H. R. 6833—29 
‘‘(iii) not intended to be a preventive or therapeutic 
intervention; and 
‘‘(iv) intended to detect an immediate- or delayed- 
type skin hypersensitivity reaction to aid in the diag-
nosis of— 
‘‘(I) an allergy to an antimicrobial agent; 
‘‘(II) an allergy that is not to an antimicrobial 
agent, if the diagnostic product was authorized 
for marketing prior to October 1, 2022; or 
‘‘(III) infection with fungal or mycobacterial 
pathogens; and 
‘‘(B) includes positive and negative controls required 
to interpret the results of a product described in subpara-
graph (A).’’. 
SEC. 1003. AUTHORITY TO ASSESS AND USE DRUG FEES. 
(a) TYPES OF FEES.— 
(1) HUMAN DRUG APPLICATION FEE.—Section 736(a) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(a)) is 
amended— 
(A) in the matter preceding paragraph (1), by striking 
‘‘fiscal year 2018’’ and inserting ‘‘fiscal year 2023’’; 
(B) in paragraph (1)(A), by striking ‘‘(c)(5)’’ each place 
it appears and inserting ‘‘(c)(6)’’; 
(C) in paragraph (1)(C), by inserting ‘‘prior to approval’’ 
after ‘‘or was withdrawn’’; and 
(D) in paragraph (1), by adding at the end the fol-
lowing: 
‘‘(H) EXCEPTION
FOR
SKIN-TEST
DIAGNOSTIC
PROD-
UCTS.—A human drug application for a skin-test diagnostic 
product shall not be subject to a fee under subparagraph 
(A).’’. 
(2) PRESCRIPTION DRUG PROGRAM FEE.—Section 736(a)(2) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379h(a)(2)) is amended— 
(A) in subparagraph (A)— 
(i) by striking ‘‘Except as provided in subpara-
graphs (B) and (C)’’ and inserting the following: 
‘‘(i) PAYMENT OF FEES.—Except as provided in sub-
paragraphs (B) and (C)’’; 
(ii) by striking ‘‘subsection (c)(5)’’ and inserting 
‘‘subsection (c)(6)’’; and 
(iii) by adding at the end the following: 
‘‘(ii) SPECIAL RULE FOR PREVIOUSLY DISCONTINUED 
DRUG PRODUCTS.—If a drug product that is identified 
in a human drug application approved as of October 
1 of a fiscal year is not a prescription drug product 
as of that date because the drug product is in the 
discontinued section of a list referenced in section 
735(3)(A)(iii), and on any subsequent day during such 
fiscal year the drug product is a prescription drug 
product, then except as provided in subparagraphs (B) 
and (C), each person who is named as the applicant 
in a human drug application with respect to such 
product, and who, after September 1, 1992, had 
pending before the Secretary a human drug application 
or supplement, shall pay the annual prescription drug
H. R. 6833—30 
program fee established for a fiscal year under sub-
section (c)(6) for such prescription drug product. Such 
fee shall be due on the last business day of such 
fiscal year and shall be paid only once for each such 
product for a fiscal year in which the fee is payable.’’; 
and 
(B) by amending subparagraph (B) to read as follows: 
‘‘(B) EXCEPTION FOR CERTAIN PRESCRIPTION DRUG PROD-
UCTS.—A prescription drug program fee shall not be 
assessed for a prescription drug product under subpara-
graph (A) if such product is— 
‘‘(i) a large volume parenteral product (a sterile 
aqueous drug product packaged in a single-dose con-
tainer with a volume greater than or equal to 100 
mL, not including powders for reconstitution or phar-
macy bulk packages) identified on the list compiled 
under section 505(j)(7); 
‘‘(ii) pharmaceutically equivalent (as defined in sec-
tion 314.3 of title 21, Code of Federal Regulations 
(or any successor regulation)) to another product on 
the list of products compiled under section 505(j)(7) 
(not including the discontinued section of such list); 
or 
‘‘(iii) a skin-test diagnostic product.’’. 
