119-s2292

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 2292 Reported in Senate

    (RS) ]

<DOC>

 Calendar No. 152
119th CONGRESS
 1st Session
 S. 2292

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 SENATE OF THE UNITED STATES

 July 15, 2025

Mr. Banks (for himself, Mr. Kaine, Mr. Kim, and Mr. Husted) introduced 
the following bill; which was read twice and referred to the Committee 
 on Health, Education, Labor, and Pensions

 September 8, 2025

 Reported by Mr. Cassidy, with an amendment
 [Strike out all after the enacting clause and insert the part printed 
 in italic]

_______________________________________________________________________

 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,

<DELETED>

SECTION 1. SHORT TITLE.</DELETED>

<DELETED> This Act may be cited as the ``Over-the-Counter Monograph 
Drug User Fee Amendments''.</DELETED>

<DELETED>

SEC. 2. FINDING.</DELETED>

<DELETED> 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.</DELETED>

<DELETED>

SEC. 3. DEFINITIONS.</DELETED>

<DELETED> 

Section 744L

    (9)
        (A) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j-71

    (9)
        (A) ) is amended--</DELETED>
 <DELETED>

    (1) in clause
            (v) , by striking ``; or'' and 
 inserting a semicolon;</DELETED>
 <DELETED>

    (2) in clause
            (vi) --</DELETED>
 <DELETED>
        (A) by striking ``addition'' and inserting 
 ``the addition''; and</DELETED>
 <DELETED>
        (B) by striking the period and inserting 
 ``; or''; and</DELETED>
 <DELETED>

    (3) by adding at the end the following:</DELETED>
 <DELETED> ``
            (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--</DELETED>
 <DELETED> ``
            (I) established by a national or 
 international standards development 
 organization; and</DELETED>
 <DELETED> ``
            (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.''.</DELETED>

<DELETED>

SEC. 4. AUTHORITY TO ASSESS AND USE OTC MONOGRAPH 
 FEES.</DELETED>

<DELETED>

    (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--
</DELETED>
 <DELETED>

    (1) in subparagraph
        (A) --</DELETED>
 <DELETED>
        (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'';</DELETED>
 <DELETED>
        (B) by striking ``Each person'' and 
 inserting the following:</DELETED>
 <DELETED> ``
            (i) Assessment of fees.--Each 
 person''; and</DELETED>
 <DELETED>
            (C) by adding at the end the 
 following:</DELETED>
 <DELETED> ``
            (ii) Applicable period.--For 
 purposes of clause
            (i) , the applicable period 
 is--</DELETED>
 <DELETED> ``
            (I) for fiscal year 
 2026, the 12-month period ending on 
 December 31, 2025;</DELETED>
 <DELETED> ``
            (II) for fiscal year 
 2027, the 9-month period ending on 
 September 30, 2026; and</DELETED>
 <DELETED> ``
            (III) for fiscal year 
 2028 and each subsequent fiscal year, 
 the 12-month period ending on September 
 30 of the preceding fiscal 
 year.'';</DELETED>
 <DELETED>

    (2) in subparagraph
        (B)
            (i) , by amending subclause
            (I) to read as follows:</DELETED>
 <DELETED> ``
            (I) has ceased all 
 activities related to OTC monograph 
 drugs prior to--</DELETED>
 <DELETED> ``

    (aa) for 
 purposes of fiscal year 2026, 
 January 1, 2025;</DELETED>
 <DELETED> ``

    (bb) for 
 purposes of fiscal year 2027, 
 January 1, 2026; and</DELETED>
 <DELETED> ``
            (cc) for 
 purposes of fiscal year 2028 
 and each subsequent fiscal 
 year, October 1 of the 
 preceding fiscal year; and''; 
 and</DELETED>
 <DELETED>

    (3) by amending subparagraph
            (D) to read as 
 follows:</DELETED>
 <DELETED> ``
            (D) Due date.--</DELETED>
 <DELETED> ``
            (i) Fiscal year 2026.--For 
 fiscal year 2026, the facility fees required 
 under subparagraph
        (A) shall be due on the 
 later of--</DELETED>
 <DELETED> ``
            (I) the first business 
 day of June of such year; or</DELETED>
 <DELETED> ``
            (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.</DELETED>
 <DELETED> ``
            (ii) Fiscal year 2027.--For 
 fiscal year 2027, the facility fees required 
 under subparagraph
        (A) shall be due--</DELETED>
 <DELETED> ``
            (I) in a first 
 installment representing 50 percent of 
 such fee, on the later of--</DELETED>
 <DELETED> ``

