93300 Federal Register / Vol. 89, No. 228 / Tuesday, November 26, 2024 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–2889] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Premarket 

Tobacco Product Applications and 

Recordkeeping Requirements 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) 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 0910–0879. 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. 

Premarket Tobacco Product 

Applications and Recordkeeping 

Requirements 

OMB Control Number 0910–0879— 

Revision 

This information collection supports 

FDA regulations. Tobacco products are 

governed by chapter IX of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) (sections 900 through 920) (21 

U.S.C. 387 through 21 U.S.C. 387t). 

Section 910(a) established requirements 

for premarket review of new tobacco 

products. 

The Consolidated Appropriations Act 

of 2022 (the Appropriations Act), that 

was 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, nontobacco 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 beginning on April 14, 2022, 

including the requirement of premarket 

review for new tobacco products. The 

Appropriations Act also makes all rules 

and guidances applicable to tobacco 

products apply to NTN products on that 

same effective date. Additionally, the 

Appropriations Act includes a transition 

period for premarket review 

requirements, directing companies to 

submit premarket tobacco product 

applications (PMTAs) for NTN products 

by May 14, 2022, to receive an 

additional 60-day period of marketing 

without being considered in violation of 

premarket review requirements. 

The PMTAs and Recordkeeping 

Requirements regulation (21 CFR 

1114.45 (§ 1114.45)) outlines 

requirements for the content, format, 

submission, and review of PMTAs, as 

well as other requirements related to 

PMTAs, including recordkeeping 

requirements, and postmarket reporting. 

FDA also requires recordkeeping 

regarding the legal marketing of PreExisting Tobacco Products (i.e., those 

products that were commercially 

marketed as of February 15, 2007) and 

products that are exempt from the 

requirements of demonstrating 

substantial equivalence. Section 

910(a)(2) of the FD&C Act requires that 

a new tobacco product be the subject of 

a PMTA marketing granted order unless 

FDA has issued an order finding it to be 

substantially equivalent to a predicate 

product or exempt from the 

requirements of demonstrating 

substantial equivalence. 

An applicant may submit a PMTA to 

demonstrate that a new tobacco product 

meets the requirements to receive a 

marketing granted order. A new tobacco 

product may not be introduced or 

delivered for introduction into interstate 

commerce under FDA regulations until 

FDA has issued a marketing granted 

order for the product (21 CFR 1114.5 

(§ 1114.5)). Further, 21 CFR 1114.7 

(§ 1114.7) describes the required content 

and format of the PMTA. The PMTA 

must contain sufficient information for 

FDA to determine whether any of the 

grounds for denial specified in section 

910(c)(2) of the FD&C Act apply. The 

application must contain the following 

sections: general information, 

descriptive information, product 

samples, labeling, a statement of 

compliance with 21 CFR part 25, a 

summary, product formulation, 

manufacturing, health risk 

investigations, effect on the population 

as a whole, and a certification 

statement. Submitters can visit the 

following web page, which describes the 

process for submitting a PMTA (https:// 

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

premarket-tobacco-productapplications). 

FDA has three forms required for use 

under §§ 1114.7(b) and 1114.9(a) (21 

CFR 1114.9(a)) when submitting PMTA 

information to the Agency: Form FDA 

4057; Form FDA 4057a; and Form FDA 

4057b. Form FDA 4057 is for use when 

submitting PMTA single and bundled 

submissions. For the purposes of this 

notice, no significant changes have been 

made to Form FDA 4057. Form FDA 

4057a is for use when firms are 

submitting amendments and other 

general correspondence. Form FDA 

4057a and the 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 

sequence with Form FDA 4057. Form 

FDA 4057a instructions have been 

updated to reflect plain language 

principles as well as accurately mapped 

to correspond to the updates made to 

Form FDA 4057a. Form FDA 4057b 

assists industry and FDA in identifying 

the products that are the subject of a 

submission where an applicant groups 

multiple PMTAs into a single 

submission (referred to as a bundled 

submission or a grouped submission). 

Form FDA 4057b has been updated to 

add the following columns: Brand; 

Subbrand; Manufacturer. This update 

aligns with the requirements of part 

1114 (21 CFR part 1114). Additionally, 

Characterizing Flavor has been included 

as a required field. 

The Center for Tobacco Products 

(CTP) is planning a significant upgrade 

to the submission process for PMTA 

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 

PMTA applications to CTP, including 

PDF-editing software, FDA’s eSubmitter 


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Desktop Tool, and FDA’s CTP Portal 

web application. 

