Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Exemptions From Substantial Equivalence Requirements for Tobacco Products, 48669-48671 [2022-17184]
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48669
Federal Register / Vol. 87, No. 153 / Wednesday, August 10, 2022 / Notices
investigation by FDA of whether the
applicant acted with due diligence.’’
Upon receipt of a due diligence petition,
FDA reviews the petition and evaluates
whether any change in the regulatory
review period is necessary. If so, the
corrected regulatory review period is
published in the Federal Register. A
due diligence petitioner not satisfied
with FDA’s decision regarding the
petition may, under § 60.40, request an
informal hearing for reconsideration of
the regulatory review period were
submitted under § 60.24(a). In addition,
a total of one due diligence petition was
submitted under § 60.30. There have
been no requests for hearings under
§ 60.40; however, for purposes of this
information collection approval, we
estimate that we may receive one
submission annually.
FDA estimates the burden of this
collection of information as follows:
the due diligence determination.
Petitioners are likely to include persons
or organizations having knowledge that
FDA’s marketing permission for that
product was not actively pursued
throughout the regulatory review
period. The information collection for
which an extension of approval is being
sought is the use of the statutorily
created due diligence petition.
During the calendar years 2019
through 2022, 15 requests for revision of
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Total annual
responses
Average
burden per
response
Total hours
60.24; revision of regulatory review period determinations
60.30; due diligence petitions ..............................................
60.40; due diligence hearings ..............................................
4
1
1
3.75
1
1
15
1
1
100
50
10
1,500
50
10
Total ..............................................................................
........................
........................
........................
........................
1,560
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the
information collection reflects a small
decrease (-1 response) associated with
submissions received under § 60.24 in
previous years.
Dated: August 4, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–17147 Filed 8–9–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2013–N–1588]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Exemptions From
Substantial Equivalence Requirements
for Tobacco Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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 September
9, 2022.
ADDRESSES: To ensure that comments on
the information collection are received,
SUMMARY:
17:26 Aug 09, 2022
Rachel Showalter, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 240–994–7399, PRAStaff@
fda.hhs.gov.
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:
Exemptions From Substantial
Equivalence Requirements for Tobacco
Products
Notice.
VerDate Sep<11>2014
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 0910–0684. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
21 CFR part 60—patent term restoration
Jkt 256001
OMB Control Number 0910–0684—
Revision
On June 22, 2009, the Family
Smoking Prevention and Tobacco
Control Act (Tobacco Control Act) (Pub.
L. 111–31) was signed into law. The
Tobacco Control Act amended the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) by adding a chapter granting
FDA important authority to regulate the
manufacture, marketing, and
distribution of tobacco products to
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
protect the public health generally and
to reduce tobacco use by minors.
The Consolidated Appropriations Act
of 2022 (Pub. L. 117–103) (the
Appropriations Act), enacted on March
15, 2022, amended the definition of the
term ‘‘tobacco product’’ in section
201(rr) of the FD&C Act (21 U.S.C.
321(rr)) to include products that contain
nicotine from any source. As a result,
non-tobacco nicotine (NTN) products
that were not previously subject to the
FD&C Act (e.g., products containing
synthetic nicotine) are now subject to all
of the tobacco product provisions in the
FD&C Act beginning on April 14, 2022,
including the requirement of premarket
review for new tobacco products.
The FD&C Act, as amended by the
Tobacco Control Act, requires that
before a new tobacco product may be
introduced or delivered for introduction
into interstate commerce, the new
tobacco product must undergo
premarket review by FDA. FDA must
issue an order authorizing the
commercial distribution of the new
tobacco product or find the product
exempt from the requirements of
substantial equivalence under section
910(a)(2)(A) of the FD&C Act (21 U.S.C.
387j(a)(2)(A)), before the product may be
introduced into commercial
distribution.
