IB 
Union Calendar No. 254 
119TH CONGRESS 
1ST SESSION H. R. 4273 
[Report No. 119–300] 
To amend the Federal Food, Drug, and Cosmetic Act to revise and extend 
the user fee program for over-the-counter monograph drugs, and for 
other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JULY 2, 2025 
Mr. LATTA (for himself, Ms. DEGETTE, Mr. CRENSHAW, and Mrs. DINGELL) 
introduced the following bill; which was referred to the Committee on En-
ergy and Commerce 
SEPTEMBER 17, 2025 
Reported with an amendment, committed to the Committee of the Whole 
House on the State of the Union, and ordered to be printed 
[Strike out all after the enacting clause and insert the part printed in italic] 
[For text of introduced bill, see copy of bill as introduced on July 2, 2025] 
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A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
revise and extend the user fee program for over-the- 
counter monograph drugs, and for other purposes. 
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Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Over-the-Counter Mono-
graph Drug User Fee Amendments’’. 
SEC. 2. FINDING. 
Congress finds that the fees authorized by the amend-
ments made in this Act will be dedicated to OTC mono-
graph drug activities, as set forth in the goals identified 
for purposes of part 10 of subchapter C of chapter VII of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 
71 et seq.), in the letters from the Secretary of Health and 
Human Services to the Chairman of the Committee on En-
ergy and Commerce of the House of Representatives and 
the Chairman of the Committee on Health, Education, 
Labor, and Pensions of the Senate, as set forth in the Con-
gressional Record. 
SEC. 3. DEFINITIONS. 
Section 744L(9)(A) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j–71(9)(A)) is amended— 
(1) in clause (v), by striking ‘‘; or’’ and inserting 
a semicolon; 
(2) in clause (vi)— 
(A) by striking ‘‘addition’’ and inserting 
‘‘the addition’’; and 
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(B) by striking the period and inserting ‘‘; 
or’’; and 
(3) by adding at the end the following: 
‘‘(vii) the addition or modification of a test-
ing procedure applicable to one or more OTC 
monograph drugs, provided that such additional 
or modified testing procedure reflects a voluntary 
consensus standard with respect to pharma-
ceutical quality that is— 
‘‘(I) established by a national or inter-
national standards development organiza-
tion; and 
‘‘(II) recognized by the Secretary 
through a process described in guidance for 
industry, initially published in July 2023, 
or any successor guidance, publicly avail-
able on the website of the Food and Drug 
Administration, which addresses voluntary 
consensus standards for pharmaceutical 
quality.’’. 
SEC. 4. AUTHORITY TO ASSESS AND USE OTC MONOGRAPH 
FEES. 
(a) TYPES OF FEES.—Section 744M(a)(1) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 
72(a)(1)) is amended— 
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(1) in subparagraph (A)— 
(A) by striking ‘‘on December 31 of the fis-
cal year or at any time during the preceding 12- 
month period’’ and inserting ‘‘at any time dur-
ing the applicable period specified in clause (ii) 
for a fiscal year’’; 
(B) by striking ‘‘Each person’’ and insert-
ing the following: 
‘‘(i) ASSESSMENT
OF
FEES.—Each 
person’’; and 
(C) by adding at the end the following: 
‘‘(ii) APPLICABLE PERIOD.—For pur-
poses of clause (i), the applicable period 
is— 
‘‘(I) for fiscal year 2026, the 12- 
month period ending on December 31, 
2025; 
‘‘(II) for fiscal year 2027, the 9- 
month period ending on September 30, 
2026; and 
‘‘(III) for fiscal year 2028 and 
each subsequent fiscal year, the 12- 
month period ending on September 30 
of the preceding fiscal year.’’; 
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(2) in subparagraph (B)(i), by amending sub-
clause (I) to read as follows: 
‘‘(I) has ceased all activities re-
lated to OTC monograph drugs prior 
to— 
‘‘(aa) for purposes of fiscal 
year 2026, January 1, 2025; 
‘‘(bb) for purposes of fiscal 
year 2027, January 1, 2026; and 
‘‘(cc) for purposes of fiscal 
year 2028 and each subsequent 
fiscal year, October 1 of the pre-
ceding fiscal year; and’’; and 
(3) by amending subparagraph (D) to read as 
follows: 
‘‘(D) DUE DATE.— 
‘‘(i) FISCAL
YEAR
2026.—For fiscal 
year 2026, the facility fees required under 
subparagraph (A) shall be due on the later 
of— 
‘‘(I) the first business day of June 
of such year; or 
‘‘(II) the first business day after 
the enactment of an appropriations 
Act providing for the collection and ob-
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‘‘(iii) SUBSEQUENT
FISCAL
YEARS.— 
For fiscal year 2028 and each subsequent 
fiscal year, the facility fees required under 
subparagraph (A) shall be due on the later 
of— 
‘‘(I) the first business day on or 
after October 1 of the fiscal year; or 
‘‘(II) the first business day after 
the date of enactment of an appropria-
tions Act providing for the collection 
and obligation of fees under this sec-
tion for the fiscal year.’’. 
