Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export Certificates for Food and Drug Administration Regulated Products, 14882-14883 [2024-04155]

Download as PDF 14882 Federal Register / Vol. 89, No. 41 / Thursday, February 29, 2024 / Notices 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: 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. ADDRESSES: DEPARTMENT OF HEALTH AND HUMAN SERVICES Notice. FOR FURTHER INFORMATION CONTACT: 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. SUMMARY: 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. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: 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 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 and Form FDA 3613f: ‘‘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)’’ khammond on DSKJM1Z7X2PROD with NOTICES Form FDA 3613g: ‘‘Certificate to Foreign Government for Devices Not Exported from the United States’’. To obtain a fillable PDF file of each form, visit https://www.fda.gov/aboutfda/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/vaccinesblood-biologics/compliance-actionsbiologics/exporting-cber-regulated- VerDate Sep<11>2014 16:39 Feb 28, 2024 Jkt 262001 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. products, (CBER); https://www.fda.gov/ medical-devices/importing-andexporting-medical-devices/exportingmedical-devices (CDRH); https:// www.fda.gov/drugs/human-drugexports/electronic-certificatespharmaceutical-product-generalinformation (CDER); and https:// www.fda.gov/animal-veterinary/importexports/exporting-animal-feed-andanimal-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 PO 00000 Frm 00083 Fmt 4703 Sfmt 4703 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, E:\FR\FM\29FEN1.SGM 29FEN1 14883 Federal Register / Vol. 89, No. 41 / Thursday, February 29, 2024 / Notices 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, 3613c, 3613f, and 3613g; submission to 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 (CDRH) ......... Drug Evaluation and Research (CDER) ............ Veterinary Medicine (CVM) ................................ 2,344 11,175 9,396 1,618 1 1 1 1 2,344 11,175 9,396 1,618 1 2 1 1 2,344 22,350 9,396 1,618 Total .............................................................................. 24,533 ........................ 24,533 ........................ 35,708 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/fdaexport-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. khammond on DSKJM1Z7X2PROD with NOTICES Number of respondents [FR Doc. 2024–04155 Filed 2–28–24; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 16:39 Feb 28, 2024 Jkt 262001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2022–E–2936 and FDA– 2022–E–2937] Determination of Regulatory Review Period for Purposes of Patent Extension; GEMTESA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for GEMTESA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product. DATES: Anyone with knowledge that any of the dates as published (see SUPPLEMENTARY INFORMATION) are incorrect must submit either electronic or written comments and ask for a redetermination by April 29, 2024. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by August 27, 2024. See ‘‘Petitions’’ in the SUPPLEMENTARY INFORMATION section for more information. 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 April 29, 2024. Comments received by SUMMARY: PO 00000 Frm 00084 Fmt 4703 Sfmt 4703 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 E:\FR\FM\29FEN1.SGM 29FEN1

Agencies

[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.

-----------------------------------------------------------------------

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, 
[email protected].

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
----------------------------------------------------------------------------------------------------------------
\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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