[Federal Register Volume 89, Number 95 (Wednesday, May 15, 2024)]
[Notices]
[Pages 42472-42474]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-10606]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-2032]


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 Agency) 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 information collection associated with 
export certificate applications for FDA-regulated human food and 
cosmetic products.

DATES: Either electronic or written comments on the collection of 
information must be submitted by July 15, 2024.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of July 15, 2024. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered

[[Page 42473]]

timely if they are received 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-2024-N-2032 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.

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--Revision

    This information collection helps support implementation of 
statutory and regulatory authorities governing the export of certain 
FDA-regulated products found in section 801 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 381), and in 21 CFR part 1, subpart E--
Imports and Exports, of Agency regulations. 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.
    Consistent with this authority, interested persons may request 
human food and cosmetic export certificates electronically via the 
Export Certification Application and Tracking System (eCATS) or 
Certificate

[[Page 42474]]

Application Process (CAP), components of the FDA Industry Systems, or 
by contacting FDA for assistance. Health certificates are the exception 
and are requested via email. To facilitate the application process, we 
have eliminated paper-based forms. All information is currently 
submitted electronically using Forms FDA 3613d, 3613e, and 3613k. 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, instructions must be downloaded and are 
accessible through 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 attributable to activities associated with export 
certificates issued for other FDA regulated products is accounted for 
and approved under OMB control number 0910-0498, this collection 
specifically supports information collection activity attributable to 
export certificates issued for human food and cosmetic products. Also, 
because we have eliminated paper-based forms, respondents who require 
assistance with completing export certificate applications online may 
contact FDA 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.
    We are revising the information collection to include a web-based 
inquiry form, Form FDA 5077, entitled ``U.S. Department of Health and 
Human Services Food and Drug Administration Export Certification 
Inquiry,'' intended to facilitate processing by cross-referencing the 
request with existing Agency data. A mockup of the proposed electronic 
form is posted to the docket to solicit public comment. For food 
products, respondents may identify facilities using their Food Facility 
Registration number, 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 product information, particularly for applications 
that include multiple products.
    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 certificate              Form No. \2\         Number of     responses per   Total annual    Average burden per response     Total hours
                                                             respondents     respondent       responses
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Cosmetics.........................  FDA 3613d............              66               3             198  0.5 (30 min.)................              99
Food..............................  FDA 3613e, 3613k.....             454              10           4,540  0.5 (30 min.)................           2,270
Export Certification Inquiry......  FDA 5077.............             520              18           9,360  0.25 (15 min.)...............              39
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    Total.........................  .....................  ..............  ..............  ..............  .............................           2,408
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\1\ There are no operating and maintenance costs associated with this collection of information.
\2\ All forms are submitted electronically via FDA Industry Systems.

    Since our last review of the information collection, we have 
adjusted our estimate of the number of respondents downward. At the 
same time, we have increased the number of responses per respondent and 
added new Form FDA 5077. Cumulatively these activities result in an 
estimated burden increase of 39 hours and 9,360 responses annually.

    Dated: May 9, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-10606 Filed 5-14-24; 8:45 am]
BILLING CODE 4164-01-P