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native tools to address workforce shortages to carry 
out such inspection activities. 
SEC. 3615. UNANNOUNCED FOREIGN FACILITY INSPEC-
TIONS 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 estab-
lishments, including the impact of announcing inspections 
to persons who own or operate foreign human drug estab-
lishments in advance of an inspection. Such pilot program 
shall evaluate— 
(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 conducting 
announced and unannounced inspections of foreign 
human drug establishments; 
(3) barriers to conducting unannounced inspec-
tions of foreign human drug establishments and any
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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 
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-
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tified barriers to conducting unannounced inspections 
of foreign human drug establishments; 
(2) findings and any associated recommenda-
tions regarding how the Secretary may achieve parity 
between domestic and foreign human drug inspec-
tions; and 
(3) the number of unannounced inspections dur-
ing 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 
TRANS-
PARENCY ON INSPECTIONS. 
(a) COORDINATION.—Section 506D of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 356d) is amend-
ed— 
(1) 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 Admin-
istration 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
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‘‘(2) any feedback or corrective or preventive ac-
tions in response to such reports.’’; and 
(2) by amending subsection (f) to read as follows: 
‘‘(f) TEMPORARY SUNSET.—Subsection (a) shall cease 
to be effective on the date that is 5 years after the date of 
enactment of the Food and Drug Administration Safety 
and Innovation Act. Subsections (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 the date of enact-
ment 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 Re-
form 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), re-
spectively; 
(B) by inserting after paragraph (2) the fol-
lowing: 
‘‘(3) describes the coordination and alignment 
activities undertaken pursuant to section 506D(g);
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† HR 2617 EAS2 
‘‘(4) provides the number of reports that were re-
quired under section 704(b)(2) to be sent to the ap-
propriate offices of the Food and Drug Administra-
tion 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 sub-
mitted 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 AGREE-
MENTS FOR INSPECTIONS AND REVIEW ACTIVITIES.—Sec-
tion 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:
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† HR 2617 EAS2 
‘‘(A)(i) the number of domestic and foreign 
establishments registered pursuant to this section 
in the previous fiscal year; 
‘‘(ii) the number of such registered establish-
ments in each region of interest; 
‘‘(iii) the number of such domestic establish-
ments and the number of such foreign establish-
ments, including the number of establishments in 
each region of interest, that the Secretary in-
spected 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 Pub-
lic 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 in-
spections 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 inspections described in clause 
(iv), including in each region of interest; and
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† HR 2617 EAS2 
‘‘(vii) the number of inspections the Sec-
retary has recognized pursuant to an agreement 
entered into pursuant to section 809, or other-
wise recognized, for each of the types of inspec-
tions described in clauses (v) and (vi), 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 recogni-
tion of inspections conducted 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
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† HR 2617 EAS2 
or geographic region, as the Secretary determines ap-
propriate.’’. 
SEC. 3617. ENHANCING TRANSPARENCY OF DRUG FACILITY 
INSPECTION 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 following: 
‘‘(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 in-
spection, 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
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† HR 2617 EAS2 
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 re-
port pursuant 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 inspec-
tions 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 hold-
ing of a regulatory meeting related to conditions ob-
served by the Secretary during an inspection, to the 
time at which the Secretary concludes that corrective 
actions to resolve such conditions have been taken. 
‘‘(4) The number of facilities that failed to im-
plement adequate corrective or preventive actions fol-
lowing a report issued pursuant to such section 
704(b), resulting in a withhold recommendation for 
an application under review, including the number of
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such facilities manufacturing each category of drugs 
listed in subparagraphs (A) through (C) of paragraph 
(1).’’. 
CHAPTER 3—MISCELLANEOUS 
SEC. 3621. REGULATION OF CERTAIN PRODUCTS AS DRUGS. 
Section 503 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 353) is amended by adding at the end the 
following: 
‘‘(h)(1) Any contrast agent, radioactive drug, or OTC 
monograph drug shall be deemed to be a drug under section 
201(g) and not a device under section 201(h). 
‘‘(2) For purposes of this subsection: 
‘‘(A) The term ‘contrast agent’ means an article 
that is intended for use in conjunction with a medical 
imaging device, and— 
‘‘(i) is a diagnostic radiopharmaceutical, as 
defined in sections 315.2 and 601.31 of title 21, 
Code of Federal Regulations (or any successor 
regulations); or 
‘‘(ii) is a diagnostic agent that improves the 
visualization of structure or function within the 
body by increasing the relative difference in sig-
nal intensity within the target tissue, structure, 
or fluid.
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‘‘(B) The term ‘radioactive drug’ has the mean-
ing given such term in section 310.3(n) of title 21, 
Code of Federal Regulations (or any successor regula-
tions), except that such term does not include— 
‘‘(i) an implant or article similar to an im-
plant; 
‘‘(ii) an article that applies radiation from 
outside of the body; or 
‘‘(iii) the radiation source of an article de-
scribed in clause (i) or (ii). 
‘‘(C) The term ‘OTC monograph drug’ has the 
meaning given such term in section 744L. 
