formulary CY 2026 (CMS-R-262)

The Centers for Medicare Medicaid Services CMS is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act …

Digital Health Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—Total Product Lifecycle Considerations for Generative Artificial Intelligence-Enabled Medical Devices

The Food and Drug Administration FDA announces a forthcoming public advisory committee meeting of the Digital Health Advisory Committee the Committee. The general function of the Committee is to provide …

Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Experience Reporting

The Food and Drug Administration FDA or Agency is announcing an opportunity for public

Agency Information Collection Activities; Proposed Collection; Comment Request; Biosimilars User Fee Program

The Food and Drug Administration FDA or Agency is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act …

Advancing Smoking Cessation: Food and Drug Administration and National Institutes of Health Priorities; Public Meeting; Request for Comments

The Food and Drug Administration FDA the Agency or we is announcing the following public meeting entitled Advancing Smoking Cessation: FDA and NIH Priorities. Jointly convened by FDA and the …

End Stage Renal Disease Annual Facility Survey Form (CMS-2744)

The Centers for Medicare Medicaid Services CMS is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act …

General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of Public Docket; Request for Comments—ProSense Cryoablation System

The Food and Drug Administration FDA announces a forthcoming public advisory committee meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee the Committee. The …

Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments— Supplemental Biologics License Application 125586/546 From AstraZeneca AB for Andexxa (Coagulation Factor Xa (Recombinant), Inactivated -zhzo); November 21, 2024

The Food and Drug Administration FDA announces a forthcoming public advisory committee meeting of the Cellular Tissue and Gene Therapies Advisory Committee the Committee. The general function of the Committee …

Agency Information Collection Activities; Proposed Collection; Comment Request; Promotion of Prescription Drugs Within a Talk Show Format

The Food and Drug Administration FDA Agency or we is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction …

Agency Information Collection Activities; Proposals, Submissions, and Approvals

The Centers for Medicare Medicaid Services CMS is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act …

Final Peer Review Organizations Sanction and Supporting Regulations (CMS-R-65)

The Centers for Medicare Medicaid Services CMS is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act …

Bid Pricing Tool (BPT) for Medicare Advantage (MA) Plans and Prescription Drug Plans (PDP) (CMS-10142)

The Centers for Medicare Medicaid Services CMS is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act …

Medicare Health Outcomes Survey (CMS-10203)

The Centers for Medicare Medicaid Services CMS is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act …

Determination of Regulatory Review Period for Purposes of Patent Extension; Wavewriter Alpha Spinal Cord Stimulator System

The Food and Drug Administration FDA or the Agency has determined the regulatory review period for WAVEWRITER ALPHA SPINAL CORD STIMULATOR SYSTEM and is publishing this notice of that determination …

Part D Coordination of Benefits Data (CMS-10171)

The Centers for Medicare Medicaid Services CMS is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act …

Determination of Regulatory Review Period for Purposes of Patent Extension; Gore Tag Thoracic Branch Endoprosthesis

The Food and Drug Administration FDA or the Agency has determined the regulatory review period for GORE TAG THORACIC BRANCH ENDOPROSTHESIS and is publishing this notice of that determination as …

Determination of Regulatory Review Period for Purposes of Patent Extension; Gore Tag Thoracic Branch Endoprosthesis

The Food and Drug Administration FDA or the Agency has determined the regulatory review period for GORE TAG THORACIC BRANCH ENDOPROSTHESIS and is publishing this notice of that determination as …

Determination of Regulatory Review Period for Purposes of Patent Extension; Pascal Precision Transcatheter Valve Repair System

The Food and Drug Administration FDA or the Agency has determined the regulatory review period for PASCAL PRECISION TRANSCATHETER VALVE REPAIR SYSTEM and is publishing this notice of that determination …

Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments

The Food and Drug Administration FDA or we announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee the Committee. The general function of …

Agency Information Collection Activities; Proposed Collection; Comment Request; Antimicrobial Animal Drug Sales and Distribution

The Food and Drug Administration FDA Agency or we is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction …