New OTC Monograph User Fees for FY2021 is Announced

BACKGROUND

On March 27, 2020, "the Coronavirus Aid, Relief, and Economic Security Act" (CARES Act) was signed into law. Section 744M of the FDCA, as added by the CARES Act, establishes an OTC monograph drug user fee program, under which FDA will assess and collect fees from submitters of OTC Monograph Order Requests (OMORs) as well as facility fees from certain manufacturers of OTC monograph drugs, to support the agency's OTC monograph drug activities.

New OTC Monograph Drug User Fee Rates for FY 2021

On March 26, 2021, the U.S. Food and Drug Administration (FDA) published new OTC Monograph user fees for fiscal year (FY) 2021. Beginning this year, FDA will require covered OTC drug facilities to pay an annual facility fee under the OTC Monograph User Fee Program (OMUFA), which was established by the passage of the March 2020 CARES Act. FDA states that facility fees for FY 2021 are due 45 days after publication of the Federal Register Notice (May 10, 2021).

Fiscal Year (FY) 2021 User Fee Rates

What are Tier 1 and Tier 2 of OMOR?

There are two types of OMORs: Tier 1 and Tier 2.

As described in section 744L(8) of the FD&C Act, a Tier 1 OMOR is any request not determined to be a Tier 2 OMOR.

As described in section 744L(9) of the FD&C Act, a Tier 2 OMOR is a request for:

Reordering of existing information in the drug facts label of an OTC monograph drug;
Addition of information to the “Other Information” section of the drug facts label of an OTC monograph drug (subject to certain limitations);
Modification to the “Directions for Use” section of the drug facts label of an OTC monograph drug, consistent with a minor dosage form change;
Standardization of the concentration or dose of a specific finalized ingredient within a particular finalized monograph;
Change to ingredient nomenclature to align with the nomenclature of a standards-setting organization; or
Addition of an interchangeable term in accordance with section 330.1 of title 21, Code of Federal Regulations (or any successor regulations).

Who Pays OMOR Fees?

As described in section 744M(a) of the FD&C Act, beginning with FY 2021, 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—

(i) a contraindication, warning, or precaution;
(ii) a statement about risk associated with misuse or abuse; or
(iii) an instruction about dosage and administration that is intended to increase the safe use of the OTC monograph drug.

What are MDF and CMO?

The agency will assess and collect facility fees for the following types of facilities:

1. OTC monograph drug facilities (MDFs), defined as:

A foreign or domestic business or other entity that, in addition to meeting other criteria, is engaged in manufacturing or processing the finished dosage form of an OTC monograph drug (see section 744L(1) of the FD&C Act).

2. Contract manufacturing organizations (CMOs), defined as:

An OTC monograph drug facility where neither the owner nor any affiliate sells the OTC monograph drug product at such facility directly to wholesalers, retailers, or consumers in the United States (see section 744L(2) of the FD&C Act).

Who Pays Facility Fees?

The facility fee will be assessed for qualifying persons who own an OTC monograph drug facility, including contract manufacturing organization facilities.

The OTC Monograph User Fee program does not assess a facility fee for human OTC drug products that are produced under an approved drug application. The Federal Register Notice referenced above will provide more information about FY 2021 facility fees.

Need Assistance with New OTC Monograph Drug User Fees?

Provision can assist in determining your applicable fees and facilitate payment to FDA as part of our OTC Drugs Registration and Compliance services. Contact Provision Consulting by email at info@provisionfda.com or by phone at +1-909-493-3276.

More Information? find it here: https://www.federalregister.gov/documents/2021/03/26/2021-06361/fee-rates-under-the-over-the-counter-monograph-drug-user-fee-program-for-fiscal-year-2021