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On December 29, 2020, the U.S Food and Drug Administration (FDA) issued a notice announcing the first ever fee rates under the over-the-counter (OTC) monograph drug user fee program (OMUFA). The Prescription Drug User Fee Act was established over a decade ago [in 1992] to provide a way to help improve the availability of resources at the Food and Drug Administration to … Annual Establishment Registration Fees: Medical Devices. What happened? FDA is applying the operating reserve adjustment to increase the FY 2021 facility fee revenue and fees to enable the Agency to maintain 3 weeks of operating reserves of carryover user fees. Well, apparently, the notice about user fees for OTC monograph drug manufacturers took some parties by surprise. The US Food and Drug Administration (FDA) has published the user fee amounts it will collect in FY2019 from the manufacturers of pharmaceuticals, generic drugs, biosimilars, medical devices and outsourcing facilities that produce compounded drugs. On Monday the 28th of December, FDA announced its scheduled Federal Register notice setting the user fees for manufacturers and contract manufacturers of OTC monograph drugs. The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2021. Based on information about manufacturing facilities registered by Dec. 31, 2019, FDA has set the user fees as follows: Manufacturer facility fee: $14,060 Section 744M of the Federal Food, Drug, and Cosmetic Act, as added by the CARES Act, establishes an OTC monograph drug user fee program, under which FDA will assess and collect fees from submitters of OMORs as well as facility fees from certain manufacturers of OTC monograph drugs, to support the agency’s OTC monograph drug activities. As the reader will recall, under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), passed on March 27, 2020, Congress significantly changed the way OTC monograph drugs are … That did not take long. This was originally missing from the original language. All medical device manufacturers and distributors must pay an annual establishment registration fee to FDA. The table below lists the user fees for each program: As we reported at the end of 2020, FDA announced in a notice the User Fees for OTC Monograph Drug Manufacturers and other fees. The US Food and Drug Administration (FDA) has published the user fee amounts it will collect in FY2020 from the manufacturers of pharmaceuticals, generic drugs, biosimilars, medical devices and outsourcing facilities that produce compounded drugs. The statement reaffirms that they will eventually be enacted (rates to be announced) and that companies that came on board as a drug manufacturer only in response to COVID will be exempt. Last week, FDA issued a final rule to establish a user fee program for a voluntary accreditation program under Section 808 of the Federal Food, Drug, and FDA has not yet released the cost of fees associated with OTC drug manufacturing facilities. The US Food and Drug Administration (FDA) has published the user fee amounts it will collect in FY2021 from manufacturers of pharmaceuticals, generic drugs, biosimilars, medical devices and outsourcing facilities. Then on Jan. 6, 2021, HHS announced that the fees are off the table. The current Food and Drug Administration (FDA) User Fee Acts for medical products were set to expire on September 30, 2017, but new agreements were signed into law on August 18, 2017, extending the programs’ authorization for another five years. FDA issued a statement on January 12, 2021, about new OTC drug user fees.

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