Department of Health and Human Services October 16, 2024 – Federal Register Recent Federal Regulation Documents

In compliance with the Paperwork Reduction Act of 1995, this notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the reinstatement with change of the information collection project "Patient Safety Organization Certification for Initial Listing and Related Forms, Patient Safety Confidentiality Complaint Form, and Common Formats", OMB No. 0935-0143 for which approval expired on September 30, 2024. This information collection was previously published in the Federal Register on August 12th, 2024 and allowed 60 days for public comment. AHRQ received no substantive comments from members of the public. The purpose of this notice is to allow an additional 30 days for public comment.

The Food and Drug Administration (FDA, Agency, or we) has determined that NOXAFIL (posaconazole) delayed-release tablets, 100 grams (g), was not withdrawn from sale for reasons of safety or effectiveness.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.