[Federal Register Volume 84, Number 143 (Thursday, July 25, 2019)]
[Notices]
[Pages 35875-35879]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15791]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by August 
26, 2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0768. 
Also include the FDA docket number found in brackets in the heading of 
this document.

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

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

[[Page 35876]]

Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and 
Cosmetic Act

OMB Control Number 0910-0768--Extension

    The Tobacco Control Act, enacted on June 22, 2009, amended the 
Federal Food, Drug, and Cosmetic Act (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.
    When the deeming final rule published, FDA revised the following 
information collections that added deemed products to these 
collections: Tobacco Product Establishment Registration and Submission 
of Certain Health Information (OMB control number 0910-0650); Tobacco 
Health Document Submission (OMB control number 0910-0654); Exemptions 
from Substantial Equivalence Requirements (OMB control number 0910-
0684); Reports Intended to Demonstrate the Substantial Equivalence of a 
New Tobacco Product (OMB control number 0910-0673); Electronic 
Importer's Entry Notice (OMB control number 0910-0046); Exports: 
Notification and Recordkeeping Requirements (OMB control number 0910-
0482); and Establishing That a Tobacco Product Was Commercially 
Marketed in the United States as of February 15, 2007 (OMB control 
number 0910-0775).
    In the Federal Register of April 22, 2019 (84 FR 16673), FDA 
published a 60-day notice requesting public comment on the extension of 
collection of information ``Deeming Tobacco Products To Be Subject to 
the Federal Food, Drug, and Cosmetic Act.'' FDA received one comment 
that was Paperwork Reduction Act (PRA) related.
    The commenter noted that they would like to see the associated 
collections that the deeming rule revised. FDA appreciates the comment 
addressing the associated deemed product information collections. FDA 
notes that in the PRA section of the deeming final rule (81 FR 28973 at 
29076) all the revised OMB information collection control numbers and 
their revised burdens were all listed. Per the comment, we have added a 
listing of all the collections the final rule revised.
    The commenter also notes that the burdens associated with deemed 
products are not all included in this notice even though the notice 
``appears intended to present a comprehensive set of burden estimates 
and analyses for information collection activities associated with . . 
. the Deeming Rule.'' FDA notes that this notice is not intended to 
cover all information collection reviews associated with the deeming 
rule. Instead, this notice only covers the information collections that 
did not already have an approved collection prior to the deeming final 
rule. For the collections that existed prior to the deeming final rule, 
FDA added the new associated deeming-related burdens to these 
previously approved OMB control numbers. We also note that some of the 
estimates from the PRA section of the deeming rule may have changed 
since the final rule published. If any estimates have changed, these 
changes have been published in the Federal Register through the process 
associated with renewing PRA collections.
    The comment also mentions the omission of the burden associated 
with the submission of harmful and potentially harmful constituents 
(HPHC) listings. FDA notes that we have not yet sought OMB approval of 
the burden associated with listing and reporting HPHCs for deemed 
products. On March 8, 2019, FDA revised the ``Extension of Certain 
Tobacco Product Compliance Deadlines Related to the Final Deeming 
Rule'' guidance (https://www.fda.gov/media/105346/download) and the 
related Small Entity Compliance Guide entitled ``FDA Deems Certain 
Tobacco Products Subject to FDA Authority, Sales and Distribution 
Restrictions, and Health Warning Requirements for Packages and 
Advertisements'' (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-deems-certain-tobacco-products-subject-fda-authority-sales-and-distribution-restrictions-and). This revision 
extends the HPHCs reporting compliance date to a date that is 6 months 
after the publication date of a final guidance regarding HPHC reporting 
under section 904(a)(3) of the FD&C Act (21 U.S.C. 287d(a)(3)) and 9 
months after that publication date for small tobacco product 
manufacturers. For products entering the market after the publication 
date of the final guidance, manufacturers must submit their HPHC report 
90 days prior to marketing the products under section 904(a)(3).
    In the preamble to the final deeming rule, FDA indicated that it 
intends to

[[Page 35877]]

issue guidance regarding HPHC reporting (and later a testing and 
reporting regulation under section 915 of the FD&C Act (21 U.S.C. 
387o)) with enough time for manufacturers to report, given the original 
3-year compliance period. At this time, FDA has not published a final 
HPHC reporting guidance and as a result, we are providing a revised 
compliance date based on when a final HPHC reporting guidance is 
issued.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--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 21 CFR 25.40
 Environmental Assessments:
    Other Tobacco, E-Cigarettes,             200            3.75             750           1,713       1,284,750
     and Nicotine Product
     Manufacturers (Electronic
     Nicotine Delivery Systems
     (ENDS) Liquids and Delivery
     Systems (Including
     Importers))................
                                 -------------------------------------------------------------------------------
        Total Hours Obtaining an  ..............  ..............  ..............  ..............       1,284,750
         FDA 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,             200               1             200               4             800
     and Nicotine Product
     Manufacturers (Electronic
     Nicotine Delivery Systems
     (ENDS) Liquids and Delivery
     Systems (Including
     Importers))................
                                 -------------------------------------------------------------------------------
        Total Hours Request for   ..............  ..............  ..............  ..............             800
         Meeting with CTP's
         Office of Science to
         Discuss Investigational
         Plan...................
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
            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 21 CFR 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 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 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 is 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 is 
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, Sec.  1143.3(c) 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.

[[Page 35878]]



                                 Table 2--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)
----------------------------------------------------------------------------------------------------------------
Certification Statement.........               5               1               5              20             100
                                 -------------------------------------------------------------------------------
    Total Exemptions From the     ..............  ..............  ..............  ..............             100
     Required Warning Statement
     Requirement................
----------------------------------------------------------------------------------------------------------------
\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. 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\
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                     Number of       Number of     Total annual     burden per
       Cigar warning plan           respondents    responses per     responses     response  (in    Total hours
                                                    respondent                        hours)
----------------------------------------------------------------------------------------------------------------
Manufacturers, Importers, and                 10               1              10             120           1,200
 Retailers......................
                                 -------------------------------------------------------------------------------
    Total Cigar Warning Plan....  ..............  ..............  ..............  ..............           1,200
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    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) are 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 in 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 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.

[[Page 35879]]



                                 Table 4--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)
----------------------------------------------------------------------------------------------------------------
Small-Scale Manufacturer                      75               1              75               2             150
 Reporting......................
                                 -------------------------------------------------------------------------------
    Total Small-Scale             ..............  ..............  ..............  ..............             150
     Manufacturer Report........
----------------------------------------------------------------------------------------------------------------
\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: July 19, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15791 Filed 7-24-19; 8:45 am]
 BILLING CODE 4164-01-P