Department of Health and Human Services December 4, 2024 – Federal Register Recent Federal Regulation Documents

This final rule describes a new mandatory alternative payment model, the Increasing Organ Transplant Access Model (IOTA Model), that will test whether performance-based upside risk payments or downside risk payments paid to or owed by participating kidney transplant hospitals increase access to kidney transplants for patients with end- stage renal disease (ESRD) while preserving or enhancing the quality of care and reducing Medicare expenditures. This final rule also adopts standard provisions that will apply to the Radiation Oncology Model, the End-Stage Renal Disease (ESRD) Treatment Choices Model, and mandatory Innovation Center models, including the IOTA Model, whose first performance period begins on or after January 1, 2025. The finalized standard provisions relate to beneficiary protections; cooperation in model evaluation and monitoring; audits and records retention; rights in data and intellectual property; monitoring and compliance; remedial action; model termination by CMS; limitations on review; miscellaneous provisions on bankruptcy and other notifications; and the reconsideration review process.

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled "Notifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula." Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), a manufacturer of a critical food (which includes infant formula) must notify FDA of a permanent discontinuance or an interruption of the manufacture of a critical food that is likely to lead to a meaningful disruption in the supply of the food in the United States. The draft guidance, when finalized, is intended to help the infant formula industry comply with this notification requirement as it pertains to infant formula.

In accordance with the requirements of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) is establishing a new system of records to be maintained by the Office of Refugee Resettlement (ORR) within HHS' Administration for Children and Families (ACF), System No. 09-80-0323, ORR Unaccompanied Children Bureau (UCB) Child Abuse or Neglect Investigation Records and Central Registry.

The Administration for Children and Families (ACF) has reorganized the Office of Planning, Research, and Evaluation (OPRE). This reorganization creates a new Office of Research and Evaluation (ORE) and an Office of the Chief Data Officer (OCDO). This notice provides the Statement of Organizations, Functions, and Delegations of Authority for the new office of officer.

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance entitled "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions." This guidance demonstrates FDA's commitment to developing innovative approaches to the regulation of artificial intelligence (AI)-enabled devices. More specifically, this guidance provides recommendations on the information to include in a Predetermined Change Control Plan (PCCP) in a marketing submission for a device that includes one or more AI-enabled device software functions (AI-DSFs). This guidance recommends that a PCCP describe the planned AI-DSF modifications, the associated methodology to develop, validate, and implement those modifications, and an assessment of the impact of those modifications. FDA reviews the PCCP as part of a marketing submission for a device to ensure the continued safety and effectiveness of the device without necessitating additional marketing submissions for implementing each modification described in the PCCP.