119-hr4273

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4273 Reported in House

    (RH) ]

<DOC>

 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 
 Energy 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]

_______________________________________________________________________

 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 Representatives 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 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.

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
        (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.''.

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 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''.

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 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. REGULATION OF CERTAIN NONPRESCRIPTION DRUGS THAT ARE MARKETED 
 WITHOUT AN APPROVED DRUG APPLICATION.

    (a) Development Advice to Sponsors or Requestors.--

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, requestors, 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 Cosmetic Act (21 U.S.C. 355h

    (b)

    (2)
        (A)
            (iv) 
            (III) ) 
is amended by striking ``requestors'' and inserting ``sponsors or 
requestors''.

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 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. 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.
 Union Calendar No. 254

119th CONGRESS

 1st Session

 H. R. 4273

 [Report No. 119-300]

_______________________________________________________________________

 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.

_______________________________________________________________________

 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