Department of Health and Human Services November 13, 2023 – Federal Register Recent Federal Regulation Documents

Submission for OMB Review; Multistate Financial Institution Data Match With Federally Assisted State Transmitted Levy (OMB No.: 0970-0169)
Document Number: 2023-24855
Type: Notice
Date: 2023-11-13
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Child Support Services (OCSE), Administration for Children and Families (ACF), is requesting the federal Office of Management and Budget (OMB) to extend approval of the Multistate Financial Institution (MSFIDM) Data Match with Federally Assisted State Transmitted (FAST) Levy, without changes, for an additional three years. The current OMB approval expires January 31, 2024.
Medicare Program; Calendar Year (CY) 2024 Home Health (HH) Prospective Payment System Rate Update; HH Quality Reporting Program Requirements; HH Value-Based Purchasing Expanded Model Requirements; Home Intravenous Immune Globulin Items and Services; Hospice Informal Dispute Resolution and Special Focus Program Requirements, Certain Requirements for Durable Medical Equipment Prosthetics and Orthotics Supplies; and Provider and Supplier Enrollment Requirements
Document Number: 2023-24455
Type: Rule
Date: 2023-11-13
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule sets forth routine updates to the Medicare home health payment rates for calendar year (CY) 2024 in accordance with existing statutory and regulatory requirements. This rule discusses comments received regarding access to home health aide services; implements home health payment-related changes; rebases and revises the home health market basket and revises the labor-related share; codifies statutory requirements for disposable negative pressure wound therapy (dNPWT); and implements the new items and services payment for the home intravenous immune globulin (IVIG) benefit. In addition, itfinalizes changes to the Home Health Quality Reporting Program (HH QRP) requirements and the expanded Home Health Value-Based Purchasing (HHVBP) Model; implements the new Part B benefit for lymphedema compression treatment items, codifies the Medicare definition of brace, and makes other codification changes based on recent legislation; adds an informal dispute resolution (IDR) and special focus program (SFP) for hospice programs; codifies DMEPOS refill policy; and finalizes proposed revisions for Medicare provider and supplier enrollment requirements.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2023-24872
Type: Notice
Date: 2023-11-13
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``Questionnaire and Data Collection Testing, Evaluation, and Research for the Agency for Healthcare Research and Quality.''
Determination That COGENTIN (Benztropine Mesylate) Injection, 1 Milligram per 1 Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2023-24882
Type: Notice
Date: 2023-11-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined that COGENTIN (benztropine mesylate) Injection, 1 milligram (mg)/1 milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Multi-Cancer Detection Devices
Document Number: 2023-24896
Type: Notice
Date: 2023-11-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Submission for Office of Management and Budget (OMB) Review; Information Comparison With Insurance Data
Document Number: 2023-24857
Type: Notice
Date: 2023-11-13
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Child Support Services (OCSS), Administration for Children and Families (ACF), is requesting the OMB to extend approval of the Information Comparison with Insurance Data, with minor changes, for an additional three years. The current OMB approval (OMB No.: (0970-0342) expires January 31, 2024.
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2023-24926
Type: Notice
Date: 2023-11-13
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2023-24920
Type: Notice
Date: 2023-11-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2023-24964
Type: Notice
Date: 2023-11-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Meeting
Document Number: 2023-24963
Type: Notice
Date: 2023-11-13
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Amended Notice of Meeting
Document Number: 2023-24962
Type: Notice
Date: 2023-11-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2023-24961
Type: Notice
Date: 2023-11-13
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2023-24971
Type: Notice
Date: 2023-11-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2023-24970
Type: Notice
Date: 2023-11-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2023-24969
Type: Notice
Date: 2023-11-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2023-24968
Type: Notice
Date: 2023-11-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2023-24967
Type: Notice
Date: 2023-11-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2023-24965
Type: Notice
Date: 2023-11-13
Agency: Department of Health and Human Services, National Institutes of Health
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