SUPPLEMENTARY INFORMATION:

I. Background

Section 744M of the FD&C Act (21 U.S.C. 379j-72), as amended by OMUFA II,^[1] authorizes FDA to assess and collect, for each of fiscal years 2026 through 2030: (1) facility fees from qualifying owners of OTC monograph drug facilities and (2) fees from submitters of qualifying OMORs. These fees are to support FDA's OTC monograph drug activities, which are detailed in section 744L(6) of the FD&C Act (21 U.S.C. 379j-71(6)) and include specified FDA activities associated with OTC monograph drugs. For OMUFA purposes:

• An OTC monograph drug is a nonprescription drug without an approved new drug application that is governed by the provisions of section 505G of the FD&C Act (21 U.S.C. 355h) (see section 744L(5) of the FD&C Act);
• An OTC monograph drug facility (MDF) is a foreign or domestic business or other entity that, in addition to meeting other criteria, is engaged in manufacturing or processing the finished dosage form of an OTC monograph drug (see section 744L(10) of the FD&C Act); and
• A contract manufacturing organization (CMO) facility is an OTC monograph drug facility where neither the owner nor any affiliate of the owner or facility sells the OTC monograph drug produced at such facility directly to wholesalers, retailers, or consumers in the United States (see section 744L(2) of the FD&C Act).
• An OMOR is a request for an administrative order, with respect to an OTC monograph drug, which is submitted under section 505G(b)(5) of the FD&C Act (see section 744L(7) of the FD&C Act).

Under section 744M(a)(1)(A) of the FD&C Act, a facility fee for FY 2027 shall be assessed with respect to each facility that is identified as an OTC monograph drug facility during the fee-liable period from January 1, 2026, through September 30, 2026.^[2] Consistent with the statute, FDA will assess and collect facility fees with respect to the two types of OTC monograph drug facilities—MDF and CMO facilities. A full facility fee will be assessed to each qualifying person that owns a facility identified as an MDF (see section 744M(a)(1)(A) of the FD&C Act), and a reduced facility fee of two-thirds will be assessed to each qualifying person that owns a facility identified as a CMO facility (see section 744M(a)(1)(B)(ii) of the FD&C Act). The facility fees for FY 2027 are due in two equal installments, in a first installment representing 50 percent of such fee due on October 1, 2026, and in a second installment representing the remaining 50 percent of such fee due on February 1, 2027 (see section 744M(a)(1)(D)(ii) of the FD&C Act).^[3]

As discussed in greater detail below, OTC monograph drug facilities are exempt from FY 2027 facility fees if they had ceased OTC monograph drug activities, and updated their registration with FDA to that effect, prior to January 1, 2026 (see section 744M(a)(1)(B)(i)(I)(bb) of the FD&C Act).

In addition to facility fees, the Agency is authorized to assess and collect fees from submitters of OMORs, except for OMORs that request certain safety-related changes (as discussed below). There are two levels of OMOR fees, based on whether the OMOR at issue is a Tier 1 or Tier 2 OMOR.^[4]

For FY 2027, the OMUFA fee rates are: MDF facility fees ($47,891), CMO facility fees ($31,927), Tier 1 OMOR fees ($614,608), and Tier 2 OMOR fees ($122,921). These fees are effective for the period from October 1, 2026, through September 30, 2027.^[5] This document is issued pursuant to section 744M(a)(4) and 744M(c)(5) of the FD&C Act and describes the calculations used to set the OMUFA facility fees and OMOR fees for FY 2027 in accordance with the directives in the statute.

II. Facility Fee Revenue Amount for FY 2027

Under OMUFA, FDA sets annual facility fees to generate the total facility fee revenues for each fiscal year established by section 744M(b) of the FD&C Act. The yearly base revenue amount is the starting point for setting annual facility fee rates. The base revenue for FY 2027 is the dollar amount of the total revenue amount for the previous fiscal year, without certain adjustments made for that previous ( printed page 48122) year, and is $40,648,348 (see section 744M(b)(2)(B) of the FD&C Act).

