There are a few links on FDA.gov that I hope you find helpful.
This link (Generic Drug User Fees) contains further links to other documents including this
FAQ. There is also a
Technical Walk-Through and Live Question and Answer Session and an
Overview and Technical Walk-Through of Self-Identification Process (archived webcast).
I don't see an obvious answer to when to submit for manufacturers just beginning, although it may be in one of the "Walk-throughs." Most Q&A assume the manufacturer has already been in business and just pays every October 1. For assistance in understanding when a GDUFA Cover Sheet is required, please contact FDA's
Division of Drug Information at 866-405-5367 or 301-796-6707 or
AskGDUFA@fda.hhs.go.
To submit your self-identification file to the FDA, you must first obtain a WebTrader account with the FDA Electronic Submission Gateway (ESG). See Setting up a WebTrader Account Checklist.
Good luck.
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Andrea Chamblee RAC, FRAPS
FDA
Silver Spring MD
United States
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Original Message:
Sent: 04-21-2014 19:02
From: Charles Van Beveren
Subject: Timing of Self-identification and GDUFA Fees
We are preparing to manufacture a generic for a client. To date we have manufactured generic non-GMP and clinical material for bio-equivalency/bio-availability studies. No commercial manufacturing has occurred and ANDA(s) have not been submitted.
When will we be responsible to self-identify as a generic manufacturer and pay the associated GDUFA fees? Are we responsible for filing during the current reporting period, ending April 30, 2014?
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Charles P Van Beveren, PhD, RAC
San Diego CA
United States
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