Who pays the OMUFA facility fee?
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.

When is the facility fee due?
The facility fee is due annually.

When are OMUFA facility fees due for FY 2022?
OTC monograph drug facility fees for FY 2022 are due June 1, 2022.

What is an OTC monograph drug facility?
Under section 744L of the FD&C Act, an OTC monograph drug facility is generally defined as a foreign or domestic business or other entity that:

1. is under one management, either direct or indirect, and at one geographic location or address engaged in manufacturing or processing the finished dosage form of an OTC monograph drug;
2. includes a finished dosage form manufacturer facility in a contractual relationship with the sponsor of one or more OTC monograph drugs to manufacture or process such drugs; and
3. does not include a business or other entity whose only manufacturing or processing activities are one or more of the following: production of clinical research supplies; testing; or placement of outer packaging on packages containing multiple products, for such purposes as creating multipacks, when each monograph drug contained within the overpackaging is already in a final packaged form prior to placement in the outer overpackaging.

What is an OTC monograph drug contract manufacturing organization (CMO) facility?
As defined in section 744L of the FD&C Act, a CMO facility is an OTC monograph drug facility where neither the owner of such manufacturing facility nor any affiliate of such owner or facility sells the OTC monograph drug produced at such facility directly to wholesalers, retailers, or consumers in the United States.

Are these CMO facilities required to pay a facility fee?
Yes, a qualifying CMO facility pays a fee equal to two-thirds of the amount of the fee for a qualifying OTC monograph drug facility that is not a CMO facility.

How were OTC monograph drug facility fees for FY 2022 calculated?
The statute mandates that facility fee rates shall be established to generate a calculated total facility revenue amount, which for FY 2022 is equal to $23,888,000 (rounded to the nearest thousand dollars). FDA determined the number of OTC monograph drug facilities subject to the two types of facility fees (MDF and CMO) using data that included registrations from the Electronic Drug Registration and Listing System (eDRLS) and the breakdown of facilities that paid FY 2021 OMUFA facility fees. FDA calculated the per-facility fee based on the number of each type of facility and other relevant factors and assumptions, consistent with the clarification in the Department of Health and Human Services’ January 12, 2021, Federal Register Notice.

More information about the calculation of FY 2022 facility fees can be found in the Federal Register Notice published on 03/16/22, “Over-The-Counter Monograph Drug User Fee Rates for Fiscal Year 2022.”

Compared to FY 2021, what is the exact rate of increase for OMUFA facility user fees for FY 2022?
The FY 2022 OMUFA facility user fee rate will increase by 19 percent compared to FY 2021.

Why did facility fees increase in FY 2022?
To calculate the facility fee rates, in accordance with our statutory authority, FDA bases its calculations on factors in each fiscal year that include the 1) number of fee-liable facilities, 2) ratio of Monograph Drug Facilities (MDF) to Contract Manufacturing Organizations (CMO), and 3) increases in the total target revenue due to inflation and other adjustments. The FY 2022 increase in facility fee rates is largely attributed to these factors:

• The FY 2022 target revenue set under the statute
• Number of Facilities: In FY 2022, FDA is estimating fewer fee-liable facilities (1,118) in comparison to those estimates from FY 2021 (1,184).
• MDF to CMO Ratio: Based on FY 2021 data and other data provided by firms regarding their operations, FDA determined the MDF to CMO ratio in FY 2022 to be 65:35, an adjustment from the FY 2021 ratio of 90:10. FDA assigns a value of 1 to each MDF and a value of 2/3 to each CMO to calculate the full fee-paying equivalent (the denominator) in setting OMUFA facility fees. Because the ratio changed (i.e., there are fewer MDFs and more CMOs), the denominator decreased causing all facility fees to increase for FY 2022.
• Inflation and Operating Reserve Adjustments: FY 2022 was the first year for which the inflation adjustment applied. FDA also made an operating reserve adjustment and otherwise reserved sufficient carryover fees to sustain program operations until facility fees for the subsequent fiscal year are due on June 1, 2023.

