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S. 2292

U.S. SenateSenate Floor Calendar

Summary

S. 2292, “Over-the-Counter Monograph Drug User Fee Amendments”, was introduced in the Senate on Jul 15, 2025 by Sen. Jim Banks (R) with 3 co-sponsors. It last saw action on Sep 8, 2025: Placed on Senate Legislative Calendar under General Orders. Calendar No. 152.


Record

Text

S. 2292 has 3 co-sponsors.

sb2292/introduced-in-senate.txt
119 S2292 IS: Over-the-Counter Monograph Drug User Fee Amendments
U.S. Senate
2025-07-15
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.
II 119th CONGRESS 1st Session S. 2292 IN THE SENATE OF THE UNITED STATES July 15, 2025 Mr. Banks (for himself and Mr. Kaine ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 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.
1.
Short title
This Act may be cited as the Over-the-Counter Monograph Drug User Fee Amendments .
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 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 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.
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
(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 additional or modified testing procedure reflects a voluntary consensus standard with respect to pharmaceutical quality that is—
(I)
established by a national or international standards development organization; 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 website of the Food and Drug Administration, which addresses voluntary consensus standards for pharmaceutical quality.
.
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 inserting the following:
(i)
Assessment of fees
Each person
; and
(C)
by adding at the end the following:
(ii)
Applicable period
For purposes 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 subclause (I) to read as follows:
(I)
has ceased all activities related 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 preceding 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 representing 50 percent of such fee, on the later of—
(aa)
October 1, 2026; or
(bb)
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; and
(II)
in a second installment representing 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 February 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 appropriations Act providing for the collection 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 inflation adjustment for the fiscal year (as determined under subsection (c)(1));
(C)
the dollar amount equal to the operating 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 Amendments , 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 established under this subsection for the previous fiscal 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 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 fiscal 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—
(I)
the applicable fee under subsection (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) 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–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 inserting 10 weeks ;
(B)
by striking subparagraph (B);
(C)
by redesignating subparagraphs (C) and (D) as subparagraphs (B) and (C), respectively; and
(D)
in subparagraph (C), as so redesignated, 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 inserting 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;
(D)
$30,000 for fiscal year 2029; and
(E)
$0 for fiscal year 2030.
; and
(4)
by striking paragraph (4) and inserting the following:
(4)
One-time facility fee workload adjustment
(A)
In general
In addition to the adjustments under paragraphs (1), (2), and (3), the Secretary may further increase the fee revenues 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 adjustment
An adjustment under this paragraph 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 fiscal years exceeds 1,625; and
(III)
with respect to facilities described in subclause (II), the average number of such facilities (expressed as a percentage) that appeared on the arrears lists pursuant to subsection (e)(1)(A)(i) over the period of the preceding 3 fiscal years is less than 30 percent.
(ii)
Amount of adjustment
An adjustment under this paragraph for a fiscal 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).
(iii)
Excess facility percentage
The excess facility percentage described in this clause is—
(I)
the amount by which the average 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, facility 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—
(1)
in paragraph (2)(D)—
(A)
in the subparagraph heading, by striking
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 .
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 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 .
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.
(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.
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.
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.

Tracker

The tracker indicates the progress of this legislation as it moves through the legislative process.

  1. Introduced2025-07-15
  2. Passed Senate
  3. Passed House
  4. Conference
  5. To President
  6. Became Law

CRS Summary

The summaries are the Congressional Research Service’s, one per stage. Read them in full.

Reported to Senate Sep 8, 2025

sb2292/reported-to-senate.md

Shown Here:
Reported to Senate (09/08/2025)

Over-the-Counter Monograph Drug User Fee Amendments

This bill reauthorizes the Over-the-Counter (OTC) Monograph Drug User Fee Program (OMUFA); revises procedures used by the Food and Drug Administration (FDA) to evaluate topical, nonprescription drugs (e.g., sunscreens); and requires the FDA to clarify the process through which a prescription drug may be switched to nonprescription status.

Under current law, many OTC drugs are marketed through compliance with an OTC monograph issued by the FDA, rather than through an approved new drug application. Monographs establish the conditions under which OTC drugs are generally recognized as safe and effective. The bill reauthorizes the collection of OMUFA fees from OTC drug facilities through FY2030 and revises methods for calculating such fees.

