Section 101(b) of the Prescription Drug User Fee Amendments of 2012, referred to in subsecs. (a)(1) and (f)(2), is section 101(b) of Pub. L. 112–144, which is set out as a note under section 379g of this title.

2022—Subsec. (b)(8). Pub. L. 117–328 added par. (8).

2016—Subsec. (a)(2)(A). Pub. L. 114–255 substituted “subsection (b)” for “subsection (c)” before period in first sentence.