This Act, referred to in subsec. (f)(3), is Pub. L. 114–255, Dec. 13, 2016, 130 Stat. 1033, known as the 21st Century Cures Act. For complete classification of this Act to the Code, see Short Title of 2016 Amendment note set out under section 201 of Title 42, The Public Health and Welfare, and Tables.

Section was enacted as part of the 21st Century Cures Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

2022—Pub. L. 117–328 amended section generally. Prior to amendment, section related to grants for studying continuous drug manufacturing.

Pub. L. 117–328, div. FF, title III, § 3204(b), Dec. 29, 2022, 136 Stat. 5819, provided that: “Section 3016 of the 21st Century Cures Act (21 U.S.C. 399h), as in effect on the day before the date of the enactment of this section [Dec. 29, 2022], shall apply with respect to grants awarded under such section before such date of enactment.”