Form FDA 3913 Form FDA 3913 User Fee Payment Refund Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. xxxx-xxxx
Expiration Date: Xxxxxxx xx, 201x

User Fee Payment Refund Request

See PRA Statement on page 4.

Section A: Organization Information
1. Date of Request (mm/dd/yyyy)

Designer note: Entry fields will be added and the
form PDF will be made “508 compliant” after FDA and
OMB gives final approval to this layout design.

2. Organization Name
3. Organization Address
Address 1 (Street address. No P.O. Boxes allowed)
Address 2 (Apartment, suite, unit, building, floor, etc.)

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City

State/Province/Region

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Country

ZIP or Postal Code

4. Type of Vendor (Select applicable)
Foreign vendor

U.S. vendor

6. DUNS (Nine-digit number required for all
foreign vendors. See instructions for additional
information.) Without this entry, refund cannot
be processed.
Entry field for this one will be here.

5. TIN/EIN (Nine-digit number required for all U.S. vendors.) Without this entry,
refund cannot be processed.
Per normal procedure, on final functional form version
the multi-line links will have background coding that will
access the entire link shown, not just the first line of it.

Entry field for this one will be here.

Information for U.S. vendors: To facilitate your request, visit https://www.sam.
gov/portal/public/SAM/ and register with Central Contractor Registration (CCR).
CCR electronically validates registrant information and shares the encrypted data
securely with the FDA. For questions about CCR, call (334) 206-7828.

Section B: Contact Information
7. Contact Name

8. Contact Title/Position

9. Contact Phone Number (Include area code)

10. Contact Email Address

Section C: Payment Information
11. Payment Amount

12. Payment Reference Number

13. PIN or Invoice Number

14. Refund Amount

15. Is this a FURLS refund request? (See instructions for more information.)
(a) FURLS Request Type
Used PIN

Yes

No (Proceed to field 16)

(b) Registration or Owner/Operator Number
Unused PIN (Proceed to field 16)

(c) Why did your facility originally pay the fee?

(d) Why do you believe your facility is not required to pay the fee?

(e) List all activities performed at your facility

(Section C continued, next page)

FORM FDA 3913 (5/15)

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PSC Publishing Services (301) 443-6740

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Section C: Payment Information (Continued)
15. Is this a FURLS refund request? (Continued)
(f) List all products manufactured at your facility

16. Reason for Request (Please explain)

17. ACKNOWLEDGEMENT: By signing this document I acknowledge that I am the official listed on this form, authorized to
execute this request on behalf of my organization. Any questions regarding this request can be directed to me via the
contact information provided.

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18. Signature

Date of Signature (mm/dd/yyyy)

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Section D: FDA Acknowledgement
19. FDA Received Date (mm/dd/yyyy)

20. Center Decision
Approved

Denied

21. If Denied, State Reason
22. Decision Date (mm/dd/yyyy)

23. Center Contact Name

OFM Use Only
24. Request Executed?
Yes

25. If No, State Reason

No

26. Final Action

27. Date of Final Action (mm/dd/yyyy)
Completed – Refunded

Completed – Not Refunded

28. OFM Contact Name

Instructions for Completing User Fee Payment Refund Request – Form FDA 3913
Form FDA 3913 is to be completed online at http://www.
fda.gov/forindustry/userfees/default.htm and is to be
used when requesting the refund of user fee payments
received by the FDA. If you need assistance in
completing this form contact the User Fee Helpdesk via
phone at (301) 796-7200 or email userfees@fda.gov.

Section A: Payment Information
1. Date of Request: Enter calendar date the form is
being completed.
2. Organization Name: This is name of the
organization submitting the request.
3. Organization Address: Enter the following
elements of the organization’s address.
FORM FDA 3913 (5/15)

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Address 1 – Enter organization’s physical street
address where the refund is to be sent. No P.O.
Boxes are allowed.
Address 2 – As needed, enter apartment, suite,
unit, building, floor, etc.
City – Enter the city where organization is located.
State/Province/Region – Enter the state, province
or region where organization is located.
Country – Enter country where organization is
located.
ZIP or Postal Code – Enter zip code or postal
code of the organization’s location.

