H. R. 2617—1410 
to, and the use of, digital health technologies in clinical 
trials by people with disabilities and pediatric populations. 
(b) SEAMLESS AND CONCURRENT CLINICAL TRIALS.— 
(1) IN
GENERAL.—Not later than 1 year after the date 
of enactment of this Act, the Secretary shall issue or revise 
draft guidance on the use of seamless, concurrent, and other 
innovative clinical trial designs to support the expedited 
development and review of applications for drugs, as appro-
priate. Not later than 18 months after the public comment 
period on such draft guidance ends, the Secretary shall issue 
a revised draft guidance or final guidance. 
(2) CONTENT.—The guidance described in paragraph (1) 
shall include— 
(A) recommendations on the use of expansion cohorts 
and other seamless clinical trial designs to assess different 
aspects of product candidates in one continuous trial, 
including how such clinical trial designs can be used as 
part of meeting the substantial evidence standard under 
section 505(d) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355(d)); 
(B) recommendations on the use of clinical trial designs 
that involve the concurrent conduct of different or multiple 
clinical trial phases, and the concurrent conduct of pre-
clinical testing, to expedite the development of new drugs 
and facilitate the timely collection of data; 
(C) recommendations for how to streamline trial logis-
tics and facilitate the efficient collection and analysis of 
clinical trial data, including any planned interim analyses 
and how such analyses could be used to streamline the 
product development and review processes; 
(D) considerations to assist sponsors in ensuring the 
rights, safety, and welfare of clinical trial participants, 
maintaining compliance with good clinical practice regula-
tions, minimizing risks to clinical trial data integrity, and 
ensuring the reliability of clinical trial results; 
(E) recommendations for communication between spon-
sors and the Food and Drug Administration on the develop-
ment of seamless, concurrent, or other adaptive clinical 
trial designs, including review of, and feedback on, clinical 
trial protocols; and 
(F) a description of the manner in which the Secretary 
will assess or evaluate data collected through seamless, 
concurrent, or other adaptive clinical trial designs to sup-
port the development of drugs. 
(c) INTERNATIONAL HARMONIZATION.—The Secretary shall, as 
appropriate, work with foreign regulators pursuant to memoranda 
of understanding or other arrangements governing the exchange 
of information to facilitate international harmonization of the regu-
lation and use of decentralized clinical trials, digital technology 
in clinical trials, and seamless, concurrent, and other adaptive 
or innovative clinical trial designs.
H. R. 2617—1411 
CHAPTER 2—INSPECTIONS 
SEC. 3611. DEVICE INSPECTIONS. 
(a) IN GENERAL.—Section 704(a)(1) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 374(a)(1)) is amended by striking 
‘‘restricted devices’’ each place it appears and inserting ‘‘devices’’. 
(b) RECORDS OR OTHER INFORMATION.— 
(1) ESTABLISHMENTS.—Section 704(a)(4)(A) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)(4)(A)) is 
amended— 
(A) by striking ‘‘an establishment that is engaged in 
the manufacture, preparation, propagation, compounding, 
or processing of a drug’’ and inserting ‘‘an establishment 
that is engaged in the manufacture, preparation, propaga-
tion, compounding, or processing of a drug or device, or 
a site or facility that is subject to inspection under para-
graph (5)(C),’’; and 
(B) by striking ‘‘records requested.’’ and inserting the 
following: ‘‘records or other information requested and a 
rationale for requesting such records or other information 
in advance of, or in lieu of, an inspection.’’. 
(2) GUIDANCE.— 
(A) IN GENERAL.—The Secretary shall issue or update 
guidance describing— 
(i) circumstances in which the Secretary intends 
to issue requests for records or other information in 
advance of, or in lieu of, an inspection under section 
704(a)(4) of the Federal Food, Drug, and Cosmetic Act, 
as amended by paragraph (1); 
(ii) processes for responding to such requests elec-
tronically or in physical form; and 
(iii) factors the Secretary intends to consider in 
evaluating whether such records and other information 
are provided within a reasonable timeframe, within 
reasonable limits, and in a reasonable manner, 
accounting for resource and other limitations that may 
exist, including for small businesses. 
(B) TIMING.—The Secretary shall— 
(i) not later than 1 year after the date of enactment 
of this Act, issue draft guidance under subparagraph 
(A); and 
(ii) not later than 1 year after the close of the 
comment period for such draft guidance, issue final 
guidance under subparagraph (A). 
