<b>Accomplishment: </b>FDA published a Federal Register Notice announcing a Part 15 Hearing which was held in November 2010. The hearing and docket allowed stakeholder groups to provide input to FDA on various issues and challenges associated with implementing an abbreviated approval pathway for biological products that are highly similar or interchangeable with an FDA-licensed biological product. The purpose of this public hearing was to create a forum for interested stakeholders to provide input regarding the agency’s implementation of the statute. The docket closed on December 31, 2010. Additional information about the public hearing, including transcripts, is available on the FDA website.1. Publish Federal Register notice to announce a Part 15 Hearing, with a docket to receive public comment on various issues, including the types of guidance documents industry believes should be a priority for the agency10/5/2010Completed10/5/20102. Hold a public Part 15 hearing to receive comments on various issues, including the types of guidance documents industry believes should be a priority for the agency during the early period of implementation11/2/2010Completed11/2/2010<b>Accomplishment: </b> In order to develop recommendations for a user fee program for 351(k) applications for FYs 2013-2017, FDA opened a public comment period on May 10, 2011 for feedback on proposed principles, fee structure, and performance goals. Following the comment period, FDA held regular consultation meetings with industry and public stakeholders from June 2011 through September 2011. After administration clearance, FDA published a Federal Register Notice outlining the proposed recommendations on December 7th, 2011, and held a public meeting to discuss the proposed recommendations on December 16th, 2011. The docket closed on January 06th, 2012. HHS transmitted the final recommendations to Congress on January 13, 2012. The final recommendations are available on FDA’s website at <a href=http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm287723.htm target=”_blank”> http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm287723.htm</a>.1. Publish Federal Register notice requesting input on the identified principles for development of a 351(k) user fee program, FDA’s proposed structure for a 351(k) user fee program that would adhere to these principles, and performance goals for this program.5/10/2011Completed5/10/20112. Publish Federal Register notice announcing availability of the draft recommendations for user fees for 351(k) applications for fiscal years 2013-2017, with a docket to receive public comment on such recommendations; hold a meeting at which the public may present its views on such recommendations; and after consideration of such public views and comments, revise such recommendations as necessary12/31/2011Completed1/6/20123. Transmit recommendations for user fees for 351(k) applications for fiscal years 2013-2017 to Congress1/15/2012Completed1/13/2012http://www.fda.gov/AboutFDA/Transparency/track/ucm237975.htmFDA-TRACK Health Care Reform Dashboard