Opportunity
Federal Register #FDA-2015-N-3326
FDA Public Meeting and Request for Comments on Biosimilar User Fee Act (BsUFA) Reauthorization and Draft Guidance for Robotically-Assisted Surgical Devices
Buyer
Food and Drug Administration
Posted
September 25, 2026
Respond By
November 25, 2026
Identifier
FDA-2015-N-3326
The Food and Drug Administration (FDA), part of the Department of Health and Human Services, is seeking public input on the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years 2028-2032. - Government Buyer: - Food and Drug Administration (FDA) - Center for Drug Evaluation and Research - No specific OEMs or vendors are named; the opportunity impacts biosimilar manufacturers and applicants. - Products/Services Requested: - Public meeting and request for comments on BsUFA IV recommendations - Draft guidance for premarket submissions of robotically-assisted surgical devices - Key Requirements and Notable Details: - Proposed changes to BsUFA include modifications to supplement categories, provisional determinations, meeting management, and fee structures - Introduction of tiered application fees and updates to small business waiver eligibility - Enhancements to regulatory science programs and review processes - Draft guidance for robotically-assisted surgical devices is open for public comment - The meeting is open to industry stakeholders, scientific and academic experts, healthcare professionals, patient and consumer advocacy groups, and the general public - No products or services are being procured; this is a request for feedback on regulatory and fee policy enhancements
Description
The Food and Drug Administration (FDA) is hosting a hybrid public meeting to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years 2028 through 2032. The BsUFA authorizes FDA to collect user fees to support the review process for biosimilar biological product applications. The current legislative authority expires in September 2027, requiring new legislation. The meeting will be held in person and virtually on October 26, 2026, with comments due by November 25, 2026.