    (aa) October 1, 
 2026; or</DELETED>
 <DELETED> ``

    (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</DELETED>
 <DELETED> ``
            (II) in a second 
 installment representing the remaining 
 50 percent of such fee, on--</DELETED>
 <DELETED> ``

    (aa) February 1, 
 2027; or</DELETED>
 <DELETED> ``

    (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.</DELETED>
 <DELETED> ``
            (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--
 </DELETED>
 <DELETED> ``
            (I) the first business 
 day on or after October 1 of the fiscal 
 year; or</DELETED>
 <DELETED> ``
            (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.''.</DELETED>
<DELETED>

    (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:</DELETED>
<DELETED> ``

    (b) Fee Revenue Amounts.--</DELETED>
 <DELETED> ``

    (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--</DELETED>
 <DELETED> ``
        (A) the annual base revenue for the 
 fiscal year (as determined under paragraph

    (2) );</DELETED>
 <DELETED> ``
        (B) the dollar amount equal to the 
 inflation adjustment for the fiscal year (as determined 
 under subsection
            (c) (1) );</DELETED>
 <DELETED> ``
            (C) the dollar amount equal to the 
 operating reserve adjustment for the fiscal year, if 
 applicable (as determined under subsection
            (c) (2) );</DELETED>
 <DELETED> ``
            (D) additional direct cost adjustments 
 (as determined under subsection
            (c) (3) );</DELETED>
 <DELETED> ``
        (E) an additional dollar amount equal 
 to--</DELETED>
 <DELETED> ``
            (i) $2,373,000 for fiscal year 
 2026;</DELETED>
 <DELETED> ``
            (ii) $1,233,000 for fiscal year 
 2027; and</DELETED>
 <DELETED> ``
            (iii) $854,000 for fiscal year 
 2028; and</DELETED>
 <DELETED> ``
        (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.</DELETED>
 <DELETED> ``

    (2) Annual base revenue.--For purposes of 
 paragraph

    (1) , the dollar amount of the annual base revenue for 
 a fiscal year shall be--</DELETED>
 <DELETED> ``
        (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</DELETED>
 <DELETED> ``
        (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) .''.</DELETED>
<DELETED>
            (c) Adjustments; Annual Fee Setting.--

Section 744M
            (c) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-72) is 
amended--</DELETED>
 <DELETED>

    (1) in paragraph

    (1) --</DELETED>
 <DELETED>
        (A) in subparagraph
        (A) , in the matter 
 preceding clause
            (i) --</DELETED>
 <DELETED>
            (i) by striking ``subsection

    (b)

    (2)
        (B) '' and inserting ``subsection

    (b)

    (1)
        (B) ''; and</DELETED>
 <DELETED>
            (ii) by striking ``fiscal year 
 2022 and each subsequent fiscal year'' and 
 inserting ``each fiscal year'';</DELETED>
 <DELETED>
        (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--
 </DELETED>
 <DELETED> ``
            (i) for fiscal year 2026--
 </DELETED>
 <DELETED> ``
            (I) the fee for fiscal 
 year 2025 under subsection

    (a)

    (2) ; 
 and</DELETED>
 <DELETED> ``
            (II) the inflation 
 adjustment percentage under 
 subparagraph
            (C) ; and</DELETED>
 <DELETED> ``
            (ii) for each of fiscal years 
 2027 through 2030--</DELETED>
 <DELETED> ``
            (I) the applicable fee 
 under subsection

    (a)

    (2) for the 
 preceding fiscal year; and</DELETED>
 <DELETED> ``
            (II) the inflation 
 adjustment percentage under 
 subparagraph
            (C) .''; and</DELETED>
 <DELETED>
            (C) in subparagraph
            (C) --</DELETED>
 <DELETED>
            (i) in the matter preceding clause
            (i) , by inserting ``the sum of'' after ``is 
 equal to'';</DELETED>
 <DELETED>
            (ii) by striking clause
            (i) ;</DELETED>
 <DELETED>
            (iii) by redesignating subclauses
            (I) and
            (II) of clause
            (ii) as clauses
            (i) and
            (ii) , respectively, and adjusting the margins 
 accordingly;</DELETED>
 <DELETED>
            (iv) by striking ``
            (ii) for each 
 of fiscal years 2024 and 2025, the sum of--''; 
 and</DELETED>
 <DELETED>
            (v) in clause
            (ii) , as so 
 redesignated, by striking ``Washington-
 Baltimore, DC-MD-VA-WV'' and inserting 
 ``Washington-Arlington-Alexandria-DC-VA-MD-
 WV'';</DELETED>
 <DELETED>

