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Or a Business Headquartered Outside the United States PRA Statement: See page 3. Section I Information about the Business Requesting Small Business Status 1. Name of business requesting MDUFA Small Business status: 2. Taxpayer Identification Number: 3. Address where business is physically located: 5. Your telephone number (Include country code & area code): 4. Name of person making this Certification: Check one response: Head of Firm 6. Your mailing address: Chief Financial Officer.

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How to fill out the Fda3602a online

This guide provides clear and concise instructions for users on how to complete the Fda3602a form online. Following these steps will help ensure that your submission is accurate and complete, aiding in your qualification for small business status with the FDA.

Follow the steps to successfully complete your Fda3602a form online:

  1. Click ‘Get Form’ button to access the Fda3602a form electronically.
  2. Fill out Section I by providing information about your business, including its legal name, Taxpayer Identification Number, physical address, and contact details of the person making the certification.
  3. In Section II, provide information regarding any affiliates you may have, including their names, Taxpayer ID Numbers, and gross receipts or sales data.
  4. Ensure you sum the total gross receipts or sales of all affiliates along with your own business to determine your qualification.
  5. Complete the certification statement in Section II, where you indicate whether your business has affiliates or not. Sign and date this certification.
  6. Finally, submit the completed form to your National Taxing Authority for Section III certification, and ensure it is returned to you for submission to the FDA.
  7. After receiving all the necessary sections completed, save changes, and choose to download, print, or share the form as needed.

Start your Fda3602a online submission today to ensure timely processing.

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FORM FDA 3602
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A small business is defined as a business, including its affiliates, whose gross receipts and sales are less than $100 million for the most recent tax year.

Facilities that manufacture, process, pack, or hold food that is intended for human or animal consumption in the United States must register with FDA before beginning these activities.

Go to FURLS at https://.access.fda.gov/oaa/. If you have never previously registered a device establishment, you will need to first create a FURLS account for the owner/operator (See Types of FURLS Accounts below).

FDA 2022 User Fee for Establishment Registration For FDA user fees 2022, the registration fee for each establishment is $5,672 (in United States dollars). There are no waivers or reductions for small establishments, businesses, or groups.

The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation.

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