Thanks for the feedback and to clarify, Victor is correct, I was speaking of OTC Monograph User Fee Act (OMUFA) fees applying to
facilities, not the fees for OTC Monograph Order Requests (OMORs). Since my original post I did find the fees have not yet been posted. Initially, OMUFA facility fees were expected to be published in mid-May 2020, with a payment deadline within 45 days of publication. However, when taking a closer look at
Section 744M(f), fees may only be collected after the posting of the appropriations act. The appropriations act, which will specify the total amount of fees to be collected each fiscal year, shall be available starting October for the next fiscal year. Following the publication of the appropriations act for 2021, FDA plans to publish the exact facility fee amounts in a Federal Register Notice (FRN). OTC Monograph drug facility fees for fiscal year 2021 will be due 45 days after publication of this FRN. Therefore, instead of 2020 fees being due in late June or early July 2020, they will now be dropped and 2021 fees will be due no earlier than mid-November 2020.
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Christopher Smith, CQE, RAC
Coastal Pharmaceutical Consultants, Inc.
7950 Old River Road
Burgaw, NC 28425, USA
910.259.8877 (land)
910.789.1232 (mobile)
chrissmith@coastalpharmaconsultants.com------------------------------
Original Message:
Sent: 24-Sep-2020 02:17
From: Joy Frestedt
Subject: Facility fees for OTC drug manufacturers
Tier 1 $500k
Tier 2 $100k
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Original Message:
Sent: 9/23/2020 8:48:00 AM
From: Christopher Smith
Subject: Facility fees for OTC drug manufacturers
The CARES Act establishes a new program for the regulation of OTC drugs and, no surprise, establishes user fees for certain OTC drug reviews and manufacturing facilities. The plan was for FDA to announce in the Fed Reg in May what the expected facility fees would be for the 2021 Fiscal Year, but I don't think FDA has yet announced anything about the facility fees. Am I mistaken?
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