Separately, the bill requires the FDA to allow for the use of real-world evidence to demonstrate the safety and effectiveness of active ingredients in topical, nonprescription drugs. The FDA must consider nonclinical tests and other alternatives to animal testing in evaluating such drugs.

The FDA must also issue guidance to clarify the application process for nonprescription drugs, including applications to switch a prescription drug to nonprescription status. The FDA must plan to engage stakeholders in identifying drugs that are promising candidates for a switch. Moreover, applicants seeking a switch may request to meet with the FDA to develop a plan for the requisite application.

Finally, the Government Accountability Office must report on (1) the OTC monograph drug supply chain, and (2) the FDA’s handling of applications to switch a prescription drug to nonprescription status.

Sponsors

Sen. Jim Banks (R) sponsors S. 2292, and 3 members have co-sponsored it, 1 of them from the day it was introduced.

Committees

S. 2292 went before 1 committee: Health, Education, Labor, and Pensions.

Health, Education, Labor, and Pensions
Health, Education, Labor, and Pensions
Reported By · Sep 8, 2025 · 747 Bills

Actions

S. 2292 has taken 5 actions since Jul 15, 2025, the latest on Sep 8, 2025.

ChamberAction
Sep 8, 2025
Senate
Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.Health, Education, Labor, and Pensions Committee
Sep 8, 2025
Senate
Placed on Senate Legislative Calendar under General Orders. Calendar No. 152.
Jul 30, 2025
Senate
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.Health, Education, Labor, and Pensions Committee
Jul 15, 2025
Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.Health, Education, Labor, and Pensions Committee
Jul 15, 2025
Introduced in Senate

Votes

S. 2292 has not gone to a roll call.

2 bills are related to S. 2292.

Titles

S. 2292 goes by 4 titles, 2 of them short titles.

  • Over-the-Counter Monograph Drug User Fee Amendments — Short Title(s) as Reported to Senate
  • Over-the-Counter Monograph Drug User Fee Amendments — Display Title
  • Over-the-Counter Monograph Drug User Fee Amendments — Short Title(s) as Introduced
  • 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. — Official Title as Introduced

Lobbying

8 clients hired 10 firms and 32 registered lobbyists who named S. 2292 in 22 quarterly filings, 2025 to 2026. Reported under the Lobbying Disclosure Act; a filing’s income covers everything its registrant worked that quarter, so the amounts below are the filings’, not this bill’s.

Filed under Health Issues, Budget/Appropriations, Taxation/Internal Revenue Code, Consumer Issues/Safety/Products, Medicare/Medicaid, Trade (domestic/foreign), Manufacturing, Pharmacy.

Clients

Who paid to be heard, by how many filings named the bill.

ClientBusinessStateFirmsFilingsReported
CONSUMER HEALTHCARE PRODUCTS ASSOCIATIONDistrict of Columbia14$858.8K
HALEON US HOLDINGS LLCConsumer health care companyNew Jersey24$100K
PERSONAL CARE PRODUCTS COUNCILCosmetic and personal care products industry trade association.District of Columbia24$60K
AMERICAN ACADEMY OF DERMATOLOGY ASSOCIATIONDistrict of Columbia14
CHATTEM, INC. DBA OPELLAManufacturer of consumer healthcare products.New Jersey13$190K
AMERICAN SOCIETY FOR DERMATOLOGIC SURGERY ASSOCIATIONIllinois11
CHATTEM, INC D/B/A OPELLAHealthcare related to nonprescription drugs and dietary supplements.New Jersey11
S.C. JOHNSON & SON, INC.District of Columbia11

Firms

Registrants who filed on the bill, by filings.

Lobbyists

Named on the filings that cite the bill. The 20 named most often, of 32.

Filings

The documents themselves, on the Senate’s Lobbying Disclosure site, largest reported first.