FDA has established a pathway for
manufacturers to request exemptions
from the substantial equivalence
requirements of the FD&C Act in
§ 1107.1 (21 CFR 1107.1) of the
Agency’s regulations. As described in
§ 1107.1(a), FDA may exempt tobacco
products that are modified by adding or
deleting a tobacco additive, or
E:\FR\FM\10AUN1.SGM
10AUN1
khammond on DSKJM1Z7X2PROD with NOTICES
48670
Federal Register / Vol. 87, No. 153 / Wednesday, August 10, 2022 / Notices
increasing or decreasing the quantity of
an existing tobacco additive, from the
requirement of demonstrating
substantial equivalence if the Agency
determines that: (1) the modification
would be a minor modification of a
tobacco product that can be sold under
the FD&C Act; (2) a report
demonstrating substantial equivalence
is not necessary to ensure that
permitting the tobacco product to be
marketed would be appropriate for the
protection of public health; and (3) an
exemption is otherwise appropriate.
Section 1107.1(b) states that a request
for exemption under section 905(j)(3) of
the FD&C Act (21 U.S.C. 387e(j)(3)) may
be made only by the manufacturer of a
legally marketed tobacco product for a
minor modification to that tobacco
product and that the manufacturer must
submit the request and all information
supporting it to FDA. The request must
be made in an electronic format that
FDA can process, review, and archive
(or a written request must be made by
the manufacturer explaining in detail
why the manufacturer cannot submit
the request in an electronic format and
requesting an alternative means of
submission to the electronic format).
An exemption request must contain:
(1) the manufacturer’s address and
contact information; (2) identification of
the tobacco product(s); (3) a detailed
explanation of the purpose for the
modification; (4) a detailed description
of the modification, including a
statement as to whether the
modification involves adding or
deleting a tobacco additive, or
increasing or decreasing the quantity of
the existing tobacco additive; (5) a
detailed explanation of why the
modification is a minor modification of
a tobacco product that can be sold under
the FD&C Act; (6) a detailed explanation
of why a report under section 905(j)(1)
of the FD&C Act intended to
demonstrate substantial equivalence is
not necessary to ensure that permitting
the tobacco product to be marketed
would be appropriate for protection of
the public health; (7) a certification (i.e.,
a signed statement by a responsible
official of the company) summarizing
the supporting evidence and providing
the rationale for the official’s
determination that the modification
does not increase the tobacco product’s
appeal to or use by minors, toxicity,
addictiveness, or abuse liability; (8)
other information justifying an
exemption; and (9) an environmental
assessment (EA) under part 25 (21 CFR
part 25; 42 U.S.C. 4332(2)) prepared in
accordance with the requirements of
§ 25.40 (21 CFR 25.40)).
VerDate Sep<11>2014
17:26 Aug 09, 2022
Jkt 256001
The National Environmental Policy
Act of 1969 (NEPA) (42 U.S.C. 4321–
4347) states national environmental
objectives and imposes upon each
Federal Agency the duty to consider the
environmental effects of its actions.
Section 102(2)(C) of NEPA requires the
preparation of an environmental impact
statement for every major Federal action
that will significantly affect the quality
of the human environment.
The FDA NEPA regulations are
contained in part 25. All applications
for exemption from substantial
equivalence require the submission of
an EA. An EA provides information that
is used to determine whether an FDA
action could result in a significant
environmental impact. Section 25.40(a)
and (c) specifies the content
requirements for EAs for non-excluded
actions.
The information required by
§ 1107.1(b) is submitted to FDA so FDA
can determine whether an exemption
from substantial equivalence to the
product is appropriate for the protection
of the public health. Section 1107.1(c)
states that FDA will review the
information submitted and determine
whether to grant or deny an exemption
based on whether the criteria in section
905(j)(3) of the FD&C Act are met. FDA
may request additional information if
necessary, to make a determination and
may consider the exemption request
withdrawn if the information is not
provided within the requested
timeframe.
This collection of information also
contains a requirement that a
manufacturer submit a report (referred
to as an ‘‘abbreviated report’’) at least 90
days prior to making an introduction or
delivery for introduction into interstate
commerce for commercial distribution
of a tobacco product. Section
905(j)(1)(A)(ii) of the FD&C Act states
that if an exemption has been requested
and granted, the manufacturer must
submit to FDA a report that
demonstrates that the tobacco product is
modified within the meaning of section
905(j)(3), the modifications are to a
product that is commercially marketed
and in compliance with the
requirements of the FD&C Act, and all
the modifications are covered by
exemptions granted by the Secretary
under section 905(j)(3).
