View all text of Subpart 10 [§ 379j-71 - § 379j-73]
§ 379j–72. Authority to assess and use OTC monograph fees
(a) Types of feesBeginning with fiscal year 2021, the Secretary shall assess and collect fees in accordance with this section as follows:
(1) Facility fee
(A) In general
(B) Exceptions
(i) Facilities that cease activitiesA fee shall not be assessed under subparagraph (A) if the identified OTC monograph drug facility—(I) has ceased all activities related to OTC monograph drugs prior to December 31 of the year immediately preceding the applicable fiscal year; and(II) has updated its registration to reflect such change under the requirements for drug establishment registration set forth in section 360 of this title.
(ii) Contract manufacturing organizations
(C) Amount
(D) Due date
(i) For first program yearFor fiscal year 2021, the facility fees required under subparagraph (A) shall be due on the later of—(I) the first business day of July of 2020; or(II) 45 calendar days after publication of the Federal Register notice provided for under subsection (c)(4)(A).
(ii) Subsequent fiscal yearsFor each fiscal year after fiscal year 2021, 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.
(2) OTC monograph order request fee
(A) In generalEach person that submits an OTC monograph order request shall be subject to a fee for an OTC monograph order request. The amount of such fee shall be—
(i) for a Tier 1 OTC monograph order request, $500,000, adjusted for inflation for the fiscal year (as determined under subsection (c)(1)(B)); and
(ii) for a Tier 2 OTC monograph order request, $100,000, adjusted for inflation for the fiscal year (as determined under subsection (c)(1)(B)).
(B) Due date
(C) Exception for certain safety changesA person who is named as the requestor in an OTC monograph order shall not be subject to a fee under subparagraph (A) if the Secretary finds that the OTC monograph order request seeks to change the drug facts labeling of an OTC monograph drug in a way that would add to or strengthen—
(i) a contraindication, warning, or precaution;
(ii) a statement about risk associated with misuse or abuse; or
(iii) an instruction about dosage and administration that is intended to increase the safe use of the OTC monograph drug.
(D) Refund of fee if order request is recategorized as a Tier 2 OTC monograph order request
(E) Refund of fee if order request refused for filing or withdrawn before filing
(F) Fees for order requests previously refused for filing or withdrawn before filing
(G) Refund of fee if order request withdrawn
(3) Refunds
(A) In general
(B) Disputes concerning fees
(4) Notice
(b) Fee revenue amounts
(1) Fiscal year 2021For fiscal year 2021, 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 fiscal year 2021 (as determined under paragraph (3));
(B) the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(2)); and
(C) additional direct cost adjustments (as determined under subsection (c)(3)).
(2) Subsequent fiscal yearsFor each of the fiscal years 2022 through 2025, 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 (3));
(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)); and
(E) additional dollar amounts for each fiscal year as follows:
(i) $7,000,000 for fiscal year 2022.
(ii) $6,000,000 for fiscal year 2023.
(iii) $7,000,000 for fiscal year 2024.
(iv) $3,000,000 for fiscal year 2025.
(3) Annual base revenueFor purposes of paragraphs (1)(A) and (2)(A), the dollar amount of the annual base revenue for a fiscal year shall be—
(A) for fiscal year 2021, $8,000,000; and
(B) for fiscal years 2022 through 2025, the dollar amount of the total revenue amount established under this subsection for the previous fiscal year, not including any adjustments made under subsection (c)(2) or (c)(3).
(c) Adjustments; annual fee setting
(1) Inflation adjustment
(A) In generalFor purposes of subsection (b)(2)(B), the dollar amount of the inflation adjustment to the annual base revenue for fiscal year 2022 and each subsequent fiscal year shall be equal to the product of—
(i) such annual base revenue for the fiscal year under subsection (b)(2); and
(ii) the inflation adjustment percentage under subparagraph (C).
(B) OTC monograph order request feesFor purposes of subsection (a)(2), the dollar amount of the inflation adjustment to the fee for OTC monograph order requests for fiscal year 2022 and each subsequent fiscal year shall be equal to the product of—
(i) the applicable fee under subsection (a)(2) for the preceding fiscal year; and
(ii) the inflation adjustment percentage under subparagraph (C).
(C) Inflation adjustment percentageThe inflation adjustment percentage under this subparagraph for a fiscal year is equal to—
(i) for each of fiscal years 2022 and 2023, the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data; and
(ii) for each of fiscal years 2024 and 2025, the sum of—(I) the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 years of the preceding 4 fiscal years, multiplied by the proportion of personnel compensation and benefits costs to total costs of OTC monograph drug activities for the first 3 years of the preceding 4 fiscal years; and(II) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of OTC monograph drug activities for the first 3 years of the preceding 4 fiscal years.
(2) Operating reserve adjustment
(A) In general
(B) Number of weeksThe number of weeks specified in this subparagraph is—
(i) 3 weeks for fiscal year 2021;
(ii) 7 weeks for fiscal year 2022;
(iii) 10 weeks for fiscal year 2023;
(iv) 10 weeks for fiscal year 2024; and
(v) 10 weeks for fiscal year 2025.
(C) Decrease
(D) Rationale for adjustment
(3) Additional direct cost adjustmentThe Secretary shall, in addition to adjustments under paragraphs (1) and (2), further increase the fee revenue and fees for purposes of subsection (b)(2)(D) by an amount equal to—
(A) $14,000,000 for fiscal year 2021;
(B) $7,000,000 for fiscal year 2022;
(C) $4,000,000 for fiscal year 2023;
(D) $3,000,000 for fiscal year 2024; and
(E) $3,000,000 for fiscal year 2025.
(4) Annual fee setting
(A) Fiscal year 2021The Secretary shall, not later than the second Monday in May of 2020—
(i) establish OTC monograph drug facility fees for fiscal year 2021 under subsection (a), based on the revenue amount for such year under subsection (b) and the adjustments provided under this subsection; and
(ii) publish fee revenue, facility fees, and OTC monograph order requests in the Federal Register.
(B) Subsequent fiscal yearsThe Secretary shall, for each fiscal year that begins after September 30, 2021, not later than the second Monday in March that precedes such fiscal year—
(i) 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
(ii) publish such fee revenue amounts, facility fees, and OTC monograph order request fees in the Federal Register.
(d) Identification of facilitiesEach person that owns an OTC monograph drug facility shall submit to the Secretary the information required under this subsection each year. Such information shall, for each fiscal year—
(1) be submitted as part of the requirements for drug establishment registration set forth in section 360 of this title; and
(2) include for each such facility, at a minimum, identification of the facility’s business operation as that of an OTC monograph drug facility.
(e) Effect of failure to pay fees
(1) OTC monograph drug facility fee
(A) In generalFailure to pay the fee under subsection (a)(1) within 20 calendar days of the due date as specified in subparagraph (D) of such subsection shall result in the following:
(i) The Secretary shall place the facility on a publicly available arrears list.
(ii) All OTC monograph drugs manufactured in such a facility or containing an ingredient manufactured in such a facility shall be deemed misbranded under section 352(ff) of this title.
(B) Application of penalties
(2) Order requests
(3) Meetings
(f) Crediting and availability of fees
(1) In general
(2) Collections and appropriation Acts
(A) In general
(B) Use of fees and limitation
(C) Compliance
(D) Provision for early payments in subsequent years
(3) Authorization of appropriations
(g) Collection of unpaid fees
(h) Construction
(June 25, 1938, ch. 675, § 744M, as added Pub. L. 116–136, div. A, title III, § 3862, Mar. 27, 2020, 134 Stat. 461.)