and its implementing regulations.\16\ These products include cigars,
pipe tobacco, waterpipe tobacco, ENDS (including e-cigarettes), and
other novel tobacco products such as certain dissolvable products and
gels. These products further include components and parts of the newly
deemed products, including pipes, e-liquids, atomizers, batteries,
cartomizers (atomizer plus replaceable fluid-filled cartridge), tank
systems, flavors for e-liquids, vials that contain e-liquids,
programmable software, flavor enhancers for waterpipe tobacco,
waterpipe cooling attachments, water

filtration base additives, flavored waterpipe tobacco charcoals, and
waterpipe bowls, valves, hoses, and heads.
---------------------------------------------------------------------------

    \16\ As stated in section 201(rr) of the Federal Food, Drug, and
Cosmetic Act in relevant part, a tobacco product: (1) Means any
product made or derived from tobacco that is intended for human
consumption, including any component, part, or accessory of a
tobacco product (except for raw materials other than tobacco used in
manufacturing a component, part, or accessory of a tobacco product);
and (2) Does not mean an article that is a drug under section
201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321(g)(1)), a device under section 201(h) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321(h)), or a combination product
described in section 503(g) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 353(g)).
---------------------------------------------------------------------------

    The final deeming action differs from most public health
regulations in that it is an enabling regulation. In addition to
directly applying the substantive requirements of chapter IX of the
FD&C Act and its implementing regulations to newly deemed tobacco
products, it enables FDA to issue further regulations related to such
products that are appropriate for the protection of the public health.
We expect that asserting our authority over these tobacco products will
enable us to propose further regulatory action in the future as
appropriate, and those actions will have their own costs and benefits.
Without deeming these products to be subject to the FD&C Act, FDA would
lack the authority to require manufacturers to provide, for example,
vital ingredient and health information about them. We would also lack
the authority to take regulatory action with respect to them, if we
determined it was appropriate to do so.
    The direct benefits of making each of the newly deemed tobacco
products subject to the requirements of chapter IX of the FD&C Act are
difficult to quantify, and we cannot predict the size of these benefits
at this time. Among other effects, new products will be subject to an
evaluation to ensure they meet the appropriate public health standard
for the pathway before they can be marketed, labeling cannot contain
misleading statements, and FDA will be made aware of the ingredients in
newly deemed tobacco products. If, without the final rule, new products
would pose substantially greater health risks than those already on the
market, the premarket requirements made effective by this final rule
would keep such products from appearing on the market and worsening the
health effects of tobacco product use. The warning statements required
by this final rule will help consumers better understand and appreciate
the risks and characteristics of tobacco products.
    The final rule as a whole will impose costs in the form of
registration, submission, and labeling requirements. Manufacturers of
newly deemed products, as well as some manufacturers of currently
regulated products, will need to comply with the warning label
provisions, which will impose additional costs, including costs for
signs with warnings at point-of-sale for cigars sold singly without
packaging. There will be potential costs for removing non-compliant
point-of-sale advertising and complying with vending machine
restrictions.
    The primary estimate for the present value of total quantified
costs over 20 years is approximately $988 million at a 3 percent
discount rate and $817 million at a 7 percent discount rate. The
quantified costs of the final rule can also be expressed as annualized
values, as shown in table 1. Unquantified costs which may be
attributable to this final rule include: Some consumer costs for users
of the newly deemed products due to loss of product variety or higher
prices; recordkeeping costs for exporters of deemed tobacco products;
compliance costs for components and parts other than complete pipes,
waterpipes, and ENDS delivery systems; the cost of testing and
reporting for HPHCs; the cost of any clinical testing that may
potentially be conducted to support SE reports; market adjustment
(friction) costs and lost producer surplus associated with product
consolidation, exit of manufacturers, and the switch to pure retailing
among retailers such as vape shops who currently engage in
manufacturing activities.

                                             Table 5--Summary of Quantified Costs Over 20 Years ($ million)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            Lower bound                     Upper bound     Lower bound                     Upper bound
                                                               (3%)        Primary  (3%)       (3%)            (7%)        Primary  (7%)       (7%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Present Value of Private Sector Costs...................           517.7           783.7         1,109.8           450.4           670.9           939.8
Present Value of Government Costs \1\...................           204.6           204.6           204.6           145.7           145.7           145.7
Present Value of Total Costs............................           722.3           988.2         1,314.4           596.1           816.5         1,085.4
Annualized Value of Private Sector Costs................            34.8            52.7            74.6            42.5            63.3            88.7
Annualized Value of Government Costs \1\................            13.8            13.8            13.8            13.8            13.8            13.8
Annualized Value of Total Costs.........................            48.5            66.4            88.3            56.3            77.1           102.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ FDA costs represent an opportunity cost, but this rule will not result in changes to overall FDA accounting costs, the size of the federal budget,
  or the total amount of tobacco industry user fees.

    Because it is not possible to compare benefits and costs directly
when the benefits are not quantified, we employ a breakeven approach.
For the reasons provided elsewhere in this preamble and in the analysis
of impacts, FDA has concluded that the benefits of the final rule
justify the costs.
    In addition to the benefits and costs of this final rule, we assess
the benefits and costs of four different approaches. These approaches
consist of regulatory alternatives (i.e., alternatives to the rule) as
well as enforcement options (i.e., periods of time during which FDA
does not intend to enforce certain requirements). First, we assess the
regulatory alternative of exempting premium cigars from regulation.
Second, we assess two hybrid regulatory alternatives/enforcement
options of providing either a 36-month or 12-month compliance period
for labeling changes. Lastly, we assess the enforcement option of not
extending the premarket review compliance policy to new flavored
tobacco products (other than tobacco flavored products).\17\ For the
sake of simplicity only, we have referred to these four approaches as
``alternatives to the rule.''
---------------------------------------------------------------------------

    \17\ Throughout the final RIA, any reference to ``flavored
tobacco products'' means flavored products other than tobacco
flavor.
---------------------------------------------------------------------------

    In addition to the above alternatives, comments discussed changing
the grandfather date as an alternative. FDA has decided not to include
this option in the analysis of alternatives because we determined that
the Agency lacks the authority to change the grandfather date.
    Primary estimates of the costs of the regulatory alternatives
appear as present values and annualized values in table 6.

   Table 6--Primary Estimate of Quantified Costs for Regulatory Alternatives (Present and Annualized Values, $
                                                  million) \1\
----------------------------------------------------------------------------------------------------------------
                                                   Present value   Present value    Annualized      Annualized
                   Alternative                         (3%)            (7%)         value  (3%)     value  (7%)
----------------------------------------------------------------------------------------------------------------
1--Exempt Premium Cigars from Regulation........             959             794              64              75
2a--36-month compliance period for labeling                  968             797              65              75
 changes........................................
Final Rule and Compliance Period................             988             817              66              77
2b--12-month compliance period for labeling                1,043             871              70              82
 changes........................................
3--Do not extend the premarket review compliance           1,141             961              77              91
 policy to new flavored tobacco products........
----------------------------------------------------------------------------------------------------------------
\1\ Nonquantified benefits are described in the text.

    In addition to the social costs described in this document, the
final rule would lead to distributional effects, such as: Reduced
revenues for firms in affected sectors, payment of user fees, and
potential changes in tax revenues.
    Domestic tobacco product manufacturers, tobacco product importers,
and vape shops are the businesses primarily affected by this rule; most
of these businesses are small. We focus the quantitative analysis of
small entities on manufacturers and importers of cigars and ENDS
products. We note that most pipe tobacco and waterpipe tobacco
manufacturers and importers are also small, and we expect the impact on
them to be similar to the impact on cigar manufacturers and importers.
Even though user fees are a transfer payment and not a societal cost,
they are a cost from the standpoint of the cigar and pipe manufacturers
who must pay them under this final rule and have been included in the
estimated burden for cigar manufacturers and importers. Estimated costs
per cigar manufacturer or importer are $278,000 to $397,000 in the
first year, $292,000 to $411,000 in the second year, and $235,000 to
$257,000 in the third year. (The inclusion of user fees in these
estimates will cause costs to be overstated for manufactures and
importers who also manufacture currently regulated products. In
addition, costs will vary by firm size as user fees are based on market
share). Estimated costs per ENDS manufacturer or importer are $827,000
to $1.21 million in the first year, $832,000 to $1.21 million in the
second year, and $22,000 to $64,000 in subsequent years. Although we do
not quantitatively examine the financial effects on vape shops, we
expect the proportion of vape shops that mix e-liquids may fall during
the initial compliance policy period for submission and FDA receipt of
PMTAs. After this initial compliance policy period, we expect that most
vape shops will continue to operate but those that have not already
switched pure retailing will likely do so. Regulatory alternatives that
would reduce costs are analyzed as potential regulatory relief options
for small businesses.
    The Economic Analysis of Impacts of the final rule performed in
accordance with Executive Order 12866, Executive Order 13563, the
Regulatory Flexibility Act, and the Unfunded Mandates Reform Act is
available at http://www.regulations.gov under the docket number(s) for
this final rule (Ref. 204) and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

XIX. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). The
title, description, and respondent description of the information
collection provisions are shown in the following paragraphs with an
estimate of the annual reporting and recordkeeping burden. Included in
the estimate is the time for reviewing instructions, searching existing
data sources, gathering and maintaining the data needed, and completing
and reviewing each collection of information.
    Title: Deeming Tobacco Products To Be Subject to the Federal Food,
Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and
Tobacco Control Act; Restrictions on the Sale and Distribution of
Tobacco Products and Required Warning Statements for Tobacco Products.
    Description: On June 22, 2009, the President signed the Tobacco
Control Act into law. In this rule, the Agency is extending FDA's
``tobacco product'' authorities in the FD&C Act to all other categories
of products meeting the statutory definition of ``tobacco product'' in
section 201(rr) of the FD&C Act, excluding accessories of deemed
tobacco products. (Two options were presented in the NPRM. Under Option
1, all products meeting the definition of a ``tobacco product,'' except
accessories of newly deemed tobacco products, would be deemed. Option 2
was the same as Option 1, except a subset of cigars known as ``premium
cigars'' would be excluded. After thorough review of the comments and
the scientific evidence, FDA has concluded that Option 1 more
effectively protects the public health and therefore has made that the
scope of the final rule.) The rule also prohibits the sale of covered
tobacco products to individuals under the age of 18 and prohibits the
sale of covered tobacco products using the assistance of any retail-
based electronic or mechanical device (such as a vending machine)
except in facilities where the retailer ensures that no person younger
than 18 years of age is present, or permitted to enter, at any time.
The requirement that a retailer sell covered tobacco products in only a
direct, face-to-face exchange without the assistance of electronic or
mechanical devices is not intended to prevent the sale of tobacco
products via the Internet, but the sale of covered tobacco products via
any medium (including the Internet) must only be to persons 18 years of
age or older.
    The rule also provides that manufacturers, distributors, importers,
and retailers are responsible for ensuring that the covered tobacco
products (in addition to cigarettes and smokeless tobacco) they
manufacture, label, advertise, package, distribute, import, sell, or
otherwise hold for sale comply with all applicable requirements.
    In addition, elsewhere in this issue of the Federal Register, FDA
has made available a final guidance to provide information on how to
establish and reference a Tobacco Product Master File (TPMF). TPMFs are
expected to reduce the burden on applicants preparing premarket and
other regulatory submissions because they can reference information in
TPMFs rather than develop the information on their own.

