Daily Rules, Proposed Rules, and Notices of the Federal Government
On July 9, 2012, GDUFA (Pub. L. 112-144, Title III) was signed into law by the President. Designed to speed delivery of safe and effective generic drugs to the public and reduce costs to industry, GDUFA requires that generic drug manufacturers pay user fees to finance critical and measurable program enhancements. The new law includes a provision to assess user fees for any original ANDA that is pending on October 1, 2012, that has not been tentatively approved. Collection of fees for applications in the backlog will provide the Agency with necessary funding to reduce the backlog and prepare to meet the ANDA review performance goals established by GDUFA. Specifically, in the Commitment Letter that accompanies the law, FDA committed to review and act on 90 percent of all ANDAs pending on October 1, 2012, by the end of fiscal year 2017.
FDA will set the backlog fee rates for FY 2013 to generate a total of $50,000,000. Therefore, to determine the fee for a pending original ANDA, we will divide $50,000,000 by the number of original ANDAs that are pending on October 1, 2012, and have not been tentatively approved as of that date.
We have estimated that absent withdrawals there could be 3,000 pending original ANDAs on October 1, 2012. Some currently pending original ANDAs are old and incomplete, and FDA anticipates that applicants will withdraw many of them before October 1, 2012, to avoid incurring the backlog fee. If 2,000 original ANDAs were to remain, the backlog fee per ANDA would be $25,000. However, this is only an estimate; the final fee, which will be published along with payment instructions in a notice in the
Payment of backlog fees will be due no later than 30 calendar days after publication in the
The fee is an obligation to the U.S. Government, and failure to pay the fee may result in collection activities by the Government under applicable laws.