[Federal Register Volume 83, Number 96 (Thursday, May 17, 2018)]
[Notices]
[Pages 22984-22985]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10551]


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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, Agency, 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: Fax written comments on the collection of information by June 
18, 2018.

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 0910-0793. 
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, 
[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

OMB Control Number 0910-0793--Revision

    This information collection supports FDA's Center for Food Safety 
and Applied Nutrition's (CFSAN) export certificate application process. 
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.
    Interested persons may request a certificate from CFSAN 
electronically via the Certificate Application Process (CAP), a 
component of FDA Industry Systems, or by contacting CFSAN for 
assistance. To facilitate the application process we have eliminated 
paper-based forms. For food products, we have expanded the electronic 
options for providing facility and product information. Respondents 
will now be able to identify facilities based on a food facility 
registration number, FDA Establishment Identification number, or 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. 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, 3613g, and 3613l and used to evaluate certificate 
requests.
    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 Form FDA 3613d are available online at 
https://www.fda.gov/cosmetics/internationalactivities/exporters/ucm353912.htm and instructions for Form FDA 3613e are available online 
at https://www.fda.gov/Food/GuidanceRegulation/ImportsExports/Exporting/ucm260280.htm. Draft screenshots of Form FDA 3613g and 3613l 
are available for comment online at https://www.fda.gov/Food/GuidanceRegulation/ImportsExports/Exporting/default.htm.
    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 2, 2018 (83 FR 133), we 
published a notice soliciting public comment of the information 
collection. Two comments were received in support of the information 
collection. One comment included technical suggestions as well 
regarding respondents' ability to review and edit data that might have 
been entered improperly. We appreciate this comment and continue to 
seek ways to utilize improved information collection

[[Page 22985]]

technologies as our resources permit. FDA notes section 801 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) also provides that 
FDA may charge a fee of up to $175 if the Agency issues a certificate 
within 20 days of receipt of a complete request for such a certificate. 
This fee may vary depending on the product type, but it will not exceed 
$175.
    We estimate the burden of the information collection as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                    Number of
          Type of respondent                FDA 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............................  3613d...................             270               3             810  0.5 (30 minutes).......             405
Food.................................  3613e, 3613g, 3613l.....             881               5           4,405  0.5 (30 minutes).......           2,203
                                                                ----------------------------------------------------------------------------------------
    Total............................  ........................  ..............  ..............  ..............  .......................           2,608
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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 CAP.

    This estimate reflects a revision resulting from the elimination of 
paper-based forms. Specifically, and based on our experience with the 
information collection, we have reduced the estimated time to prepare a 
submission from 1.5 hours to 0.5 hour. The previous estimate was based 
on the time necessary to prepare a paper submission, but all firms 
requesting export certificates now provide submissions electronically 
via CAP. We believe that the time to prepare an electronic submission 
is under 0.25 hour, but are estimating 0.5 hour as a conservative 
approach to address all scenarios. We base our estimates of the total 
annual responses on our experience with certificate applications 
received in the past 3 fiscal years.
    We expect that most firms requesting export certificates in the 
next 3 years will choose to take advantage of the option of electronic 
submission via CAP. If a firm is unable to submit their information via 
CAP, they may contact CFSAN and request assistance. CFSAN will assist 
firms in entering their information into the electronic system so that 
the firm may receive their export certificates in a timely manner. Our 
burden estimates in table 1 are based on the expectation of 100 percent 
participation in the electronic submission process. Providing the 
opportunity to submit the information in electronic format has reduced 
our previous estimates for the time to prepare each submission.

    Dated: May 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10551 Filed 5-16-18; 8:45 am]
BILLING CODE 4164-01-P