FDA 3613a SUPPLEMENTARY INFORMATION CERTIFICATE OF EXPORTABILITY R

Form Approved: 0MB No. 0910-0498; Expiration Date: 8/31/2021

SUPPLEMENTARY INFORMATION
CERTIFICATE OF EXPORTABILITY REQUESTS

Department of Health and Human Services
Food and Drug Administration

Send the Exp01t Certificate Requests and supporting documents to the appropriate Center within FDA that would have
control over your product:
CBER: CBER regulates biological products, including blood and blood products, vaccines, allergenics, tissues, and
cellular and gene therapies. CBER also regulates the medical devices involved in the co)lection, processing, testing,
manufacture and administration of licensed blood, blood components and cellular products and all HIV test kits used
both to screen donor blood, blood components, and cellular products and to diagnose, treat, and monitor persons with
HIV and AIDS. Please see pages 7 for CBER instructions on how to apply for this certificate.
CDRH: CDRH regulates devices ranging from thermometers to kidney dialysis machines and electronic products that
emit radiation such as microwaves. Please submit your application on line using https://www.access.fda.gov/oaa.
Please see page 8 for CDRH instructions on the 801 Certificate. Please see page 9 for CDRH instructions for the 802
Ce1tificate.
CVM: Feed/food, drugs and devices used in pets, farm animals, and other animals are regulated by the Food and Drug
Administration, Center for Veterinary Medicine, Division of Compliance (HFV-234), 12225 Willdns Avenue,
MPN4 #133, Rockville; MD 20852. If you have any questions, please email [email protected].
Please see page 10 for CVM instructions on how to fill out this form and apply for this certificate.
1A. Requestor Information
Address

Name
Firm
i· ,-'

_____________________________
Owner operator number (if applicable)

Telephone number

FAX number

Firm Tax ID code

Email address

____________________________________________________
1 C. Shipping Account Number and/or Label (Mailing supplies

18. Billing Address (if not the same as requestor)

____________________________
may be sent along with tl1is form.)

Alternate Billing Email Address (if not the same as requestor)

Certificates will be sent electronically

2. Manufacturer Information (The following entries are to be entered separately for each firm; multiple entry sets arn provided)
Address (P.O. Box not acceptable)

Firm or Firm Establishment Identifier (FEI)
__________________
Registration number/Firm
______________________
Establishment Identifier (FEI)

____________________
Date
of last FDA inspection

(Item 4 entry sets continued, next page)

Center for Biologics Evaluation and Research (CBER)
instructions are on page 7.

Center for Devices and Radiological Health (CDRH)
instructions for 802 are on page 9.

Center for Devices and Radiological Health (CDRH)
instructions for 801(e)(1) begin on page 8. ·

Center for Veterinary Medicine (CVM)
instructions are on page 10.

FORM FDA 3613a (2119)

Page 1 of 10

PSC Publishing Scr'\'i«s(lOl) ·Hl-6740

EF

2. Manufacturer Infor mation (Continued)

Same Changes from Page 1

Firm

Address (P.O. Box not acceptable)

Registration number/Firm
Establishment Identifier (FEI)

Date of last FDA inspection

Firm

Address (P.O. Box not acceptable)

Registration number/Firm
Establishment Identifier (FEI)

Date of last FDA inspection

Firm

Address (P.O. Box not acceptable)

Registration number/Firm
Establishment Identifier (FEI)

Date of last FDA inspection

Firm

Address (P.O. Box not acceptable)

Registration number/Firm
Establishment Identifier (FEI)

Date of last FDA inspection

Firm

Address (P.O. Box not acceptable)

Registration number/Firm
Establishment Identifier (F�I)

Date of last FDA inspection

Firm

Address (P.O. Box not acceptable)

Registration number/Firm
Establishment Identifier (FEI)

Date of last FDA inspection

Product name
CVMeCATs will ask for Product name and National Drug Code
________
Product class

_________________________
D Class 1
D Class2
D Class3

__________________
Does
the product have an
0Yes
__________
approved IDE?
If___________________
yes, provide IDE number: ------ - - - �
These are not applicable to animal products

4. List country(ies) for which the Certificates are requested. Please list at least list one country.

FORM FDA 3613a (2119)

Page 2 of 10

No Changes to Section 4 or 5

5.Other information to appear on the certificate.

6. Should
the country destination be listed on the certificate? (Note: CDRH does not list specific country on the certificate
------------------------------------------------------------------------------------------------------------------------------unless
requested.)
-----------------CVMeCATS Will Not Ask This Question

0 Yes

0 No

Indicate the total number of certificates requested:

----------------------------------------------------------------------------------------------------7. Are
you exporting pursuant to section 801 (e) or section 802 of the Act?

