Department of Health and Human Services September 26, 2024 – Federal Register Recent Federal Regulation Documents

This final rule implements policies in the Medicaid Drug Rebate Program (MDRP) related to the new legislative requirements in the Medicaid Services Investment and Accountability Act of 2019 (MSIAA), which address drug misclassification, as well as drug pricing and product data misreporting by manufacturers. Additionally, we are finalizing several other proposed program integrity and program administration provisions or modifications in this final rule, including revising and finalizing key definitions used in the MDRP. This rule also finalizes a provision not directly related to MDRP that makes revisions to the third-party liability regulation due to amendments made by the Bipartisan Budget Act (BBA) of 2018. We also are finalizing our proposal to rescind revisions made by the December 31, 2020 final rule "Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements" ("the 2020 final rule") to the Determination of Best Price and Determination of Average Manufacturer Price (AMP) sections.

The Administration for Community Living (ACL) is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under section 506(c)(2)(A) of the Paperwork Reduction Act of 1995. This 30-day notice collects comments on the information collection requirements related to the proposed new information collection requirements relating to the ACL Administration on Aging Formula Grant Programs (OMB Control Number 0985-New).

The Food and Drug Administration (FDA or we) is announcing the withdrawal, without prejudice to a future filing, of a food additive petition (FAP 2A4832) proposing that the food additive regulations for chlorine dioxide be amended to provide for an additional method for producing the additive.

The Administration for Community Living (ACL) announces the intent to award a single-source supplement to the current cooperative agreement held by the National Association of State Directors of Developmental Disabilities Services (NASDDDS) for the Co-Occurring Resource Center for Individuals with I/DD, called The Link Center. The purpose of this project is to improve the quality of life for people with intellectual and/or developmental disabilities (I/DD), brain injuries, and co-occurring mental health conditions by supporting state agencies with policy development, service design, and service coordination resources, and sharing resources to individuals, families, direct support professionals, clinicians, and other policymakers. The administrative supplement for FY 2024 will amount to $410,318 bringing the total award for FY 2024 to $1,060,000.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for OGSIVEO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.