[Federal Register Volume 86, Number 49 (Tuesday, March 16, 2021)]
[Notices]
[Pages 14452-14454]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05369]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-2347]
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 we) 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 the information collection provisions
associated with export certificate applications for FDA-regulated human
food and cosmetic products.
DATES: Submit either electronic or written comments on the collection
of information by May 17, 2021.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before May 17, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 17, 2021. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is 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-2014-N-2347 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.
[[Page 14453]]
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--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 autopopulate 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.
All information is entered using electronic Forms FDA 3613d, 3613e,
and 3613k and used to evaluate certificate requests. 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, you have to download the instructions,
which are accessible from 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 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 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.
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 respondent Form No. \2\ Number of responses per Total annual Average burden per response Total hours
respondents respondent responses (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: March 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-05369 Filed 3-15-21; 8:45 am]
BILLING CODE 4164-01-P