Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Tobacco Product Applications and Recordkeeping Requirements

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Published

July 16, 2024

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on premarket tobacco product applications and recordkeeping requirements.

Full Text

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<title>Federal Register, Volume 89 Issue 136 (Tuesday, July 16, 2024)</title>
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[Federal Register Volume 89, Number 136 (Tuesday, July 16, 2024)]
[Notices]
[Pages 57907-57913]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-15570]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-2889]

Agency Information Collection Activities; Proposed Collection;
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, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on premarket tobacco product
applications and recordkeeping requirements.

DATES: Either electronic or written comments on the collection of
information must be submitted by September 16, 2024.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of September 16, 2024. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be

[[Page 57908]]

considered timely if they are received on or before that date.

Electronic Submissions

Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

Submit written/paper submissions as follows:
<bullet> Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2024-N-2889 for ``Premarket Tobacco Product Applications and
Recordkeeping Requirements.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: 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#a8f8fae9fbdcc9cecee8ceccc986c0c0db86cfc7de"><span class="__cf_email__" data-cfemail="cc9c9e8d9fb8adaaaa8caaa8ade2a4a4bfe2aba3ba">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Premarket Tobacco Product Applications and Recordkeeping Requirements--
Part 1114 (21 CFR Part 1114)

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 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

[[Page 57909]]

without being considered in violation of premarket review requirements.
The Premarket Tobacco Product Applications and Recordkeeping
Requirements regulation (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 (Sec. 1114.5). Further, 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) 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.
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 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 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. 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. A copy of revised FDA
Form 4057, 4057a, 4057b and the validator tool will be available in the
docket of this notice for review.
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

[[Page 57910]]

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,
cancelled, 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 Center for Tobacco Products' 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 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>).
FDA estimates the burden of this collection of information as
follows:

Table 1--Estimated Annual Reporting Burden \1\ \2\ \3\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR part; Activity; Form FDA Number of responses per Total annual Average burden per Total Hours
# respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
1114.5; Submission of Standard 215 1 215 1,713 368,295
Bundled PMTAs \2\.............
PMTA Submission; Form FDA 4057. 215 1 215 0.58 (35 minutes) 125
PMTA Amendment and General 80 4 320 0.16 (10 minutes) 51
Correspondence Submission;
Form FDA 4057a................
PMTA Unique Identification for 215 1 215 0.58 (35 minutes) 125
New Tobacco Products; Form FDA
4057b.........................
Tobacco Product Grouping 215 1 215 0.08 (5 minutes) 17
Spreadsheet Validator.........
1114.41; Reporting Requirements 10 3 30 50 1,500
(periodic reports)............
1114.9; Amendments............. 24 2 48 188 9,024
1114.13; Change in Ownership... 10 1 10 1 10
1114.15; Supplemental 2 1 2 428 856
applications..................
1114.17; Resubmissions......... 5 1 5 565 2,825
1114.49(b) and (c); Waiver from 1 1 1 0.25 (15 minutes) 1
Electronic Submission.........
----------------------------------------------------------------------------------------------------------------
Total...................... 347 .............. 1,276 .................. 382,828
----------------------------------------------------------------------------------------------------------------
\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

[[Page 57911]]

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 submissions).
We believe the original PMTA burden in 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 standalone, 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 standalone 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
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

[[Page 57912]]

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 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.
We anticipate 40 respondents will request meetings with CTP's
Office of Science to discuss investigational plans. We base this figure
on the average number of meeting requests received over the past 3
years and assume this will include meetings regarding NTN products. To
request this meeting, applicants should compile and submit information
to FDA for meeting approval. We assume 720 hours is necessary to
compile and request a meeting with OS. This burden is covered under OMB
control number 0910-0731, Meetings with Industry and Investigators on
the Research and Development of Tobacco Products.
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 Substantial 1 1 1 2 2
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-

[[Page 57913]]

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 adjustment to adding a new form,
the validator tool, and reevaluating our current estimates.

Dated: July 11, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-15570 Filed 7-15-24; 8:45 am]
BILLING CODE 4164-01-P

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