[Federal Register Volume 86, Number 129 (Friday, July 9, 2021)]
[Notices]
[Pages 36282-36283]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14650]


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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 Certificates

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) 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: Submit written comments (including recommendations) on the 
collection of information by August 9, 2021.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0793. Also include the FDA docket 
number found in brackets in the heading of this document.

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, 
<a href="/cdn-cgi/l/email-protection#76262437250217101036101217581e1e0558111900"><span class="__cf_email__" data-cfemail="f0a0a2b1a384919696b0969491de989883de979f86">[email protected]</span></a>.

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 Certificates

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 auto-populate 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

[[Page 36283]]

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 FDA 3613k, where Form FDA 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 (<a href="/cdn-cgi/l/email-protection#32717461737c774a425d4046715740465b545b5153465b5d5c725456531c5a5a411c555d44"><span class="__cf_email__" data-cfemail="e9aaafbaa8a7ac9199869b9daa8c9b9d808f808a889d808687a98f8d88c781819ac78e869f">[email protected]</span></a>) 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 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.
    In the Federal Register of March 16, 2021 (86 FR 14452), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. We received one comment offering general 
support for our cosmetic export certificate program. The comment also 
recommended FDA consider providing certificates that allow exporters to 
use an exemption from requirements in China for animal testing for 
certain imported cosmetic products. We appreciate the comment and 
continue to seek ways to increase the utility of the information 
collection as our limited resources permit. At the same time, the 
comment did not suggest we revise the burden we attribute to the 
associated information collection activity.
    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      Total hours
                                                                   respondents     respondent       responses      response (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
                                                                ----------------------------------------------------------------------------------------
    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: July 2, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-14650 Filed 7-8-21; 8:45 am]
BILLING CODE 4164-01-P


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