Please see the March 16, 2022, FRN titled “Over-The-Counter Monograph Drug User Fee Rates for Fiscal Year 2022" for the methods utilized in calculating OMUFA fee rates for FY 2022.

Does the FY 2022 OMUFA facility fee apply to facilities that manufacture or process hand sanitizer products during the COVID-19 public health emergency?
No. Consistent with the Department of Health and Human Services’ (HHS) Notice published on January 12, 2021, FDA will not assess OMUFA facility fees upon those firms that first registered with FDA  on or after the January 27, 2020 declaration of the COVID-19 public health emergency (PHE)  solely  for purposes of manufacturing OTC hand sanitizer products during the PHE.

Under the FD&C Act, whether an entity is subject to OMUFA fees has no bearing on whether the entity or the entity’s products are subject to other requirements under the FD&C Act.  FDA will continue to use its regulatory compliance and enforcement tools to protect consumers, including from potentially dangerous or sub-potent hand sanitizers.  

Does the FY 2022 OMUFA facility fee apply to my facility?
The FD&C Act defines which facilities are subject to an OMUFA fee. As stated above, the OMUFA FY 2022 facility fee applies to facilities meeting the FD&C Act definition of an OTC monograph drug facility, in addition to other criteria, as described in the Federal Register Notice “Over-The-Counter Monograph Drug User Fee Rates for Fiscal Year 2022” issued on 03/16/2022. Further, FD&C Act section 744M(d) requires each person that owns an OTC monograph drug facility to submit information about the facility’s business operation as part of annual establishment registration under FD&C Act section 510.

The FY 2022 OMUFA facility fee does not apply to the facilities and entities detailed below:

• those facilities that only manufacture the active pharmaceutical ingredient (or API) of an OTC monograph drug, which do not meet the definition of an OTC monograph drug facility under section 744L(10)(A)(i)(II) of the FD&C Act);
• OTC monograph drug facilities that had ceased all activities related to OTC monograph drugs prior to December 31, 2020, and had updated their registration with FDA to reflect that change (see section 744M(a)(1)(B)(i) of the FD&C Act); or
• entities that first registered with FDA on or after the January 27, 2020, declaration of the COVID-19 public health emergency (PHE), solely for purposes of manufacturing hand sanitizer products during the PHE.

Will the facility fee be assessed per product listing submitted (label), one fee per formula, or one per facility?
The annual facility fee is assessed “per facility,” in accordance with the definition of an OTC monograph drug facility, as set forth in section 744L(10) of the FD&C Act, and the authority for facility fees under section 744M of the FD&C Act.  As defined in the statute, an OTC monograph drug facility means 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.  OTC monograph drug facilities can include a contract manufacturing organization (CMO) facility (see section 744L(10) of the FD&C Act).  A CMO facility is an OTC monograph drug facility where neither the owner nor any affiliate of the owner or facility sells the OTC monograph drug produced at such facility directly to wholesalers, retailers, or consumers in the United States (see section 744L(2) of the FD&C Act).

I received a fee notice, but I don’t think my facility should be charged an OMUFA facility fee for FY 2022. What should I do?
If you believe your facility is not an OTC monograph drug facility as described in this Notice and should not be assessed an OMUFA FY 2022 facility fee, please contact CDERCollections@fda.hhs.gov.

What is an FDA Establishment Identification number?
An FDA Establishment Identification (FEI) number is a unique identifier issued by FDA to track inspections of the regulated establishment or facility. FEI numbers are also used to track OTC facility fee payments. Please note that an FEI number is different from a Central File Number and Federal Tax Identification Number. As stated in section 744L(4) of the FD&C Act, FEIs are automatically generated by FDA’s Field Accomplishments and Compliance Tracking System (FACTS) (or any successor system).