A submitter must first download and 

complete PDF versions of FDA Form 

4057 and/or 4057a for PMTA 

applications and amendments, 

respectively, using any PDF-editing 

software. After 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 

Transmittal Form and providing contact 

information, the completed FDA Form 

4057 and/or 4057a, 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 the CTP Portal, an 

organization must first go through the 

process of setting up an Industry 

Account Manager (IAM) (https://

www.fda.gov/tobacco-products/ 

manufacturing/request-industryaccount-manager-iam-ctp-portal), 

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 the FDA 

Forms 4057 and 4057a for PMTA 

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 4057b after 

applicants complete Form FDA 4057b 

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 and 

user-friendly 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. 

After submission of a PMTA, FDA 

may request, and an applicant may 

submit, an amendment to a pending 

PMTA. FDA generally expects that 

when an applicant submits a PMTA, the 

submission will include all information 

required by section 910(b)(1) of the 

FD&C Act and part 1114 to enable FDA 

to determine whether it should 

authorize the marketing of a new 

tobacco product. However, FDA 

recognizes that additional information 

may be needed to complete the review 

of a PMTA and, therefore FDA allows 

the submission of amendments to a 

pending application. 

An applicant may transfer ownership 

of its PMTA at any time, including 

when FDA has yet to act on it. Section 

1114.13 describes the steps that an 

applicant would be required to take 

when it changes ownership of a PMTA. 

This section is intended to facilitate 

transfers of ownership and help ensure 

that FDA has current information 

regarding the ownership of a PMTA. 

Supplemental PMTAs are an 

alternative format of submitting a PMTA 

(§ 1114.15). Applicants that have 

received a marketing granted order are 

able to submit a supplemental PMTA to 

seek marketing authorization for a new 

tobacco product that results from a 

modification or modifications to the 

original tobacco product that received 

the marketing granted order. FDA 

restricts the use of supplemental PMTAs 

to only changes that require the 

submission of limited information or 

revisions to ensure that FDA can 

efficiently review the application. 

If an applicant receives a marketing 

denial order, they may submit a 

resubmission to respond to the 

deficiencies outlined in the marketing 

denial order (§ 1114.17). A resubmission 

may be submitted for the same tobacco 

product that received a marketing denial 

order or for a different new tobacco 

product that results from changes 

necessary to address the deficiencies 

outlined in a marketing denial order. 

This application format allows an 

applicant to address the deficiencies 

described in a marketing denial order 

without having to undertake the effort of 

submitting a standard PMTA. The 

resubmission format is not available for 

PMTAs that FDA refused to accept, 

refused to file, canceled, or 

administratively closed, or that the 

applicant withdrew because FDA has 

not previously completed reviews of 

such applications upon which it can 

rely, and such applications may need 

significant changes to be successfully 

resubmitted. 

FDA requires applicants that receive a 

marketing granted order to submit 

postmarket reports. Postmarket reports 

determine or facilitate a determination 

of whether there may be grounds to 

withdraw or temporarily suspend a 

marketing granted order (§ 1114.41). 

Additionally, § 1114.41 describes the 

reports that FDA would require through 

this regulation; however, FDA may 

require additional reporting in an 

individual applicant’s marketing 

granted order. Applicants are required 

to submit two types of postmarket 

reports after receiving a marketing 

granted order: periodic reports and 

adverse experience reports. Periodic 

reports are required to be submitted 

within 60 calendar days of the reporting 

date specified in the marketing granted 

order. FDA anticipates that the reports 

would be required on an annual basis, 

but FDA may require in a specific order 

that reports be made more or less 

frequently depending upon several 

factors. 

Applicants are also required to report 

all serious and unexpected adverse 

experiences associated with the tobacco 

product that have been reported to the 

applicant or of which the applicant is 

aware. The serious and unexpected 

adverse experience reports must be 

submitted to the CTP’s Office of Science 

through the HHS Safety Reporting Portal 

(https://www.safetyreporting.hhs.gov/) 

within 15 calendar days after receiving 

or becoming aware of a serious or 

unexpected adverse experience. FDA’s 

Safety Reporting Portal is approved 

under OMB control number 0910–0291. 

Applicants receiving a marketing 

granted order are required to maintain 

all records necessary to facilitate a 

determination of whether there are or 

may be grounds to withdraw or 

temporarily suspend the marketing 

granted order, including records related 

to both the application and postmarket 

reports, and ensure that such records 

remain readily available to FDA upon 

request (§ 1114.45). Under 

§ 1114.45(a)(1), an applicant must also 

retain any additional documentation 

supporting the application and 

postmarket reports that was not 

submitted to FDA. 

