
[Federal Register Volume 84, Number 28 (Monday, February 11, 2019)]
[Notices]
[Pages 3188-3190]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01819]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0075]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Experimental Study on Measuring Consumer Comprehension 
of Displays of Harmful and Potentially Harmful Constituents in Tobacco 
Products and Tobacco Smoke

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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 and to 
allow 60 days for public comment in response to the notice. This notice 
solicits comments on an experimental study on measuring consumer 
comprehension of displays of harmful and potentially harmful 
constituents (HPHCs) in tobacco products and tobacco smoke.

DATES: Submit either electronic or written comments on the collection 
of information by April 12, 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 April 12, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of April 12, 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-0075 for ``Experimental Study on Measuring Consumer 
Comprehension of Displays of Harmful and Potentially Harmful 
Constituent in Tobacco Products and Tobacco Smoke.'' 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

[[Page 3189]]

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, 
PRAStaff@fda.hhs.gov.

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 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 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.

Experimental Study on Measuring Consumer Comprehension of Displays of 
Harmful and Potentially Harmful Constituents in Tobacco Products and 
Tobacco Smoke

OMB Control Number 0910--NEW

    On June 22, 2009, the Family Smoking Prevention and Tobacco Control 
Act (Pub. L. 111-31) (Tobacco Control Act) was signed into law. This 
law amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 
granted FDA the authority to regulate the manufacture, marketing, and 
distribution of cigarettes, cigarette tobacco, roll-your-own tobacco, 
and smokeless tobacco products to protect the public health and to 
reduce tobacco use by minors. The Tobacco Control Act also gave FDA the 
authority to issue regulations deeming other products that meet the 
statutory definition of a tobacco product to be subject to chapter IX 
of the FD&C Act (section 901(b) of the FD&C Act (21 U.S.C. 387a(b))).
    In accordance with that authority, on May 10, 2016, FDA issued a 
final rule deeming all products that meet the statutory definition of 
tobacco product, except accessories of newly deemed tobacco products, 
to be subject to FDA's tobacco product authority. The deemed products 
include electronic nicotine delivery systems, cigars, waterpipe 
(hookah), pipe tobacco, nicotine gels, dissolvables that were not 
already subject to the FD&C Act, and other tobacco products that may be 
developed in the future (final deeming rule) (81 FR 28973).
    Among other requirements, section 904(e) of the FD&C Act (21 U.S.C. 
387d(e)) requires FDA to establish, and periodically revise as 
appropriate, a list of HPHCs, including smoke constituents, to health 
in each tobacco product by brand and by quantity in each brand and 
subbrand. Section 904(d)(1) of the FD&C Act further requires that this 
list be published in a format that is understandable and not misleading 
to a lay person (the Section 904(d) list).
    FDA has undertaken a rigorous science-based research approach to 
ensure that the Section 904(d) list is not misleading to lay persons. 
As part of this research, FDA is seeking to conduct an experimental/
quantitative study (4,500 online surveys), consisting of adult and 
youth (aged 13-17) participants to evaluate the best way to convey 
information about HPHCs in tobacco products and tobacco smoke, by brand 
and by quantity in each brand and subbrand, in a format that is 
understandable and not misleading to a lay person. Participants will 
view sample formats and complete an online survey that will include 
questions regarding their understanding of the HPHC information 
presented to them. The purpose of the research is to gain insight on 
consumer comprehension of, and preferences regarding, HPHC 
presentations that will inform the Agency's efforts in connection with 
publishing the Section 904(d) list.
    FDA estimates the burden of this new information collection as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
       Type of respondent            Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Youth Screener..................           1,800               1           1,800            0.05              90
Youth Survey....................           1,500               1           1,500            0.33             500
                                 -------------------------------------------------------------------------------
    Total Youth Hours...........  ..............  ..............  ..............  ..............             590
Adult Screener..................           3,400               1           3,400            0.05             170
Adult Survey....................           3,000               1           3,000            0.33           1,000
                                 -------------------------------------------------------------------------------
    Total Adult Hours...........  ..............  ..............  ..............  ..............           1,170
                                 -------------------------------------------------------------------------------
        Total Burden Hours......  ..............  ..............  ..............  ..............           1,760
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    For this study, potential participants will be recruited by a 
market research firm that maintains an internet panel, and information 
will be collected through self-administered, online screening tests and 
surveys of youth aged 13-17 and adults aged 18 and older. Approximately 
5,200 respondents (1,800 youth and 3,400 adults) will be requested to 
complete a screening test to determine eligibility for participation in 
the study, estimated to take

[[Page 3190]]

approximately 3 minutes (0.05 hour) per screening test, for a total of 
260 hours for screening activities. Respondents who qualify for the 
study will be directed to the survey. Approximately 4,500 participants 
(1,500 youth and 3,000 adults) will complete the survey, estimated to 
take 20 minutes (0.33 hour) per survey, for a total of 1,500 hours for 
completion of both adult and adolescent samples. The length of time to 
complete the screening test and survey are based on the research firm's 
experience that panel members answer approximately 2.5 questions per 
minute. This data collection will take place one time in 2019. Thus, 
the total estimated burden is estimated to be 1,760 hours.

    Dated: February 5, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-01819 Filed 2-8-19; 8:45 am]
BILLING CODE 4164-01-P