SEC. 3612. BIORESEARCH MONITORING INSPECTIONS. 
(a) IN GENERAL.—Section 704(a) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 374(a)) is amended by adding at 
the end the following: 
‘‘(5)(A) The Secretary may, to ensure the accuracy and reli-
ability of studies and records or other information described in 
subparagraph (B) and to assess compliance with applicable require-
ments under this Act or the Public Health Service Act, enter sites 
and facilities specified in subparagraph (C) in order to inspect 
such records or other information.
H. R. 2617—1412 
‘‘(B) An inspection under this paragraph shall extend to all 
records and other information related to the studies and submis-
sions described in subparagraph (E), including records and informa-
tion related to the conduct, results, and analyses of, and the protec-
tion of human and animal trial participants participating in, such 
studies. 
‘‘(C)(i) The sites and facilities subject to inspection by the Sec-
retary under this paragraph are those owned or operated by a 
person described in clause (ii) and which are (or were) utilized 
by such person in connection with— 
‘‘(I) developing an application or other submission to the 
Secretary under this Act or the Public Health Service Act 
related to marketing authorization for a product described in 
paragraph (1); 
‘‘(II) preparing, conducting, or analyzing the results of a 
study described in subparagraph (E); or 
‘‘(III) holding any records or other information described 
in subparagraph (B). 
‘‘(ii) A person described in this clause is— 
‘‘(I) the sponsor of an application or submission specified 
in subparagraph (E); 
‘‘(II) a person engaged in any activity described in clause 
(i) on behalf of such a sponsor, through a contract, grant, 
or other business arrangement with such sponsor; 
‘‘(III) an institutional review board, or other individual 
or entity, engaged by contract, grant, or other business arrange-
ment with a nonsponsor in preparing, collecting, or analyzing 
records or other information described in subparagraph (B); 
or 
‘‘(IV) any person not otherwise described in this clause 
that conducts, or has conducted, a study described in subpara-
graph (E) yielding records or other information described in 
subparagraph (B). 
‘‘(D)(i) Subject to clause (ii), an entity that owns or operates 
any site or facility subject to inspection under this paragraph shall 
provide the Secretary with access to records and other information 
described in subparagraph (B) that is held by or under the control 
of such entity, including— 
‘‘(I) permitting the Secretary to record or copy such informa-
tion for purposes of this paragraph; 
‘‘(II) providing the Secretary with access to any electronic 
information system utilized by such entity to hold, process, 
analyze, or transfer any records or other information described 
in subparagraph (B); and 
‘‘(III) permitting the Secretary to inspect the facilities, 
equipment, written procedures, processes, and conditions 
through which records or other information described in 
subparagraph (B) is or was generated, held, processed, ana-
lyzed, or transferred. 
‘‘(ii) Nothing in clause (i) shall negate, supersede, or otherwise 
affect the applicability of provisions, under this or any other Act, 
preventing or limiting the disclosure of confidential commercial 
information or other information considered proprietary or trade 
secret. 
‘‘(iii) An inspection under this paragraph shall be conducted 
at reasonable times and within reasonable limits and in a reason-
able manner.
H. R. 2617—1413 
‘‘(E) The studies and submissions described in this subpara-
graph are each of the following: 
‘‘(i) Clinical and nonclinical studies submitted to the Sec-
retary in support of, or otherwise related to, applications and 
other submissions to the Secretary under this Act or the Public 
Health Service Act for marketing authorization of a product 
described in paragraph (1). 
‘‘(ii) Postmarket safety activities conducted under this Act 
or the Public Health Service Act. 
‘‘(iii) Any other clinical investigation of— 
‘‘(I) a drug subject to section 505 or 512 of this Act 
or section 351 of the Public Health Service Act; or 
‘‘(II) a device subject to section 520(g). 
‘‘(iv) Any other submissions made under this Act or the 
Public Health Service Act with respect to which the Secretary 
determines an inspection under this paragraph is warranted 
in the interest of public health. 
‘‘(F) This paragraph clarifies the authority of the Secretary 
to conduct inspections of the type described in this paragraph 
and shall not be construed as a basis for inferring that, prior 
to the date of enactment of this paragraph, the Secretary lacked 
the authority to conduct such inspections, including under this 
Act or the Public Health Service Act.’’. 
