Minor Changes Planned For User Fee Application Forms

Posted 17 May 2012 | By

The cover sheet used by pharmaceutical and biotechnology companies when submitting their user fees scheduled to receive an upgrade, the US Food and Drug Administration (FDA) revealed in a Federal Register posting.

The sheets are currently mandatory for companies, which pay the agency fees in return for having their applications reviewed under the terms of the Prescription Drug User Fee Act (PDUFA). "Because the submission of user fees concurrently with applications and supplements is requires," writes FDA, "review of an application by FDA cannot begin until the fee is submitted."

To do so, companies utilize the agency's FDA 3397 form, which FDA explains "is designed to provide the minimum necessary information to determine whether a fee is required for review of an application, to determine the amount of the fee required and to account for and track user fees."

FDA says it plans to revise the form in four ways, including updating the websites listed to assist sponsors, adding a privacy act notice, adding addition information for sponsors of 351(k) applications and allowing sponsors to use a drug's "proper name" on the form.

Read more:

FDA - Agency Information Collection Activities; Proposals, Submissions, and Approvals: User Fee Cover Sheet


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