; (2) New clinical investigation exclusivity Section 505(c)(3)(E)(iv) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(c)(3)(E)(iv) ) is amended by inserting , and the supplement shows a significant clinical benefit over existing therapies manufactured by the applicant in the 5-year period preceding the submission of the application, before the Secretary . (3) Biological product exclusivity (A) In general Section 351(k)(7)(A) of the Public Health Service Act ( 42 U.S.C. 262(k)(7)(A) ) is amended by striking 12 years and inserting 7 years . (B) Conforming amendments Paragraphs (2)(A) and (3)(A) of section 351(m) of the Public Health Service Act ( 42 U.S.C. 262(m) ) is amended by striking 12 years each place it appears and inserting 7 years . (b) Applicability The amendments made by subsection (a) apply only with respect to a drug or biological product for which the listed drug (as described in section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(7) ) or reference product (as such term is used in section 351 of the Public Health Service Act ( 42 U.S.C. 262 )) is approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act or licensed under section 351(a) of the Public Health Service Act, as applicable, on or after the date of enactment of this Act. (c) GAO study Not later than 1 year after the date of enactment of this Act, the Comptroller General of the United States shall conduct a study and submit to Congress a report that includes— (1) (A) the number of requests for designation as a drug for a rare disease or condition under section 526 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bb ) the Food and Drug Administration receives each year in the previous 10-year period; (B) the number of such requests granted, denied, and pending; (C) the names of all drugs receiving such designation during such period, including the date of approval and indication for which market exclusivity was granted