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S. 2292
U.S. Senate•Senate 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.txt119 S2292 IS: Over-the-Counter Monograph Drug User Fee AmendmentsU.S. Senate2025-07-15text/xmlENPursuant 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 BILLTo 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 titleThis Act may be cited as the Over-the-Counter Monograph Drug User Fee Amendments .2.FindingCongress 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.DefinitionsSection 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 feesSection 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 feesEach person; and(C)by adding at the end the following:(ii)Applicable periodFor 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 2026For 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 2027For 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 yearsFor 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 amountsSection 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 generalFor 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 revenueFor 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 settingSection 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 generalIn 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 adjustmentAn 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 adjustmentAn 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 percentageThe 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 settingThe 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 feesSection 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 strikingin 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 requirementsSection 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)AuthorizationSections 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 requirementsSection 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 dateThe 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 clauseNotwithstanding 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.
- Introduced2025-07-15
- Passed Senate
- Passed House
- Conference
- To President
- 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.mdShown 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.

Actions
S. 2292 has taken 5 actions since Jul 15, 2025, the latest on Sep 8, 2025.
| Chamber | Action | |||
|---|---|---|---|---|
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.
Related bills
2 bills are related to S. 2292.
HR 4273Over-the-Counter Monograph Drug User Fee AmendmentsSep 17, 2025 · Placed on the Union Calendar, Calendar No. 254. · Related bill
S 2529A bill to increase the clarity and predictability of the process for developing applications for Rx-to-nonprescription switches.Jul 30, 2025 · Read twice and referred to the Committee on Health, Education, Labor, and Pensi… · Related billTitles
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.
| Client | Business | State | Firms | Filings | Reported |
|---|---|---|---|---|---|
| CONSUMER HEALTHCARE PRODUCTS ASSOCIATION | — | District of Columbia | 1 | 4 | $858.8K |
| HALEON US HOLDINGS LLC | Consumer health care company | New Jersey | 2 | 4 | $100K |
| PERSONAL CARE PRODUCTS COUNCIL | Cosmetic and personal care products industry trade association. | District of Columbia | 2 | 4 | $60K |
| AMERICAN ACADEMY OF DERMATOLOGY ASSOCIATION | — | District of Columbia | 1 | 4 | — |
| CHATTEM, INC. DBA OPELLA | Manufacturer of consumer healthcare products. | New Jersey | 1 | 3 | $190K |
| AMERICAN SOCIETY FOR DERMATOLOGIC SURGERY ASSOCIATION | — | Illinois | 1 | 1 | — |
| CHATTEM, INC D/B/A OPELLA | Healthcare related to nonprescription drugs and dietary supplements. | New Jersey | 1 | 1 | — |
| S.C. JOHNSON & SON, INC. | — | District of Columbia | 1 | 1 | — |
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.
| Lobbyist | Firms | Clients | Filings |
|---|---|---|---|
| CHRISTINE O'CONNOR | 1 | 1 | 4 |
| DAVID SPANGLER | 1 | 1 | 4 |
| JENNIFER MANGONE | 1 | 1 | 4 |
| JOLIE BROCHIN | 1 | 1 | 4 |
| KARRY VIOLETTE | 1 | 1 | 4 |
| MARC SCHLOSS | 1 | 1 | 4 |
| NICHOLAS BEEK | 1 | 1 | 4 |
| PHILLIP HARBISON | 1 | 1 | 4 |
| ANNA ABRAM | 1 | 1 | 3 |
| BRIAN POMPER | 1 | 1 | 2 |
| BRITTANY HERNANDEZ | 1 | 1 | 2 |
| CHERYL JAEGER | 1 | 1 | 2 |
| GENEVIEVE STRAND | 1 | 1 | 2 |
| HAILEY RAY | 1 | 1 | 2 |
| HAZEN MARSHALL | 1 | 1 | 2 |
| JASON VAN PELT | 1 | 1 | 2 |
| JONATHAN MARTINEZ | 1 | 1 | 2 |
| KANDIS MCCLURE | 1 | 1 | 2 |
| KARIN ROSS | 1 | 1 | 2 |
| LUCIA PANZA | 1 | 1 | 2 |
Filings
The documents themselves, on the Senate’s Lobbying Disclosure site, largest reported first.