Currently, FDA does allow for the submission and use of information to
be incorporated by reference similar to master file programs for other
FDA-regulated products.

A. Responses to Comments Regarding Proposed Collection of Information

1. Whether the Proposed Collection of Information Is Necessary for the
Proper Performance of FDA's Functions, Including Whether the
Information Will Have Practical Utility
    (Comment 279) We received several comments regarding the practical
utility of the information to be collected by FDA under the proposed
regulations. The main concern among comments was that some of the
requirements impose significant administrative burdens without
generating useful information. Also, the comments believed that FDA is
predicting that the paperwork burden will force almost all of the e-
cigarette products to come off the market because manufacturers will go
out of business.
    (Response) FDA's regulation of the newly deemed products and the
information the Agency is seeking will benefit the public health. As
FDA discussed in the NPRM, deeming all tobacco products to be subject
to chapter IX of the FD&C Act will provide FDA with critical
information regarding the health risks of the products. FDA has not
received any data indicating that regulation ``will destroy almost all
of the e-cigarette products on the market.'' We also note that FDA is
announcing a compliance policy for small-scale tobacco product
manufacturers, offering them targeted relief to address concerns that
small manufacturers may need additional time to comply with certain
requirements of the deeming rule, as discussed in section IV.D. This
compliance policy will provide small-scale tobacco product
manufacturers (i.e., those manufacturers with 150 employees or fewer
and $5,000,000 or less in annual revenues) with additional time to
submit ingredient listing information (under section 904(a)(1)) and
health documents (under section 904(a)(4)). This policy also provides
that, for the first 30 months following the effective date of the rule,
small-scale tobacco product manufacturers may receive extensions of
time for providing responses to SE deficiency letters.
    (Comment 280) One comment stated that FDA's proposed regulation is
unnecessary and does not address any valid need in society. It also
stated that the PRA should set limits on regulations that do not
provide significant return to the U.S. population. Another comment
asked that FDA not stifle advertisements, nor saddle the industry with
unnecessary testing and reporting standards that stifle innovation and
increase costs.
    (Response) FDA disagrees with comments suggesting that FDA's rule
will have such effects on industry or the nation. FDA finds that
deeming tobacco products and applying the automatic provisions of the
FD&C Act in accordance with this final rule will result in significant
public health benefits and that the additional restrictions imposed by
this rule are appropriate for the protection of the public health. For
example, benefits that will arise as a result of deeming ENDS,
including FDA review of premarket submissions/applications for new
tobacco products in the United States pursuant to sections 905 and 910
of the FD&C Act, which will result in increased product consistency.
FDA expects to receive premarket submissions/applications from ENDS
manufacturers that will allow the Agency to determine whether a new
product is substantially equivalent to a valid predicate product,
exempt from SE., or appropriate for the protection of the public
health.
2. Accuracy of FDA's Estimate of the Burden of the Proposed Collection
of Information, Including the Validity of the Methodology and
Assumptions Used
    (Comment 281) Many comments argued that their products could be
driven from the market due to the paperwork reporting requirements and
FDA's authorization process. The comments claimed that many companies
(particularly e-cigarette companies) lack experience or the systems in
place to comply with the NPRM and that the premarket requirements would
discourage the development of new products. They also said that
requirements like labeling and registration would be unfeasible for
small producers lacking the experience of navigating this regulatory
environment.
    (Response) FDA expects that the greater regulatory certainty
created by the premarket review process will help companies to invest
in creating novel products that benefit the health of the population as
a whole, with greater confidence that the improved products in which
they have invested will enter the market without having to compete
against equally novel products that do not have to meet the same basic
requirements. We also note that FDA is announcing a compliance policy
for small-scale tobacco product manufacturers, offering them targeted
relief in certain areas to address concerns that small manufacturers
may need additional time to comply with certain requirements of the
FD&C Act, as discussed in section IV.D. This compliance policy will
provide small-scale tobacco product manufacturers (i.e., those
manufacturers with 150 employees or fewer and $5,000,000 or less in
annual revenues) with additional time to submit ingredient listing
information (under section 904(a)(1)) and health documents (under
section 904(a)(4)). This policy also provides that, for the first 30
months following the effective date of the rule, small-scale tobacco
product manufacturers may receive extensions of time for providing
responses to SE deficiency letters.
    (Comment 282) Several comments stated that the PMTA process imposes
a number of burdens on manufacturers, the most onerous burden being the
requirement for scientific investigations.
    (Response) In the NPRM (79 FR 23142 at 23176), FDA included
discussion intended to supplement and clarify the requirement for
scientific investigations. As we noted, FDA expects that, in some
cases, it will be possible for an applicant to obtain a PMTA marketing
order without conducting new nonclinical or clinical studies where
there is an established body of evidence regarding the public health
impact of the product. Therefore, FDA believes that certain categories
of PMTAs may not require significant financial and administrative
resources associated with clinical investigations. Elsewhere in this
issue of the Federal Register, FDA is announcing the availability of a
draft guidance, which when final will provide the Agency's current
thinking regarding some appropriate means of addressing the premarket
authorization requirements for newly deemed ENDS products, including
the need for ``clinical studies'' for the purposes of preparing PMTAs
for ENDS. In addition, elsewhere in this issue of the Federal Register,
FDA has made available a final guidance to provide information on how
to establish and reference a Tobacco Product Master File. TPMFs are
expected to reduce the burden on applicants preparing premarket and
other regulatory submissions.
    We also note that FDA is announcing an enforcement policy for
small-scale tobacco product manufacturers, offering them targeted
relief in certain areas to address concerns that smaller manufacturers
may have, as discussed in section IV.D. This compliance policy will
provide small-scale tobacco product manufacturers (i.e., those
manufacturers with 150 employees or

fewer and $5,000,000 or less in annual revenues) with additional time
to submit ingredient listing information (under section 904(a)(1)) and
health documents (under section 904(a)(4)). This policy also provides
that, for the first 30 months following the effective date of the rule,
small-scale tobacco product manufacturers may receive extensions of
time for providing responses to SE deficiency letters.
    (Comment 283) Several comments expressed concern that FDA failed to
provide any data on the number or type of e-cigarette businesses
currently operating in the United States. According to the comments,
there are at least 1,250 businesses. Other comments estimated that
there are 14,000 to 16,000 e-cigarette retail outlets in the United
States. They stated that these small manufacturing entities will not be
able to participate in the PMTA process and most will go out of
business.
    (Response) At the time of the NPRM, FDA did not have precise
estimates for ENDS products. Now that we have more data, the Agency is
estimating the numbers for ENDS liquids and delivery systems elsewhere
in the PRA section. As stated previously, FDA believes the TPMF process
will help companies as they can reference information in TPMFs rather
than develop the information on their own. Additionally, the
enforcement policy for small-scale tobacco product manufacturers will
assist small manufacturers. This compliance policy will provide small-
scale tobacco product manufacturers (i.e., those manufacturers with 150
employees or fewer and $5,000,000 or less in annual revenues) with
additional time to submit ingredient reporting (under sections 904 and
915) and health documents (under section 904). This policy also
provides that small-scale tobacco product manufacturers may receive
extensions of time for providing responses to SE deficiency letters.
    (Comment 284) Some comments noted that the NPRM made it appear that
FDA would not allow any SE reports to be submitted for e-cigarette
products, as there were only about a half dozen first generation e-
cigarette products that were sold in the United States in February 2007
(the grandfather date), and those products are not substantially
equivalent to any of today's products. Comments stated that applicants
would then need to submit PMTAs and estimated that each PMTA would cost
a successful applicant between $3 and $20 million.
    (Response) The FD&C Act provides three pathways for obtaining FDA
authorization to market a new tobacco product. Where a new product does
not meet the requirements for SE exemption under section 905(j)(3) and
does not have an appropriate predicate under section 905(j)(1)(A)(i) or
is otherwise unable make a showing supporting a finding of SE., the
manufacturer of the new product must submit a PMTA. As FDA stated in
the NPRM, the Agency expects that some applicants may not need to
engage in resource-intensive clinical investigations and provide long-
term data to prepare and submit a complete PMTA. In addition, elsewhere
in this issue of the Federal Register, FDA has made available draft
guidance, which when final will describe FDA's current thinking
regarding some appropriate means of addressing the premarket
authorization requirements for newly deemed ENDS products, including
the need for clinical studies for the purposes of preparing PMTAs for
ENDS.
    (Comment 285) Several comments argued that FDA has greatly
underestimated the total number of e-liquid products that are on the
market. According to one comment, there are nearly 1,700 e-cigarette
and e-liquid businesses on record, which does not include the many
companies that manufacture hardware components used in ARPVs. One
comment stated that a recent study found that greater than 34,000
different e-liquid products alone were sold on the Internet (i.e. 7,764
unique brand flavors averaging 4.4 different nicotine levels per brand)
not including different vegetable glycerin/propylene glycol water
levels or components in 466 identified different e-cigarette brands.
Several comments estimated that there are 5,000 to 15,000 e-liquid
producers and e-cigarette retail establishments in the United States.
Other comments projected that there are at least 100,000 e-cigarette
products currently on the market.
    Similarly, some commenters felt that FDA grossly underestimated the
number of responses for certain proposed information collections. For
example, they noted that the NPRM states that FDA expects only 25 new
product applications from e-cigarette manufacturers. They claimed that
FDA has either miscalculated the number of distinct brands and types of
e-cigarettes on the market, or the Agency expects most manufacturers to
exit the market rather than submit product applications.
    (Response) We have revised our estimates to reflect the most recent
information available at the time of drafting this final analysis. FDA
estimates the average number of vape shops that meet the definition of
a manufacturer are 4,250. FDA also estimates that there will be 186
other manufacturers and 14 importers of ENDS products.
    (Comment 286) Many comments said that FDA's estimates of the
burdens imposed by the rule's information collection requirements are
understated. Specifically, they stated that the Agency's estimates of
the number of respondents in the category of ``other tobacco, e-
cigarettes, and nicotine product manufacturers,'' as well as the number
of products on the market manufactured by these companies, were off by
orders of magnitude.
    (Response) Based on the comments and other evidence, FDA estimates
there will be 186 manufacturers of ENDS products. Regarding the number
of products, the number will depend on what type of submission is being
sent to FDA. The burden charts in this section detail the current
estimates FDA believes to be accurate.
    (Comment 287) Some comments indicated that FDA equates the time and
financial burden of preparing a PMTA with an SE application, but the
PMTA requirements are significantly more burdensome than SE
requirements, and it is completely unreasonable to allocate the same
amount of man-hours needed to successfully complete a PMTA and an SE
application.
    (Response) The Agency has revised the estimated burden per PMTA
response to an average of 1,500 hours to complete a PMTA. In reaching
this average, FDA considered efficiencies achieved through manufacturer
experience, application overlap, economies of scale, incorporation of
evidence by reference, and other means including availability of the SE
FAQ guidance. Based on this information, FDA believes an SE submission
will take considerably less time and money. If the manufacturer is
unable to show that its product is substantially equivalent to a
predicate product or that its product is exempt from SE., then the
manufacturer must submit a PMTA. The requirements of a PMTA may vary
based on the type and complexity of the product.
    (Comment 288) One comment said that FDA erred in its estimate of
the in-house cost burdens imposed by the proposed information
collections. The comment said internal costs can only be excluded when
estimating the burden of an information collection if such costs are
related to ``usual and customary'' activities. In this case, the
comment believed FDA did not consider the types of internal costs that
will be incurred by companies to comply with the information
collections.
    (Response) FDA disagrees with this comment. The Agency was thorough
in

