Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Tobacco Product Applications and Recordkeeping Requirements

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Published

November 26, 2024

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

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.

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[Federal Register Volume 89, Number 228 (Tuesday, November 26, 2024)]
[Notices]
[Pages 93300-93304]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-27655]

[[Page 93300]]

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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.

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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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#ce9e9c8f9dbaafa8a88ea8aaafe0a6a6bde0a9a1b8"><span class="__cf_email__" data-cfemail="e2b2b0a3b196838484a2848683cc8a8a91cc858d94">[email&#160;protected]</span></a>.

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, 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 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
(Sec. 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 Pre-Existing 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 (Sec. 1114.5)).
Further, 21 CFR 1114.7 (Sec. 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 (<a href="https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/premarket-tobacco-product-applications">https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/premarket-tobacco-product-applications</a>).
FDA has three forms required for use under Sec. Sec. 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

[[Page 93301]]

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
(<a href="https://www.fda.gov/industry/fda-esubmitter/using-esubmitter-prepare-tobacco-product-submissions">https://www.fda.gov/industry/fda-esubmitter/using-esubmitter-prepare-tobacco-product-submissions</a>) 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 (<a href="https://www.fda.gov/tobacco-products/manufacturing/submit-documents-ctp-portal">https://www.fda.gov/tobacco-products/manufacturing/submit-documents-ctp-portal</a>) 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) (<a href="https://www.fda.gov/tobacco-products/manufacturing/request-industry-account-manager-iam-ctp-portal">https://www.fda.gov/tobacco-products/manufacturing/request-industry-account-manager-iam-ctp-portal</a>), 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
(Sec. 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 (Sec. 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 (Sec. 1114.41).
Additionally, Sec. 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
(<a href="https://www.safetyreporting.hhs.gov/">https://www.safetyreporting.hhs.gov/</a>) 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 (Sec. 1114.45). Under Sec.
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

[[Page 93302]]

and related documents to FDA in electronic format. Under Sec.
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 (<a href="https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/premarket-tobacco-product-applications">https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/premarket-tobacco-product-applications</a>).
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 web-based 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 web-based 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 1 2 3
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Number of
1 CFR part; activity; form FDA # Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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1114.5; Submission of Standard Bundled PMTAs 215 1 215 1,713.................................... 368,295
\2\.
PMTA Submission; Form FDA 4057............... 215 1 215 0.58 (35 minutes)........................ 125
PMTA Amendment and General Correspondence 80 4 320 0.16 (10 minutes)........................ 51
Submission; Form FDA 4057a.
PMTA Unique Identification for New Tobacco 215 1 215 0.58 (35 minutes)........................ 125
Products; Form FDA 4057b.
Tobacco Product Grouping Spreadsheet 215 1 215 0.08 (5 minutes)......................... 17
Validator.
1114.41; Reporting Requirements (periodic 10 3 30 50....................................... 1,500
reports).
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 1 1 1 0.25 (15 minutes)........................ 1
Submission.
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Total.................................... .............. .............. 1,276 ......................................... 382,828
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ FDA 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.
\3\ Totals 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

[[Page 93303]]

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 Sec. Sec. 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 Sec. 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 Sec. 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 Sec.
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 Sec.
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

[[Page 93304]]

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 Sec. 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 Sec. 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 (Sec.
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 Sec. 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 x 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 (Sec. 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\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR part; activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
1114.45; PMTA records........... 215 1 215 2 430
1100.204; Pre-existing products 1 1 1 2 2
records........................
1107.3; Exemptions from 1 1 1 2 2
Substantial Equivalence (SE)
records........................
-------------------------------------------------------------------------------
Total....................... .............. .............. 217 .............. 434
----------------------------------------------------------------------------------------------------------------
\1\ There 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 stand-
alone 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]
BILLING CODE 4164-01-P

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