Information Submitted In Response To Termination Of Participation

Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research

For FDA Use Only
SSC Pilot Program
Application Number

SECURE SUPPLY CHAIN (SSC)
PILOT PROGRAM APPLICATION

Form Approved
OMB Control Number: 0910-XXXX
Expiration Date: Xxxxxx xx, 20XX
See OMB Statement on page 5.

A. APPLICANT INFORMATION
1. Business Information
Business Name

Address

Telephone Number

DUNS Number

City

State

2. U.S. Primary Contact

3. U.S. Secondary Contact

Name

Name

Telephone Number

Telephone Number

E-mail Address

E-mail Address

ZIP

4. Importer of Record
Importer Name

Address

DUNS Number

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5. Importer of Record’s IRS Number (Optional)

-OR-

Importer of Record’s FDA Establishment Identifier
(FEI) (FEI verified by FDA)

6. Customs Trade Partnership Against Terrorism (C-TPAT)
Supply Chain Validated as C-TPAT Tier II or
Tier III? (Select one)
Tier II

Status Verification Interface (SVI) Number (When available)

Application Date (When available)

Tier III

B. PRODUCT INFORMATION
7. New Drug Application (NDA)/Abbreviated New
Drug Application (ANDA) Number

8. National Drug Code (NDC) Number

9. FDA Product Code

10. Commercial Invoice Description

(Continuation page will be provided.)

11. Foreign Manufacturer
Name

Address

DUNS Number

12. CBP Manufacturer ID (MID) (For manufacturer)

FORM FDA 3676 (4/12)

13. Foreign Manufacturer FEI or Central File Number (CFN)

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PSC Publishing Services (301) 443-6740

EF

[FDA Use Only] SSC Pilot Program Application Number:
14. Describe methods of product identification, lot designation, and product tracing through the supply chain.

(Continuation page will be provided.)

C. LOGISTICS
15. U.S. Port of Entry

16. U.S. Port of Arrival (If different from Port of Entry)

17. Broker/Customs - Broker/Filer Information
Broker/Customs - Broker/Filer Name

Telephone Number

Address

DUNS Number

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E-mail Address

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18. Ultimate Consignee Information
Ultimate Consignee Name

Address

DUNS Number

19. Ultimate Consignee IRS Number (Optional)

-OR-

Ultimate Consignee FEI (FEI verified by FDA)

20. Foreign Shipper Information
Foreign Shipper Name

Address

DUNS Number

FEI

21. CBP Manufacturer ID (MID) (For shipper)

D. OTHER INFORMATION
22. Provide the full name and address of the location of records confirming the application information and documentation for all
shipments of the product that the applicant is submitting for inclusion in the SSC pilot program. Provide point of contact including
an e-mail address and telephone number.

FORM FDA 3676 (4/12)

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[FDA Use Only] SSC Pilot Program Application Number:
23. Describe Recall/Correction Plans, including the following: point of contact; method of communication; method for product
identification; procedures for returned products; and procedures for controlling and disposing of returned product.

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(Continuation page will be provided.)

24. Describe your plan for promptly correcting concerns that FDA identifies regarding specific importations or your secure supply
chain.

(Continuation page will be provided.)

FORM FDA 3676 (4/12)

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[FDA Use Only] SSC Pilot Program Application Number:

E. DETAILS OF YOUR SECURE SUPPLY CHAIN
Please provide a detailed narrative of the process by which the active pharmaceutical ingredient (API) and/or finished drug product
will be brought into the United States, from the point of product manufacture to delivery to the ultimate consignee. This narrative
must include, at a minimum, the following information:
A. API source, including DUNS number;
B. Source of finished drug product;
C. Master file number (if applicable);
D. Overview of the supply chain including facilities where manufacturing, packaging, labeling, and storage occur; and their DUNS
number when available or if not already provided above;
E. Transport from packager to port of lading;
F. Port of lading process from delivery to un-lading of vessel;
G. Transport process to the United States, including stops before arrival in the United States; and
H. Transport from port of arrival to ultimate consignee.

