H. R. 2617—1419 
related to conditions observed 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 implement ade-
quate corrective or preventive actions following a report issued 
pursuant to such section 704(b), resulting in a withhold rec-
ommendation for an application under review, including the 
number of 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 Regu-
lations (or any successor regulations); or 
‘‘(ii) is a diagnostic agent that improves the visualiza-
tion of structure or function within the body by increasing 
the relative difference in signal intensity within the target 
tissue, structure, or fluid. 
‘‘(B) The term ‘radioactive drug’ has the meaning given 
such term in section 310.3(n) of title 21, Code of Federal Regula-
tions (or any successor regulations), except that such term 
does not include— 
‘‘(i) an implant or article similar to an implant; 
‘‘(ii) an article that applies radiation from outside of 
the body; or 
‘‘(iii) the radiation source of an article described 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 section 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— 
‘‘(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)’’.
H. R. 2617—1420 
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 Administra-
tion, established under section 1011 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 399b), shall— 
(1) review and, as appropriate, update the Women’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 Representatives 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 shall develop, begin 
implementation of, and submit to the appropriate committees of 
Congress and post on the website of the Food and Drug Administra-
tion, a coordinated strategy 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 develop-
ment, 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 ADMINISTRATION STRA-
TEGIC WORKFORCE PLAN.—Each Food and Drug Administration 
Strategic Workforce Plan under subsection (a) shall— 
‘‘(1) include agency-wide human capital strategic goals and 
priorities for recruiting, hiring, training, developing, and 
retaining a qualified workforce for the Food and Drug Adminis-
tration; 
‘‘(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 Administration 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 miti-
gate those risks; 
‘‘(4) establish performance measures, benchmarks, 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
H. R. 2617—1421 
‘‘(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 subsection (a), the 
Secretary shall consider— 
‘‘(1) the number of employees (including senior leadership 
and non-senior leadership employees) eligible for retirement, 
the expertise of such employees, and the employing center 
of such employees; 
‘‘(2) the vacancy and turnover rates for employees 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 Viewpoint Survey 
for employees of the Food and Drug Administration, 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 different medical special-
ists), and how such rates of pay impact the ability of the 
Secretary to achieve the strategic 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 Adminis-
tration Strategic Workforce Plan issued pursuant to subsection 
(a), with the exception of the first such Food and Drug Administra-
tion Strategic Workforce Plan, shall include an evaluation of— 
‘‘(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 priorities 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 challenges for the Food and Drug 
Administration, including protecting such workforce during public 
health emergencies.’’. 
SEC. 3624. ENHANCING FOOD AND DRUG ADMINISTRATION HIRING 
AUTHORITY FOR SCIENTIFIC, TECHNICAL, AND PROFES-
SIONAL 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 positions’’; and 
(B) by inserting ‘‘and the regulation of food and cos-
metics’’ after ‘‘medical products’’; and 
(2) in subsection (d)(1)— 
(A) in the matter preceding subparagraph (A)—
H. R. 2617—1422 
(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 extent’’ and 
all that follows through ‘‘, including’’ 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 subpara-
graph (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 applicable 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 recruitment’’. 
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 defray’’ and 
inserting the following: ‘‘shall be available— 
‘‘(I) for fiscal year 2023, to defray’’; 
(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 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 mainte-
nance, renovation, and repair of facilities and 
acquisition, maintenance, and repair of fixtures, 
furniture, and other necessary materials and sup-
plies in connection with the process for the review 
of human drug applications, is no less than the 
amount allocated for such costs, excluding any 
such costs paid from fees collected under this sec-
tion, for fiscal year 1997, multiplied by the adjust-
ment 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— 
(1) in subparagraph (B)(i)—
H. R. 2617—1423 
(A) by striking ‘‘available for a fiscal year beginning 
after fiscal year 2012’’ and inserting the following: ‘‘avail-
able— 
‘‘(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 additional 
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 necessary materials and supplies in connec-
tion with the process for the review of biosimilar 
biological product applications, is no less than 
$20,000,000, multiplied by the adjustment factor 
applicable to the fiscal year involved.’’; and 
(2) in subparagraph (C), by striking ‘‘subparagraph (B) 
in any fiscal year if the costs described in such subparagraph’’ 
and inserting ‘‘subparagraph (B)(i) in any fiscal year if the 
costs allocated as described in subclause (I) or (II) of such 
subparagraph, as applicable,’’. 