‘‘(3) Nothing in this subsection shall be construed as 
allowing for the classification of a product as a drug (as 
defined in section 201(g)) if such product— 
‘‘(A) is not described in paragraph (1); and 
‘‘(B) meets the definition of a device under sec-
tion 201(h), 
unless another provision of this Act otherwise indicates a 
different classification. 
‘‘(4) The Secretary shall waive the application fee 
under sections 736 and 744B for applications for drugs that 
are—
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† HR 2617 EAS2 
‘‘(A) on the date of enactment of the Prescription 
Drug User Fee Amendments of 2022, legally marketed 
as devices; and 
‘‘(B) deemed drugs pursuant to paragraph (1)’’. 
SEC. 3622. WOMEN’S HEALTH RESEARCH ROADMAP. 
Not later than 2 years after the date of enactment of 
this Act, the Office of Women’s Health of the Food and Drug 
Administration, established under section 1011 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 399b), 
shall— 
(1) review and, as appropriate, update the Wom-
en’s Health Research Roadmap issued in December 
2015; and 
(2) brief the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Committee 
on Energy and Commerce of the House of Representa-
tives on the review and, as appropriate, any resulting 
update. 
SEC. 3623. STRATEGIC WORKFORCE PLAN AND REPORT. 
Chapter VII of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 371 et seq.) is amended by inserting after 
section 714A the following: 
‘‘SEC. 714B. STRATEGIC WORKFORCE PLAN AND REPORT. 
‘‘(a) IN GENERAL.—Not later than September 30, 
2023, and at least every 4 years thereafter, the Secretary
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† HR 2617 EAS2 
shall develop, begin implementation of, and submit to the 
appropriate committees of Congress and post on the website 
of the Food and Drug Administration, a coordinated strat-
egy and report to provide direction for the activities and 
programs of the Secretary to recruit, hire, train, develop, 
and retain the workforce needed to fulfill the public health 
mission of the Food and Drug Administration, including 
to facilitate collaboration across centers, to keep pace with 
new biomedical, technological, and scientific advancements, 
and support the development, review, and regulation of 
medical products. Each such report shall be known as the 
‘Food and Drug Administration Strategic Workforce Plan’. 
‘‘(b) USE OF THE FOOD AND DRUG ADMINISTRATION 
STRATEGIC WORKFORCE PLAN.—Each center within the 
Food and Drug Administration shall develop and update, 
as appropriate, a strategic plan that will be informed by 
the Food and Drug Administration Strategic Workforce 
Plans developed under subsection (a). 
‘‘(c) CONTENTS OF THE FOOD AND DRUG ADMINISTRA-
TION STRATEGIC WORKFORCE PLAN.—Each Food and 
Drug Administration Strategic Workforce Plan under sub-
section (a) shall— 
‘‘(1) include agency-wide human capital stra-
tegic goals and priorities for recruiting, hiring, train-
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† HR 2617 EAS2 
ing, developing, and retaining a qualified workforce 
for the Food and Drug Administration; 
‘‘(2) establish specific actions the Secretary will 
take to achieve such strategic goals and priorities and 
address the workforce needs of the Food and Drug Ad-
ministration in the forthcoming fiscal years; 
‘‘(3) identify challenges and risks the Secretary 
will face in meeting its strategic goals and priorities, 
and the actions the Secretary will take to overcome 
those challenges and mitigate those risks; 
‘‘(4) establish performance measures, bench-
marks, or other elements that the Secretary will use 
to measure and evaluate progress in achieving such 
strategic goals and priorities and the effectiveness of 
such strategic goals and priorities; and 
‘‘(5) define functions, capabilities, and gaps in 
such workforce and identify strategies to recruit, hire, 
train, develop, and retain such workforce. 
‘‘(d) CONSIDERATIONS.—In developing each Food and 
Drug Administration Strategic Workforce Plan under sub-
section (a), the Secretary shall consider— 
‘‘(1) the number of employees (including senior 
leadership and non-senior leadership employees) eligi-
ble for retirement, the expertise of such employees, 
and the employing center of such employees;
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‘‘(2) the vacancy and turnover rates for employ-
ees with different types of expertise and from different 
centers, including any changes or trends related to 
such rates; 
‘‘(3) the results of the Federal Employee View-
point Survey for employees of the Food and Drug Ad-
ministration, including any changes or trends related 
to such results; 
‘‘(4) rates of pay for different types of positions, 
including rates for different types of expertise within 
the same field (such as differences in pay between dif-
ferent medical specialists), and how such rates of pay 
impact the ability of the Secretary to achieve the stra-
tegic goals and priorities described in subsection (c); 
‘‘(5) the statutory hiring authorities used to hire 
Food and Drug Administration employees, and the 
time to hire across different hiring authorities; and 
‘‘(6) any other timely and relevant information, 
as the Secretary determines appropriate. 
‘‘(e) EVALUATION
OF PROGRESS.—Each Food and 
Drug Administration Strategic Workforce Plan issued pur-
suant to subsection (a), with the exception of the first such 
Food and Drug Administration Strategic Workforce Plan, 
shall include an evaluation of—
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‘‘(1) the progress the Secretary has made, based 
on the performance measures, benchmarks, and other 
elements that measure successful recruitment, hiring, 
training, development, and retention activities; and 
‘‘(2) whether actions taken in response to the 
Plan improved the capacity of the Food and Drug 
Administration to achieve the strategic goals and pri-
orities described in subsection (c)(1). 