    (2) in paragraph

    (2) --</DELETED>
 <DELETED>
        (A) in subparagraph
        (A) --</DELETED>
 <DELETED>
            (i) by striking ``fiscal year 2021 
 and subsequent fiscal years'' and inserting 
 ``each fiscal year'';</DELETED>
 <DELETED>
            (ii) by striking ``subsections

    (b)

    (1)
        (B) and

    (b)

    (2)
            (C) '' and inserting 
 ``subsection

    (b)

    (1)
            (C) ''; and</DELETED>
 <DELETED>
            (iii) by striking ``the number of 
 weeks specified in subparagraph
        (B) '' and 
 inserting ``10 weeks'';</DELETED>
 <DELETED>
        (B) by striking subparagraph
        (B) ;</DELETED>
 <DELETED>
            (C) by redesignating subparagraphs
            (C) and
            (D) as subparagraphs
        (B) and
            (C) , respectively; 
 and</DELETED>
 <DELETED>
            (D) in subparagraph
            (C) , as so 
 redesignated, by striking ``paragraph

    (4) establishing'' and inserting ``paragraph

    (5) publishing'';</DELETED>
 <DELETED>

    (3) in paragraph

    (3) --</DELETED>
 <DELETED>
        (A) in the matter preceding subparagraph
        (A) , by striking ``subsection

    (b)

    (2)
            (D) '' and inserting 
 ``subsection

    (b)

    (1)
            (D) ''; and</DELETED>
 <DELETED>
        (B) by striking subparagraphs
        (A) through
        (E) and inserting the following:</DELETED>
 <DELETED> ``
        (A) $135,000 for fiscal year 
 2026;</DELETED>
 <DELETED> ``
        (B) $300,000 for fiscal year 
 2027;</DELETED>
 <DELETED> ``
            (C) $55,000 for fiscal year 
 2028;</DELETED>
 <DELETED> ``
            (D) $30,000 for fiscal year 2029; 
 and</DELETED>
 <DELETED> ``
        (E) $0 for fiscal year 2030.''; 
 and</DELETED>
 <DELETED>

    (4) by striking paragraph

    (4) and inserting the 
 following:</DELETED>
 <DELETED> ``

    (4) One-time facility fee workload adjustment.--
 </DELETED>
 <DELETED> ``
        (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.</DELETED>
 <DELETED> ``
        (B) Adjustment described.--</DELETED>
 <DELETED> ``
            (i) Conditions for adjustment.--
 An adjustment under this paragraph may be made 
 for a fiscal year only if--</DELETED>
 <DELETED> ``
            (I) an adjustment under 
 this paragraph had not been made for 
 any prior fiscal year;</DELETED>
 <DELETED> ``
            (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</DELETED>
 <DELETED> ``
            (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.</DELETED>
 <DELETED> ``
            (ii) Amount of adjustment.--An 
 adjustment under this paragraph for a fiscal 
 year shall equal the product of--</DELETED>
 <DELETED> ``
            (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</DELETED>
 <DELETED> ``
            (II) the excess facility 
 percentage described in clause
            (iii) .</DELETED>
 <DELETED> ``
            (iii) Excess facility 
 percentage.--The excess facility percentage 
 described in this clause is--</DELETED>
 <DELETED> ``
            (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</DELETED>
 <DELETED> ``
            (II) 1,625.</DELETED>
 <DELETED> ``

    (5) Annual fee setting.--The Secretary shall, 
 not later than 60 days before the first day of each fiscal 
 year--</DELETED>
 <DELETED> ``
        (A) establish for such fiscal year, 
 based on the revenue amounts under subsection

    (b) and 
 the adjustments provided under this subsection--
 </DELETED>
 <DELETED> ``
            (i) OTC monograph drug facility 
 fees under subsection

    (a)

