Department of Health and Human Services September 3, 2024 – Federal Register Recent Federal Regulation Documents

This notice acknowledges receipt and review by the Secretary of the Department of Health and Human Services (the Secretary) of the 2023 Consensus Based Entity Annual Report to Congress as mandated by section 1890(b)(5) of the Social Security Act (the Act). The Secretary has reviewed and is publishing the report in the Federal Register together with the Secretary's comments on the report.

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting for the Advisory Committee to the Director, Centers for Disease Control and Prevention (ACD, CDC). This is a hybrid meeting, accessible both in person and virtually (webcast live via the World Wide Web). It is open to the public and limited only by the space available.

In accordance with the Federal Advisory Committee Act, the Department of Health and Human Services is hereby giving notice that the charter for the Advisory Committee on Organ Transplantation (ACOT or Committee) is renewed. The effective date of the renewed charter is August 31, 2024.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Coal Workers' Health Surveillance Program (CWHSP). The CWHSP is a congressionally-mandated medical examination program for monitoring the health of coal miners and was originally established under the Federal Coal Mine Health and Safety Act of 1969 with all subsequent amendments (the Act).

The Food and Drug Administration (FDA, Agency, or we) is classifying the intervertebral body graft containment device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the intervertebral body graft containment device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.

The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Roche Molecular Systems, Inc, for the cobas SARS-CoV-2 & Influenza A/B nucleic acid test for use on the cobas Liat System, that includes the cobas SARS-CoV-2 & Influenza A/B Quality Control Kit. FDA revoked the Authorization under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holder. The revocation, which includes an explanation of the reasons for revocation, is reprinted at the end of this document.

The Food and Drug Administration (FDA or we) is classifying the digital therapy device for Attention Deficit Hyperactivity Disorder into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the digital therapy device for Attention Deficit Hyperactivity Disorder's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.

The Office of Community Services (OCS), Administration for Children and Families (ACF), U.S. Department of Health and Human Services, is requesting an extension of approval for a recently approved information collection: OCS Affordable Housing and Supportive Services Demonstration (Office of Management and Budget (OMB) #: 0970- 0628, Expiration Date: September 30, 2024). This information collection was originally approved for 6 months as an emergency approval. In addition to extending the approval, OCS seeks to update the burden estimates to accommodate an anticipated increase in the number of grant recipients, as well as to collect additional responses to several of the instruments. OCS also seeks to make updates to approved forms.

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.