Sec. 6504. Authority to assess and use OTC monograph fees
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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 ; and 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 ; 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(c) ) 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). ; and 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. ; and 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 ; and in subsequent years by striking (after fiscal year 2021) ; and in paragraph (3), by striking 2021 through 2025 and inserting 2026 through 2030 .
Connections4 off-index
4 references not yet in our index
- 21 USC 379j–72(a)(1)
- 21 USC 379j–72(b)
- 21 USC 379j–72(c)
- 21 USC 379j–72(f)
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cites case law
Sec. 6504
Authority to assess and use OTC monograph fees
Cite21 USC 379j–72(a)(1)
Cite21 USC 379j–72(b)
Cite21 USC 379j–72(c)
Cite21 USC 379j–72(f)
Cites 4Cited by 0 across 0 sources