A. FY 2027 Statutory Fee Revenue Adjustment for Inflation

Under OMUFA, the annual base revenue amount for facility fees is adjusted for inflation for FY 2027, per section 744M(c)(1) of the FD&C Act. That provision states that the dollar amount of the inflation adjustment is equal to the product of the annual base revenue for the fiscal year and the inflation adjustment percentage. For FY 2027, the inflation adjustment percentage is equal to the sum of:

• The average annual percent change in cost, per full-time equivalent (FTE) position of the FDA, of all personnel compensation and benefits (PC&B) paid with respect to such positions for the first 3 years of the preceding 4 FYs, multiplied by the proportion of PC&B costs to total costs of the OTC monograph drug activities for the first 3 years of the preceding 4 FYs (see section 744M(c)(1)(C)(i) of the FD&C Act); and
• The average annual percent change that occurred in the Consumer Price Index (CPI) for urban consumers (Washington-Arlington-Alexandria, DC-VA-MD-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 PC&B costs to total 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 1 summarizes the actual cost and FTE data for the specified FYs, provides the percent changes from the previous FYs, and provides the average percent changes over the first 3 of the 4 FYs preceding FY 2027. The 3-year average is 5.7330 percent.

Under the statute, this 5.7330 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)(i) 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.

The payroll adjustment is 5.7330 percent from table 1 multiplied by 61.2359 percent from table 2, resulting in 3.5107 percent.

Table 3 provides the summary data for the percent changes in the specified CPI for the Washington-Arlington-Alexandria, DC-VA-MD-WV area.^[6]

The statute specifies that this 2.8330 percent be multiplied by the proportion of all costs other than PC&B to total costs of OTC monograph drug activities (see section 744M(c)(1)(C)(ii) of the FD&C Act). Because 61.2359 percent was obligated for PC&B (as shown in table 2), 38.7641 percent is the portion of costs other than PC&B (100 percent−61.2359 percent = 38.7641 percent). The non-payroll adjustment is 2.8330 percent × 38.7641 percent, or 1.0982 percent.

Next, we add the payroll adjustment (3.5107 percent) to the non-payroll adjustment (1.0982 percent), for a total inflation adjustment of 4.6089 percent (rounded) for FY 2027.

Pursuant to the statute, the FY 2027 base revenue of $40,648,348 is increased by the total inflation adjustment of 4.6089 percent, yielding an inflation adjusted base revenue amount of $42,521,790 for FY 2027 (see section 744M(c)(1)(A)).

B. FY 2027 Statutory Additional Dollar Amounts Adjustment

OMUFA II requires that the facility fee revenue be increased by an additional dollar amount for each of fiscal years 2026-2028. For FY 2027, the inflation adjusted revenue amount of $42,521,790 is increased by an additional dollar amount of $1,233,000 ( printed page 48123) as specified in the statute (see section 744M(b)(1)(E)(ii) of the FD&C Act). This yields an adjusted fee revenue subtotal of $43,754,790.

C. FY 2027 Statutory Fee Revenue Adjustment for Additional Direct Cost

Fee revenue is further adjusted for additional direct costs as specified in the statute. In FY 2027, $300,000 is added to the facility fee revenues to account for additional direct costs (see section 744M(c)(3)(B) of the FD&C Act). Adding the additional direct costs amount of $300,000 to $43,754,790 yields an additional direct cost adjusted fee revenue of $44,054,790.

D. FY 2027 Statutory Fee Revenue Adjustment for Operating Reserve

Under OMUFA, FDA may further increase the FY 2027 facility fee revenue and fees if such an adjustment is necessary to provide up to 10 weeks of operating reserves of carryover user fees for OTC monograph drug activities (see section 744M(c)(2)(A) of the FD&C Act). Accordingly, in setting fees for FY 2027, the Agency must estimate its carryover for FY 2027 to ensure the Agency has sufficient operating reserves of carryover user fees to mitigate certain financial risks, such as under collections, unanticipated surges in program costs, or a lapse in appropriations. Under the statute, if FDA has carryover for OTC monograph drug activities that would exceed 10 weeks of such operating reserves, FDA is required to decrease FY 2027 fee revenues and fees to provide for not more than 10 weeks of operating reserves of carryover user fees (see section 744M(c)(2)(B) of the FD&C Act).

To determine the FY 2026 end-of-year operating reserves of carryover user fees, the Agency assessed the operating reserve of carryover user fees at the end of June 2026 and forecast collections and obligations for the remainder of FY 2026. FDA estimates the FY 2027 operating reserve of carryover user fees to be $15,554,437.

To determine whether the carryover is within the 10-week limit for the operating reserve, the Agency starts with the additional direct cost adjusted fee revenue of 44,054,790 (calculated in section C), divides it by 52 to yield a weekly operating amount of $847,207, and then multiplies the weekly operating reserve amount ($847,207) by 10, resulting in an operating reserve limit of $8,472,075. Because the estimated FY 2027 carryover is above the 10-week threshold, FDA is applying a downward operating reserve adjustment of $7,082,362, equivalent to approximately 8 weeks, to bring the operating reserve of carryover user fees to the statutory limit for such operating reserves (see section 744M(c)(2)(B) of the FD&C Act). The final FY 2027 OMUFA target facility fee revenue is $36,972,000 (rounded to the nearest thousand dollars).