Description of Respondents: The
respondents to this collection of
information are tobacco product
manufacturers defined as any person,
including any repacker or relabeler,
who: (1) manufactures, fabricates,
assembles, processes, or labels a tobacco
product; or (2) imports a finished
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
tobacco product for sale or distribution
in the United States.
Section 1107.1(b) requires that the
exemption request and supporting
information be submitted in an
electronic format that FDA can process,
review, and archive. The exemption
request and supporting information
must be legible and in English. These
requirements ensure that FDA can
review the exemption request
expeditiously and appropriately. FDA
provides information on its website on
how manufactures may provide
electronic submissions and regulatory
correspondence, such as the exemption
request and supporting information, as
well as the abbreviated report, to FDA
(e.g., information on electronic media
and methods of transmission). Steps on
how to prepare and the recommended
structure of an exemption request and
abbreviated report can be found at:
https://www.fda.gov/tobacco-products/
market-and-distribute-tobacco-product/
exemption-substantial-equivalence.
Information on how to submit
exemption requests and abbreviated
reports to the CTP Portal can be found
here: https://www.fda.gov/tobaccoproducts/manufacturing/submitdocuments-ctp-portal.
FDA does not anticipate any need to
submit an exemption request or
supporting information in a nonelectronic format. However, a company
that is not able to submit the
documentation in an electronic format
may submit a written request to the
Center for Tobacco Products document
control center (https://www.fda.gov/
tobacco-products/about-center-tobaccoproducts-ctp/contact-ctp).
In the Federal Register of February
25, 2022 (87 FR 10797), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. One comment responsive
to the four information collection topics
solicited was received. The comment
stated that the Agency should consider
making the exemption request pathway
(section 905(j)(3) of the FD&C Act) more
flexible for new products, devices, and
technology innovations.
FDA appreciates the comment and
notes that although we may consider the
comment, these types of actions may
necessitate guidance (as noted in the
comment). Currently, we believe that
the exemption pathway is providing
applicants an efficient pathway to make
additive changes to their products and
receive a marketing order. If the Agency
decides to consider revising the
suggested actions, these types of actions
would need to be done pursuant to
separate notice and comment
procedures.
E:\FR\FM\10AUN1.SGM
10AUN1
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Federal Register / Vol. 87, No. 153 / Wednesday, August 10, 2022 / Notices
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section and/or activity
§ 1107.1(b); Optional preparation of tobacco product exemption from substantial equivalence request; and
§ 25.40; Preparation of an environmental assessment ....
§ 1107.1(c); Preparation of additional information for tobacco product exemption from substantial equivalence
request ..............................................................................
Abbreviated report submitted to demonstrate: tobacco
product is modified under section 905(j)(3) of the FD&C
Act, modifications are to a product that is commercially
marketed and compliant, and modifications covered by
exemptions granted by Secretary under section 905(j)(3)
Total ..............................................................................
khammond on DSKJM1Z7X2PROD with NOTICES
1There
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
812
1
812
24
19,488
150
1
150
3
450
1,217
1
1,217
2
2,434
........................
........................
........................
........................
22,372
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA estimates that we will receive
812 exemption requests under
§ 1107.1(b) for 24 hours per response
including EA for a total of 19,488 hours.
Since an EA is required for each
§ 1107.1(b) (Optional Preparation of
Tobacco Product Exemption From
Substantial Equivalence Request), the
burden per response for EAs (12 hours)
has been combined with the 12 hours
for an exemption request for a total of
24 hours per response.
FDA further estimates, that we will
receive 150 submissions requiring
additional information in support of the
initial exemption request, and it is
expected that it will take an average of
3 hours to prepare the additional
information for a total of 450 hours.
FDA estimates that 1,217 respondents
will prepare 1,217 responses and each
response will take approximately 2
hours to prepare an abbreviated report,
as required by section 905(j)(1)(A)(ii),
for a total of 2,434 hours. The estimates
reflect a decrease of 1,217 hours to
account for a reduction in average
response time for preparing an
abbreviated report. FDA provides a
recommended format for applicants in
the exemption order letter that
significantly reduces the burden hours
for preparing the abbreviated report.
