Department of Health and Human Services June 24, 2024 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #288 entitled "Chemistry, Manufacturing, and Controls in Support of Recombinant Protein Products for Veterinary Medicinal Use." This draft guidance describes the FDA Center for Veterinary Medicine's (CVM) recommendations for the information that should be included in Chemistry, Manufacturing, and Controls (CMC) submissions to New Animal Drug Applications (NADAs), Conditional New Animal Drug Applications (CNADAs), Investigational New Animal Drug (INAD) files, and Veterinary Master Files (VMFs) specific to recombinant protein-based intermediates, drug substances, and drug products. Recombinant proteins are produced with recombinant deoxyribonucleic acid (DNA) technology. The production of recombinant proteins has unique characteristics; therefore, the recommended information related to manufacture, characterization, and stability may differ from other FDA guidances specific to synthetic chemical substances.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled "Best Practices for Meeting Management." This workshop is being conducted to fulfill a commitment to hold a public meeting to discuss best practices for meeting management in the seventh authorization of the Prescription Drug User Fee Act (PDUFA VII). The purpose of the public workshop is to discuss issues related to submission of meeting requests, efficient time management, finalizing meeting agenda, development and submission of meeting background packages, and lessons learned from the Coronavirus Disease 2019 (COVID-19) pandemic including the use of virtual meeting platforms. The public workshop will also discuss and share experience and metrics related to specific PDUFA meeting activities associated with the Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) meetings in fiscal years (FYs) 2021 through 2023. This will include Type D and Initial Targeted Engagement for Regulatory Advice on CBER/ CDER Products (INTERACT) meetings, which began with PDUFA VII in FY 2023. Learnings from the public meeting could inform FDA's internal process improvement efforts and, as appropriate, be reflected in an update to the "Best Practices for Communication Between IND [Investigational New Drug Application] Sponsors and FDA During Drug Development" guidance.

This document corrects typographical and technical errors in the final rule that appeared in the May 10, 2024 Federal Register, entitled "Medicare and Medicaid Programs; Minimum Staffing Standards for Long-Term Care Facilities and Medicaid Institutional Payment Transparency Reporting (referred to hereafter as the "Minimum Staffing final rule"). The effective date of the Minimum Staffing final rule is June 21, 2024.

The Food and Drug Administration (FDA, Agency, or we) has determined that INVEGA (paliperidone) extended-release tablet, 1.5 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

The U.S. Code of Federal Regulations requires each agency to establish, in accordance with regulations prescribed by the Office of Personnel Management, one or more Senior Executive Service (SES) Performance Review Boards (PRBs).