For fiscal year 2003, a small business is one with gross sales or receipts of no more than $30 million, including sales and receipts of all affiliates, partners, and parent firms; FDA may adjust this threshold in future years. An applicant who must pay a fee must pay the standard fee unless it qualifies as a small business. To qualify for reduced fees, a small business must submit Federal income tax forms (for itself, and all affiliates, partners, and parent firms), showing that its sales and receipts do not exceed $30 million. If the $30 million small business threshold is shown to reduce user fee revenues by more than 16%, FDA may adjust the threshold to a lower level. You must qualify as a small business at least 60 days before your first submission in any fiscal year you want to pay the reduced small business fees. Each year, as fees are adjusted, small business fees will be set at the following levels: | Determination of Small Business Fees | | Application | Small Business Fee | - Premarket application (PMA, PDP, BLA)
- Premarket report (premarket approval application for a reprocessed device)
- Panel-track supplement
- Efficacy supplement
- 180-day supplement
- Real-time supplement
| 38% of standard fee | | 80% of standard fee for FY 2004 and subsequent fiscal years |
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