On December 8, 2010, the Food and Drug Administration (FDA) published a notice requesting that stakeholders – particularly patient and consumer advocacy groups, health care professionals, and scientific and academic experts – notify FDA if they intend to participate in consultation meetings on the development of a user fee program for biosimilar and interchangeable biological product applications. The meetings will comply with an ACA mandate regarding consultation with stakeholders on the goals for the biosimilar and interchangeable biological product application review process for fiscal years 2013 through 2017 in advance of submission of recommendations to Congress. FDA earlier had requested information on companies (and their trade associations) that would be affected by a biosimilar user fee program. Notifications of intention to participate are due by January 10, 2011.