Public Meeting on PDUFA VI Reauthorization
Monday, August 15, 2016 from 9:00 AM to 2:00 PM (EDT)
Date: August 15, 2016
Time: 9:00 a.m. to 2:00 p.m.
Location: FDA White Oak Campus
10903 New Hampshire Ave.
Building 31 Conference Center, The Great Room (Rm 1503A)
Silver Spring, MD 20993
(Enter at Building 1 to clear security)
The Food and Drug Administration (FDA or Agency) is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2018 through 2022. PDUFA authorizes FDA to collect fees and use them for the process for the review of human drug applications. The current legislative authority for PDUFA expires in September 2017. At that time, new legislation will be required for FDA to continue collecting prescription drug user fees in future fiscal years. Following discussions with the regulated industry and periodic consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act (FD&C Act) directs FDA to publish the recommendations for the reauthorized program in the Federal Register, hold a meeting at which the public may present its views on such recommendations, and provide for a period of 30 days for the public to provide written comments on such recommendations. FDA will then consider such public views and comments and revise such recommendations as necessary.
There will be an opportunity for stakeholders to provide comments during an Open Public Comment session at the end of the meeting. Sign-up for Open Public Comment will take place on the day of the meeting.
The proposed commitment letter can be found here: http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm446608.htm
The Federal Register Notice announcing this meeting can be found here: https://www.federalregister.gov/articles/2016/07/19/2016-16916/meetings-prescription-drug-user-fee-act
For more information about travelling to FDA's White Oak Campus, see here: http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241748.htm.