Department of Health and Human Services June 5, 2023 – Federal Register Recent Federal Regulation Documents

This final rule removes expired language addressing staff and patient COVID-19 testing requirements for LTC Facilities issued in the interim final rule with comment ``Medicare and Medicaid Programs, Clinical Laboratory Improvement Amendments (CLIA), and Patient Protection and Affordable Care Act; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency'' published in the September 2, 2020 Federal Register. The rule also finalizes requirements for these facilities to provide education about COVID-19 vaccines and to offer COVID-19 vaccines to residents, clients, and staff. In addition, the rule withdraws the regulations in the interim final rule with comment (IFC) ``Omnibus COVID-19 Health Care Staff Vaccination'' published in the November 5, 2021 Federal Register, and finalizes certain provisions of the ``COVID-19 Vaccine Requirements for Long-Term Care (LTC) Facilities and Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs-IID) Residents, Clients, and Staff'' IFC, published in the May 13, 2021 Federal Register.

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 Evaluating Deep Learning Algorithm Assessment of Digital Photographs for Dental Public Health Surveillance. This project entails one-time data collection of oral health data from 1,000 school students to examine the feasibility and validity of using digital photos taken by non-dental professionals, which are analyzed by deep learning algorithms to assess youth's oral health status.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Drug-Drug Interaction Assessment for Therapeutic Proteins.'' With the continued market growth and increased clinical use of therapeutic proteins, it is important to understand the nature of and the potential for drug-drug interactions (DDIs) with these products. The purpose of this guidance is to help sponsors of investigational new drug applications (INDs) and applicants of biologics license applications (BLAs) determine the need for DDI studies for a therapeutic protein by providing a systematic, risk-based approach. This guidance finalizes the draft guidance of the same title issued on August 10, 2020.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals.'' This guidance finalizes the draft guidance entitled ``Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics'' issued on February 20, 2020.

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 continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled National Youth Tobacco Surveys (NYTS), which aims to collect data on tobacco use among middle- and high school students.

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 continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Sealant Efficiency Assessment for Locals and States (SEALS). This data will be collected from local school sealant programs to generate efficiency performance measures, which will allow CDC to identify feasible benchmarks and best practices contributing to school sealant program efficiency.

The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for use during the COVID-19 pandemic. FDA has issued an Authorization for the drug product GOHIBIC (vilobelimab) as requested by InflaRx GmbH's (InflaRx). The Authorization contains, among other things, conditions on the emergency use of the authorized product. The Authorization follows the February 4, 2020, determination by the Secretary of Health and Human Services (HHS), as amended on March 15, 2023, that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves a novel (new) coronavirus. The virus, now named SARS-CoV-2, causes the illness COVID-19. On the basis of such determination, the Secretary of HHS declared on March 27, 2020, that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to the FD&C Act, subject to the terms of any authorization issued under that section. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.