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Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 Guidance for Industry. S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research

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How to fill out assessing user fees under

01

Step 1: Identify the purpose for assessing user fees.

02

Step 2: Determine the applicable regulations or guidelines for assessing user fees.

03

Step 3: Determine the cost elements that will be included in the user fees.

04

Step 4: Establish a methodology for calculating the user fees.

05

Step 5: Develop a fee schedule based on the calculated user fees.

06

Step 6: Communicate the user fees to the relevant stakeholders.

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Step 7: Implement the user fee assessment process and collect the fees.

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Step 8: Monitor and evaluate the effectiveness of the user fee assessment process.

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Step 9: Make necessary adjustments to the user fee assessment process as needed.

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Government agencies and departments that provide services or facilities to the public.

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Organizations that offer membership or subscription-based services.

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