Notice2022-10462
Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Tobacco Product Applications and Recordkeeping Requirements
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Published
May 16, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on "Premarket Tobacco Product Applications and Recordkeeping Requirements."
Full Text
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<title>Federal Register, Volume 87 Issue 94 (Monday, May 16, 2022)</title>
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[Federal Register Volume 87, Number 94 (Monday, May 16, 2022)]
[Notices]
[Pages 29749-29753]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-10462]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-2854]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Premarket Tobacco Product Applications and
Recordkeeping Requirements
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on ``Premarket Tobacco Product Applications
and Recordkeeping Requirements.''
DATES: Submit either electronic or written comments on the collection
of information by July 15, 2022.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before July 15, 2022. 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 July 15, 2022. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is 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-2019-N-2854 for ``Premarket Tobacco Product Applications and
Recordkeeping Requirements.'' Received comments, those filed in a
[[Page 29750]]
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#336361726047525555735557521d5b5b401d545c45"><span class="__cf_email__" data-cfemail="16464457456277707056707277387e7e6538717960">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Premarket Tobacco Product Applications and Recordkeeping Requirements--
21 CFR 1114
OMB Control Number 0910-0879--Extension
This information collection supports the requirements for the
content, format, submission recordkeeping, and postmarket reporting
requirements of a premarket tobacco product application (PMTA). Section
910(a) (21 U.S.C. 387j(a)) of the Federal Food, Drug, and Cosmetic Act
(FD&C) established requirements for premarket review of new tobacco
products and the implementing regulations are found in 21 CFR
subchapter K, part 1114 (part 1114).
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 this part until FDA has issued a
marketing granted order for the product (Sec. 1114.5). Further, Sec.
1114.7 describes the required content and format of the PMTA. The PMTA
must contain sufficient information for FDA to determine whether any of
the grounds for denial specified in section 910(c)(2) of the FD&C Act
apply. The application must contain the following sections: General
information, descriptive information, product samples, labeling, a
statement of compliance with 21 CFR part 25, a summary, product
formulation, manufacturing, health risk investigations, effect on the
population as a whole, and a certification statement.
Submitters can visit the following web page which describes the
process for submitting a PMTA (<a href="https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/premarket-tobacco-product-applications">https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/premarket-tobacco-product-applications</a>).
After submission of a PMTA FDA may request, and an applicant may
submit, an amendment to a pending PMTA. FDA generally expects that when
an applicant submits a PMTA, the submission will include all
information required by section 910(b)(1) of the FD&C Act and part 1114
to enable FDA to determine whether it should authorize the marketing of
a new tobacco product. However, FDA recognizes that additional
information may be needed to complete the review of a PMTA and,
therefore FDA allows the submission of amendments to a pending
application.
An applicant may transfer ownership of its PMTA at any time,
including when FDA has yet to act on it. Section 1114.13 describes the
steps that an applicant would be required to take when it changes
ownership of a PMTA. This section is intended to facilitate transfers
of ownership and help ensure that FDA has current information regarding
the ownership of a PMTA.
A supplemental PMTA are an alternative format of submitting a PMTA
(Sec. 1114.15). 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 restricts the use of
supplemental PMTAs to only changes that require the submission of
limited information or revisions to ensure that FDA can efficiently
review the application.
If an applicant receives a no marketing granted order, they may
submit a resubmission to respond to the deficiencies outlined (Sec.
1114.17). A resubmission may be submitted for the same tobacco product
that received a marketing denial order or for a different
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new tobacco product that results from changes necessary to address the
deficiencies outlined in a marketing denial order. This application
format allows an applicant to address the deficiencies described in a
marketing denial order without having to undertake the effort of
submitting a standard PMTA. The resubmission format is not available
for PMTAs that FDA refused to accept, refused to file, cancelled, or
administratively closed, or that the applicant withdrew because FDA has
not previously completed reviews of such applications upon which it can
rely, and such applications may need significant changes to be
successfully resubmitted.
FDA requires applicants that receive a marketing granted order to
submit postmarket reports. Postmarket reports determine or facilitate a
determination of whether there may be grounds to withdraw or
temporarily suspend a marketing granted order. Applicants are required
to submit two types of postmarket reports after receiving a marketing
granted order: Periodic reports and adverse experience reports.
Periodic reports are required to be submitted within 60 calendar days
of the reporting date specified in the marketing granted order.
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. The
serious and unexpected adverse experience reports must be submitted to
the Center for Tobacco Products' Office of Science through the HHS
Safety Reporting Portal (<a href="https://www.safetyreporting.hhs.gov/">https://www.safetyreporting.hhs.gov/</a>) within
15 calendar days after receiving or becoming aware of a serious or
unexpected adverse experience. FDA's Safety Reporting Portal is
approved under OMB control number 0910-0645.
Applicants receiving a marketing granted order are required to
maintain all records necessary to facilitate a determination of whether
there are or may be grounds to withdraw or temporarily suspend the
marketing granted order, including records related to both the
application and postmarket reports, and ensure that such records remain
readily available to the Agency upon request (Sec. 1114.45).
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) (U.S.C. 321(rr)) of the FD&C Act
to include products that contain nicotine from any source. As a result,
non-tobacco nicotine (NTN) products that were not previously subject to
the FD&C Act (e.g., products containing synthetic nicotine) are now
subject to all of the tobacco product provisions in the FD&C Act
beginning on April 14, 2022, including the requirement of premarket
review for new tobacco products. The Appropriations Act also makes all
rules and guidances applicable to tobacco products apply to NTN
products on that same effective date, 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 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. On April 14, 2022, OMB granted an emergency clearance
under this collection to include NTN products and its associated
burden. OMB granted a 6-month approval, and as such per the
requirements of the PRA, the Agency is seeking comment on these new
estimates.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
21 CFR part; activity; form Number of responses per Total annual Average burden Total hours
FDA No. respondents respondent responses per response
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1114.5; Submission of Standard 1 1 1 1,713........... 1,713
Bundled PMTAs \2\.
