This morning, the FDA published the OTC Monograph request Fee rates for FY 2024 in a pre-publication Federal Register notice (here); these rates cover fees for OTC monograph order requests (OMORs) for which there are Tier 1 and Tier 2 requests. The distinction for the two classifications of OMORs are a Tier 1 request (usually for the addition of new or innovative ingredients as an OTC) and Tier 2 requests (for other, more minor, changes to products).
The FDA notes that “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.”
The new rates for Tier 1 and Tier 2 requests and a comparison to FY 2023 rates are provided in the chart below.
|Fee Category||FY 2023||FY 2024|
New facility OTC fees have not yet been announced (at least we can’t find them) for FY 2024, but we will hopefully be seeing them shortly!