Section 1114.49 requires an applicant 

to submit a PMTA and all supporting 


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and related documents to FDA in 

electronic format. Under § 1114.49(c), 

an applicant that has a waiver would 

submit a paper submission to the 

address that FDA provides in the letter 

granting the waiver. 

Submitters can visit the following 

web page, which describes the process 

for submitting a PMTA (https://

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

premarket-tobacco-productapplications). 

In the Federal Register of July 16, 

2024 (89 FR 57907), 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 nine comments that were 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 PMTA 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 

PMTA 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 modifications 

to the FDA Form 4057a and to inform 

stakeholders that FDA Forms 4057 and 

4057a would be made available as webbased forms through the new CTP Portal 

NG. The wireframes provided in the 

Notice were intended to serve as an 

approximate representation of the 

planned web-form fields and workflow 

specifically associated with the new 

4057 and 4057a web forms for public 

comment, and as such, do not detail all 

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 PMTAs 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 Premarket 

Tobacco Product Applications 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 123

1 CFR part; activity; form FDA # Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden per 

response Total hours 

1114.5; Submission of Standard Bundled PMTAs 2 ... 215 1 215 1,713 ...................... 368,295 

PMTA Submission; Form FDA 4057 ........................... 215 1 215 0.58 (35 minutes) ... 125 

PMTA Amendment and General Correspondence 

Submission; Form FDA 4057a.

80 4 320 0.16 (10 minutes) ... 51 

PMTA Unique Identification for New Tobacco Products; Form FDA 4057b.215 1 215 0.58 (35 minutes) .. 125 

Tobacco Product Grouping Spreadsheet Validator .... 215 1 215 0.08 (5 minutes) ..... 17 

1114.41; Reporting Requirements (periodic reports) .. 10 3 30 50 ........................... 1,500 

1114.9; Amendments .................................................. 24 2 48 188 ......................... 9,024 

1114.13; Change in Ownership ................................... 10 1 10 1 ............................. 10 

1114.15; Supplemental applications ........................... 2 1 2 428 ......................... 856 

1114.17; Resubmissions ............................................. 5 1 5 565 ......................... 2,825 

1114.49(b) and (c); Waiver from Electronic Submission.1 1 1 0.25 (15 minutes) .. 1 

Total ...................................................................... ........................ ........................ 1,276 ................................ 382,828 

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

2FDA anticipates that applicants will submit bundled PMTAs, which are single submissions containing PMTAs for several similar or related 

products. We estimate that a bundle will contain on average between 6 and 11 distinct products. 3Totals may not sum due to rounding. 

Table 1 describes the estimated 

annual reporting burden. FDA has based 

these estimates on Agency experience 

with current PMTA submissions. FDA 

has based these estimates on experience 

with this information collection, 

information available from interactions 

with industry, and FDA expectations 

regarding established requirements for 

premarket review of new tobacco 

products. We have revised our previous 

estimates based on these experiences. In 

addition, FDA is revising this collection 

to incorporate the burden for PMTA 

submissions received under OMB 

control number 0910–0768 (which 

covers the burden for electronic nicotine 

delivery system (ENDS) products PMTA 


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submissions). We believe the original 

PMTA burden in OMB control number 

0910–0768 is now covered by the 

current PMTA process under this 

control number. Although that burden 

only covered ENDS products these 

estimates include all categories of 

products. 

FDA estimates that we will receive 

215 PMTAs for a new tobacco product 

each year under part 1114. Our average 

represents a wide range of hours that 

will be required for these applications 

under different circumstances, with 

some requiring more hours (e.g., as 

many as 5,000 hours for early 

applications that involve complex 

products and for which the company 

has no experience conducting studies or 

preparing analysis of public health 

impacts, or for which reliance on master 

files is not possible) as well as many 

requiring fewer hours (e.g., as few as 50 

hours for applications for products that 

are very similar to other new products). 

FDA estimates that it will take each 

respondent approximately 1,500 hours 

to prepare a PMTA seeking an order 

from FDA allowing the marketing of a 

new tobacco product. FDA also 

estimates that it would on average take 

an additional 213 hours to prepare an 

environmental assessment (EA) in 

accordance with the requirements of 21 

CFR 25.40, for a total of 1,713 hours per 

PMTA application. 

FDA assumes that firms will submit 

all applications as PMTA bundles. We 

believe that bundling PMTAs results in 

efficiencies for applicants when 

compared to submitting stand-alone, 

full-text submissions for each product. 

