On December 7, 2011, the Food & Drug Administration (FDA) published a notice discussing its proposed recommendations for implementing the ACA’s user fee program for biosimilar biological products for FYs 2013 through 2017. The notice summarizes the four proposed types of fees (Biosimilar Product Development Fees, Marketing Application Fees, Establishment Fees and Product Fees), along with the proposed performance goals and procedures for the user fee program. FDA will accept comments on the proposed recommendations until January 6, 2012. The proposal also will be the subject of a December 16, 2011 meeting. After the public meeting and review of comments, FDA will revise the recommendations as necessary and present them to Congress.