[Federal Register Volume 84, Number 77 (Monday, April 22, 2019)]
[Notices]
[Pages 16673-16676]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08046]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0305]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Deeming Tobacco Products To Be Subject to the Federal 
Food, Drug, and Cosmetic Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the information collection ``Deeming 
Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic 
Act (FD&C Act).''

DATES: Submit either electronic or written comments on the collection 
of information by June 21, 2019.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before June 21, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of June 21, 2019. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2019-N-0305 for ``Deeming Tobacco Products To Be Subject to the 
FD&C Act.'' Received comments, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance

[[Page 16674]]

of FDA's functions, including whether the information will have 
practical utility; (2) the accuracy of FDA's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Deeming Tobacco Products To Be Subject to the FD&C Act

OMB Control Number 0910-0768--Extension

    The Tobacco Control Act, enacted on June 22, 2009, amended the FD&C 
Act and provided FDA with the authority to regulate tobacco products 
(Pub. L. 111-31; 123 Stat. 1776). Specifically, section 101(b) of the 
Tobacco Control Act amended the FD&C Act by adding chapter IX (21 
U.S.C. 387 through 387u), which provides FDA with tools to regulate 
tobacco products. Section 901 of the FD&C Act (21 U.S.C. 387a) states 
that Chapter IX--Tobacco Products applies to all cigarettes, cigarette 
tobacco, roll-your-own tobacco, and smokeless tobacco and to any other 
tobacco products that the Secretary of Health and Human Services by 
regulation deems to be subject to this chapter.
    The FD&C Act provides FDA authority to regulate cigarettes, 
cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any 
other tobacco products that the Agency by regulation deems to be 
subject to the law. On May 10, 2016 (81 FR 28973) FDA issued a final 
rule to deem products meeting the statutory definition of ``tobacco 
product'' to be subject to the FD&C Act. This final rule extended FDA's 
``tobacco product'' authorities under Chapter IX to all tobacco 
products that meet the statutory definition of ``tobacco product'' in 
section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)).
    Section 910(a)(1) of the FD&C Act (21 U.S.C. 387j(a)(1)) defines a 
``new tobacco product'' as a tobacco product that was not commercially 
marketed in the United States on February 15, 2007, or a 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 substantial equivalence.
    Section 910(b) of the FD&C Act states that a premarket tobacco 
application (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 Office of Science in the Center for 
Tobacco Products (CTP) to discuss their investigational plan. The 
request for a meeting should be sent in writing to the Director of 
CTP's Office of Science 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 estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                                                      Average
                                     Number of       Number of     Total annual     burden per
            Activity                respondents   responses  per     responses     response  (in    Total hours
                                                     respondent                       hours)
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Obtaining an FDA Order Authorizing Marketing of Tobacco Product (the application) and 21 CFR 25.40 Environmental
                                                  Assessments:
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Other Tobacco, E-Cigarettes, and             200            3.75             750           1,713       1,284,750
 Nicotine Product Manufacturers
 (Electronic Nicotine Delivery
 Systems (ENDS) Liquids and
 Delivery Systems (Including
 Importers))....................
    Total Hours Obtaining an FDA  ..............  ..............  ..............  ..............       1,284,750
     Order Authorizing Marketing
     of Tobacco Product (the
     application)...............
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                Request for Meeting with CTP's Office of Science to Discuss Investigational Plan:
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Other Tobacco, E-Cigarettes, and             200               1             200               4             800
 Nicotine Product Manufacturers
 (Electronic Nicotine Delivery
 Systems (ENDS) Liquids and
 Delivery Systems (Including
 Importers))....................
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    Total Hours Request for       ..............  ..............  ..............  ..............             800
     Meeting with CTP's Office
     of Science to Discuss
     Investigational Plan.......
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        Total Hours               ..............  ..............  ..............  ..............       1,285,550
         ``Applications for
         Premarket Review of New
         Tobacco Products``.....
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\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 21 CFR 25.40, for a 
total of 1,713 hours per PMTA application. This average represents a 
wide range of hours that

[[Page 16675]]

will be required for these applications under different circumstances, 
with a small number 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). A PMTA may require one or more types of studies including 
chemical analysis, nonclinical studies, and clinical studies. FDA also 
estimates the number of PMTAs that FDA expects to receive annually will 
be 750 (642 ENDS Liquids and 108 ENDS Delivery Systems).
    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.
    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 
products currently subject to the FD&C Act and an assumption that 
manufacturers would submit applications for the premarket review of 
tobacco products.
    In Sec.  1143.3(c) (21 CFR 1143.3(c)) an exemption is provided to 
the manufacturer of a product that otherwise would be required to 
include the warning statement in Sec.  1143.3(a)(1) on its packages and 
in its advertisements, i.e., ``WARNING: This product contains nicotine. 
Nicotine is an addictive chemical.'' This warning will be required to 
appear on at least 30 percent of the two principal display panels of 
the package and on at least 20 percent of the area of the 
advertisement.
    To obtain an exemption from this requirement, a manufacturer would 
be required to certify to FDA that its product does not contain 
nicotine and that the manufacturer has data to support that assertion. 
For any product that obtains this exemption, the section requires that 
the product bear the statement: ``This product is made from tobacco.'' 
The parties that package and label such products will share 
responsibility for ensuring that this alternative statement is included 
on product packages and in advertisements. Companies are permitted to 
obtain an exemption from this warning requirement in the event that 
such tobacco products are developed in the future.