We expect to receive bundled PMTAs 

where applicants can use the same 

evidence to support PMTAs for similar 

or related products. Bundling PMTAs 

into a single submission would 

eliminate the administrative burden of 

having to reproduce the same evidence 

in a stand-alone PMTA for each 

product. 

FDA has three forms required for use 

under §§ 1114.7(b) and 1114.9(a) when 

submitting PMTA information to the 

Agency. Form FDA 4057 is for use when 

submitting PMTA single and bundled 

submissions. FDA estimates that 215 

respondents will submit PMTA bundles 

using this form at 0.58 (35 minutes) per 

response. Included in this estimate are 

the 15 expected bundles submitted for 

NTN products. The number 215 is 

accounting for the bundles of ENDS 

products and the 1 bundle we expect to 

receive yearly for originally regulated 

products for a total of 125 hours. 

Form FDA 4057a is for use when 

firms are submitting amendments and 

other general correspondence; as such, 

we expect 80 applicants to submit 4057a 

for either amendments or general 

correspondence submissions. Our 

estimate is 0.16 (10 minutes) per 

response to fill out this form. Included 

in this estimate are the 15 expected 

submissions submitted from NTN 

products. We estimate there will be at 

least four amendments per application 

for a total of 51 hours. With most 

applications being submitted toward the 

end of our 3-year range, we expect fewer 

amendments during this period. With 

updated forms and additional guidance 

given by the Agency, FDA expects 

applicants to submit more complete 

applications, reducing the need for the 

issuance of Deficiency letters and 

Environmental Information request 

letters. As a result, we expect applicants 

to submit fewer amendments with Form 

FDA 4057a. However, FDA expects 

amendments from earlier applications to 

be submitted during this period. As a 

result, we have decreased the number of 

responses per respondent (from 14 to 4 

responses) associated with Form FDA 

4057. 

Form FDA 4057b assists industry and 

FDA in identifying the products that are 

the subject of a submission where an 

applicant groups multiple PMTAs into a 

single submission (referred to as a 

bundled submission or a grouped 

submission). FDA has previously stated 

that one approach to submitting PMTAs 

could be to group applications for 

products that are both from the same 

manufacturer or domestic importer and 

in the same product category and 

subcategory into a single submission. 

FDA intends to consider information on 

each tobacco product as a separate, 

individual PMTA as required under 

§ 1114.7(c)(3)(iii). By having the 

identifying information for products 

contained in a submission 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. As 

a result, we decreased the average 

burden per response associated with the 

Form FDA 4057b by 10 minutes (from 

45 to 35 minutes per response). 

The form assists applicants in 

providing the unique identifying 

information for each product in a 

grouped submission of PMTAs. A 

respondent would utilize Form FDA 

4057b once for each submission. We 

assume the submitter could include 

from 1 to 2,000 products in each Form 

FDA 4057b. Entering data for up to 

2,000 rows can take approximately 4 

hours on average per Form FDA 4057b 

for manual data entry. We reflect the 

average time of 35 minutes per response 

based on the assumption that we expect 

to receive an average of nine bundled 

products per submission. Included in 

this estimate are the 15 expected 

submissions submitted from NTN 

products. Assuming 35 minutes per 

Form FDA 4057b for 215 applications, 

we estimate a total burden of 125 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 ‘‘FDA 4057b—PMTA Unique 

Identification for New 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 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 to 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 the use of the validator tool 

will take an average of 5 minutes per 

response. 

Applicants are required under 

§ 1114.41 to submit two types of reports 

after receiving a marketing granted 

order: periodic reports and adverse 

experience reports. Applicants must 

submit periodic reports within 60 

calendar days of the reporting date 

specified in the marketing granted order 

(or potentially sooner if they choose to 

use the application as the basis for a 

supplemental PMTA under § 1114.15). 

FDA anticipates that the reports will be 

required on an annual basis, but FDA 

may require, by a specific order, that 

reports be made more or less frequently 

depending upon a number of factors 

(e.g., the novelty of the type of product). 

As such, FDA estimates under § 1114.41 

that 10 respondents will submit a 

periodic report with 3 responses per 

respondent. This number is based on 

the average number of periodic report 


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submissions received between 2020 and 

2022. The Agency estimates that 

periodic reports will take on average of 

50 hours per response for a total of 

1,500 hours. FDA expects this number 

to increase as we continue to authorize 

more products in the PMTA pathway. 

As FDA continues to grant marketing 

authorization for more submissions, 

FDA expects the number of respondents 

and total responses to grow. As a result, 

we have increased the number of 

responses per respondent (from one to 

three responses per respondent) 

associated with periodic reports. 

