1001 and other applicable federal statutes. Signature of person making this Small Business Certification Request must be signed by the person identified in item Date of this Small Business Certification Request MM/DD/YYYY FORM FDA 3602 8/18 Page 1 of 2 EF a. Name of Affiliate b. Taxpayer ID Number c. Gross Receipts or Sales Total Gross Receipts or Sales of All Affiliates sum of lines 1 through 15 sum of lines 16 and 17 PRIVACY ACT NOTICE This notice is provided pursuant to the Privacy Act of 1974 5 U.S.C. 552a. The collection of this information is authorized by 21 U.S.C. 379i and 379j. FDA will use the information to assess qualification as a small business collect and process user fee payments and facilitate debt collection under the Debt Collection Improvement Act. OMB Number 0910-0508 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Expiration Date June 30 2019 PRA Statement See next page. MDUFA SMALL BUSINESS CERTIFICATION REQUEST Application for FY 20 For a Bu....
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How to fill out the FDA 3602 online
The FDA 3602 form is essential for businesses seeking to certify their status as small businesses under the Medical Device User Fee Amendments (MDUFA). This guide will provide clear, step-by-step instructions on how to effectively complete the FDA 3602 online.
Follow the steps to complete the FDA 3602 form online.
- Click ‘Get Form’ button to obtain the form and open it in your preferred electronic document software.
- Identify the fiscal year for which you are requesting the Small Business Certification. Clearly indicate this in the upper right section of the form header.
- In Section I, provide the name of your business as it appears on your Federal tax form.
- Enter your business's Federal Employer Identification Number (EIN) in the specified field, ensuring it matches your tax documentation.
- Provide the physical address where your business operates, including details necessary for someone to locate the business.
- List the name and contact details of the person responsible for this certification. Include their position in the business.
- In the field for affiliate information, indicate if your business has affiliates. If yes, confirm that they are listed in Section II.
- Complete the certification statement at the end of Section I. Check the correct response box regarding your affiliates and gross receipts.
- Proceed to Section II to list any affiliates, providing each entity's name, Taxpayer ID number, and total gross receipts or sales.
- Calculate the total gross receipts for all listed affiliates, as well as the gross receipts for your business, ensuring they meet the qualification criteria.
- Once you have filled in all required fields accurately, print the completed form. Sign and date it before submission.
- Submit your completed FDA 3602 form, along with required supporting documents, to the designated FDA mailing address.
- If assistance is needed while filling out the form, contact the Division of Industry and Consumer Education.
Start completing your FDA 3602 form online today to take advantage of the benefits available for small businesses.
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