Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products, 26121-26123 [2019-11657]
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<![CDATA[
26121
Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Notices
tobacco product may also serve as the
predicate tobacco product in a section
905(j) report (intended to be used
toward demonstrating substantial
equivalence) for a new tobacco product
(section 905(j)(1)A)(i) of the FD&C Act
(21 U.S.C. 387e(j)(1)(A)(i))).
The guidance recommends that the
manufacturer submit information
adequate to demonstrate that the
tobacco product was commercially
marketed in the United States as of
February 15, 2007. Examples of such
information may include, but are not
limited to, the following: dated copies of
advertisements, dated catalog pages,
dated promotional material, and dated
bills of lading.
In the Federal Register of October 17,
2018 (83 FR 52488), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. Two comments were
received; however, they were not PRA
related.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
FD&C Act sections or action
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
(in hours)
Total hours
Submit evidence of commercial marketing in the United
States as of February 15, 2007 .......................................
1,000
1
1,000
5
5,000
jbell on DSK3GLQ082PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA’s estimate of the number of
respondents is based on the fact that
requesting an Agency determination of
the grandfathered status of a tobacco
product under the guidance is not
required and also on the number of
grandfathered submissions received
from 2011 to June 2018. We estimate
submissions have increased due to the
effective date of the deeming rule. FDA
has stated that, for deemed combustible
products that were on the market as of
August 8, 2016, it does not intend to
initiate enforcement for failure to have
premarket authorization until August 8,
2021. FDA has also stated that, for
deemed noncombustible products that
were on the market as of August 8, 2016,
it does not intend to initiate
enforcement for failure to have
premarket authorization until August 8,
2022. Because interested persons are
seeking information on the
grandfathered status of tobacco products
in advance of these dates, FDA expects
a drop in the number of grandfathered
submissions following those dates. The
number of hours to gather the evidence
is FDA’s estimate of how long it might
take a manufacturer to review, gather,
and submit dated information if making
a request for Agency determination.
FDA further estimates it would take a
manufacturer approximately 5 hours to
put together this collection of evidence
and to submit the package to FDA for
review. FDA estimates that it would
take approximately 5,000 hours
annually to respond to this collection of
information.
Our estimated burden for the
information collection reflects an
overall increase of 4,235 hours. We
attribute this adjustment to an updated
number of submissions received
through this approval and the number of
VerDate Sep<11>2014
19:03 Jun 04, 2019
Jkt 247001
submissions expected in the next 3
years.
Dated: May 30, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–11659 Filed 6–4–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0147]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry and Food and Drug
Administration Staff; Section 905(j)
Reports: Demonstrating Substantial
Equivalence for Tobacco Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
(PRA).
DATES: Fax written comments on the
collection of information by July 5,
2019.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
SUMMARY:
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
comments should be identified with the
OMB control number 0910–0673. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, 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:
Guidance for Industry and Food and
Drug Administration Staff; Section
905(j) Reports: Demonstrating
Substantial Equivalence for Tobacco
Products
OMB Control Number 0910–0673—
Extension
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, among other
things, a chapter granting FDA 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 FD&C Act, as amended by the
Tobacco Control Act, generally 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
E:\FR\FM\05JNN1.SGM
05JNN1
26122
Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Notices
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
(section 910 of the FD&C Act).
The Tobacco Control Act also gave
FDA the authority to issue a regulation
deeming all other products that meet the
statutory definition of a tobacco product
to be subject to chapter IX of the FD&C
Act (section 901(b) of the FD&C Act (21
U.S.C. 387a(b))). On May 10, 2016, FDA
issued that rule, extending FDA’s
tobacco product authority to all
products that meet the definition of
tobacco product in the law (except for
accessories of newly regulated tobacco
products), including electronic nicotine
delivery systems, cigars, hookah, pipe
tobacco, nicotine gels, dissolvables that
were not already subject to the FD&C
Act, and other tobacco products that
may be developed in the future (81 FR
28974 at 28976) (‘‘the Deeming final
rule’’).