| Client | Registrant | Period | Reported | Document |
|---|---|---|---|---|
| AMERICAN ACADEMY OF DERMATOLOGY ASSOCIATION | AMERICAN ACADEMY OF DERMATOLOGY ASSOCIATION | 2025 third_quarter | $1.1M | 3rd Quarter - Report |
| AMERICAN ACADEMY OF DERMATOLOGY ASSOCIATION | AMERICAN ACADEMY OF DERMATOLOGY ASSOCIATION | 2026 first_quarter | $620K | 1st Quarter - Report |
| AMERICAN ACADEMY OF DERMATOLOGY ASSOCIATION | AMERICAN ACADEMY OF DERMATOLOGY ASSOCIATION | 2026 second_quarter | $580K | 2nd Quarter - Report |
| AMERICAN ACADEMY OF DERMATOLOGY ASSOCIATION | AMERICAN ACADEMY OF DERMATOLOGY ASSOCIATION | 2025 fourth_quarter | $450K | 4th Quarter - Report |
| CONSUMER HEALTHCARE PRODUCTS ASSOCIATION | CONSUMER HEALTHCARE PRODUCTS ASSOCIATION | 2025 third_quarter | $254.1K | 3rd Quarter - Report |
| CONSUMER HEALTHCARE PRODUCTS ASSOCIATION | CONSUMER HEALTHCARE PRODUCTS ASSOCIATION | 2025 fourth_quarter | $245.5K | 4th Quarter - Report |
| HALEON US HOLDINGS LLC | HALEON US HOLDINGS LLC | 2025 third_quarter | $220K | 3rd Quarter - Report |
| HALEON US HOLDINGS LLC | HALEON US HOLDINGS LLC | 2025 fourth_quarter | $210K | 4th Quarter - Report |
| CONSUMER HEALTHCARE PRODUCTS ASSOCIATION | CONSUMER HEALTHCARE PRODUCTS ASSOCIATION | 2026 second_quarter | $199.8K | 2nd Quarter - Report |
| CHATTEM, INC D/B/A OPELLA | CHATTEM, INC D/B/A OPELLA | 2025 third_quarter | $160K | 3rd Quarter - Report |
| CONSUMER HEALTHCARE PRODUCTS ASSOCIATION | CONSUMER HEALTHCARE PRODUCTS ASSOCIATION | 2026 first_quarter | $159.4K | 1st Quarter - Report |
| PERSONAL CARE PRODUCTS COUNCIL | THE PERSONAL CARE PRODUCTS COUNCIL | 2025 fourth_quarter | $120K | 4th Quarter - Report |
| PERSONAL CARE PRODUCTS COUNCIL | THE PERSONAL CARE PRODUCTS COUNCIL | 2025 third_quarter | $110K | 3rd Quarter - Report |
| S.C. JOHNSON & SON, INC. | S.C. JOHNSON & SON, INC. | 2025 fourth_quarter | $79.4K | 4th Quarter - Report |
| CHATTEM, INC. DBA OPELLA | AKIN GUMP STRAUSS HAUER & FELD | 2026 first_quarter | $70K | 1st Quarter - Report |
| CHATTEM, INC. DBA OPELLA | AKIN GUMP STRAUSS HAUER & FELD | 2025 fourth_quarter | $60K | 4th Quarter - Report |
| CHATTEM, INC. DBA OPELLA | AKIN GUMP STRAUSS HAUER & FELD | 2025 third_quarter | $60K | 3rd Quarter - Report |
| HALEON US HOLDINGS LLC | CROSSROADS STRATEGIES, LLC | 2025 fourth_quarter | $50K | 4th Quarter - Report |
| HALEON US HOLDINGS LLC | CROSSROADS STRATEGIES, LLC | 2025 third_quarter | $50K | 3rd Quarter - Report |
| PERSONAL CARE PRODUCTS COUNCIL | MARSHALL & POPP, LLC | 2025 fourth_quarter | $30K | 4th 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.txtLegislative Subjects
S. 2292 carries 4 of CRS’s legislative subjects, from Congressional oversight to User charges and fees.
s2292/subjects.txtSource: congress.gov · legiscan.com