its identification of usual and customary activities. The Agency used
various existing data sources and considered all the costs associated
with the collections of information. In reaching this average cost, FDA
considered efficiencies achieved through manufacturer experience,
application overlap, economies of scale, incorporation of evidence by
reference, and other means.
    (Comment 289) A few comments stated that most of the cost burden
created by paperwork requirements will fall upon consumers, as hundreds
of thousands of American consumers would lose access to what the
comments state are ``low-risk products'' that have allowed consumers to
quit smoking. They said FDA should take into consideration small
business and consumer stakeholders' suggested alternatives to minimize
the NPRM's potential impact.
    (Response) FDA disagrees with these comments. This final rule will
prevent new products from entering the market that are not appropriate
for the protection of the public health, are not substantially
equivalent to a valid predicate product, or are not exempt from SE. We
also note that FDA is announcing a compliance policy for small-scale
tobacco product manufacturers, offering them targeted relief in certain
areas to address concerns that smaller manufacturers may need
additional time to comply with certain requirements of the FD&C Act, as
discussed in section IV.D. This compliance policy will provide small-
scale tobacco product manufacturers (i.e., those manufacturers with 150
employees or fewer and $5,000,000 or less in annual revenues) with
additional time to submit ingredient listing information (under section
904(a)(1)) and health documents (under section 904(a)(4)). This policy
also provides that, for the first 30 months following the effective
date of the rule, small-scale tobacco product manufacturers may receive
extensions of time for providing responses to SE deficiency letters.
    (Comment 290) Several comments stated that FDA significantly
underestimated the burden on the tobacco industry. The Agency estimated
that 13,745 products will be affected by the NPRM and almost 90 percent
of them were cigars and pipe tobacco. They noted that FDA estimated
that up to 7,869 products will submit SE reports within the first 24
months after the rule is finalized, which they believed was very low,
especially given the February 15, 2007, grandfather date.
    (Response) FDA used available public information to estimate the
burden on the tobacco industry and the comments did not provide
empirical evidence of a different number of affected products. However,
based on experience with currently regulated products and changes in
the industry we have revised the burden accordingly. The Agency also
finds that these comments have not provided evidence as to why the
grandfather date will cause applicants to submit more SE applications
than FDA estimated.
    (Comment 291) One comment argued that FDA has greatly
underestimated the number of premium cigar products that will be
subject to premarket review. According to the comment, premium cigar
makers are distinct from other tobacco product manufacturers in the
number of products they market and the volume of those lines. This
comment stated that the average number of cigars produced for any given
product in a year is 32,655, with 33.6 percent of reported annual
production rates at or below 10,000 units.
    Several other comments argued that the typical premium cigar
manufacturer may have over 100 unique stock keeping units (SKUs) and
typically will turn over about 15 percent of those SKUs in any given
year. Their data indicates there are at least 10,000 and maybe as many
as 20,000 unique SKUs in the United States, which would add to FDA's
workload for evaluating new product applications. They also estimated
that the premium hand-rolled cigar category alone could generate
numbers in excess of 10,000 new product applications.
    Other comments stated that the premarket application process will
be costly and time consuming for cigar manufacturers and will likely
result in many different kinds of newly deemed tobacco products being
removed from the marketplace. The constant variation in the cigar
tobacco used to make premium cigars will create significant regulatory
burdens and costs for cigar manufacturers to be constantly submitting
premarket applications. Comments stated that cigar manufacturers that
are unable to bear the cost of applications will cease bringing new
products to the marketplace.
    The comments expressed similar concerns regarding e-cigarettes,
stating that each e-cigarette manufacturer would need to submit a PMTA
for every brand of e-cigarette currently being sold and new e-
cigarettes introduced into the marketplace. Small manufacturers may not
have the financial resources to submit PMTAs, which will result in the
removal of e-cigarettes from the marketplace. The end result of the
PMTA process will be a significant negative impact on small businesses.
    (Response) The FD&C Act provides for three marketing pathways for
new tobacco products--SE to a valid predicate product, exemption from
SE., and PMTA. If the manufacturer is unable to show that its product
is substantially equivalent to a valid predicate product or that its
product is exempt from SE., then the firm must submit a PMTA. The
requirements and costs of a PMTA may vary based on the type and
complexity of the product. For example, where there is limited
understanding of a product's potential impact on public health, several
nonclinical and clinical studies may be required for market
authorization. In such case, the requirements and cost of the PMTA
likely would be higher than for a product in which there is already
substantial scientific data on the potential public health impact.
    (Comment 292) Many comments noted that FDA included a small number
of PMTAs for e-cigarette products in its analysis. Some comments stated
that if this is the case, FDA's estimates would probably include only a
fraction of the products that are believed to be used to stop smoking
cigarettes. They commented that the cost burdens of the paperwork
requirements will result in an unnecessary price increase for the
consumer and the PMTA requirements will limit the availability of e-
cigarettes to addicted smokers trying to quit. Their concern is the
burden of the paperwork would fall on both merchants and consumers.
    (Response) FDA disagrees with these comments. The Agency's
intention is not to impose additional costs to consumers but, instead,
to prevent new products from entering the market that are not
appropriate for the protection of the public health, are not
substantially equivalent to a predicate product, or are not exempt from
SE. Per Agency experience and updates in the industry, FDA has updated
the number of ENDS products we estimate will submit a PMTA.
    (Comment 293) Some comments disagreed with FDA's estimate that it
expects only one ``other tobacco, e-cigarette and nicotine product
manufacturers'' respondent to submit an annual health and toxicological
report and its estimate that there would only be one respondent to
self-certify that its product does not contain nicotine. They stated
that there may be hundreds of e-liquid manufacturers self-certifying
for use of the alternative statement, because it is standard industry
practice to offer 0 milligram nicotine flavors in vials.

    (Response) At this time, we do not have sufficient evidence to
warrant revising the burden estimates.
    (Comment 294) Many comments stated that FDA's estimates do not
reflect the realities of the market and FDA's estimates assume that
most of these small companies will be forced to exit the industry
because of the high compliance and paperwork burdens envisioned by the
NPRM. However, others believed that as the market evolves, many
companies will continue to operate and comply with FDA's regulations.
    Further, many other comments stated that, at best, FDA's estimate
that there are only 140 to 188 potential respondents in the category of
``other tobacco, e-cigarettes, and nicotine product manufacturers'' is
``egregiously off target'' based on the available evidence. They
believed that the entire industry will be eliminated as a result of the
regulatory and paperwork burdens in the NPRM. They also noted that the
reason for the difference between 140 and 188 in the Analysis of
Impacts and PRA sections is unclear.
    (Response) There is a high level of uncertainty in the number of
manufacturers of ENDS. FDA is required to estimate burden as part of
the PRA analysis. As many comments describe, the industry is ever
changing; during the time that the NPRM was in review, and since the
NPRM was published, the ENDS industry has grown. The comments on the
number of ENDS manufacturers provided industry estimates rather than
concrete data sources. In the case of non-retail manufacturers, the
comment did not always specify whether the cited numbers included both
domestic and foreign manufacturers, or only domestic manufactures.
Therefore, considerable uncertainty remains as to the number of
domestic non-retail manufacturers. Similarly, the comments did not
address the number of non-retail importers. In the Regulatory Impact
Analysis (RIA) for this final rule, based on logo counts from trade
association Web sites and FDA listening sessions, it is estimated that
there are 168 to 204 formal manufacturers of ENDS products (not
including ENDS retail establishments that meet the definition of a
manufacturer). For the PRA analysis, we took the average for a total of
186 manufacturers. We also estimate that there are 14 importers of ENDS
products.
    (Comment 295) Many comments stated that it would not be possible to
complete a PMTA within 24 months after the effective date of the final
rule and that it is an insufficient amount of time for manufacturers to
conduct any required clinical studies in support of a PMTA.
    (Response) As stated throughout this document, FDA is providing a
24-month compliance period for manufacturers to submit (and for FDA to
receive) a PMTA. If manufacturers submit the appropriate applications
during this compliance period, FDA will not enforce against those
manufacturers continuing to market their products without FDA
authorization for a certain time period. For products using the PMTA
pathway, this compliance period closes 36 months after the effective
date. Once the continued compliance period ends, FDA intends to
actively monitor and enforce the premarket authorization requirements
regarding products on the market without authorization even if the
respective submission is still under review. As noted previously, FDA
expects that, in some cases, it will be possible for an applicant to
obtain a PMTA order without conducting any new nonclinical or clinical
studies where there is an established body of evidence regarding the
public health impact of the product. Therefore, FDA believes that many
PMTAs may not require significant administrative resources associated
with clinical investigations.
    (Comment 296) Several comments noted that if FDA requires health
documents from manufacturers and importers of newly deemed tobacco
products, the Agency should establish a similar production timeline as
it did for currently regulated products (i.e., cigarettes, cigarette
tobacco, smokeless tobacco, and roll-your-own tobacco) and only require
production of health documents developed during the 6-month period
following the effective date of the regulation.
    (Response) As stated in the compliance date tables, the compliance
period for manufacturers of products currently on the market to submit
health documents is 6 months after the effective date of the final
rule. Manufacturers of products entering the market after the effective
date of the final rule must comply within 90 days before delivery of
the product for introduction into interstate commerce. With this final
rule, FDA also is announcing that it will extend the compliance period
for an additional 6 months from the effective date to allow small-scale
tobacco product manufacturers time to organize, compile, and digitize
documents. Additionally, as stated elsewhere, FDA generally does not
intend to take enforcement action regarding the submission of all such
documents at this time so long as a specified set of documents are
submitted by [the effective date plus 6 months]. FDA will publish
additional guidance that specifies the scope of such documents with
sufficient advance time for manufacturers and importers to prepare
their submissions.
    (Comment 297) Some comments stated that FDA has underestimated the
number of other tobacco product manufacturers that will submit the
required health documents.
    (Response) FDA based this burden estimate on the existing
collection that applies to tobacco products currently subject to the
FD&C Act and FDA experience. The comments did not provide a basis or an
estimate of other tobacco product manufacturers for FDA to utilize in
its review, and the Agency is not aware of any information that
warrants changing this estimate. We note that at this time, FDA intends
to limit enforcement to finished tobacco products. A finished tobacco
product refers to a tobacco product, including all components and
parts, sealed in final packaging intended for consumer use (e.g.,
filters, filter tubes, e-cigarettes, or e-liquids sold separately to
consumers or as part of kits). FDA does not at this time intend to
enforce this requirement for components and parts of newly deemed
products that are sold or distributed solely for further manufacturing
into finished tobacco products. However, any component or part of a
newly deemed tobacco product that is sold directly to consumers as a
``finished tobacco product'' will be required to comply with the
premarket review requirements discussed throughout this document.
    (Comment 298) Some comments stated that e-liquid companies should
be allowed to amend their ingredient lists if they add or remove
ingredients or increase the maximum concentration of any of their
current ingredients in any of their products, rather than submit a new
ingredient list for the new product.
    (Response) Ingredient listings contain important data that enable
FDA to gain better understanding of the contents of regulated products.
This information will assist FDA in assessing potential health risks
and determining if future regulations to address these health risks are
warranted. In addition, when an e-liquid manufacturer adds or removes
ingredients from a product, it becomes a ``new tobacco product.''
    (Comment 299) Several comments disagreed with FDA's proposed
premarket review burdens for pipe tobacco manufacturers. At least one
comment indicated that FDA's proposed estimate that it will receive
only one

