Article preview from "The Gray Sheet" - September 24, 2012
The new fiscal year starts Oct. 1, but FDA will not be able to spend the full amount of fiscal year 2013 industry user fees as a result of an emergency spending bill, and Congress is not expected to fix the issue until after the election in November at the earliest.
User Fee Limbo: FDA Will Not Have Access To Extra Industry Funds At FY 2013 Start
Article preview from "The Gray Sheet" - September 24, 2012
FDA is not going to get its hands on an expected extra influx of user fees from the device industry come Oct. 1 as a result of an emergency spending bill heading towards enactment. How long the additional funds will remain untouchable by the agency remains to be seen.
FDA is slated to receive approximately $30 million in additional revenue from device companies in user fees for fiscal year 2013 compared to 2012, according to the user fee reauthorization deal negotiated with industry and enacted in July as part of the FDA Safety and Innovation Act (FDASIA).
But Congress was preparing to leave town last week with no plans to fix language in a government spending bill that will restrict FDA from using the full amount of the 2013 user fees. Legislators will not reconvene until after the election in November.
The House passed a continuing resolution bill earlier this month to keep the federal government funded through next March at fiscal 2012 levels, plus a small increase. The Senate was preparing to vote on the same bill late in the evening on Sept. 21 before adjourning for the session.
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