FDA report on PREA enforcement

Section 508(b) of the Food and Drug Administration Safety and Innovation Act (21 U.S.C. 355c–1(b)) is amended— (1) in paragraph (11), by striking the semicolon at the end and inserting, including an evaluation of compliance with deadlines provided for in deferrals and deferral extensions;; (2) in paragraph (15), by striking and at the end; (3) in paragraph (16), by striking the period at the end and inserting; and; and (4) by adding at the end the following: (17) a listing of penalties, settlements, or payments under section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353) for failure to comply with requirements under such section 505B, including, for each penalty, settlement, or payment, the name of the drug, the sponsor thereof, and the amount of the penalty, settlement, or payment imposed..

Section 508(b) of the Food and Drug Administration Safety and Innovation Act (21 U.S.C. 355c–1(b)) is amended— (1) in paragraph (11), by striking the semicolon at the end and inserting, including an evaluation of compliance with deadlines provided for in deferrals and deferral extensions;; (2) in paragraph (15), by striking and at the end; (3) in paragraph (16), by striking the period at the end and inserting; and; and (4) by adding at the end the following: (17) a listing of penalties, settlements, or payments under section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353) for failure to comply with requirements under such section 505B, including, for each penalty, settlement, or payment, the name of the drug, the sponsor thereof, and the amount of the penalty, settlement, or payment imposed..