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(Continuation page will be provided.)

FORM FDA 3676 (4/12)

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[FDA Use Only] SSC Pilot Program Application Number:

F. ACKNOWLEDGEMENT
The undersigned acknowledges that it wishes to participate in the Food and Drug Administration (FDA) Secure Supply
Chain (SSC) pilot program. The undersigned understands the criteria for acceptance in the SSC pilot program, as
set forth in the third FEDERAL REGISTER notice, published on
titled “Secure Supply Chain Pilot
mm/dd/yyyy

Program,” and that FDA will determine participation based on the date of application and whether the program criteria
are met. If accepted for participation in the SSC pilot program, the undersigned understands that FDA will monitor its
entries to check for compliance with the program’s criteria.
To participate in the SSC pilot program, the undersigned will maintain records that confirm the information provided in
this application for the duration of the applicant’s participation in the program, and will ensure that these records will
be readily available when requested by FDA. FDA requests that these records be maintained for a period of at least 3
years after the pilot ends or the applicant’s participation in the pilot ends.
The undersigned agrees to submit a modified application detailing any changes to the information contained in this
secure supply chain application and obtain FDA authorization of these changes to continue participation.
The undersigned understands that FDA plans to run the SSC pilot program from
although FDA may terminate the program sooner or extend the ending date.

mm/dd/yyyy*

to
mm/dd/yyyy^

* Insert date 180 days after date of publication in the FEDERAL REGISTER announcing that FDA is accepting applications.
^ Insert date 30 months after date of publication in the FEDERAL REGISTER announcing that FDA is accepting applications.

AFT

Signature of applicant or applicant’s authorized representative

Date

DR

This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 3.5 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
1350 Piccard Drive, Room 400
Rockville, MD 20850
“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.”
the new PRA
Designer note: This is
ping the 3.5 hours
burden statement, kee
e noted previtim
nse
estimated respo
m.
for
c
cifi
spe
this
ously for

FORM FDA 3676 (4/12)

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Instructions for Completion of FORM FDA 3676
SECURE SUPPLY CHAIN (SSC) PILOT PROGRAM APPLICATION
Note: Applicants must file a separate application for each finished product or active pharmaceutical ingredient (API) for which inclusion in the SSC pilot program is sought.

dosage unit, dosage description (special markings, color,
and tablet), and dosage package for the product that the
applicant is submitting for inclusion in the SSC pilot
program.

A. Applicant Information
1. This is the legal name of the applicant to the SSC pilot
program. Provide the full name, address, DUNS number,
and telephone number of the applicant.
2. Provide the U.S. primary contact full name, phone number,
and e-mail address.
3. Provide the U.S. secondary contact full name, phone
number, and e-mail address.

11. Provide the full firm name and site-specific address of the
foreign manufacturer of the product that the applicant is
submitting for inclusion in the SSC pilot program.
12. Provide the U.S. Customs and Border Protection (CBP)
Manufacturer Identification Code (MID) for the foreign
manufacturer of the product that the applicant is submitting
for inclusion in the SSC pilot program.

4. Provide the full firm name, DUNS number, and address
for the Importer of Record. The importer of record is the
person, establishment, or representative responsible for
making entry of imported goods in accordance with all
laws affecting such importation.
5. The IRS Number is optional. If not provided, contact FDA
to determine the appropriate FEI.

13. Provide the FDA Establishment Identifier (FEI) or facility
Central File Number (CFN) for the foreign manufacturer of
the product that the applicant is submitting for inclusion in
the SSC pilot program.
14. Describe the methods of product identification, lot
designation, and product tracing through the supply chain
of the product that the applicant is submitting for inclusion
in the SSC pilot program.

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6. Customs Trade Partnership Against Terrorism (C-TPAT) –
Indicate in the space provided if the supply chain is
C-TPAT Tier II or Tier III Validated (either Yes or No).