(b) FEE REVENUE AMOUNTS.—Section 744M(b) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 
72(b)) is amended to read as follows: 
‘‘(b) FEE REVENUE AMOUNTS.— 
‘‘(1) IN GENERAL.—For each of the fiscal years 
2026 through 2030, fees under subsection (a)(1) shall 
be established to generate a total facility fee revenue 
amount equal to the sum of— 
‘‘(A) the annual base revenue for the fiscal 
year (as determined under paragraph (2)); 
‘‘(B) the dollar amount equal to the infla-
tion adjustment for the fiscal year (as deter-
mined under subsection (c)(1)); 
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‘‘(C) the dollar amount equal to the oper-
ating reserve adjustment for the fiscal year, if 
applicable (as determined under subsection 
(c)(2)); 
‘‘(D) additional direct cost adjustments (as 
determined under subsection (c)(3)); 
‘‘(E) an additional dollar amount equal 
to— 
‘‘(i) $2,373,000 for fiscal year 2026; 
‘‘(ii) $1,233,000 for fiscal year 2027; 
and 
‘‘(iii) $854,000 for fiscal year 2028; 
and 
‘‘(F) in the case of a fiscal year for which 
the Secretary applies the one-time facility fee 
workload adjustment under subsection (c)(4), the 
dollar amount equal to such adjustment. 
‘‘(2) 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 2026, the dollar amount 
of the total revenue amount established for fiscal 
year 2025 under this subsection as in effect on 
the day before the date of enactment of the Over- 
the-Counter Monograph Drug User Fee Amend-
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ments, not including any adjustments made for 
such fiscal year 2025 under subsection (c)(2), as 
so in effect; and 
‘‘(B) for fiscal years 2027 through 2030, the 
dollar amount of the total revenue amount estab-
lished under this subsection for the previous fis-
cal year, not including any adjustments made 
for such previous fiscal year under subsection 
(c)(2) or (c)(3).’’. 
(c) ADJUSTMENTS; ANNUAL FEE SETTING.—Section 
744M(c) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 379j–72) is amended— 
(1) in paragraph (1)— 
(A) in subparagraph (A), in the matter pre-
ceding clause (i)— 
(i) by striking ‘‘subsection (b)(2)(B)’’ 
and inserting ‘‘subsection (b)(1)(B)’’; and 
(ii) by striking ‘‘fiscal year 2022 and 
each subsequent fiscal year’’ and inserting 
‘‘each fiscal year’’; 
(B) in subparagraph (B), by striking ‘‘fis-
cal year 2022’’ and all that follows through the 
period at the end and inserting the following: ‘‘a 
fiscal year shall be equal to the product of— 
‘‘(i) for fiscal year 2026— 
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‘‘(I) the fee for fiscal year 2025 
under subsection (a)(2); and 
‘‘(II) the inflation adjustment per-
centage under subparagraph (C); and 
‘‘(ii) for each of fiscal years 2027 
through 2030— 
‘‘(I) the applicable fee under sub-
section (a)(2) for the preceding fiscal 
year; and 
‘‘(II) the inflation adjustment per-
centage under subparagraph (C).’’; and 
(C) in subparagraph (C)— 
(i) in the matter preceding clause (i), 
by inserting ‘‘the sum of’’ after ‘‘is equal 
to’’; 
(ii) by striking clause (i); 
(iii) by redesignating subclauses (I) 
and (II) of clause (ii) as clauses (i) and 
(ii), respectively, and adjusting the margins 
accordingly; 
(iv) by striking ‘‘(ii) for each of fiscal 
years 2024 and 2025, the sum of—’’; and 
(v) in clause (ii), as so redesignated, 
by striking ‘‘Washington-Baltimore, DC– 
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MD–VA–WV’’ and inserting ‘‘Washington– 
Arlington–Alexandria–DC–VA–MD–WV’’; 
(2) in paragraph (2)— 
(A) in subparagraph (A)— 
(i) by striking ‘‘fiscal year 2021 and 
subsequent fiscal years’’ and inserting ‘‘each 
fiscal year’’; 
(ii) by striking ‘‘subsections (b)(1)(B) 
and (b)(2)(C)’’ and inserting ‘‘subsection 
(b)(1)(C)’’; and 
(iii) by striking ‘‘the number of weeks 
specified in subparagraph (B)’’ and insert-
ing ‘‘10 weeks’’; 
(B) by striking subparagraph (B); 
(C) by redesignating subparagraphs (C) 
and (D) as subparagraphs (B) and (C), respec-
tively; and 
(D) in subparagraph (C), as so redesig-
nated, by striking ‘‘paragraph (4) establishing’’ 
and inserting ‘‘paragraph (5) publishing’’; 
(3) in paragraph (3)— 
(A) in the matter preceding subparagraph 
(A), by striking ‘‘subsection (b)(2)(D)’’ and in-
serting ‘‘subsection (b)(1)(D)’’; and 
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‘‘(II) the average number of OTC 
monograph drug facilities subject to a 
facility fee under subsection (a)(1) over 
the period of the preceding 3 fiscal 
years exceeds 1,625; and 
‘‘(III) with respect to facilities de-
scribed in subclause (II), the average 
number of such facilities (expressed as 
a percentage) that appeared on the ar-
rears lists pursuant to subsection 
(e)(1)(A)(i) over the period of the pre-
ceding 3 fiscal years is less than 30 
percent. 
