June 5, 2023 – Federal Register Recent Federal Regulation Documents

The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is seeking nominations for membership on the Advisory Committee to the Director (ACD). The ACD consists of up to 15 experts knowledgeable in areas pertinent to the CDC mission, such as public health, global health, health disparities, biomedical research, and other fields, as applicable.

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.

The Environmental Protection Agency (EPA) is finalizing a limited approval and limited disapproval of a revision to the Eastern Kern Air Pollution Control District (EKAPCD or ``District'') portion of the California State Implementation Plan (SIP). This revision concerns emissions of oxides of nitrogen (NOX) from Portland Cement Kilns. Under the authority of the Clean Air Act (CAA or the Act), this action simultaneously approves a local rule that regulates these emission sources and directs California to correct rule deficiencies. We are finalizing a limited approval of a local rule that regulates these emission sources because the rule would strengthen the current SIP-approved version of EKAPCD's Portland cement kiln rule. We are finalizing a limited disapproval of this revision due to the presence of exemptions for periods of startup, shutdown, and malfunction (breakdown), which are inconsistent with CAA requirements.