Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Cosmetic Export Certificate Application Process, 42472-42474 [2024-10606]
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<![CDATA[
42472
Federal Register / Vol. 89, No. 95 / Wednesday, May 15, 2024 / Notices
ANNUAL BURDEN ESTIMATES
Number of
responses per
respondent
(total over
request
period)
Number of
respondents
(total over
request
period)
Instrument
Average
burden per
response
(in hours)
Total/annual
burden
(in hours)
Program director survey (Instrument 1) ...........................................................
ERSEA lead staff survey (Instrument 2) .........................................................
Onsite coordination a ........................................................................................
Head Start parent/caregiver survey (Instrument 3) .........................................
Community partner survey (Instrument 4) .......................................................
ERSEA lead staff focus group guide (Instrument 5) .......................................
60
60
60
600
180
24
1
1
1
1
1
1
0.17
0.75
1.5
0.5
0.25
1.5
10.2
45
90
300
45
36
Estimated Total Annual Burden Hours .....................................................
........................
........................
........................
526.2
a There
is no instrument associated with this activity. We will ask each program director to nominate a staff person who will help coordinate
data collection activities. This line accounts for the time of the onsite coordinator.
Authority: Head Start Act Section 640
[42 U.S.C. 9835].
Mary C. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2024–10578 Filed 5–14–24; 8:45 am]
BILLING CODE 4184–22–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0026]
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product;
OJEMDA (tovorafenib)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of a priority review voucher to
the sponsor of a rare pediatric disease
product application. The Federal Food,
Drug, and Cosmetic Act (FD&C Act)
authorizes FDA to award priority review
vouchers to sponsors of approved rare
pediatric disease product applications
that meet certain criteria. FDA is
required to publish notice of the award
of the priority review voucher. FDA has
determined that OJEMDA (tovorafenib),
approved on April 23, 2024,
manufactured by Day One
Biopharmaceuticals, Inc., meets the
criteria for a priority review voucher.
FOR FURTHER INFORMATION CONTACT:
Cathryn Lee, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–1394.
SUPPLEMENTARY INFORMATION: FDA is
announcing the issuance of a priority
review voucher to the sponsor of an
approved rare pediatric disease product
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SUMMARY:
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19:12 May 14, 2024
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application. Under section 529 of the
FD&C Act (21 U.S.C. 360ff), FDA will
award priority review vouchers to
sponsors of approved rare pediatric
disease product applications that meet
certain criteria. FDA has determined
that OJEMDA (tovorafenib),
manufactured by Day One
Biopharmaceuticals, Inc., meets the
criteria for a priority review voucher.
OJEMDA (tovorafenib) is indicated for
the treatment of patients 6 months of
age and older with relapsed or refractory
pediatric low-grade glioma harboring a
BRAF fusion or rearrangement, or BRAF
V600 mutation.
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/ForIndustry/
DevelopingProductsforRare
DiseasesConditions/
RarePediatricDisease
PriorityVoucherProgram/default.htm.
For further information about OJEMDA
(tovorafenib), go to the ‘‘Drugs@FDA’’
website at https://www.accessdata.
fda.gov/scripts/cder/daf/.
Dated: May 9, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–10583 Filed 5–14–24; 8:45 am]
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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.
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 FDAregulated human food and cosmetic
products.
SUMMARY:
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 https://
www.regulations.gov 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
DATES:
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Federal Register / Vol. 89, No. 95 / Wednesday, May 15, 2024 / Notices
timely if they are received on or before
that date.
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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–
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 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
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19:12 May 14, 2024
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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.
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.
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
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42473
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 FDAregulated 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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Federal Register / Vol. 89, No. 95 / Wednesday, May 15, 2024 / Notices
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 (https://www.fda.gov/food/foodexport-certificates/online-applicationsexport-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,
instructions must be downloaded and
are accessible through 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 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
(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.
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 crossreferencing 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
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Type of certificate
Form No. 2
Cosmetics ......................................
Food ..............................................
Export Certification Inquiry ............
FDA 3613d ...................................
FDA 3613e, 3613k .......................
FDA 5077 .....................................
66
454
520
3
10
18
198
4,540
9,360
0.5 (30 min.) ...............
0.5 (30 min.) ...............
0.25 (15 min.) .............
99
2,270
39
Total .......................................
.......................................................
........................
........................
........................
.....................................
2,408
Total hours
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]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–4785]
Gina Acosta: Final Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (FD&C Act) permanently
debarring Gina Acosta from providing
services in any capacity to a person that
has an approved or pending drug
product application. FDA bases this
order on a finding that Ms. Acosta was
convicted of a felony under Federal law
for conduct that relates to the regulation
of a drug product under the FD&C Act.
Ms. Acosta was given notice of the
SUMMARY:
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proposed debarment and an opportunity
to request a hearing to show why she
should not be debarred. As of March 6,
2024 (30 days after receipt of the
notice), Ms. Acosta has not responded.
Ms. Acosta’s failure to respond and
request a hearing constitutes a waiver of
Ms. Acosta’s right to a hearing
concerning this matter.
DATES: This order is applicable May 15,
2024.
ADDRESSES: Any application by Ms.
Acosta for special termination of
debarment under section 306(d)(4) of
the FD&C Act (21 U.S.C. 335a(d)(4)) may
be submitted at any time as follows:
Electronic Submissions
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
An application submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
E:\FR\FM\15MYN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 95 (Wednesday, May 15, 2024)]
[Notices]
[Pages 42472-42474]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-10606]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://www.regulations.gov 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:
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-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 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.
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--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
[[Page 42474]]
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
(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, instructions must be downloaded and are
accessible through 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 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 ([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.
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