(b) REVIEW
OF PROCESSES
AND PRACTICES; GUIDANCE
FOR 
INDUSTRY.— 
(1) IN GENERAL.—The Secretary shall— 
(A) review processes and practices in effect as of the 
date of enactment of this Act applicable to inspections 
of foreign and domestic sites and facilities described in 
subparagraph (C)(i) of section 704(a)(5) of the Federal Food, 
Drug, and Cosmetic Act, as added by subsection (a); and 
(B) evaluate whether any updates are needed to facili-
tate the consistency of such processes and practices. 
(2) GUIDANCE.— 
(A) IN GENERAL.—The Secretary shall issue guidance 
describing the processes and practices applicable to inspec-
tions of sites and facilities described in subparagraph (C)(i) 
of section 704(a)(5) of the Federal Food, Drug, and Cosmetic 
Act, as added by subsection (a), including with respect 
to the types of records and information required to be 
provided, best practices for communication between the 
Food and Drug Administration and industry in advance 
of or during an inspection or request for records or other 
information, and other inspections-related conduct, to the 
extent not specified in existing publicly available Food and 
Drug Administration guides and manuals for such inspec-
tions. 
(B) TIMING.—The Secretary shall— 
(i) not later than 18 months after the date of 
enactment of this Act, issue draft guidance under 
subparagraph (A); and 
(ii) not later than 1 year after the close of the 
public comment period for such draft guidance, issue 
final guidance under subparagraph (A).
H. R. 2617—1414 
SEC. 3613. IMPROVING FOOD AND DRUG ADMINISTRATION INSPEC-
TIONS. 
(a) RISK FACTORS FOR ESTABLISHMENTS.—Section 510(h)(4) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(h)(4)) 
is amended— 
(1) by redesignating subparagraph (F) as subparagraph 
(G); and 
(2) by inserting after subparagraph (E) the following: 
‘‘(F) The compliance history of establishments in the 
country or region in which the establishment is located 
that are subject to regulation under this Act, including 
the history of violations related to products exported from 
such country or region that are subject to such regulation.’’. 
(b) USE OF RECORDS.—Section 704(a)(4) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 374(a)(4)) is amended— 
(1) by redesignating subparagraph (C) as subparagraph 
(D); and 
(2) by inserting after subparagraph (B) the following: 
‘‘(C) The Secretary may rely on any records or other information 
that the Secretary may inspect under this section to satisfy require-
ments that may pertain to a preapproval or risk-based surveillance 
inspection, or to resolve deficiencies identified during such inspec-
tions, if applicable and appropriate.’’. 
(c) RECOGNITION OF FOREIGN GOVERNMENT INSPECTIONS.—Sec-
tion 809 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
384e) is amended— 
(1) in subsection (a)(1), by inserting ‘‘preapproval or’’ before 
‘‘risk-based inspections’’; and 
(2) by adding at the end the following: 
‘‘(c) PERIODIC REVIEW.— 
‘‘(1) IN GENERAL.—Beginning not later than 1 year after 
the date of the enactment of the Food and Drug Omnibus 
Reform Act of 2022, the Secretary shall periodically assess 
whether additional arrangements and agreements with a for-
eign government or an agency of a foreign government, as 
allowed under this section, are appropriate. 
‘‘(2) REPORTS TO CONGRESS.—Beginning not later than 4 
years after the date of the enactment of the Food and Drug 
Omnibus Reform Act of 2022, and every 4 years thereafter, 
the Secretary shall submit to the Committee on Energy and 
Commerce of the House of Representatives and the Committee 
on Health, Education, Labor, and Pensions of the Senate a 
report describing the findings and conclusions of each review 
conducted under paragraph (1).’’. 
SEC. 3614. GAO REPORT ON INSPECTIONS OF FOREIGN ESTABLISH-
MENTS MANUFACTURING DRUGS. 
(a) IN GENERAL.—Not later than 18 months after the date 
of the enactment of this Act, the Comptroller General of the United 
States shall submit to the Committee on Energy and Commerce 
of the House of Representatives and the Committee on Health, 
Education, Labor, and Pensions of the Senate a report on inspec-
tions conducted by— 
(1) the Secretary of foreign establishments pursuant to 
subsections (h) and (i) of section 510 and section 704 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360; 374); 
or
H. R. 2617—1415 
(2) a foreign government or an agency of a foreign govern-
ment pursuant to section 809 of such Act (21 U.S.C. 384e). 