    (1) ; and</DELETED>
 <DELETED> ``
            (ii) OTC monograph order request 
 fees under subsection

    (a)

    (2) ; and</DELETED>
 <DELETED> ``
        (B) publish such fee revenue amounts, 
 facility fees, and OTC monograph order request fees in 
 the Federal Register.''.</DELETED>
<DELETED>
            (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--</DELETED>
 <DELETED>

    (1) in paragraph

    (2)
            (D) --</DELETED>
 <DELETED>
        (A) in the subparagraph heading, by 
 striking ``in subsequent years''; and</DELETED>
 <DELETED>
        (B) by striking ``(after fiscal year 
 2021)''; and</DELETED>
 <DELETED>

    (2) in paragraph

    (3) , by striking ``2021 through 
 2025'' and inserting ``2026 through 2030''.</DELETED>

<DELETED>

SEC. 5. REAUTHORIZATION; REPORTING REQUIREMENTS.</DELETED>

<DELETED> 

Section 744N of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379j-73) is amended--</DELETED>
 <DELETED>

    (1) in subsection

    (a) --</DELETED>
 <DELETED>
        (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</DELETED>
 <DELETED>
        (B) by striking ``

section 3861

    (b) of the 
 CARES Act'' and inserting ``

section 2 of the Over-the-
 Counter Monograph Drug User Fee Amendments'';</DELETED>
 <DELETED>

    (2) in subsection

    (b) , by striking ``fiscal year 
 2021 and each subsequent fiscal year'' and inserting ``each 
 fiscal year''; and</DELETED>
 <DELETED>

    (3) in subsection
            (d) , by striking ``2025'' each 
 place it appears and inserting ``2030''.</DELETED>

<DELETED>

SEC. 6. SUNSET DATES.</DELETED>

<DELETED>

    (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.</DELETED>
<DELETED>

    (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.</DELETED>

<DELETED>

SEC. 7. EFFECTIVE DATE.</DELETED>

<DELETED> 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.</DELETED>

<DELETED>

SEC. 8. SAVINGS CLAUSE.</DELETED>

<DELETED> 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.</DELETED>

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.

    (a) Performance Report.--

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 the 
 following:
 ``

    (1) In general.--Not later than 120 calendar days after 
 the end of each fiscal year'';
        (B) by striking ``

section 3861

    (b) of the CARES 
 Act'' and inserting ``

section 2 of the Over-the-Counter 
 Monograph Drug User Fee Amendments''; and
            (C) by adding at the end the following:
 ``

    (2) Additional information.--Beginning with fiscal year 
 2026, the annual report under this subsection shall include--
 ``
        (A) the progress of the Food and Drug 
 Administration in achieving the goals, and future plans 
 for meeting the goals, including--
 ``
            (i) the number of Tier 1 OTC monograph 
 order requests for which a proposed order was 
 issued, and the number of such requests for 
 which a final order was issued, in the previous 
 fiscal year;
 ``
            (ii) the number of Tier 2 OTC monograph 
 order requests for which a proposed order was 
 issued, and the number of such requests for 
 which a final order was issued, in the previous 
 fiscal year;
 ``
            (iii) the number of specified safety OTC 
 monograph order requests for which a proposed 
 order was issued, and the number of such 
 requests for which a final order was issued, in 
 the previous fiscal year;
 ``
            (iv) the number of generally recognized 
 as safe and effective finalization OTC 
 monograph order requests for which a proposed 
 order was issued, and the number of such 
 requests for which a final order was issued, in 
 the previous fiscal year;
 ``
            (v) the average timeline for processing 
 OTC monograph order requests, in the aggregate 
 and by submission type, in the previous fiscal 
 year; and
 ``
            (vi) postmarket safety activities with 
 respect to OTC monograph drugs, including--
 ``
            (I) collecting, developing, and 
 reviewing safety information on OTC 
 monograph drugs, including adverse 
 event reports;
 ``
            (II) developing and using 
 improved analytical tools, adverse 
 event data-collection systems, 
 including information technology 
 systems, to assess potential safety 
 problems, including access to external 
 databases; and
 ``
            (III) activities under 

section 760;
 ``
        (B) information regarding registration of OTC 
 monograph drug facilities and contract manufacturing 
 organization facilities and payment of registration 
 fees by such facilities, including--
 ``
            (i) the OTC monograph drug facilities and 
 contract manufacturing organization facilities 
 that were first registered under 

