Overview:
On March 14, 2022, FDA announced the rates for over-the-counter (OTC) monograph drug user fees for fiscal year (FY) 2022 in a Federal Register Notice titled “Over-The-Counter Monograph Drug User Fee Rates for Fiscal Year 2022.” It publishes fees for OTC monograph drug facilities and OTC Monograph Order Requests (OMORs) for FY 2022.
On which Factors does the FDA base its calculations for each Fiscal Year?
- Number of fee-liable facilities
- Ratio of Monograph Drug Facilities (MDF) to Contract Manufacturing Organizations (CMO)
- Increases in the total target revenue due to inflation and other adjustments.
What is the reason for this increase?
FDA recognizes that the FY 2022 facility fee rates are increased 19 percent in comparison to the FY 2021 facility fee rates and this increase is largely attributed to the decrease in the number of fee-liable facilities, change in the FY 2022 MDF to CMO ratio to 65:35 from the FY 2021 ratio of 90:10, and the inflation and operating reserve adjustments.
FY 2022 Facility User Fee Rates
| Monograph Drug Facility (MDF) Facility Fee | $24,178 |
| Contract Manufacturing Organization (CMO) Facility Fee | $16,119 |
FY 2022 OMOR Fee Rates
| Tier 1 | $507,201 |
| Tier 2 | $101,404 |
There are two types of OMORs: Tier 1 and Tier 2. Tier 1 OMOR is any request not determined to be a Tier 2 OMOR.
Tier 1 OMORs include additions & Tier 2 OMOR is a request
| Tier 1 OMORs include additions of: |
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| Tier 2 OMOR is a request for: |
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Attention to this Information!
Based on program implementation experience or other factors, FDA 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.
Each person that submits an OMOR is subject to an OMOR fee upon submission of the OMOR. However, a person that submits an OMOR shall not be subject to an OMOR fee 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.
- a contraindication, warning, or precaution;
- a statement about risk associated with misuse or abuse; or
- an instruction about dosage and administration that is intended to increase the safe use of the OTC monograph drug.
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OTC monograph facility
Under the statute, FY 2022 OMOR fees are $500,000 for Tier 1 OMORs and $100,000 for Tier 2 OMORs, adjusted for inflation. Therefore, the FY 2022 fee for a Tier 1 OMOR is $507,021 and for a Tier 2 OMOR is $101,404.
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