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H.R. 6433 (112th): FDA User Fee Corrections Act of 2012

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The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress.


10/5/2012--Public Law. FDA User Fee Corrections Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food and Drug Administration Safety and Innovation Act (P.L. 112-144), to: (1) make clerical corrections to provisions of such Act; and (2) eliminate the restriction that appropriated funds shall be available only for payment of increases in the cost of reviewing medical device applications, including related personnel costs.

Specifies due dates in FY2013 under FFDCA for the drug master file fee, the abbreviated new drug application and prior approval supplement filing fees, and the generic drug facility and active pharmaceutical ingredient facility fees.