‘‘(ii) AMOUNT
OF
ADJUSTMENT.—An 
adjustment under this paragraph for a fis-
cal year shall equal the product of— 
‘‘(I) the total facility revenue 
amount determined under subsection 
(b) for the fiscal year, exclusive of the 
adjustment under this paragraph for 
such fiscal year; and 
‘‘(II) the excess facility percentage 
described in clause (iii). 
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‘‘(iii) 
EXCESS
FACILITY
PERCENT-
AGE.—The excess facility percentage de-
scribed in this clause is— 
‘‘(I) the amount by which the av-
erage number of OTC monograph drug 
facilities subject to a facility fee under 
subsection (a)(1) over the preceding 3 
fiscal years exceeds 1,625; divided by 
‘‘(II) 1,625. 
‘‘(5) ANNUAL
FEE
SETTING.—The Secretary 
shall, not later than 60 days before the first day of 
each fiscal year— 
‘‘(A) establish for such fiscal year, based on 
the revenue amounts under subsection (b) and 
the adjustments provided under this subsection— 
‘‘(i) OTC monograph drug facility fees 
under subsection (a)(1); and 
‘‘(ii) OTC monograph order request 
fees under subsection (a)(2); and 
‘‘(B) publish such fee revenue amounts, fa-
cility fees, and OTC monograph order request 
fees in the Federal Register.’’. 
(d) CREDITING AND AVAILABILITY OF FEES.—Section 
744M(f) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 379j–72(f)) is amended— 
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(1) in paragraph (2)(D)— 
(A) in the subparagraph heading, by strik-
ing ‘‘IN SUBSEQUENT YEARS’’; and 
(B) by striking ‘‘(after fiscal year 2021)’’; 
and 
(2) in paragraph (3), by striking ‘‘2021 through 
2025’’ and inserting ‘‘2026 through 2030’’. 
SEC. 5. REAUTHORIZATION; REPORTING REQUIREMENTS. 
Section 744N of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j–73) is amended— 
(1) in subsection (a)— 
(A) by striking ‘‘Beginning with fiscal year 
2021, and not later than 120 calendar days after 
the end of each fiscal year thereafter’’ and insert-
ing ‘‘Not later than 120 calendar days after the 
end of each fiscal year’’; and 
(B) by striking ‘‘section 3861(b) of the 
CARES Act’’ and inserting ‘‘section 2 of the 
Over-the-Counter Monograph Drug User Fee 
Amendments’’; 
(2) in subsection (b), by striking ‘‘fiscal year 
2021 and each subsequent fiscal year’’ and inserting 
‘‘each fiscal year’’; and 
(3) in subsection (d), by striking ‘‘2025’’ each 
place it appears and inserting ‘‘2030’’. 
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SEC. 6. REGULATION OF CERTAIN NONPRESCRIPTION 
DRUGS THAT ARE MARKETED WITHOUT AN 
APPROVED DRUG APPLICATION. 
(a) DEVELOPMENT ADVICE TO SPONSORS OR REQUES-
TORS.—Section 505G(h) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355h(h)) is amended by striking 
‘‘sponsors or requestors’’ and inserting ‘‘sponsors, reques-
tors, or organizations nominated by sponsors or requestors 
to represent their interests in a proceeding’’. 
(b) 
TECHNICAL
CORRECTION.—Section 
505G(b)(2)(A)(iv)(III) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355h(b)(2)(A)(iv)(III)) is amended by 
striking ‘‘requestors’’ and inserting ‘‘sponsors or reques-
tors’’. 
SEC. 7. SUNSET DATES. 
(a) AUTHORIZATION.—Sections 744L and 744M of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 
71; 379j–72) shall cease to be effective October 1, 2030. 
(b) REPORTING REQUIREMENTS.—Section 744N of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 
73) shall cease to be effective January 31, 2031. 
SEC. 8. EFFECTIVE DATE. 
The amendments made by this Act shall take effect on 
October 1, 2025, or the date of the enactment of this Act, 
whichever is later, except that fees under part 10 of sub-
chapter C of chapter VII of the Federal Food, Drug, and 
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Cosmetic Act (21 U.S.C. 379j–71 et seq.) shall be assessed 
beginning October 1, 2025, regardless of the date of the en-
actment of this Act. 
SEC. 9. SAVINGS CLAUSE. 
Notwithstanding the amendments made by this Act, 
part 10 of subchapter C of chapter VII of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j–71 et seq.), as in 
effect on the day before the date of enactment of this Act, 
shall continue to be in effect with respect to assessing and 
collecting any fee required by such part for a fiscal year 
prior to fiscal year 2026. 
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