Agency Information Collection Activities; Proposed Collection; Comment Request; Substantial Equivalence Reports for Tobacco Products

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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 substantial equivalence reports for tobacco products.

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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 57903-57907]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-15569]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-2888]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Substantial Equivalence Reports for Tobacco Products

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

[[Page 57904]]

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 substantial equivalence
reports for tobacco products.

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 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-2011-D-0147 for ``Substantial Equivalence Reports.'' 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#aefefceffddacfc8c8eec8cacf80c6c6dd80c9c1d8"><span class="__cf_email__" data-cfemail="134341524067727575537577723d7b7b603d747c65">[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 revision 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.

Substantial Equivalence Reports for Tobacco Products--21 CFR 1107.18
and 1107.19

OMB Control Number 0910-0673--Revision

This information collection supports FDA requirements for the
content and format of Substantial Equivalence (SE) Reports which are
utilized to establish the substantial equivalence of a tobacco product.
Sections 905(j)(1)(A)(i) and 910(a) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 387e(j)(1)(A)(i) and 387j(a))
established requirements for substantial equivalence and premarket
review of new tobacco

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products and the implementing regulations per the SE final rule (86 FR
55224) are found in Sec. Sec. 1107.18 and 1107.19 (21 CFR 1107.18 and
1107.19).
An SE Report can be submitted by any manufacturer for any new
tobacco product seeking an FDA substantially equivalent order, under
section 905(j) of the FD&C Act. A substantially equivalent tobacco
product is one that has been found by FDA to have either the same
characteristics as a predicate product or has different characteristics
than the predicate tobacco product, but the SE Report demonstrates that
the new product does not raise different questions of public health. A
predicate tobacco product is one that was commercially marketed (other
than for test marketing) in the United States as of February 15, 2007,
or is a product previously found to be substantially equivalent by FDA.
Generally, an applicant may amend its SE Report (21 CFR 1107.20),
withdraw its SE Report after submission (21 CFR 1107.22), and change
the ownership of its SE Report (21 CFR 1107.24). Electronic submission
of SE Reports is required, unless the applicant requests and is granted
a waiver.
FDA will have three forms required for use (once this revision is
approved) under Sec. 1107.18(a) when submitting an SE Report to the
Agency: Form FDA 3965; Form FDA 3965a; and Form FDA 3965b.
Form FDA 3965 is for use when submitting a tobacco SE Report to the
Agency. Form FDA 3965 and its corresponding instructions have been
updated to assist industry users in completing the form efficiently and
correctly. The flow and organization of the form have been updated to
follow a consistent style and appearance with other FDA forms related
to tobacco product submissions.
Form FDA 3965a is the Tobacco Substantial Equivalence Report
Amendment and General Correspondence Submission form that was formerly
Form FDA 3964. FDA has revised the form number of Form FDA 3964 to Form
FDA 3965a to align to Form FDA 3965, the Tobacco Substantial
Equivalence Report Submission. Form FDA 3965a is for use when firms are
submitting amendments and other general correspondence for an SE Report
to the Agency. Form FDA 3965a and its corresponding instructions have
been updated to assist industry users in completing the form
efficiently and correctly. The flow and organization of the form have
been updated to follow a consistent style and appearance with Form FDA
3965. As part of the form organization update, Form FDA 3965a has been
split into three main parts: Applicant Information, Amendment
Information, and General Correspondence. Industry users are able to
select the submission type, selecting from Amendment or General
Correspondence, in Part B of Section I--Applicant Information. After a
selection is made, industry users may skip to the appropriate section
to complete. Form FDA 3965b is the new SE Unique Identification for New
and Predicate Tobacco Products form that assists industry and FDA in
identifying the products that are the subject of a submission where an
applicant groups multiple SE Reports into a single submission (referred
to as a bundled submission or a grouped submission).
The Consolidated Appropriations Act of 2022 (Pub. L. 117-103) (the
Appropriations Act), enacted on March 15, 2022, amended the definition
of the term ``tobacco product'' in section 201(rr) of the FD&C Act (21
U.S.C. 321(rr)) to include products that contain nicotine from any
source. As a result, non-tobacco nicotine (NTN) products that were not
previously subject to the FD&C Act (e.g., products containing synthetic
nicotine) are now subject to all of the tobacco product provisions in
the FD&C Act that began on April 14, 2022, including the requirement of
premarket review for new tobacco products. The Appropriations Act also
makes all regulations and guidances applicable to tobacco products
apply to NTN products on that same effective date.
The Center for Tobacco Products (CTP) is planning a significant
upgrade to the submission process for SE applications. This upgrade,
known as the CTP Portal Next Generation (CTP Portal NG), is a pivotal
step forward in streamlining the application process for the tobacco
industry. Presently, the tobacco industry uses multiple tools in the
preparation and submission of SE applications to CTP, including 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 Form FDA 3965 and 3965a for SE applications and amendments,
respectively, using any PDF-editing software. Once the PDF form is
complete, the tobacco industry uses the eSubmitter Desktop tool
(<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 Form FDA 3965 and/or 3965a, and any supporting documentation.
When complete, the eSubmitter tool then packages the submission form,
data, and documents into a ZIP file, saved locally, and the tobacco
industry must log into their CTP Portal account (<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 Form FDA 3965 and 3965a for SE applications and amendments,
respectively, which will improve the submission preparation process for
the tobacco industry as it will provide tools to expedite the entry of
data and supporting documentation, dynamically guide users to relevant
sections of the forms based on their input, and improve quality by
providing helpful information on the questions being requested and
verifying all required data has been provided. CTP Portal NG has a
built-in process for applicants to upload Form FDA 3965b after
applicants complete Form FDA 3965b and validate it using a new
validator tool. When complete, CTP Portal NG allows applicants to
submit the completed web forms to CTP for review. This innovation
eliminates the current three-step process using PDF-editing software,
eSubmitter, and CTP Portal and provides a more integrated, user-
friendly experience. A copy of Form FDA 3965, 3965a, 3965b 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.
Submitters can visit the following web page which describes the
process for submitting a SE Report: https://www.fda.gov/tobacco-
products/market-

