0879 supporting statement A FINAL 4.13.22

U.S Food and Drug Administration
Center for Tobacco Products
Premarket Tobacco Product Applications and Recordkeeping Requirements
0910-0879
SUPPORTING STATEMENT Part A
A. Justification
1. Circumstances Making the Collection of Information Necessary
The Tobacco Control Act was enacted on June 22, 2009, amending the Federal Food,
Drug, and Cosmetic Act (FD&C Act) and providing FDA with the authority to regulate
tobacco products (Pub. L. 111-31; 123 Stat. 1776). Section 910(a) established
requirements for premarket review of new tobacco products.
The Consolidated Appropriations Act of 2022 (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 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) will be 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, which includes the Premarket Tobacco Product Application and
Recordkeeping Requirements final rule. Additionally, the Appropriations Act includes a
transition period for premarket review requirements, directing companies to submit
premarket tobacco product applications (PMTAs) for NTN products by May 14, 2022, to
receive an additional 60 day period of marketing without being considered in violation of
premarket review requirements.
FDA is finalizing requirements for the content, format, submission, and review of
PMTAs, as well as other requirements related to PMTAs, including recordkeeping
requirements, and post market reporting. FDA will also require 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. A manufacturer may choose to submit a PMTA
under section 910(b) of the FD&C Act to satisfy the requirements of premarket review.
Section 910(b)(1) describes the required contents of a PMTA, which in addition to

1

specific items, allows FDA to require applicants to submit other information relevant to
the subject matter of the application.
As described in 21 CFR § 1114.5 1 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 21 CFR part 1114 until FDA has issued a marketing granted order for
the product. Further, § 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 Federal Food, Drug, and Cosmetic
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.
Under § 1114.9 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, § 1114.9 will allow the
submission of amendments to a pending application.
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. An applicant may transfer ownership of its PMTA at any time, including when
FDA has yet to act on it.
Section 1114.15 discusses supplemental PMTAs which are an alternative format of
submitting a PMTA. Specifically, supplemental PMTAs are a standardized crossreferencing format that FDA would implement under its authority of section 701(a) of the
FD&C Act to efficiently enforce section 910 for submissions that are based on a PMTA
that FDA has previously reviewed. Applicants that have received a marketing granted
order would be 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 will restrict the use of
supplemental PMTAs to only changes that require the submission of limited information
or revisions to ensure that FDA is able to efficiently review the application. An applicant
would also be able to submit a supplemental PMTA for modifications made to comply
with a product standard issued under section 907 of the FD&C Act where FDA specifies
that the submission of supplemental PMTAs would be appropriate.
Section 1114.17 describes resubmissions, which are an alternative format for submitting
an application that meets the requirements of § 1114.7 or § 1114.15 to seek a marketing
1

All references to regulatory sections of the Code of Federal Regulations are to Chapter 21 unless otherwise noted.

2

granted order for a tobacco product by responding to the deficiencies outlined in a no
marketing granted order. 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. 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.
Section 1114.41 would require applicants that receive a marketing granted order to
submit postmarket reports. FDA requires postmarket reports to determine or facilitate a
determination of whether there may be grounds to withdraw or temporarily suspend a
marketing granted order. Additionally, § 1114.41 describes the reports that FDA would
require through this regulation; however, FDA may require additional reporting in an
individual applicant’s marketing granted order. Applicants would be required under §
1114.41 to submit two types of reports after receiving a marketing granted order: periodic
reports and adverse experience reports. Applicants would need to submit periodic reports
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 a
number of factors. Applicants would also be 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 under § 1114.41(a)(2). The serious and
unexpected adverse experience reports must be submitted to CTP’s Office of Science
through the HHS Safety Reporting Portal within 15 calendar days after receiving or
becoming aware of a serious or unexpected adverse experience. FDA’s Safety reporting
portal is approved under 0910-0645.
Section 1114.45 would require applicants receiving a marketing granted order 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 the agency upon request. Under § 1114.45(a)(1), an applicant
must retain all documents submitted to FDA as part of an application and postmarket
reports. An applicant must also retain any additional documentation supporting the
application and postmarket reports that was not submitted to FDA.
Section § 1100.200 states that subpart C of part 1100 would establish requirements for
the maintenance of records by tobacco product manufacturers who introduce a PreExisting Tobacco Product, or deliver it for introduction, into interstate commerce.
Section § 1107.3 describes that each applicant who submits an abbreviated report under
section 905(j)(1)(A)(ii) of the FD&C Act and receives a letter acknowledging the receipt

