Rounding out the User Fee announcements, the Over-the-Counter Monograph Drug User Fee Program (OMUFA) announced its FY 2025 fees on July 31, 2024.  The Federal Register Notice announcing the new fees can be found here.  The update was only to the OTC Monograph Order Request (OMOR) fee rates – it did not include an update for the facility fees as those were due in June 2024 (see further information on the facility fees in the Lachman blog here).  The OMOR fees increased by 4.15%, in accordance with inflation.  As one might expect, the increases in OMUFA OMOR fees are moderate compared to the increases observed in the other User Fee programs overall.  As a reminder of what the Tiers mean, descriptions are provided below as footnotes to the fee chart.

Comparison of FY 2024 and FY 2025 OMUFA Fees

Over-the-Counter Monograph User Fees
Fee Type Description FY 2024 FY 2025 Difference
OMOR Fees Tier 1a $537,471 $559,777 $22,306
Tier 2b $107,494 $111,955 $4,461

 

  1. Tier 1 OMOR (as described in section 744L(8) of the FD&C Act, a Tier 1 OMOR is any request not determined to be a Tier 2 OMOR):
    1. A new ingredient to a monograph that already has one or more ingredients that have been found to be GRASE.
    2. A new indication to a monograph that already has one or more ingredients that have been found to be GRASE, and the new indication applies to one or more of the GRASE ingredients.
    3. New monograph therapeutic category (each ingredient proposed for the new therapeutic category will be a separate OMOR).
  2. TIER 2 OMOR (per section 744L(9) of the FD&C Act):
    1. Reordering of existing information in the drug facts label of an OTC monograph drug;
    2. Addition of information to the “Other Information” section of the drug facts label of an OTC monograph drug (subject to certain limitations);
    3. Modification to the “Directions for Use” section of the drug facts label of an OTC monograph drug, consistent with a minor dosage form change;
    4. Standardization of the concentration or dose of a specific finalized ingredient within a particular finalized monograph;
    5. Change to ingredient nomenclature to align with nomenclature of a standards-setting organization; or
    6. Addition of an interchangeable term in accordance with section 330.1 of title 21, Code of Federal Regulations (or any successor regulations).

Based on program implementation experience or other factors found appropriate by the FDA, the Agency may also characterize any OMOR as a Tier 2 OMOR (including recharacterizing a request from Tier 1 to Tier 2) and publish such determination in a proposed order issued pursuant to section 505G of the FD&C Act.