The FDA released a draft guidance on assessing user fees under the BsUFA II agreement approved by Congress earlier this year. The draft discusses the agency's implementation of the agreement and certain intended policy and procedural changes. For instance, the guidance explains the new fee structure under BsUFA II and the types of fees biosimilar sponsors will pay. It also describes when the various fees are incurred, how they are to be submitted, what happens when a sponsor fails to pay the fees, and how requests for reconsideration or an appeal are to be filed. Notice of the draft is slated for publication in Thursday's Federal Register and will be followed by a 60-day comment period.