Department of Health and Human Services December 17, 2024 – Federal Register Recent Federal Regulation Documents

This final rule has finalized certain proposals from the Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability Proposed Rule (HTI-2 Proposed Rule) and in doing so supports the access, exchange, and use of electronic health information. Specifically, this final rule amends the information blocking regulations to revise two existing information blocking exceptions and establish an additional reasonable and necessary activity that does not constitute information blocking referred to as the Protecting Care Access Exception.

This rule finalizes updates to the HHS list of select agents and toxins that could pose a severe threat to public health and safety. These updates were proposed along with other changes to the select agent and toxin regulations, which will be addressed in a separate regulatory action. In a companion document published in this issue of the Federal Register, the U.S. Department of Agriculture (USDA) is making parallel regulatory changes.

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is seeking nominations for membership on the Clinical Laboratory Improvement Advisory Committee (CLIAC). CLIAC, consisting of up to 20 members including the Chair, represents a diverse membership across laboratory specialties, professional roles (laboratory management, technical specialists, physicians, nurses), and practice settings (academic, clinical, public health), and includes a consumer representative.

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.

On December 9, 2024, CMS published a notice in the Federal Register that sought comment on a collection of information concerning CMS-2088-17 (OMB control number 0938-0037) entitled "Community Mental Health Center Cost Report." The OMB control number identifying the aforementioned information collection request is incorrectly listed in the SUPPLEMENTARY INFORMATION section of the notice. This document corrects the error.