Agency Information Collection Activities; Proposed Collection; Comment Request; Export Certificates for Food and Drug Administration Regulated Products, 73349-73351 [2023-23561]
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Federal Register / Vol. 88, No. 205 / Wednesday, October 25, 2023 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–4259]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Export Certificates
for Food and Drug Administration
Regulated Products
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 export certificates
for FDA regulated products.
DATES: Either electronic or written
comments on the collection of
information must be submitted by
December 26, 2023.
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
December 26, 2023. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are received
on or before that date.
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SUMMARY:
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
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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–
2023–N–4259 for ‘‘Export Certificates
for FDA Regulated Products.’’ 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
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73349
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:
Rachel Showalter, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 240–994–7399, 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,
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 88, No. 205 / Wednesday, October 25, 2023 / Notices
when appropriate, and other forms of
information technology.
Export Certificates for FDA Regulated
Products
OMB Control Number 0910–0498—
Extension
This information collection supports
the implementation of FDA statutory
and regulatory provisions and related
forms. Sections 801(e) and 802 of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 381(e) and 382)
pertain to the export of FDA-regulated
products and are intended to ease
restrictions on exportation. The
provisions also require the Agency to
issue written export certifications
within 20 days of any request. To offset
Agency resource expenditures for
processing certifications requests, the
statute provides that FDA may charge
firms a fee not to exceed $175.
The information collection contains
five FDA forms (Form FDA 3613, 3613a,
3613b, 3613c, and 3613g) related to
exporting FDA-regulated products. A
description of each form is provided in
table 1. To obtain a fillable PDF file of
each form, visit https://www.fda.gov/
about-fda/reports-manuals-forms/forms,
and type ‘‘3613’’ in the search field. We
accept online applications for export
certificates for specific product areas
through web-based application systems.
To access these web-based application
systems, visit the FDA Industry Systems
web page at https://www.access.fda.gov.
We are in the process of revising the
forms to remove paper submission
instructions for specific product areas
where paper submissions are no longer
accepted.
To learn more about how to complete
these forms and general information for
specific product areas, visit: https://
www.fda.gov/vaccines-blood-biologics/
exporting-cber-regulated-products/fdaforms-certificates-exporting and https://
www.fda.gov/vaccines-blood-biologics/
exporting-cber-regulated-products/howcomplete-fda-export-certificate-forms;
https://www.fda.gov/drugs/humandrug-exports/electronic-certificatespharmaceutical-product-generalinformation; https://www.fda.gov/
medical-devices/importing-andexporting-medical-devices/exportingmedical-devices; and https://
www.fda.gov/animal-veterinary/importexports/exporting-animal-feed-andanimal-drugs.
TABLE 1—CERTIFICATES AND USES
Type of Certificate/Form FDA#
Use
Form FDA 3613: ‘‘Supplementary Information Certificate to Foreign
Government Requests’’.
‘‘Exporter’s Certification Statement Certificate to Foreign Government’’.
‘‘Exporter’s Certification Statement Certificate to Foreign Government
(For Human Tissue Intended for Transplantation)’’.
Form FDA 3613a: ‘‘Supplementary Information Certificate of
Exportability Requests’’.
‘‘Exporter’s Certification Statement Certificate of Exportability’’.
Form FDA 3613b: ‘‘Supplementary Information Certificate of a Pharmaceutical Product’’.
‘‘Exporter’s Certification Statement Certificate of a Pharmaceutical
Product’’.
Form FDA 3613c: ‘‘Supplementary Information Non-Clinical Research
Use Only Certificate’’.
‘‘Exporter’s Certification Statement (Non-Clinical Research Use Only)’’.
Form FDA 3613g: ‘‘Certificate to Foreign Government for Devices Not
Exported from the United States’’.
Appropriate centers within FDA
review product information submitted
by firms in support of the firms’
certificate requests. We rely on
respondents to certify their compliance
with all applicable requirements of the
For the export of products legally marketed in the United States
For the export of products not approved for marketing in the United
States (unapproved products) that meet the requirements of sections
801(e) or 802 of the FD&C Act
Conforms to the format established by the World Health Organization
and is intended for use by the importing country when the product in
question is under consideration for a product license that will authorize its importation and sale or for renewal, extension, amending, or
reviewing a license
For the export of a non-clinical research use only product, material, or
component that is not intended for human use and which may be
marketed in, and legally exported from the United States under the
FD&C Act
For the shipping of devices not exported from the United States that
may be legally marketed in the United States.
