Notice2023-23561
Agency Information Collection Activities; Proposed Collection; Comment Request; Export Certificates for Food and Drug Administration Regulated Products
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Published
October 25, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 205 (Wednesday, October 25, 2023)</title>
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[Federal Register Volume 88, Number 205 (Wednesday, October 25, 2023)]
[Notices]
[Pages 73349-73351]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-23561]
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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.
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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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#055557445671646363456361642b6d6d762b626a73"><span class="__cf_email__" data-cfemail="742426352700151212341210155a1c1c075a131b02">[email protected]</span></a>.
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 <a href="https://www.fda.gov/about-fda/reports-manuals-forms/forms">https://www.fda.gov/about-fda/reports-manuals-forms/forms</a>, 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 <a href="http://www.access.fda.gov">http://www.access.fda.gov</a>. 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: <a href="https://www.fda.gov/vaccines-blood-biologics/exporting-cber-regulated-products/fda-forms-certificates-exporting">https://www.fda.gov/vaccines-blood-biologics/exporting-cber-regulated-products/fda-forms-certificates-exporting</a> and <a href="https://www.fda.gov/vaccines-blood-biologics/exporting-cber-regulated-products/how-complete-fda-export-certificate-forms">https://www.fda.gov/vaccines-blood-biologics/exporting-cber-regulated-products/how-complete-fda-export-certificate-forms</a>; <a href="https://www.fda.gov/drugs/human-drug-exports/electronic-certificates-pharmaceutical-product-general-information">https://www.fda.gov/drugs/human-drug-exports/electronic-certificates-pharmaceutical-product-general-information</a>;
<a href="https://www.fda.gov/medical-devices/importing-and-exporting-medical-devices/exporting-medical-devices">https://www.fda.gov/medical-devices/importing-and-exporting-medical-devices/exporting-medical-devices</a>; and <a href="https://www.fda.gov/animal-veterinary/import-exports/exporting-animal-feed-and-animal-drugs">https://www.fda.gov/animal-veterinary/import-exports/exporting-animal-feed-and-animal-drugs</a>.
Table 1--Certificates and Uses
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Type of Certificate/Form FDA# Use
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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.
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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 <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-export-certificates">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-export-certificates</a>.
We estimate the burden of this collection of information as
follows:
Table 2--Estimated Annual Reporting Burden \1\
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Number of
FDA center Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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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)..........................
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Total....................... .............. .............. .............. .............. 33,293
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\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
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