Federal Register / Vol. 89, No. 228 / Tuesday, November 26, 2024 / Notices 93305 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–2888] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Substantial 

Equivalence Reports for Tobacco 

Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, 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 December 

26, 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 0910–0673. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

JonnaLynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, 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. 

Substantial Equivalence Reports for 

Tobacco Products 

OMB Control Number 0910–0673— 

Revision 

This information collection supports 

FDA requirements for the content and 

format of Substantial Equivalence (SE) 

Reports which are utilized to establish 

the substantial equivalence of a tobacco 

product. Sections 905(j)(1)(A)(i) and 

910(a) of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) (21 U.S.C. 

387e(j)(1)(A)(i) and 387j(a)) established 

requirements for substantial equivalence 

and premarket review of new tobacco 

products and the implementing 

regulations per the SE final rule (86 FR 

55224) are found in §§ 1107.18 and 

1107.19 (21 CFR 1107.18 and 1107.19). 

An SE Report can be submitted by any 

manufacturer for any new tobacco 

product seeking an FDA substantially 

equivalent order, under section 905(j) of 

the FD&C Act. A substantially 

equivalent tobacco product is one that 

has been found by FDA to have either 

the same characteristics as a predicate 

product or has different characteristics 

than the predicate tobacco product, but 

the SE Report demonstrates that the new 

product does not raise different 

questions of public health. A predicate 

tobacco product is one that was 

commercially marketed (other than for 

test marketing) in the United States as 

of February 15, 2007, or is a product 

previously found to be substantially 

equivalent by FDA. Generally, an 

applicant may amend its SE Report (21 

CFR 1107.20), withdraw its SE Report 

after submission (21 CFR 1107.22), and 

change the ownership of its SE Report 

(21 CFR 1107.24). Electronic submission 

of SE Reports is required, unless the 

applicant requests and is granted a 

waiver. 

FDA will have three forms required 

for use (once this revision is approved) 

under § 1107.18(a) when submitting an 

SE Report to the Agency: Form FDA 

3965; Form FDA 3965a; and Form FDA 

3965b. 

Form FDA 3965 is for use when 

submitting a tobacco SE Report to the 

Agency. Form FDA 3965 and its 

corresponding instructions have been 

updated to assist industry users in 

completing the form efficiently and 

correctly. The flow and organization of 

the form have been updated to follow a 

consistent style and appearance with 

other FDA forms related to tobacco 

product submissions. 

Form FDA 3965a is the Tobacco 

Substantial Equivalence Report 

Amendment and General 

Correspondence Submission form that 

was formerly Form FDA 3964. FDA has 

revised the form number of Form FDA 

3964 to Form FDA 3965a to align to 

Form FDA 3965, the Tobacco 

Substantial Equivalence Report 

Submission. Form FDA 3965a is for use 

when firms are submitting amendments 

and other general correspondence for an 

SE Report to the Agency. Form FDA 

3965a and its corresponding 

instructions have been updated to assist 

industry users in completing the form 

efficiently and correctly. The flow and 

organization of the form have been 

updated to follow a consistent style and 

appearance with Form FDA 3965. As 

part of the form organization update, 

Form FDA 3965a has been split into 

three main parts: Applicant Information, 

Amendment Information, and General 

Correspondence. Industry users are able 

to select the submission type, selecting 

from Amendment or General 

Correspondence, in Part B of Section I— 

Applicant Information. After a selection 

is made, industry users may skip to the 

appropriate section to complete. Form 

FDA 3965b is the new SE Unique 

Identification for New and Predicate 

Tobacco Products form that assists 

industry and FDA in identifying the 

products that are the subject of a 

submission where an applicant groups 

multiple SE Reports into a single 

submission (referred to as a bundled 

submission or a grouped submission). 

The Consolidated Appropriations Act 

of 2022 (Pub. L. 117–103) (the 

Appropriations Act), enacted on March 

15, 2022, amended the definition of the 

term ‘‘tobacco product’’ in section 

201(rr) of the FD&C Act (21 U.S.C. 

