Federal Register / Vol. 88, No. 205 / Wednesday, October 25, 2023 / Notices 73349 

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. 

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, 


lotter on DSK11XQN23PROD with NOTICES1
73350 Federal Register / Vol. 88, No. 205 / Wednesday, October 25, 2023 / Notices 

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/fdaforms-certificates-exporting and https:// 

www.fda.gov/vaccines-blood-biologics/ 

exporting-cber-regulated-products/howcomplete-fda-export-certificate-forms; 

https://www.fda.gov/drugs/humandrug-exports/electronic-certificatespharmaceutical-product-generalinformation; https://www.fda.gov/ 

medical-devices/importing-andexporting-medical-devices/exportingmedical-devices; and https://

www.fda.gov/animal-veterinary/importexports/exporting-animal-feed-andanimal-drugs. 

TABLE 1—CERTIFICATES AND USES

Type of Certificate/Form FDA# Use 

Form 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-fdaguidance-documents/fda-exportcertificates. 

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 hours 

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

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

Center for Drug Evaluation and Research (CDER) ............ 6,981 1 6,981 1 6,981 

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

Total .............................................................................. ........................ ........................ ........................ ........................ 33,293 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 88, No. 205 / Wednesday, October 25, 2023 / Notices 73351 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Biodefense Science Board 

Public Meeting 

AGENCY: Administration for Strategic 

Preparedness and Response (ASPR), 

Department of Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: The National Biodefense 

Science Board (NBSB) will publicly 

meet using an online format on 

Thursday, November 30, 2023 (12:30 to 

4:00 p.m. ET). Notice of the meeting is 

required under section 10(a)(2) of the 

Federal Advisory Committee Act 

(FACA). The NBSB provides expert 

advice and guidance to the U.S. 

Department of Health and Human 

Services (HHS) regarding current and 

future chemical, biological, radiological, 

and nuclear threats, as well as other 

matters related to disaster preparedness 

and response. The Administration for 

Strategic Preparedness and Response 

(ASPR) manages and convenes the 

NBSB on behalf the Secretary of HHS. 

The NBSB will discuss and vote on two 

sets of recommendations related to 

COVID–19 pandemic lessons, Project 

NextGen vaccine and therapeutic 

products, and disaster preparedness 

training. 

Procedures for Public Participation: 

The public and expert stakeholders are 

invited to observe the meeting. Preregistration (Zoom) is required. Anyone 

may submit questions and comments to 

the NBSB by email (NBSB@hhs.gov) 

before the meeting. American Sign 

Language translation and 

Communication Access Real-Time 

Translation will be provided. 

Representatives from industry, 

academia, health professions, health 

care consumer organizations, nonfederal government agencies, or 

community-based organizations may 

request up to seven minutes to speak 

directly to the Board. Requests to speak 

to the Board will be approved in 

consultation with the Board Chair and 

based on time available during the 

meeting. Requests to speak to the NBSB 

during the public meeting must be sent 

to NBSB@hhs.gov by close of business 

on November 23, 2023. Please provide 

the full name, credentials, official 

position(s), and relevant affiliations for 

the speaker and a brief description of 

the intended topic. Presentations that 

contain material with a commercial 

bias, advertising, marketing, or 

solicitations will not be allowed. A 

meeting summary will be available on 

the NBSB website post-meeting. 

FOR FURTHER INFORMATION CONTACT: 

CAPT Christopher Perdue; NBSB 

Designated Federal Official, (202) 480– 

7226; NBSB@HHS.GOV. 

Dawn O’Connell, 

Assistant Secretary for Preparedness and 

Response. 

[FR Doc. 2023–23532 Filed 10–24–23; 8:45 am] 

BILLING CODE 4150–37–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Citizenship and Immigration 

Services 

[OMB Control Number 1615–0092] 

Agency Information Collection 

Activities; Revision of a Currently 

Approved Collection: E-Verify Program 

AGENCY: U.S. Citizenship and 

Immigration Services, Department of 

Homeland Security. 

ACTION: 30-Day notice. 

SUMMARY: The Department of Homeland 

Security (DHS), U.S. Citizenship and 

Immigration Services (USCIS) will be 

submitting the following information 

collection request to the Office of 

Management and Budget (OMB) for 

review and clearance in accordance 

with the Paperwork Reduction Act of 

1995. The purpose of this notice is to 

allow an additional 30 days for public 

comments. 

DATES: Comments are encouraged and 

will be accepted until November 24, 

2023. 

ADDRESSES: Written comments and/or 

suggestions regarding the item(s) 

contained in this notice, especially 

regarding the estimated public burden 

and associated response time, must be 

submitted via the Federal eRulemaking 

Portal website at http://

www.regulations.gov under e-Docket ID 

number USCIS–2007–0023. All 

submissions received must include the 

OMB Control Number 1615–0092 in the 

body of the letter, the agency name and 

Docket ID USCIS–2007–0023. 

FOR FURTHER INFORMATION CONTACT: 

USCIS, Office of Policy and Strategy, 

Regulatory Coordination Division, 

Samantha Deshommes, Chief, telephone 

number (240) 721–3000 (This is not a 

toll-free number; comments are not 

accepted via telephone message.). Please 

note contact information provided here 

is solely for questions regarding this 

notice. It is not for individual case 

status inquiries. Applicants seeking 

information about the status of their 

individual cases can check Case Status 

Online, available at the USCIS website 

at http://www.uscis.gov, or call the 

USCIS Contact Center at 800–375–5283 

(TTY 800–767–1833). 

SUPPLEMENTARY INFORMATION: 

Comments 

The information collection notice was 

previously published in the Federal 

Register on June 29, 2023, at 88 FR 

42091, allowing for a 60-day public 

comment period. USCIS received two 

comments in connection with the 60- 

day notice. 

You may access the information 

collection instrument with instructions, 

or additional information by visiting the 

Federal eRulemaking Portal site at: 

http://www.regulations.gov and enter 

USCIS–2007–0023 in the search box. 

The comments submitted to USCIS via 

this method are visible to the Office of 

Management and Budget and comply 

with the requirements of 5 CFR 

1320.12(c). All submissions will be 

posted, without change, to the Federal 

eRulemaking Portal at http://

www.regulations.gov, and will include 

any personal information you provide. 

Therefore, submitting this information 

makes it public. You may wish to 

consider limiting the amount of 

personal information that you provide 

in any voluntary submission you make 

to DHS. DHS may withhold information 

provided in comments from public 

viewing that it determines may impact 

the privacy of an individual or is 

offensive. For additional information, 

please read the Privacy Act notice that 

is available via the link in the footer of 

http://www.regulations.gov. 


lotter on DSK11XQN23PROD with NOTICES1