Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Tobacco Product Applications and Recordkeeping Requirements, 63502-63505 [2022-22708]
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63502
Federal Register / Vol. 87, No. 201 / Wednesday, October 19, 2022 / Notices
Regulations Staff (HFV–6), Center for
Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Regarding tracers used in animal food:
Diego Paiva, Center for Veterinary
Medicine (HFV–229), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–6785,
Diego.Paiva@fda.hhs.gov.
Regarding tracers used in animal drug
products: Rebecca Owen, Center for
Veterinary Medicine (HFV–141), Food
and Drug Administration, 7500 Standish
Pl., Rockville, MD 20855, 240–402–
0670, Rebecca.Owen@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
jspears on DSK121TN23PROD with NOTICES
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR 501.22 have been
approved under OMB control number
17:58 Oct 18, 2022
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/animal-veterinary/
guidance-regulations/guidanceindustry, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: October 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–22705 Filed 10–18–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
In the Federal Register of March 2,
2022 (87 FR 11719), FDA published the
notice of availability for a draft GIF #258
entitled ‘‘Use of Tracers in Animal
Food, Type A Medicated Articles, and
Medicated Feeds’’ giving interested
persons until May 2, 2022, to comment
on the draft guidance. FDA received one
comment submission on the draft
guidance and the comments in that
submission were considered as the
guidance was finalized. The guidance
announced in this notice finalizes the
draft guidance dated March 2, 2022.
This guidance replaces CPG Sec.
680.100 ‘‘Tracers in Animal Feed.’’
This level 1 guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on the use of tracers in
animal food, Type A medicated articles,
and medicated feeds. It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
VerDate Sep<11>2014
0910–0721. The collections of
information in 21 CFR part 514 have
been approved under OMB control
number 0910–0032.
Jkt 259001
[Docket No. FDA–2019–N–2854]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Premarket
Tobacco Product Applications and
Recordkeeping Requirements
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Food and Drug
Administration (FDA) 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 November
18, 2022.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
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 0910–0879.
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, PRAStaff@fda.hhs.gov.
SUMMARY:
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In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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 Act) established
requirements for premarket review of
new tobacco products and the
implementing regulations are found in
part 1114 (21 CFR part 1114),
subchapter K.
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 (§ 1114.5). 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 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 (https://
www.fda.gov/tobacco-products/marketand-distribute-tobacco-product/
premarket-tobacco-productapplications).
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
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Federal Register / Vol. 87, No. 201 / Wednesday, October 19, 2022 / Notices
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
(§ 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 (§ 1114.17). A
resubmission may be submitted for the
same tobacco product that received a
marketing denial order or for a different
new tobacco product that results from
changes necessary to address the
deficiencies outlined in a marketing
denial order. This application format
allows an applicant to address the
deficiencies described in a marketing
denial order without having to
undertake the effort of submitting a
standard PMTA. The resubmission
format is not available for PMTAs that
FDA refused to accept, refused to file,
cancelled, or administratively closed, or
that the applicant withdrew because
FDA has not previously completed
reviews of such applications upon
which it can rely, and such applications
may need significant changes to be
successfully resubmitted.
FDA requires applicants that receive a
marketing granted order to submit
postmarket reports. Postmarket reports
determine or facilitate a determination
of whether there may be grounds to
withdraw or temporarily suspend a
marketing granted order. 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 (https://
www.safetyreporting.hhs.gov/) within
15 calendar days after receiving or
becoming aware of a serious or
unexpected adverse experience. FDA’s
Safety Reporting Portal is approved
under OMB control number 0910–0291.
Applicants receiving a marketing
granted order are required to maintain
all records necessary to facilitate a
determination of whether there are or
may be grounds to withdraw or
temporarily suspend the marketing
granted order, including records related
to both the application and postmarket
reports, and ensure that such records
remain readily available to the Agency
upon request (§ 1114.45).
63503
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.
In the Federal Register of May 16,
2022 (87 FR 29749), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
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21 CFR part; activity; form FDA #
Number of
responses per
respondent
Total annual
responses
1114.5; Submission of Standard Bundled PMTAs 2 ............
PMTA Submission; Form FDA 4057 ...................................
1
39
1
1
1
39
PMTA Amendment and General Correspondence Submission; Form FDA 4057a.
PMTA Grouping Submission; Form FDA 4057b .................
39
14
546
39
1
39
1114.41; Reporting Requirements (periodic reports) ..........
1114.9; Amendments ...........................................................
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 .....
4
24
1
2
3
4
1
1
2
1
1
1
6
1
4
48
1
2
3
24
1
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Average
burden per
response
1,713 .............
0.75 (45 minutes).
0.16 (10 minutes).
0.75 (45 minutes).
50 ..................
188 ................
1 ....................
428 ................
565 ................
1 ....................
0.25 (15 minutes).
Total hours
1,713
29
87
29
200
9,024
1
856
1,695
24
0.25
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Federal Register / Vol. 87, No. 201 / Wednesday, October 19, 2022 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
........................
........................
........................
........................
21 CFR part; activity; form FDA #
Total ..............................................................................
Total hours
13,658
1 There
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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
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.
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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. The number 39 is accounting
for the bundles of ENDS products and
includes 15 new expected bundles
submitted for NTN 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. FDA estimates
that 39 respondents will submit
amendments and other general
correspondence using this form at 0.16
(10 minutes) per response, including 15
new expected submissions related to
applications submitted for 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
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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. Included in
this estimate are the 15 new expected
submissions submitted from NTN
products.