section 510
            (c) or 510
            (i) in the fiscal year; and
 ``
            (ii) for each OTC monograph drug facility 
 and contract manufacturing organization 
 facility that was assessed a facility fee under 
 

section 744M

    (a) in the fiscal year, whether the 
 facility paid such fee;
 ``
            (C) the status of implementation of evidence and 
 testing standards for nonprescription drugs intended 
 for topical administration, including--
 ``
            (i) the application of evidence or 
 testing standards; and
 ``
            (ii) the number of active ingredient 
 requests for nonprescription drugs intended for 
 topical administration reviewed using the 
 standards under 

section 505G

    (b) ; and
 ``
            (D) the progress of the Food and Drug 
 Administration in allowing nonclinical testing 
 alternatives to animal testing for the consideration of 
 sunscreen active ingredients.
 ``

    (3) Confidentiality.--Nothing in paragraph

    (2) shall be 
 construed to authorize the disclosure of information that is 
 prohibited from disclosure under 

section 301

    (j) of this Act or 
 

section 1905 of title 18, United States Code, or that is 
 subject to withholding under 

section 552

    (b)

    (4) of title 5, 
 United States Code.'';

    (2) in subsection

    (b) , by striking ``fiscal year 2021 and 
 each subsequent fiscal year'' and inserting ``each fiscal 
 year''; and

    (3) in subsection
            (d) --
        (A) by striking ``2025'' each place it appears and 
 inserting ``2030''; and
        (B) by adding at the end the following:
 ``

    (4) Minutes of negotiation meetings.--
 ``
        (A) Public availability.--The Secretary shall 
 make publicly available, on the public website of the 
 Food and Drug Administration, robust written minutes of 
 all negotiation meetings conducted under this 
 subsection between the Food and Drug Administration and 
 the regulated industry, not later than 30 days after 
 each such negotiation meeting.
 ``
        (B) Content.--The robust written minutes 
 described under subparagraph
        (A) shall contain, in 
 detail, any substantive proposal made by any party to 
 the negotiations as well as significant controversies 
 or differences of opinion during the negotiations and 
 their resolution.''.

    (b) GAO Report.--

    (1) In general.--Not later than September 30, 2027, the 
 Comptroller General of the United States shall submit to the 
 Committee on Health, Education, Labor, and Pensions of the 
 Senate and the Committee on Energy and Commerce of the House of 
 Representatives a report assessing the supply chain of over-
 the-counter monograph drugs.

    (2) Contents.--The report required under paragraph

    (1) shall include an assessment of--
        (A) the overall stability of the supply chain of 
 over-the-counter monograph drugs;
        (B) what information is collected by the Food and 
 Drug Administration with respect to the supply chain of 
 over-the-counter monograph drugs;
            (C) how the Food and Drug Administration uses 
 information collected on the supply chain of over-the-
 counter monograph drugs to inform regulatory decisions;
            (D) how the Food and Drug Administration 
 coordinates with other Federal agencies to monitor and 
 mitigate disruptions to the supply chain of over-the-
 counter monograph drugs; and
        (E) the unique characteristics of the over-the-
 counter monograph drug marketplace and what additional 
 authorities or information the Food and Drug 
 Administration may need to ensure the stability of the 
 supply chain of over-the-counter monograph drugs.

SEC. 6. TREATMENT OF ACTIVE INGREDIENTS FOR TOPICAL ADMINISTRATION.

    (a) In General.--

Section 505G of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355h) is amended by adding at the end the 
following:
 ``

    (r) Evidence and Testing Standards for Active Ingredients for 
Topical Administration.--
 ``

    (1) Evidence and testing standards for active ingredients 
 for topical administration.--The Secretary shall--
 ``
        (A) in evaluating the generally recognized as 
 safe and effective status of active ingredients used in 
 nonprescription drugs intended for topical 
 administration for purposes of subsection

    (a) , utilize 
 standards that allow for the use of real world evidence 
 (as defined in 

section 505F

    (b) ), as appropriate, as 
 part of a comprehensive evaluation of scientific 
 evidence to demonstrate the safety and effectiveness of 
 such active ingredients, to supplement evidence from 
 traditional clinical trials, provided that such 
 standards allow the Secretary to evaluate whether the 
 benefits of such active ingredients outweigh the risks; 
 and
 ``
        (B) apply subsection