(c) GDUFA AUTHORITY.—Section 744B of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j–42) is amended— 
(1) in subsection (e)(2), by striking ‘‘744A(11)(C)’’ and 
inserting ‘‘744A(12)(C)’’; and 
(2) in subsection (i)(2)— 
(A) in subparagraph (A)(ii)— 
(i) by striking ‘‘available for a fiscal year beginning 
after fiscal year 2012’’ and inserting the following: 
‘‘available— 
‘‘(I) for fiscal year 2023,’’; 
(ii) by striking ‘‘the fiscal year involved.’’ and 
inserting ‘‘such fiscal year; and’’; and 
(iii) by adding at the end the following: 
‘‘(II) for fiscal year 2024 and each subsequent 
fiscal year, to defray the costs of human generic 
drug activities (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 activities), 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 mainte-
nance, renovation, and repair of facilities and 
acquisition, maintenance, and repair of fixtures, 
furniture, and other necessary materials and sup-
plies in connection with human generic drug activi-
ties, is no less than $97,000,000 multiplied by
H. R. 2617—1425 
SEC. 3626. USER FEE PROGRAM TRANSPARENCY AND ACCOUNT-
ABILITY. 
(a) PDUFA.— 
(1) REAUTHORIZATION; REPORTING REQUIREMENTS.—Section 
736B(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379h–2(a)) is amended— 
(A) in paragraph (1)— 
(i) in subparagraph (B)— 
(I) in clause (vii), by striking ‘‘; and’’ and 
inserting a semicolon; 
(II) in clause (viii), by striking the period and 
inserting ‘‘; and’’; and 
(III) by adding at the end the following: 
‘‘(ix) the number of investigational new drug 
applications submitted per fiscal year, including for 
each review division.’’; and 
(ii) by adding at the end the following flush text: 
‘‘Nothing in subparagraph (B) shall be construed to authorize 
the disclosure of information that is prohibited from disclosure 
under section 301(j) of this Act or section 1905 of title 18, 
United States Code, or that is subject to withholding under 
section 552(b)(4) of title 5, United States Code.’’; 
(B) by adding at the end of paragraph (3)(B) the fol-
lowing: 
‘‘(v) For fiscal years 2023 and 2024, of the meeting 
requests from sponsors for which the Secretary has 
determined that a face-to-face meeting is appropriate, 
the number of face-to-face meetings requested by spon-
sors to be conducted in person (in such manner as 
the Secretary shall prescribe on the website of the 
Food and Drug Administration), and the number of 
such in-person meetings granted by the Secretary, with 
both such numbers disaggregated by the relevant 
agency center.’’; and 
(C) in paragraph (4)— 
(i) by amending subparagraph (A) to read as fol-
lows: 
‘‘(A) data, analysis, and discussion of the changes in 
the number of individuals hired as agreed upon in the 
letters described in section 1001(b) of the Prescription Drug 
User Fee Amendments of 2022 and the number of 
remaining vacancies, the number of full-time equivalents 
funded by fees collected pursuant to section 736, and the 
number of full-time equivalents funded by budget authority 
at the Food and Drug Administration by each division 
within the Center for Drug Evaluation and Research, the 
Center for Biologics Evaluation and Research, the Office 
of Regulatory Affairs, and the Office of the Commissioner;’’; 
(ii) by amending subparagraph (B) to read as fol-
lows: 
‘‘(B) data, analysis, and discussion of the changes in 
the fee revenue amounts and costs for the process for 
the review of human drug applications, including identi-
fying— 
‘‘(i) drivers of such changes; and
H. R. 2617—1426 
‘‘(ii) changes in the average total cost per full- 
time equivalent in the prescription drug review pro-
gram;’’; 
(iii) in subparagraph (C), by striking the period 
and inserting ‘‘; and’’; and 
(iv) by adding at the end the following: 
‘‘(D) data, analysis, and discussion of the changes in 
the average full-time equivalent hours required to complete 
review of each type of human drug application.’’. 