new product application for pipe tobacco products grossly
underestimates the number of brands of pipe tobacco that have entered
the market since 2007 or indicates that the Agency expects all but one
manufacturer to voluntarily stop production of new pipe tobacco
products without submitting an SE report or PTMA application. In
addition, the comments stated that pipe tobacco manufacturers will
incur cost and time burdens if they are required to submit PMTAs for
each new blend of pipe tobacco that they manufacture, including
millions of dollars per year in research to prepare the PMTAs.
    (Response) At this time, FDA finds there is insufficient evidence
to increase the burden estimates. FDA believes that pipe tobacco
manufacturers will utilize the SE and SE exemption pathways. We believe
they are manufactured similarly with few, if any, modifications and
many of the ingredients and suppliers are the same as those utilized in
previous years.
    (Comment 300) Several comments pointed out inconsistencies between
the PRA and Analysis of Impacts sections in the NPRM. They noted that
the Analysis of Impacts clearly states that FDA does not have an
estimate of e-cigarette entities that would register with FDA. If FDA
could not estimate the number of affected entities in the Analysis of
Impacts, they believed this should also be reflected in the PRA
section. In addition, they stated that the estimated number of PMTAs
(25) in the PRA section contradicts the number of estimated PMTAs in
the Analysis of Impacts.
    (Response) The RIA and PRA analyses are conducted to fulfill
different purposes and must adhere to different requirements; as a
result, the two analyses would rarely, if ever, be the same. For
example, the time horizons for the analyses are typically different.
Information collections are approved for a up to a 3-year period and
are reanalyzed every time they are up for extension, whereas a
prospective RIA is conducted before a rule is issued using a time
horizon chosen to capture the most important effects of the rule
(generally 20 years). If estimates differ from year to year, the RIA
will often explicitly identify how the estimates vary, whereas the PRA
analysis will most often use an average or the estimate for the current
year. Regulatory impact analyses also tend to make more frequent use of
ranges rather than point estimates.
    As referenced previously, there is a high level of uncertainty in
the number of manufacturers for ENDS. In the RIA for this final rule,
based on logo counts from trade association Web sites and FDA listening
sessions, it is estimated that there are 168 to 204 formal
manufacturers of ENDS products. For the PRA analysis, we took the
average of 168 and 204 for a total of 186 manufacturers. We also
estimate that there are 14 importers of ENDS products.
    (Comment 301) A number of comments also noted that FDA should be
required to estimate and report the full social costs of eliminating
what they considered to be beneficial products from the market where
the manufacturers are unable to afford the PMTA costs.
    (Response) FDA is not aware of any evidence indicating that such
social costs will accrue. Nevertheless, such estimates are outside the
scope of the PRA analysis.
3. Ways To Enhance the Quality, Utility, and Clarity of the Information
To Be Collected
    (Comment 302) One comment stated that FDA has not consulted with
industry nor has the Agency audited industry recordkeeping to support
the assumption that manufacturers have enough information to prepare SE
reports.
    (Response) FDA's proposed burden estimates are based on information
available at the time of preparing the NPRM. If interested parties have
evidence that warrants revising these burden estimates, they were
requested to submit such evidence during the comment period for FDA to
take into account when preparing final burden estimates.
    (Comment 303) One comment recommended that the Office of
Information and Regulatory Affairs (OIRA) should void the proposed
regulations as they relate to e-cigarettes, that OIRA and FDA should
urge Congress to work with FDA to create a new regulatory framework for
e-cigarettes, and, at the very least, that OIRA require that FDA
prepare new estimates of the paperwork burdens.
    (Response) FDA disagrees with this comment. FDA has estimated the
PRA burdens with the best evidence that is currently available. In
addition, as stated in the NPRM and throughout this final rule, the
deeming provisions are beneficial to the public health and the
additional provisions are appropriate for the protection of the public
health.
4. Ways To Minimize the Burden of the Collection of Information on
Respondents, Including Through the Use of Automated Collection
Techniques, When Appropriate, and Other Forms of Information Technology
    (Comment 304) One comment asserted that, under the PRA, a review of
regulations should include an attempt to ensure that the paperwork is
not unduly burdensome. The comment also stated that FDA appears to be
ignoring the greatest cost of the paperwork burden (i.e., most
manufacturers will find the paperwork burden to be so great that they
will abandon products or their entire businesses without attempting to
comply with the requirements). They argued that FDA should follow the
requirements as stated in the PRA and limit data collection to
information that is useful and dependable.
    (Response) FDA disagrees with this comment. FDA has faithfully
complied with the all aspects of the PRA and any other applications
laws and regulations.

B. Existing Burdens Associated With Tobacco Products Currently Subject
to the FD&C Act (i.e., Cigarettes, Cigarette Tobacco, Roll-Your-Own
Tobacco, and Smokeless Tobacco) With Approved OMB Control Numbers

    The information collection requirements referenced in this section
are amending currently approved information collections. Once the rule
is finalized, the associated collections of information will be
submitted to OMB for approval as revisions to the currently approved
information collections. After submission to OMB, the revised
collections and associated documents can be viewed at OMB's public Web
site (http://www.reginfo.gov).
    The burden estimates found in this section include existing
collections that have been approved by OMB and cover tobacco products
that are currently subject to the FD&C Act (i.e., cigarettes, cigarette
tobacco, roll-your-own tobacco, and smokeless tobacco). In developing
the burden estimates for newly deemed tobacco products, FDA based the
estimates on the existing collections that currently cover cigarettes,
cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.
1. Tobacco Product Establishment Registration and Submission of Certain
Health Information (OMB Control Number 0910-0650)
    Description of Respondents: The respondents to this collection of
information are manufacturers or importers, or agents thereof, of new
and currently regulated tobacco products

who are required to make submissions to FDA under section 904 of the
FD&C Act, including the submission of an initial list of all
ingredients in their tobacco products and the submission of information
whenever additives or their quantities are changed. The respondents to
this collection are also persons engaged in the manufacture,
preparation, compounding, or processing of a tobacco product or tobacco
products who must register their establishments and submit a list of
all tobacco products being manufactured, prepared, compounded, or
processed by that person for commercial distribution at the time of
registration under section 905 of the FD&C Act.
    Section 101 of the Tobacco Control Act amended the FD&C Act by
adding sections 905 and 904. Section 905(b) of the FD&C Act requires
that every person who owns or operates any establishment in any State
engaged in the manufacture, preparation, compounding, or processing of
a tobacco product or tobacco products register with FDA the name,
places of business, and all establishments owned or operated by that
person. Section 905(i)(1) of the FD&C Act requires that all
registrants, at the time of registration, must submit to FDA a list of
all tobacco products that are being manufactured, prepared, compounded,
or processed by that person for commercial distribution, along with
certain accompanying consumer information and other labeling for such
products and a representative sampling of advertisements.
    If an ENDS retail establishment engages in these activities, it
will be required to register and list their products with FDA. These
requirements apply under the statute for all distinct products
manufactured, and they enable FDA to assess the landscape of products
manufactured by these entities. If ENDS retail establishments are
custom mixing e-liquids and/or other ENDS products or components, then
they will have to list each combination that they sell. For such
establishments to continue to engage in mixing after this rule becomes
effective, they would need to satisfy the requirements for
manufacturers and the premarket authorization of new tobacco products
as a result of this final rule. We note, however, that FDA does not
intend to enforce the premarket authorization requirements during
staggered compliance periods following the effective date, as stated
previously in this preamble to this rule.
    Section 904(a)(1) of the FD&C Act requires each tobacco product
manufacturer or importer, or agent thereof, to submit a listing of all
ingredients, including tobacco, substances, compounds, and additives
that are added by the manufacturer to the tobacco, paper, filter, or
other part of each tobacco product by brand and by quantity in each
brand and subbrand. Section 904(c) of the FD&C Act also requires
submission of information whenever additives or their quantities are
changed.
    As previously referenced in section IV, for small-scale tobacco
product manufacturers, FDA is providing a one-time allowance of an
additional 6 months after the effective date of this final rule for
initial reporting of ingredients. This regulatory relief is only for
small-scale tobacco product manufacturers.
    FDA issued guidance documents on both (1) Registration and Product
Listing for Owners and Operators of Domestic Tobacco Product
Establishments (74 FR 58298, November 12, 2009) and (2) Listing of
Ingredients in Tobacco Products (74 FR 62795, December 1, 2009) to
assist persons making these submissions to FDA under the FD&C Act.
Although electronic submission of registration, product listing, and
ingredient listing information are not required, FDA strongly
encourages electronic submission to facilitate efficiency and
timeliness of data management and collection. To that end, FDA designed
the eSubmitter application, and then the FDA FURLS, to streamline the
data entry process for registration, product listing, and ingredient
listing. This tool allows for importation of large quantities of
structured data, attachments of files (e.g., in PDFs and certain media
files), and automatic acknowledgement of FDA's receipt of submissions.
FDA also developed paper forms (Form FDA 3741--Registration and Listing
for Owners and Operators of Domestic Tobacco Product Establishments and
Form FDA 3742--Listing of Ingredients in Tobacco Products) as
alternative submission tools. Both the FURLS and the paper forms can be
accessed at http://www.fda.gov/tobacco. FDA estimates the additional
annual burden for the information collection as a result of this rule
as follows:

                                                     Table 7--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
                  Activity                       Number of     responses per   Total annual     Average burden per response  (in hours)     Total hours
                                                respondents   respondent \2\     responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
                            Tobacco Product Establishment Initial First Year Registration (electronic and paper submission):
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cigar Entities (Including Large and Small,               221               1             221  2.........................................             442
 and Importers).
Pipe and Waterpipe Tobacco Entities                       96               1              96  2.........................................             192
 (Including Importers (22)).
Other Tobacco, E-Cigarettes, and Nicotine                193               1             193  2.........................................             386
 Product Entities and ENDS Products
 Importers (7) \3\.
Vape shops that qualify as manufacturers \4\           4,250               1           4,250  2.........................................           8,500
                                             -----------------------------------------------------------------------------------------------------------
    Total Tobacco Product Establishment       ..............  ..............  ..............  ..........................................           9,520
     Initial First Year Registration.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                 Tobacco Product Establishment Recurring Registration (electronic and paper submission):
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cigar Entities (Including Large and Small,               221               1             221  0.20 (12 minutes).........................              44
 and Importers).
Pipe and Waterpipe Tobacco Entities                       96               1              96  0.20 (12 minutes).........................              19
 (Including Importers (22)).
Other Tobacco, E-Cigarettes, and Nicotine                193               1             193  0.20 (12 minutes).........................              39
 Product Entities and ENDS Products
 Importers (7) \3\.

