Form FDA 766 Changes

APPLICATION FOR AUTHORIZATION TO RELABEL OR RECONDITION
NON-COMPLIANT ARTICLES

FORM APPROVED: OMB No. 0910-0046
EXPIRATION DATE: 6/30/2023

Public reporting burden time for this collection of information is estimated to
average .25 hour 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 the address to the right:

Department of Health and Human
Services Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

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 control number.

Please do NOT send your completed form
to the above PRA Staff email address.

SECTION 1 Instructions for completing the FORM FDA-766 are found on pages 3 and 4.
1. TO:

2. APPLICATION DATE

Director of
Division, Food and Drug Administration

3. ENTRY NO. AND LINE NO.

4. PRODUCT
Application is hereby made for authorization to bring the article(s)
below into compliance with the Federal Food, Drug, and Cosmetic
5. QUANTITY
Act and other related Act(s).
6. QUANTITY TO BE RECONDITIONED

7. PRODUCTION CODES

8. Redelivery bond has been posted by the applicant. The article(s) will be kept apart from all other article(s) and will be available for
inspection at all reasonable times. The operations, if authorized, will be carried out at:
and will require about
days to complete. A detailed description of the method by which the article(s) will be brought into
compliance is given in the space below:

We will pay all supervisory costs in accordance with current regulations.
9. APPLICANT AND FIRM NAME

10. ADDRESS OF FIRM

11. APPLICANT’S SIGNATURE

SECTION 2 - FDA ACTION ON APPLICATION
13. DATE

12. TO: (Name and Address)

14. Your application has been:

Denied because:

Approved with the following conditions:

Time limit within which to complete authorized operations:
When the authorized operations are completed, fill in the importer’s certificate on the reverse side and return this notice to
this office.
15. SIGNATURE OF DIVISION DIRECTOR

FORM FDA 766 (11/20)

16. DIVISION

17. DATE

Page 1
PSC Publishing Services (301) 443-6740

EF

SECTION 3 - IMPORTER’S CERTIFICATE
18. Location where reconditioning operation occurred

19. DATE

20a. I certify that the work to be performed under the authorization has been completed and the article(s) are now ready for
inspection at:
20b. Contact Information:
21. The rejected portion is ready for the approved disposition under FDA or CBP supervision and is held at:
22. APPLICANT AND FIRM NAME

23. APPLICANT'S SIGNATURE

SECTION 4 - REPORT OF INVESTIGATOR / INSPECTOR
TO

24. DATE (MM/DD/YYYY)

PORT DIRECTOR OR DIVISION DIRECTOR

25. I have examined the within-described article(s) and find them to be the identical article(s) described herein, and that they have been:
on:

, 20

,

as authorized, except:

SECTION 5 - DATA ON RECONDITIONED ARTICLE(S)
26. Acceptable Portion:
27. Rejections:
28. Loss (if any):
29. Did importer recondition entire shipment?
30. Time and cost of supervision:
31. INSPECTING OFFICER NAME

32. DATE (MM/DD/YYYY)

33. INSPECTING OFFICER SIGNATURE

FORM FDA 766 (11/20)

Page 2

Instructions for Completing FORM FDA 766 (Reconditioning Proposal)
APPLICATION FOR AUTHORIZATION TO RELABEL OR RECONDITION NON-COMPLIANT ARTICLES
The following instructions can be used by Industry and FDA field staff when requesting and processing requests to recondition FDA
regulated products that have been detained due to a violation of the Act. Please note that it is no longer necessary to submit the form
in triplicate.

PAGE 1 OF FORM FDA 766:
SECTION 1: To be completed by the Importer of Record
1. To: DIRECTOR: Enter the name of the Food and Drug Administration Division Office that will be receiving the
reconditioning proposal.
2. APPLICATION DATE: Enter the date of the proposal in MM/DD/YYYY format.
3. ENTRY NO. AND LINE NO. Enter the applicable entry number and line number. (Please note that adding the line information is
important. Ex. Format: 123-4567891-9/11-1)
4. PRODUCT: Enter product name as it appears on the label and brief description of the product.
5. QUANTITY: Enter the total quantity of product.
6. QUANTITY TO BE RECONDITIONED: Enter the quantity of product to be reconditioned.
7. PRODUCTION CODES: Enter the production code or other unique identifiers. (Ex. Lot numbers, expiration dates, production codes
and specific quantities to be reconditioned)
8. Enter the following in box #8:
• The name and address of the location where reconditioning operations will take place: (Include contact information, name and
phone number, and the complete name and address of the location.)

