FDA Announces FY 2025 OTC Monograph Order Request (OMOR) Fee Rates

July 30, 2024

The FDA has announced the OTC Monograph Order Request (OMOR) fee rates for fiscal year 2025. Learn about the fee schedule, payment procedures, and compliance guidance from Garg Law.

Today, the U.S. Food and Drug Administration (FDA) announced the over-the-counter (OTC) Monograph Order Request (OMOR) fee rates for fiscal year (FY) 2025. This announcement was made in a Federal Register notice (FRN) titled “Over-The-Counter Monograph Drug User Fee Program – OTC Monograph Order Requests (OMORs) Fee Rates for Fiscal Year 2025.”

Key Details

Fee Rates and Schedule

The FRN provides detailed information on the OMOR fee rates for FY 2025, covering the period from October 1, 2024, to September 30, 2025. The notice includes:

OMOR fee calculations
Fee due dates
Fee payment procedures

Fiscal Year 2025 OMOR Fee Rates

The fee schedule for FY 2025 is as follows:

Tier 1 OMOR: $559,777
Tier 2 OMOR: $111,955

For precise fee amounts, refer to the official Federal Register notice.

Importance of OMOR Fees

OMOR fees are essential for:

Supporting the FDA’s efforts to review and approve OTC monograph drugs.
Ensuring that the FDA has the resources to maintain high standards for drug safety and efficacy.

Fee Payment Procedures

Details on how to calculate and pay OMOR fees are outlined in the FRN. Ensure timely payment to avoid any compliance issues.

Compliance and Assistance

Garg Law can help you navigate these fee changes and ensure compliance with FDA regulations. Our team is well-versed in FDA requirements and can provide the necessary guidance for your business.

Contact us today for expert legal advice and support.

Read the full FDA article here.

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