Get Fda 3794 Instructions 2013-2025

Completing Form FDA 3794 is essential for certain drug applications and submissions to the FDA. This guide offers step-by-step instructions to ensure users accurately fill out the form online, making the process clear and straightforward.

Follow the steps to successfully complete the FDA 3794 form online.

1. Click ‘Get Form’ button to obtain the form and open it in the online editor.
2. Fill in the 'Applicant, holder or owner' section with the legal entity that owns the submission. Ensure to list the official name and address for record purposes, not the facility location unless applicable.
3. Complete the 'Representative or U.S. agent' section by providing the authorized contact's details, including name, title, phone number, and email. This person will respond to any inquiries related to the cover sheet.
4. Indicate the correct 'Fiscal Year' to which the payment applies, remembering that the fiscal year runs from October 1 of one year to September 30 of the next.
5. Select the appropriate 'Generic Drug User Fee Type' by checking the box that corresponds to your submission type: ANDA, PAS, Type II API DMF, Facility, or Backlog.
6. If applicable, provide the 'Application Number for ANDA' in a six-digit format, using leading zeroes as necessary.
7. Specify the 'Established Name of Product' as per the application, which will assist in validation.
8. Indicate if you are amending an ANDA or PAS submission, ensuring to specify if no final action has been taken.
9. If your submission includes API manufacturing information that does not reference a Type II API Drug Master File, ensure to understand the associated fees as per the regulations.
10. List the quantity of APIs included in your ANDA or PAS submission, ensuring not to double count APIs already included in previous submissions.
11. For each API listed, provide the 'Name of Drug Substance' to clarify which substances are being referenced.
12. Indicate the address and FEI (FDA Establishment Identifier) of each facility involved, ensuring you can reference the specific facility’s DUNS number.
13. Confirm whether the fee required by Section 744B(a)(3)(F) has been previously paid, to avoid duplicate payments.
14. If the fee has been paid, provide the User Fee Payment I.D. number associated with the payment to streamline processing.
15. For PET drugs, note that these are exempt from fees when applicable, to be reflected during the checkout process.
16. Finalize by reviewing all sections for accuracy and completeness before saving changes, downloading, printing, or sharing your form.

Complete your documents online with confidence and ensure proper submission of your FDA 3794 form.