FDA 3613c Supplementary Information Non-Clinical Research Use Only

Form Approved: OMB No. 0910-0498; Expiration Date: 10/31/2010

Department of Health and Human Services
Food and Drug Administration

SUPPLEMENTARY INFORMATION
NON-CLINICAL RESEARCH USE ONLY CERTIFICATE

1. Requestor Information
Name

Address

Firm

Telephone number

FAX number

Firm Tax ID code

Email address

2. Manufacturer Information
Firm

Address (P.O. Box not acceptable)

Registration number (if applicable)

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

4. List country(ies) for which the Certificates are requested.

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

No

Indicate the total number of certificates requested:

CBER instructions are on page 3.
FORM FDA 3613c (11/09)

CDRH instructions are on page 4.
Page 1 of 5

PSC Graphic Arts: (301) 443-1090

EF

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 (11/09)

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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.

General Instructions:
• The “Certificate to Foreign Government” is for the export of
products legally marketed in the United States. Certificate requests
should include the information listed in
Supplementary
Information – Certificate to Foreign Government 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 ensure that the
appropriate Exporter Certification Statements for Certificate to
Foreign Government Requests for Human Cells, Tissues, and
Cellular and Tissue-Based Products (procured prior to May 25,
2005, or on or after May 25, 2005) is signed by a responsible official
of the exporting firm and is enclosed with the certificate request.
• 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 801(e) or 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
exporting firm and is enclosed with the certificate request.
• The “Certificate of a Pharmaceutical Product” conforms to
the format established by the World Health Organization (WHO)
and is intended for use by the importing country when the product
in question is under consideration for a product license that will
authorize its importation and sale or for renewal, extension,
amending or reviewing a license. WHO Certificate requests
should include the information listed in
Supplementary
Information – Certificate of a Pharmaceutical Product
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.
• The “Non-clinical Research Use Only Certificate is for the
export of a non-clinical research use only product, material, or
FORM FDA 3613c (11/09)

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.
• In most cases, one product will be listed per certificate. However,
products that were approved under the same PLA / BLA, NDA,
PMA or 510(k) application or similar unapproved products may
be listed on the same certificate based on the available space for a
one page certificate. Certificate requests for listing multiple
products will be evaluated on a case-by-case basis.
• 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.
• Questions may be directed to the Import/Export Team at 301827-6201.
• 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
1401 Rockville Pike, Attention: HFM-624
Rockville, MD 20852-1448
or via FAX at 301-827-9189
• 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 FEDEX form 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 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.

10. Only hardcopy requests can be filled at this time.
11. Mark on the envelope "Request for Non-Clinical Research Use
Only Certificates". Please include a completed return Fedex Air
bill to expedite the return of the certificates. 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.
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.
8. If more than 3 products are to be included on the certificate, this
will necessitate the creation of additional pages. The requestor
will need to provide BOTH a paper and electronic version of
this information. 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: [email protected]
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
returned and will need to be resubmitted for FDA review.
FORM FDA 3613c (11/09)

12. CDRH has the authority to charge $175 for the first certificate
and $15 for any subsequent certificate issued at that time, up to
a total of 50 pages (including the certificate and any attachment
pages). For example, if you request a certificate which is 10
pages in total length you may only request 5 certificates. You
will be charged $175 for the first and $15 for each of the 4
additional certificates. If your request exceeds 50 pages you
will incur additional charges.
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
[email protected]

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[Applies equally to CBER and CDRH portions of this form.]
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.
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer (HFA-710)
5600 Fishers Lane
Rockville, MD 20857
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FORM FDA 3613c (11/09)

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