FDA Unveils Online User Fee System

The FDA has launched a web-based User Fee System that is integrated with the agency's accounting system, through which customers can create and submit Form FDA 3397, agency officials announced at the Drug Information Association's Electronic Document Management Conference in Philadelphia.

Form FDA 3397, the Prescription Drug User Fee Act (PDUFA) user fee cover sheet, provides basic information to enable the FDA to determine whether a drug application fee is required, set the fee and track payments, according to the FDA.

The agency designed the system -- a single portal for all user fees -- to be user-friendly, with the familiar online "shopping cart" approach, officials said.

Industry can access the system at http://www.fda.gov/oc/pdufa/coversheet.html (http://www.fda.gov/oc/pdufa/coversheet.html). Customers must register their organization before creating the cover sheet, after which the system will generate a payment identification number. Registration requires an employer identification number, contact name, company name, address, telephone and fax numbers, an email address and a Dun & Bradstreet Number. The system then automatically calculates the cover sheet fee based on the customer's answers to questions about the type of application to be submitted.

The data is sent electronically to the Center for Drug Evaluation and Research or the Center for Biologics Evaluation and Research and to the agency's Office of Financial Management, and back again as needed, officials said.

For more information, go to the website, write to userfees@fda.gov (mailto:userfees@fda.gov) or call (301) 827-9539.