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 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 (§ 1114.41(a)(2)) for
tobacco products with marketing orders.
We assume the same number of firms
submitting periodic reports will submit
adverse experience reports. 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 § 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 × 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 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
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Federal Register / Vol. 87, No. 201 / Wednesday, October 19, 2022 / Notices
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
utilize the resubmission format for the
same tobacco product for which FDA
issued a marketing denial order or for a
new tobacco product that results from
changes necessary to address the
deficiencies described 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
amendments to bundles yearly, we
estimate 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 also estimate that 50 percent
of the applications that receive
marketing denial orders 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.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR part; activity
Average
burden per
recordkeeping
Total annual
records
Total hours
1114.45; PMTA Records .....................................................
1100.204; Pre-existing Products Records ...........................
1107.3; Exemptions From Substantial Equivalence (SE)
Records ............................................................................
39
1
1
1
39
1
2
2
78
2
1
1
1
2
2
Total ..............................................................................
........................
........................
........................
........................
82
1 There
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Number of
records per
recordkeeper
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 (§ 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.
Relative to the emergency approval by
OMB our estimated burden for the
information collection reflects an
overall increase of 72 hours and a
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corresponding increase of 117
responses/records. We attribute this
adjustment to the addition of NTN
product submissions.
Dated: October 11, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–22708 Filed 10–18–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development; Notice of Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
PO 00000
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and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel; Neonatal Research
Network.
Date: November 7–8, 2022.
Closed: 10:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Eunice
Kennedy Shriver National Institute of Child
Health and Human Development, 6710B
Rockledge Drive, Room 2140, Bethesda, MD
20892–7510 (Virtual Meeting).
Contact Person: Joanna Kubler-Kielb,
Scientific Review Officer, Scientific Review
Branch, Eunice Kennedy Shriver National
Institute of Child Health and Human
Development, NIH 6710B, Rockledge Drive,
Room 2140, Bethesda, MD 20892, (301) 435–
6916, kielbj@mail.nih.gov.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel; Neonatal Research
Network and Maternal-Fetal Medicine Units
Network: Data Coordinating Centers.
Date: November 10, 2022.
Closed: 1:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
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]]>Agencies
[Federal Register Volume 87, Number 201 (Wednesday, October 19, 2022)]
[Notices]
[Pages 63502-63505]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-22708]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-2854]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Premarket Tobacco
Product Applications and Recordkeeping Requirements
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) 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 November 18, 2022.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. 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 0910-0879.
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,
[email protected].
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.
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 Act) established requirements for premarket review of new tobacco
products and the implementing regulations are found in part 1114 (21
CFR part 1114), subchapter K.
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 (https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/premarket-tobacco-product-applications).
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
[[Page 63503]]
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 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 (https://www.safetyreporting.hhs.gov/) within
15 calendar days after receiving or becoming aware of a serious or
unexpected adverse experience. FDA's Safety Reporting Portal is
approved under OMB control number 0910-0291.
Applicants receiving a marketing granted order are required to
maintain all records necessary to facilitate a determination of whether
there are or may be grounds to withdraw or temporarily suspend the
marketing granted order, including records related to both the
application and postmarket reports, and ensure that such records remain
readily available to 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.
In the Federal Register of May 16, 2022 (87 FR 29749), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR part; activity; form Number of responses per Total annual Average burden Total hours
FDA # respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
1114.5; Submission of Standard 1 1 1 1,713........... 1,713
Bundled PMTAs \2\.
PMTA Submission; Form FDA 4057 39 1 39 0.75 (45 29
minutes).
PMTA Amendment and General 39 14 546 0.16 (10 87
Correspondence Submission; minutes).
Form FDA 4057a.
PMTA Grouping Submission; Form 39 1 39 0.75 (45 29
FDA 4057b. minutes).
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 0.25 (15 0.25
from Electronic Submission. minutes).
---------------------------------------------------------------------------------
[[Page 63504]]
Total..................... .............. .............. .............. ................ 13,658
----------------------------------------------------------------------------------------------------------------
\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 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. The number 39 is
accounting for the bundles of ENDS products and includes 15 new
expected bundles submitted for NTN 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. FDA estimates that 39 respondents will
submit amendments and other general correspondence using this form at
0.16 (10 minutes) per response, including 15 new expected submissions
related to applications submitted for 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. Assuming 45 minutes per Form FDA 4057b
for 39 applications, we estimate a total burden of 29 hours for this
activity. Included in this estimate are the 15 new expected submissions
submitted from NTN products.
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 (Sec. 1114.41(a)(2)) for
tobacco products with marketing orders. We assume the same number of
firms submitting periodic reports will submit adverse experience
reports. 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 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
[[Page 63505]]
assigned 1 hour acknowledging the requirement.
Section 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 utilize the resubmission
format for the same tobacco product for which FDA issued a marketing
denial order or for a new tobacco product that results from changes
necessary to address the deficiencies described 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 amendments to bundles yearly, we estimate 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 also estimate that
50 percent of the applications that receive marketing denial orders
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.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR part; activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
1114.45; PMTA Records........... 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........................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 82
----------------------------------------------------------------------------------------------------------------
\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.
Relative to 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: October 11, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-22708 Filed 10-18-22; 8:45 am]
BILLING CODE 4164-01-P
