I 

117TH CONGRESS 

2D SESSION H. R. 6980 

To direct the Secretary of Health and Human Services to conduct a pilot 

program under which the Secretary increases the conduct of unannounced 

inspections of foreign human drug establishments and evaluates the differences between 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. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 8, 2022 

Mr. HUDSON (for himself and Ms. ESHOO) introduced the following bill; which 

was referred to the Committee on Energy and Commerce 

A BILL 

To direct the Secretary of Health and Human Services to 

conduct a pilot program under which the Secretary increases the conduct of unannounced inspections of foreign human drug establishments and evaluates the differences between 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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 


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•HR 6980 IH

1 SECTION 1. UNANNOUNCED FOREIGN FACILITY INSPEC2 TIONS PILOT PROGRAM. 

3 (a) IN GENERAL.—The Secretary of Health and 

4 Human Services (referred to in this section as the ‘‘Sec5 retary’’) shall conduct a pilot program under which the 

6 Secretary increases the conduct of unannounced inspec7 tions of foreign human drug establishments and evaluates 

8 the differences between inspections of domestic and for9 eign human drug establishments, including the impact of 

10 announcing inspections to persons who own or operate for11 eign human drug establishments in advance of an inspec12 tion. Such pilot program shall evaluate— 

13 (1) differences in the number and type of viola14 tions of section 501(a)(2)(B) of the Federal Food, 

15 Drug, and Cosmetic Act (21 U.S.C. 351(a)(2)(B)) 

16 identified during unannounced and announced in17 spections of foreign human drug establishments and 

18 any other significant differences between each type 

19 of inspection; 

20 (2) costs and benefits associated with con21 ducting announced and unannounced inspections of 

22 foreign human drug establishments; 

23 (3) barriers to conducting unannounced inspec24 tions of foreign human drug establishments and any 

25 challenges to achieving parity between domestic and 

26 foreign human drug establishment inspections; and 


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•HR 6980 IH

1 (4) approaches for mitigating any negative ef2 fects of conducting announced inspections of foreign 

3 human drug establishments. 

4 (b) PILOT PROGRAM INITIATION.—The Secretary 

5 shall initiate the pilot program under this section not later 

6 than 180 days after the date of enactment of this Act. 

7 (c) REPORT.—The Secretary shall, not later than 180 

8 days following the completion of the pilot program, make 

9 available on the website of the Food and Drug Administra10 tion a final report on the pilot program under this section, 

11 including— 

12 (1) findings and any associated recommenda13 tions with respect to the evaluation under subsection 

14 (a), including any recommendations to address iden15 tified barriers to conducting unannounced inspec16 tions of foreign human drug establishments; 

17 (2) findings and any associated recommenda18 tions regarding how the Secretary may achieve par19 ity between domestic and foreign human drug in20 spections; and 

21 (3) the number of unannounced inspections 

22 during the pilot that would not be unannounced 

23 under existing practices. 

Æ 


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