(2) REAUTHORIZATION.—Section 736B(f) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379h–2(f)) is amended— 
(A) by redesignating paragraphs (4) through (6) as 
paragraphs (5) through (7), respectively; 
(B) by inserting after paragraph (3) the following: 
‘‘(4) UPDATES TO CONGRESS.—The Secretary, in consultation 
with regulated industry, shall provide regular updates on nego-
tiations on the reauthorization of this part to the Committee 
on Health, Education, Labor, and Pensions of the Senate and 
the Committee on Energy and Commerce of the House of Rep-
resentatives.’’; and 
(C) in paragraph (7), as so redesignated— 
(i) in subparagraph (A)— 
(I) by striking ‘‘Before presenting the rec-
ommendations developed under paragraphs (1) 
through (5) to the Congress, the’’ and inserting 
‘‘The’’; and 
(II) by inserting ‘‘, not later than 30 days 
after each such negotiation meeting’’ before the 
period at the end; and 
(ii) in subparagraph (B), by inserting ‘‘, in sufficient 
detail,’’ after ‘‘shall summarize’’. 
(b) MDUFA.— 
(1) REAUTHORIZATION; REPORTING REQUIREMENTS.—Section 
738A(a)(1)(A) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379j–1(a)(1)(A)) is amended— 
(A) in clause (ii)— 
(i) in subclause (II), by striking ‘‘; and’’ and 
inserting a semicolon; 
(ii) in subclause (III), by striking the period and 
inserting a semicolon; and 
(iii) by adding at the end the following: 
‘‘(IV) the number of investigational device 
exemption applications submitted under section 
520(g) per fiscal year, including for each review 
division; and 
‘‘(V) the number of expedited development and 
priority review requests and designations under 
section 515B per fiscal year, including for each 
review division. 
Nothing in this clause shall be construed to authorize 
the disclosure of information that is prohibited from 
disclosure under section 301(j) of this Act or section 
1905 of title 18, United States Code, or that is subject 
to withholding under section 552(b)(4) of title 5, United 
States Code.’’; and 
(B) in clause (iv) (relating to rationale for MDUFA 
program changes)—
H. R. 2617—1427 
(i) by amending subclause (I) to read as follows: 
‘‘(I) data, analysis, and discussion of the 
changes in the number of individuals hired as 
agreed upon in the letters described in section 
2001(b) of the Medical Device User Fee Amend-
ments of 2022 and the number of remaining vacan-
cies, the number of full-time equivalents funded 
by fees collected pursuant to section 738, and the 
number of full time equivalents funded by budget 
authority at the Food and Drug Administration 
by each division within the Center for Devices 
and Radiological Health, the Center for Biologics 
Evaluation and Research, the Office of Regulatory 
Affairs, and the Office of the Commissioner;’’; 
(ii) by amending subclause (II) to read as follows: 
‘‘(II) data, analysis, and discussion of the 
changes in the fee revenue amounts and costs 
for the process for the review of device applications, 
including identifying— 
‘‘(aa) drivers of such changes; and 
‘‘(bb) changes in the average total cost 
per full-time equivalent in the medical device 
review program;’’; 
(iii) in subclause (III), by striking the period and 
inserting ‘‘; and’’; and 
(iv) by adding at the end the following: 
‘‘(IV) data, analysis, and discussion of the 
changes in the average full-time equivalent hours 
required to complete review of medical device 
application types.’’. 