321(rr)) to include products that contain 

nicotine from any source. As a result, 

non-tobacco nicotine (NTN) products 

that were not previously subject to the 

FD&C Act (e.g., products containing 

synthetic nicotine) are now subject to all 

of the tobacco product provisions in the 

FD&C Act that began on April 14, 2022, 

including the requirement of premarket 

review for new tobacco products. The 

Appropriations Act also makes all 

regulations and guidances applicable to 

tobacco products apply to NTN 

products on that same effective date. 

The Center for Tobacco Products 

(CTP) is planning a significant upgrade 

to the submission process for SE 

applications. This upgrade, known as 

the CTP Portal Next Generation (CTP 

Portal NG), is a pivotal step forward in 

streamlining the application process for 

the tobacco industry. Presently, the 

tobacco industry uses multiple tools in 

the preparation and submission of SE 

applications to CTP, including PDFediting software, FDA’s eSubmitter 

Desktop tool, and FDA’s CTP Portal web 

application. A submitter must first 

download and complete PDF versions of 

Form FDA 3965 and 3965a for SE 

applications and amendments, 

respectively, using any PDF-editing 

software. Once the PDF form is 

complete, the tobacco industry uses the 

eSubmitter Desktop tool (https://

www.fda.gov/industry/fda-esubmitter/ 

using-esubmitter-prepare-tobaccoproduct-submissions) to prepare the 

submission for delivery to CTP, which 

requires creating a new submission 

using eSubmitter’s electronic CTP 


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Transmittal Form and providing contact 

information, the completed Form FDA 

3965 and/or 3965a, and any supporting 

documentation. When complete, the 

eSubmitter tool then packages the 

submission form, data, and documents 

into a ZIP file, saved locally, and the 

tobacco industry must log into their CTP 

Portal account (https://www.fda.gov/ 

tobacco-products/manufacturing/ 

submit-documents-ctp-portal) and 

upload the packaged submission ZIP 

file. To use CTP Portal, an organization 

must first go through the process of 

setting up an Industry Account Manager 

(IAM) (https://www.fda.gov/tobaccoproducts/manufacturing/requestindustry-account-manager-iam-ctpportal), which will then allow the IAM 

to manage CTP Portal accounts for their 

organization and submit submissions. 

The new CTP Portal NG application 

transforms this process by providing the 

tobacco industry with the ability to 

create, prepare, and deliver their 

submissions in one place. CTP Portal 

NG will provide web forms of Form 

FDA 3965 and 3965a for SE applications 

and amendments, respectively, which 

will improve the submission 

preparation process for the tobacco 

industry as it will provide tools to 

expedite the entry of data and 

supporting documentation, dynamically 

guide users to relevant sections of the 

forms based on their input, and improve 

quality by providing helpful 

information on the questions being 

requested and verifying all required data 

has been provided. CTP Portal NG has 

a built-in process for applicants to 

upload Form FDA 3965b after 

applicants complete Form FDA 3965b 

and validate it using a new validator 

tool. When complete, CTP Portal NG 

allows applicants to submit the 

completed web forms to CTP for review. 

This innovation eliminates the current 

three-step process using PDF-editing 

software, eSubmitter, and CTP Portal 

and provides a more integrated, userfriendly experience. 

Existing CTP Portal user accounts will 

be migrated to CTP Portal NG. Users 

may be prompted for a password reset 

during their initial login to the new 

system. The process for creating new 

user accounts and overall user account 

management will largely remain 

consistent with the current system. CTP 

is committed to ensuring a smooth 

transition to CTP Portal NG and will 

provide necessary support and guidance 

throughout this change. 

Submitters can visit the following 

web page which describes the process 

for submitting a SE Report: https://

www.fda.gov/tobacco-products/marketand-distribute-tobacco-product/ 

substantial-equivalence. 

In the Federal Register of July 16, 

2024 (89 FR 57903), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. FDA received one 

comment responsive to the four 

information collection topics solicited 

and one comment that was not 

responsive to those topics. 

(Comment) FDA should provide 

clarity around how Portal Next 

Generation will operate and hold a 

workshop to solicit feedback from 

regulated industry prior to its 

implementation. In addition, FDA 

should focus on other SE process 

reforms that can have an even greater 

impact on efficiency. 

(Response) Thank you for your 

detailed comments in response to the 

Federal Register Notice regarding the 

proposed information collection for SE 

reports and associated recordkeeping 

requirements. We appreciate your 

engagement and value your feedback on 

the planned upgrade to the submission 

process through the CTP Portal NG. 

