Notice2021-14650
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Cosmetic Export Certificates
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
July 9, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 129 (Friday, July 9, 2021)</title>
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[Federal Register Volume 86, Number 129 (Friday, July 9, 2021)]
[Notices]
[Pages 36282-36283]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <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#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
(<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, you have to download the instructions,
which are accessible from 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 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 <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 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>.
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
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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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