; (2) by striking paragraph (1); (3) by redesignating paragraph (2) as paragraph (1); (4) in paragraph (1) as so redesignated, by striking the period at the end and inserting ; or ; and (5) by adding at the end the following: (2) as applicable, 15 days after the drug receives a designation as a breakthrough therapy, fast track product, or regenerative advanced therapy under subsection (a), (b), or (g), respectively, of section 506. .