Timeline for Implementation of OTC Monograph Reform Fees Under Provisions in H.R. 748 (the CARES Act)

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Article | Jun 23, 2020

What follows is a timeline for implementation of OTC monograph reform under HR 748, also known as the CARES Act.

December 31, 2019 Retroactive date for facilities subject to monograph drug facility fee requirement for fiscal year 2021 (which starts October 1, 2020). In future years, facility fees will be assessed on monograph facilities with activities as of December 31 or at any time in the preceding year unless the facility has ceased all monograph activities and updated its facility registration before December 30. In future years, FDA anticipates publishing a notice for firms to audit/amend facility registrations ahead of the deadline date.
October 1, 2020 at the earliest FDA will publish facility fee amount after fiscal year 2021 appropriations authorize fee collection. The earliest date would be the first day of the fiscal year, October 1. 2020. For fiscal years 2022 through 2025, FDA will set and publish the facility fee for then-current fiscal year by the second Monday in March.
Fourth quarter 2020 at the earliest Facility fees are due 45 days after FDA publishes a notice on the fee amount. For future years, facility fees are dues the later of the first business day in June or the first business day after enactment of appropriations authority.
Fourth quarter 2020 at the earliest Twenty calendar days after fiscal year 2021 due date, FDA will post a public arrears list for facilities failing to pay. Similarly, in future years FDA will post an arrears list 20 days after the fiscal year due date. OTC monograph drugs manufactured in such facilities will be deemed misbranded. OTC monograph drug order requests submitted by a sponsor or requestor not paying fees will be considered incomplete, and ineligible for closed meetings.
February 1, 2022 FDA publishes first report to Congress on implementation of their fee authority, fee uses and collections.