3

of an abbreviated report from FDA must maintain all records to support a determination
that their exemption request meets the requirements of section 905(j)(3)(A)(i) of the
FD&C Act that the modification to a product additive described in the exemption request
was a minor modification made to a tobacco product that can be sold under the FD&C
Act, and that an exemption is otherwise appropriate.
Section 1114.49 would require an applicant to submit a PMTA and all supporting and
related documents to FDA in electronic format. Under § 1114.49(c), an applicant that has
a waiver would submit a paper submission to the address that FDA provides in the letter
granting the waiver.
2. Purpose and Use of the Information Collection
This rule will interpret and establish requirements related to the basic content and format
of premarket tobacco product applications (PMTAs), the procedure by which FDA would
review PMTAs, and the maintenance of records regarding the legal marketing of certain
tobacco products without PMTAs. The rule also addresses issues such as the procedures
of retention of records related to the PMTA, confidentiality of application information,
electronic submission of the PMTA and amendments, and postmarket reporting
requirements.
This rule applies to tobacco product manufacturers. Manufacturer is defined here as any
person, including any repacker or relabeler, who: (1) manufactures, fabricates, assembles,
processes, or labels a tobacco product; or (2) imports a finished tobacco product for sale
or distribution in the United States.
Respondents are for profit businesses from the private sector.
3. Use of Improved Information Technology and Burden Reduction
FDA requires electronic submission of PMTAs. FDA estimates that approximately 99%
of respondents will submit electronically. FDA is also allowing for the alternative
submittal of applications for premarket review in paper form for those individuals
requesting a waiver from submitting in an electronic format.
4. Efforts to Identify Duplication and Use of Similar Information
This information collection is not duplicative. The FD&C Act, as amended by the
Tobacco Control Act, is the only legislation which requires premarket review of new
tobacco products. The FDA is the only Federal agency responsible for the collection of
such premarket review information, and the primary federal regulatory authority with
respect to the manufacture, marketing, and distribution of tobacco products. FDA
received PRA approval for the Deeming Rule in 2016 (0910-0768). The rule provided
CTP the authority to collect full PMTAs for ENDS products.

4

The PMTA rule sets forth the content and format requirements for new tobacco product
application submissions. It further codifies the general procedures and creates postmarket
reporting requirements for applicants that receive marketing granted orders. The rule also
requires tobacco product manufacturers to submit their applications electronically via
new submission forms and to keep records establishing that their tobacco products are
legally marketed.
Although both collections contain PMTA application submissions, the burden under the
Deeming rule does not cover any tobacco products beyond ENDS and only a full
application submission. Whereas the PMTA rule covers PMTAs from any new tobacco
product entity and submissions of bundled applications. Therefore, no duplication of data
exists.
5. Impact on Small Businesses or Other Small Entities
The FD&C Act authorizes the submission of this information from all manufacturers of
tobacco products that submit PMTAs.
We estimate that we would receive, on average, 1 bundle every 2 years, impacting at
most 10 small entities over the burden estimate timeframe. Furthermore, firms would
only submit originally regulated bundles if the expected lifetime profits from submission
were greater than the expected lifetime cost of submission. Therefore, while this cost
may be significant for some small entities, we do not anticipate that it would affect a
substantial number of small entities. It is important to note that ENDS PMTA
submissions were not added to the total burden for this rule as its currently approved
under a separate OMB control number (0910-0768).
6. Consequences of Collecting the Information Less Frequently
Where a new tobacco product is not substantially equivalent to a tobacco product
commercially marketed in the United States as of February 15, 2007 or exempt from the
requirement to obtain a substantial equivalence determination, applicants must submit a
premarket tobacco product application under section 910(b) of the FD&C Act and receive
a marketing granted order under section 910(c)(1)(A)(i) prior to marketing the product.
Collecting the information less frequently would not meet the FD&C Act premarket
requirements. There are no legal obstacles to reduce the burden.
Respondents to this collection of information include those manufacturers seeking a
marketing granted order for a new tobacco product under section 910 who must submit a
premarket tobacco product application under section 910(b). If this information were not
collected, FDA would be unable to make the findings required by section 910(c) of the
FD&C Act in order to provide a marketing granted order under section 910(c)(1)(A)(i)
prior to the manufacturer being able to market the product.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