Therefore, FDA now estimates that the
hours for the collection of information
associated with exemptions from
substantial equivalence requirements
total 22,372 hours.
Although there may be year-to-year
variability in the absolute number of
exemption requests submitted, FDA
considers any trends in our analysis,
and the overall number of extension
requests from manufacturers of tobacco
products has remained consistent.
VerDate Sep<11>2014
17:26 Aug 09, 2022
Jkt 256001
Additionally, although manufacturers of
NTN products are now subject to all of
the tobacco product provisions in the
FD&C Act, including the need to submit
premarket submissions to FDA and
obtain authorization from the Agency to
market their product, FDA expects to
receive premarket tobacco product
applications for most currently
marketed NTN products. FDA does not
expect to receive many exemption
requests for currently marketed NTN
products. Thus, no additional
adjustments to the number of
respondents in our burden estimate are
needed for NTN products as the current
estimate accounts for some year-to-year
variability in the absolute number of
exemption requests submitted.
Dated: August 4, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–17184 Filed 8–9–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2004–N–0451]
Food and Drug Administration
Modernization Act of 1997:
Modifications to the List of Recognized
Standards, Recognition List Number:
058
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing a publication containing
SUMMARY:
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
modifications the Agency is making to
the list of standards FDA recognizes for
use in premarket reviews (FDA
Recognized Consensus Standards). This
publication, entitled ‘‘Modifications to
the List of Recognized Standards,
Recognition List Number: 058’’
(Recognition List Number: 058), will
assist manufacturers who elect to
declare conformity with consensus
standards to meet certain requirements
for medical devices.
Either electronic or written
comments can be submitted on the
notice at any time. These modifications
to the list of recognized standards are
applicable August 10, 2022.
DATES:
You may submit comments
on the current list of FDA Recognized
Consensus Standards at any time as
follows:
ADDRESSES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov 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
E:\FR\FM\10AUN1.SGM
10AUN1
Agencies
[Federal Register Volume 87, Number 153 (Wednesday, August 10, 2022)]
[Notices]
[Pages 48669-48671]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-17184]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1588]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Exemptions From
Substantial Equivalence Requirements for Tobacco Products
AGENCY: Food and Drug Administration, 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 September 9, 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 0910-0684. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
[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.
Exemptions From Substantial Equivalence Requirements for Tobacco
Products
OMB Control Number 0910-0684--Revision
On June 22, 2009, the Family Smoking Prevention and Tobacco Control
Act (Tobacco Control Act) (Pub. L. 111-31) was signed into law. The
Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act
(FD&C Act) by adding a chapter granting FDA important authority to
regulate the manufacture, marketing, and distribution of tobacco
products to protect the public health generally and to reduce tobacco
use by minors.
The Consolidated Appropriations Act of 2022 (Pub. L. 117-103) (the
Appropriations Act), enacted on March 15, 2022, amended the definition
of the term ``tobacco product'' in section 201(rr) of the FD&C Act (21
U.S.C. 321(rr)) to include products that contain nicotine from any
source. As a result, non-tobacco nicotine (NTN) products that were not
previously subject to the FD&C Act (e.g., products containing synthetic
nicotine) are now subject to all of the tobacco product provisions in
the FD&C Act beginning on April 14, 2022, including the requirement of
premarket review for new tobacco products.
The FD&C Act, as amended by the Tobacco Control Act, requires that
before a new tobacco product may be introduced or delivered for
introduction into interstate commerce, the new tobacco product must
undergo premarket review by FDA. FDA must issue an order authorizing
the commercial distribution of the new tobacco product or find the
product exempt from the requirements of substantial equivalence under
section 910(a)(2)(A) of the FD&C Act (21 U.S.C. 387j(a)(2)(A)), before
the product may be introduced into commercial distribution.