FD&C Act both at the time the
certification request is submitted to FDA
and at the time the certification is
submitted to the respective foreign
government. Information regarding
FDA’s Export Certificates may be found
on our website at https://www.fda.gov/
regulatory-information/search-fdaguidance-documents/fda-exportcertificates.
We estimate the burden of this
collection of information as follows:
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
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FDA center
Center
Center
Center
Center
for
for
for
for
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Biologics Evaluation and Research (CBER) ......
Devices and Radiological Health .......................
Drug Evaluation and Research (CDER) ............
Veterinary Medicine (CVM) ................................
2,344
11,175
6,981
1,618
1
1
1
1
2,344
11,175
6,981
1,618
1
2
1
1
2,344
22,350
6,981
1,618
Total ..............................................................................
........................
........................
........................
........................
33,293
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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Federal Register / Vol. 88, No. 205 / Wednesday, October 25, 2023 / Notices
Based on a current evaluation of the
information collection, we have
adjusted the burden estimate. Our
estimated burden for the information
collection reflects an overall increase of
2,687 hours and a corresponding
increase of 2,687 responses. CDER has
instituted electronic certificates of
pharmaceutical product (eCPP) to
streamline the application process and
reduce the time from receipt to issuance
of export certificates. The increase in
CDER export application requests is
attributable to the implementation of the
eCPP and an increase in drug exports.
The increase is offset by a decrease in
CVM and CBER export applications
attributable to consequences of the
pandemic.
Dated: October 20, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–23561 Filed 10–24–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Biodefense Science Board
Public Meeting
Language translation and
Communication Access Real-Time
Translation will be provided.
Representatives from industry,
academia, health professions, health
care consumer organizations, nonfederal government agencies, or
community-based organizations may
request up to seven minutes to speak
directly to the Board. Requests to speak
to the Board will be approved in
consultation with the Board Chair and
based on time available during the
meeting. Requests to speak to the NBSB
during the public meeting must be sent
to NBSB@hhs.gov by close of business
on November 23, 2023. Please provide
the full name, credentials, official
position(s), and relevant affiliations for
the speaker and a brief description of
the intended topic. Presentations that
contain material with a commercial
bias, advertising, marketing, or
solicitations will not be allowed. A
meeting summary will be available on
the NBSB website post-meeting.
FOR FURTHER INFORMATION CONTACT:
CAPT Christopher Perdue; NBSB
Designated Federal Official, (202) 480–
7226; NBSB@HHS.GOV.
Dawn O’Connell,
Assistant Secretary for Preparedness and
Response.
Administration for Strategic
Preparedness and Response (ASPR),
Department of Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
[FR Doc. 2023–23532 Filed 10–24–23; 8:45 am]
BILLING CODE 4150–37–P
The National Biodefense
Science Board (NBSB) will publicly
meet using an online format on
Thursday, November 30, 2023 (12:30 to
4:00 p.m. ET). Notice of the meeting is
required under section 10(a)(2) of the
Federal Advisory Committee Act
(FACA). The NBSB provides expert
advice and guidance to the U.S.
Department of Health and Human
Services (HHS) regarding current and
future chemical, biological, radiological,
and nuclear threats, as well as other
matters related to disaster preparedness
and response. The Administration for
Strategic Preparedness and Response
(ASPR) manages and convenes the
NBSB on behalf the Secretary of HHS.
The NBSB will discuss and vote on two
sets of recommendations related to
COVID–19 pandemic lessons, Project
NextGen vaccine and therapeutic
products, and disaster preparedness
training.
