Department of Health and Human Services April 14, 2021 – Federal Register Recent Federal Regulation Documents
Results 1 - 10 of 10
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notification for a New Dietary Ingredient
The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Mark Reinhard: Final Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Mark Reinhard from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Reinhard was convicted of a felony under Federal law for conduct that relates to the regulation of a drug product under the FD&C Act. Mr. Reinhard was given notice of the proposed permanent debarment and an opportunity to request a hearing to show why he should not be debarred within the timeframe prescribed by regulation. Mr. Reinhard has not responded to the notice. Mr. Reinhard's failure to respond and request a hearing within the prescribed timeframe constitutes a waiver of his right to a hearing concerning this action.
Agency Information Collection Request. 60-Day Public Comment Request
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Agency Information Collection Request. 30-Day Public Comment Request
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Medicare Program; FY 2022 Hospice Wage Index and Payment Rate Update, Hospice Conditions of Participation Updates, Hospice and Home Health Quality Reporting Program Requirements
This rule proposes updates to the hospice wage index, payment rates, and aggregate cap amount for Fiscal Year 2022. This rule proposes changes to the labor shares of the hospice payment rates, proposes clarifying regulations text changes to the election statement addendum that was implemented on October 1, 2020, includes information on hospice utilization trends and solicits comments regarding hospice utilization and spending patterns. In addition, this rule proposes to make permanent selected regulatory blanket waivers that were issued to Medicare-participating hospice agencies during the COVID-19 public health emergency and updates the hospice conditions of participation. The proposed rule would update the Hospice Quality Reporting Program. The proposed rule requests information on advancing to digital quality measurement, the use of Fast Healthcare Interoperability Resources, addresses the White House Executive Order related to health equity in the Hospice Quality Reporting Program and provides updates to advancing Health Information Exchange. Finally, this rule proposes changes beginning with the January 2022 public reporting for the Home Health Quality Reporting Program to address exceptions related to the COVID-19 public health emergency.
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