Overview
In September 2023, the U.S. Food and Drug Administration FDA published the OTC Monograph request Fee rates for FY 2024 in a pre-publication Federal Register notice.
Introduction
The U.S. Food and Drug Administration (FDA) has published OTC Monograph Order Request Fees for FY 2024 are rates that cover costs for OMORs, which can be divided into Tier 1 and Tier 2 requests. A Tier 1 request (often for the addition of novel or innovative ingredients as an OTC) and a Tier 2 request (for other, more minor adjustments to goods) are the two categories for OMORs.
Product-specific Change Fees
The OMOR requests to make specific safety adjustments to a medicine covered by an OTC monograph, no money will be charged.
No fee will be charged if FDA determines that the OMOR intends to modify the drug facts labeling of an OTC monograph medication in a way that would strengthen or add to any of the following:
- Contraindication, warning, or caution.
- Statement about the risk of misuse or abuse.
- Dosage and administration instruction intended to increase the medication’s safety.
Fee Adjustment:
The OMOR charge is adjusted for inflation under OMUFA beginning with FY 2022 and through every subsequent fiscal year.
According to that clause, the relevant fee for the previous fiscal year multiplied by the inflation adjustment percentage results in the dollar amount of the inflation adjustment to the fee for OMORs.
For the period of October 1, 2023, through September 30, 2024, the revised OMOR fee rates are in effect.
| Fee category | FY 2024 fee rates |
| OMOR: | |
| Tier 1 | $537,471 |
| Tier 2 | $107,494 |
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References
Learn more about FDA. For the link, click here
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