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 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2023-N-4259]
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Notice.
 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, 
                        *PRAStaff@fda.hhs.gov.*


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, 
                    ( print 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 
                    *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
Type of Certificate/Form FDA#
UseForm FDA 3613: “Supplementary Information Certificate to Foreign Government Requests”
For the export of products legally marketed in the United 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 Information Certificate of Exportability Requests”
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“Exporter's Certification Statement Certificate of Exportability”Form FDA 3613b: “Supplementary Information Certificate of a Pharmaceutical Product”
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“Exporter's Certification Statement Certificate of a Pharmaceutical Product”Form FDA 3613c: “Supplementary Information Non-Clinical Research Use Only Certificate”
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“Exporter's Certification Statement (Non-Clinical Research Use Only)”Form FDA 3613g: “Certificate to Foreign Government for Devices Not Exported from the United States”
For the shipping of devices not exported from the United States that may be legally marketed in the United States.
 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
FDA center
Number of
                             respondents
Number of
                             responses per 
                             respondent
Total annual responses
Average
                             burden per 
                             response
Total hoursCenter for Biologics Evaluation and Research (CBER)
2,344
1
2,344
1
2,344Center for Devices and Radiological Health
11,175
1
11,175
2
22,350Center for Drug Evaluation and Research (CDER)
6,981
1
6,981
1
6,981Center for Veterinary Medicine (CVM)
1,618
1
1,618
1
1,618Total




33,2931
                         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. 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