Free FDA-3613e.p65 - Federal

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Form Approved: OMB No. 0910-0498; Expiration Date: 3/31/09

Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition 1. Food Manufacturer Information
Manufacturer name

FOOD EXPORT CERTIFICATE APPLICATION

Date

Doing business as name (If other than "Manufacturer name" to left, and you wish this name to appear on the export certificate)

State License/Registration number Contact person name Contact phone/fax Contact email

Postal Address

City Country

State

ZIP/postal code

2. Exporting Company Information (if applicable)
Export company name State License/Registration number Address

Contact person name Contact phone/fax/or email

City Country

State

ZIP/postal code

3. Shipment Description
Product Common Name Manufacturer Description/Comments

Continue on additional page(s) as needed.

4. Intended Destination of Shipment (Country)
Name of country

5. Send Certificate To
Firm name

Manufacturer

Distributor Address

Other (provide the following information)

City Contact person name Country

State

ZIP/postal code

6. Send Certificate Via
Carrier name (U.S. Mail, FedEx, etc.) Account number (If applicable)

7. Fees
Fees are $10 per certificate, and will be billed upon receipt of this application.
Copies of certificate:
Number

x
Fee/copy

=

Total $

FORM FDA 3613e (2/06)

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PSC Graphics: (301) 443-1090 EF

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8. Label(s)
Attach an original or an electronic copy of any applicable product label(s). A fax copy is acceptable only if it is readable.

9. Verification

The undersigned verifies that all ingredients are approved for use by FDA or appear on the GRAS list, and each product is intended for human consumption and is available for sale in the U.S. without restriction.
Signature Name and Title Date

Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition

FOOD EXPORT CERTIFICATE APPLICATION Instructions
For Manufacturers/Distributors
1. The Manufacturer/Distributor fills out the application information describing the consignment, manufacturer (note that different processing facilities of the manufacturer may be listed on the table describing the foods), where and how to send the certificate, optional information as needed, and applicant signature, name and date. 2. The Manufacturer/Distributor submits the application (by mail, fax, email), along with labels as applicable. The label must be legible. 6. The Official maintains in his records an identical copy of the signed Certificate, marked "Copy" for a period of at least two years. 7. In the event that the Manufacturer fails to comply with the law as stated on the Certificate, the Official will reject the application and promptly notify the Manufacturer that the Certificate cannot be issued.

After the Certificate Has Been Issued
8. The Manufacturer/Distributor forwards the Certificate to the foreign Importer and verifies that it is acceptable. 9. If the Certificate is not acceptable, the Exporter notifies the FDA Official that the certificate has not been accepted by the Importer, and the Official will promptly attempt to reconcile the issue with the Importer. 10. If an original certificate is destroyed or lost, the Manufacturer/ Distributor can request an identical replacement, bearing the unique identification number and same expiration date, to be issued by the Official and marked "Replacement."

For FDA Officials
3. FDA official reviews the application to be sure all the blanks are filled in properly, verifies manufacturer's license or registration, and investigates inspection data on the listed products. 4. The Official may require an inspection prior to issuance of the export certificate. 5. The Official prints the Certificate on watermarked Department letterhead, assigns a unique registration number and expiration date, signs, dates, seals and issues the Certificate as indicated.

Paperwork Reduction Act Statement Public reporting burden for this collection of information is estimated to average 1 hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to the address below. Food and Drug Administration Center for Food Safety and Applied Nutrition (HFS-550) 5100 Paint Branch Parkway College Park, MD 20740 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.

FORM FDA 3613e (2/06)

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