 So in original. Probably should be “the fee”.

established under subsection (d)(2) (referred to in this section as an “operating reserve fee”) for the first fiscal year in which an advisory review fee is assessed to such person. The person is not subject to an operating reserve fee for any other fiscal year.

Statutory Notes and Related Subsidiaries

Effective Date

Section effective Oct. 1, 2007, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2007, see section 107 of Pub. L. 110–85, set out as an Effective and Termination Dates of 2007 Amendment note under section 379g of this title.