Department of Health and Human Services March 27, 2023 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or we) 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 (PRA).

This notice announces the approval of the application of the Accreditation Commission for Health Care (ACHC) as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program for all specialty and subspecialty areas under CLIA. We have determined that the ACHC meets or exceeds the applicable CLIA requirements. In this notice, we announce the approval and grant the ACHC deeming authority for a period of 6 years.

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.

In accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces the following meeting of 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. Time will be available for public comment.

The Food and Drug Administration (FDA or Agency) is announcing the fee rates under the over-the-counter (OTC) monograph drug user fee program (OMUFA) for fiscal year (FY) 2023. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to assess and collect user fees from qualifying manufacturers of OTC monograph drugs and submitters of OTC monograph order requests. This notice publishes the OMUFA fee rates for FY 2023.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.'' FDA recognizes that it will take time for device manufacturers, device distributors, healthcare facilities, healthcare providers, patients, consumers, and FDA to adjust from policies adopted and operations implemented during the COVID-19 public health emergency (PHE) to ``normal operations.'' To provide a clear policy for all stakeholders and FDA staff, the Agency is issuing this guidance to describe FDA's general recommendations for a phased transition process with respect to devices that fall within certain enforcement policies issued during the COVID-19 PHE declared by the Secretary of Health and Human Services (the Secretary) under the Public Health Service Act (PHS Act), including recommendations regarding submitting a marketing submission, as applicable, and taking other actions with respect to these devices. This guidance applies to devices that fall within enforcement policies in guidances included in List 1 of this guidance. The phased transition process outlined in this guidance will begin on the ``implementation date.'' The implementation date is the day the PHE expires or 45 days after the finalization of this guidance, whichever comes later. Because the COVID-19 section 319 PHE declaration is anticipated to expire at least 45 days after the finalization of this guidance, or May 11, 2023, the implementation date is that date. The guidances in List 1 of this guidance will no longer be in effect after the 180-day transition period ends.