Department of Health and Human Services May 10, 2024 – Federal Register Recent Federal Regulation Documents
Results 1 - 16 of 16
Prospective Grant of an Exclusive Patent License: Antibody-Drug Conjugates (ADCs) for Targeting CD56-Positive Tumors
The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the SUPPLEMENTARY INFORMATION section of this Notice to McSAF Inside Oncology SAS ("McSAF Inside Oncology") located in Tours, France.
Agency Information Collection Activities: Proposed Collection; Comment Request
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 of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
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 of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Medicare and Medicaid Programs: Application From The Compliance Team (TCT) for Continued Approval of Its Rural Health Clinic (RHC) Accreditation Program
This final notice announces our decision to approve The Compliance Team (TCT) for continued recognition as a national accrediting organization (AO) for Rural Health Clinics (RHCs) that wish to participate in the Medicare or Medicaid programs.
Remanufacturing of Medical Devices; Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Remanufacturing of Medical Devices." This final guidance is intended to help clarify whether activities performed on devices are likely "remanufacturing." This final guidance also clarifies existing regulatory requirements for remanufacturers and includes recommendations for information that should be included in labeling to help assure the continued quality, safety, and effectiveness of devices that are intended to be serviced over their useful life.
Modified Risk Tobacco Product Application: Renewal Application for IQOS 3.0 System Holder and Charger, Heated Tobacco Product, Submitted by Philip Morris Products S.A.
The Food and Drug Administration (FDA or Agency) is announcing an opportunity to provide public comment on a modified risk tobacco product application (MRTPA). The application is for renewal of an existing modified risk tobacco product (MRTP) order for the IQOS 3.0 System Holder and Charger, a Heated Tobacco Product (HTP), submitted by Philip Morris Products S.A.
Modified Risk Tobacco Product Application: Renewal Applications for IQOS 2.4 System Holder and Charger, Marlboro Amber HeatSticks, Marlboro Green Menthol HeatSticks, and Marlboro Blue Menthol HeatSticks, Heated Tobacco Products and Heated Tobacco Product Consumables, Submitted by Philip Morris Products S.A.
The Food and Drug Administration (FDA or Agency) is announcing an opportunity to provide public comment on modified risk tobacco product applications (MRTPAs). The applications are for the renewal of existing MRTP orders for IQOS 2.4 System Holder and Charger, Marlboro Amber HeatSticks, Marlboro Green Menthol HeatSticks and Marlboro Blue Menthol HeatSticks, Heated Tobacco Products (HTPs) and HTP Consumables, submitted by Philip Morris Products S.A.
Foster Care Legal Representation
This rule allows title IV-E agencies to claim Federal financial participation (FFP) for the administrative costs of: legal representation in foster care proceedings provided by an attorney representing the title IV-E agency or any other public agency (including an Indian tribe) which has an agreement in effect under which the other agency has placement and care responsibility of a title IV-E eligible child; independent legal representation provided by an attorney representing a child in title IV-E foster care, a child who is a candidate for title IV-E foster care (hereafter, referred to as a child "who is eligible for title IV-E foster care"), the child's parent(s), the child's relative caregiver(s), and the child's Indian custodian(s) in foster care and other civil legal proceedings as necessary to carry out the requirements in the title IV-E agency's title IV-E foster care plan; and legal representation provided by an attorney representing an Indian child's tribe, or representation of an Indian child's tribe provided by a non-attorney, when the child's tribe participates or intervenes in any state court proceeding for the foster care placement or termination of parental rights (TPR) of an Indian child who is in title IV-E foster care or an Indian child who is a candidate for title IV-E foster care.
Medicaid Program; Ensuring Access to Medicaid Services
This final rule takes a comprehensive approach to improving access to care, quality and health outcomes, and better addressing health equity issues in the Medicaid program across fee-for-service (FFS), managed care delivery systems, and in home and community-based services (HCBS) programs. These improvements increase transparency and accountability, standardize data and monitoring, and create opportunities for States to promote active beneficiary engagement in their Medicaid programs, with the goal of improving access to care.
Medicare and Medicaid Programs; Minimum Staffing Standards for Long-Term Care Facilities and Medicaid Institutional Payment Transparency Reporting
This final rule establishes minimum staffing standards for long-term care facilities, as part of the Biden-Harris Administration's nursing home reform initiative to ensure safe and quality care in long- term care facilities. In addition, this rule requires States to report the percent of Medicaid payments for certain Medicaid-covered institutional services that are spent on compensation for direct care workers and support staff.
Medicaid Program; Medicaid and Children's Health Insurance Program (CHIP) Managed Care Access, Finance, and Quality
This final rule will advance CMS's efforts to improve access to care, quality and health outcomes, and better address health equity issues for Medicaid and Children's Health Insurance Program (CHIP) managed care enrollees. The final rule addresses standards for timely access to care and States' monitoring and enforcement efforts, reduces State burdens for implementing some State directed payments (SDPs) and certain quality reporting requirements, adds new standards that will apply when States use in lieu of services and settings (ILOSs) to promote effective utilization and that specify the scope and nature of ILOSs, specifies medical loss ratio (MLR) requirements, and establishes a quality rating system for Medicaid and CHIP managed care plans.
Submission for Office of Management and Budget Review; Risk Determination Hearings for Unaccompanied Children (New Collection)
The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting approval from the Office of Management and Budget (OMB) and inviting public comments on the proposed information collection. The request consists of several forms that will allow the Unaccompanied Children (UC) Program to implement a new set of hearings ("Risk Determination hearings"), which will serve as due process protections for children in ORR care.
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