III. Facility Fee Calculations

A. Facility Fee Revenues and Fees

For FY 2027, facility fee rates are being established to generate a total target revenue amount, as determined under the statute, equal to $36,972,000 (rounded to the nearest thousand dollars). FDA used the methodology described below to determine the appropriate number of MDF and CMO facilities to be used in setting the OMUFA facility fees for FY 2027. FDA took into consideration that the CMO facility fee is equal to two-thirds of the amount of the MDF facility fee (see section 744M(a)(1)(B)(ii) of the FD&C Act).

B. Calculating the Number of Qualifying Facilities and Setting the Facility Fees

For FY 2027, FDA utilized available data consisting of the number of facilities that at the time of fee-setting were registered in FDA's Electronic Drug Registration and Listing System (eDRLS) to manufacture human OTC drug products produced under a monograph ^[7] during the FY 2027 fee-liable period ( i.e., January 1, 2026, through September 30, 2026, and that paid prior FY OMUFA facility fees, as the primary sources for estimating the number of each facility fee type ( i.e., MDF and CMO). In addition, the Agency considered data provided by firms regarding their operation as MDFs and CMOs during FY 2026 ( i.e., October 1, 2025, through September 30, 2026) when they were submitting OTC Monograph User Fee Cover Sheets to pay the FY 2026 fee. This data supported FDA's estimate of the number of firms operating as MDF and CMO facilities during the FY 2027 fee-liable period ( i.e., January 1, 2026, through September 30, 2026), and informed FDA's calculation of the number and ratio of MDF and CMO facilities used in determining the FY 2027 fee rates.^[8] FDA's review of data also reflected input received during the FY 2027 fee-liable period from facilities whose manufacturing or processing practices meet the definition of fee-eligible OTC monograph drug facilities, to help capture those facilities that are in the market during the FY 2027 fee-liable period and intend to remain in the market during FY 2027.

Those facilities that only manufacture the active pharmaceutical ingredient of an OTC monograph drug do not meet the definition of an OTC monograph drug facility (see section 744L(10)(A)(i)(II)) of the FD&C Act). Likewise, a facility is not an OTC monograph drug facility if its only manufacturing or processing activities are one or more of the following: (1) production of clinical research supplies; (2) testing; or (3) placement of outer packaging on packages containing multiple products, for such purposes as creating multipacks, when each monograph drug product contained within the overpackaging is already in a final packaged form prior to placement in the outer overpackaging (see section 744L(10)(A)(iii) of the FD&C Act).

In undertaking the statutorily directed fee calculations for FY 2027 fees, the Agency also made certain assumptions, including that: (1) facilities that have deregistered in eDRLS have exited the market; (2) facilities that FDA believes registered incorrectly as OTC monograph drug facilities (for example, the associated drug listings for these facilities did not include OTC monograph drugs but instead indicated such products as nonprescription drug products marketed under an approved drug application or nonprescription animal drug products) were not engaged in manufacturing or processing the finished dosage form of an OTC monograph drug; (3) facilities that registered but did not have an active ( printed page 48124) OTC monograph drug product listing associated in their registration profile were not manufacturing or processing such drug products; (4) additional facilities are estimated to register from the time of fee setting through the end of the FY 2027 fee liability period at the same rate as the prior 3 year average ( i.e., FYs 2024-2026); (5) a portion of facilities that newly registered including projected numbers of new registrants during the fee liable period are estimated to be in arrears based on a detailed review of the prior 3-year average ( i.e., FYs 2023-2025); and (6) facilities that remain on the arrears list for failure to satisfy the FY 2026 facility fee as of June 22, 2026 are likely to be placed on the FY 2027 arrears list as well.

Based on the above-referenced factors and assumptions, FDA estimates there will be 905 OMUFA fee-paying units. The Agency estimates that 56 percent (905 × 0.56 = 507, rounded) will incur the MDF fee and 44 percent (905 × 0.44 = 398, rounded) will incur the CMO fee.

To determine the number of full fee-paying equivalents (the denominator) to be used in setting the OMUFA fees, FDA assigns a value of 1 to each MDF (507) and a value of 2/3 to each CMO (398 × 2/3 = 265) for a full facility equivalent of 772 (rounded). The target fee revenue of $36,972,000 is then divided by 772 for an MDF fee of $47,891 and a CMO fee of $31,927.

