14882 Federal Register / Vol. 89, No. 41 / Thursday, February 29, 2024 / Notices 

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, PRAStaff@

fda.hhs.gov. 

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 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)’’.

For the export of products legally marketed in the United States. 

Form FDA 3613a: ‘‘Supplementary Information Certificate of 

Exportability Requests’’.

‘‘Exporter’s Certification Statement Certificate of Exportability’’ ..............

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. 

Form FDA 3613b and Form FDA 3613f: ‘‘Supplementary Information 

Certificate of a Pharmaceutical Product’’.

‘‘Exporter’s Certification Statement 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. 

Form FDA 3613c: ‘‘Supplementary Information Non-Clinical Research 

Use Only Certificate’’.

‘‘Exporter’s Certification Statement (Non-Clinical Research Use Only)’’

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. 

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. 

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-regulatedproducts, (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 

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, 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 41 / Thursday, February 29, 2024 / Notices 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, 3613c, 3613f, and 

3613g; submission to FDA center 

Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Center for Biologics Evaluation and Research (CBER) ...... 2,344 1 2,344 1 2,344 

Center for Devices and Radiological Health (CDRH) ......... 11,175 1 11,175 2 22,350 

Center for Drug Evaluation and Research (CDER) ............ 9,396 1 9,396 1 9,396 

Center for Veterinary Medicine (CVM) ................................ 1,618 1 1,618 1 1,618 

Total .............................................................................. 24,533 ........................ 24,533 ........................ 35,708 

1There 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. 

[FR Doc. 2024–04155 Filed 2–28–24; 8:45 am] 

BILLING CODE 4164–01–P 

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. 

SUMMARY: 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 

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 


khammond on DSKJM1Z7X2PROD with NOTICES