[Federal Register Volume 89, Number 41 (Thursday, February 29, 2024)]
[Notices]
[Pages 14882-14883]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-04155]



[[Page 14882]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-4259]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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, the Agency, or we) is 
announcing that a proposed collection of information has been submitted 
to the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the 
collection of information by April 1, 2024.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0498. Also include the FDA docket 
number found in brackets in the heading of this document.

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#7f2f2d3e2c0b1e19193f191b1e5117170c51181009"><span class="__cf_email__" data-cfemail="59090b180a2d383f3f193f3d387731312a773e362f">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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. 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 FDA forms (Form FDA 3613, 
3613a, 3613b, 3613c, 3613f, and 3613g) related to exporting FDA-
regulated products. A description of each form is provided in table 1.

                     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
``Exporter's Certification Statement      products) that meet the
 Certificate of Exportability''.          requirements of sections
                                          801(e) or 802 of the FD&C Act.
Form FDA 3613b and Form FDA 3613f:       Conforms to the format
 ``Supplementary Information              established by the World
 Certificate of a Pharmaceutical          Health Organization and is
 Product''.                               intended for use by the
``Exporter's Certification Statement      importing country when the
 Certificate of a Pharmaceutical          product in question is under
 Product''.                               consideration for a product
                                          license that will authorize
                                          its importation and sale or
                                          for renewal, extension,
                                          amending, or reviewing a
                                          license.
Form FDA 3613c: ``Supplementary          For the export of a non-
 Information Non-Clinical Research Use    clinical research use only
 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.
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.
------------------------------------------------------------------------

    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. For additional 
information on export certification processing for specific product 
areas refer to the following websites: https://www.fda.gov/vaccines-blood-biologics/compliance-actions-biologics/exporting-cber-regulated-products, (CBER); https://www.fda.gov/medical-devices/importing-and-exporting-medical-devices/exporting-medical-devices (CDRH); https://www.fda.gov/drugs/human-drug-exports/electronic-certificates-pharmaceutical-product-general-information (CDER); and https://www.fda.gov/animal-veterinary/import-exports/exporting-animal-feed-and-animal-drugs (CVM).
    We are transitioning to a requirement for electronic submission of 
the forms related to medical device products. Therefore, we revised FDA 
Forms 3613, 3613a, 3613c, and 3613g to remove the paper submission 
instructions in the portions of the forms related to medical device 
products.
    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: https://www.fda.gov/RegulatoryInformation/Guidances/ucm125789.htm. Agency guidance 
documents are issued in accordance with our good guidance practice 
regulations in 21 CFR 10.115,

[[Page 14883]]

which provide for public comment at any time.
    In the Federal Register of October 25, 2023 (88 FR 73349), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 2--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
  Forms FDA 3613, 3613a, 3613b,                      Number of
    3613c, 3613f, and 3613g;         Number of     responses per   Total annual   Average burden    Total hours
    submission to FDA center        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 (CDRH).....
Center for Drug Evaluation and             9,396               1           9,396               1           9,396
 Research (CDER)................
Center for Veterinary Medicine             1,618               1           1,618               1           1,618
 (CVM)..........................
                                 -------------------------------------------------------------------------------
    Total.......................          24,533  ..............          24,533  ..............          35,708
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    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. Further 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.
    The estimated burden for the information collection reflects an 
overall adjustment increase of 5,102 hours and a corresponding increase 
of 5,102 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 COVID-19 pandemic. In addition, 
revised form instructions related to medical device products are 
included in the information collection request.

    Dated: February 23, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-04155 Filed 2-28-24; 8:45 am]
BILLING CODE 4164-01-P


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