FDA 3613c Supplementary Information Non-Clinical Research Use Only

Form Approved: OMB No. 0910-0498; Expiration Date: xx/xx/201x

Department of Health and Human Services
Food and Drug Administration

SUPPLEMENTARY INFORMATION
NON-CLINICAL RESEARCH USE ONLY CERTIFICATE

Send the Export 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 collection, 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 page 4 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 online using https://www.access.fda.gov/oaa. For
questions regarding CECATS please send an email to cecats@fda.hhs.gov.
Complete pages 1, 2, and 3 for devices. Please see page 5 for CDRH instructions.
Please submit your request preferably online using CECATS, or by U.S. Mail if unable to use CECATS.
1. Requestor Information
Name

Address

Firm

Telephone number

FAX number

Firm Tax ID code

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

Email address

3. Shipping Account Number and/or Label (Mailing supplies my
be sent along with this form.)

4. Manufacturer Information
Firm

Address (P.O. Box not acceptable)

Registration number/Firm Establishment Identifier (FEI) (if applicable)

Center for Biologics Evaluation and Research (CBER)
instructions begin on page 4.
FORM FDA 3613c (2/15)

Center for Devices and Radiological Health (CDRH)
instructions are on page 5.
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PSC Publishing Services (301) 443-6740

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5. List Product(s), Material(s), or Component(s) to be exported for non-clinical research use only.

Product codes (if applicable)

6. List country(ies) for which the Certificates are requested. Please list at least 1 country.

7. Should the country destination be listed on the certificate? (Note: CDRH does not list a specific country on the certificate unless
requested.)
Yes

No

FORM FDA 3613c (2/15)

Indicate the total number of certificates requested:
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Department of Health and Human Services
Food and Drug Administration

EXPORTER’S CERTIFICATION STATEMENT
“NON-CLINICAL RESEARCH USE ONLY CERTIFICATE”
for CBER and CDRH

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 these non-clinical research use product(s), material(s), or component(s) are to be used for nonclinical research use only. The product(s), material(s), or component(s) will not be used in the prevention, treatment, or
diagnosis of human disease. These non-clinical research use only materials will be labeled in accordance with 21 CFR
809.10(c)(2)(i) or 21 CFR 312.160, as appropriate, and exported as they are presently being sold or offered for sale in
the United States. I further certify that these non-clinical research use only materials will comply with the due diligence
requirements in 21 CFR 312.160, where applicable.
SIGNATURE

DATE

NAME AND TITLE

Making or submitting false statements on any documents submitted to FDA may constitute violations of the United
States Code Title 18, Chapter 47, Section 1001 with penalties including up to $250,000 in fines and up to 5 years
imprisonment.

FORM FDA 3613c (2/15)

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Department of Health and Human Services
Food and Drug Administration

EXPORT CERTIFICATION
Submission Requirements for Requesting Certificates for
Exporting Products to Foreign Countries (for CBER)
Background
Firms exporting products from the U.S. are often asked by foreign
customers or foreign governments to supply a certification relating
to products subject to the Federal Food, Drug, and Cosmetic Act and
other acts the Food and Drug Administration (FDA) administers.
Under the FDA Export Reform and Enhancement Act of 1996
(the Act), FDA is authorized to issue certificates for drugs, animal
drugs, and devices within 20 days of receipt of a request for such a
certificate. A fee of up to $175 may be charged for each certificate
issued. In addition to issuing export certificates for approved or
licensed products, the FDA will also issue export certificates for
unapproved products that meet the requirements of Sections 801(e)
or 802 of the Act.

• Errors 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.
• Questions may be directed to the Import/Export Team at 240-4029155 or by email at CBERexportcert@fda.hhs.gov.
• Send the request and supporting documents to:
Food and Drug Administration
Center for Biologics Evaluation and Research
Office of Compliance and Biologics Quality
Division of Case Management
10903 New Hampshire Ave.
Building 71, Room G112
Silver Spring, MD 20993-0002

General Instructions:
• The “Non-clinical Research Use Only Certificate is for the export
of a non-clinical research use only product, material, or component
that is not intended for human use which may be marketed in, and
legally exported from the United States under the Federal Food,
Drug, and Cosmetic Act. Certificate requests should include the
information listed in Supplementary Information - Non-clinical
Research Use Only Certificate Requests (PDF, Text). Please
ensure that the Exporter’s Certification Statement is signed by a
responsible official of the exporting firm and is enclosed with the
certificate request.
• Please type certificate requests or print clearly.
• If information is omitted in the application by the requestor or if
clarification is needed on the supplied information, the requestor
will be contacted via telephone or FAX. If the requestor does not
provide the necessary information within 48 hours, the request for
certificates will be returned and will need to be resubmitted for
FDA review.
FORM FDA 3613c (2/15)