5

There are no special circumstances for this collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
As required by section 3506(c)(2)(B) of the Paperwork Reduction Act of 1995 (PRA),
FDA provided an opportunity for public comment on the information collection
requirements of the proposed rule that published in the Federal Register of September 25,
2019 (84 FR 50566) and March 10, 2020 (85 FR 13840). In response to this rule FDA
received two PRA-related comments:
(Comment) One comment made specific comments requesting changes to elements in
Form 4057.
(Response) FDA has considered these comments and agrees that many updates are
necessary. The list below details the updates we have made to the form in response to the
comments.
• FDA has harmonized, as appropriate, terms used within the PMTA and other FDA
forms.
• FDA has revised the form by adding fields for address and contact information for
manufacturer information to provide for the situation where the manufacturer is
different from the Applicant.
• FDA agrees that the draft form did not collect organization information for certain
parties. Additionally, FDA has revised the form by providing fields to enter
organization information for certain parties, e.g., the authorized representative. FDA
has revised the form by providing additional fields to describe the alternate point of
contact.
• FDA has revised section III which now contains additional fields to identify crossreferenced submissions (ITP, SE, and MRTPA) and formal meetings held with FDA
that pertain to the PMTA. For example, the applicant can now input in the revised
form document keywords, document filenames, and submission dates for crossreferenced content. For formal meetings with FDA, the applicant can now input in the
revised form the new tobacco product name. These fields would also help ensure
FDA identify the cross-referenced content or related submission.
• Section III of the revised form also contains new fields (e.g., “document keyword”
and “document filename”) that allow the submitter to adequately describe the content
they are cross-referencing. Section III now allows the applicant to indicate if the
cross-referenced content is relevant to a specific product or to all bundled products in
the application. Across all product categories, the subcategory of “co-package” has
been removed. However, co-packaged items can be grouped within the same
submission and the unique identification of this co-packaged product would include
the specific items needed to identify each product within the co-package.
• In section IV, FDA has added a “Submission Table of Contents” with fields for
“filename,” “title,” “table of contents category,” and “keyword” in order that FDA
can easily identify the application contents listed in section IV.

6

(Comment) One comment made specific comments requesting changes to elements in
Form FDA 4057a.
(Response) FDA has considered these comments and agrees that many updates are
necessary. The list below details the updates we have made to the form in response to the
comments.
• FDA has combined sections I and IV to only ask for current owner’s information
once. The current owner’s information is now only required in section I of the
revised form.
• FDA now allows the manufacturer’s address and contact information to be provided
(if a different entity from the applicant) contact information is to be provided.
• FDA has revised the form to allow the organization’s name to be provided (where an
organization is an alternate point of contact). Additionally, FDA added a field so that
organizational affiliation of the authorized representative information can be
provided.
• For a change in authorized representative FDA agrees that “Replace” is the
appropriate step and has added this as an option in section I, subsection C of the form.
• The form has been edited to allow the submitter to indicate the purpose of the
amendment (i.e., whether it was for a single new tobacco product or for a
bundled/grouped submission).
• Section III of the form has been revised to allow the submitter to indicate the
addition, updating or removal of cross-referenced content, related submissions, and
meetings with FDA. Section III now allows the submitter to describe the crossreferenced content, related submissions, and meetings, and to indicate the purpose of
the cross-referenced content, related submissions, and meetings. Additionally,
section III allows the submitter to indicate whether the submitter intends to “add,”
“update” or “remove” referenced content, related submissions, and meetings.
• Section III of the revised form now contains a “submission summary” field which
allows the applicant to be used to describe the subject of the amendment.
• Section II of the revised form now allows information for “bundled” or grouped
PMTAs to be submitted. Section II now allows submitters to submit updated tobacco
product information for all new tobacco products including co-packaged products.
Additionally, section II of the revised form enables submitters to describe the subject
of their correspondence and provide a submission summary describing the intended
use of the submitted contents.
Where appropriate, FDA has harmonized the terminology in the form with other FDA
forms and has harmonized the layout of the Amendment and General Correspondence
submission form with the layout of the PMTA submission form. For example, section I
of the revised PMTA form is used to describe the applicant, the authorized representative,
the alternate point of contact and other applicant information. Correspondingly, section I
of the revised Amendment and General Correspondence submission form is used to
update applicant information. Similarly, section II of the revised PMTA form is used to
set out tobacco product information. Correspondingly, section II of the revised
Amendment and General Correspondence submission form is used to update tobacco
product information. FDA received generally supportive comments regarding proposed
7

