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

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Treatment of Stage I-III Squamous Cell Anal Cancer, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 35 new drug applications (NDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Post- Warning Letter Meetings Under GDUFA.'' This draft guidance provides information on the implementation of the Post-Warning Letter Meeting process for certain drug manufacturing facilities, a program enhancement agreed upon by the Agency and industry as part of the negotiations relating to the reauthorization of the Generic Drug User Fee Amendments (GDUFA), as described in ``GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027'' (GDUFA III commitment letter). Specifically, this draft guidance describes the process detailed in the GDUFA III commitment letter for how an eligible facility may request a Post-Warning Letter Meeting with FDA regarding the facility's ongoing remediation efforts to current good manufacturing practice (CGMP) deficiencies described in a warning letter, how to prepare and submit a complete meeting package, and how FDA intends to conduct the Post-Warning Letter Meeting.

This document extends the comment period for the proposed rule titled ``Medicare Program; Hospital Outpatient Prospective Payment System: Remedy for the 340B-Acquired Drug Payment Policy for Calendar Years 2018-2022'' that was published in the July 11, 2023 Federal Register. The comment period for the proposed rule, which would otherwise end on September 5, 2023, is extended until September 11, 2023.

The Food and Drug Administration (FDA, Agency, or we) is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Over-the-Counter (OTC) Monograph Drug User Fee Program (OMUFA) for fiscal years (FYs) 2026 through 2030. OMUFA authorizes FDA to assess and collect user fees to support OTC monograph drug activities. The current legislative authority for OMUFA expires September 30, 2025. At that time, new legislation will be required to reauthorize the OMUFA program for future fiscal years. The Federal Food, Drug, and Cosmetic Act (FD&C Act) directs that FDA consult with the public as part of the OMUFA reauthorization process. FDA invites public comment as the Agency begins the process to reauthorize the program for FYs 2026 through 2030.