• On October 1, 1996, CBER was given the authority to charge $175
for the first two certificates and $85 for any subsequent certificates
issued for the same product(s) in response to the same certificate
request. Please do not submit a check with your request, as FDA
will bill you quarterly for issued certificates.
• You may enclose a completed air billing number and mailing
supplies to expedite the return of Certificates.
Issuance of a “Certificate to Foreign Government”, “Certificate
of Exportability” or “Certificate of a Pharmaceutical Product”
will not preclude regulatory action by FDA, if warranted, against
products covered by the Certificate.
A “Certificate to Foreign Government”, “Certificate of
Exportability” or “Certificate of a Pharmaceutical Product” is
issued by FDA solely for export purposes and may not be used
for domestic advertising.

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Department of Health and Human Services
Food and Drug Administration

INSTRUCTIONS FOR PAPER REQUESTS FOR
NON-CLINICAL RESEARCH USE ONLY CERTIFICATE
(for CDRH)
1. The “Non-Clinical Research Use Only” certificate is for
product(s), material(s), or component(s) that are not used to
prevent, treat, or diagnose human disease.
2. The manufacturing facility is required to label these products
according to 21 CFR 809.10(c)(2)(i) or 21 CFR 312.160, as
appropriate.

11. Mark on the envelope “Request for Non-Clinical Research Use
Only Certificates”. Please include the electronic return UPS or
FedEx label that FDA can use to mail the certificates to you.
Send the form along with certificate request to:
Food and Drug Administration
CDRH - Office of Compliance
Export Certificates
10903 New Hampshire Avenue
Building 66, Room 2621
Silver Spring, MD 20993-0002

3. All products listed on Non-Clinical Research Use Only Certificate
must be exported from the U.S.
4. Each Non-Clinical Research Use Only Certificate request must
be requested by the U.S. manufacturer. Requests received from
a foreign firm will not be considered. A U.S. firm must appear
on each Non-Clinical Research Use Only Certificate.
5. All contract manufacturers and contract sterilizers involved in
the manufacturing process must be identified on the 3613c form
regardless if they are to appear on the certificate.

12. CDRH has the authority to charge $175.00 for the first certificate
and $15.00 each for the subsequent copies. This is valid for
requests that are up to 50 pages each. Certificate includes the
certificate page and the attachment pages.
If the request is more than 50 pages, then the total number of
pages created by the request is divided by 50 and that number
will be the number of certificates that will be charged at $175.00
and the remaining number of certificates will be charged at
$15.00 each.

6. It is the requestor’s responsibility to ensure that the information
is supplied correctly, including spelling.
7. Please ensure that the Exporter’s Certification Statement is signed
by a responsible official of the exporting firm.

Example: If you request 15 certificates and each certificate has
12 attachment pages plus the certificate page that means each
certificate is 13 pages, your request will generate 195 pages in
all, this number will be divided by 50 that equals 3.9 which is
rounded to 4. Therefore you will be charged for 4 certificates at
$175.00 each and the remaining 11 at $15.00 each.

8. If more than 3 products are to be included on the certificate, this
will necessitate the creation of additional pages.
Explanation of the three product limit on the certficate: The
reason FDA wants only three products is to avoid typing errors
and to ensure that the certificate looks neat. If the product names
are long we suggest you create an attachment page. Essentially,
FDA wants you to minimize the writing on the certificate page.
Please note that all firms appearing on the actual certificate must
also appear on these additional pages. If you have questions about
how to format these pages, please send an email to: exportcert@
cdrh.fda.gov.
9. If information is omitted in the application by the requestor or
if clarification is needed, the requestor will be contacted via
email or phone. If the requestor does not supply the necessary
information within 48 hours, the request for certificates will be
closed and will need to be resubmitted for FDA review.
10 Errors 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.
FORM FDA 3613c (2/15)

Please note the maximum number of attachment pages is 49
pages. If you have more than 49 pages you will need to split the
request to two requests..
13. Please do not submit a check with your request, as FDA will bill
you quarterly.
14. Issuance of a certificate will not preclude regulatory action by
FDA, if warranted, against products covered by the Certificate.
15. A certificate is issued by FDA solely for export purposes and
may not be used for domestic advertising.
16. If you have any questions, please call 301 796-7400 or email
exportcert@cdrh.fda.gov
17. Please use a separate sheet to list any information that does not fit
on the Supplementary Information due to lack of space, you may
list the heading as “Attachment to Supplementary Information,”
e.g., contract manufacturer/contract sterilizer information,
product information, etc.

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

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Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
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FORM FDA 3613c (2/15)

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