💰FY 2026 Priority Review Voucher Fee Rate by FDA
The Food and Drug Administration (FDA or the Agency) is announcing the fee rate for using a priority review voucher for fiscal year (FY) 2026. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended, authorizes FDA to determine and collect priority review user fees for certain applications for review of human drug or biological products when those applications use a tropical disease, rare pediatric disease, or material threat medical countermeasure (MCM) priority review voucher. These vouchers are awarded to the sponsors of tropical disease, rare pediatric disease, or material threat MCM product applications, respectively, that meet the requirements of the FD&C Act, upon FDA approval of such applications. The amount of the fee for using a priority review voucher is determined each fiscal year, based on the difference between the average cost incurred by FDA to review a human drug application designated as priority review in the previous fiscal year, and the average cost incurred in the review of an application that is not subject to priority review in the previous fiscal year. This notice establishes the FY 2026 priority review fee rate applicable to submission of eligible applications for review of human drug or biological products using a rare pediatric disease, material threat MCM, or tropical disease priority review voucher and outlines the payment procedures for such fees.
Learn More🚑Nominations Open for National Emergency Medical Services Advisory Council
The Department solicits nominations for membership to serve on the National Emergency Medical Services Advisory Council (NEMSAC). The purpose of NEMSAC is to serve as a nationally recognized council of Emergency Medical Services (EMS) representatives and consumers to provide advice and recommendations regarding EMS to DOT. Through NHTSA, NEMSAC's advice is provided to the Secretary of Transportation and the Federal Interagency Committee on Emergency Medical Services (FICEMS).
Learn More🧫FDA Reclassifies Hepatitis B Assays, Easing Market Entry
The Food and Drug Administration (FDA) is issuing a final order reclassifying qualitative hepatitis B virus (HBV) antigen assays (product code LOM), HBV antibody assays (product code LOM), and quantitative HBV nucleic acid-based assays (product code MKT), all of which are postamendments class III devices, into class II (special controls), subject to premarket notification. FDA is also establishing the special controls that are necessary to provide a reasonable assurance of safety and effectiveness of these device types.
Learn More🏥Public Meeting Notice for National Heart, Lung, and Blood Institute
This notice announces an upcoming meeting of the National Heart, Lung, and Blood Advisory Council under the Department of Health and Human Services. The public is invited to attend, with details on accessibility, meeting format, and agenda items related to program policies and issues being discussed.
Learn More💊Catalent Greenville Inc. Applies for Controlled Substances Import License
Catalent Greenville, Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.
Learn More📊VA Modifies Record System Under Privacy Act of 1974
As required by the Privacy Act of 1974, notice is hereby given that VA is modifying the system of records titled "VHA Corporate Data Warehouses-VA" (172VA10). This system is used for clinical decision support, mobile applications presenting patient data, and statistical analysis to produce various management, workload tracking, and follow- up reports. It is also used to track and evaluate the ordering and delivery of equipment, services, and patient care; track the planning, distribution, and utilization of resources; monitor the performance of Veterans Integrated Service Networks; and allocate clinical and administrative support to patient medical care.
Learn More🏥Proposed Information Collection on Patient Safety Culture in Hospitals
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 extension, without change, of the currently approved information collection project "Surveys on Patient Safety Culture Hospital Database" (OMB No. 0935-0162).
Learn More🏥Notice on Modified System of Records for Veterans and Beneficiaries
Pursuant to the Privacy Act of 1974, notice is hereby given that the VA is modifying the system of records titled Veterans and Beneficiaries Purchased Care Community Health Care Claims, Correspondence, Eligibility, Inquiry and Payment Files--VA (54VA10NB3). This system is used for establishing and monitoring eligibility to receive VA benefits, processing claims for medical care and services, and processing stipends. This system also has a database that uses accumulator calculation and makes transactions using the Payer Electronic Data Interchange Transaction Application System to process claims for medical care and services and payments.
Learn More💊Proposed 340B Rebate Model Pilot Program Information Collection Notice
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Learn More🏥HUD Announces Sale of Healthcare Mortgage Loans for Bid 2026-1
HUD is announcing the competitive, sealed bid sale of eight unsubsidized healthcare mortgage loans, without Federal Housing Administration (FHA) insurance. This sale, referred to as HLS 2026-1, is scheduled to occur on or about October 22, 2025. This notice also describes generally the bidding process for the sale and certain persons who are ineligible to bid.
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