Section 1114.13 allows an applicant 

to transfer ownership of a PMTA to a 

new owner. FDA believes this will be 

infrequent, so we have assigned 1 hour 

acknowledging the requirement. 

Section 1114.15 is an alternative 

format of submitting a PMTA, 

supplemental PMTA, meeting the 

requirements of § 1114.7 that would 

reduce the burden associated with the 

submission and review of an 

application. Our estimated number of 2 

respondents is based on the number 

estimated for postmarket reports, which 

is 4 bundles (approximately 34 

products). Not all applicants will 

resubmit modifications to previously 

authorized products, so we estimate 2 

bundles (which is approximately 17 

products). FDA estimates further that a 

supplemental PMTA will take 25 

percent of the time it takes (estimated at 

428 hours per response) to complete an 

original submission (including EA 

hours). We estimate a total of 856 

burden hours for this activity. 

Under § 1114.17 an applicant may 

submit a resubmission for the same 

tobacco product that received a 

marketing denial order or for a different 

new tobacco product that results from 

changes necessary to address the 

deficiencies outlined in a marketing 

denial order. Based on Agency 

experience, we are estimating that of all 

bundles received in 2020 through 2023, 

that an average of three bundles are 

authorized. If we receive 24 bundles 

yearly, and based on historical data, 58 

percent fail at acceptance (8 bundles 

remaining), 17 percent fail at filing (7 

bundles remaining), and 25 percent 

receive marketing orders (5 bundles 

remaining). We estimate that 50 percent 

will resubmit in a year. Thus, the 

number of respondents is three. FDA 

estimates that a resubmission will take 

33 percent of the time it takes to 

complete an original submission 

(including EA hours) estimated at 565 

hours per response for a total of 1,695 

hours. As FDA continues to deny 

marketing authorization for more 

submissions FDA expects the number of 

respondents and total responses to 

grow. 

Firms must also submit adverse 

experience reports (§ 1114.41(a)(2)) for 

tobacco products with marketing orders. 

We assume the same number of firms 

submitting periodic reports will submit 

adverse experience reports. Firms may 

submit voluntary and mandatory 

adverse experience reports using Form 

FDA 3800 under OMB control number 

0910–0291. 

Under § 1114.9 firms will prepare 

amendments to PMTA bundles in 

response to deficiency letters. These 

amendments contain additional 

information that we need to complete 

substantive review. We anticipate 2 

responses back per bundle and 

therefore, we estimate that 24 

respondents will submit 48 

amendments (24 × 2). Assuming 1,500 

hours as the time to prepare and submit 

a full PMTA and amendments may on 

average take 10 percent to 15 percent of 

that time (150–225 hours). We averaged 

this time out (12.5 percent of a full 

submission preparation time) and 

arrived at 188 hours per response. FDA 

estimates the total burden hours for 

preparing amendments is 9,024 hours. 

An applicant is required to submit a 

PMTA and all supporting and related 

documents to FDA in electronic format 

that FDA can process, review, and 

archive unless an applicant requests, 

and FDA grants, a waiver from this 

requirement (§ 1114.49). FDA does not 

believe we will receive many waivers, 

so we have assigned one respondent 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. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR part; activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

1114.45; PMTA records ....................................................... 215 1 215 2 430 

1100.204; Pre-existing products records ............................. 1 1 1 2 2 

1107.3; Exemptions from Substantial Equivalence (SE) 

records .............................................................................. 1 1 1 2 2 

Total .............................................................................. ........................ ........................ 217 ........................ 434 

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

Table 2 describes the annual 

recordkeeping burden. FDA estimates 

that 215 recordkeepers will maintain 

records at 2 hours per record. Included 

in this estimate are the 15 expected 

recordkeepers of NTN products. Firms 

are also required to establish and 

maintain records related to SE 

exemption requests and pre-existing 

products. We expect the burden hours 

to be negligible for SE exemption 

requests. Firms would have already 

established the required records when 

submitting the SE exemption request. 

Similarly, we expect the hours to be 

negligible for any pre-existing tobacco 

products that have already submitted 

stand-alone pre-existing tobacco 

product submissions, because firms 

would have established the required 

records when submitting the standalone pre-existing tobacco product 

submissions. We estimate that it would 

take 2 hours per record to establish the 

required records for a total of 4 hours for 

pre-existing products records and SE 

exemptions. 

Our estimated burden for the 

information collection reflects an 

overall increase of 369,555 hours and a 

corresponding increase of 1,302 

responses/records. We attribute this to 

the validator tool and reevaluating our 

current estimates. 

Dated: November 20, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–27655 Filed 11–25–24; 8:45 am] 

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