The purpose of the Federal Register 

Notice was to introduce updates to the 

FDA Form 3965 and 3965a (previously 

3964) paper forms and to inform 

stakeholders that FDA Forms 3965 and 

3965a (previously 3964) will be made 

available as web forms through the new 

CTP Portal NG. The wireframes 

included in the Notice were intended to 

serve as an approximate representation 

of the fields and workflow specifically 

associated with the new 3965 and 3965a 

web forms for public comment, and as 

such, do not detail all of the planned 

functionality for CTP Portal NG nor do 

they represent the final versions of the 

forms. 

The CTP acknowledges and agrees 

with the need for further clarity 

regarding the implementation and 

functionality of CTP Portal NG. To 

address these concerns, CTP will 

provide the regulated industry, and 

other stakeholders, an opportunity to 

engage directly with the new system, 

navigate the platform, and offer 

substantive feedback on the workflow 

and usability of the new Portal. 

Additionally, we would like to clarify 

that SE applications submitted under 

the current system will be seamlessly 

integrated into the new platform. The 

intent of CTP Portal NG is to streamline 

and enhance the efficiency of the 

submission process by providing webbased forms that simplify data entry, 

minimize the need for multiple tools, 

and support the submission of required 

information in a structured manner. 

CTP looks forward to engaging with 

our industry partners and will take all 

feedback into consideration to ensure 

that the final implementation of CTP 

Portal NG meets the needs of the 

regulated community while fulfilling 

CTP’s regulatory and statutory 

obligations. 

FDA is also actively working on 

improving the application review 

process. As new processes are 

developed, FDA is committed to 

transparency with industry and other 

stakeholders. CTP Portal NG is in line 

with our intent to improve application 

review. It helps the applicant provide 

information required by the Substantial 

Equivalent and Recordkeeping 

Requirements regulations in an 

identifiable format. Additionally, the 

guidance provided in CTP Portal NG 

will reduce applicant burden by 

highlighting missing information in 

fields that contain required content 

prior to submission and providing 

applicants with an opportunity to 

include missing content. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 3

Activity; FDA form; 21 CFR 

section 

Number of 

respondents 

Number of 

responses 

per 

respondent 

Total 

annual 

responses 

Average burden per 

response 

Total 

hours 

SE Report—1107.18 ......................................................... 1,139 1 1,139 300 ......................... 341,700 

SE Report where applicant provides certification for identical characteristics—1107.18(g) and 1107.18(l)(2).431 1 431 10 ........................... 4,310 

Form FDA 3965—Tobacco Substantial Equivalence Report Submission.1,570 1 1,570 0.75 (45 minutes) .. 1,178 


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Federal Register / Vol. 89, No. 228 / Tuesday, November 26, 2024 / Notices 93307 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 3—Continued 

Activity; FDA form; 21 CFR 

section 

Number of 

respondents 

Number of 

responses 

per 

respondent 

Total 

annual 

responses 

Average burden per 

response 

Total 

hours 

Form FDA 3965a 2—Tobacco Amendment and General 

Correspondence Report.

628 1 628 0.16 (10 minutes) ... 100 

Form FDA 3965b—SE Unique Identification for New and 

Predicate Tobacco Products.

1,570 1 1,570 1 ............................. 1,570 

SE Grouping Spreadsheet Validator ................................. 1,570 1 1,570 0.08 (5 minutes) ..... 126 

Waiver from Electronic submission—1107.62(b) .............. 5 1 5 0.25 (15 minutes) ... 1 

Totals .......................................................................... ...................... .................... 6,913 ................................ 348,985 

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

2Formerly Form FDA 3964, Tobacco Substantial Equivalence Report Amendment and General Correspondence Submission. 

3Totals may not sum due to rounding. 

FDA has based these estimates on 

experience with this information 

collection, information we have 

available from interactions with 

industry, registration and listing data, 

information related to other regulated 

products, and FDA expectations 

regarding the tobacco industry’s use of 

the substantial equivalence pathway to 

market their products. We have revised 

our previous estimates based on these 

experiences. Utilizing registration and 

listing data for deemed tobacco 

products, the estimated annual number 

of SE Reports is expected to be 1,570. 

