Department of Health and Human Services November 6, 2023 – Federal Register Recent Federal Regulation Documents

Revision of HHS National Environmental Policy Act Compliance Procedures To Incorporate Federal Flood Risk Management Standard Procedures
Document Number: 2023-24348
Type: Notice
Date: 2023-11-06
Agency: Department of Health and Human Services
HHS is proposing a revision to its floodplain management procedures to include climate science if an action takes place in a floodplain.
Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model
Document Number: 2023-23915
Type: Rule
Date: 2023-11-06
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule updates and revises the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year (CY) 2024. This rule also updates the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury (AKI). In addition, this final rule updates requirements for the ESRD Quality Incentive Program and the ESRD Treatment Choices Model.
National Institute of Environmental Health Sciences; Amended Notice of Meeting
Document Number: 2023-24507
Type: Notice
Date: 2023-11-06
Agency: Department of Health and Human Services, National Institutes of Health
Determination That FORADIL (Formoterol Fumarate) Inhalation Powder, 0.012 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2023-24506
Type: Notice
Date: 2023-11-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) has determined that FORADIL (formoterol fumarate) inhalation powder, 0.012 milligrams (mg)/inhalation (inh), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for formoterol fumarate inhalation powder, 0.012 mg/inh, if all other legal and regulatory requirements are met.
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