A U.S. business is a business headquartered in the United States. If you are a U.S. business, you should follow the guidance provided in this section. If your business is headquartered in a foreign country, you should follow the guidance in Section V (Guidance for Foreign Businesses). If you believe you qualify as a small business and want to pay reduced fees or have fees waived (for your first premarket application/report), you should submit the following
documents to the FDA:
- A completed Form FDA 3602 (MDUFA Small Business Certification Request, for a Business Headquartered in the United States) include your Organization ID Number (Org ID) in box 2a of Form FDA 3602. Org ID is a system-generated number assigned to a new organization during the User Fee account creation process that uniquely identifies your business in the FDA User Fee System. 7 Your Org ID is separate and distinct from any other number that may be associated with your company. See Section VII (Frequently Asked Questions) of this guidance for instructions on obtaining your Org ID;
- a complete, signed copy of your original Federal (U.S.) income tax return for the most recent tax year;
- a separate Federal (U.S.) income tax return for each U.S. affiliate; and
- certified Section III of Form FDA 3602A for each foreign affiliate.
FDA will review your Form FDA 3602 and supporting materials within 60 calendar days of
receipt. Upon completion of our review, we will send you a letter that indicates whether or
not your business has been qualified under MDUFA as a small business. A qualified small
business is then eligible for a reduced or waived fee for submissions made during the FY. If
your business is qualified as a small business, FDA’s decision letter will assign you a Small
Business Decision number. You should provide this number to FDA each time you want to
receive a small business fee discount for any of your eligible applications or, if you qualify,
when you want to obtain a fee waiver for your first premarket application/report.