When several full SE Reports contain 

identical content, these SE Reports may 

be bundled into a single submission. 

Similarly, SE Reports in which the 

characteristics of the products are 

certified as identical and the contents of 

the SE Reports are also identical, these 

may also be bundled. FDA anticipates 

the burden for an applicant to be 

generally the same if they submit 

bundled submissions or individual 

applications as such, both are captured 

under SE Reports. As mentioned 

previously, NTN products that were not 

previously subject to the FD&C Act (e.g., 

products containing synthetic nicotine) 

are now subject to all tobacco product 

provisions in the FD&C Act beginning 

on April 14, 2022. Based on this new 

authority, we do not believe a change is 

needed in our burden estimates because 

FDA has received significantly fewer 

NTN SE Reports than anticipated. 

Table 1 describes the annual reporting 

burden per the requirements in 

§§ 1107.18 and 1107.19. FDA estimates 

that we will receive 1,139 full initial SE 

Reports for a new tobacco product each 

year under § 1107.18 that take a 

manufacturer approximately 300 hours 

to prepare. We have consolidated our 

previous numbers in the burden chart of 

full and bundled SE Reports (683 and 

456) to reach the 1,139 estimate. In 

addition, anyone submitting an SE 

Report is required to submit an 

environmental assessment prepared in 

accordance with 21 CFR 25.40 under 

§ 1107.18(k). The burden for 

environmental reports has been 

included in the burden per response for 

each type of SE Report. 

FDA estimates receiving 239 SE 

Reports where applicants provide a 

certification for some identical 

characteristics under §§ 1107.18(g) and 

1107.18(l)(2). We also estimate receiving 

192 bundled SE Reports where 

applicants provide a certification for 

some identical characteristics under 

§§ 1107.18(g) and 1107.18(l)(2) (other 

than the initial SE Report in the 

bundle). FDA anticipates the burden for 

an applicant to be generally the same if 

they submit bundled submissions or 

individual applications as such, both 

are captured under SE Report where 

applicant provides certification for 

identical characteristics. We believe that 

the number of SE Reports that include 

a certification will increase because 

applicants may certify that certain 

characteristics are identical in the new 

tobacco product and the predicate 

tobacco product. However, in the 

absence of specific information on how 

many more applicants might choose to 

certify, we are maintaining our previous 

estimates at this time. As certification 

statements and additional guidance are 

given by the Agency within Form FDA 

3965, FDA expects applicants to submit 

less technical information. As a result, 

we expect applicants total burden hours 

per applications to decrease. Therefore, 

we have decreased the burden per 

response for these SE Reports. 

Manufacturers are required to submit 

SE Reports electronically (§ 1107.62 (21 

CFR 1107.62)). We estimate that it 

would initially take about 45 minutes 

per product to fill out the Form FDA 

3965. However, for amendments, we 

estimate that filling out Form FDA 

3965a will take 10 minutes as applicants 

can copy and paste from the first 

submission. Section 1107.62(b) also 

allows applicants to request a waiver 

from the electronic format requirement. 

Based on experience since 

implementing the Premarket Tobacco 

Product Application (PMTA) rule, FDA 

does not believe we will receive many 

waivers, so we have decreased the 

number of respondents to five 

respondents to acknowledge the option 

to submit a waiver. Consistent with our 

other application estimates for waivers, 

we believe it would take 0.25 hours (15 

minutes) per waiver for a total of 1 hour. 

FDA is revising this collection to 

include a new form (Form FDA 3965b) 

and a validator tool for Form FDA 3965b 

that will help applicants submit 

information for their SE Reports in the 

correct format. Form FDA 3965b assists 

industry and FDA in identifying the 

products that are the subject of a 

submission, particularly where an 

applicant groups multiple new tobacco 

products into a single submission. This 

includes grouping products that are 

from the same manufacturer or domestic 

importer and in the same product 

category and subcategory into a single 

submission. FDA discussed bundled 

submissions in the SE rule (86 FR 

55224) and noted that FDA intends to 

consider information on each new 

tobacco product and its corresponding 

predicate tobacco product as a separate, 

individual SE Report as required under 

§ 1107.18(c)(7), § 1107.18(g), and 

§ 1107.19. By having the identifying 

information for products contained in 

an SE Report be more clearly organized 

within the required forms, FDA will be 

able to process and review the 

applications contained in a grouped 

submission more efficiently. 

