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Get Fda 3794 Instructions 2012
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How to fill out the FDA 3794 Instructions online
This guide provides a comprehensive overview on how to fill out the FDA 3794 Instructions form online. Designed to facilitate users through each section of the form, this guide ensures clarity and ease of understanding.
Follow the steps to complete the FDA 3794 Instructions form
- Press the ‘Get Form’ button to access the FDA 3794 form and open it in the online editor.
- Fill in the applicant, holder, or owner information. This section should detail the legal person or entity in control of the submission, including their name and address of record.
- Provide the representative or U.S. agent's details. This is the authorized person listed to communicate with the FDA, including their name, title, telephone number, and email address.
- Indicate the fiscal year. Specify the U.S. government's fiscal year relevant to the payment, which runs from October 1 to September 30.
- Select the type of generic drug user fee applicable to this cover sheet by checking the corresponding box for ANDA, PAS, Type II API DMF, Facility, or Backlog.
- Enter the six-digit application number for the ANDA if applicable, ensuring to include leading zeroes if the number contains fewer than six digits.
- Provide the established name of the product and indicate if modifying an existing ANDA or PAS submission awaiting final action.
- If applicable, list the API manufacturing information that does not reference a Type II API DMF and state the quantity of APIs for the ANDA or PAS submission.
- For each API mentioned, provide the name of the drug substance in that field.
- Detail the facilities involved by providing their name, address, FDA Establishment Identifier (FEI), and Facility DUNS number.
- Identify the APIs manufactured at each facility, ensuring you provide correct details to avoid complications in processing.
- Indicate if the fee required under Section 744B(a)(3)(F) has already been paid for any API/facility combinations specified.
- For each API/facility combination, input the User Fee Payment ID number confirming the fee payment status.
- If relevant, confirm if the submission involves PET drugs, as these may be exempt from certain fees.
- Once all fields are accurately filled, save your changes, and proceed to download, print, or share the completed form as needed.
Start compiling the necessary information and complete your FDA 3794 Instructions online today.
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