Form FDA 4057b. Comments agreed the form was a positive step towards streamlining
the current PMTA submission process, as well as promoting efficient processing and
review of bundled PMTAs.
(Comment) One comment noted that Form FDA 4057b failed to include an “oral
tobacco-derived nicotine (OTDN)” category or subcategory designation. The comment
argued that OTDN products are both distinct, being tobacco-free and non-dissolvable,
and one of the fastest growing tobacco product segments in the U.S. market. Including
an OTDN product subcategory would provide clarity for applicants and streamline FDA
review of these products. The comment also noted that Form FDA 4057b requires
applicants to include characterizing flavor information but does not define this term in
Form FDA 4057b or within the proposed rule.
(Response) Providing unique identifying information, such as product category or
subcategory, ensures FDA can identify the new tobacco product and distinguish it from
other tobacco products, including additional new tobacco products in a bundled
submission submitted using Form FDA 4057b, and assists FDA in performing its
acceptance and filing reviews. At this time, FDA does not yet have the experience
necessary to create requirements for OTDN as a standalone product category or
subcategory. Review of OTDN products will be handled on a case-by-case basis and any
future decision to update or change the requirements of the rule and form to include
OTDN products will follow appropriate notice and comment procedures. While the rule
does not specifically include OTDN as a category or subcategory, where an applicant
believes its new tobacco product, such as OTDN, does not fit within a product category
set forth in the rule, it should identify the product category as “other”. Applicants are
encouraged to include any properties in addition to those required by the “other” category
or subcategory to fully identify the tobacco product, if applicable.
In addition, the requirement for applicants to include product-specific information, such
as characterizing flavor(s), corresponds to the general information requirements of
§ 1114.7.(c)(3)(iii) that will allow FDA to quickly check whether the product is within
CTP’s purview and identify the specific product that is the subject of the submission. For
the characterizing flavor item, FDA is looking to see how the applicant identifies the
tobacco product as having no characterizing flavor or having a particular characterizing
flavor. If applicants do not consider the product to have a characterizing flavor,
applicants must state “none”. As discussed in the proposed rule, applicants that have
questions regarding how to describe their product’s characterizing flavor are encouraged
to contact FDA prior to submission.
(Comment) Another comment noted that while the use of Form FDA 4057b would be a
positive step, the current PMTA process is prohibitively expensive for most individual
manufacturers of nicotine e-liquids.
(Response) As discussed in the proposed regulatory impact analysis, FDA has considered
the costs and benefits associated with the rule, if finalized. While there are costs
associated with the rule, the analysis also noted that the rule, would create cost savings
for firms and for FDA by reducing the number of follow-on submissions for PMTAs (i.e.,
additional PMTAs submitted for the same product(s) after FDA refuses to accept or file,

