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During the ongoing federal government shutdown, FDA activities will be limited to work involving the safety of human life or the protection of property, and activities funded by carryover user fee balances PDUFA, GDUFA, and MDUFA.
During the ongoing federal government shutdown, FDA activities related to medical products will be limited to excepted work involving the safety of human life or the protection of property, including criminal law enforcement work, and activities funded by carryover user fee balances under the Prescription Drug User Fee Act (PDUFA), Generic Drug User Fee Amendments (GDUFA), and the Medical Device User Fee Amendments (MDUFA). FDA posted a detailed list on its website.
Beginning on October 1, 2013, and continuing until the date of enactment of an FY 2014 appropriation or Continuing Resolution, carryover user fee balances will be spent on activities for which the fees are authorized under PDUFA, GDUFA, or MDUFA, as applicable, the agency reports.
FDA will not have legal authority to accept user fees assessed for FY 2014 until an FY 2014 appropriation or Continuing Resolution for FDA is enacted. This means 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.
The agency reports that it does not anticipate that the lapse in appropriations will affect its routine product review process for submissions within the scope of the PDUFA or GDUFA programs, provided that applicable fees were paid before Oct. 1, 2013. However, FDA reports, it cannot predict whether there will be delays in these programs in the event of a protracted lapse in appropriations.
Generally, scheduled advisory committee meetings regarding the approval of, or postmarketing safety issues regarding, products within the scope of the PDUFA, GDUFA, or MDUFA programs may go forward during the lapse period, subject to constraints on resources and travel, the agency reports. Other advisory committee meetings that can be conducted with carryover user fee balances will be handled on a case-by-case basis.