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pdf“CERTIFICATE” (EXPORTS) APPLICATION – FORM FDA 3613d
Instructions
You will need to determine the requirements for importing products from the importing country. NOTE: Do not request a cosmetic certificate for a product classified as a drug in the United
States. The terms “drug” and “cosmetic” are defined in the Federal Food, Drug, and Cosmetic Act (Sections 201 (g) and (i)).
• The term “drug’’ means articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease
in man or other animals, and articles (other than foods and
dietary supplements) intended to affect the structure or any
function of the body of man or other animals.
• The term “cosmetic’’ means articles intended to be rubbed,
poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and articles intended for use as a component of
any such articles; except that such term shall not include
soap (soap is defined in the Code of Federal Regulations at
21 CFR 701.20).
1. Requester Information
Enter the requester’s name and contact information. The requester is the person requesting the export certificate and is
responsible for filing the signed form. The requester must have
a U.S. postal address.
rier and your account number. Do not mail self-address stamped
envelopes.
5. Fees
Cosmetic certificates issued by FDA cost $10.00 for each certificate. Do not send payment with your request. We will send
an invoice when we issue the certificate(s).
6. Signature
This box requires an original signature of the requester, the
person identified in Box 1. Copies and faxes are not accepted.
The signature verifies that you as the requester hereby present
and acknowledge that the company is aware that in making
this request the company is subject to the terms and provisions of Title 18, Section 1001, U.S. Code, which makes it a
criminal offense to falsify, conceal, or cover up a material fact;
make any material false, fictitious, or fraudulent statement or
representation; or make or use any false writing or document
knowing the same to contain any materially false, fictitious, or
fraudulent statement or entry. Failure to sign Form FDA 3613d
will result in an incomplete application, which will be returned
to the requester.
PROOF
Enter the exporting company name and contact information.
The exporting company is the U.S. manufacturer or firm that is
requesting the export certificate. The requester and the exporting company may be the same.
Type a Product List. The Product List should be typed on an
8.5" X 11" sheet of paper and have “Product List” centered at
the top of the page. Align the list with the left margin. Type a
numbered list of the products and brand names, exactly as they
appear on the cosmetic product labels. You may include a company letter head on your product specific list. Include a Product
List for the quantity of certificate you requested on your application. The submitted product list(s) will be attached to each
certificate.
3. Number of Certificates Requested and Products
Listed on Each Certificate
Do not submit labels. Additional information may be requested
upon review of your application.
2. Exporting Company Information
Enter the number of certificates that you require for exporting
your products and the number of products listed on your product specific list. There is a maximum of 10 export certificates
per application. Export certificates are intended to be used once
for a single shipment of products.
Mail your Certificate form, along with your product list(s) to:
4. Certificate Delivery
This box is optional. Certificates will be mailed via the U.S. Postal
Service (regular mail) unless you provide an express mail car-
Certificate (Exports) Request
Office of Cosmetics and Colors, HFS-125, CPK-2
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740-3835
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.
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
1350 Piccard Drive, Room 400
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 3613d (9/10)
Page 1 of 2
PSC Graphics (301) 443-1090
EF
Form Approved: OMB No. 0910-0498; Expiration Date: 10/31/2010
Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
OFFICE OF COSMETICS AND COLORS
“CERTIFICATE” (EXPORTS) APPLICATION
Date
1. Requester Information
Company name
Address
Contact person name
Contact phone
City
Contact fax
State
Contact email
Country
ZIP/postal code
2. Exporting Company Information (the name and address to appear on the certificate)
Company name
Product Web site
Address
PROOF
Contact person name
City
Contact phone
State
Contact fax
Country
ZIP/postal code
Contact email
3. Number of Certificates Requested and Products Listed on Each Certificate
Number of Certificates:
Number of Products:
You must type a “PRODUCT LIST” for each certificate requested. This Product List will be attached to your export Certificate.
For each product include the exact brand name as it appears on the label. See instructions on page 1.
4. Certificate Delivery
Certificates will be mailed via the U.S. Postal Service (regular mail) unless you make special arrangements as follows:
Carrier name (express mail)
Your account number
5. Fees
$10 for each certificate. Do not send money. You will receive an invoice.
6. Signature
“The requester hereby presents and acknowledges that the company is aware that in making this request the company is subject to the terms
and provisions of Title 18, Section 1001, United States Code which makes it a criminal offense to falsify, conceal, or cover up a material fact;
make any material false, fictitious, or fraudulent statement or representation; or make or use any false writing or document knowing the same
to contain any materially false, fictitious, or fraudulent statement or entry.”
Signature
FORM FDA 3613d (9/10)
Name and Title
Page 2 of 2
Date
| File Type | application/pdf |
| File Title | FDA-3613d.p65 |
| Author | PSC Graphics |
| File Modified | 2010-09-21 |
| File Created | 2010-09-17 |