PMTA Submission; Form FDA 4057 39 1 39 .75 (45 minutes) 29
PMTA Amendment and General 39 14 546 .16 (10 minutes) 87
Correspondence Submission;
Form FDA 4057a.
PMTA Grouping Submission; Form 39 1 39 .75 (45 minutes) 29
FDA 4057b.
1114.41; Reporting 4 1 4 50.............. 200
Requirements (periodic
reports).
1114.9; Amendments............ 24 2 48 188............. 9,024
1114.13; Change in Ownership.. 1 1 1 1............... 1
1114.15; Supplemental 2 1 2 428............. 856
applications.
1114.17; Resubmissions........ 3 1 3 565............. 1,695
1114.41(a)(2); Adverse 4 6 24 1............... 24
Experience Reports.
1114.49(b) and (c); Waiver 1 1 1 .25 (15 minutes) .25
from Electronic Submission.
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Total..................... .............. .............. .............. ................ 13,658
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ FDA anticipates that applicants will submit bundled PMTAs, which are single submissions containing PMTAs for
a number of similar or related products. We estimate that a bundle will contain on average between 6 and 11
distinct products.
Table 1 describes the estimated annual reporting burden. FDA has
based these estimates on the full analysis of economic impacts and
experience with current PMTA submissions received under OMB control
number 0910-0768 (which covers the burden for electronic nicotine
delivery system (ENDS) products PMTA submissions). 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
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
[[Page 29752]]
take each respondent approximately 1,500 hours to prepare a PMTA
seeking an order from FDA allowing the marketing of a new tobacco
product. FDA also estimates that it would on average take an additional
213 hours to prepare an environmental assessment (EA) in accordance
with the requirements of 21 CFR 25.40, for a total of 1,713 hours per
PMTA application.
FDA assumes that firms will submit all applications as PMTA
bundles. We also considered updated data on market consolidation that
has occurred since the 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.
FDA has three forms for use when submitting PMTA information to the
Agency. 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. Included in this
estimate are the 15 new expected bundles submitted for NTN products.
The number 39 is accounting for the bundles of ENDS products and the 1
bundle we expect to receive yearly for originally regulated products
for a total of 29 hours.
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. Included in this estimate are the 15
new expected submissions submitted from NTN products. We estimate there
will be at least 14 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.
Form FDA 4057b assists industry and FDA in identifying the products
that are the subject of a submission where an applicant groups multiple
PMTAs into a single submission (referred to as a bundled submission or
a grouped submission). FDA has previously stated that one approach to
submitting PMTAs could be to group applications for products that are
both from the same manufacturer or domestic importer and in the same
product category and subcategory into a single submission. The form
assists applicants in providing the unique identifying information for
each product in a grouped submission of PMTAs. A respondent would
utilize Form FDA 4057b once for each submission 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. We 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. Included in this estimate are the 15
new expected submissions submitted from NTN products. Assuming 45
minutes per Form FDA 4057b for 39 applications, we estimate a total
burden of 29 hours for this activity.
FDA estimates under Sec. 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 and the addition
of NTN products. The Agency estimates that periodic reports will take
on average of 50 hours per response for a total of 200 hours. Firms
must 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.
Under Sec. 1114.9 firms will prepare amendments to PMTA bundles in
response to deficiency letters. These amendments contain additional
information that we need to complete substantive review. We anticipate
2 responses back per bundle and therefore, we estimate that 24
respondents will submit 48 amendments (24 x 2). Assuming 1,500 hours as
the time to prepare and submit a full PMTA and amendments may on
average take 10 percent to 15 percent of that time (150-225). 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 Sec. 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 Sec. 1114.15 is an alternative format of submitting a PMTA
that meets the requirements of Sec. 1114.7 that would reduce the
burden associated with the submission and review of an application. Our
estimated number of 2 respondents is based on the number estimated for
postmarket reports, which is 4 bundles (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 Sec. 1114.17 an applicant may submit a resubmission for the
same tobacco product that received a marketing denial order or for a
different new tobacco product that results from changes necessary to
address the deficiencies outlined in a marketing denial order. 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.
An applicant is required to submit a PMTA and all supporting and
related documents to FDA in electronic format that FDA can process,
review, and archive unless an applicant requests, and FDA grants, a
waiver from this requirement. 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.
[[Page 29753]]
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Average
21 CFR part; activity Number of records per Total annual burden per Total hours
recordkeepers recordkeeper records recordkeeping
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1114.45; PMTA records........... 39 1 39 2 78
1100.204; Pre-existing products 1 1 1 2 2
records........................
1107.3; Exemptions from 1 1 1 2 2
Substantial Equivalence (SE)
records........................
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Total....................... .............. .............. .............. .............. 82
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2 describes the annual recordkeeping burden. FDA estimates
that 39 recordkeepers will maintain records at 2 hours per record.
Included in this estimate are the 15 expected new recordkeepers of NTN
products. Firms are also required to establish and maintain records
related to SE exemption requests and pre-existing products (Sec.
1100.200 states that subpart C of part 1100). We expect the burden
hours to be negligible for SE exemption requests. Firms would have
already established the required records when submitting the SE
exemption request. Similarly, we expect the hours of 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.
Based on the emergency approval by OMB our estimated burden for the
information collection reflects an overall increase of 72 hours and a
corresponding increase of 117 responses/records. We attribute this
adjustment to the addition of NTN product submissions.
Dated: May 10, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-10462 Filed 5-13-22; 8:45 am]
BILLING CODE 4164-01-P
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