‘‘(f) ADDITIONAL CONSIDERATIONS.—The Food and 
Drug Administration Strategic Workforce Plan issued in 
fiscal year 2023 shall address the effect of the COVID–19 
pandemic on hiring, retention, and other workforce chal-
lenges for the Food and Drug Administration, including 
protecting such workforce during public health emer-
gencies.’’. 
SEC. 3624. ENHANCING FOOD AND DRUG ADMINISTRATION 
HIRING AUTHORITY FOR SCIENTIFIC, TECH-
NICAL, AND PROFESSIONAL PERSONNEL. 
Section 714A of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379d–3a) is amended— 
(1) in subsection (a)— 
(A) by inserting ‘‘, including cross-cutting 
operational positions,’’ after ‘‘professional posi-
tions’’; and
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† HR 2617 EAS2 
(B) by inserting ‘‘and the regulation of food 
and cosmetics’’ after ‘‘medical products’’; and 
(2) in subsection (d)(1)— 
(A) in the matter preceding subparagraph 
(A)— 
(i) by striking ‘‘the 21st Century Cures 
Act’’ and inserting ‘‘the Food and Drug 
Omnibus Reform Act of 2022’’; and 
(ii) by striking ‘‘that examines the ex-
tent’’ and all that follows through ‘‘, includ-
ing’’ and inserting ‘‘that includes’’; 
(B) in subparagraph (A)— 
(i) by inserting ‘‘updated’’ before 
‘‘analysis’’; and 
(ii) by striking ‘‘; and’’ and inserting 
a semicolon; 
(C) by redesignating subparagraph (B) as 
subparagraph (C); 
(D) by inserting after subparagraph (A) the 
following: 
‘‘(B) an analysis of how the Secretary has 
used the authorities provided under this section, 
and a plan for how the Secretary will use the 
authority under this section, and other applica-
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† HR 2617 EAS2 
ble hiring authorities, for employees of the Food 
and Drug Administration; and’’; and 
(E) in the matter preceding clause (i) of 
subparagraph (C), as so redesignated, by striking 
‘‘a recruitment’’ and inserting ‘‘an updated re-
cruitment’’. 
SEC. 3625. FACILITIES MANAGEMENT. 
(a) PDUFA AUTHORITY.—Section 736(g)(2) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379h(g)(2)) is amended— 
(1) in subparagraph (A)(ii)— 
(A) by striking ‘‘shall be available to de-
fray’’ and inserting the following: ‘‘shall be 
available— 
‘‘(I) for fiscal year 2023, to de-
fray’’; 
(B) by striking the period and inserting ‘‘; 
and’’; and 
(C) by adding at the end the following: 
‘‘(II) for fiscal year 2024 and 
each subsequent fiscal year, to defray 
the costs of the resources allocated for 
the process for the review of human 
drug applications (including such costs 
for an additional number of full-time
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† HR 2617 EAS2 
equivalent positions in the Department 
of Health and Human Services to be 
engaged in such process), only if the 
sum of the amounts allocated by the 
Secretary for such costs, excluding costs 
paid from fees collected under this sec-
tion, plus other costs for the mainte-
nance, renovation, and repair of facili-
ties and acquisition, maintenance, and 
repair of fixtures, furniture, and other 
necessary materials and supplies in 
connection with the process for the re-
view of human drug applications, is no 
less than the amount allocated for such 
costs, excluding any such costs paid 
from fees collected under this section, 
for fiscal year 1997, multiplied by the 
adjustment factor.’’; and 
(2) in subparagraph (B), by striking ‘‘for the 
process for the review of human drug applications’’ 
and inserting ‘‘as described in subclause (I) or (II) of 
such subparagraph, as applicable’’. 
(b) BSUFA AUTHORITY.—Section 744H(f)(2) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 
52(f)(2)) is amended—
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† HR 2617 EAS2 
(1) in subparagraph (B)(i)— 
(A) by striking ‘‘available for a fiscal year 
beginning after fiscal year 2012’’ and inserting 
the following: ‘‘available— 
‘‘(I) for fiscal year 2023,’’; 
(B) by striking ‘‘the fiscal year involved.’’ 
and inserting ‘‘such fiscal year; and’’; and 
(C) by adding at the end the following: 
‘‘(II) for fiscal year 2024 and 
each subsequent fiscal year, to defray 
the costs of the process for the review of 
biosimilar biological product applica-
tions (including such costs for an addi-
tional number of full-time equivalent 
positions in the Department of Health 
and Human Services to be engaged in 
such process), only if the sum of the 
amounts allocated by the Secretary for 
such costs, excluding costs paid from 
fees collected under this section, plus 
other costs for the maintenance, ren-
ovation, and repair of facilities and 
acquisition, maintenance, and repair 
of fixtures, furniture, and other nec-
essary materials and supplies in con-