Vaccines, Blood & Biologics
Information about CBER Activities During the Government Shutdown
- Emergency work involving the safety of human life or the protection of property;
- Criminal law enforcement work; and
- Activities funded by carryover user fee balances, including user fee balances under the Prescription Drug User Fee Act (PDUFA), and Medical Device User Fee Amendments (MDUFA). Carryover user fee balances will only be spent on activities for which the fees are authorized under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
With respect to medical product user fees, during the lapse period, FDA will not have legal authority to accept user fees assessed for FY 2014 until an FY 2014 appropriation for FDA is enacted. This will mean that FDA will not be able to accept any regulatory submissions for FY 2014 that require a fee payment and that are submitted during the lapse period.