Notice2024-27654
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substantial Equivalence Reports for Tobacco Products
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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, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Full Text
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<title>Federal Register, Volume 89 Issue 228 (Tuesday, November 26, 2024)</title>
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[Federal Register Volume 89, Number 228 (Tuesday, November 26, 2024)]
[Notices]
[Pages 93305-93308]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-27654]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-2888]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Substantial
Equivalence Reports for Tobacco Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing that a proposed collection of information has been submitted
to the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by December 26, 2024.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <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 0910-0673. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
<a href="/cdn-cgi/l/email-protection#56060417052237303016303237783e3e2578313920"><span class="__cf_email__" data-cfemail="66363427351207000026000207480e0e1548010910">[email 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.
Substantial Equivalence Reports for Tobacco Products
OMB Control Number 0910-0673--Revision
This information collection supports FDA requirements for the
content and format of Substantial Equivalence (SE) Reports which are
utilized to establish the substantial equivalence of a tobacco product.
Sections 905(j)(1)(A)(i) and 910(a) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 387e(j)(1)(A)(i) and 387j(a))
established requirements for substantial equivalence and premarket
review of new tobacco products and the implementing regulations per the
SE final rule (86 FR 55224) are found in 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
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Transmittal Form and providing contact information, the completed Form
FDA 3965 and/or 3965a, and any supporting documentation. When complete,
the eSubmitter tool then packages the submission form, data, and
documents into a ZIP file, saved locally, and the tobacco industry must
log into their CTP Portal account (<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.
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: <a href="https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/substantial-equivalence">https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/substantial-equivalence</a>.
In the Federal Register of July 16, 2024 (89 FR 57903), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received one comment responsive to the
four information collection topics solicited and one comment that was
not responsive to those topics.
(Comment) FDA should provide clarity around how Portal Next
Generation will operate and hold a workshop to solicit feedback from
regulated industry prior to its implementation. In addition, FDA should
focus on other SE process reforms that can have an even greater impact
on efficiency.
(Response) Thank you for your detailed comments in response to the
Federal Register Notice regarding the proposed information collection
for SE reports and associated recordkeeping requirements. We appreciate
your engagement and value your feedback on the planned upgrade to the
submission process through the CTP Portal NG.
The purpose of the Federal Register Notice was to introduce updates
to the FDA Form 3965 and 3965a (previously 3964) paper forms and to
inform stakeholders that FDA Forms 3965 and 3965a (previously 3964)
will be made available as web forms through the new CTP Portal NG. The
wireframes included in the Notice were intended to serve as an
approximate representation of the fields and workflow specifically
associated with the new 3965 and 3965a web forms for public comment,
and as such, do not detail all of the planned functionality for CTP
Portal NG nor do they represent the final versions of the forms.
The CTP acknowledges and agrees with the need for further clarity
regarding the implementation and functionality of CTP Portal NG. To
address these concerns, CTP will provide the regulated industry, and
other stakeholders, an opportunity to engage directly with the new
system, navigate the platform, and offer substantive feedback on the
workflow and usability of the new Portal.
Additionally, we would like to clarify that SE applications
submitted under the current system will be seamlessly integrated into
the new platform. The intent of CTP Portal NG is to streamline and
enhance the efficiency of the submission process by providing 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 Substantial Equivalent
and Recordkeeping Requirements regulations in an identifiable format.
Additionally, the guidance provided in CTP Portal NG will reduce
applicant burden by highlighting missing information in fields that
contain required content prior to submission and providing applicants
with an opportunity to include missing content.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden 1 3
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Number of
Number of responses Total annual
Activity; FDA form; 21 CFR section respondents per responses Average burden per response Total hours
respondent
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SE Report--1107.18.............................. 1,139 1 1,139 300........................................ 341,700
SE Report where applicant provides certification 431 1 431 10......................................... 4,310
for identical characteristics--1107.18(g) and
1107.18(l)(2).
Form FDA 3965--Tobacco Substantial Equivalence 1,570 1 1,570 0.75 (45 minutes).......................... 1,178
Report Submission.
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Form FDA 3965a \2\--Tobacco Amendment and 628 1 628 0.16 (10 minutes).......................... 100
General Correspondence Report.
Form FDA 3965b--SE Unique Identification for New 1,570 1 1,570 1.......................................... 1,570
and Predicate Tobacco Products.
SE Grouping Spreadsheet Validator............... 1,570 1 1,570 0.08 (5 minutes)........................... 126
Waiver from Electronic submission--1107.62(b)... 5 1 5 0.25 (15 minutes).......................... 1
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Totals...................................... ............ ........... 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.
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
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3965b once for each submission. We assume the submitter could include
from 1 to 2,000 products in each Form FDA 3965b. Entering data for up
to 2,000 rows can take approximately 4 hours on average per Form FDA
3965b for manual data entry. We reflect the average time of 60 minutes
per response based on the assumption that we expect to receive an
average of 25 bundled products per submission. Assuming 60 minutes per
Form FDA 3965b for 1,570 applications, we estimate a total burden of
1,570 hours for this activity.
The FDA Tobacco Product Grouping Spreadsheet Validator (Validator)
is a free software that validates the content of FDA product grouping
spreadsheets such as ``Form FDA 3965b--SE Unique Identification for New
and Predicate Tobacco Products.'' The Validator is available for
voluntary use by the tobacco industry (sponsors, manufacturers, and
importers) prior to submitting a product grouping spreadsheet to FDA.
The Validator allows industry users to validate product attributes
in their product grouping spreadsheet with the defined and accepted
product data standards and to make corrections as needed. If there are
no errors found in a spreadsheet, the Validator will produce a
certificate of completion that can be saved locally and included with
the applicants FDA submission voluntarily. If errors are found during
validation, the Validator will provide the applicants with the error at
the end of each impacted row of the spreadsheet, allowing applicants to
make necessary changes.
The software and any output files reside locally on an applicant's
computer, allowing them to work on the product grouping spreadsheet
offline. The Validator does not transmit any data across the web to
FDA. FDA does not have the ability to access, review, or supplement the
information on local computers through this application. We estimate
that use of the Validator will take an average of 5 minutes per
response.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Average burden
Activity; 21 CFR section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
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Recordkeeping SE Report under 471 1 471 5 2,355
1107.18-1107.58................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
FDA estimates that 30 percent of SE Reports or 471 respondents will
maintain required records related to their SE Reports at 5 hours per
record for a total of 2,355 recordkeeping hours (table 2). The first SE
Report in a chain must use a tobacco product commercially marketed
(other than for test marketing) in the United States as of February 15,
2007, as a predicate product for the SE Report. Therefore, we believe
that manufacturers will have records on those ``original'' predicate
tobacco products from their initial SE Reports.
Our estimated burden for the information collection reflects an
overall increase of 69,010 hours and a corresponding increase of 2,905
responses/records. We attribute this to adding a new form, providing
the validator tool, and reevaluating our current estimates.
Dated: November 20, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-27654 Filed 11-25-24; 8:45 am]
BILLING CODE 4164-01-P
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