(b) FEE REVENUE AMOUNTS.— 
(1) IN GENERAL.—Paragraph (1) of section 736(b) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(b)) is 
amended to read as follows: 
‘‘(1) IN GENERAL.—For each of the fiscal years 2023 through 
2027, fees under subsection (a) shall, except as provided in 
subsections (c), (d), (f), and (g), be established to generate 
a total revenue amount under such subsection that is equal 
to the sum of— 
‘‘(A) the annual base revenue for the fiscal year (as 
determined under paragraph (3)); 
‘‘(B) the dollar amount equal to the inflation adjust-
ment for the fiscal year (as determined under subsection 
(c)(1)); 
‘‘(C) the dollar amount equal to the strategic hiring 
and retention adjustment for the fiscal year (as determined 
under subsection (c)(2)); 
‘‘(D) the dollar amount equal to the capacity planning 
adjustment for the fiscal year (as determined under sub-
section (c)(3)); 
‘‘(E) the dollar amount equal to the operating reserve 
adjustment for the fiscal year, if applicable (as determined 
under subsection (c)(4)); 
‘‘(F) the dollar amount equal to the additional direct 
cost adjustment for the fiscal year (as determined under 
subsection (c)(5)); and 
‘‘(G) additional dollar amounts for each fiscal year as 
follows: 
‘‘(i) $65,773,693 for fiscal year 2023. 
‘‘(ii) $25,097,671 for fiscal year 2024. 
‘‘(iii) $14,154,169 for fiscal year 2025. 
‘‘(iv) $4,864,860 for fiscal year 2026. 
‘‘(v) $1,314,620 for fiscal year 2027.’’.
H. R. 6833—31 
(2) ANNUAL BASE REVENUE.—Paragraph (3) of section 736(b) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(b)) 
is amended to read as follows: 
‘‘(3) ANNUAL BASE REVENUE.—For purposes of paragraph 
(1), the dollar amount of the annual base revenue for a fiscal 
year shall be— 
‘‘(A) for fiscal year 2023, $1,151,522,958; and 
‘‘(B) for fiscal years 2024 through 2027, the dollar 
amount of the total revenue amount established under 
paragraph (1) for the previous fiscal year, not including 
any adjustments made under subsection (c)(4) or (c)(5).’’. 
(c) ADJUSTMENTS; ANNUAL FEE SETTING.— 
(1) INFLATION ADJUSTMENT.—Section 736(c)(1)(B)(ii) of the 
Federal 
Food, 
Drug, 
and 
Cosmetic 
Act 
(21 
U.S.C. 
379h(c)(1)(B)(ii)) is amended by striking ‘‘Washington-Balti-
more, DC–MD–VA–WV’’ and inserting ‘‘Washington-Arlington- 
Alexandria, DC–VA–MD–WV’’. 
(2) STRATEGIC HIRING AND RETENTION ADJUSTMENT.—Sec-
tion 736(c) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 379h(c)) is amended— 
(A) by redesignating paragraphs (2) through (6) as 
paragraphs (3) through (7), respectively; and 
(B) by inserting after paragraph (1) the following: 
‘‘(2) STRATEGIC HIRING AND RETENTION ADJUSTMENT.—For 
each fiscal year, after the annual base revenue established 
in subsection (b)(1)(A) is adjusted for inflation in accordance 
with paragraph (1), the Secretary shall further increase the 
fee revenue and fees by the following amounts: 
‘‘(A) For fiscal year 2023, $9,000,000. 
‘‘(B) For each of fiscal years 2024 through 2027, 
$4,000,000.’’. 
(3) CAPACITY PLANNING ADJUSTMENT.—Paragraph (3), as 
redesignated, of section 736(c) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379h(c)) is amended to read as follows: 
‘‘(3) CAPACITY PLANNING ADJUSTMENT.— 
‘‘(A) IN
GENERAL.—For each fiscal year, after the 
annual base revenue established in subsection (b)(1)(A) 
is adjusted in accordance with paragraphs (1) and (2), 
such revenue shall be adjusted further for such fiscal year, 
in accordance with this paragraph, to reflect changes in 
the resource capacity needs of the Secretary for the process 
for the review of human drug applications. 
‘‘(B) METHODOLOGY.—For purposes of this paragraph, 
the Secretary shall employ the capacity planning method-
ology utilized by the Secretary in setting fees for fiscal 
year 2021, as described in the notice titled ‘Prescription 
Drug User Fee Rates for Fiscal Year 2021’ published in 
the Federal Register on August 3, 2020 (85 Fed. Reg. 
46651). The workload categories used in applying such 
methodology in forecasting shall include only the activities 
described in that notice and, as feasible, additional activi-
ties that are directly related to the direct review of applica-
tions and supplements, including additional formal meeting 
types, the direct review of postmarketing commitments 
and requirements, the direct review of risk evaluation and 
mitigation strategies, and the direct review of annual 
reports for approved prescription drug products. Subject