
[Federal Register Volume 80, Number 6 (Friday, January 9, 2015)]
[Notices]
[Pages 1422-1423]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-00130]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-2347]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Food and Cosmetic Export Certificate Application 
Process

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information and 
to allow 60 days for public comment in response to the notice. This 
notice invites comments on the information collection provisions 
associated with export certificate applications for FDA regulated food 
and cosmetic products.

DATES: Submit either electronic or written comments on the collection 
of information by March 10, 2015.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Food and Cosmetic Export Certificate Application Process (21 U.S.C. 
381(e)) (OMB Control Number 0910-NEW)

    Some foreign countries require manufacturers of FDA regulated 
products to provide an export certificate for the products they wish to 
export to that country. A Certificate of Free Sale is a certificate 
(not pertaining to a particular production lot or export consignment) 
that indicates that the particular product is marketed in the United 
States or eligible for export, and that the particular manufacturer has 
no unresolved enforcement actions pending before or taken by FDA. FDA's 
Center for Food Safety and Applied Nutrition (CFSAN) issues such 
certificates for food, food additives, seafood, dietary supplements, 
and cosmetics. Interested persons may request a certificate by using 
the electronic CFSAN Certificate Application Process, which is part of 
FDA Unified Registration and Listing System, or by submitting a paper 
Form FDA 3613d for cosmetic products or a paper Form FDA 3613e for food 
products. We use the information submitted to determine whether to 
issue the requested certificate.
    OMB has approved the submission of requests for export certificates 
on paper Forms FDA 3613d and FDA 3613e and, electronically, via the 
CFSAN Certificate Application Process under OMB control number 0910-
0498. This notice announces that, to ensure the efficient review of the 
information collection by OMB under the PRA, we are seeking to obtain a 
new OMB control number for Forms FDA 3613d and FDA 3613e and the CFSAN 
Certificate Application Process to reflect that the electronic 
submission system for food and cosmetic export certificates is separate 
from the electronic submission system associated with export 
certificates for other FDA regulated products approved under OMB 
control number 0910-0498. Upon OMB approval of this information 
collection request, we will adjust the burden hours associated with 
Forms FDA 3613d and FDA 3613e and the CFSAN Certificate Application 
Process approved under OMB control number 0910-0498.
    We request the following information on Form FDA 3613d and the 
CFSAN Certificate Application Process, as currently approved by OMB: 
The name of and contact information for the requester; the name of and 
contact information for the exporting company (if different from 
requester); a designation of the type of certificate requested 
(``general'' or ``product-specific''); if product-specific, a list of 
the exact brand names of the products; the contact person, company name 
and address where the requested certificate should be sent; and, the 
name and account number (if applicable) of the requester's preferred 
carrier for delivery of the certificate. Finally, Form FDA 3613d and 
the CFSAN Certificate Application Process requires the requester's 
signature, the name and title of the person signing the form, as well 
as the date signed.
    We request the following information on Form FDA 3613e and the 
CFSAN Certificate Application Process, as currently approved by OMB: 
The name of and contact information for the manufacturer, as well as 
the manufacturer's state license or registration number; the name of 
and contact information for the exporting company (if different from 
manufacturer), as well as the exporting company's state license or 
registration number; a description of the shipment including the 
product, the common name, the manufacturer, and a description or 
additional comments; the name of the country to which the requester of 
the certificate intends to ship the product; the contact person, firm 
name and address where the requested certificate should be sent; and, 
the name and account number (if applicable) of the requester's 
preferred carrier for delivery of the certificate. Form FDA 3613e and 
the CFSAN Certificate Application Process requires the requestor to 
submit an original or copy of the applicable product label or labels. 
Finally, Form FDA 3613e and the CFSAN Certificate Application Process

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requires the submitter's signature, the name and title of the person 
signing the form, as well as the date signed.
    Description of Respondents: The respondents to this collection of 
information are firms interested in exporting U.S.-manufactured food 
and cosmetic products to foreign countries that require export 
certificates.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                             Number of
                   Type of respondent                        FDA form        Number of     responses per   Total annual   Average burden    Total hours
                                                            number \2\      respondents     respondent       responses     per response
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Cosmetics...............................................           3613d             600               1             600             1.5             900
Conventional Food (Including Seafood)...................           3613e             398               1             398             1.5             597
Dietary Supplements, Food for Special Dietary Use,                 3613e           2,129               4           2,129             1.5           3,194
 Infant Formula, and Medical Foods......................
Food Additives and Food Contact Substances..............           3613e             167               1             167             1.5             251
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    Total...............................................  ..............  ..............  ..............  ..............  ..............           4,942
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\1\ There are no operating and maintenance costs associated with this collection of information.
\2\ Form FDA 3613d and Form FDA 3613e may be submitted electronically via the Certificate Application Process.

    For the purpose of this information collection request, we are 
basing our estimate of the average burden per response in column 6 of 
Table 1 on the estimates previously submitted to and approved by OMB 
under control number 0910-0498. Our estimate of the average burden per 
response in column 6 of Table 1 varies according to the product 
category for which the certificate is requested. We base our estimates 
of the total annual responses in column 5 of Table 1 on our experience 
with certificate applications received in the past 2 fiscal years. Some 
respondents send in requests as often as three or four times a month 
while others may submit only periodic requests.
    We expect that most if not all firms requesting export certificates 
in the next 3 years will choose to take advantage of the option of 
electronic submission via the CFSAN Certificate Application Process. 
Thus, our burden estimates in Table 1 are based on the expectation of 
100 percent participation in the electronic submission process. The 
opportunity to provide the information in electronic format could 
reduce the Agency's previous estimates for the time to prepare each 
submission. However, as a conservative approach for the purpose of this 
analysis, we are assuming that the opportunity to submit the 
information in electronic format will have no effect on the average 
time to prepare a submission.

    Dated: January 5, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-00130 Filed 1-8-15; 8:45 am]
BILLING CODE 4164-01-P