FDA has established a pathway for manufacturers to request
exemptions from the substantial equivalence requirements of the FD&C
Act in Sec. 1107.1 (21 CFR 1107.1) of the Agency's regulations. As
described in Sec. 1107.1(a), FDA may exempt tobacco products that are
modified by adding or deleting a tobacco additive, or
[[Page 48670]]
increasing or decreasing the quantity of an existing tobacco additive,
from the requirement of demonstrating substantial equivalence if the
Agency determines that: (1) the modification would be a minor
modification of a tobacco product that can be sold under the FD&C Act;
(2) a report demonstrating substantial equivalence is not necessary to
ensure that permitting the tobacco product to be marketed would be
appropriate for the protection of public health; and (3) an exemption
is otherwise appropriate.
Section 1107.1(b) states that a request for exemption under section
905(j)(3) of the FD&C Act (21 U.S.C. 387e(j)(3)) may be made only by
the manufacturer of a legally marketed tobacco product for a minor
modification to that tobacco product and that the manufacturer must
submit the request and all information supporting it to FDA. The
request must be made in an electronic format that FDA can process,
review, and archive (or a written request must be made by the
manufacturer explaining in detail why the manufacturer cannot submit
the request in an electronic format and requesting an alternative means
of submission to the electronic format).
An exemption request must contain: (1) the manufacturer's address
and contact information; (2) identification of the tobacco product(s);
(3) a detailed explanation of the purpose for the modification; (4) a
detailed description of the modification, including a statement as to
whether the modification involves adding or deleting a tobacco
additive, or increasing or decreasing the quantity of the existing
tobacco additive; (5) a detailed explanation of why the modification is
a minor modification of a tobacco product that can be sold under the
FD&C Act; (6) a detailed explanation of why a report under section
905(j)(1) of the FD&C Act intended to demonstrate substantial
equivalence is not necessary to ensure that permitting the tobacco
product to be marketed would be appropriate for protection of the
public health; (7) a certification (i.e., a signed statement by a
responsible official of the company) summarizing the supporting
evidence and providing the rationale for the official's determination
that the modification does not increase the tobacco product's appeal to
or use by minors, toxicity, addictiveness, or abuse liability; (8)
other information justifying an exemption; and (9) an environmental
assessment (EA) under part 25 (21 CFR part 25; 42 U.S.C. 4332(2))
prepared in accordance with the requirements of Sec. 25.40 (21 CFR
25.40)).
The National Environmental Policy Act of 1969 (NEPA) (42 U.S.C.
4321-4347) states national environmental objectives and imposes upon
each Federal Agency the duty to consider the environmental effects of
its actions. Section 102(2)(C) of NEPA requires the preparation of an
environmental impact statement for every major Federal action that will
significantly affect the quality of the human environment.
The FDA NEPA regulations are contained in part 25. All applications
for exemption from substantial equivalence require the submission of an
EA. An EA provides information that is used to determine whether an FDA
action could result in a significant environmental impact. Section
25.40(a) and (c) specifies the content requirements for EAs for non-
excluded actions.
The information required by Sec. 1107.1(b) is submitted to FDA so
FDA can determine whether an exemption from substantial equivalence to
the product is appropriate for the protection of the public health.
Section 1107.1(c) states that FDA will review the information submitted
and determine whether to grant or deny an exemption based on whether
the criteria in section 905(j)(3) of the FD&C Act are met. FDA may
request additional information if necessary, to make a determination
and may consider the exemption request withdrawn if the information is
not provided within the requested timeframe.
This collection of information also contains a requirement that a
manufacturer submit a report (referred to as an ``abbreviated report'')
at least 90 days prior to making an introduction or delivery for
introduction into interstate commerce for commercial distribution of a
tobacco product. Section 905(j)(1)(A)(ii) of the FD&C Act states that
if an exemption has been requested and granted, the manufacturer must
submit to FDA a report that demonstrates that the tobacco product is
modified within the meaning of section 905(j)(3), the modifications are
to a product that is commercially marketed and in compliance with the
requirements of the FD&C Act, and all the modifications are covered by
exemptions granted by the Secretary under section 905(j)(3).
Description of Respondents: The respondents to this collection of
information are tobacco product manufacturers defined 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.
