Section 7(b) of the Orphan Drug Act, referred to in subsec. (c)(3)(A), is section 7(b) of Pub. L. 97–414, which is set out in a note under section 241 of this title.

2004—Subsec. (c)(4). Pub. L. 108–375 added par. (4).

For delegation of certain functions of the President under this section, see Ex. Ord. No. 13179, Dec. 7, 2000, 65 F.R. 77487, set out as a note under section 7384 of this title.