I 
119TH CONGRESS 
1ST SESSION H. R. 4273 
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 
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. 
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 
Monograph Drug User Fee Amendments’’. 
SEC. 2. FINDING. 
Congress finds that the fees authorized by the 
amendments made in this Act will be dedicated to OTC 
monograph drug activities, as set forth in the goals identi-
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fied 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 Energy 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 Congressional 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 insert-
ing a semicolon; 
(2) in clause (vi)— 
(A) by striking ‘‘addition’’ and inserting 
‘‘the addition’’; and 
(B) by striking the period and inserting ‘‘; 
or’’; and 
(3) by adding at the end the following: 
‘‘(vii) the addition or modification of a 
testing procedure applicable to one or more 
OTC monograph drugs, provided that such ad-
ditional or modified testing procedure reflects a 
voluntary consensus standard with respect to 
pharmaceutical quality that is— 
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‘‘(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 
available on the agency website, which ad-
dresses 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 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 
72(a)(1)) is amended— 
(1) in subparagraph (A)— 
(A) by striking ‘‘on December 31 of the 
fiscal year or at any time during the preceding 
12-month period’’ and inserting ‘‘at any time 
during 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 
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(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.’’; 
(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 
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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 
obligation of fees under this section 
for such year. 
‘‘(ii) FISCAL
YEAR
2027.—For fiscal 
year 2027, the facility fees required under 
subparagraph (A) shall be due— 
‘‘(I) in a first installment rep-
resenting 50 percent of such fee, on 
the later of— 
‘‘(aa) October 1, 2026; or 
‘‘(bb) the first business day 
after the enactment of an appro-
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priations Act providing for the 
collection and obligation of fees 
under this section for such year; 
and 
‘‘(II) in a second installment rep-
resenting the remaining 50 percent of 
such fee, on— 
‘‘(aa) February 1, 2027; or 
‘‘(bb) if an appropriations 
Act 
described 
in 
subclause 
(I)(bb) is not in effect on Feb-
ruary 1, 2027, the first business 
day after enactment of such an 
appropriations Act. 
‘‘(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 appro-
priations Act providing for the collec-
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tion and obligation of fees under this 
section 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)); 
‘‘(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; 
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‘‘(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 Amendments, not including any adjust-
ments 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 
established under this subsection for the pre-
vious fiscal year, not including any adjustments 
made for such previous fiscal year under sub-
section (c)(2) or (c)(3).’’. 
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(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 
preceding 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— 
‘‘(I) the fee for fiscal year 2025 
under subsection (a)(2); and 
‘‘(II) the inflation adjustment 
percentage under subparagraph (C); 
and 
‘‘(ii) for each of fiscal years 2027 
through 2030— 
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‘‘(I) the applicable fee under sub-
section (a)(2) for the preceding fiscal 
year; and 
‘‘(II) the inflation adjustment 
percentage 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) as clauses (i) and (ii), respec-
tively, and adjusting the margins accord-
ingly; 
(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– 
MD–VA–WV’’ and inserting ‘‘Washington– 
Arlington–Alexandria–DC–VA–MD–WV’’; 
(2) in paragraph (2)— 
(A) in subparagraph (A)— 
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(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 
(B) by striking subparagraphs (A) through 
(E) and inserting the following: 
‘‘(A) $135,000 for fiscal year 2026; 
‘‘(B) $300,000 for fiscal year 2027; 
‘‘(C) $55,000 for fiscal year 2028; 
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‘‘(D) $0 for fiscal year 2029; and 
‘‘(E) $30,000 for fiscal year 2030.’’; and 
(4) by striking paragraph (4) and inserting the 
following: 
‘‘(4) ONE-TIME FACILITY FEE WORKLOAD AD-
JUSTMENT.— 
‘‘(A) IN GENERAL.—In addition to the ad-
justments under paragraphs (1), (2), and (3), 
the Secretary may further increase the fee reve-
nues and fees through a one-time adjustment 
made for fiscal year 2028, 2029, or 2030, in 
accordance with this paragraph. 
‘‘(B) ADJUSTMENT DESCRIBED.— 
‘‘(i) 
CONDITIONS
FOR
ADJUST-
MENT.—An adjustment under this para-
graph may be made for a fiscal year only 
if— 
‘‘(I) an adjustment under this 
paragraph had not been made for any 
prior fiscal year; 
‘‘(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 fis-
cal years exceeds 1,625; and 
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‘‘(III) with respect to facilities 
described in subclause (II), the aver-
age number of such facilities (ex-
pressed as a percentage) that ap-
peared on the arrears lists pursuant 
to subsection (e)(1)(A)(i) over the pe-
riod of the preceding 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 percent-
age described in clause (iii). 
‘‘(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 pre-
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ceding 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 sub-
section— 
‘‘(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.—Sec-
tion 744M(f) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j–72(f)) is amended— 
(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 
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(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 Cos-
metic 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 
inserting ‘‘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’’. 
SEC. 6. 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. 
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(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. 7. 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 
subchapter C of chapter VII of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j–71 et seq.) shall be 
assessed beginning October 1, 2025, regardless of the date 
of the enactment of this Act. 
SEC. 8. 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. 
Æ 
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