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FDA UPDATE Aug 8, 2006

August 8th: Small Business Qualification, Worksheet and Certification FY 2007

Firms with annual gross sales or receipts of $30 million or less, including the gross sales and receipts of all affiliates, partners, and parent firms, may qualify for a fee waiver for their first PMA. Firms with annual gross sales or receipts of $100 million or less, including the gross sales and receipts of all affiliates, partners, and parent firms, may qualify for lower rates for all applications that are subject to a fee.

If you believe you qualify as a small business and want to pay reduced or waived fees, you should submit an FY 2007 MDUFMA Small Business Qualification Certification (Form FDA 3602 for FY 2007), your Federal income tax return for the most recent tax year, and the Federal income tax returns of each of your affiliates, partners, and parent firms for the most recent tax year. FDA will review your Certification and Federal income tax returns within 60 days and will send you our decision that you are, or are not, a small business eligible for reduced or waived fees for submissions you make during FY 2007.

Even if a firm qualified under the act as a small business for MDUFMA fees in FY 2006, it must obtain a new small business certification and decision number for FY 2007 and for each subsequent FY. This can be initiated any time after the publication of this notice.

A firm that does not have an FY 2007 small business qualification decision number from FDA will not be permitted to submit the reduced small business fees for applications submitted during FY 2007. FDA urges firms to apply for this qualification at least 60 days before they intend to submit their application and fee.

In order to understand policies and procedures for small business certification, please follow the below stated link for FDA guidance.

http://www.fda.gov/cdrh/mdufma/guidance/2007.pdf

If you have comments regarding this update, please email us at info@mdiconsultants.com

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