Procedures for Public Participation:
The public and expert stakeholders are
invited to observe the meeting. Preregistration (Zoom) is required. Anyone
may submit questions and comments to
the NBSB by email (NBSB@hhs.gov)
before the meeting. American Sign
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SUMMARY:
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DEPARTMENT OF HOMELAND
SECURITY
U.S. Citizenship and Immigration
Services
[OMB Control Number 1615–0092]
Agency Information Collection
Activities; Revision of a Currently
Approved Collection: E-Verify Program
U.S. Citizenship and
Immigration Services, Department of
Homeland Security.
ACTION: 30-Day notice.
AGENCY:
The Department of Homeland
Security (DHS), U.S. Citizenship and
Immigration Services (USCIS) will be
submitting the following information
collection request to the Office of
Management and Budget (OMB) for
review and clearance in accordance
with the Paperwork Reduction Act of
1995. The purpose of this notice is to
allow an additional 30 days for public
comments.
DATES: Comments are encouraged and
will be accepted until November 24,
2023.
SUMMARY:
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73351
Written comments and/or
suggestions regarding the item(s)
contained in this notice, especially
regarding the estimated public burden
and associated response time, must be
submitted via the Federal eRulemaking
Portal website at https://
www.regulations.gov under e-Docket ID
number USCIS–2007–0023. All
submissions received must include the
OMB Control Number 1615–0092 in the
body of the letter, the agency name and
Docket ID USCIS–2007–0023.
FOR FURTHER INFORMATION CONTACT:
USCIS, Office of Policy and Strategy,
Regulatory Coordination Division,
Samantha Deshommes, Chief, telephone
number (240) 721–3000 (This is not a
toll-free number; comments are not
accepted via telephone message.). Please
note contact information provided here
is solely for questions regarding this
notice. It is not for individual case
status inquiries. Applicants seeking
information about the status of their
individual cases can check Case Status
Online, available at the USCIS website
at https://www.uscis.gov, or call the
USCIS Contact Center at 800–375–5283
(TTY 800–767–1833).
SUPPLEMENTARY INFORMATION:
ADDRESSES:
Comments
The information collection notice was
previously published in the Federal
Register on June 29, 2023, at 88 FR
42091, allowing for a 60-day public
comment period. USCIS received two
comments in connection with the 60day notice.
You may access the information
collection instrument with instructions,
or additional information by visiting the
Federal eRulemaking Portal site at:
https://www.regulations.gov and enter
USCIS–2007–0023 in the search box.
The comments submitted to USCIS via
this method are visible to the Office of
Management and Budget and comply
with the requirements of 5 CFR
1320.12(c). All submissions will be
posted, without change, to the Federal
eRulemaking Portal at https://
www.regulations.gov, and will include
any personal information you provide.
Therefore, submitting this information
makes it public. You may wish to
consider limiting the amount of
personal information that you provide
in any voluntary submission you make
to DHS. DHS may withhold information
provided in comments from public
viewing that it determines may impact
the privacy of an individual or is
offensive. For additional information,
please read the Privacy Act notice that
is available via the link in the footer of
https://www.regulations.gov.
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]]>Agencies
[Federal Register Volume 88, Number 205 (Wednesday, October 25, 2023)]
[Notices]
[Pages 73349-73351]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-23561]
[[Page 73349]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-4259]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Export Certificates for Food and Drug Administration
Regulated Products
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 export certificates for FDA regulated
products.
DATES: Either electronic or written comments on the collection of
information must be submitted by December 26, 2023.
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 December 26, 2023. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered 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-2023-N-4259 for ``Export Certificates for FDA Regulated Products.''
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: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
[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,
[[Page 73350]]
when appropriate, and other forms of information technology.
Export Certificates for FDA Regulated Products
OMB Control Number 0910-0498--Extension
This information collection supports the implementation of FDA
statutory and regulatory provisions and related forms. Sections 801(e)
and 802 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 381(e) and 382) pertain to the export of FDA-regulated products
and are intended to ease restrictions on exportation. The provisions
also require the Agency to issue written export certifications within
20 days of any request. To offset Agency resource expenditures for
processing certifications requests, the statute provides that FDA may
charge firms a fee not to exceed $175.