D

For more information on C-TPAT see http://www.cbp.gov/
xp/cgov/trade/cargo_security/ctpat/

C. Logistics

Status Verification Interface (SVI) Number – Indicate the
SVI number of the space provided when available.

15. Provide the U.S. port of entry where a consumption entry
will be filed with CBP for the product that the applicant is
submitting for inclusion in the SSC pilot program.

Application Date – Indicate in the space provided the date
that the applicant applied for C-TPAT Tier II or Tier III
status when available.

16. Provide the U.S. port of arrival (if different from the
U.S. port of entry) for the product that the applicant is
submitting for inclusion in the SSC pilot program.
17. Provide the full firm name, DUNS number, address, and
e-mail of the firm (Broker/Customs - Broker/Filer) that will
be filing entry of the product identified in the application
with CBP.

B. Product Information
7. New Drug Application (NDA)/Abbreviated New Drug
Application (ANDA) Number – Provide the NDA and/
or ANDA number for the product that the applicant is
submitting for inclusion in the SSC pilot program. For
APIs, submit the NDA/ANDA number for the approved
products in which the API will be used.

18. Provide the full firm name, DUNS number, and address of
the Ultimate Consignee of the product that the applicant is
submitting for inclusion in the SSC pilot program.

8. National Drug Code (NDC) Number – Provide the NDC
number for the product that the applicant is submitting for
inclusion in the SSC pilot program.
9. Provide the FDA product code for the product that the
applicant is submitting for inclusion in the SSC pilot
program.
10. Commercial Invoice Description (also known as the
Product Description) – Provide the complete product
name (trade name and chemical name), dosage strength,
FORM FDA 3676 (4/12)

19. The IRS Number is optional. If not provided, contact FDA
to determine the appropriate FEI.
20. Provide the full firm name, DUNS number, and address
for the foreign shipper of the product that the applicant is
submitting for inclusion in the SSC pilot program.
21. Provide the U.S. Customs and Border Protection (CBP)
Manufacturer Identification Code (MID) for the foreign
shipper of the product that the applicant is submitting for
inclusion in the SSC pilot program. Also, provide the FEI.

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D. Other Information

• Master file number (if applicable);

22. Provide the full name and address of the location of records
confirming the application information and documentation
for all shipments of the product that the applicant is
submitting for inclusion in the SSC pilot program.
Provide a point of contact including an e-mail address and
telephone number.

• Overview of the supply chain including facilities where
manufacturing, packaging, labeling, and storage occur;

23. Provide Recall/Correction Plans that would be used
for returned products and procedures for controlling
and disposing of returned products that the applicant is
submitting for inclusion in the SSC pilot program.

• Transport process to the United States, including stops
before arrival in the United States;

• Transport from packager to port of lading;
• Port of lading process from delivery to un-lading of
vessel;

• Transport from port of arrival to ultimate consignee; and
• Include DUNS number for each business entity identified
in the application when available.

24. Provide a plan that would be used to correct deficiencies
identified by FDA regarding specific importations or the
firm’s secure supply chain process.

F. Acknowledgement

E. Details of YourSecure Supply Chain
Provide a detailed narrative of the process by which the
active pharmaceutical ingredient (API) and/or finished drug
product that the applicant is submitting for inclusion in the
SSC pilot program will be brought into the United States,
from the point of product manufacture to delivery to the
ultimate consignee. The narrative must include at least the
following information:
• API source;
• Source of finished drug product;

FORM FDA 3676 (4/12)

Sign the acknowledgement if you wish to participate in
the SSC pilot program. The applicant, by signing the
acknowledgement, understands the criteria for acceptance
in the SSC pilot, as set forth in the third FEDERAL
REGISTER notice, published on (insert Month, Day, Year)
titled “Secure Supply Chain Pilot Program,” and that FDA
will determine participation in the pilot program. The
acknowledgement also contains terms for participation
in the SSC pilot program that include maintaining and
making records available to FDA, and notifying FDA
with information about any changes to the secure supply
process.

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