Revision and revocation

Section 564(g)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3(g)(2)) is amended— (1) in subparagraph (B), by striking or at the end; (2) by redesignating subparagraph (C) as subparagraph (D); and (3) by inserting after subparagraph (B) the following: (C) the Secretary determines that fraudulent material statements were made, or material information was concealed, with respect to the circumstances described under subsection (b)(1) or the criteria under subsection (c); or.