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and-distribute-tobacco-product/substantial-equivalence.
FDA estimates the burden of this collection of information as
follows:

Table 1--Estimated Annual Reporting Burden \1\ \3\
----------------------------------------------------------------------------------------------------------------
Number of
Activity; FDA form; 21 CFR Number of responses per Total annual Average burden per Total hours
section respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
SE Report--1107.18............. 1,139 1 1,139 300............... 341,700
SE Report where applicant 431 1 431 10................ 4,310
provides certification for
identical characteristics--
1107.18(g) and 1107.18(l)(2).
Form FDA 3965--Tobacco 1,570 1 1,570 0.75 (45 minutes). 1,178
Substantial Equivalence Report
Submission.
Form FDA 3965a\2\--Tobacco 628 1 628 0.16 (10 minutes). 100
Amendment and General
Correspondence Report.
Form FDA 3965b--SE Unique 1,570 1 1,570 1................. 1,570
Identification for New and
Predicate Tobacco Products.
SE Grouping Spreadsheet 1,570 1 1,570 0.08 (5 minutes).. 126
Validator.
Waiver from Electronic 5 1 5 0.25 (15 minutes). 1
submission--1107.62(b).
--------------------------------------------------------------------------------
Totals..................... 2,203 .............. 6,913 .................. 348,985
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Formerly Form FDA 3964, Tobacco Substantial Equivalence Report Amendment and General Correspondence
Submission.
\3\ Totals may not sum due to rounding.

FDA has based these estimates on experience with this information
collection, information we have available from interactions with
industry, registration and listing data, information related to other
regulated products, and FDA expectations regarding the tobacco
industry's use of the substantial equivalence pathway to market their
products. We have revised our previous estimates based on these
experiences. Utilizing registration and listing data for deemed tobacco
products, the estimated annual number of SE Reports is expected to be
1,570.
When several full SE Reports contain identical content, these SE
Reports may be bundled into a single submission. Similarly, SE Reports
in which the characteristics of the products are certified as identical
and the contents of the SE Reports are also identical, these may also
be bundled. FDA anticipates the burden for an applicant to be generally
the same if they submit bundled submissions or individual applications
as such, both are captured under SE Reports. As mentioned previously,
NTN products that were not previously subject to the FD&C Act (e.g.,
products containing synthetic nicotine) are now subject to all tobacco
product provisions in the FD&C Act beginning on April 14, 2022. Based
on this new authority, we do not believe a change is needed in our
burden estimates because FDA has received significantly fewer NTN SE
Reports than anticipated.
Table 1 describes the annual reporting burden per the requirements
in Sec. Sec. 1107.18 and 1107.19. FDA estimates that we will receive
1,139 full initial SE Reports for a new tobacco product each year under
Sec. 1107.18 that take a manufacturer approximately 300 hours to
prepare. We have consolidated our previous numbers in the burden chart
of full and bundled SE Reports (683 and 456) to reach the 1,139
estimate. In addition, anyone submitting an SE Report is required to
submit an environmental assessment prepared in accordance with 21 CFR
25.40 under Sec. 1107.18(k). The burden for environmental reports has
been included in the burden per response for each type of SE Report.
FDA estimates receiving 239 SE Reports where applicants provide a
certification for some identical characteristics under Sec. Sec.
1107.18(g) and 1107.18(l)(2). We also estimate receiving 192 bundled SE
Reports where applicants provide a certification for some identical
characteristics under Sec. Sec. 1107.18(g) and 1107.18(l)(2) (other
than the initial SE Report in the bundle). FDA anticipates the burden
for an applicant to be generally the same if they submit bundled
submissions or individual applications as such, both are captured under
SE Report where applicant provides certification for identical
characteristics. We believe that the number of SE Reports that include
a certification will increase because applicants may certify that
certain characteristics are identical in the new tobacco product and
the predicate tobacco product. However, in the absence of specific
information on how many more applicants might choose to certify, we are
maintaining our previous estimates at this time. As certification
statements and additional guidance are given by the Agency within Form
FDA 3965, FDA expects applicants to submit less technical information.
As a result, we expect applicants total burden hours per applications
to decrease. Therefore, we have decreased the burden per response for
these SE Reports.
Manufacturers are required to submit SE Reports electronically
(Sec. 1107.62 (21 CFR 1107.62)). We estimate that it would initially
take about 45 minutes per product to fill out the Form FDA 3965.
However, for amendments, we estimate that filling out Form FDA 3965a
will take 10 minutes as applicants can copy and paste from the first
submission. Section 1107.62(b) also allows applicants to request a
waiver from the electronic format requirement. Based on experience
since implementing the Premarket Tobacco Product Application (PMTA)
rule, FDA does not believe we will receive many waivers, so we have
decreased the number of respondents to five respondents to acknowledge
the option to submit a waiver. Consistent with our other application
estimates for waivers, we believe it would take 0.25 hours (15 minutes)
per waiver for a total of 1 hour.
We anticipate five respondents will request meetings with CTP's
Office of Science (OS) 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 90 hours are
necessary to compile and request a meeting with OS. This burden is
already