(b) CONTENTS.—The report conducted under subsection (a) shall 
include— 
(1) what alternative tools, including remote inspections 
or remote evaluations, other countries are utilizing to facilitate 
inspections of foreign establishments; 
(2) how frequently trusted foreign regulators conduct 
inspections of foreign facilities that could be useful to the 
Food and Drug Administration to review in lieu of its own 
inspections; 
(3) how frequently and under what circumstances, 
including for what types of inspections, the Secretary utilizes 
existing agreements or arrangements under section 809 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384e) and 
whether the use of such agreements could be appropriately 
expanded; 
(4) whether the Secretary has accepted reports of inspec-
tions of facilities in China and India conducted by entities 
with which they have entered into such an agreement or 
arrangement; 
(5) what additional foreign governments or agencies of 
foreign governments the Secretary has considered entering into 
a mutual recognition agreement with and, if applicable, reasons 
why the Secretary declined to enter into a mutual recognition 
agreement with such foreign governments or agencies; 
(6) what tools, if any, the Secretary used to facilitate inspec-
tions of domestic facilities that could also be effectively utilized 
to appropriately inspect foreign facilities; 
(7) what steps the Secretary has taken to identify and 
evaluate tools and strategies the Secretary may use to continue 
oversight with respect to inspections when in-person inspections 
are disrupted; 
(8) how the Secretary is considering incorporating alter-
native tools into the inspection activities 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 identify and 
evaluate how the Secretary may use alternative tools to address 
workforce shortages to carry out such inspection activities. 
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 unan-
nounced and announced inspections of foreign human drug 
establishments and any other significant differences between 
each type of inspection;
H. R. 2617—1416 
(2) costs and benefits associated with conducting announced 
and unannounced inspections of foreign human drug establish-
ments; 
(3) barriers to conducting unannounced inspections of for-
eign 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 con-
ducting announced inspections of foreign human drug establish-
ments. 
(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 fol-
lowing 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 establish-
ments; 
(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. 
SEC. 3616. ENHANCING COORDINATION AND TRANSPARENCY ON 
INSPECTIONS. 
(a) COORDINATION.—Section 506D of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 356d) is amended— 
(1) by adding at the end the following: 
‘‘(g) COORDINATION.—The Secretary shall ensure timely and 
effective internal coordination and alignment among the field inves-
tigators of the Food and Drug Administration and the staff of 
the Center for Drug Evaluation and Research’s Office of Compliance 
and Drug Shortage 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.’’; and 
(2) by amending subsection (f) to read as follows: 
‘‘(f) TEMPORARY SUNSET.—Subsection (a) shall cease to be effec-
tive on the date that is 5 years after the date of enactment of 
the Food and Drug Administration Safety and Innovation Act. Sub-
sections (b), (c), and (e) shall not be in effect during the period 
beginning 5 years after the date of enactment of the Food and 
Drug Administration Safety and Innovation Act and ending on
H. R. 2617—1417 
the date of enactment of the Food and Drug Omnibus Reform 
Act of 2022. Subsections (b), (c), and (e) shall be in effect beginning 
on the date of enactment of the Food and Drug Omnibus Reform 
Act of 2022.’’. 
(b) REPORTING.— 
(1) AMENDMENTS.—Section 506C–1(a) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 356c–1(a)) is amended— 
(A) by redesignating paragraphs (3) through (7) as 
paragraphs (5) through (9), respectively; 
(B) by inserting after paragraph (2) the following: 
‘‘(3) describes the coordination and alignment activities 
undertaken pursuant to section 506D(g); 
‘‘(4) provides the number of reports that were required 
under section 704(b)(2) to be sent to the appropriate offices 
of the Food and Drug Administration with expertise regarding 
drug shortages, and the number of such reports that were 
sent;’’; and 
(C) in paragraph (5)(A), as so redesignated, by striking 
‘‘paragraph (7)’’ and inserting ‘‘paragraph (9)’’. 
(2) APPLICABILITY.—The amendments made by paragraph 
(1) shall apply with respect to reports submitted under section 
506C–1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
356c–1) on or after March 31, 2024. 