                                 Table 2--Estimated Annual Reporting Burden \1\
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                                                                                      Average
                                     Number of       Number of     Total annual     burden per
            Activity                respondents   responses  per     responses     response  (in    Total hours
                                                     respondent                       hours)
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Certification Statement.........               5               1               5              20             100
                                 -------------------------------------------------------------------------------
    Total Exemptions From the     ..............  ..............  ..............  ..............             100
     Required Warning Statement
     Requirement................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The estimated average burden per response is based on currently 
approved information collection estimates. Although very few 
certifications are expected for tobacco products that do not contain 
nicotine, FDA estimates that the number of certification submissions 
could rise if the Agency decides in the future to address not only 
nicotine, but any other addictive substances.
    The estimated hours listed in the burden table for certification 
submissions reflect the time needed to test the product for nicotine 
and to prepare and submit the self-certification request. FDA expects 
that these types of certifications will be rare and estimates that the 
Agency will receive on average five submissions per year.
    FDA concludes that the labeling statements in Sec. Sec.  
1143.3(a)(1) and 1143.5(a)(1) and the alternative statement in Sec.  
1143.3(c) (i.e., ``This product is made from tobacco'') are not subject 
to review by OMB because they do not constitute a ``collection of 
information'' under the PRA (44 U.S.C. 3501-3520). Rather, these 
labeling statements are a ``public disclosure'' of information 
originally supplied by the Federal Government to the recipient for the 
purpose of ``disclosure to the public'' (5 CFR 1320.3(c)(2)).

                                 Table 3--Estimated Annual Reporting Burden \1\
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                                                                                      Average
                                     Number of       Number of     Total annual     burden per
       Cigar warning plan           respondents   responses  per     responses     response  (in    Total hours
                                                     respondent                       hours)
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Manufacturers, Importers, and                 10               1              10             120           1,200
 Retailers......................
                                 -------------------------------------------------------------------------------
    Total Cigar Warning Plan....  ..............  ..............  ..............  ..............           1,200
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 16676]]

    The requirement for submission of warning plans for cigar products, 
and the specific requirements relating to the random display and 
distribution of required warning statements on cigar packaging and 
quarterly rotation of required warning statements in alternating 
sequence on cigar product advertising, appear in Sec.  1143.5(c).
    The six warnings for cigars (five specifically for cigars and the 
one addictiveness warning) will be required to be randomly displayed in 
each 12-month period, in as equal a number of times as is possible on 
each brand of cigar sold in product packaging and be randomly 
distributed in all areas of the United States in which the product is 
marketed accordance with a warning plan submitted to and approved by 
FDA. For advertisements, the warning statements must be rotated 
quarterly in alternating sequence in each advertisement for each brand 
of cigar in accordance with a warning plan submitted to and approved by 
FDA.
    FDA published a final guidance in August 2018 (https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM534739.pdf) to assist manufacturers, importers, distributors, and 
retailers of cigars with the submission of warning plans. FDA will work 
with the submitters to ensure that the plans submitted meet the 
established criteria for approval under 21 CFR part 1143.
    The warning statements on cigar packaging must be randomly 
displayed in each 12-month period, in as equal a number of times as is 
possible on each brand of cigar sold and are required to be randomly 
distributed in all areas of the United States in which the product is 
marketed in accordance with a warning plan submitted by the responsible 
cigar manufacturer, importer, distributor, or retailer to and approved 
by FDA.
    FDA also requires that the required warning statements be rotated 
quarterly in alternating sequence in each advertisement for each brand 
of cigar, regardless of whether the cigar is sold in product packaging. 
This rotation of warning statements in cigar advertisements also must 
be done in accordance with a warning plan submitted by the responsible 
cigar manufacturer, importer, distributor, or retailer to and approved 
by FDA.
    The burden estimates are based on FDA's experience with cigar 
warning plans, smokeless warning plans, and the associated information 
collection (OMB control number 0910-0671) as well as warning plans for 
cigarettes submitted to the Federal Trade Commission prior to the 
implementation of the Tobacco Control Act on June 22, 2009.
    We estimate 10 entities will submit warning plans, and it will take 
an average of 120 hours per respondent to prepare and submit a warning 
plan for packaging and advertising for a total of 1,200 hours.

                                 Table 4--Estimated Annual Reporting Burden \1\
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                                                                                      Average
                                     Number of       Number of     Total annual     burden per
            Activity                respondents    responses per     responses     response  (in    Total hours
                                                    respondent                        hours)
----------------------------------------------------------------------------------------------------------------
Small-Scale Manufacturer                      75               1              75               2             150
 Reporting......................
                                 -------------------------------------------------------------------------------
    Total Small-Scale             ..............  ..............  ..............  ..............             150
     Manufacturer Report........
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Generally, FDA considers a ``small-scale tobacco product 
manufacturer'' to be a manufacturer of any regulated tobacco product 
that employs 150 or fewer full-time equivalent employees and has annual 
total revenues of $5,000,000 or less. FDA considers a manufacturer to 
include each entity that it controls, is controlled by, or is under 
common control with such manufacturer. To help make FDA's individual 
enforcement decisions more efficient, a manufacturer may voluntarily 
submit information regarding employment and revenues. FDA does not 
believe many manufacturers who fit the criteria of a small-scale 
tobacco product manufacturer would submit the voluntary information.
    FDA estimates that there are approximately 75 small-scale 
manufacturers who will voluntarily submit information. FDA believes it 
will take respondents 2 hours to voluntarily submit information 
regarding employment and revenues for a total of 150 hours.
    The total estimated burden for this information collection is 
1,286,950 reporting hours, and 1,040 annual responses. Our estimated 
burden for the information collection reflects an overall decrease of 
39,050 hours and a corresponding decrease of 315 responses. We 
attribute this adjustment to updated information in the number of 
submissions we received over the last few years.

    Dated: April 17, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-08046 Filed 4-19-19; 8:45 am]
 BILLING CODE 4164-01-P


