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