The FD&C Act authorizes three
premarket pathways for a new tobacco
product to legally enter the market.
Submission of a section 905(j)(1)(A)(i)
report intended to demonstrate
substantial equivalence and, in
response, an order from the Agency
finding that the new tobacco product is
substantially equivalent to a predicate
tobacco product and in compliance with
the requirements of the FD&C Act, is
one pathway. Under section
905(j)(1)(A)(i) of the FD&C Act (21
U.S.C. 387e(j)(1)(A)(i)), a tobacco
product manufacturer must show that a
new tobacco product is substantially
equivalent, within the meaning of
section 910, to a tobacco product
commercially marketed (other than for
test marketing) in the United States as
of February 15, 2007, or to a tobacco
product that the Secretary of Health and
Human Services has previously
determined, under subsection (a)(3) of
section 910, is substantially equivalent
and that it is in compliance with the
requirements of the FD&C Act. The
comparison product chosen by the
tobacco product manufacturer is
referred to by FDA as the predicate
tobacco product.
The guidance document associated
with this collection of information
contains recommendations on preparing
reports intended to demonstrate
substantial equivalence to a predicate
tobacco product as required under
section 905(j)(1)(A)(i) of the FD&C Act.
FDA’s guidance entitled ‘‘Demonstrating
the Substantial Equivalence of a New
Tobacco Product: Responses to
Frequently Asked Questions’’
(December 2016) may be accessed at
https://www.fda.gov/TobaccoProducts/
Labeling/RulesRegulationsGuidance/
default.htm. In that guidance, FDA
recommends that certain modifications
might be addressed in a ‘‘Product
Quantity Change Report,’’ which is a
more streamlined Substantial
Equivalence (SE) Report for certain
modifications that should be easier for
manufacturers to prepare.
In the Federal Register of September
6, 2018 (83 FR 45251), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. FDA received seven
comments that were PRA related.
Commenters noted that the burden
estimates seem low given current
experience and rounds of review by
FDA, but that FDA could reduce the
current burden by increasing
transparency in the SE process by
issuing a rulemaking related to SE.
These comments concerned the burdens
related to the SE program and noted that
lack of a rule related to the SE pathway
has contributed to that burden. In
addition, commenters stated that lack of
clarity on the content of SE Reports,
including the lack of clarity regarding
the information that might be needed
when a new tobacco product has ‘‘same
characteristics’’ or ‘‘different
characteristics,’’ contributes to that
burden.
We believe that recent activities
undertaken by FDA will help address
these concerns and support maintaining
the current estimates, which are
averages of burden across a number of
years. Specifically, in October 2018,
FDA held a public workshop that
provided industry stakeholders with
additional information on SE content
and process (https://www.fda.gov/
TobaccoProducts/NewsEvents/
ucm615443.htm). More recently, FDA
issued a notice of proposed rulemaking
related to the content and format of SE
Reports (84 FR 12740, April 2, 2019),
which would establish the required
content of SE Reports and explain FDA
review practices. This proposed rule
also provides potential approaches to
addressing same characteristics and
different characteristics, along with
examples, and considerations FDA may
evaluate in determining whether
difference(s) in characteristics cause the
new tobacco product to raise different
questions of public health. FDA is
seeking comment on that proposed rule.
In addition, we note that several of
the commenters are cigar industry
stakeholders who indicated that
submissions may be higher for cigar
products than our current estimates
reflect, and we acknowledge that future
collections may be further refined to
reflect changes in numbers of
submissions due to more SE
submissions for cigar products related to
the Deeming final rule.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Total annual
responses
Average
burden per
response
Total hours
Full SE 905(j)(1)(A)(i) and 910(a) ........................................
Full SE 905(j)(1)(A)(i) and 910(a) Bundled .........................
Product Quantity Change SE Report ..................................
Product Quantity Change Bundled SE Report ....................