    (b)

    (6)
            (C) to the regulation 
 of active ingredients used in drugs intended for 
 topical administration.
 ``

    (2) Non-animal testing methods for topical active 
 ingredients.--
 ``
        (A) In general.--The Secretary shall consider the 
 types of nonclinical tests described in paragraphs

    (1) through

    (4) of the first subsection

    (z) of 

section 505 
 (as inserted by 

section 3209

    (a)

    (2) of the Health 
 Extenders, Improving Access to Medicare, Medicaid, and 
 CHIP, and Strengthening Public Health Act of 2022 
 (division FF of Public Law 117-328)), or any other 
 alternative to animal testing that the Secretary 
 determines appropriate, in the consideration of drugs 
 intended for topical administration under this section.
 ``
        (B) Guidance.--Not later than 1 year after the 
 date of enactment of this subsection, the Secretary 
 shall issue new draft guidance on how sponsors can use 
 nonclinical testing alternatives to animal testing, as 
 appropriate, to meet safety and efficacy standards 
 under this section for drugs intended for topical 
 administration.
 ``

    (3) Clarification.--Nothing in this subsection shall be 
 construed to alter, supersede, or limit the standards for 
 making determinations of whether a drug is generally recognized 
 as safe and effective under 

section 201

    (p) or the standards set 
 forth under 

section 505 for determining the safety and 
 effectiveness of drugs.''.

    (b) Sunscreen Final Administrative Order.--A final administrative 
order on nonprescription sunscreen active ingredients issued under 

section 3854 of the Coronavirus Aid, Relief, and Economic Security Act 
(Public Law 116-136; 21 U.S.C. 360fff-3 note) shall--

    (1) account for historical data regarding the safety of 
 sunscreen active ingredients that have previously been accepted 
 for marketing in the United States;

    (2) account for the role of broad spectrum sunscreens with 
 a Sun Protection Factor of 15 or higher in effective skin 
 cancer prevention; and

    (3) incorporate the evidence and testing standards for 
 sunscreen active ingredients detailed in 

section 505G

    (r) of the 
 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355h) (as added 
 by subsection

    (a) ).

SEC. 7. INCREASING THE CLARITY AND PREDICTABILITY OF THE PROCESS FOR 
 DEVELOPING APPLICATIONS FOR RX-TO-NONPRESCRIPTION 
 SWITCHES.

