Notice2024-10606
Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Cosmetic Export Certificate Application Process
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 15, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 95 (Wednesday, May 15, 2024)</title>
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[Federal Register Volume 89, Number 95 (Wednesday, May 15, 2024)]
[Notices]
[Pages 42472-42474]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#540406150720353232143230357a3c3c277a333b22"><span class="__cf_email__" data-cfemail="6f3f3d2e3c1b0e09092f090b0e4107071c41080019">[email protected]</span></a>.
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
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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
(<a href="https://www.fda.gov/food/food-export-certificates/online-applications-export-certificates-food">https://www.fda.gov/food/food-export-certificates/online-applications-export-certificates-food</a>). All ``forms'' are electronic and part of the
eCATS or CAP portal accessed via <a href="https://www.access.fda.gov">https://www.access.fda.gov</a>. To view
representations of the forms, instructions must be downloaded and are
accessible through the following links: <a href="https://www.fda.gov/cosmetics/cosmetics-exporters/online-applications-export-certificates-cosmetics">https://www.fda.gov/cosmetics/cosmetics-exporters/online-applications-export-certificates-cosmetics</a>
and <a href="https://www.fda.gov/food/food-export-certificates/online-applications-export-certificates-food">https://www.fda.gov/food/food-export-certificates/online-applications-export-certificates-food</a>.
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 (<a href="/cdn-cgi/l/email-protection#6b282d382a252e131b04191f280e191f020d02080a1f0204052b0d0f0a45030318450c041d"><span class="__cf_email__" data-cfemail="54171207151a112c243b2620173126203d323d3735203d3b3a143230357a3c3c277a333b22">[email protected]</span></a>) or
telephone (240-402-2307). Instructions for requesting export
certificates for cosmetics (Form FDA 3613d) are available online at
<a href="https://www.fda.gov/cosmetics/cosmetics-exporters/online-applications-export-certificates-cosmetics">https://www.fda.gov/cosmetics/cosmetics-exporters/online-applications-export-certificates-cosmetics</a> and instructions for requesting export
certificates for food (Forms FDA 3613e and Form 3613k) are available
online at <a href="https://www.fda.gov/food/food-export-certificates/online-applications-export-certificates-food">https://www.fda.gov/food/food-export-certificates/online-applications-export-certificates-food</a>.
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
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