8

or issues a marketing denial order in response to, an initial PMTA). The analysis also
noted small manufacturers who submit ENDS PMTA bundles would benefit from the
proposed rule, if finalized. Submitted bundles, such as those submitted via Form FDA
4057b, would receive marketing granted orders through the PMTA pathway earlier with
rulemaking than without rulemaking, increasing lifetime profits for the ENDS products
included in the submitted ENDS bundles.
9. Explanation of Any Payment or Gift to Respondents
This information collection does not provide for any payment or gift to respondents.
10. Assurance of Confidentiality Provided to Respondents
Section 906(c) of the FD&C Act prohibits FDA from disclosing any information reported
to FDA if that information is confidential commercial or trade secret information exempt
from disclosure under FOIA Exemption 4 (5 U.S.C. 552(b)(4)). The provision contains
exceptions allowing disclosure of the information to other officers of employees
concerned with carrying out the tobacco products chapter of the FD&C Act and, when
relevant, in any proceeding under the tobacco products chapter of the FD&C Act.
Section 301(j) of the FD&C Act generally prohibits release of trade secret information
obtained by FDA outside of the Department of Health and Human Services, except to
courts when relevant in any judicial proceeding under the FD&C Act and to Congress in
response to an authorized Congressional request. CTP also identified privacy compliance
requirements and coordinated with FDA’s Privacy Officer to ensure responsible offices
in CTP satisfy all in accordance with law and policy. CTP received HHS approval on the
privacy impact assessment and was assigned PIA Unique Identifier P-7465194-382822.
11. Justification for Sensitive Questions
This information collection does not contain questions of a sensitive nature.
12. Estimates of Annualized Burden Hours and Costs
12 a. Annualized Hour Burden Estimate
Table 1.—Estimated Annual Reporting Burden (per this rule)
No. of
Average
“21 CFR Part” and
No. of
Responses
Total Annual
Burden per
Activity
Respondents
per
Responses
Response
Respondent
1114.5 Submission of
Standard Bundled
1
1
1
1,713
PMTAs1

9

Total
Hours
1,713

Premarket Tobacco
Product Application
(PMTA) Submission
(FDA Form 4057)
Premarket Tobacco
Product Application
Amendment
And General
Correspondence
Submission (FDA
Form 4057a)

39

1

39

.75

29

39

14

546

.16

87

Premarket Tobacco
Product Application
Grouping Submission
(FDA Form 4057b)

39

1

39

0.75

29

1114.41 Reporting
Requirements
(periodic reports)

4

1

4

50

200

1114.9 Amendments

24

2

48

188

9,024

1

1

1

1

1

2

1

2

428

856

3

1

3

565

1,695

4

6

24

1

24

1

1

1

.25

.25

1114.13 Change in
Ownership
1114.15 Supplemental
applications
1114.17
Resubmissions
1114.41(a)(2)
Adverse Experience
Reports
1114.49(b) and (c)
Waiver from
Electronic Submission
Total

13,658

FDA anticipates that applicants will submit bundled PMTAs, which are single submissions containing PMTAs for
a number of similar or related products. We estimate that a bundle will contain on average between 6 and 11
distinct products.

1

FDA has based these estimates on the full analysis of economic impacts and experience
with current PMTA submissions. The estimates for OMB control number 0910-0768
covers the burden for ENDS products PMTA submissions. These estimates were
originally published in the Deeming Rule and recently in the Federal Register of Apr 22,
2019 (84 FR 16673). In that rule we described that this 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
10

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 in accordance with the requirements of § 25.40, for a total of 1,713 hours per
PMTA application.
Table 1 describes the estimated annual reporting burden per the requirements in this rule.
For this analysis, FDA assumes that firms will submit all applications as PMTA bundles.
We also considered updated data on market consolidation that has occurred since
Deeming Rule published. For originally regulated products that would receive marketing
granted orders through the PMTA pathway. For originally regulated products we expect
to receive one full PMTA submission for a total of 1,713 hours. 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.
Additional efficiencies this creates for FDA can include, lessening the burden for FDA to
process the submission and upload the files into our systems for review. Also, this is a
review resource efficiency where we can review products more efficiently where the data
can be reviewed once for multiple products to which it applies rather than reviewing
individually for each separate PMTA (if we don’t know it’s identical data for many
products across that are individually submitted).
Other than as specifically described for supplemental PMTAs and resubmissions, having
previously submitted a PMTA for an ENDS product could improve the efficiency of
preparing a subsequent PMTA; however, whether and how much of a benefit it could
provide would depend on both the quality of the prior submission and how similar the
product is to the one in the new PMTA.
FDA conducted a thorough analysis of the current paperwork burden associated with the
PMTA program and other similar forms and applied the most accurate burden to the
forms; however, upon further review and certain updates made to the form based on
comments received and product categorization changes, FDA has revised the burden
associated with entering the data into the form (which includes searching existing data
sources and gathering and maintaining the data needed) to be 45 minutes per individual
product (rather than 30 minutes per product) on Form FDA 4057. For Form FDA 4057a,
FDA has revised the burden for this form to 10 minutes (from 5 minutes). This form
serves several purposes from changing a point of contact (minimal burden) to providing
additional substantive information for the purpose of the review of the PMTA application
(more burdensome).