Section 1107.1(b) requires that the exemption request and
supporting information be submitted in an electronic format that FDA
can process, review, and archive. The exemption request and supporting
information must be legible and in English. These requirements ensure
that FDA can review the exemption request expeditiously and
appropriately. FDA provides information on its website on how
manufactures may provide electronic submissions and regulatory
correspondence, such as the exemption request and supporting
information, as well as the abbreviated report, to FDA (e.g.,
information on electronic media and methods of transmission). Steps on
how to prepare and the recommended structure of an exemption request
and abbreviated report can be found at: https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/exemption-substantial-equivalence. Information on how to submit exemption requests and
abbreviated reports to the CTP Portal can be found here: https://www.fda.gov/tobacco-products/manufacturing/submit-documents-ctp-portal.
FDA does not anticipate any need to submit an exemption request or
supporting information in a non-electronic format. However, a company
that is not able to submit the documentation in an electronic format
may submit a written request to the Center for Tobacco Products
document control center (https://www.fda.gov/tobacco-products/about-center-tobacco-products-ctp/contact-ctp).
In the Federal Register of February 25, 2022 (87 FR 10797), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One comment responsive to the four
information collection topics solicited was received. The comment
stated that the Agency should consider making the exemption request
pathway (section 905(j)(3) of the FD&C Act) more flexible for new
products, devices, and technology innovations.
FDA appreciates the comment and notes that although we may consider
the comment, these types of actions may necessitate guidance (as noted
in the comment). Currently, we believe that the exemption pathway is
providing applicants an efficient pathway to make additive changes to
their products and receive a marketing order. If the Agency decides to
consider revising the suggested actions, these types of actions would
need to be done pursuant to separate notice and comment procedures.
[[Page 48671]]
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden 1
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section and/or activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Sec. 1107.1(b); Optional 812 1 812 24 19,488
preparation of tobacco product
exemption from substantial
equivalence request; and Sec.
25.40; Preparation of an
environmental assessment.......
Sec. 1107.1(c); Preparation of 150 1 150 3 450
additional information for
tobacco product exemption from
substantial equivalence request
Abbreviated report submitted to 1,217 1 1,217 2 2,434
demonstrate: tobacco product is
modified under section
905(j)(3) of the FD&C Act,
modifications are to a product
that is commercially marketed
and compliant, and
modifications covered by
exemptions granted by Secretary
under section 905(j)(3)........
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 22,372
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA estimates that we will receive 812 exemption requests under
Sec. 1107.1(b) for 24 hours per response including EA for a total of
19,488 hours. Since an EA is required for each Sec. 1107.1(b)
(Optional Preparation of Tobacco Product Exemption From Substantial
Equivalence Request), the burden per response for EAs (12 hours) has
been combined with the 12 hours for an exemption request for a total of
24 hours per response.
FDA further estimates, that we will receive 150 submissions
requiring additional information in support of the initial exemption
request, and it is expected that it will take an average of 3 hours to
prepare the additional information for a total of 450 hours.
FDA estimates that 1,217 respondents will prepare 1,217 responses
and each response will take approximately 2 hours to prepare an
abbreviated report, as required by section 905(j)(1)(A)(ii), for a
total of 2,434 hours. The estimates reflect a decrease of 1,217 hours
to account for a reduction in average response time for preparing an
abbreviated report. FDA provides a recommended format for applicants in
the exemption order letter that significantly reduces the burden hours
for preparing the abbreviated report. Therefore, FDA now estimates that
the hours for the collection of information associated with exemptions
from substantial equivalence requirements total 22,372 hours.
Although there may be year-to-year variability in the absolute
number of exemption requests submitted, FDA considers any trends in our
analysis, and the overall number of extension requests from
manufacturers of tobacco products has remained consistent.
Additionally, although manufacturers of NTN products are now subject to
all of the tobacco product provisions in the FD&C Act, including the
need to submit premarket submissions to FDA and obtain authorization
from the Agency to market their product, FDA expects to receive
premarket tobacco product applications for most currently marketed NTN
products. FDA does not expect to receive many exemption requests for
currently marketed NTN products. Thus, no additional adjustments to the
number of respondents in our burden estimate are needed for NTN
products as the current estimate accounts for some year-to-year
variability in the absolute number of exemption requests submitted.
Dated: August 4, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-17184 Filed 8-9-22; 8:45 am]
BILLING CODE 4164-01-P