80 FR 20230 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Cosmetic Export Certificate Application Process

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 72 (April 15, 2015)

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

[Federal Register Volume 80, Number 72 (Wednesday, April 15, 2015)]
[Notices]
[Pages 20230-20231]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-08617]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by May 15, 
2015.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-NEW and 
title ``Food and Cosmetic Export Certificate Application Process (21 
U.S.C. 381(e)).'' Also include the FDA 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 Road; COLE-14526, Silver 
Spring, MD 20993-0002 [email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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

[[Page 20231]]

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.
    In the Federal Register of January 9, 2015 (80 FR 1422), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. We received four comments in response to the 
notice. The comments generally supported the necessity and practical 
utility of the information collected during the export certificate 
application process for food, however no comments were received 
regarding the export certificate application process for cosmetics. Our 
responses to the comments are discussed below.
    One comment had concerns about our request for the manufacturer's 
(and exporter's, if different from manufacturer) state license or 
registration number on Form FDA 3613e, stating that doing so could 
allow third parties unnecessary and/or unauthorized access to 
confidential commercial information. We appreciate this comment and 
note that we do not place the firm's state license or registration 
numbers on the certificates we issue. In addition, confidential 
commercial information is protected from disclosure under the Freedom 
of Information Act under sections 552(a) and (b) (5 U.S.C. 552(a) and 
(b)), and under our regulations at 21 CFR part 20. At the same time, 
the state license or registration number is necessary for our review of 
the application. We verify the license or registration and investigate 
inspection data on the listed products.
    One comment suggested ways we might modify the electronic 
submission system, including expanding the number of characters that 
may be entered per data field; developing corporate identification 
numbers and passwords, permitting a product label to be submitted 
electronically through the CFSAN Certificate Application Process; and, 
permitting a submitter to pay the application fees electronically 
within the CFSAN Certificate Application Process. Similarly, another 
comment discussed possible changes to the content of the Export 
Certificates or the Certificates of Free Sale that we issue for food, 
including incorporating pagination to indicate the number of sequential 
pages that would be part of the certificate; adding statements that the 
product is fit for human consumption, may be freely sold or exported in 
the United States, and, is produced in a manner consistent with good 
manufacturing practice; and providing the applicant the ability to 
request the type of certificate referenced on the header of the 
document and to request additional services, such as a notarized 
certificate document or expedited processing. While we are not able to 
accommodate the suggested modifications at this time, we will consider 
them as we contemplate future revisions to the relevant forms and 
solicit additional comments at that time through a notice published in 
the Federal Register.
    Finally, one comment was received that did not respond to any of 
the four information collection topics solicited and is therefore not 
addressed by the Agency.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                             Number of                        Average
                        Category                             FDA form        Number of     responses per   Total annual     burden per      Total hours
                                                              No.\2\        respondents     respondent       responses       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, & Medical Foods........................
Food Additives and Food Contact Substances..............           3613e             167               1             167             1.5             251
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............  ..............           4,942
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\1\ There are no operating and maintenance costs associated with this collection of information.
\2\ Forms FDA 3613d and 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: March 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-08617 Filed 4-14-15; 8:45 am]
 BILLING CODE 4164-01-P