has ceased all activities related to OTC monograph drugs prior to December 31 of the year immediately preceding the applicable fiscal year; and

has updated its registration to reflect such change under the requirements for drug establishment registration set forth in section 360 of this title.

the first business day of July of 2020; or

45 calendar days after publication of the Federal Register notice provided for under subsection (c)(4)(A).

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 a Tier 1 OTC monograph order request, $500,000, adjusted for inflation for the fiscal year (as determined under subsection (c)(1)(B)); and

for a Tier 2 OTC monograph order request, $100,000, adjusted for inflation for the fiscal year (as determined under subsection (c)(1)(B)).

a contraindication, warning, or precaution;

a statement about risk associated with misuse or abuse; or

an instruction about dosage and administration that is intended to increase the safe use of the OTC monograph drug.

$7,000,000 for fiscal year 2022.

$6,000,000 for fiscal year 2023.

$7,000,000 for fiscal year 2024.

$3,000,000 for fiscal year 2025.

such annual base revenue for the fiscal year under subsection (b)(2); and

the inflation adjustment percentage under subparagraph (C).

the applicable fee under subsection (a)(2) for the preceding fiscal year; and

the inflation adjustment percentage under subparagraph (C).

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

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

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.

3 weeks for fiscal year 2021;

7 weeks for fiscal year 2022;

10 weeks for fiscal year 2023;

10 weeks for fiscal year 2024; and

10 weeks for fiscal year 2025.

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

publish fee revenue, facility fees, and OTC monograph order requests in the Federal Register.

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.

The Secretary shall place the facility on a publicly available arrears list.

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.