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

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.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a document entitled "Amended Environmental Assessment for Production of AquAdvantage Salmon at the Bay Fortune and Rollo Bay Facilities on Prince Edward Island, Canada." This amended environmental assessment (EA) has been prepared by FDA in support of the approved new animal drug application (NADA 141-454) concerning AquAdvantage Salmon (AAS), in response to an order by the U.S. District Court, Northern District of California.

The Food and Drug Administration (FDA or the Agency) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. FDA seeks to include the views of individuals on its advisory committee regardless of their gender identification, religious affiliation, racial and ethnic identification, or disability status and, therefore, encourages nominations of appropriately qualified candidates from all groups.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment." This guidance provides clarification to industry and FDA staff of the Federal regulations that relate to diagnostic x-ray equipment. These regulations pertain to the recordkeeping, reporting, manufacturing, importing, and installation of an "electronic product" as defined in FDA regulations. This guidance supersedes FDA's 1989 guidance entitled "Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment."

The Food and Drug Administration's (FDA), Center for Veterinary Medicine's (CVM), Office of Management (OM) and Office of New Animal Drug Evaluation (ONADE) have modified their organizational structures. The new organizational structures were approved by the Secretary of Health and Human Services on July 22, 2024.

The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), announces the renewal of the charter of the Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP).

In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

This final rule addresses policies for assessing performance year (PY) 2023 financial performance of Medicare Shared Savings Program (Shared Savings Program) Accountable Care Organizations (ACOs); establishing benchmarks for ACOs starting agreement periods in 2024, 2025, and 2026; and calculating factors used in the application cycle for ACOs applying to enter a new agreement period beginning on January 1, 2025, and the change request cycle for ACOs continuing their participation in the program for PY 2025, as a result of significant, anomalous, and highly suspect billing activity for selected intermittent urinary catheters on Medicare Durable Medical Equipment, Prosthetics, Orthotics & Supplies (DMEPOS) claims. Under the Shared Savings Program, providers of services and suppliers that participate in ACOs continue to receive traditional Medicare fee-for-service (FFS) payments under Medicare Parts A and B, but the ACO may be eligible to receive a shared savings payment if it meets specified quality and savings requirements. ACOs participating in two-sided models may also share in losses. In this final rule, we respond to public comments we received on the proposal to mitigate the impact of significant, anomalous, and highly suspect billing activity on Medicare Shared Savings Program financial calculations in calendar year (CY) 2023.

This notice announces the annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. The adjustment to the AIC threshold amounts will be effective for requests for ALJ hearings and judicial review filed on or after January 1, 2025. The calendar year 2025 AIC threshold amounts are $190 for ALJ hearings and $1,900 for judicial review.

The Office of Community Services (OCS), Administration for Children and Families (ACF), U.S. Department of Health and Human Services, is proposing to continue to collect data to understand diaper need and outcomes for beneficiaries of the Diaper Distribution Demonstration and Research Pilot (DDDRP).

In compliance with the requirement of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide an opportunity for public comment on proposed data collection projects, the National Institutes of Health, National Cancer Institute (NCI) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

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.