Instructions (Continued)

4. Type of Vendor: Select the appropriate box to
indicate whether the organization is a U.S. or
foreign vendor.

Center for Devices and Radiological Health
(CDRH). Check “Unused PIN” if PIN was not used
to register, and proceed to field 16.

5. TIN/EIN: (U.S. vendor only) Enter organization’s
nine-digit federal Taxpayer Identification Number
(TIN) or Employer Identification Number (EIN).
Without this entry, the refund request cannot be
processed.

(b) Registration or Owner/Operator
Number – Enter FURLS registration or owner/
operator number.

6. DUNS: (Foreign vendor only) Enter organization’s
nine-digit Dun & Bradstreet Data Universal
Numbering System (DUNS) number. If you do not
know your DUNS number or need to request one,
visit www.dnb.com or call (800) 234-3867. Without
this entry the refund cannot be processed.

(d) Why do you believe your facility is not
required to pay the fee? – Provide reason why
the facility should not be required to pay the fee.

Section B: Contact Information

(c) Why did your facility originally pay the
fee? – Provide reason why the user fee was paid.

(e) List all activities performed at your
facility – Provide list of all activities currently
performed at your facility (i.e. manufacture medical
device, contract sterilizer, etc.).

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7. Contact Name: Enter the name of the person
requesting the refund.

8. Contact Title/Position: Enter the position/title of
the person requesting the refund.
9. Contact Phone Number: Enter the phone number
of the person requesting the refund.
10. Contact Email Address: Enter the email address
of the person requesting the refund.

Section C: Payment Information

(f) List all products manufactured at your
facility – Provide list of all products associated
with each activity.

16. Reason for Request: Provide a brief description of
why refund is being requested.
17. Acknowledgement: Review acknowledgment,
confirming that you are the authorized
representative listed on this form and have
provided valid contact information in the event that
there are questions pertaining to the request.
18. Signature: Place signature of listed authorizing
official here.

11. Payment Amount: Enter the amount (in U.S.
Dollars) of the payment that is to be refunded.
12. Payment Reference Number: If payment was
remitted via check, money order or bank draft,
enter the check or money order number; if made
electronically via Automated Clearing House (ACH)
or credit card, enter the confirmation number; if
made via wire transfer, enter the trace or Input
Message Accountability Data (IMAD) number.
13. PIN or Invoice Number: Enter the Payment
Identification Number (PIN) or invoice number
where payment was applied.

Date of Signature – Date document is signed by
authorizing official.

Section D: FDA Acknowledgement
This section is for FDA use only. An FDA
representative will fill out the following items:
19. FDA Received Date: Enter date that request was
received by FDA.
20. Center Decision: Check appropriate box,
indicating if request was approved or denied.

14. Refund Amount: Enter the amount (in U.S.
Dollars) that is to be refunded.

21. If Denied, State Reason: If response to field 20
was “Denied”, provide reason.

15. Is this a FURLS refund request? If request is for
fees paid for registration within the FDA Unified
Registration and Listing System (FURLS), check
the appropriate box. If response is “Yes”, complete
fields (a) through (f). If response is “No”, proceed to
field 16.

22. Decision Date: Enter date decision was made.

(a) FURLS Request Type – Check “Used PIN” if
PIN was used to register your facility with FDA’s
FORM FDA 3913 (5/15)

23. Center Contact Name: Enter name of the Center’s
action officer.
24. Request Executed: Check the appropriate box,
indicating if request was executed.
25. If No, State Reason: If response to field 24 was
“No”, provide reason.

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Instructions (Continued)

26. Final Action: Check the appropriate box, indicating
if request was refunded or not refunded.

28. OFM Contact Name: Enter name of the OFM
action officer.

27. Date of Final Action: Enter date that final action
was taken on request.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 0.40 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

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“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number.”

FORM FDA 3913 (5/15)

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