Over-the-Counter Monograph Drug User Fee Program-Facility Fee Rates for Fiscal Year 2025

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <DEPDOC>[Docket No. FDA-2025-N-0648]</DEPDOC> <SUBJECT>Over-the-Counter Monograph Drug User Fee Program—Facility Fee Rates for Fiscal Year 2025</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Notice. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration (FDA, the Agency, or we) is announcing the over-the-counter (OTC) monograph drug facility (MDF) fee rates under the OTC monograph drug user fee program (OMUFA) for fiscal year (FY) 2025. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to assess and collect user fees from qualifying manufacturers of OTC monograph drugs and submitters of OTC monograph order requests (OMORs). This notice publishes the OMUFA facility fee rates for FY 2025. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> These facility fees are effective on October 1, 2024, and will remain in effect through September 30, 2025. </DATES> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Olufunmilayo Ariyo, Office of Financial Management, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 240-402-4989; or the User Fees Support Staff at <E T="03">OO-OFBA-OFM-UFSS-Government@fda.hhs.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background</HD> Section 744M of the FD&C Act (21 U.S.C. 379j-72), authorizes FDA to assess and collect: (1) facility fees from qualifying owners of OTC monograph drug facilities and (2) fees from submitters of qualifying OTC OMORs. The OTC OMOR fee rates for FY 2025 were published on July 31, 2024. <SU>1</SU> <FTREF/> OMUFA 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 various FDA activities associated with OTC monograph drugs. For OMUFA purposes: <FTNT> <SU>1</SU>   <E T="03">https://www.federalregister.gov/documents/2024/07/31/2024-16878/over-the-counter-monograph-drug-user-fee-program-otc-monograph-order-request-fee-rates-for-fiscal.</E> </FTNT> • 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 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). Under section 744M(a)(1)(A) of the FD&C Act, a facility fee for FY 2025 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, 2024, through December 31, 2024. <SU>2</SU> <FTREF/> 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 2025 are due on June 2, 2025 (see section 744M(a)(1)(D)(ii) of the FD&C Act). <SU>3</SU> <FTREF/> <FTNT> <SU>2</SU>  Under section 744M(a)(1) of the FD&C Act, “Each person that owns a facility identified as an OTC monograph drug facility on December 31 of the fiscal year or at any time during the preceding 12-month period shall be assessed an annual fee for each such facility.” For purposes of FY 2025 facility fees, that time period is January 1, 2024, through December 31, 2024. </FTNT> <FTNT> <SU>3</SU>  Assuming that, as we anticipate, the FY 2025 fee appropriation will occur prior to June 3, 2025. Under section 744M(a)(1)(D)(ii), the FY 2025 facility fees are due on the later of: (1) the first business day of June 2025 ( <E T="03">i.e.,</E> June 3, 2025) or (2) the first business day after the enactment of an appropriations Act providing for the collection and obligation of FY 2025 OMUFA fees. </FTNT> As discussed in greater detail below: • OTC monograph drug facilities are exempt from FY 2025 facility fees if they had ceased OTC monograph drug activities, and updated their registration with FDA to that effect, prior to December 31, 2023 (see section 744M(a)(1)(B)(i) of the FD&C Act). • Entities that registered with FDA during the Coronavirus Disease 2019 (COVID-19) pandemic whose sole activity with respect to OTC monograph drugs during the pandemic consisted of manufacturing OTC hand sanitizer products  <SU>4</SU> <FTREF/> and had ceased manufacturing hand sanitizer products and delisted and deregistered in FDA's Electronic Drug Registration and Listing System (eDRLS) accordingly before 12 a.m. Eastern Time on December 31, 2024, are not identified as OTC monograph drug facilities subject to OMUFA facility fees for FY 2025. <SU>5</SU> <FTREF/> <FTNT> <SU>4</SU>  The term “hand sanitizer” commonly refers to consumer antiseptic rubs. However, because the Department of Health and Human Services (HHS) notice published January 12, 2021, referred to “persons that entered the over-the-counter drug market to supply hand sanitizer products in response to the COVID-19 Public Health Emergency” (86 FR 2420, <E T="03">https://www.federalregister.gov/documents/2021/01/12/2021-00237/notice-that-persons-that-entered-the-over-the-counter-drug-market-to-supply-hand-sanitizer-during</E> ), we are using the same terminology—“hand sanitizer products”—to refer to OTC monograph drug products intended for use (without water) as antiseptic hand rubs or antiseptic hand wipes by consumers or healthcare personnel. </FTNT> <FTNT> <SU>5</SU>  See HHS <E T="04">Federal Register</E> notice of January 12, 2021, 86 FR 2420, <E T="03">https://www.federalregister.gov/documents/2021/01/12/2021-00237/notice-that-persons-that-entered-the-over-the-counter-drug-market-to-supply-hand-sanitizer-during.</E> </FTNT> For FY 2025, the OMUFA facility fee rates are: MDF facility fees ($37,556) and CMO facility fees ($25,037). These fees are effective for the period from October 1, 2024, through September 30, 2025. <SU>6</SU> <FTREF/> This document is issued pursuant to section 744M(a)(4) and 744M(c)(4)(B) of the FD&C Act and describes the calculations used to set the OMUFA facility fees for FY 2025 in accordance with the directives in the statute. <FTNT> <SU>6</SU>  These OMUFA facility fees are for FY 2025, per section 744M(a) of the FD&C Act. </FTNT> <HD SOURCE="HD1">II. Facility Fee Revenue Amount for FY 2025</HD> <HD SOURCE="HD2">A. Base Fee Revenue Amount</HD> 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 2025 is the dollar amount of the total revenue amount for the previous fiscal year, without certain adjustments made for that previous year, and is $29,253,365 (see section 744M(b)(3)(B) of the FD&C Act). <HD SOURCE="HD2">B. Fee Revenue Adjustment for Inflation</HD> Under OMUFA, the annual base revenue amount for facility fees is adjusted for inflation for FY 2025, 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 2025 the inflation adjustment percentage is the sum of: • (I) the average annual percent change in cost, per full-time equivalent (FTE) position of FDA, 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 (PC&B) costs to total costs of the OTC monograph drug activities for the first 3 years of the preceding 4 fiscal years (see section 744M(c)(1)(C)(ii)(I) of the FD&C Act); and • (II) the average annual percent change that occurred in the Consumer Price Index (CPI) 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 (see section 744M(c)(1)(C)(ii)(II) of the FD&C Act). As a result of a geographical revision made by the Bureau of Labor and Statistics in January 2018, the “Washington, DC-Baltimore” index was discontinued and replaced with two separate indices ( <E T="03">i.e.,</E> the “Washington-Arlington-Alexandria” and “Baltimore-Columbia-Towson” indices). To continue applying a CPI that best reflects the geographic region in which FDA is located and that provides the most current data available, the “Washington-Arlington-Alexandria” index is used in calculating the inflation adjustment percentage. Table 1 summarizes the actual cost and FTE data for the specified fiscal years, provides the percent changes from the previous fiscal ye ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 33k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━