Over-the-Counter Monograph Drug User Fee Amendments

This Act may be cited as the Over-the-Counter Monograph Drug User Fee Amendments.
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.
Section 744L(9)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–71(9)(A)) is amended—
in clause (v), by striking ; or and inserting a semicolon;
in clause (vi)—
by striking addition and inserting the addition; and
by striking the period and inserting ; or; and
by adding at the end the following:
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—
established by a national or international standards development organization; and
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.
Section 744M(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–72(a)(1)) is amended—
in subparagraph (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;
by striking Each person and inserting the following:
Each person
by adding at the end the following:
For purposes of clause (i), the applicable period is—
for fiscal year 2026, the 12-month period ending on December 31, 2025;
for fiscal year 2027, the 9-month period ending on September 30, 2026; and
for fiscal year 2028 and each subsequent fiscal year, the 12-month period ending on September 30 of the preceding fiscal year.
in subparagraph (B)(i), by amending subclause (I) to read as follows:
has ceased all activities related to OTC monograph drugs prior to—
for purposes of fiscal year 2026, January 1, 2025;
for purposes of fiscal year 2027, January 1, 2026; and
for purposes of fiscal year 2028 and each subsequent fiscal year, October 1 of the preceding fiscal year; and
by amending subparagraph (D) to read as follows:
For fiscal year 2026, the facility fees required under subparagraph (A) shall be due on the later of—
the first business day of June of such year; or
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.
For fiscal year 2027, the facility fees required under subparagraph (A) shall be due—
in a first installment representing 50 percent of such fee, on the later of—
October 1, 2026; or
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
in a second installment representing the remaining 50 percent of such fee, on—
February 1, 2027; or
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.
For fiscal year 2028 and each subsequent fiscal year, the facility fees required under subparagraph (A) shall be due on the later of—
the first business day on or after October 1 of the fiscal year; or
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.
Section 744M(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–72(b)) is amended to read as follows:
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—
the annual base revenue for the fiscal year (as determined under paragraph (2));
the dollar amount equal to the inflation adjustment for the fiscal year (as determined under subsection (c)(1));
the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(2));
additional direct cost adjustments (as determined under subsection (c)(3));
an additional dollar amount equal to—
$2,373,000 for fiscal year 2026;
$1,233,000 for fiscal year 2027; and
$854,000 for fiscal year 2028; and
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.
For purposes of paragraph (1), the dollar amount of the annual base revenue for a fiscal year shall be—
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
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).
Section 744M(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–72) is amended—
in paragraph (1)—
in subparagraph (A), in the matter preceding clause (i)—
by striking subsection (b)(2)(B) and inserting subsection (b)(1)(B); and
by striking fiscal year 2022 and each subsequent fiscal year and inserting each fiscal year;
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—
for fiscal year 2026—
the fee for fiscal year 2025 under subsection (a)(2); and
the inflation adjustment percentage under subparagraph (C); and
for each of fiscal years 2027 through 2030—
the applicable fee under subsection (a)(2) for the preceding fiscal year; and
the inflation adjustment percentage under subparagraph (C).
in subparagraph (C)—
in the matter preceding clause (i), by inserting the sum of after is equal to;
by striking clause (i);
by redesignating subclauses (I) and (II) of clause (ii) as clauses (i) and (ii), respectively, and adjusting the margins accordingly;
by striking (ii) for each of fiscal years 2024 and 2025, the sum of—; and
in clause (ii), as so redesignated, by striking Washington-Baltimore, DC–MD–VA–WV and inserting Washington–Arlington–Alexandria–DC–VA–MD–WV;
in paragraph (2)—
in subparagraph (A)—
by striking fiscal year 2021 and subsequent fiscal years and inserting each fiscal year;
by striking subsections (b)(1)(B) and (b)(2)(C) and inserting subsection (b)(1)(C); and
by striking the number of weeks specified in subparagraph (B) and inserting 10 weeks;
by striking subparagraph (B);
by redesignating subparagraphs (C) and (D) as subparagraphs (B) and (C), respectively; and
in subparagraph (C), as so redesignated, by striking paragraph (4) establishing and inserting paragraph (5) publishing;
in paragraph (3)—
in the matter preceding subparagraph (A), by striking subsection (b)(2)(D) and inserting subsection (b)(1)(D); and
by striking subparagraphs (A) through (E) and inserting the following:
$135,000 for fiscal year 2026;
$300,000 for fiscal year 2027;
$55,000 for fiscal year 2028;
$30,000 for fiscal year 2029; and
$0 for fiscal year 2030.
by striking paragraph (4) and inserting the following:
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.
An adjustment under this paragraph may be made for a fiscal year only if—
an adjustment under this paragraph had not been made for any prior fiscal year;
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
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.
An adjustment under this paragraph for a fiscal year shall equal the product of—
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
the excess facility percentage described in clause (iii).
The excess facility percentage described in this clause is—
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
1,625.
The Secretary shall, not later than 60 days before the first day of each fiscal year—
establish for such fiscal year, based on the revenue amounts under subsection (b) and the adjustments provided under this subsection—
OTC monograph drug facility fees under subsection (a)(1); and
OTC monograph order request fees under subsection (a)(2); and
publish such fee revenue amounts, facility fees, and OTC monograph order request fees in the Federal Register.
Section 744M(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–72(f)) is amended—
in paragraph (2)(D)—
in the subparagraph heading, by striking in subsequent years; and
by striking (after fiscal year 2021); and
in paragraph (3), by striking 2021 through 2025 and inserting 2026 through 2030.
Section 744N of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–73) is amended—
in subsection (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
by striking section 3861(b) of the CARES Act and inserting section 2 of the Over-the-Counter Monograph Drug User Fee Amendments;
in subsection (b), by striking fiscal year 2021 and each subsequent fiscal year and inserting each fiscal year; and
in subsection (d), by striking 2025 each place it appears and inserting 2030.
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.
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.
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.
Section 744N of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–73) shall cease to be effective January 31, 2031.
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.
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.