(c) REPORTING
OF MUTUAL RECOGNITION AGREEMENTS
FOR 
INSPECTIONS AND REVIEW ACTIVITIES.—Section 510(h) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360(h)) is amended— 
(1) in paragraph (6)— 
(A) in the matter preceding subparagraph (A), by 
striking ‘‘Beginning in 2014, not’’ and inserting ‘‘Not’’; 
(B) by amending subparagraph (A) to read as follows: 
‘‘(A)(i) the number of domestic and foreign establish-
ments registered pursuant to this section in the previous 
fiscal year; 
‘‘(ii) the number of such registered establishments in 
each region of interest; 
‘‘(iii) the number of such domestic establishments and 
the number of such foreign establishments, including the 
number of establishments in each region of interest, that 
the Secretary inspected in the previous fiscal year; 
‘‘(iv) the number of inspections to support actions by 
the Secretary on applications under section 505 of this 
Act or section 351 of the Public Health Service Act, 
including the number of inspections to support actions by 
the Secretary on supplemental applications, including 
changes to manufacturing processes, the Secretary con-
ducted in the previous fiscal year; 
‘‘(v) the number of routine surveillance inspections the 
Secretary conducted in the previous fiscal year, including 
in each region of interest; 
‘‘(vi) the number of for-cause inspections the Secretary 
conducted in the previous fiscal year, not including inspec-
tions described in clause (iv), including in each region 
of interest; and 
‘‘(vii) the number of inspections the Secretary has rec-
ognized pursuant to an agreement entered into pursuant 
to section 809, or otherwise recognized, for each of the 
types of inspections described in clauses (v) and (vi),
H. R. 2617—1418 
including for inspections of establishments in each region 
of interest.’’; 
(C) in subparagraph (B), by striking ‘‘; and’’ and 
inserting a semicolon; 
(D) in subparagraph (C), by striking the period and 
inserting ‘‘; and’’; and 
(E) by adding at the end the following: 
‘‘(D) the status of the efforts of the Food and Drug 
Administration to expand its recognition of inspections con-
ducted or recognized by foreign regulatory authorities 
under section 809, including any obstacles to expanding 
the use of such recognition.’’; and 
(2) by adding at the end the following: 
‘‘(7) REGION
OF
INTEREST.—For purposes of paragraph 
(6)(A), the term ‘region of interest’ means a foreign geographic 
region or country, including the People’s Republic of China, 
India, the European Union, the United Kingdom, and any other 
country or geographic region, as the Secretary determines 
appropriate.’’. 
SEC. 3617. ENHANCING TRANSPARENCY OF DRUG FACILITY INSPEC-
TION TIMELINES. 
Section 902 of the FDA Reauthorization Act of 2017 (21 U.S.C. 
355 note) is amended to read as follows: 
‘‘SEC. 902. ANNUAL REPORT ON INSPECTIONS. 
‘‘Not later than 120 days after the end of each fiscal year, 
the Secretary of Health and Human Services shall post on the 
website of the Food and Drug Administration information related 
to inspections of facilities necessary for approval of a drug under 
subsection (c) or (j) of section 505 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355) or approval of a device under 
section 515 of such Act (21 U.S.C. 360e) that were conducted during 
the previous fiscal year. Such information shall include the fol-
lowing: 
‘‘(1) The median time following a request from staff of 
the Food and Drug Administration reviewing an application 
or report to the beginning of the inspection, including— 
‘‘(A) 
the 
median 
time 
for 
drugs 
described 
in 
505(j)(11)(A)(i) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355(j)(11)(A)(i)); 
‘‘(B) the median time for drugs for which a notification 
has been submitted in accordance with section 506C(a) 
of such Act (21 U.S.C. 356c(a)) during the previous fiscal 
year; and 
‘‘(C) the median time for drugs on the drug shortage 
list in effect under section 506E of such Act (21 U.S.C. 
356e) at the time of such request. 
‘‘(2) The median time from the issuance of a report pursu-
ant to section 704(b) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 374(b)) to the sending of a warning letter, 
issuance of an import alert, or holding of a regulatory meeting 
for inspections for which the Secretary concluded that regu-
latory or enforcement action was indicated, including the 
median time for each category of drugs listed in subparagraphs 
(A) through (C) of paragraph (1). 
‘‘(3) The median time from the sending of a warning letter, 
issuance of an import alert, or holding of a regulatory meeting