Vape shops that qualify as manufacturers \4\           4,250               1           4,250  0.20 (12 minutes).........................             850
                                             -----------------------------------------------------------------------------------------------------------
Total Tobacco Product Establishment           ..............  ..............  ..............  ..........................................             952
 Recurring Registration.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                      Tobacco Product Listing Initial First Year (electronic and paper submission):
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cigar Entities (Including Large and Small,               221               1             221  2.........................................             442
 and Importers).
Pipe and Waterpipe Tobacco Entities                       96               1              96  2.........................................             192
 (Including Importers (22)).
Other Tobacco, E-Cigarettes, and Nicotine                193               1             193  2.........................................             386
 Product Entities and ENDS Products
 Importers (7)) \3\.
Vape shops that qualify as manufacturers \4\           4,250               1           4,250  2.........................................           8,500
                                             -----------------------------------------------------------------------------------------------------------
    Total Hours Tobacco Product Listing       ..............  ..............  ..............  ..........................................           9,520
     Initial First Year.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                          Tobacco Product Listing Recurring (electronic and paper submission):
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cigar Entities (Including Large and Small,               221               2             442  0.40 (24 minutes).........................             177
 and Importers).
Pipe and Waterpipe Tobacco Entities                       96               2             192  0.40 (24 minutes).........................              77
 (Including Importers (22)).
Other Tobacco, E-Cigarettes, and Nicotine                193               2             386  0.40 (24 minutes).........................             154
 Product Entities and ENDS Products
 Importers (7) \3\.
Vape shops that qualify as manufacturers \4\           4,250               2           8,500  0.40 (24 minutes).........................           3,400
                                             -----------------------------------------------------------------------------------------------------------
    Total Hours Tobacco Product Listing       ..............  ..............  ..............  ..........................................           3,808
     Recurring.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                      Obtaining a Dun and Bradstreet (DUNS) Number:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cigar Entities (Including Large and Small,               221               1             221  0.5 (30 minutes)..........................             111
 and Importers).
Pipe and Waterpipe Tobacco Entities                       96               1              96  0.5 (30 minutes)..........................              48
 (Including Importers (22)).
Other Tobacco, E-Cigarettes, and Nicotine                193               1             193  0.5 (30 minutes)..........................              97
 Product Entities and ENDS Products
 Importers (7) \3\.
Vape shops that qualify as manufacturers \4\           4,250               1           4,250  0.5 (30 minutes)..........................           2,125
                                             -----------------------------------------------------------------------------------------------------------
    Total Hours Obtaining DUNS Number.......  ..............  ..............  ..............  ..........................................           2,381
                                             -----------------------------------------------------------------------------------------------------------
        Total Hours Registration, Product     ..............  ..............  ..............  ..........................................          26,181
         Listing, and DUNS Number.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                          Tobacco Product Ingredient Listing (electronic and paper submission):
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cigar Entities (Including Large and Small,               329            5.38           1,770  3.........................................           5,310
 and Importers).
Pipe and Waterpipe Tobacco Entities                      117           20.62           2,413  3.........................................           7,239
 (Including Importers (43)).
Other Tobacco, E-Cigarettes, and Nicotine                200           11.40           2,280  3.........................................           6,840
 Product Entities and ENDS Products
 Importers (7) \3\.
Vape shops that qualify as manufacturers \4\           4,250           11.73          49,853  1.........................................          49,853
                                             -----------------------------------------------------------------------------------------------------------
    Total Hours Submitting Product            ..............  ..............  ..............  ..........................................          69,242
     Ingredient Listing.
                                             -----------------------------------------------------------------------------------------------------------
        Total Burden Tobacco Product          ..............  ..............  ..............  ..........................................         121,604
         Establishment Registration and
         Submission of Certain Health
         Information.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ This number is estimated to be the total annual responses divided by the number of respondents, rounded to the nearest tenth.
\3\ Importers are included throughout this Table 7 to the extent that they engage in the manufacture, preparation, compounding, or processing of tobacco
  products, which includes repackaging or otherwise changing the container, wrapper, or labeling of any tobacco product package in furtherance of the
  distribution of the tobacco product from the original place of manufacturer to the person who makes final delivery or sale to the ultimate consumer or
  use.
\4\ FDA assumes that vape shops will register and list only during the first two years after the rule becomes effective.

    Based on aggregate information obtained from the TTB, in 2013 there
were 113 domestic manufacturers of cigars, 216 importers of cigars, 74
manufacturers of pipe (including waterpipe) tobacco, and 43 importers
of pipe (including waterpipe) tobacco who will be required to register
under section 905 of the FD&C Act. For the purposes of this analysis,
FDA estimates that the majority of the 4,250 vape shops that qualify as
manufacturers will only register and list in the first two years after
the rule becomes effective. In addition, FDA estimates that 186 ENDS
manufacturers will be required to register under section 905 of the
FD&C Act.
    Product listing information is provided at the time of
registration. Currently, registration and listing requirements only
apply to domestic establishments engaged in the manufacture,
preparation, compounding, or processing of a tobacco product. This
includes importers to the extent that they engage in the manufacture,
preparation, compounding, or processing of a tobacco product, including
repackaging or otherwise changing the container, wrapper, or labeling
of any tobacco product package.\18\ Foreign establishments are not
required to register and list until FDA issues regulations establishing
such requirements in accordance with section 905(h) of the FD&C Act. To
account for the foregoing, we include both domestic manufacturing
establishments and importers in our estimates. Specifically, for the
PRA analysis, we have used the midpoint between TTB permit counts for
manufacturers and permit counts for manufacturers and importers as a
likely overestimate of the number of entities that need to comply with
registration and product listing (The Analysis of Impacts includes
importers in the upper bound.)
---------------------------------------------------------------------------

    \18\ Under the Internal Revenue Code, the manufacture,
preparation, compounding, or processing of a tobacco product may
require a permit as a manufacturer of tobacco products. As we
understand TTB's permitting requirements, entities lacking a
manufacturer permit, including importers, may not engage in any of
the listed activities, including repackaging tobacco products after
such products are released from customs custody. It is unclear
whether TTB would require a manufacturer permit for all activities
for which FDA would determine the entity must register and list;
because there may be some entities with import permits for which FDA
would conclude registration is necessary, FDA includes those numbers
as part of its upper-bound estimate of affected entities.
---------------------------------------------------------------------------

    The PRA burden estimates have been updated to fully incorporate the
use of an electronic system known as FURLs for submitting registration
and product listing information to FDA. With the FURLs system,
manufacturers can enter information quickly and easily. For example,
product label pictures can be uploaded directly and we anticipate that
most, if not all companies, already have electronic versions of their
labels for printing, sales, or marketing purposes. We anticipate that
initial entity registration will take 2 hours and initial product
listing will take an additional 2 hours per entity.
    FDA estimates that the initial first year submission of
registration information required by section 905 of the FD&C Act will
take 2 hours per establishment, with a total of 4,760 establishments
that will be required to register under this rule, for a total of 9,520
hours (4,760 x 2).
    The estimate for the number of product listing submissions for
cigars is derived by using product counts from two retail Web sites:
http://www.cigarsinternational.com/ and http://www.pipesandcigars.com/.
These two large Internet retailers had larger product offerings than
other sites reviewed and sell both mass-market and specialty products.
Estimates of product formulations and product-package combinations for
cigars are centered over the product counts from the two Web sites. To
derive the product listing count for pipe tobacco, we count the
products on a Web site with a broad product offering, http://www.pipesandcigars.com/. We estimate formulations with the number of
the product names and product-packages with the number of product-
package combinations. FDA derives the product listing estimate for ENDS
products by consulting experts at FDA's CTP who cataloged the ENDS
products currently available on five Web sites and in scanner data from
Nielsen. FDA estimates that the initial first year submission of
product listing information required by section 905 of the FD&C Act
will take 2 hours per submission for 4,760 submissions/annual responses
for a total of 9,520 hours.
    Once information is entered into FURLs, the twice yearly
confirmation of annual registration and product listing updates is
simplified as all information previously entered is maintained in the
system. Therefore, we expect the recurring burden of subsequent years
for updating registration and product listing information will take 1
hour annually per establishment (12 minutes for registration and 48
minutes for product listing). The total hours are 4,760 (952 updating
registration and 3,808 product listing).
    FDA estimates that obtaining a DUNS number will take 30 minutes.
FDA assumes that all the establishment facilities that will be required
to register under section 905 of the FD&C Act would obtain a DUNS
number, with a total of 4,760 establishments that would need to obtain
this number. The total burden to obtain a DUNS number is 26,181 hours.
    FDA estimates that the submission of ingredient listing information
as required by section 904 of the FD&C Act will take 3 hours per
tobacco product based on the estimates found in the existing
collection. The Agency estimates that approximately 56,316 ingredient
listings/annual responses will be submitted annually based on the
methodology used for estimating the number of product listing
submissions described in this section. The total ingredient listing
reporting is 69,242 hours. FDA estimates that the total burden for
tobacco product establishment registration and ingredient listing
reporting is 121,604 hours.
2. Tobacco Health Document Submission (OMB Control Number 0910-0654)
    Description of Respondents: Respondents to this collection of
information are tobacco product manufacturers or, importers, or agents
thereof, who will submit all documents to FDA developed after June 22,
2009, that relate to health, toxicological, behavioral, or physiologic
effects of current or future tobacco products. As stated elsewhere,
however, FDA generally does not intend to take enforcement action
regarding the submission of all such documents at this time so long as
a specified set of documents are submitted by [the effective date plus
6 months]. FDA will publish additional guidance that specifies the
scope of documents that manufacturers and importers will be required to
submit by [the effective date plus 6 month], with sufficient advance
time for manufacturers and importers to prepare their submissions.
    Section 904(a)(4) of the FD&C Act requires each tobacco product
manufacturer or importer, or agent thereof, to submit all documents to
FDA developed after June 22, 2009, that relate to health,
toxicological, behavioral, or physiologic effects of current or future
tobacco products, their constituents (including smoke constituents),
ingredients, components, and additives (tobacco health documents). To
address concerns of certain small businesses relating to the tobacco
health documents requirement, FDA is extending the compliance period
for small-scale tobacco product

manufacturers for an additional 6 months following the end of the
generally applicable compliance period to allow submitters time to
organize, compile, and digitize documents.
    FDA is collecting the information submitted under section 904(a)(4)
of the FD&C Act through an electronic portal and through a paper form
(Form FDA 3743) for those individuals who choose not to use the
electronic portal.
    FDA estimates the additional annual burden for the information
collection as a result of this rule as follows:

                                 Table 8--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                                                Average
                                     Number of       Number of     Total annual     burden per
            Activity                respondents    responses per     responses     response  (in    Total hours
                                                    respondent                        hours)
----------------------------------------------------------------------------------------------------------------
Cigar Manufacturers (Including                 2               4               8              50             400
 Large and Small)...............
Pipe and Waterpipe Tobacco                     1               4               4              50             200
 Manufacturers..................
Other Tobacco, E-Cigarettes, and               1               4               4              50             200
 Nicotine Product Manufacturers
 ENDS...........................
Importers of Cigars and Pipe                   1               4               4              50             200
 Tobacco Who Are Considered
 Manufacturers..................
Importers of Other Tobacco, E-                 1               4               4              50             200
 Cigarettes, and Nicotine
 Product Manufacturers ENDS.....
                                 -------------------------------------------------------------------------------
    Total Hours Health Document   ..............  ..............  ..............  ..............           1,200
     Submission.................
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA estimates that a tobacco health document submission for cigars,
pipe and waterpipe tobacco, other tobacco, tobacco importers, and
importers of ENDS required by section 904(a)(4) of the FD&C Act, will
take approximately 50 hours per submission based on the existing
collection that applies to tobacco products currently subject to the
FD&C Act and FDA experience. To derive the number of respondents for
this provision, FDA assumes that very few manufacturers or importers,
or agents thereof, would have health documents to submit. Therefore,
the Agency estimates that approximately six submissions (two for cigar
manufacturers, one for pipe and waterpipe tobacco manufacturers, one
for other tobacco product manufacturers, and one for tobacco importers,
and one for importers of ENDS who are considered manufacturers) will be
submitted on an annual basis. FDA estimates the total number of hours
is 1,200 hours (6 submissions multiplied by 4 times per year multiplied
by 50 average burden hours).
3. Exemptions From Substantial Equivalence Requirements (OMB Control
Number 0910-0684)
    Description of Respondents: Respondents to this collection of
information are manufacturers of deemed tobacco products who are
requesting an exemption from the SE requirements of the FD&C Act.
    In a final rule that published on July 5, 2011, FDA established
procedures for manufacturers to request exemptions from the SE
requirements of the Tobacco Control Act (SE exemptions final rule). The
SE exemptions final rule was issued under section 905(j)(3) of the FD&C
Act, which provides that FDA may exempt from the requirements relating
to the demonstration of SE tobacco products that are modified by adding
or deleting a tobacco additive, or increasing or decreasing the
quantity of an existing tobacco additive, if FDA determines that: (1)
Such modification would be a minor modification of a tobacco product
that can be sold under the FD&C Act, (2) a report is not necessary to
ensure that permitting the tobacco product to be marketed would be
appropriate for protection of the public health, and (3) an exemption
is otherwise appropriate.
    The exemption request may be made only by the manufacturer of a
legally marketed tobacco product for a minor modification to that
manufacturer's product, and the request (and supporting information)
must be submitted in an electronic format that FDA can process, review,
and archive. In addition, the request and all supporting information
must be legible and in (or translated into) the English language.
    An exemption request must be submitted with supporting
documentation and contain:
     The manufacturer's address and contact information;
     identification of the tobacco product(s);
     a detailed explanation of the purpose for the
modification;
     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 an
existing tobacco additive;
     a detailed explanation of why the modification is a minor
modification of a tobacco product that can be sold under the FD&C Act;
     a detailed explanation of why a report under section
905(j)(1)(A)(i) intended to demonstrate SE is not necessary to ensure
that permitting the tobacco product to be marketed would be appropriate
for the protection of the public health;
     a certification summarizing the supporting evidence and
providing the rationale for why the modification does not increase the
tobacco products appeal to or use by minors, toxicity, addictiveness,
or abuse liability;
     other information justifying an exemption; and
     an environmental assessment under part 25 (21 CFR part 25)
prepared in accordance with Sec.  25.40.
    This information will enable FDA to determine whether the exemption
request is appropriate for the protection of the public health. There
is also a procedural mechanism for rescinding an exemption if FDA finds
the exemption is not appropriate for the protection of the public
health. In general, FDA will rescind an exemption only after providing
the manufacturer notice of the rescission and an opportunity for an
informal hearing under part 16 (21 CFR part 16). However, FDA may
rescind an exemption prior to notice and opportunity for a hearing
under part 16 if the continuance of the exemption presents a serious
risk to public health. In that case, FDA would provide the manufacturer
an opportunity for a

hearing as soon as possible after the rescission.
    FDA reviews the information submitted in support of the request and
determines whether to grant or deny the request based on whether the
criteria specified in the statute are satisfied. FDA may request
additional information from the manufacturer if necessary to make the
determination. If the manufacturer fails to respond within the
timeframe requested, FDA will consider the exemption request withdrawn.
    FDA estimates the additional annual burden for the information
collection as a result of this rule as follows:

    Table 9--Estimated Annual Reporting Burden (When Manufacturers Choose to Seek Exemption From Substantial
                                                Equivalence) \1\
----------------------------------------------------------------------------------------------------------------
                                                                                Average
                                     Number of       Number of     Total annual     burden per
   21 CFR Section and activity      respondents    responses per     responses     response (in     Total hours
                                                  respondent \2\                      hours)
----------------------------------------------------------------------------------------------------------------
     Sec.   1107.1(b) Optional Preparation of Tobacco Product Exemption From Substantial Equivalence Request
                        Including Sec.   25.40 Preparation of an Environmental Assessment
----------------------------------------------------------------------------------------------------------------
Cigar Manufacturers (Including               196               1             196              24           4,704
 Large, Small, and Importers)...
Pipe and Waterpipe Tobacco                   105               1             105              24           2,520
 Manufacturers (Including
 Importers).....................
Other Tobacco, E-Cigarettes, and              18               1              18              24             432
 Nicotine Product Manufacturers
 (ENDS and Delivery Systems
 (Including Importers)).........
                                 -------------------------------------------------------------------------------
    Total Hours (Sec.             ..............  ..............  ..............  ..............           7,656
     1107.1(b)).................
----------------------------------------------------------------------------------------------------------------
      Sec.   1107.1(c) Preparation of Additional Information for Tobacco Product Exemption From Substantial
                                              Equivalence Request:
----------------------------------------------------------------------------------------------------------------
Cigar Manufacturers (Including                59               1              59               3             177
 Large, Small, and Importers)...
Pipe and Waterpipe Tobacco                    32               1              32               3              96
 Manufacturers (Including
 Importers).....................
Other Tobacco, E-Cigarettes, and               3               1               3               3               9
 Nicotine Product Manufacturers
 (ENDS and Delivery Systems
 (Including Importers)).........
                                 -------------------------------------------------------------------------------
    Total Hours (Sec.             ..............  ..............  ..............  ..............             282
     1107.1(c)).................
----------------------------------------------------------------------------------------------------------------
 Section 905(j)(1)(A)(ii) of the FD&C Act: If exemption granted, report submitted to demonstrate tobacco product
is modified under section 905(j)(3), modifications are to a product that is commercially marketed and compliant,
              and modifications covered by exemptions granted by Secretary under section 905(j)(3):
----------------------------------------------------------------------------------------------------------------
Cigar Manufacturers (Including               293               1             293               3             879
 Large, Small, and Importers)...
Pipe and Waterpipe Tobacco                   156               1             156               3             468
 Manufacturers (including
 importers).....................
Other Tobacco, E-Cigarettes, and              26               1              26               3              78
 Nicotine Product Manufacturers
 (ENDS and Delivery Systems
 (Including Importers)).........
                                 -------------------------------------------------------------------------------
    Total Hours (section          ..............  ..............  ..............  ..............           1,425
     905(j)(1)(A)(ii))..........
----------------------------------------------------------------------------------------------------------------
        Total Hours Exemptions    ..............  ..............  ..............  ..............           9,363
         From Substantial
         Equivalence
         Requirements...........
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ This number is estimated to be the total annual responses divided by the number of respondents, rounded to
  the nearest hundredth.

    The estimated average burden per response (in hours) is based on
the burdens associated with the existing information collection that
applies to tobacco products currently subject to the FD&C Act (i.e.,
cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless
tobacco). FDA estimates that we will receive 319 exemption requests
under Sec.  1107.1(b) for 24 hours per response including EA for a
total of 7,656 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 SE request for a total of 24
hours.
    FDA estimates, based on the existing information collection that
applies to tobacco products currently subject to the FD&C Act, we will
receive 94 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
282 hours.
    FDA estimates that 475 respondents will prepare 475 responses and
each response will take approximately 3 hours to prepare, as required
by section 905(j)(1)(A)(ii), for a total of 1,425 hours. This
collection of information requires a manufacturer to submit a 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 of the modifications are
covered by exemptions granted by the Secretary pursuant to section
905(j)(3). FDA estimated the total hours for exemptions from
Substantial Equivalence Requirements would be 9,363 hours.
    FDA's estimates are based on full analysis of economic impacts
(Ref. 204) and information gathered from other FDA-regulated products.
4. Reports Intended To Demonstrate the Substantial Equivalence of a New
Tobacco Product (OMB Control Number 0910-0673)
    Description of Respondents: Respondents to this collection of
information are manufacturers of deemed tobacco products who seek to
submit a report to FDA demonstrating that a tobacco product is
substantially equivalent to a valid predicate product under section
905(j)(1)(A)(i) of the FD&C Act.
    Section 905(j)(1) of the FD&C Act authorizes FDA to establish the
form and manner of the submission. FDA issued guidance intended to
assist persons submitting reports under section 905(j) of the FD&C Act
and to explain, among other things, FDA's interpretation of the
statutory sections related to SE (see the Guidance for Industry and FDA
Staff entitled ``Section 905(j) Reports: Demonstrating Substantial
Equivalence for Tobacco Products'' (76 FR 789, January 6, 2011)).
    Under the recently issued guidance, which published in the Federal
Register of September 8, 2015, entitled, ``Demonstrating the
Substantial Equivalence of a New Tobacco Product: Responses to
Frequently Asked Questions'' (Edition 2), FDA is recommending that
certain modifications might be addressed in either a ``Same
Characteristics SE Report'' or ``Product Quantity Change Report.'' In
some circumstances manufacturers may be able to submit a shorter SE
report. In particular, if a tobacco product is distinct (e.g., it has a
different name), but has the same characteristics as a valid predicate
product, manufacturers may submit a Same Characteristics SE Report. If
the only change to the tobacco product is a change to product quantity,
and the per-weight composition inside the package remains identical,
the manufacturer may submit a Product Quantity Change SE Report. FDA's
CTP estimates that it will take less time to prepare those shorter SE
reports.
    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.
    FDA recognizes that many manufacturers of newly deemed products may
be at the inception of their businesses. Therefore, FDA is announcing
that the Agency may grant extension requests made by small-scale
tobacco product manufacturers for SE Reports that need additional time
to respond to deficiency letters for the first 30 months following the
effective date of this rule.
    FDA estimates the additional annual burden for the information
collection as a result of this rule as follows:

                                 Table 10--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                                                Average
                                     Number of       Number of     Total annual     burden per
            Activity                respondents    responses per     responses     response (in     Total hours
                                                  respondent \2\                      hours)
----------------------------------------------------------------------------------------------------------------
         Full SE Initial Sections 905(j)(1)(A)(i) and 910(a) and Sec.   25.40 Environmental Assessments:
----------------------------------------------------------------------------------------------------------------
Cigar Manufacturers (Including               168               1             168             300          50,400
 Large, Small, and Importers)...
Pipe and Waterpipe Tobacco                   151               1             151             300          45,300
 Manufacturers (Including
 Importers).....................
Other Tobacco, E-Cigarettes, and              16               1              16             300           4,800
 Nicotine Product Manufacturers
 (ENDS and Delivery Systems
 (Including Importers)).........
                                 -------------------------------------------------------------------------------
    Total Hours (sections         ..............  ..............  ..............  ..............         100,500
     905(j)(1)(A)(i) and 910(a))
----------------------------------------------------------------------------------------------------------------
             Full SE Bundled 905(j)(1)(A)(i) and 910(a) and Sec.   25.40 Environmental Assessments:
----------------------------------------------------------------------------------------------------------------
Cigar Manufacturers (Including               151               1             151              90          13,590
 Large, Small, and Importers)...
Pipe and Water Tobacco                        83               1              83              90           7,470
 Manufacturers (Including
 Importers).....................
Other Tobacco, E-Cigarettes, and              16               1              16              90           1,440
 Nicotine Product Manufacturers
 (ENDS and Delivery Systems
 (Including Importers)).........
                                 -------------------------------------------------------------------------------
    Total Hours.................  ..............  ..............  ..............  ..............          22,500
----------------------------------------------------------------------------------------------------------------
                   Same Characteristics SE Report and Sec.   25.40 Environmental Assessments:
----------------------------------------------------------------------------------------------------------------
Cigar Manufacturers (Including               285               1             285              47          13,395
 Large, Small, and Importers)...
Pipe and Waterpipe Tobacco                   132               1             132              47           6,204
 Manufacturers (Including
 Importers).....................
Other Tobacco, E-Cigarettes, and               1               1               1              47              47
 Nicotine Product Manufacturers
 (ENDS and Delivery systems
 (Including Importers)).........
                                 -------------------------------------------------------------------------------

    Total Same Characteristics..  ..............  ..............  ..............  ..............          19,646
----------------------------------------------------------------------------------------------------------------
                   Product Quantity Change Initial and Sec.   25.40 Environmental Assessments:
----------------------------------------------------------------------------------------------------------------
Cigar Manufacturers (Including               108               1             108              87           9,396
 Large, Small, and Importers)...
Pipe and Waterpipe Tobacco                    30               1              30              87           2,610
 Manufacturers (Including
 Importers).....................
Other Tobacco, E-Cigarettes, and               1               1               1              87              87
 Nicotine Product Manufacturers
 (ENDS and Delivery systems
 (Including Importers)).........
                                 -------------------------------------------------------------------------------
    Total Product Quantity        ..............  ..............  ..............  ..............          12,093
     Change Initial.............
----------------------------------------------------------------------------------------------------------------
                   Product Quantity Change Bundled and Sec.   25.40 Environmental Assessments:
----------------------------------------------------------------------------------------------------------------
Cigar Manufacturers (Including                42               1              42              62           2,604
 Large, Small, and Importers)...
Pipe and Waterpipe Tobacco                    12               1              12              62             744
 Manufacturers (Including
 Importers).....................
Other Tobacco, E-Cigarettes, and               1               1               1              62              62
 Nicotine Product Manufacturers
 (ENDS and Delivery systems
 (Including Importers)).........
                                 -------------------------------------------------------------------------------
    Total Product Quantity        ..............  ..............  ..............  ..............           3,410
     Change.....................
                                 -------------------------------------------------------------------------------
        Total Hours (``Reports    ..............  ..............  ..............  ..............         158,149
         Intended to Demonstrate
         the Substantial
         Equivalence of a New
         Tobacco Product'').....
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ This number is estimated to be the total annual responses divided by the number of respondents, rounded to
  the nearest hundredth.

    FDA has based these estimates on the full analysis of economic
impacts (Ref. 204) and experience with the existing information
collection that applies to tobacco products currently subject to the
FD&C Act (i.e., cigarettes, cigarette tobacco, roll-your-own tobacco,
and smokeless tobacco). In addition, anyone submitting an SE report is
required to submit an environmental assessment under Sec.  25.40.
    The burden for environmental reports has been included in the
burden per response for each type of SE report.
    FDA estimates that 335 respondents will prepare and submit 335
section 905(j)(1)(A)(i) Full SE Initial reports each year and that it
will take a manufacturer approximately 300 hours per report to prepare
the reports of SE and environmental assessment for a new tobacco
product.
    FDA estimates that we will receive 335 Full SE Initial reports for
a total of 100,500 hours. We estimate 250 Full SE Bundled Reports for a
total of 22,500 hours. FDA estimates that we will receive 418 Same
Characteristics SE Reports for a total of 19,646 hours. FDA estimates
receiving 139 Initial Product Quantity Change reports for a total of
12,093 hours. We estimate receiving 55 Product Quantity Change Bundled
SE reports for a total of 3,410 hours. Based on FDA's experience with
environmental assessments (EAs) for currently regulated tobacco
products, we expect industry to spend 80 hours to prepare an
environmental assessment for a full SE Report, but less time to prepare
an environmental assessment for shorter SE reports.
    Therefore, FDA estimates the burden for submission of SE
information will be 158,149 hours.
5. Electronic Importer's Entry Notice (OMB Control Number 0910-0046)
    Description of Respondents: Respondents to this collection of
information are importers of tobacco products being imported or offered
for import into the United States whose products meet the same
requirements of the Tobacco Control Act as domestic tobacco products.
    With the passage of the Tobacco Control Act, section 801 of the
FD&C Act (21 U.S.C. 381) was amended to add tobacco products to the
inventory of FDA-regulated products. The revised section 801 charges
the Secretary of Health and Human Services, through FDA, with the
responsibility of assuring that foreign-origin, FDA-regulated foods,
drugs, cosmetics, medical devices, radiological health, and tobacco
products being imported or offered for import into the United States
meet the same requirements of the FD&C Act as domestic products and for
preventing products from entering the country if they are not in
compliance. The discharge of this responsibility involves close
coordination and cooperation between FDA headquarters and field
inspectional personnel and the U.S. Customs and Border Protection
(CBP). This collection of information is being used by FDA to review
and prevent imported products from entering the United States if the
products do not meet the same requirements of the FD&C Act as do
domestic products.
    Until October 1995, importers were required to file manual entry on
OMB-approved forms, which were accompanied by related documents.
Information provided by these forms included information such as
country of origin, name of the importing vessel, entry number (assigned
by CBP), port of entry, the port of lading and unlading, value in U.S.
dollars, shipper or manufacturer, importer of record, original
consignee, broker, broker's

reference number and CBP house box number, bill of lading numbers, and
location of goods. FDA stopped using these paper forms effective
October 1, 1995, to eliminate duplication of information and to reduce
the paperwork burden both on the import community and FDA. The Agency
then developed and implemented an automated nationwide entry processing
system, which enabled FDA to more efficiently obtain and process the
information it requires to fulfill its regulatory responsibility.
    Most of the information FDA requires to carry out its regulatory
responsibilities under section 801 of the FD&C Act is already provided
electronically by filers to CBP. Because CBP relays this data to FDA
using an electronic interface, the majority of data submitted by the
entry filer need be done only once.
    FDA estimates the additional annual burden for the information
collection as a result of this rule as follows:

                                                     Table 11--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
                  Activity                       Number of     responses per   Total annual     Average burden per response (in hours)      Total hours
                                                respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Importers of Cigars who are Considered                   216             159          34,344  0.14 (8\1/2\ minutes)                                4,808
 Manufacturers.
Importers of Pipe and Waterpipe Tobacco Who               43             123           5,289  0.14 (8\1/2\ minutes)                                  740
 Are Considered Manufacturers.
Importers Other Tobacco, E-Cigarettes, and                14              68             952  0.14 (8\1/2\ minutes)                                  133
 Nicotine Product Manufacturers (ENDS).
                                             -----------------------------------------------------------------------------------------------------------
    Total Hours Importation of Tobacco        ..............  ..............  ..............  ..........................................           5,681
     Products.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA estimates the burden hours to be 5,681 burden hours (4,808 +
740 + 133 hours). This reflects the addition of the newly deemed
tobacco products to the list of FDA's regulated products. When testing
the use of electronic and paper forms, FDA determined that the average
time for completing either electronic or manual entries was the same.
    Based on the original data collected by FDA when the importer entry
notice information collection was most recently approved, it is
expected that each respondent will take 0.14 hour (8\1/2\ minutes) to
respond. The estimated hours per response are expected to remain the
same for tobacco importers.
    FDA estimates that there will be no additional costs to provide
import data electronically to FDA, as filers already have equipment and
software in place to enable them to provide data to CBP via the
automated system. Therefore, no additional software or hardware need be
developed or purchased to enable filers to file the FDA data elements
at the same time they file entries electronically with CBP.
6. Exports: Notification and Recordkeeping Requirements (OMB Control
Number 0910-0482)
    Description of Respondents: Respondents are manufacturers,
distributors, and other persons who export tobacco products not
intended for sale in the United States.
    In a rule published on February 2, 2012 (77 FR 5171), FDA amended
certain of its general regulations to include tobacco products, where
appropriate, in light of FDA's authority to regulate these products
under the Tobacco Control Act (conforming amendments rule). The
conforming amendments rule subjects tobacco products to the same
general requirements that apply to other FDA-regulated products, where
appropriate.
    The conforming amendments rule amended 21 CFR 1.101(b), among other
sections, to require persons who export human drugs, biologics,
devices, animal drugs, foods, cosmetics, and tobacco products that may
not be sold in the United States to maintain records demonstrating
their compliance with the requirements in section 801(e)(1) of the FD&C
Act. Section 801(e)(1) requires exporters to keep records demonstrating
that the exported product: (1) Meets with the foreign purchaser's
specifications; (2) does not conflict with the laws of the foreign
country; (3) is labeled on the outside of the shipping package that is
intended for export; and (4) is not sold or offered for sale in the
United States. These criteria also could be met by maintaining other
documentation, such as letters from a foreign government agency or
notarized certifications from a responsible company official in the
United States stating that the exported product does not conflict with
the laws of the foreign country.
    FDA estimates the annual burden for the information collection as a
result of this rule as follows:

                                                   Table 12--Estimated Annual Recordkeeping Burden 1 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Average burden
                         Activity                              Number of      Number of records     Total annual    per recordkeeping     Total hours
                                                             recordkeepers     per recordkeeper       records           (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    21 CFR 1.101(b):
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cigar Manufacturers (Large and Small)....................                 57                  3                171                 22              3,762
Pipe and Waterpipe Tobacco Manufacturers.................                 37                  3                111                 22              2,442
Other Tobacco, E-Cigarettes, and Nicotine Product                         93                  3                279                 22              6,138
 Manufacturers (ENDS)....................................
                                                          ----------------------------------------------------------------------------------------------

    Exports: Notification and Recordkeeping Requirements.  .................  .................  .................  .................             12,342
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ At publication of the NPRM, the burden for these activities were under OMB control number 0910-0690. The burden has since been transferred to OMB
  control number 0910-0482.

