Agency Information Collection Activities; Proposed Collection; Comment Request; Export Certificates for FDA Regulated Products

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Published

October 23, 2026

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.

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<title>Federal Register, Volume 91 Issue 204 (Friday, October 23, 2026)</title>
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[Federal Register Volume 91, Number 204 (Friday, October 23, 2026)]
[Notices]
[Pages 66848-66850]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-21714]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2026-N-11074]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Export Certificates for FDA 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 22, 2026.

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 22, 2026. 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-2026-N-11074 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: Kelly Covington, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 240-402-5661,
<a href="/cdn-cgi/l/email-protection#025250435176636464426466632c6a6a712c656d74"><span class="__cf_email__" data-cfemail="b8e8eaf9ebccd9dedef8dedcd996d0d0cb96dfd7ce">[email&#160;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

[[Page 66849]]

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.

Export Certificates for FDA Regulated Products

OMB Control Number 0910-0498--Revision

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. Section 801(e)(4)
of the FD&C Act provides that persons exporting FDA-regulated products
may request FDA to certify that the product meets the requirements of
the FD&C Act. 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 seven FDA forms (Form FDA 3613,
3613a, 3613b, 3613c, and 3613g) related to exporting FDA-regulated
products. A description of each form is provided below. 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, <a href="http://www.access.fda.gov">http://www.access.fda.gov</a>. The Center for Biologics Evaluation and Research
(CBER) and The Center for Veterinary Medicine (CVM) are transitioning
to a requirement for electronic submission of the forms related to
biological products and medical devices, as well as food, drugs, and
devices for animals. Therefore, we are in the process of revising FDA
Forms 3613, 3613a, and 3613b to remove the paper submission
instructions related to biological products and medical devices, as
well as food, drugs, and devices for animals.
The forms are also being updated to align with those of the other
FDA Centers for conformity and to help improve clarity and accuracy.
Proposed revisions include, but are not limited to the following:
<bullet> CVM intends to include a field for insertion of the
National Drug Code, which is the product listing number that identifies
the drug and is legally required for animal drugs.
<bullet> CBER is revising the exporter's certification statement of
FDA Form 3613 (for Human Cells, Tissues, and Cellular and Tissue-Based
Products (HCT/Ps) Regulated Solely under Section 361 of the Public
Health Service Act) to more closely align the with the exporter's
certification statement used for CBER's Certificate to Foreign
Government, as applicable for the requirements of Title 21, Code of
Federal Regulations Part 1271. In addition, these revisions will
provide more clear examples of how establishments and products
identified in the FDA Form 3613 Supplementary Information must be in
compliance with Part 1271.
Additionally, CVM is adding two new forms. FDA Form 3613h
Supplementary Information; Certificate of Free Sale and FDA Form 3613i
Supplementary Information; Current Good Manufacturing Practice
Certificate. These forms were created for improved clarity as
previously the Certificate to Foreign Government FDA Form 3613 was used
to apply for both these certificate types, which can lead to confusion.
The scope of the collection includes provisions introduced under
the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) that
may require supplemental information for exported product certificates.
The data elements have been incorporated into our current form
versions. The fact that FDA has issued an export certificate does not
preclude FDA from taking appropriate regulatory action against a
product covered by the certificate.
We developed the guidance document entitled, ``Exports Under the
FDA Export Reform and Enhancement Act of 1996'' (December 1996) to
assist respondents to the information collection. The guidance
summarizes and explains the basic requirements and procedures under the
FDA Export Reform and Enhancement Act of 1996 (Public Law 104-134, as
amended by Public Law 104-180) for exporting human drugs, animal drugs,
biological products, devices, food, food additives, color additives,
and dietary supplements that may not be sold or distributed in the
United States. The 1996 law amended sections 801 and 802 of the FD&C
Act, as well as section 351(h) of the Public Health Service Act,
simplifying the requirements for exporting unapproved human drugs,
biological products, and devices. In addition, the FDA Export Reform
and Enhancement Act substantially reduced the requirements for
exporting unapproved new animal drugs and provided a new option for
exporting unapproved devices. The guidance document is available from
our website at: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-exports-under-fda-export-reform-and-enhancement-act-1996">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-exports-under-fda-export-reform-and-enhancement-act-1996</a>.
<a href="https://www.fda.gov/media/138075/download">https://www.fda.gov/media/138075/download</a>.
In addition, we developed the guidance document ``FDA Export
Certification'' (August 2021) which is intended to provide a general
description of FDA export certification to industry and foreign
governments. The guidance document is available from our website at:
<a href="http://www.fda.gov/RegulatoryInformation/Guidances/ucm125789.htm">http://www.fda.gov/RegulatoryInformation/Guidances/ucm125789.htm</a>.
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> (CBER); <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>
(CDER); and <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> (CDRH). In
addition, the CVM web-

[[Page 66850]]

based application offers a guide on how to fill out the forms,
entitled: ``Center for Veterinary Medicine Export Certification
Application and Tracking System (CVM eCATS) Step-by-Step Instructions
for Industry Applicants.''

Table 1--Certificates and Uses
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Type of certificate Use
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``Supplementary Information Certificate For the export of products
to Foreign Government Requests''. legally marketed in the United
``Exporter's Certification Statement States.
Certificate to Foreign Government''.
``Exporter's Certification Statement
Certificate to Foreign Government (For
Human Tissue Intended for
Transplantation)''.
``Certificate of Free Sale''...........
``Supplementary Information Certificate For the export of products not
of Exportability Requests''. approved for marketing in the
Exporter's Certification Statement United States (unapproved
Certificate of Exportability''. products) that meet the
requirements of sections
801(e) or 802 of the FD&C Act.
``Supplementary Information Certificate Conforms to the format
of a Pharmaceutical Product''. established by the World
``Exporter's Certification Statement Health Organization and is
Certificate of a Pharmaceutical intended for use by the
Product''. 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.
``Supplementary Information Non- For the export of a non-
Clinical Research Use Only clinical research use only
Certificate''. product, material, or
``Exporter's Certification Statement component that is not intended
(Non-Clinical Research Use Only)''. for human use and which may be
marketed in, and legally
exported from the United
States under the FD&C Act.
``Certificate to Foreign Government for For the shipping of devices not
Devices Not Exported from the United exported from the U.S. that
States''. may be legally marketed in the
U.S.
``Current Good Manufacturing Practice For verification of compliance
Certificate''. with current good
manufacturing practice
requirements of a previously
issued certificate.
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Appropriate centers within FDA review product information submitted
by firms in support of the firm's 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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Form FDA 3613, 3613(a), 3613(b), Number of
3613(c), 3613(f), 3613(g); Number of responses per Total annual Average burden Total hours
Submission to FDA Center respondents respondent responses per response
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Center for Biologics Evaluation 2,234 1 2,234 3 6,702
and Research (CBER)............
Center for Devices and 12,070 1 12,070 2 24,140
Radiological Health (CDRH).....
Center for Drug Evaluation and 9236 1 9236 2 18,472
Research (CDER)................
Center for Veterinary Medicine 1,630 1 1,630 1 1,630
(CVM)..........................
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Total....................... .............. .............. .............. .............. 50,944
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

Based on a current evaluation of the information collection, we
have adjusted the burden estimate. We attribute these changes to the
average number of responses received over the last three years. In
addition, CBER and CDER have increased the average burden response time
for their collections by one hour. Our estimated burden for the
information collection reflects an overall increase of 3,052 responses
and a corresponding increase of 17,021 hours.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-21714 Filed 10-22-26; 8:45 am]
BILLING CODE 4164-01-P

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