Notice2024-17641
Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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
August 8, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the 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.
Full Text
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<title>Federal Register, Volume 89 Issue 153 (Thursday, August 8, 2024)</title>
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[Federal Register Volume 89, Number 153 (Thursday, August 8, 2024)]
[Notices]
[Pages 64925-64926]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-17641]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-2032]
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, the 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: Submit written comments (including recommendations) on the
collection of information by September 9, 2024.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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#28787a697b5c494e4e684e4c490640405b064f475e"><span class="__cf_email__" data-cfemail="fcacaebdaf889d9a9abc9a989dd294948fd29b938a">[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 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
[[Page 64926]]
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 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 a burden associated with information collection activities
for 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#7b383d283a353e030b14090f381e090f121d12181a0f1214153b1d1f1a55131308551c140d"><span class="__cf_email__" data-cfemail="7e3d382d3f303b060e110c0a3d1b0c0a1718171d1f0a1711103e181a1f5016160d50191108">[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.
In the Federal Register of May 15, 2024 (89 FR 42472), we published
a 60-day notice requesting public comment on the proposed collection of
information. Although two comments were received, neither appeared to
be responsive to the information collection topics solicited in the
notice, nor suggested FDA modify its burden estimates.
We therefore estimate the burden of the collections 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
respondents respondent responses hours
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Cosmetics.......................... FDA 3613d.................. 66 3 198 0.5 (30 minutes)........... 99
Food............................... FDA 3613e, 3613k........... 454 10 4,540 0.5 (30 minutes)........... 2,270
Export Certification Inquiry....... FDA 5077................... 520 18 9,360 0.25 (15 minutes).......... 2,340
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Total.......................... ........................... .............. ............... .............. ........................... 4,709
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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 2,433 hours and 9,547 responses annually.
Dated: August 5, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-17641 Filed 8-7-24; 8:45 am]
BILLING CODE 4164-01-P
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