    The Agency has estimated the number of respondents and burden hours
associated with the recordkeeping requirements by reviewing Agency
records and using Agency expert resources who have experience and
information regarding tobacco product exporters. FDA estimates that 187
establishments (50 percent of all the tobacco manufacturers listed in
the collection of information under OMB Control Number 0910-0046 in
this document who manufacture cigars, pipe tobacco, waterpipe, other
tobacco products, and ENDS) could be involved in the exporting of all
tobacco products annually. Based on previous recordkeeping estimates
for the exporter's reporting burden in the existing OMB-approved
collection of information (OMB Control Number 0910-0482, ``Export
Notification and Recordkeeping Requirements''), each establishment will
maintain an average of three records per year, and it will take each
recordkeeper an average of 22 hours per recordkeeper to maintain each
record. The Agency estimates 12,342 burden hours will be needed for
tobacco product exporters to create and maintain records demonstrating
compliance with section 801(e)(1) of the FD&C Act.
7. Establishing That a Tobacco Product Was Commercially Marketed in the
United States as of February 15, 2007 (OMB Control Number 0910-0775)
    Description of Respondents: Respondents to this collection of
information are manufacturers of tobacco products who wish to
demonstrate that their tobacco product was commercially marketed in the
United States on February 15, 2007, and is a grandfathered product not
subject to premarket review.
    On September 29, 2014, FDA published the guidance document entitled
``Establishing That a Tobacco Product Was Commercially Marketed in the
United States as of February 15, 2007''. This guidance provides
information on how a manufacturer may demonstrate that a tobacco
product was commercially marketed in the United States on February 15,
2007, and is, therefore, a grandfathered product not subject to
premarket review. The guidance recommends that the manufacturer provide
evidence that may include, among other things, dated copies of
advertisements, dated catalog pages, dated promotional material, and
dated bills of lading. FDA recommends that the manufacturer submit
adequate information to demonstrate that the tobacco product was
commercially marketed in the United States on February 15, 2007.
    The estimate for the number of hours in the existing collection is
FDA's estimate of how long it might take one to review, gather, and
submit dated information if making a request for an Agency
determination.
    FDA estimates the annual burden for the information collection as a
result of this rule as follows:

                                 Table 13--Estimated Annual Reporting Burden 1 2
----------------------------------------------------------------------------------------------------------------
                                                                                Average
                                     Number of       Number of     Total annual     burden per
            Activity                respondents    responses per     responses     response (in     Total hours
                                                    respondent                        hours)
----------------------------------------------------------------------------------------------------------------
Cigar Manufacturers (including                 1               1               1               5               5
 large and small cigars and
 importers).....................
Pipe Tobacco Manufacturers                     1               1               1               5               5
 (Including Importers)..........
Other Tobacco, E-Cigarettes, and               1               1               1               5               5
 Nicotine Product Manufacturers
 (Including Importers)..........
                                 -------------------------------------------------------------------------------
    Total Hours Establishing      ..............  ..............  ..............  ..............              15
     that a Tobacco Product was
     Commercially Marketed in
     the United States as of
     February 15, 2007..........
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ At publication of the NPRM, this collection was not yet approved by OMB. On September 8, 2014, OMB approved
  the information collection for 3 years.

    Based on FDA's experiences to date, and given that stand-alone
grandfather submissions are purely voluntary, FDA does not anticipate
that many manufacturers will make such submissions, but this option is
available. As such, we assigned one respondent annually per type of
product FDA estimates it will take a manufacturer approximately 5 hours
to complete and submit for FDA review the evidence required by this
collection of information for a total of 15 hours.

C. Burdens Associated With Tobacco Products Currently Subject to the
FD&C Act But Not Yet Approved by OMB

    The information collections described in this section also involve
collections that have been previously made available for public comment
because they involved tobacco products currently subject to chapter IX
of the FD&C Act. However, these information collections have not yet
been approved by OMB.

    FDA based the estimates on the existing collections that were
previously made available for comment.
     Applications for Premarket Review of New Tobacco Products
    Description of Respondents: The respondents to this collection of
information are manufacturers who seek a marketing authorization order
under section 910(c)(1)(A)(i) of the FD&C Act.
    On September 28, 2011, FDA announced the availability of a draft
guidance entitled ``Applications for Premarket Review of New Tobacco
Products''. This guidance, when finalized, will represent the Agency's
current thinking on the topic. Section 910(a)(1) of the FD&C Act
defines a ``new tobacco product'' as a tobacco product that was not
commercially marketed in the United States on February 15, 2007, or
modification (including a change in design, any component, any part, or
any constituent, including a smoke constituent, or in the content,
delivery or form of nicotine, or any other additive or ingredient) of a
tobacco product where the modified product was commercially marketed in
the United States after February 15, 2007. An order under section
910(c)(1)(A)(i) of the FD&C Act is required prior to marketing a new
tobacco product. This requirement applies unless the product has been
shown to be substantially equivalent to a valid predicate product or is
exempt from SE.
    Section 910(b) of the FD&C Act states that a PMTA shall contain
full reports of all investigations of health risks; a full statement of
all components, ingredients, additives, and properties, and of the
principle or principles of operation of such tobacco product; a full
description of methods of manufacturing and processing (which includes;
a listing of all manufacturing, packaging, and control sites for the
product); an explanation of how the product complies with applicable
tobacco product standards; samples of the product and its components;
and labeling.
    FDA also encourages persons who would like to study their new
tobacco product to meet with the OS in CTP to discuss their
investigational plan. The request for a meeting should be sent in
writing to the Director of CTP's OS and should include adequate
information for FDA to assess the potential utility of the meeting and
to identify FDA staff necessary to discuss agenda items. FDA is
required to deny a PMTA and issue an order that the product may not be
introduced or delivered for introduction into interstate commerce under
section 910(c)(1)(A)(ii) of the FD&C Act if FDA finds that:
     The manufacturer has not shown that the product is
appropriate for the protection of the public health,
     the manufacturing, processing, or packing methods,
facilities, or controls do not conform to good manufacturing practices
issued under section 906(e) of the FD&C Act,
     the labeling is false or misleading in any particular, or
     the manufacturer has not shown that the product complies
with any tobacco product standard in effect under section 907 of the
FD&C Act.
    FDA estimates the annual burden for the information collection as a
result of this rule as follows:

                                 Table 14--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                                                Average
                                     Number of       Number of     Total annual     burden per
            Activity                respondents    responses per     responses     response (in     Total hours
                                                    respondent                        hours)
----------------------------------------------------------------------------------------------------------------
Obtaining an FDA Order Authorizing Marketing of Tobacco Product (the application) and Sec.   25.40 Environmental
                                                  Assessments:
----------------------------------------------------------------------------------------------------------------
Other Tobacco, E-Cigarettes, and             200            3.75             750           1,713       1,284,750
 Nicotine Product Manufacturers
 (ENDS Liquids and ENDS Delivery
 Systems (Including Importers)).
    Total Hours Obtaining an FDA  ..............  ..............  ..............  ..............       1,284,750
     Order Authorizing Marketing
     of Tobacco Product (the
     application)...............
----------------------------------------------------------------------------------------------------------------
                Request for Meeting with CTP's Office of Science to Discuss Investigational Plan:
----------------------------------------------------------------------------------------------------------------
Other Tobacco, E-Cigarettes, and             200               1             200               4             800
 Nicotine Product Manufacturers
 (ENDS Liquids and ENDS Delivery
 Systems (Including Importers)).
    Total Hours Request for       ..............  ..............  ..............  ..............             800
     Meeting with CTP's Office
     of Science to Discuss
     Investigational Plan.......
        Total Hours               ..............  ..............  ..............  ..............       1,285,550
         ``Applications for
         Premarket Review of New
         Tobacco Products''.....
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA estimates that it will take each respondent approximately 1,500
hours to prepare a PMTA seeking an order from FDA allowing the
marketing of a new tobacco product. FDA also estimates that it would on
average take an additional 213 hours to prepare an environmental
assessment in accordance with the requirements of Sec.  25.40, for a
total of 1,713 hours per PMTA application. 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).
    Although FDA has decreased the burden per each PMTA, we have
increased the number of expected responses for ENDS manufacturers. We
attribute this increase to the rapid growing ENDS market since the NPRM
was published. FDA's estimate includes anticipated burden for the
writing of an application, including intracompany edits and approvals.
FDA also estimates the number of PMTAs that FDA expects to receive
annually will be 750 (642 ENDS Liquids and 108 ENDS Delivery Systems).
    We are clarifying here that a PMTA may require one or more types of
studies including chemical analysis,

nonclinical studies, and clinical studies. FDA expects that chemical
and design parameter analysis would include the testing of applicable
HPHCs and nonclinical analysis would include literature synthesis and,
as appropriate, some combination of in vitro or in vivo studies, and
computational analyses. For the clinical study component, one or more
types of studies may be included to address, as needed, perception, use
pattern, or health impact. It is possible that an applicant may not
need to conduct any new nonclinical or clinical studies. We note that
for most applications, FDA does not expect that applicants will include
randomized clinical trials, like those conducted to support drug and
device approvals.
    For tobacco products already on the market at the time of the final
rule, much of the information required to support a PMTA may be
obtained from previously published research on similar products.
Therefore, FDA expects that a large portion of applications may be
reviewed with no or minimal new nonclinical or clinical studies being
conducted to support an application. In contrast, nonclinical and
clinical studies may be required for market authorization of a new
product for which there is limited understanding of its potential
impact on the public health. The range of hours involved to compile
these two types of applications would be quite variable.
    FDA anticipates that the 200 potential respondents to this
collection may need to meet with CTP's Office of Science to discuss
their investigational plans. To request this meeting, applicants should
compile and submit information to FDA for meeting approval. FDA
estimates that it will take approximately 4 hours to compile this
information, for a total of 800 hours additional burden (200
respondents x 4 hours).
    Therefore, the total annual burden for submitting PMTA applications
is estimated to be 1,285,550 hours. FDA's estimates are based on the
corresponding information collection estimates that apply to tobacco