The information collection contains five FDA forms (Form FDA 3613,
3613a, 3613b, 3613c, and 3613g) related to exporting FDA-regulated
products. A description of each form is provided in table 1. To obtain
a fillable PDF file of each form, visit https://www.fda.gov/about-fda/reports-manuals-forms/forms, and type ``3613'' in the search field. We
accept online applications for export certificates for specific product
areas through web-based application systems. To access these web-based
application systems, visit the FDA Industry Systems web page at https://www.access.fda.gov. We are in the process of revising the forms to
remove paper submission instructions for specific product areas where
paper submissions are no longer accepted.
To learn more about how to complete these forms and general
information for specific product areas, visit: https://www.fda.gov/vaccines-blood-biologics/exporting-cber-regulated-products/fda-forms-certificates-exporting and https://www.fda.gov/vaccines-blood-biologics/exporting-cber-regulated-products/how-complete-fda-export-certificate-forms; https://www.fda.gov/drugs/human-drug-exports/electronic-certificates-pharmaceutical-product-general-information;
https://www.fda.gov/medical-devices/importing-and-exporting-medical-devices/exporting-medical-devices; and https://www.fda.gov/animal-veterinary/import-exports/exporting-animal-feed-and-animal-drugs.
Table 1--Certificates and Uses
------------------------------------------------------------------------
Type of Certificate/Form FDA# Use
------------------------------------------------------------------------
Form FDA 3613: ``Supplementary For the export of products
Information Certificate to Foreign legally marketed in the United
Government Requests''. States
``Exporter's Certification Statement
Certificate to Foreign Government''.
``Exporter's Certification Statement
Certificate to Foreign Government (For
Human Tissue Intended for
Transplantation)''.
Form FDA 3613a: ``Supplementary For the export of products not
Information Certificate of approved for marketing in the
Exportability Requests''. United States (unapproved
products) that meet the
requirements of sections
801(e) or 802 of the FD&C Act
``Exporter's Certification Statement
Certificate of Exportability''.
Form FDA 3613b: ``Supplementary Conforms to the format
Information Certificate of a established by the World
Pharmaceutical Product''. Health Organization and is
intended for use by the
importing country when the
product in question is under
consideration for a product
license that will authorize
its importation and sale or
for renewal, extension,
amending, or reviewing a
license
``Exporter's Certification Statement
Certificate of a Pharmaceutical
Product''.
Form FDA 3613c: ``Supplementary For the export of a non-
Information Non-Clinical Research Use clinical research use only
Only Certificate''. product, material, or
component that is not intended
for human use and which may be
marketed in, and legally
exported from the United
States under the FD&C Act
``Exporter's Certification Statement
(Non-Clinical Research Use Only)''.
Form FDA 3613g: ``Certificate to For the shipping of devices not
Foreign Government for Devices Not exported from the United
Exported from the United States''. States that may be legally
marketed in the United States.
------------------------------------------------------------------------
Appropriate centers within FDA review product information submitted
by firms in support of the firms' certificate requests. We rely on
respondents to certify their compliance with all applicable
requirements of the FD&C Act both at the time the certification request
is submitted to FDA and at the time the certification is submitted to
the respective foreign government. Information regarding FDA's Export
Certificates may be found on our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-export-certificates.
We estimate the burden of this collection of information as
follows:
Table 2--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
FDA center Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Center for Biologics Evaluation 2,344 1 2,344 1 2,344
and Research (CBER)............
Center for Devices and 11,175 1 11,175 2 22,350
Radiological Health............
Center for Drug Evaluation and 6,981 1 6,981 1 6,981
Research (CDER)................
Center for Veterinary Medicine 1,618 1 1,618 1 1,618
(CVM)..........................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 33,293
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 73351]]
Based on a current evaluation of the information collection, we
have adjusted the burden estimate. Our estimated burden for the
information collection reflects an overall increase of 2,687 hours and
a corresponding increase of 2,687 responses. CDER has instituted
electronic certificates of pharmaceutical product (eCPP) to streamline
the application process and reduce the time from receipt to issuance of
export certificates. The increase in CDER export application requests
is attributable to the implementation of the eCPP and an increase in
drug exports. The increase is offset by a decrease in CVM and CBER
export applications attributable to consequences of the pandemic.
Dated: October 20, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-23561 Filed 10-24-23; 8:45 am]
BILLING CODE 4164-01-P