•
•

The approximate time (in days) it will take to complete the reconditioning operations.
A detailed description of the method by which the merchandise will be brought into compliance. If additional space is needed,
attach the additional documentation to the form. Documentation may include the following: labeling, photographs, private
laboratory information.

9. APPLICANT AND FIRM NAME: Enter the name of applicant and firm requesting the reconditioning proposal. This will usually be the
individual/firm that will be billed for the supervisory costs.
10. ADDRESS OF FIRM: Enter the firm address that is requesting the reconditioning proposal.
11. APPLICANT'S SIGNATURE: Signature of applicant requesting the reconditioning proposal.

SECTION 2 - FDA ACTION ON APPLICATION: To be completed by the FDA Compliance Officer
12. TO: Enter the name and address identified in 9. and 10. above.
13. DATE: Enter date of action on application in MM/DD/YYYY format. (EX: 11/12/2019)
14. Denied/Approved:

•
•
•
•
•

Mark the “Denied because:” box if the application is denied. Enter the reason for the denial in the space below.
Mark the “Approved with the following conditions:” box if the application is approved. Enter any conditions on which the
application was approved in the space below.
Add the statement in the box: “ARTICLES SHOULD BE HELD INTACT PENDING THE RECEIPT OF FDA'S RELEASE
NOTICE.”
Add the current hourly and mileage rates for supervision per 21 CFR 1.99. (Note: this is not an estimation of the total cost
of supervision.)
Enter time limit within which the Importer has to complete the authorized reconditioning operations. (Enter the date as
indicated on the Notice of FDA Action authorizing the reconditioning operations.)

15. SIGNATURE OF DIVISION DIRECTOR: Signature of official authorizing or denying the reconditioning proposal. This is often the
compliance officer. May be signed electronically.
16. DIVISION: Enter the FDA Division office approving or denying the reconditioning proposal.
17. DATE: Enter the date the reconditioning proposal was approved or denied in a MM/DD/YYYY format. (EX: 11/12/2019)

FORM FDA 766 (11/20)

Page 3

PAGE 2 OF FORM FDA 766:
SECTION 3 - IMPORTER'S CERTIFICATE: To be completed by the Importer of Record when the authorized
reconditioning operations have been completed.
18. Location where reconditioning operations occurred: Enter the location where the reconditioning operations occurred. This is usually
the same location as box 8 on page 1.
19. DATE: Enter the date the reconditioning operations were completed in a MM/DD/YYYY format (EX: 11/12/2019)
20a. Enter the location where the reconditioned goods are ready for inspection if different than location specified in box 18.
20b. Contact information: Enter the contact information for the location where goods are ready for inspection.
21. Enter the location, if necessary, where the rejected portions are held if different than the location specified in box 20.
(If different than location where goods are ready for inspection).
22. APPLICANT AND FIRM NAME: Enter name of applicant/importer that is certifying reconditioning operations were performed as
authorized.
23. APPLICANT'S SIGNATURE: Signature of applicant/importer.

SECTION 4 - REPORT OF INVESTIGATOR/INSPECTOR: To be completed by FDA Investigator/Inspector or
individual verifying the reconditioning was completed.
24. DATE: Enter the date of investigator's/inspector's report in a MM/DD/YYYY format. (EX: 11/12/2019)
25. Enter the results of the field examination and whether they were reconditioned as authorized.

•
•

Enter the month, day and year of the examination of the goods in the spaces provided.
In the space provided, enter or describe any discrepancy observed during the field examination of the reconditioned goods.

SECTION 5 - DATA ON RECONDITIONED ARTICLE(S): To be completed by FDA Investigator/Inspector or
individual verifying the reconditioning was completed.
26. Acceptable Portion: Enter the quantity of the portion reconditioned successfully.
27. Rejections: Enter the quantity of the portion that was not reconditioned successfully.
28. Loss (if any): Enter any losses.
29. Enter response to question “Did importer recondition entire shipment?”
30. Enter time, mileage, and cost of supervision for all applicable FDA staff. (See RPM Section “Supervisory Charges”). Refer to
OASIS screen, “Reconditioning Results - Detail Supervision Costs.”
31. INSPECTING OFFICER: Enter the name of the FDA inspecting officer.
32. DATE: Enter the date of inspection of cleaned goods in a MM/DD/YYYY format. (EX: 11/12/2019)
33. INSPECTING OFFICER SIGNATURE: Enter the signature of the FDA inspecting officer.

FORM FDA 766 (11/20)

Page 4