IV. OMOR Fee Calculations

For FY 2027, the Tier 1 OMOR fee is $614,608 and the Tier 2 OMOR fee is $122,921, including an adjustment for inflation (see sections 744M(a)(2)(A)(i) and (ii) of the FD&C Act, respectively). OMOR fees are not included in the OMUFA target revenue calculation, which is based on the facility fees (see section 744M(b) of the FD&C Act).

An OMOR fee is generally assessed to each person who submits an OMOR (see section 744M(a)(2)(A) of the FD&C Act). OMOR fees are due on the date of the submission of the OMOR (see section 744M(a)(2)(B) of the FD&C Act). The payor should submit the OMOR fee that applies to the type of OMOR they are submitting ( i.e., Tier 1 or Tier 2). FDA will determine whether the appropriate OMOR fee has been submitted following receipt of the OMOR and the fee.

An OMOR fee will not be assessed if the OMOR seeks to make certain safety changes with respect to an OTC monograph drug. Specifically, no fee will be assessed if FDA finds that the OMOR seeks to change the drug facts labeling of an OTC monograph drug in a way that would add to or strengthen: (1) a contraindication, warning, or precaution; (2) a statement about risk associated with misuse or abuse; or (3) an instruction about dosage and administration that is intended to increase the safe use of the OTC monograph drug (see section 744M(a)(2)(C) of the FD&C Act).

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 OMOR, $500,000, adjusted for inflation for the FY (see section 744M(a)(2)(A)(i) of the FD&C Act); and

(2) For a Tier 2 OMOR, $100,000, adjusted for inflation for the FY (see section 744M(a)(2)(A)(ii) of the FD&C Act).

In addition, under section 744M(c)(1)(B)(ii) of the FD&C Act and for purposes of section 744M(a)(2) of the FD&C Act, the inflation adjustment for the FY 2027 OMOR fee shall be equal to the product of:

(1) the fee for FY 2026 under section 744M(a)(2) of the FD&C Act; and

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

Therefore, for FY 2027, the base of OMOR fees taken from the preceding FY ( i.e., FY 2026) are: Tier 1: $587,529 and Tier 2: $117,505. The FY 2027 inflation adjustment percentage is: 4.6089 percent.

V. Fee Schedule for FY 2027

The fee rates for FY 2027 are displayed in Table 4.

VI. Electronic Federal Payment Methods

The new facility fee rates are effective for the period from October 1, 2026, through September 30, 2027. To pay the MDF and CMO fees, use the OMUFA FY 2027 Facility Fee Invoice that will be issued by the Agency in August and December 2026 for the October 1st, 2026 and February 1st, 2027 installment due dates, respectively. The OTC Monograph Drug User Fee Cover Sheet will not be available for FY 2027 payments.

Payments made to FDA must be made in U.S. currency drawn on a U.S. bank by electronic check, credit card, or wire transfer. The preferred method for payments to FDA is online using electronic check (Automated Clearing House (ACH), also known as eCheck) or credit card (Discover, VISA, MasterCard, American Express). FDA has partnered with the U.S. Department of the Treasury to utilize Pay.gov, a web-based payment application, for online electronic payment. The Pay.gov feature is available on the FDA website upon receipt of an invoice. Secure electronic payments to FDA can be submitted using the User Fees Payment Portal at https://userfees.fda.gov/​pay. ( Note: Only full payments are accepted; no partial payments can be made online). Electronic payment options are based on the balance due. Payment by credit card is available for balances less than $25,000. If the balance exceeds this amount, only the ACH option is available. Payments must be made using U.S. bank accounts as well as U.S. credit cards.

For payments made by wire transfer, include the invoice number to ensure that the payment is applied to the correct fee(s). Without the invoice number, the payment may not be applied. The originating financial institution may charge a wire transfer fee. Include applicable wire transfer fees with payment to ensure fees are fully paid. Questions about wire transfer fees should be addressed to the financial institution. The following account information should be used to send payments by wire transfers: U.S. Department of the Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, Account No.: 75060099, Routing No.: 021030004, SWIFT: FRNYUS33.

FDA's tax identification number is 53-0196965. If a fee is not paid in full, the fee will be treated as a claim of the U.S. Government (see section 744M(g) of the FD&C Act and 45 CFR part 30), meaning the invoice balance due amount is referred to collection.

If you are assessed an FY 2027 OMUFA facility fee and believe your facility is not an OTC monograph drug facility as described in this notice, please contact FDAUserFees@fda.hhs.gov.

91 FR 48121