FDA increases OTC monograph facility fees in reissued notice

Following a dispute with the Department of Health and Human Services (HSS) that resulted in its initial notice being withdrawn, the US Food and Drug Administration (FDA) on Thursday reissued its notice announcing fee rates for its newly created over-the-counter (OTC) monograph drug user fee program (OMUFA) for FY2021.
 
FDA initially issued the notice on 29 December, but it was quickly withdrawn by HHS over public outcry against FDA’s plans to collect user fees from companies such as liquor distilleries that stepped in to manufacture hand sanitizers under the agency’s temporary enforcement policy during the COVID-19 pandemic. (RELATED: What happened with FDA’s OTC monograph user fee notice?, Regulatory Focus 7 January 2021).
 
“Following FDA’s issuance of the initial OMUFA user fee notice, the FDA determined that certain hand sanitizer producers — those which registered with FDA during the COVID-19 public health emergency (PHE) solely to produce hand sanitizer products during the COVID-19 PHE — would not be required to pay OMUFA facility fees,” said Patrizia Cavazzoni, acting director of the Center for Drug Evaluation and Research.
 
In a new Federal Register notice, FDA has set updated rates for the fees it will collect under OMUFA for FY2021, excluding companies that registered with FDA as OTC drugmakers solely to produce hand sanitizers in line with the agency’s temporary enforcement policy. While the fees for OTC monograph order requests (OMORs) are fixed under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), the fee rates for monograph drug facilities (MDFs) and contract manufacturing organizations (CMOs) are calculated based on the number and type of establishments that are expected to pay the fees.
 
Because the number of establishments has decreased from the agency’s earlier estimate due to the exclusion of companies solely manufacturing hand sanitizers during the COVID-19 PHE, the fee rates for MDFs and CMOs listed in the reissued notice have increased by about 45%. The fees cover the period from 1 October 2020 through 30 September 2021 and facility fees must be paid within 45 days of the publication of the notice.
 

Fee Category	FY2021 Fee Rates
OMOR Tier 1	$500,000
OMOR Tier 2	$100,000
MDF facility fee	$20,322
CMO facility fee	$13,548

 
 OMUFA, FDA’s newest user fee program, was created in March 2020 under the CARES Act to modernize and reform the agency’s regulation of OTC monograph products. Like FDA’s other user fee programs, the CARES Act grants the secretary of HHS the authority to assess and collect two types of fees: facility fees and OTC monograph order request fees. Under the CARES Act, an OTC monograph drug facility is, “a foreign or domestic business or other entity that is … engaged in manufacturing or processing the finished dosage form of an OTC monograph drug.” The act also specifies that firms are required to pay a facility fee for the current fiscal year for facilities identified as OTC monograph drug facilities on 31 December or at any time during the preceding 12-month period.
 
FDA, Federal Register Notice