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agreement with such foreign governments or agen-
cies; 
(6) what tools, if any, the Secretary used to fa-
cilitate inspections of domestic facilities that could 
also be effectively utilized to appropriately inspect 
foreign facilities; 
(7) what steps the Secretary has taken to iden-
tify and evaluate tools and strategies the Secretary 
may use to continue oversight with respect to inspec-
tions when in-person inspections are disrupted; 
(8) how the Secretary is considering incor-
porating alternative tools into the inspection activi-
ties conducted pursuant to the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 301 et seq.); and 
(9) what steps the Secretary has taken to iden-
tify and evaluate how the Secretary may use alter-
native tools to address workforce shortages to carry 
out such inspection activities. 
SEC. 725. UNANNOUNCED FOREIGN FACILITY INSPECTIONS 
PILOT PROGRAM. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services (referred to in this section as the ‘‘Sec-
retary’’) shall conduct a pilot program under which the 
Secretary increases the conduct of unannounced surveil-
lance inspections of foreign human drug establishments 
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and evaluates the differences between such inspections of 
domestic and foreign human drug establishments, includ-
ing the impact of announcing inspections to persons who 
own or operate foreign human drug establishments in ad-
vance of an inspection. Such pilot program shall evalu-
ate— 
(1) differences in the number and type of viola-
tions 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; 
(2) costs and benefits associated with con-
ducting announced and unannounced inspections of 
foreign human drug establishments; 
(3) barriers to conducting unannounced inspec-
tions 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 ef-
fects of conducting announced inspections of foreign 
human drug establishments. 
(b) PILOT PROGRAM SCOPE.—The inspections evalu-
ated under the pilot program under this section shall be 
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routine surveillance inspections and shall not include in-
spections 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 recommenda-
tions with respect to the evaluation under subsection 
(a), including any recommendations to address iden-
tified barriers to conducting unannounced inspec-
tions of foreign human drug establishments; 
(2) findings and any associated recommenda-
tions regarding how the Secretary may achieve par-
ity between domestic and foreign human drug in-
spections; and 
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(3) the number of unannounced inspections 
during the pilot program that would not be unan-
nounced under existing practices. 
SEC. 726. REAUTHORIZATION OF INSPECTION PROGRAM. 
Section 704(g)(11) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 374(g)(11)) is amended by strik-
ing ‘‘2022’’ and inserting ‘‘2027’’. 
SEC. 727. ENHANCING INTRA-AGENCY COORDINATION AND 
PUBLIC HEALTH ASSESSMENT WITH REGARD 
TO COMPLIANCE ACTIVITIES. 
(a) COORDINATION.—Section 506D of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 356d) is 
amended by adding at the end the following: 
‘‘(g) COORDINATION.—The Secretary shall ensure 
timely and effective internal coordination and alignment 
among the field investigators of the Food and Drug Ad-
ministration and the staff of the Center for Drug Evalua-
tion and Research’s Office of Compliance and Drug Short-
age Program regarding— 
‘‘(1) the reviews of reports shared pursuant to 
section 704(b)(2); and 
‘‘(2) any feedback or corrective or preventive 
actions in response to such reports.’’. 
(b) REPORTING.— 
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(1) IN GENERAL.—Section 506C–1(a)(2) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
356c–1(a)(2)) is amended to read as follows: 
‘‘(2)(A) describes the communication between 
the field investigators of the Food and Drug Admin-
istration and the staff of the Center for Drug Eval-
uation and Research’s Office of Compliance and 
Drug Shortage Program, including the Food and 
Drug Administration’s procedures for enabling and 
ensuring such communication; 
‘‘(B) provides the number of reports described 
in section 704(b)(2) that were required to be sent to 
the appropriate offices of the Food and Drug Ad-
ministration and the number of such reports that 
were sent; and 
‘‘(C) describes the coordination and alignment 
activities undertaken pursuant to section 506D(g);’’. 
(2) APPLICABILITY.—The amendment made by 
paragraph (1) shall apply with respect to reports 
submitted on or after March 31, 2023. 
SEC. 728. REPORTING OF MUTUAL RECOGNITION AGREE-
MENTS FOR INSPECTIONS AND REVIEW AC-
TIVITIES. 
(a) IN GENERAL.—Not later than December 31, 
2022, and annually thereafter, the Secretary of Health 
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