; and (B) by inserting , or which is provisionally approved under section 524B of such Act before the semicolon. 347. Consolidating exclusivity periods for drugs treating rare diseases and conditions (a) In general Subsection (a) of section 527 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360cc ) is amended to read as follows: (a) Exclusivity (1) In general Except as provided in subsection (b), if the Secretary approves an application filed pursuant to section 505, or issues a license under section 351 of the Public Health Service Act, for a drug designated under section 526 for a rare disease or condition, the Secretary may not approve an application filed pursuant to section 505, or issue a license under section 351 of the Public Health Service Act, for the same drug for the same disease or condition for a person who is not the holder of such approved application or of such license until the expiration of the exclusivity period described in paragraph (2). (2) Exclusivity period described The exclusivity period described in this paragraph, with respect to a drug designated under section 526 for a rare disease or condition, is— (A) a single 7-year period of exclusivity with respect to the first designation of such drug under such section for that rare disease or condition