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FDA Reissues Notice Announcing Increased OTC Monograph Facility Fees

On March 26, 2021, the FDA updated and reissued the fee rates for the newly created over-the-counter (OTC) monograph Drug User Fee program (OMFUA) for FY2021 in a Federal Register Notice (FRN) titled “Fee Rates under the Over-The-Counter Monograph Drug User Fee Program for Fiscal Year 2021.” The CARES Act, passed by Congress on March 27, 2020, established OMUFA, FDA’s newest user fee program, which granted FDA the ability to assess and collect two types of fees: OTC monograph drug facility (MDF) fees and OTC Monograph Order Request (OMOR) fees. 

The initial notice issued by FDA on December 29, 2020, was quickly withdrawn by the HSS amid controversy surrounding FDA’s plan to collect user fees from manufacturers, including liquor distilleries, that stepped up to meet the US (and world) demand for increased production of hand sanitizers under the Agency’s temporary enforcement policy during the COVID-19 pandemic. 

Who is impacted:  

A full facility fee will be assessed to each qualifying person that owns a facility identified as an MDF (see section 744M(a)(1)(A) of the FD&C Act), and a reduced facility fee of two-thirds will be assessed to each qualifying person that owns a facility identified as a contract manufacturing organization (CMO) facility (see section 744M(a)(1)(B)(ii) of the FD&C Act). The facility fees are due 45 days after the date of publication of this notice (see section 744M(a)(1)(D)(i) of the FD&C Act).

In the reissued FRN, companies that registered with FDA during the COVID-19 public health emergency (PHE) whose sole activity with respect to OTC monograph drugs during the pandemic consists (or had consisted) of manufacturing OTC hand sanitizer products would not be required to pay OMUFA facility fees.

OTC monograph drug facilities are exempt from FY 2021 facility fees if they had ceased OTC monograph drug activities, and updated their registration with FDA to that effect, prior to December 31, 2019 (see section 744M(a)(1)(B)(i) of the FD&C Act).

The Fees:  

In addition to facility fees, the FDA is authorized to assess and collect fees from submitters of an OMOR, except for OMORs that request certain safety-related changes. There are two levels of OMOR fees based on whether the OMOR at issue is a Tier 1 or Tier 2 OMOR.

For FY 2021, the OMUFA fee rates are as follows: Tier 1 OMOR fees ($500,000), Tier 2 OMOR fees ($100,000), MDF facility fees ($20,322), and CMO facility fees ($13,548). These fees cover the period from October 1, 2020 through September 30, 2021, and facility fees must be paid within 45 days of the publication of the notice. This document is issued pursuant to sections 744M(a)(4) and (c)(4)(A) [5] of the FD&C Act.

Payment:  

Information about fee payment options and procedures can be found in the March 26, 2021 FRN. Payment must be made in US currency by electronic check or wire transfer and made payable to the order of the FDA.

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Copyright © 2021 Womble Bond Dickinson (US) LLP All Rights Reserved.National Law Review, Volume XI, Number 91
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About this Author

Heather Hatcher Life Sciences & Pharmaceuticals Womble Bond Dickinson Winston-Salem, NC
Regulatory Scientist

*Heather Hatcher is not licensed to practice law. Her activities are directly supervised by members of the firm licensed to practice law in the firm’s Winston-Salem office.

Heather joined the firm as a Regulatory Scientist. She has extensive experience in Regulatory Affairs and as a basic and clinical research scientist. She effectively guides clients through the complex regulatory landscape governed by the US Food and Drug Administration (FDA) toward market authorization. In addition to advising clients on early regulatory strategy and product development issues, Heather...

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Christine is an experienced product liability litigation and regulatory compliance attorney with more than 20 years of experience defending manufacturers and laboratories in complex cases in which medical and scientific facts were at issue. She focuses her practice on food and beverage regulation and litigation, as well as smoking and health litigation.

In her practice defending food product manufacturers, Christine relies on her first-hand experience as a small business owner of a company that makes snacks inspired by the dietary restrictions...

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