ClientRegistrantPeriodReportedDocument
AMERICAN ACADEMY OF DERMATOLOGY ASSOCIATIONAMERICAN ACADEMY OF DERMATOLOGY ASSOCIATION2025 third_quarter$1.1M3rd Quarter - Report
AMERICAN ACADEMY OF DERMATOLOGY ASSOCIATIONAMERICAN ACADEMY OF DERMATOLOGY ASSOCIATION2026 first_quarter$620K1st Quarter - Report
AMERICAN ACADEMY OF DERMATOLOGY ASSOCIATIONAMERICAN ACADEMY OF DERMATOLOGY ASSOCIATION2026 second_quarter$580K2nd Quarter - Report
AMERICAN ACADEMY OF DERMATOLOGY ASSOCIATIONAMERICAN ACADEMY OF DERMATOLOGY ASSOCIATION2025 fourth_quarter$450K4th Quarter - Report
CONSUMER HEALTHCARE PRODUCTS ASSOCIATIONCONSUMER HEALTHCARE PRODUCTS ASSOCIATION2025 third_quarter$254.1K3rd Quarter - Report
CONSUMER HEALTHCARE PRODUCTS ASSOCIATIONCONSUMER HEALTHCARE PRODUCTS ASSOCIATION2025 fourth_quarter$245.5K4th Quarter - Report
HALEON US HOLDINGS LLCHALEON US HOLDINGS LLC2025 third_quarter$220K3rd Quarter - Report
HALEON US HOLDINGS LLCHALEON US HOLDINGS LLC2025 fourth_quarter$210K4th Quarter - Report
CONSUMER HEALTHCARE PRODUCTS ASSOCIATIONCONSUMER HEALTHCARE PRODUCTS ASSOCIATION2026 second_quarter$199.8K2nd Quarter - Report
CHATTEM, INC D/B/A OPELLACHATTEM, INC D/B/A OPELLA2025 third_quarter$160K3rd Quarter - Report
CONSUMER HEALTHCARE PRODUCTS ASSOCIATIONCONSUMER HEALTHCARE PRODUCTS ASSOCIATION2026 first_quarter$159.4K1st Quarter - Report
PERSONAL CARE PRODUCTS COUNCILTHE PERSONAL CARE PRODUCTS COUNCIL2025 fourth_quarter$120K4th Quarter - Report
PERSONAL CARE PRODUCTS COUNCILTHE PERSONAL CARE PRODUCTS COUNCIL2025 third_quarter$110K3rd Quarter - Report
S.C. JOHNSON & SON, INC.S.C. JOHNSON & SON, INC.2025 fourth_quarter$79.4K4th Quarter - Report
CHATTEM, INC. DBA OPELLAAKIN GUMP STRAUSS HAUER & FELD2026 first_quarter$70K1st Quarter - Report
CHATTEM, INC. DBA OPELLAAKIN GUMP STRAUSS HAUER & FELD2025 fourth_quarter$60K4th Quarter - Report
CHATTEM, INC. DBA OPELLAAKIN GUMP STRAUSS HAUER & FELD2025 third_quarter$60K3rd Quarter - Report
HALEON US HOLDINGS LLCCROSSROADS STRATEGIES, LLC2025 fourth_quarter$50K4th Quarter - Report
HALEON US HOLDINGS LLCCROSSROADS STRATEGIES, LLC2025 third_quarter$50K3rd Quarter - Report
PERSONAL CARE PRODUCTS COUNCILMARSHALL & POPP, LLC2025 fourth_quarter$30K4th Quarter - Report

Classification

The Congressional Research Service files S. 2292 under Health, one of its 31 policy areas, and gives it 4 legislative subjects.

CRS Subjects

CRS assigns every bill one policy area from its 31; S. 2292’s is Health.

s2292/policy-areas.txt
HealthAgriculture and FoodAnimalsArmed Forces and National SecurityArts, Culture, ReligionCivil Rights and Liberties, Minority IssuesCommerceCongressCrime and Law EnforcementEconomics and Public FinanceEducationEmergency ManagementEnergyEnvironmental ProtectionFamiliesFinance and Financial SectorForeign Trade and International FinanceGovernment Operations and PoliticsHousing and Community DevelopmentImmigrationInternational AffairsLabor and EmploymentLawNative AmericansPublic Lands and Natural ResourcesScience, Technology, CommunicationsSocial WelfareSports and RecreationTaxationTransportation and Public WorksWater Resources Development

Legislative Subjects

S. 2292 carries 4 of CRS’s legislative subjects, from Congressional oversight to User charges and fees.

s2292/subjects.txt
Congressional oversightDrug safety, medical device, and laboratory regulationSupply chainUser charges and fees

Source: congress.gov · legiscan.com