The form assists applicants in 

providing the unique identifying 

information for each product in single 

and grouped submissions of SE Reports. 

A respondent would utilize Form FDA 


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3965b once for each submission. We 

assume the submitter could include 

from 1 to 2,000 products in each Form 

FDA 3965b. Entering data for up to 

2,000 rows can take approximately 4 

hours on average per Form FDA 3965b 

for manual data entry. We reflect the 

average time of 60 minutes per response 

based on the assumption that we expect 

to receive an average of 25 bundled 

products per submission. Assuming 60 

minutes per Form FDA 3965b for 1,570 

applications, we estimate a total burden 

of 1,570 hours for this activity. 

The FDA Tobacco Product Grouping 

Spreadsheet Validator (Validator) is a 

free software that validates the content 

of FDA product grouping spreadsheets 

such as ‘‘Form FDA 3965b—SE Unique 

Identification for New and Predicate 

Tobacco Products.’’ The Validator is 

available for voluntary use by the 

tobacco industry (sponsors, 

manufacturers, and importers) prior to 

submitting a product grouping 

spreadsheet to FDA. 

The Validator allows industry users to 

validate product attributes in their 

product grouping spreadsheet with the 

defined and accepted product data 

standards and to make corrections as 

needed. If there are no errors found in 

a spreadsheet, the Validator will 

produce a certificate of completion that 

can be saved locally and included with 

the applicants FDA submission 

voluntarily. If errors are found during 

validation, the Validator will provide 

the applicants with the error at the end 

of each impacted row of the 

spreadsheet, allowing applicants to 

make necessary changes. 

The software and any output files 

reside locally on an applicant’s 

computer, allowing them to work on the 

product grouping spreadsheet offline. 

The Validator does not transmit any 

data across the web to FDA. FDA does 

not have the ability to access, review, or 

supplement the information on local 

computers through this application. We 

estimate that use of the Validator will 

take an average of 5 minutes per 

response. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity; 21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average burden per recordkeeping 

Total hours 

Recordkeeping SE Report under 1107.18–1107.58 ........... 471 1 471 5 2,355 

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

FDA estimates that 30 percent of SE 

Reports or 471 respondents will 

maintain required records related to 

their SE Reports at 5 hours per record 

for a total of 2,355 recordkeeping hours 

(table 2). The first SE Report in a chain 

must use a tobacco product 

commercially marketed (other than for 

test marketing) in the United States as 

of February 15, 2007, as a predicate 

product for the SE Report. Therefore, we 

believe that manufacturers will have 

records on those ‘‘original’’ predicate 

tobacco products from their initial SE 

Reports. 

Our estimated burden for the 

information collection reflects an 

overall increase of 69,010 hours and a 

corresponding increase of 2,905 

responses/records. We attribute this to 

adding a new form, providing the 

validator tool, and reevaluating our 

current estimates. 

Dated: November 20, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–27654 Filed 11–25–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–4040–0008] 

Agency Information Collection 

Request; 60-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before January 27, 2025. 

ADDRESSES: Submit your comments to 

sagal.musa@hhs.gov or by calling (202) 

205–2634. 

FOR FURTHER INFORMATION CONTACT: 

When submitting comments or 

requesting information, please include 

the document identifier 4040–0008–60D 

and project title for reference, to Sagal 

Musa, email: sagal.musa@hhs.gov, or 

call (202) 205–2634 the Reports 

Clearance Officer. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

Title of the Collection: Budget 

Information for Construction Programs 

(SF–424C). 

Type of Collection: Extension. 

OMB No.: 4040–0008. 

Abstract 

Budget Information for Construction 

Programs (SF–424C) is used by 

applicants to apply for Federal financial 

assistance. The Budget Information for 

Construction Programs (SF–424C) form 

allows the applicants to provide budget 

details as part of their grant proposals. 

This form is evaluated by Federal 

agencies as part of the overall grant 

application. This IC expires on February 

28, 2025. Grants.gov seeks a three-year 

clearance of these collections. 


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