11

FDA developed Form FDA 4057 for use when submitting PMTA single and bundled
submissions. FDA estimates that 39 respondents will submit PMTA bundles using this
form at 0.75 (45 minutes) per response. The number 39 is accounting for the bundles of
ENDS products 2 and the 1 bundle we expect to receive yearly for originally regulated
products for a total of 29 hours.
FDA developed Form FDA 4057a for use when firms are submitting amendments and
other general correspondence. Our estimate is 0.16 (10 minutes) per response to fill out
this form. We estimate there will be at least fourteen amendments per application for a
total of 87 hours. With most applications being submitted toward the end of our 3-year
range, we expect fewer amendments during this period. However, FDA expects
correspondence from earlier applications to be submitted during this period.
FDA developed an additional form (Form FDA 4057b) that will assist industry and FDA
in identifying the products that are the subject of a submission where an applicant group
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 discussed bundled submissions in the proposed rule (84
FR 50566 at 50578) and noted that FDA intends to consider information on each tobacco
product as a separate, individual PMTA. The form will assist applicants in providing the
unique identifying information for each product in a grouped submission of PMTAs that
are required § 1114.7(c)(3)(iii). By having the identifying information for products
contained in a submission be more clearly organized, FDA will be able to more
efficiently process and review the applications contained in a grouped submission.
Based on the Form FDA 4057 for use when submitting PMTA single and bundled
submissions, a respondent would utilize Form FDA 4057b once for each submission
containing more than one PMTA. We assume the submitter could include from 2 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.
However, FDA’s original estimate that Form 4057b would estimate 4 hours per response
was a high-end estimate and not an average. We now reflect the average time of 45
minutes per response based on the assumption that we expect to receive an average of
nine bundled products per submission. Assuming 45 minutes per Form FDA 4057b for
39 applications, we estimate a total burden of 29 hours for this activity.
FDA estimates under § 1114.41 that four respondents will submit a periodic report. This
number is based on the average number of periodic report submissions expected between
2020-2022. The RIA estimates that periodic reports will take between 20 and 80 hours
per submission. For this estimate, we use the average of 50 per response for a total of
200 hours.
Now including revised estimates for products made or derived from tobacco, or containing nicotine from any
source, that is intended for human consumption.

2

12

Under § 1114.9 firms will prepare amendments to PMTA bundles in response to
deficiency letters. These amendments contain additional information that we need to
complete substantive review. In the RIA we state in our limited history reviewing
PMTAs, we on average issue two deficiency letters. Based on this, we would anticipate
two responses back per bundle. Therefore, we estimate that 24 respondents will submit
48 amendments (24 × 2). Assuming 1,500 hours as the time to prepare and submit a full
PMTA and amendments may on average take 10 percent to 15 percent of that time (150225). 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.
Section § 1114.13 would allow 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 that meets the
requirements of § 1114.7 that would reduce the burden associated with the submission
and review of an application. Our estimated number of 2 respondents is based on the
number estimated for postmarket reports, which is 4 bundles (which is 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 to do an
original submission (including EA hours) for 428 hours per response. We estimate a total
of 856 burden hours for this activity.
Under § 1114.17 an applicant may submit a resubmission for the same tobacco product
that received a marketing denial order or for a different new tobacco product that results
from changes necessary to address the deficiencies outlined in a marketing denial order.
Based on the preliminary RIA, we are estimating that out of all bundles received in 2020,
2021, and 2022, that an average of three bundles are authorized. If we receive 24 bundles
yearly, and based on historical data, 58 percent fail at acceptance (down to 8 bundles
remaining), 17 percent fail at filing (down to 7 bundles remaining), and 25 percent
receive marketing orders (5 left). We estimate that 50 percent will try to resubmit in a
year. Thus, this number of respondents is three (rounded up). FDA estimates that a
resubmission will take 33 percent of the time it takes to complete an original submission
(including EA hours) at 565 hours per response for a total of 1,695 hours.
Under § 1114.41(a)(2), firms would also submit adverse experience reports for tobacco
products with marketing orders. We assume the same number of firms submitting
periodic reports will submit adverse experience reports. Currently, firms may voluntarily
submit adverse experience reports using Form FDA 3800 under OMB control number
0910-0645. We have based our estimates on this information collection which estimates
that it takes 1 hour (for mandatory reporting) to complete this form for tobacco products
for a total of 24 hours.