(2) REAUTHORIZATION.—Section 738A(b) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j–1(b)) is 
amended— 
(A) by redesignating paragraphs (4) through (6) as 
paragraphs (5) through (7), respectively; 
(B) by inserting after paragraph (3) the following: 
‘‘(4) UPDATES TO CONGRESS.—The Secretary, in consultation 
with regulated industry, shall provide regular updates on nego-
tiations on the reauthorization of this part to the Committee 
on Health, Education, Labor, and Pensions of the Senate and 
the Committee on Energy and Commerce of the House of Rep-
resentatives.’’; and 
(C) in paragraph (7), as so redesignated— 
(i) in subparagraph (A)— 
(I) by striking ‘‘Before presenting the rec-
ommendations developed under paragraphs (1) 
through (5) to the Congress, the’’ and inserting 
‘‘The’’; and 
(II) by inserting ‘‘, not later than 30 days 
after each such negotiation meeting’’ before the 
period at the end; and 
(ii) in subparagraph (B), by inserting ‘‘, in sufficient 
detail,’’ after ‘‘shall summarize’’. 
(c) GDUFA.— 
(1) REAUTHORIZATION; REPORTING REQUIREMENTS.—Section 
744C(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 379j–43(a)(3)) is amended—
H. R. 2617—1428 
(A) by amending subparagraph (A) to read as follows: 
‘‘(A) data, analysis, and discussion of the changes in 
the number of individuals hired as agreed upon in the 
letters described in section 3001(b) of the Generic Drug 
User Fee Amendments of 2022 and the number of 
remaining vacancies, the number of full-time equivalents 
funded by fees collected pursuant to section 744B, and 
the number of full time equivalents funded by budget 
authority at the Food and Drug Administration by each 
division within the Center for Drug Evaluation and 
Research, the Center for Biologics Evaluation and 
Research, the Office of Regulatory Affairs, and the Office 
of the Commissioner;’’; 
(B) by amending subparagraph (B) to read as follows: 
‘‘(B) data, analysis, and discussion of the changes in 
the fee revenue amounts and costs for human generic drug 
activities, including— 
‘‘(i) identifying drivers of such changes; and 
‘‘(ii) changes in the total average cost per full- 
time equivalent in the generic drug review program;’’; 
(C) in subparagraph (C), by striking the period at 
the end and inserting ‘‘; and’’; and 
(D) by adding at the end the following: 
‘‘(D) data, analysis, and discussion of the changes in 
the average full-time equivalent hours required to complete 
review of each type of abbreviated new drug application.’’. 
(2) REAUTHORIZATION.—Section 744C(f) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j–43(f)) is amended— 
(A) by redesignating paragraphs (4) through (6) as 
paragraphs (5) through (7), respectively; 
(B) by inserting after paragraph (3) the following: 
‘‘(4) UPDATES TO CONGRESS.—The Secretary, in consultation 
with regulated industry, shall provide regular updates on nego-
tiations on the reauthorization of this part to the Committee 
on Health, Education, Labor, and Pensions of the Senate and 
the Committee on Energy and Commerce of the House of Rep-
resentatives.’’; and 
(C) in paragraph (7), as so redesignated— 
(i) in subparagraph (A)— 
(I) by striking ‘‘Before presenting the rec-
ommendations developed under paragraphs (1) 
through (5) to the Congress, the’’ and inserting 
‘‘The’’; and 
(II) by inserting ‘‘, not later than 30 days 
after each such negotiation meeting’’ before the 
period at the end; and 
(ii) in subparagraph (B), by inserting ‘‘, in sufficient 
detail,’’ after ‘‘shall summarize’’. 
(d) BSUFA.— 
(1) REAUTHORIZATION; REPORTING REQUIREMENTS.—Section 
744I(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 379j–53(a)(4)) is amended— 
(A) by amending subparagraph (A) to read as follows: 
‘‘(A) data, analysis, and discussion of the changes in 
the number of individuals hired as agreed upon in the 
letters described in section 4001(b) of the Biosimilar User 
Fee Amendments of 2022 and the number of remaining