2024-16878. Over-the-Counter Monograph Drug User Fee Program-OTC Monograph Order Request Fee Rates for Fiscal Year 2025

Table 1—FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Changes

	2021	2022	2023	3-Year average
Total PC&B	$3,039,513,000	$3,165,477,000	$3,436,513,000
Total FTE	18,501	18,474	18,729
PC&B per FTE	$164,289	$171,348	$183,486
Percent Change from Previous Year	0.1811%	4.2967%	7.0838%	3.8539%

Under the statute, this 3.8539 percent is multiplied by the proportion of PC&B costs to the total FDA costs of OTC monograph drug activities for the first 3 years of the preceding 4 FYs (see section 744M(c)(1)(C)(ii) of the FD&C Act).

Table 2 shows the PC&B and the total obligations for OTC monograph drug activities for the first 3 of the preceding 4 FYs.

Table 2—PC&B as a Percent of Total Cost of OTC Monograph Drug Activities

	2021	2022	2023	3-Year average
Total PC&B	$23,133,775	$25,415,237	$39,133,075
Total Costs	$35,030,659	$49,644,273	$68,480,052
PC&B Percent	66.0387%	51.1947%	57.1452%	58.1262%

The payroll adjustment is 3.8539 percent from table 1 multiplied by 58.1262 percent resulting in 2.2401 percent.

Table 3 provides the summary data for the percent changes in the specified CPI for the Washington-Arlington-Alexandria, DC-VA-MD-WV. The data are published by the Bureau of Labor Statistics on its website: https://data.bls.gov/​pdq/​SurveyOutputServlet?​data_​tool=​dropmap&​series_​id=​CUURS35ASA0,CUUSS35ASA0.

Table 3—Annual and 3-Year Average Percent Change in CPI for Washington-Arlington-Alexandria, DC-VA-MD-WV Area

Year	2021	2022	2023	3-Year average
Annual CPI	277.73	296.12	305.32
Annual Percent Change	3.9568%	6.6212%	3.1069%	4.5616%

The statute specifies that this 4.5616 percent be multiplied by the proportion of all costs other than PC&B to total costs of OTC monograph drug activities. Because 58.1262 percent was obligated for PC&B (as shown in table 2), 41.8738 percent is the portion of costs other than PC&B (100 percent minus 58.1262 percent equals 41.8738 percent). The non-payroll adjustment is 4.5616 percent times 41.8738 percent, or 1.9101 percent.

Next, we add the payroll adjustment (2.2401 percent) to the non-payroll adjustment (1.9101 percent), for a total inflation adjustment of 4.1502 percent (rounded) for FY 2025.

IV. OMOR Fee Calculations

Under section 744M(a)(2)(A) of the FD&C Act, each person that submits a qualifying OMOR shall be subject to a fee for an OMOR. The amount of such fee shall be:

(1) For a Tier 1 OTC monograph order request, $500,000, adjusted for inflation for the FY (see section 744M(c)(1)(B) of the FD&C Act); and

(2) For a Tier 2 OTC monograph order request, $100,000, adjusted for inflation for the FY (see section 744M(c)(1)(B) of the FD&C Act).

In addition, under section 744M(c)(1)(B) of the FD&C Act and for purposes of section 744M(a)(2) of the FD&C Act, the dollar amount of the inflation adjustment to the fee for OMORs for FY 2022 and each subsequent FY shall be equal to the product of:

(1) The applicable fee under section 744M(a)(2) of the FD&C Act for the preceding FY; and

(2) The inflation adjustment percentage under section 744M(c)(1)(C) of the FD&C Act.

Thus, for FY 2025, the base of OMOR fees taken from the preceding FY ( i.e., FY 2024) are: Tier 1: $537,471 and Tier 2: $107,494. The FY 2025 inflation adjustment percentage is: 4.1502%.

V. Fee Schedule

The fee rates for FY 2025 are displayed in Table 4.

Table 4—Fee Schedule for FY 2025

Fee category	FY 2025 fee rates
OMOR:
Tier 1	$559,777
Tier 2	111,955