[Federal Register Volume 86, Number 49 (Tuesday, March 16, 2021)]
[Notices]
[Pages 14452-14454]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05369]


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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 or we) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the information collection provisions 
associated with export certificate applications for FDA-regulated human 
food and cosmetic products.

DATES: Submit either electronic or written comments on the collection 
of information by May 17, 2021.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before May 17, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of May 17, 2021. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2014-N-2347 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Food and Cosmetic Export 
Certificate Application Process.'' Received comments, those filed in a 
timely manner (see ADDRESSES), will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at https://www.regulations.gov or at the Dockets Management Staff 
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

[[Page 14453]]


FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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, including 
each proposed extension of an existing 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

OMB Control Number 0910-0793--Extension

    Some countries may require manufacturers of FDA-regulated products 
to provide certificates for products they wish to export to that 
country. Accordingly, firms exporting products from the United States 
often ask FDA to provide such a ``certificate.'' In many cases, foreign 
governments are seeking official assurance that products exported to 
their countries can be marketed in the United States, or that they meet 
specific U.S. requirements. In some cases, review of an FDA export 
certificate may be required as part of the process to register or 
import a product into another country. An export certificate generally 
indicates that the particular product is marketed in the United States 
or otherwise 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 
export certificates for human food and cosmetic products. Interested 
persons may request a certificate electronically via the CFSAN Export 
Certification Application and Tracking System (CFSAN eCATS) or 
Certificate Application Process (CAP), components of the FDA Industry 
Systems, or by contacting CFSAN for assistance. Health certificates are 
the exception and are requested via email. To facilitate the 
application process, we have eliminated paper-based forms. For food 
products, respondents are able to identify facilities using their Food 
Facility Registration, an FDA Establishment Identifier number, or a 
Data Universal Numbering System number. The system uses these 
identifiers to locate and autopopulate name and address information, 
eliminating the need for users to manually enter this information and 
reducing the time to complete the application. For some applications, 
respondents can also upload product information via a spreadsheet, 
which reduces the time needed to enter product information, 
particularly for applications that include multiple products.
    All information is entered using electronic Forms FDA 3613d, 3613e, 
and 3613k and used to evaluate certificate requests. The eCATS Module 
is Form 3613k, where 3613e is the Certificate of Free Sale (https://www.fda.gov/food/food-export-certificates/online-applications-export-certificates-food). All ``forms'' are electronic and part of the eCATS 
or CAP portal accessed via https://www.access.fda.gov. To view 
representations of the forms, you have to download the instructions, 
which are accessible from the following links: https://www.fda.gov/cosmetics/cosmetics-exporters/online-applications-export-certificates-cosmetics and https://www.fda.gov/food/food-export-certificates/online-applications-export-certificates-food.
    While burden associated with information collection activities for 
export certificates issued for other FDA-regulated products is approved 
under OMB control number 0910-0498, this collection specifically 
supports export certificates issued by CFSAN. Also, because we have 
eliminated paper-based forms, respondents who require assistance with 
completing export certificate applications online may contact CFSAN 
directly by email ([email protected]) or telephone 
(240-402-2307). Instructions for requesting export certificates for 
cosmetics (Form FDA 3613d) are available online at https://www.fda.gov/cosmetics/cosmetics-exporters/online-applications-export-certificates-cosmetics and instructions for requesting export certificates for food 
(Forms FDA 3613e and Form 3613k) are available online at https://www.fda.gov/food/food-export-certificates/online-applications-export-certificates-food.
    Description of Respondents: The respondents to this collection of 
information are firms interested in exporting U.S.-manufactured human 
food and cosmetic products to foreign countries that require export 
certificates.
    We estimate 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              Form No. \2\         Number of     responses per   Total annual    Average burden per response     Total hours
                                                             respondents     respondent       responses              (in hours)
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Cosmetics.........................  FDA 3613d............             113               3             339  0.5 (30 minutes).............             170
Food..............................  FDA 3613e, 3613k.....             468               9           4,212  0.5 (30 minutes).............           2,106
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[[Page 14454]]

 
    Total.........................  .....................  ..............  ..............  ..............  .............................           2,276
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ All forms are submitted electronically via FDA Industry Systems.

    Based on a review of the information collection since our last OMB 
approval, we have reduced our burden estimate. The burden estimate has 
been lowered due to a reduced number of respondents. We base our 
estimates on our experience with certificate applications received in 
the past 3 fiscal years.

    Dated: March 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-05369 Filed 3-15-21; 8:45 am]
BILLING CODE 4164-01-P