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covered under OMB control number 0910-0731.
FDA is revising this collection to include a new form (Form FDA
3965b) and a validator tool for Form FDA 3965b that will help
applicants submit information for their SE Reports in the correct
format. Form FDA 3965b assists industry and FDA in identifying the
products that are the subject of a submission, particularly where an
applicant groups multiple new tobacco products into a single
submission. This includes grouping products that are from the same
manufacturer or domestic importer and in the same product category and
subcategory into a single submission. FDA discussed bundled submissions
in the SE rule (86 FR 55224) and noted that FDA intends to consider
information on each new tobacco product and its corresponding predicate
tobacco product as a separate, individual SE Report as required under
Sec. 1107.18(c)(7), Sec. 1107.18(g), and Sec. 1107.19. By having the
identifying information for products contained in an SE Report be more
clearly organized within the required forms, FDA will be able to
process and review the applications contained in a grouped submission
more efficiently.
The form assists applicants in providing the unique identifying
information for each product in single and grouped submissions of SE
Reports. A respondent would utilize Form FDA 3965b once for each
submission. We assume the submitter could include from 1 to 2,000
products in each Form FDA 3965b. Entering data for up to 2,000 rows can
take approximately 4 hours on average per Form FDA 3965b for manual
data entry. We reflect the average time of 60 minutes per response
based on the assumption that we expect to receive an average of 25
bundled products per submission. Assuming 60 minutes per Form FDA 3965b
for 1,570 applications, we estimate a total burden of 1,570 hours for
this activity.
The FDA Tobacco Product Grouping Spreadsheet Validator (Validator)
is a free software that validates the content of FDA product grouping
spreadsheets such as ``Form FDA 3965b--SE Unique Identification for New
and Predicate Tobacco Products.'' The Validator is available for
voluntary use by the tobacco industry (sponsors, manufacturers, and
importers) prior to submitting a product grouping spreadsheet to FDA.
The Validator allows industry users to validate product attributes
in their product grouping spreadsheet with the defined and accepted
product data standards and to make corrections as needed. If there are
no errors found in a spreadsheet, the Validator will produce a
certificate of completion that can be saved locally and included with
the applicants FDA submission voluntarily. If errors are found during
validation, the Validator will provide the applicants with the error at
the end of each impacted row of the spreadsheet, allowing applicants to
make necessary changes.
The software and any output files reside locally on an applicant's
computer, allowing them to work on the product grouping spreadsheet
offline. The Validator does not transmit any data across the web to
FDA. FDA does not have the ability to access, review, or supplement the
information on local computers through this application. We estimate
that use of the Validator will take an average of 5 minutes per
response.

Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Total Average burden
Activity; 21 CFR section Number of records per annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Recordkeeping SE Report under 1107.18- 471 1 471 5 2,355
1107.58..............................
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

FDA estimates that 30 percent of SE Reports or 471 respondents will
maintain required records related to their SE Reports at 5 hours per
record for a total of 2,355 recordkeeping hours (table 2). The first SE
Report in a chain must use a tobacco product commercially marketed
(other than for test marketing) in the United States as of February 15,
2007, as a predicate product for the SE Report. Therefore, we believe
that manufacturers will have records on those ``original'' predicate
tobacco products from their initial SE Reports.
Our estimated burden for the information collection reflects an
overall increase of 69,010 hours and a corresponding increase of 2,905
responses/records. We attribute this 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. 2024-15569 Filed 7-15-24; 8:45 am]
BILLING CODE 4164-01-P

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