SBIA Webinar Tomorrow: OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2021 User Fees - June 3, 2021

Receive this email as a forward? Subscribe to CDER SBIA industry updates. FDA | CDER | Small Business and Industry Assistance WEBINARS OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2021 User Fees  TOMORROW: June 3, 2021 | 1:00 - 2:00 p.m. Eastern This webinar is FREE. Register FDA will provide an overview of the Over-The-Counter (OTC) Monograph Drug User Fee Program (OMUFA) and describe the key elements of the program as it relates to OMUFA user fees. TOPICS Provide an overview of OMUFA as it relates to user fees Discuss the registration process for over-the-counter monograph drug facilities Describe the different fee types for OMUFA Discuss fiscal year 2021 target revenue, fee rates, and timelines Discuss the penalties associated with failure to pay OMUFA user fees Provide an overview of the fee payment process Discuss OMUFA refund eligibility   AUDIENCE This webinar is intended for those involved with or with an interest in OTC monograph drug products and/or non-prescription drugs, including: Regulatory affairs professionals  Industry partners  Researchers  Foreign regulators  Consultants  Clinical research coordinators Importers  Supply chain  Healthcare professionals General public CONTINUING EDUCATION Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations.  Certificates are only available during the two weeks post-event. This course: has been pre-approved by RAPS as eligible for credits (appropriate to real-time attendance) towards a participant's RAC recertification upon full completion. has been pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area. has been pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant's RQAP re-registration. has been approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material. The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry. Register for Upcoming Training Watch Learning Library Recordings on YouTube Subscribe to CDER SBIA Email Updates Follow on LinkedIn Follow on Twitter

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