💊FDA Meeting on Reauthorization of Prescription Drug User Fee Act
The Food and Drug Administration (FDA, the Agency, or we) is hosting a public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2028 through 2032. PDUFA authorizes FDA to collect user fees to support the process for the review of human drug applications. The current legislative authority for PDUFA expires in September 2027. At that time, new legislation will be required for FDA to continue collecting prescription drug user fees in future fiscal years. The Federal Food, Drug, and Cosmetic Act (FD&C Act) directs that FDA begin the PDUFA reauthorization process by publishing a notice in the Federal Register requesting public input and holding a public meeting where the public may present its views on the reauthorization. FDA invites public comment as the Agency begins the process to reauthorize the program in FYs 2028 through 2032. These comments will be published and available on FDA's website.
Learn More💊FDA's Generic Drug User Fee Program Information Collection Overview
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Learn More💊FDA Notice on Prescription Drug User Fee Program Details
The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Learn More🚬FDA Request for Comments on Tobacco User Fees Information Collection
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on "Tobacco Products, User Fees, Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products."
Learn More🌾2025/2026 AMS Services Fee Increases and Business Impacts
The Agricultural Marketing Service (AMS) is announcing the 2025/2026 rates it will charge for voluntary grading, inspection, certification, auditing, and laboratory services for a variety of agricultural commodities including meat and poultry, fruits and vegetables, eggs, dairy products, rice, and cotton and tobacco. The 2025/2026 regular, overtime, holiday, and laboratory services rates will be applied at the beginning of the crop year, fiscal year or as required by law depending on the commodity. Other starting dates are added to this notice based on cotton industry practices. This action establishes the rates for user-funded programs based on costs incurred by AMS. This year, cost-based analyses indicated the need to increase certain user fee rates when current rates are insufficient to cover the costs of providing the service. While cost-saving measures have and will continue to be implemented, user fee rate increases are necessary to offset rising operational costs. In cases where current rates are sufficient to cover the costs of providing the service, user fee rates remain unchanged. Furthermore, AMS is announcing the fees it will charge warehouse operators for voluntary services associated with the administration of the United States Warehouse Act, including the license action fees, service license fees, inspection fees, and annual user fees for warehouse services for fiscal year 2026, which begins October 1, 2025. This year, AMS will minimize the impact on industry by limiting any increases to cover inflationary costs only.
Learn More📝IRS Notice on User Fee Forms 8717 and 8717-A Comments
The Internal Revenue Service, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. The IRS is soliciting comments concerning Form 8717, User Fee for Employee Plan Determination Letter Request, and Form 8717-A, User Fee for Employee Plan Opinion Letter Request.
Learn More💵APHIS User Fee System Modification and Business Implications
Pursuant to the Privacy Act of 1974 and Office of Management and Budget Circular No. A-108, the U.S. Department of Agriculture (USDA) gives notice that an agency component, the Animal and Plant Health Inspection Service (APHIS), proposes to modify an existing system of records notice titled, APHIS Veterinary Services User Fee System, USDA/APHIS-18. The system will be renamed the APHIS User Fee System, USDA/APHIS-18. This system, among other things, helps APHIS track, collect, and process fees associated with services APHIS provides.
Learn More✈️Delay on User Fees for Agricultural Quarantine Inspection Services
On May 7, 2024, the Animal and Plant Health Inspection Service published in the Federal Register a final rule amending the user fee regulations associated with the agricultural quarantine and inspection program. The final rule went into effect on October 1, 2024, with the exception of the removal of an exemption to the commercial aircraft user fee for small commercial passenger aircraft, which was scheduled to go into effect on April 1, 2025. In this document, we are issuing a postponement of the effective date of the removal of the exemption to the commercial aircraft user fee for small commercial passenger aircraft for 60 days, from April 1, 2025, to June 2, 2025.
Learn More💊FDA Biosimilars User Fee Program
The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Learn More🐾APHIS User Fee Increases Impacting Veterinary Services in 2025
The Animal and Plant Health Inspection Service (APHIS) is announcing adjusted user fee rates for the costs of providing certain goods and services, including veterinary diagnostic goods and services and veterinary services for imports and exports of live animals and animal products. This action is necessary because the regulations provide that APHIS will issue such a notice. This action ensures that the fees charged more closely align with the costs of providing the goods or services, thus ensuring program solvency.
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