683
456
239
192
1
1
1
1
683
456
239
192
300
90
87
62
204,900
41,040
20,793
11,904
Total ..............................................................................
........................
........................
........................
........................
278,637
1 There
jbell on DSK3GLQ082PROD with NOTICES
Number of
responses per
respondent
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA’s estimates are based on
experience with SE Reports, initial
updated deemed registration and listing
data, interactions with the industry, and
information related to other regulated
VerDate Sep<11>2014
19:03 Jun 04, 2019
Jkt 247001
products. The estimated number of SE
Reports is expected to increase from an
annual average of 979 to 1,570.
When groups of full or product
quantity change SE Reports have
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
identical content, they may be bundled;
when a group of similar reports are
bundled, the subsequent bundled
reports are expected to take less time to
prepare than the initial report.
E:\FR\FM\05JNN1.SGM
05JNN1
jbell on DSK3GLQ082PROD with NOTICES
Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Notices
FDA has based these estimates on
information it now has available from
interactions with the industry,
information related to other regulated
products, and FDA expectations
regarding the tobacco industry’s use of
the section 905(j) pathway to market
their products. Table 1 describes the
annual reporting burden as a result of
the implementation of the substantial
equivalence requirements of sections
905(j)(1)(A)(i) and 910(a) of the FD&C
Act for an SE application.
FDA estimates that 683 respondents
will prepare and submit 683 section
905(j)(1)(A)(i) SE Reports each year. In
addition, anyone submitting an SE
Report is required to submit an
environmental assessment (EA) under
21 CFR 25.40. The burden for
environmental reports has been
included in the burden per response for
each type of SE report. Based on FDA’s
experience with EAs for currently
regulated tobacco products, we expect
industry to spend 80 hours to prepare
an environmental assessment for a SE
Report. Thus, FDA estimates that it will
take a manufacturer approximately 300
hours per report to prepare an SE Report
and the EA for a new tobacco product,
which is a total of 204,900 hours each
year.
In addition, we estimate receiving 456
Full SE Bundled Reports at 90 hours per
submission for a total of 41,040 hours
each year.
FDA estimates that it will receive 239
Product Quantity Change SE Reports
each year and that it will take a
manufacturer approximately 87 hours to
prepare this report for a total of 20,793
hours. This includes time to prepare the
environmental assessment, which FDA
believes will take less time due to the
typically more limited modification(s)
included in a Product Quantity Change
SE Report. We estimate receiving 192
Product Quantity Change Bundled SE
Reports each year at approximately 62
hours per submission for a total of
11,904 hours; this number excludes the
time for the initial SE Report, which
was previously accounted for.
Therefore, FDA estimates the annual
burden for submission of SE
information will be 278,637 hours. This
is an increase of 106,759 hours from the
currently approved burden. We attribute
this increase to an increase in the
number of SE Reports we expect related
to Deemed products (e.g., based on the
initial registration and listing
information).
VerDate Sep<11>2014
19:03 Jun 04, 2019
Jkt 247001
Dated: May 30, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–11657 Filed 6–4–19; 8:45 am]
BILLING CODE 4164–01–P
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.
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: Fax written comments on the
collection of information by July 5,
2019.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0684. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, 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
OMB Control Number 0910–0684—
Extension
On June 22, 2009, the Family
Smoking Prevention and Tobacco
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
26123
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 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, before the
product may be introduced into
commercial distribution (section 910 of
the FD&C Act (21 U.S.C. 387j)).
The Tobacco Control Act also gave
FDA the authority to issue a regulation
deeming all other products that meet the
statutory definition of a tobacco product
to be subject to Chapter IX of the FD&C
Act (section 901(b) (21 U.S.C. 387a(b))).
On May 10, 2016, FDA issued that rule,
extending FDA’s tobacco product
authority to all products that meet the
definition of tobacco product in the law
(except for accessories of newly
regulated tobacco products), including
electronic nicotine delivery systems,
cigars, hookah, pipe tobacco, nicotine
gels, dissolvables that were not already
subject to the FD&C Act, and other
tobacco products that may be developed
in the future (81 FR 28974 at 28976,
May 10, 2016) (‘‘the final deeming
rule’’)).
