Prescription Drug User Fee Rates for Fiscal Year 2027

2026-14073, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments

The FDA wants to make it easier for drug makers who work in several locations to register as one company instead of many. They’re also updating rules for foreign drug companies to match new laws about handling health threats. If you’re in drug manufacturing, get ready to comment by September 11, 2026, and keep an eye on possible paperwork changes that could affect your business.

2026-13047, Establishment Registration and Product Listing for Tobacco Products

The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.

2026-15345, Food Safety Modernization Act Voluntary Qualified Importer Program User Fee Rate for Fiscal Year 2027

The Food and Drug Administration (FDA or we) is announcing the fiscal year (FY) 2027 annual fee rate for importers approved to participate in the Voluntary Qualified Importer Program (VQIP) that is authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). This fee is effective on August 1, 2026, and will remain in effect through September 30, 2027.

2026-15336, Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2027

The Food and Drug Administration (FDA or we) is announcing the fiscal year (FY) 2027 fee rates for certain domestic and foreign facility reinspections, failures to comply with a recall order, and importer reinspections that are authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA).

2026-15346, Biosimilar User Fee Rates for Fiscal Year 2027

Starting October 1, 2026, companies making biosimilar drugs will pay updated fees to the FDA for developing and getting approval for their products. These fees cover new drug development, application reviews, and yearly program costs. This helps the FDA keep biosimilar drug reviews speedy and fair while supporting innovation.

2026-15335, Medical Device User Fee Rates for Fiscal Year 2027

The Food and Drug Administration (FDA, Agency, or we) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2027. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Medical Device User Fee Amendments of 2022 (MDUFA V), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2027, which apply from October 1, 2026, through September 30, 2027, and provides information on how the fees for FY 2027 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.

Previous: 2026-15333, Agency Information Collection Activities: Submission for OMB Review, Comment Request; Application for Surplus Federal Real Property Public Benefit Conveyance and BRAC Program for Emergency Management Use

The Federal Emergency Management Agency (FEMA) will submit the information collection abstracted below to the Office of Management and Budget for review and clearance in accordance with the requirements of the Paperwork Reduction Act of 1995. FEMA invites the general public to take this opportunity to comment on an extension of a currently approved information collection. In accordance with the requirements of the Paperwork Reduction Act of 1995, this notice seeks comments concerning the application process for the conveyance of Federal real property for public benefit. The purpose of this application is to implement the processes and procedures for the successful, lawful, and expeditious conveyance of real property from the Federal government to public entities such as State, local, city, town, or other like government bodies as it relates to emergency management response purposes, including fire and rescue services. Compliance will ensure that properties will be fully positioned to use at their highest and best potentials as required by General Services Administration (GSA) and Department of Defense (DOD)/Department of War (DOW) regulations, Federal law, Executive Orders, and the Code of Federal Regulations (CFR).

Next: 2026-15335, Medical Device User Fee Rates for Fiscal Year 2027

The Food and Drug Administration (FDA, Agency, or we) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2027. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Medical Device User Fee Amendments of 2022 (MDUFA V), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2027, which apply from October 1, 2026, through September 30, 2027, and provides information on how the fees for FY 2027 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.