[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]



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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 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,

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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 http://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
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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 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\
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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.


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    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