Department of Health and Human Services May 2, 2023 – 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 (the 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.

This document is to alert Medicare Diabetes Prevention Program (MDPP) expanded model suppliers and interested parties that although current MDPP flexibilities permitted pursuant to regulations issued during the Public Health Emergency (PHE) for COVID-19 are scheduled to expire on May 11, 2023, we are specifying an effective date, for purposes of the regulations of December 31, 2023, through which in- person delivery of MDPP services can be suspended. This extended effective date applies for all MDPP suppliers to allow additional time to resume in-person services. MDPP suppliers may use all of or part of this period to extend the flexibilities described in the regulations. This document provides information to MDPP suppliers regarding the extension of the ability to suspend in-person services as the PHE for COVID-19 concludes.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of April 12, 2023. The document announced the availability of a final guidance entitled ``A Risk-Based Approach to Monitoring of Clinical InvestigationsQuestions and Answers; Guidance for Industry.'' The notice of availability for this final guidance was published with an incorrect OMB control number. This document corrects that error.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.