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
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.
E:\FR\FM\05JNN1.SGM
05JNN1
]]>Agencies
[Federal Register Volume 84, Number 108 (Wednesday, June 5, 2019)]
[Notices]
[Pages 26121-26123]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11657]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0147]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
and Food and Drug Administration Staff; Section 905(j) Reports:
Demonstrating Substantial Equivalence 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 (PRA).
DATES: Fax written comments on the collection of information by July 5,
2019.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0673.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[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.
Guidance for Industry and Food and Drug Administration Staff; Section
905(j) Reports: Demonstrating Substantial Equivalence for Tobacco
Products
OMB Control Number 0910-0673--Extension
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, among other things, a chapter granting FDA
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 FD&C Act, as amended by the Tobacco Control Act, generally
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
[[Page 26122]]
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 (section 910 of the FD&C Act).
The Tobacco Control Act also gave FDA the authority to issue a
regulation deeming all other products that meet the statutory
definition of a tobacco product to be subject to chapter IX of the FD&C
Act (section 901(b) of the FD&C Act (21 U.S.C. 387a(b))). On May 10,
2016, FDA issued that rule, extending FDA's tobacco product authority
to all products that meet the definition of tobacco product in the law
(except for accessories of newly regulated tobacco products), including
electronic nicotine delivery systems, cigars, hookah, pipe tobacco,
nicotine gels, dissolvables that were not already subject to the FD&C
Act, and other tobacco products that may be developed in the future (81
FR 28974 at 28976) (``the Deeming final rule'').
The FD&C Act authorizes three premarket pathways for a new tobacco
product to legally enter the market. Submission of a section
905(j)(1)(A)(i) report intended to demonstrate substantial equivalence
and, in response, an order from the Agency finding that the new tobacco
product is substantially equivalent to a predicate tobacco product and
in compliance with the requirements of the FD&C Act, is one pathway.
Under section 905(j)(1)(A)(i) of the FD&C Act (21 U.S.C.
387e(j)(1)(A)(i)), a tobacco product manufacturer must show that a new
tobacco product is substantially equivalent, within the meaning of
section 910, to a tobacco product commercially marketed (other than for
test marketing) in the United States as of February 15, 2007, or to a
tobacco product that the Secretary of Health and Human Services has
previously determined, under subsection (a)(3) of section 910, is
substantially equivalent and that it is in compliance with the
requirements of the FD&C Act. The comparison product chosen by the
tobacco product manufacturer is referred to by FDA as the predicate
tobacco product.
The guidance document associated with this collection of
information contains recommendations on preparing reports intended to
demonstrate substantial equivalence to a predicate tobacco product as
required under section 905(j)(1)(A)(i) of the FD&C Act. FDA's guidance
entitled ``Demonstrating the Substantial Equivalence of a New Tobacco
Product: Responses to Frequently Asked Questions'' (December 2016) may
be accessed at https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm. In that guidance, FDA recommends
that certain modifications might be addressed in a ``Product Quantity
Change Report,'' which is a more streamlined Substantial Equivalence
(SE) Report for certain modifications that should be easier for
manufacturers to prepare.
In the Federal Register of September 6, 2018 (83 FR 45251), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received seven comments that were PRA
related. Commenters noted that the burden estimates seem low given
current experience and rounds of review by FDA, but that FDA could
reduce the current burden by increasing transparency in the SE process
by issuing a rulemaking related to SE. These comments concerned the
burdens related to the SE program and noted that lack of a rule related
to the SE pathway has contributed to that burden. In addition,
commenters stated that lack of clarity on the content of SE Reports,
including the lack of clarity regarding the information that might be
needed when a new tobacco product has ``same characteristics'' or
``different characteristics,'' contributes to that burden.
