Sec. 513. Unannounced foreign facility inspections pilot program
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The Secretary of Health and Human Services (referred to in this section as the Secretary ) shall conduct a pilot program under which the Secretary increases the conduct of unannounced inspections of foreign human drug facilities and evaluates the differences between inspections of domestic and foreign human drug facilities, including the impact of announcing inspections to persons who own or operate foreign human drug facilities in advance of an inspection. Such pilot program shall evaluate— 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 during unannounced and announced inspections of foreign human drug facilities and any other significant differences between each type of inspection; costs and benefits associated with conducting announced and unannounced inspections of foreign human drug facilities; barriers to conducting unannounced inspections of foreign human drug facilities and any challenges to achieving parity between domestic and foreign human drug facility inspections; and approaches for mitigating any negative effects of conducting announced inspections of foreign human drug facilities.
The Secretary shall initiate the pilot program under this section not later than 180 days after the date of enactment of this Act. The Secretary shall, not later than 180 days following the completion of the pilot program, make available on the website of the Food and Drug Administration a final report on the pilot program under this section, including— 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 facilities; findings and any associated recommendations regarding how the Secretary may achieve parity between domestic and foreign human drug inspections; and the number of unannounced inspections during the pilot that would not be unannounced under existing practices.
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Sec. 513
Unannounced foreign facility inspections pilot program
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