On March 26, 2021, the FDA updated and reissued the charge rates for the recently created over-the-counter (OTC) monograph Drug User Fee application (OMFUA) to get FY2021 at a Federal Register Notice (FRN) titled”Fee Rates below the Over-The-Counter Monograph Drug User Fee Program for Fiscal Year 2021.” The CARES Act, passed by Congress on March 27, 2020, based OMUFA, FDA’s brand new user fee program, that allowed FDA the capacity to estimate and gather two kinds of charges: OTC monograph drug center (MDF) charges and OTC Monograph Order Request (OMOR) fees.
The first notice issued by FDA on December 29, 2020, was rapidly pulled from the HSS amid controversy surrounding FDA’s strategy to collect user fees from manufacturers, such as liquor distilleries, that stepped up to fulfill with the US (and world) requirement for greater generation of hand sanitizers below the Agency’s temporary police coverage throughout the COVID-19 pandemic.
A complete facility charge will be assessed to every qualifying individual that possesses a facility identified as a MDF (see segment 744M(a)(1)(A) of this FD&C Act), along with a diminished facility charge of two-thirds will be evaluated to each qualifying individual that possesses a facility identified as a contract manufacturing organization (CMO) centre (see part 744M(a)(1)(B)(ii) of this FD&C Act). The centre fees are due 45 days following the date of publication of the note (see part 744M(a)(1)(D)(I) of their FD&C Act).
From the reissued FRN, firms which registered with FDA throughout the COVID-19 public health crisis (PHE) whose only activity with regard to OTC monograph medication throughout the pandemic includes (or’d consisted) of producing OTC hand sanitizer goods wouldn’t be asked to cover OMUFA center fees.
OTC monograph drug centers are exempt from FY 2021 facility charges when they’d stopped OTC monograph drug actions, and upgraded their registration with FDA to this impact, before December 31, 2019 (see department 744M(a)(1)(B ) )(I) of their FD&C Act).
Along with facility charges, the FDA is authorized to assess and collect penalties from submitters of an OMOR, except for OMORs that ask specific safety-related alterations. There are two degrees of OMOR fees predicated on if the OMOR at issue is a Tier 1 or Tier 2 OMOR.
For FY 2021, the OMUFA commission rates are as follows: Tier 1 OMOR charges ($500,000), Grade 2 OMOR charges ($100,000), MDF facility charges ($20,322), and CMO facility fees ($13,548).
Information regarding payment options and processes are seen at the March 26, 2021 FRN. Payment has to be made in US money by electronic check or wire transfer and made payable to the purchase of the FDA.