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Notice to Applicants Submitting Direct-to-Consumer Television Advertisements for Advisory Review to CDER/CBER for Fiscal Year 2008
Congress has passed the Food and Drug Administration Amendments Act of 2007 (FDAAA) and the President has signed the bill. The law creates a new direct-to-consumer (DTC) user fee program starting in fiscal year (FY) 2008. The statute specifies that any DTC television (TV) advertisements submitted to FDA for advisory review on or after October 1, 2007 will be assessed fees.
Because of the delay in passage of the legislation, we have not yet issued the Federal Register notice establishing the fee rates for FY 2008 and explaining how those fee rates were calculated. For FDA to announce the rates, we are required to ask companies to notify the FDA if they intend to participate in the program and how many DTC TV advertisements they plan on submitting during FY 2008. We expect to publish a Federal Register notice soon asking companies about their intent to participate in the program. Applicants that wish to participate in the program will notify the FDA within 30 days of publication of the Federal Register notice (1) if they plan to participate and (2) how many advisory reviews they intend to request in FY 2008. After the 30 day period has expired, FDA will calculate the rates and publish a second Federal Register notice announcing the rates. FDA also expects to provide guidance to industry on how to submit DTC advisory review packages for review under the DTC TV User Fee Program and will issue a Federal Register notice to announce the availability of the guidance.
If you have further questions regarding the DTC TV User Fee Program please contact Wayne Amchin, Project Manager, Division of Drug Marketing, Advertising, and Communications, at 301-796-1200 or email DDMAC at dtcp@fda.hhs.gov.
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DTC User Fees
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Date created: October 1, 2007 |