13

Section § 1114.49 would require an applicant 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. 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 .25 hours (15 minutes) per waiver for a
total of .25 hours.

"21 CFR Part"
and "Activity”
1114.45
PMTA
Records
1100.204 PreExisting
products
records
1107.3
Exemptions
from
Substantial
Equivalence
records
Total

Table 2.--Estimated Annual Recordkeeping Burden
Average Burden
Total
No. of
No. of
Annual
per
Records per
Recordkeepers
Recordkeeping
Records
Recordkeeper

Total
Hours

39

1

39

2

78

1

1

1

2

2

1

1

1

2

2

82

Table 2 describes the annual recordkeeping burden per the requirements in this rule. FDA
estimates that 39 recordkeepers will maintain records at 2 hours per record. Additionally,
the rule, would require that firms establish and maintain records related to SE Exemption
Requests and Pre-Existing products. We expect the burden hours of this rule 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 of this rule to be negligible for any Pre-Existing Tobacco Products that have
already submitted Standalone Pre-Existing Tobacco Product Submissions, because firms
would have established the required records when submitting the Standalone Pre-Existing
Tobacco Product Submissions. We believe this time is usual and customary for these
firms. We estimate that it would take 2 hours per record to establish the required records
for a total of 4 hours. Therefore, the total recordkeeping burden hours is estimated to be
82 hours.

14

The total burden for these new collections of information in this rulemaking is 13,658
reporting hours and 82 recordkeeping hours for a total of 13,740 hours.
12b. Annualized Cost Burden Estimate
We estimate the costs from the rule using the cost of labor. Following guidelines from
the Department of Health and Human Services
(https://aspe.hhs.gov/system/files/pdf/242926/HHS_RIAGuidance.pdf), we estimate the
cost of labor as the fully loaded wage, or the wage including benefits and overhead equal
to 100 percent of the mean wage. For industry wages, we use wage per hour adjusted for
benefits and overhead estimated at $86.20 per hour.
Occupation
Composite Wage
for Preparing
PMTAs and
Related Reports
Total

Total Burden
Hours

Hourly Wage Rate

Total
Respondent
Costs

13,740

$86.20

$1,184,338
$1,184,338

13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital
Costs
There are no capital, start-up, operating or maintenance costs associated with this
information collection.
14. Annualized Cost to the Federal Government
FDA anticipates that the Federal government will incur the following costs:
Staff Costs
Total annual cost to the Federal government = $7,150,000
Full-time Equivalents (FTEs) = 55
Annual Cost per FTE=$130,000
15. Explanation for Program Changes or Adjustments
The Food and Drug Administration is submitting this revision under emergency clearance
procedures to revise Form FDA 4057b to account for products containing non-tobacco
derived nicotine through PMTA applications. Effective April 14, 2022, Section 201(rr) of
the FD&C Act now applies to “any product made or derived from tobacco, or containing
nicotine from any source, that is intended for human consumption”. Form FDA 4057b
has been modified to be in alignment with the changes to the definition of “tobacco
product” in section 201(rr) of the FD&C Act. Currently, we do not have an accurate
15

assessment of how this will affect our burden estimates. For this emergency clearance
request, FDA has added burden to account for products containing non-tobacco derived
nicotine. This resulted in an increase of 45 responses and 148 hours. The new estimated
burden for this collection is 13,740 hours.
16. Plans for Tabulation and Publication and Project Time Schedule
FDA does not intend to publish the results of this information collection.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
FDA is not seeking approval not to display the expiration date of OMB approval.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

16