We believe that recent activities undertaken by FDA will help
address these concerns and support maintaining the current estimates,
which are averages of burden across a number of years. Specifically, in
October 2018, FDA held a public workshop that provided industry
stakeholders with additional information on SE content and process
(https://www.fda.gov/TobaccoProducts/NewsEvents/ucm615443.htm). More
recently, FDA issued a notice of proposed rulemaking related to the
content and format of SE Reports (84 FR 12740, April 2, 2019), which
would establish the required content of SE Reports and explain FDA
review practices. This proposed rule also provides potential approaches
to addressing same characteristics and different characteristics, along
with examples, and considerations FDA may evaluate in determining
whether difference(s) in characteristics cause the new tobacco product
to raise different questions of public health. FDA is seeking comment
on that proposed rule.
In addition, we note that several of the commenters are cigar
industry stakeholders who indicated that submissions may be higher for
cigar products than our current estimates reflect, and we acknowledge
that future collections may be further refined to reflect changes in
numbers of submissions due to more SE submissions for cigar products
related to the Deeming final rule.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Activity Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Full SE 905(j)(1)(A)(i) and 683 1 683 300 204,900
910(a).........................
Full SE 905(j)(1)(A)(i) and 456 1 456 90 41,040
910(a) Bundled.................
Product Quantity Change SE 239 1 239 87 20,793
Report.........................
Product Quantity Change Bundled 192 1 192 62 11,904
SE Report......................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 278,637
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
FDA's estimates are based on experience with SE Reports, initial
updated deemed registration and listing data, interactions with the
industry, and information related to other regulated products. The
estimated number of SE Reports is expected to increase from an annual
average of 979 to 1,570.
When groups of full or product quantity change SE Reports have
identical content, they may be bundled; when a group of similar reports
are bundled, the subsequent bundled reports are expected to take less
time to prepare than the initial report.
[[Page 26123]]
FDA has based these estimates on information it now has available
from interactions with the industry, information related to other
regulated products, and FDA expectations regarding the tobacco
industry's use of the section 905(j) pathway to market their products.
Table 1 describes the annual reporting burden as a result of the
implementation of the substantial equivalence requirements of sections
905(j)(1)(A)(i) and 910(a) of the FD&C Act for an SE application.
FDA estimates that 683 respondents will prepare and submit 683
section 905(j)(1)(A)(i) SE Reports each year. In addition, anyone
submitting an SE Report is required to submit an environmental
assessment (EA) under 21 CFR 25.40. The burden for environmental
reports has been included in the burden per response for each type of
SE report. Based on FDA's experience with EAs for currently regulated
tobacco products, we expect industry to spend 80 hours to prepare an
environmental assessment for a SE Report. Thus, FDA estimates that it
will take a manufacturer approximately 300 hours per report to prepare
an SE Report and the EA for a new tobacco product, which is a total of
204,900 hours each year.
In addition, we estimate receiving 456 Full SE Bundled Reports at
90 hours per submission for a total of 41,040 hours each year.
FDA estimates that it will receive 239 Product Quantity Change SE
Reports each year and that it will take a manufacturer approximately 87
hours to prepare this report for a total of 20,793 hours. This includes
time to prepare the environmental assessment, which FDA believes will
take less time due to the typically more limited modification(s)
included in a Product Quantity Change SE Report. We estimate receiving
192 Product Quantity Change Bundled SE Reports each year at
approximately 62 hours per submission for a total of 11,904 hours; this
number excludes the time for the initial SE Report, which was
previously accounted for.
Therefore, FDA estimates the annual burden for submission of SE
information will be 278,637 hours. This is an increase of 106,759 hours
from the currently approved burden. We attribute this increase to an
increase in the number of SE Reports we expect related to Deemed
products (e.g., based on the initial registration and listing
information).
Dated: May 30, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-11657 Filed 6-4-19; 8:45 am]
BILLING CODE 4164-01-P
