UNANNOUNCED FOREIGN FACILITY INSPECTIONS PILOT PROGRAM.

SEC. 3615. UNANNOUNCED FOREIGN FACILITY INSPECTIONS PILOT PROGRAM.(a) In General.—The Secretary shall conduct a pilot program under which the Secretary increases the conduct of unannounced surveillance inspections of foreign human drug establishments and evaluates the differences between such inspections of domestic and foreign human drug establishments, including the impact of announcing inspections to persons who own or operate foreign human drug establishments in advance of an inspection. Such pilot program shall evaluate—(1) differences in the number and type of violations of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351(a)(2)(B)) identified as a result of unannounced and announced inspections of foreign human drug establishments and any other significant differences between each type of inspection;136 STAT. 5874 (2) costs and benefits associated with conducting announced and unannounced inspections of foreign human drug establishments; (3) barriers to conducting unannounced inspections of foreign human drug establishments and any challenges to achieving parity between domestic and foreign human drug establishment inspections; and (4) approaches for mitigating any negative effects of conducting announced inspections of foreign human drug establishments. (b) Pilot Program Scope.—The inspections evaluated under the pilot program under this section shall be routine surveillance inspections and shall not include inspections conducted as part of the Secretary’s evaluation of a request for approval to market a drug submitted under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or the Public Health Service Act (42 U.S.C. 201 et seq.). (c) Pilot Program Initiation.—The Secretary shall initiate the pilot program under this section not later than 180 days after the date of enactment of this Act. (d) Report.—The Secretary shall, not later than 180 days following the completion of the pilot program under this section, make available on the website of the Food and Drug Administration a final report on the pilot program under this section, including—(1) findings and any associated recommendations with respect to the evaluation under subsection (a), including any recommendations to address identified barriers to conducting unannounced inspections of foreign human drug establishments; (2) findings and any associated recommendations regarding how the Secretary may achieve parity between domestic and foreign human drug inspections; and (3) the number of unannounced inspections during the pilot program that would not be unannounced under practices in use as of the date of the enactment of this Act.