    (a) In General.--

Section 505

    (b) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355

    (b) ) is amended by adding at the end the 
following:
 ``

    (7) Rx-to-nonprescription switches.--
 ``
        (A) Meetings.--Any person planning to submit an 
 application for an Rx-to-nonprescription switch may 
 submit to the Secretary a written request for a 
 meeting, for purposes of developing a plan for such 
 application that addresses the potential risks to 
 public health of such switch and the evidence necessary 
 to support such application, including the design of 
 any necessary studies, and the format and content of 
 the planned application. The Secretary may grant such a 
 meeting, as appropriate, consistent with established 
 procedures for granting meetings with, and providing 
 written responses to, sponsors of applications under 
 this section. Each such meeting shall be documented in 
 meeting minutes.
 ``
        (B) Guidance.--
 ``
            (i) In general.--Not later than 18 months 
 after the date of enactment of this paragraph, 
 the Secretary shall issue guidance to increase 
 the clarity and predictability of the process 
 and standards for approval of applications for 
 nonprescription drugs under this section, 
 including in the case of applications for an 
 Rx-to-nonprescription switch, especially with 
 respect to prescription drugs with well-
 established safety profiles for which an 
 applicant may seek approval for nonprescription 
 use.
 ``
            (ii) Contents.--The guidance under clause
            (i) shall--
 ``
            (I) describe how published 
 reports in medical literature, any 
 previous finding of safety or 
 effectiveness for the drug under this 
 section, the results of significant 
 human experience with the drug, 
 unpublished studies and other data, and 
 other sources of information may be 
 used to support an application for a 
 nonprescription drug, including in the 
 context of an application for an Rx-to-
 nonprescription switch;
 ``
            (II) set forth procedures for 
 sponsors to request meetings described 
 in subparagraph
        (A) and document the 
 recommendations made in such meetings;
 ``
            (III) describe evidentiary 
 expectations to support approval of an 
 application for a nonprescription drug, 
 including in the context of an 
 application for an Rx-to-
 nonprescription switch, including how 
 sponsors can demonstrate that consumers 
 can appropriately self-select and use 
 the drug and comprehend the 
 nonprescription drug label; and
 ``
            (IV) provide recommendations for 
 how mechanisms, in addition to the 
 required Drug Facts Label, such as 
 mobile applications and decision aids, 
 can be incorporated into the 
 information submitted in support of an 
 application for an Rx-to-
 nonprescription switch.
 ``
            (C) Plan to engage with stakeholders.--Not later 
 than 1 year after the date of enactment of this 
 paragraph, the Secretary shall develop and make 
 publicly available on the website of the Food and Drug 
 Administration a plan to engage stakeholders on steps 
 and factors for application holders and other 
 stakeholders to consider in identifying approved 
 prescription drugs that may be promising candidates for 
 applications for an Rx-to-nonprescription switch.
 ``
            (D) === Definition. ===
-The term `Rx-to-nonprescription 
 switch' means the approval of an application, or 
 supplemental application, as applicable, submitted 
 under this section by the holder of an approved 
 application for a prescription drug seeking approval to 
 market such drug as a nonprescription drug, including 
 for--
 ``
            (i) a full Rx-to-nonprescription switch, 
 under which a drug previously approved for 
 prescription use only is--
 ``
            (I) approved for nonprescription 
 use under the same conditions of use as 
 applied to the drug when approved for 
 prescription use; or
 ``
            (II) approved for nonprescription 
 use subject to one or more additional 
 conditions for nonprescription use; and
 ``
            (ii) a partial Rx-to-nonprescription 
 switch, under which the drug is approved for 
 nonprescription use only under certain 
 conditions of use described in the approved 
 labeling, while the drug otherwise remains 
 approved for prescription use only.
 ``
        (E) Rule of construction.--Nothing in this 
 paragraph shall be construed to--
 ``
            (i) supersede or modify the authority of 
 the Secretary under 

section 505G with respect 
 to the regulation of OTC monograph drugs; or
 ``
            (ii) authorize the disclosure by the 
 Secretary of confidential commercial 
 information or trade secrets.''.

    (b) GAO Report.--

    (1) In general.--Not later than 1 year after the date of 
 enactment of this Act, the Comptroller General of the United 
 States shall submit to the Committee on Health, Education, 
 Labor, and Pensions of the Senate and the Committee on Energy 
 and Commerce of the House of Representatives a report that 
 evaluates--
        (A) the number of applications for an Rx-to-
 nonprescription switch approved during the period 
 beginning on October 1, 2022, and ending on the date of 
 the report;
        (B) the number of drugs for which an application 
 for an Rx-to-nonprescription switch was approved during 
 such period subject to an additional condition for 
 nonprescription use;
            (C) among the drugs for which an application for a 
 full or partial Rx-to-nonprescription switch was 
 approved during such period, the average length of time 
 from receipt by the Food and Drug Administration of the 
 application to the approval of such application;
            (D) the number of partial Rx-to-nonprescription 
 switch applications approved during such period, and 
 the number of applications for such a partial switch 
 was not approved;
        (E) any barriers to timely and predictable review 
 of applications for an Rx-to-nonprescription switch;
        (F) engagement by the Food and Drug Administration 
 with public stakeholders, including public meetings or 
 additional activities, to support review of 
 applications for an Rx-to-nonprescription switch; and
        (G) opportunities for collaboration between the 
 Center for Drug Evaluation and Research and the Centers 
 for Medicare & Medicaid Services for the purpose of 
 analyzing health insurance claims data for commonly 
 prescribed drugs that appear to be suitable for an Rx-
 to-nonprescription switch.

    (2) === Definition. ===
-In this subsection, the term ``Rx-to-
 nonprescription switch'' has the meaning given such term in 
 paragraph

    (7) of 

section 505

    (b) of the Federal Food, Drug, and 
 Cosmetic Act (21 U.S.C. 244

    (b) ), as added by subsection

    (a) .

SEC. 8. 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. 9. 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. 10. 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.
 Calendar No. 152

119th CONGRESS

 1st Session

 S. 2292

_______________________________________________________________________

 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 8, 2025

 Reported with an amendment