Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Cosmetic Export Certificate Application Process, 14452-14454 [2021-05369]
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14452
Federal Register / Vol. 86, No. 49 / Tuesday, March 16, 2021 / Notices
information suggesting that NIPRIDE
RTU (sodium nitroprusside), 10 mg/50
mL (0.2 mg/mL), was withdrawn for
reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
NIPRIDE RTU (sodium nitroprusside),
10 mg/50 mL (0.2 mg/mL), from sale.
We have also independently evaluated
relevant literature and data for possible
postmarketing adverse events. We have
found no information that would
indicate that this drug product was
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list NIPRIDE RTU (sodium
nitroprusside), 10 mg/50 mL (0.2 mg/
mL), in the ‘‘Discontinued Drug Product
List’’ section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. ANDAs that refer
to NIPRIDE RTU (sodium
nitroprusside), 10 mg/50 mL (0.2 mg/
mL), may be approved by the Agency as
long as they meet all other legal and
regulatory requirements for the approval
of ANDAs. If FDA determines that
labeling for this drug product should be
revised to meet current standards, the
Agency will advise ANDA applicants to
submit such labeling.
Dated: March 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–05324 Filed 3–15–21; 8:45 am]
BILLING CODE 4164–01–P
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.
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,
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:52 Mar 15, 2021
Jkt 253001
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 FDAregulated human food and cosmetic
products.
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.
DATES:
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.
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
• 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-201509-18/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.
E:\FR\FM\16MRN1.SGM
16MRN1
Federal Register / Vol. 86, No. 49 / Tuesday, March 16, 2021 / Notices
Food and Cosmetic Export Certificate
Application Process
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, PRAStaff@
fda.hhs.gov.
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.
SUPPLEMENTARY INFORMATION:
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
14453
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-exportcertificates/online-applications-exportcertificates-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/onlineapplications-export-certificatescosmetics and https://www.fda.gov/
food/food-export-certificates/onlineapplications-export-certificates-food.
While burden associated with
information collection activities for
export certificates issued for other FDAregulated products is approved under
OMB control number 0910–0498, this
collection specifically supports export
certificates issued by CFSAN. Also,
because we have eliminated paperbased forms, respondents who require
assistance with completing export
certificate applications online may
contact CFSAN directly by email
(CFSANExportCertification@
fda.hhs.gov) or telephone (240–402–
2307). Instructions for requesting export
certificates for cosmetics (Form FDA
3613d) are available online at https://
www.fda.gov/cosmetics/cosmeticsexporters/online-applications-exportcertificates-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-exportcertificates/online-applications-exportcertificates-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:
jbell on DSKJLSW7X2PROD with NOTICES
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Type of
respondent
Form No. 2
Cosmetics ..........
Food ..................
FDA 3613d ...................................
FDA 3613e, 3613k .......................
VerDate Sep<11>2014
16:52 Mar 15, 2021
Jkt 253001
Number of
respondents
PO 00000
Number of
responses per
respondent
113
468
Frm 00051
Fmt 4703
3
9
Sfmt 4703
Total annual
responses
339
4,212
E:\FR\FM\16MRN1.SGM
Average burden per
response
(in hours)
0.5 (30 minutes) .....
0.5 (30 minutes) .....
16MRN1
Total hours
170
2,106
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Federal Register / Vol. 86, No. 49 / Tuesday, March 16, 2021 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Form No. 2
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden per
response
(in hours)
......................................................
........................
........................
........................
................................
Type of
respondent
Total ...........
Total hours
2,276
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–D–0770]
Best Practices in Developing
Proprietary Names for Human
Nonprescription Drug Products; Draft
Guidance for Industry; Availability;
Reopening of the Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Notice of availability; reopening
of the comment period.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
reopening the comment period for the
notice entitled ‘‘Best Practices in
Developing Proprietary Names for
Human Nonprescription Drug Products;
Draft Guidance for Industry;
Availability’’ that appeared in the
Federal Register of December 9, 2020.
The Agency is taking this action to
allow interested persons additional time
to submit comments.
DATES: FDA is reopening the comment
period for the notice published on
December 9, 2020 (85 FR 79187).
Submit either electronic or written
comments on the draft guidance by June
14, 2021 to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:52 Mar 15, 2021
Jkt 253001
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–
2020–D–0770 for ‘‘Best Practices in
Developing Proprietary Names for
Human Nonprescription Drug
Products.’’ Received comments 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
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
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-201509-18/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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
E:\FR\FM\16MRN1.SGM
16MRN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
