FDA 3613c Supplementary Information Non-Clinical Research Use Only

Form Approved: OMB No. 0910-0498; Expiration Date: 2/28/06

SUPPLEMENTARY INFORMATION
NON-CLINICAL RESEARCH USE ONLY CERTIFICATE

Department of Health and Human Services
Food and Drug Administration
1. Requestor Information
Name

Address

Firm

Telephone number

FAX number

Firm Tax ID code

2. Manufacturer Information
Address (P.O. Box not acceptable)

Firm

Registration number (if applicable)

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

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

5. Should the country destination be listed on the certificate?
Yes

No

Indicate the total number of certificates requested:

CBER instructions begin on page 3.
FORM FDA 3613c (2/06)

CDRH instructions begin on page 4.
Page 1 of 7

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

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
non-clinical 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

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

Department of Health and Human Services
Food and Drug Administration

EXPORTER’S CERTIFICATION STATEMENT
“NON-CLINICAL RESEARCH USE ONLY PRODUCT(S),
MATERIAL(S), OR COMPONENTS”
for 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 components 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 research use only materials will be labeled in accordance with 21 CFR
809.10(c)(2)(i), and exported as they are presently being sold or offered for sale in the United States.
I hereby make this certification of compliance statement to FDA with full knowledge that the making or submission of
false statements represent violations of United States Code Title 18, Chapter 47, Section 1001. Penalties include up to
$250,000 in fines and up to five years imprisonment.
SIGNATURE

DATE

NAME AND TITLE

FORM FDA 3613c (2/06)

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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.

ponent 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 Cosemetic 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 requester or if
clarification is needed on the supplied information, the requester
will be contacted via telephone or FAX. If the requester 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:

and Drug Administration
FFood
O
Center
for Biologics Evaluation and Research
of Compliance and Biologics Quality
PRO Office
• The “Certificate of Exportability” is for the export of products
Division of Case Management
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 com-

FORM FDA 3613c (2/06)

1401 Rockville Pike, Attention: HFM-624
Rockville, MD 20852-1448
or via FAX at 301-594-0940
• 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.

Page 3 of 7

Department of Health and Human Services
Food and Drug Administration

INSTRUCTIONS FOR REQUESTS FOR
NON-CLINICAL RESEARCH USE ONLY CERTIFICATE
(for CDRH)
1. Complete the “Exporter’s Certification Statement” and the
“Supplementary Information Sheet.” Please ensure that you sign
the Exporter’s Certification Statement on your firm’s letterhead.

7. Clearly mark on the outside of the envelope containing the request as a “Request for Certificates.” If you have any questions,
please call 240 276-0132 or email [email protected].

2. Using the attached example (Attachment I), prepare on plain
white 8 ½” x 11” bond paper, the Non-Clinical Research Use
Only Certificate (print margin one inch, top margin two inches,
44 lines per page). You may also submit this information on a CD
or disk using Microsoft Word or compatible software.

8. CDRH has the authority to charge $175 for the first certificate
and $15 for any subsequent certificates issued for the same
product(s) in response to the same request. Please do not submit a check with your request, as FDA bill quarterly.

3.

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information is omitted in the application by the requester or if
If more than three products/materials to be included on the CertifiPR 9. Ifclarification
is needed on the supplied information, the requester
cate, provide a typed list of products/materials (please provide
complete products/materials description as it appears on the
labeling) on consecutively numbered 8 ½” x 11” sheets of paper
(Attachment J). Do not submit catalogs or catalog pages.

will be contacted via email, telephone, or FAX. If the requester
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.

4. Each request is limited to a total of 100 pages, including the
Certificate. If your need exceeds the 100 page limit, you must
request additional certificates. For example, if you request a
certificate with 9 attachment pages (for a total of 10 pages), you
may request up to 1 original and 9 subsequent certificates.

10. Issuance of a “Certificate to Foreign Government” or “Certificate of Exportability” will not preclude regulatory action by
FDA, if warranted, against products covered by the Certificate.

5. Enclose a self-addressed stamped envelope or FEDEX envelope large enough to accommodate the requested Certificate(s).

11. A “Certificate to Foreign Government” or “Certificate of
Exportability” is issued by FDA solely for export purposes and
may not be used for domestic advertising.

6. Send the request and supporting documents to:
Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
Attention: HFZ-307
2094 Gaither Road
Rockville, MD 20850
FORM FDA 3613c (2/06)

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instructions for Requests of Non-clinical Research Use Only Certificates (for CDRH) (Continued)

ATTACHMENT I

EXAMPLE

Certificate No.

NON-CLINICAL USE RESEARCH ONLY CERTIFICATE
In order to allow the importation of United States products into foreign countries, the U.S. Food and Drug
Administration (FDA) certifies the following information concerning the product(s), materials(s), or component(s)
to be exported listed below:
NAME OF PRODUCT(S)/MATERIAL(S)
(GENERIC NAME IF APPLICABLE)

NAME OF MANUFACTURER, ADDRESS

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The product(s), material(s), or component(s) described above and the plant(s) where it is produced are subject to the jurisdiction of the FDA under the Federal, Drug, and Cosmetic Act (FD&C Act). FDA does not
routinely inspect non-clinical research use product(s), material(s), or component(s), since these products are
not subject to current good manufacturing practice requirements.
FDA does certify that the above product(s), material(s), or component(s) may be marketed in, and legally
exported from, the United States of America at this time.

Regulatory Policy and Systems Branch
Office of Compliance
Center for Devices and Radiological Health

This certificate expires 24 months
from the date notarized.
COUNTY OF MONTGOMERY
STATE OF MARYLAND
Subscribed and sworn to before me this

day of

month

Signature

FORM FDA 3613c (2/06)

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year.

instructions for Requests of Non-clinical Research Use Only Certificates (for CDRH) (Continued)

ATTACHMENT J

EXAMPLE OF ATTACHMENT PAGE(S)

Non-clinical Research Use Only Certificate – Attachment (Page # of # Pages)
Name of Product(s)

List all
product(s)
separately
and state
associated
devices

Please place
this statement at the
end of your
product list

Name of Manufacturer/Address

Rollover main

NRCE Inc.

Coating

1123 Mary Drive

Lanalen

Larry, MA 01832

“END OF PRODUCT LIST”

Please list
company name
and address on
all attachment
pages

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Paper Type: Plain White
8-1/2” x 11” Bond
Margins: Top
Left
Right
Bottom

1”
1”
1”
1”

Lower Right Corner 2-1/2” (to
allow for gold seal)

Gold
Seal
Note: Please list as many products
on each page as possible, minimum
Font size 9.

FORM FDA 3613c (2/06)

Format should be
“Page # of Total
pages”

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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 applicable address below.
Food and Drug Administration
Center for Biologics Evaluation
and Research
1401 Rockville Pike
Rockville, MD 20857

Food and Drug Administration
Center for Devices and
Radiological Health
2094 Gaither Road
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 control number.

FORM FDA 3613c (2/06)

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