O To section 801(e)

To section 802
O
-------------

Section 7 will now read as follows: Please check this box to verify you are exporting

pursuant to section 801(e) of the Act.

____________________________________________________________________________________________________
NOTE:
To meet the requirements for exporting products pursuant to section 802 of the Act, an exporter must maintain records of the

_________________________________________________________________________________________________________________
product(s) exported and the countries to which they were exported. Notification of exporting unapproved drugs or devices, including
_________________________________________________________________________________________________________________
biologics,
pursuant to section 802(g) of the Act is separate from requesting or receiving a Certificate of Exportability. Notification to FDA
____________________________________________________________________________________________________
is required when the exporter first begins to export and should be sent to the same address for requesting export certificates.

FORM FDA 3613a (2/19)

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Department of Health and Human SeNices
Food and Drug Administration

EXPORTER'S CERTIFICATION STATEMENT
"CERT/FICA TE OF EXPORTABILITY"
for CBER and CVM

FIRM NAME

As the responsible official or designee of the company named above, I hereby certify to the United States Food and Drug
Administration that:
l. The product(s) accords to the specifications of the foreign purchaser;

2. The product(s) is not in conflict with the laws of the country to which it is intended for export;
3. The product(s) is labeled on the outside of the shipping package that it is intended for export;
4. The product(s) is not sold or offered for sale in the United States;
5. Each product(s) identified on the request and certificate is being exported from the United States;
6. All contract manufacturers, contract sterilizers, etc. involved in the manufacturing process have been identified
on the Application,; and
7. The manufacturer is currently registered and has listed each of its products identified for export as required by
section 510 of the Act and CFR Part 207, 607, 807.
------------------------------------------------------------------------(Check
below, if exporting under Section 802 of the Act.)

This does not apply to animal products

D
In addition, I hereby certify to the FDA that pursuant to Section 802(£)(1) of the Act, the product(s) being
-----------------------------------------------------------------------------------------

-----------------------------------------------------------------------------------------------------------------------------------------exported
has been manufactured, processed, packaged, and held in substantial conformity with current good
..
----------------------------------------------manufacturing
practice requirements.

SIGNATURE

..

,'

'

'

DATE

NAME AND TITLE

I hereby make this Certification of Compliance Statement for FDA with full knowledge that the making or submission
of false statements represent violations of the United States Code Title 18, Chapter 47, Section 1001.
Penalties include up to $250,000 in fines and up to 5 years imprisonment.
FORM FDA 3613a (2/19)

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Department of Health and Human Services
Food and Drug Administration

INSTRUCTIONS FOR COMPLETION OF
APPUCATION FOR CERTIFICATES OF EXPORTABILITY
(forCVM)
I. The "Certificate of Exportability" is for the export of products
not approved for marketing in the United States (unapproved
products) that meet the requirements of Sections 80l(e) qr 802 of
the Act. Certificate requests should include the information listed
in Supplementary Information - Certificate of Exportability
Requests (PDF, Text). Please ensure that the Exporter's
Certification Statement is signed by a responsible official of the
exp01ting firm and is enclosed with the ce1tificate request.

4. Requests for certificates should be sent to:

2. If the requested information on the application form is not
provided by the cxpo1ting firm or if clarification is needed on
the supplied information, the exporting firm will be contacted
via telephone or email. If the exp01ting firm does riot provide the
necessary information within 48 hours, the request for certificates
will be returned and will need to be resubmitted. You may
enclose a completed air billing number and mailing supplies to
expedite return of the Certificates. A certificate will be issued for
each product.

5. The fee for preparing and issuing a single certificate for animal
drugs is $175; the first duplicate of that original is $155; and $70
for each subsequent duplicate per request. The fee for preparing
and issuing each certificate for animal feed/food will not exceed
$175. Please do not include-the fee payment with your requests;
the exporting firm will be billed quarterly.

Food and Drug Administration
Center for Veterinary Medicine
Division of Compliance (HFV-234)
12225 Wilkins Avenue, MPN4 #133
Rockville, MD 20852
[email protected] - for inquiries)

3. Enors made by FDA during the preparation of export certificates
will be corrected, at no cost to the applicant, within 45 days after
issuance..
• Errors made in the application, by the submitter, cannot be
corrected. A new application must be submitted.

This section applies only to requirements of the Pape1work 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 1 hour per response, including the time to review
instructions, seai'ch 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 Operations
Paperwork Reduction Act (PRA) Staff

PRAStafJ@[da.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless if displays a currently valid 0MB number. "

FORM FDA 3613a (2/19)

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