Document ID: FDA-2018-N-0821-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Investigation of Consumer Perceptions of Expressed Modified Risk Claims
Posted Date: 2018-05-21T04:00Z

[Federal Register Volume 83, Number 98 (Monday, May 21, 2018)]
[Notices]
[Pages 23464-23466]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10723]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0821]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Investigation of Consumer Perceptions of Expressed 
Modified Risk Claims

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 the investigation of consumer perceptions of 
expressed modified risk claims.

DATES: Submit either electronic or written comments on the collection 
of information by July 20, 2018.

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 July 20, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of July 20, 2018. 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-2018-N-0821 for ``Investigation of Consumer Perceptions of 
Expressed Modified Risk Claims.'' 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

[[Page 23465]]

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 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.

Investigation of Consumer Perceptions of Expressed Modified Risk Claims

OMB Control Number 0910--NEW

    FDA's Center for Tobacco Products proposes to conduct a study to 
develop generalizable scientific knowledge to help inform its 
implementation of section 911 of the Federal Food, Drug, and Cosmetic 
Act (FD&C Act) (21 U.S.C. 387k), wherein FDA will be evaluating 
information submitted to the Agency about how consumers understand and 
perceive modified risk tobacco products (MRTPs). Section 911 of the 
FD&C Act authorizes FDA to grant orders to persons to allow the 
marketing of MRTPs. The term ``modified risk tobacco product'' means 
any tobacco product that is sold or distributed for use to reduce harm 
or the risk of tobacco-related disease associated with commercially 
marketed tobacco products. FDA can issue a risk modification order 
under section 911(g)(1) of the FD&C Act authorizing the marketing of a 
MRTP only if the Agency determines that the product, as it is used by 
consumers, will significantly reduce harm and the risk of tobacco-
related disease to individual tobacco users and benefit the health of 
the population as a whole, taking into account both users of tobacco 
products and persons who do not currently use tobacco products (section 
911(g)(1) of the FD&C Act). Alternatively, with respect to tobacco 
products that may not be commercially marketed under section 911(g)(1) 
of the FD&C Act, FDA may issue an exposure modification order under 
section 911(g)(2) of the FD&C Act authorizing the marketing of a MRTP 
if, the Agency determines that the standard in section 911(g)(2) of the 
FD&C Act is met, including, among other requirements, that: Any aspect 
of the label, labeling, or advertising that would cause the product to 
be an MRTP is limited to an explicit or implicit representation that 
the tobacco product or its smoke does not contain or is free of a 
substance or contains a reduced level of a substance, or presents a 
reduced exposure to a substance in tobacco smoke; the order would be 
appropriate to promote the public health; the issuance of the order is 
expected to benefit the population as a whole taking into account both 
users and nonusers of tobacco products; and the existing evidence 
demonstrates that a measurable and substantial reduction in morbidity 
and mortality among individual tobacco users is reasonably likely to be 
shown in subsequent studies (section 911(g)(2) of the FD&C Act). In 
addition, section 911 of the FD&C Act requires that any advertising or 
labeling concerning modified risk products enable the public to 
comprehend the information concerning modified risk and to understand 
the relative significance of such information in the context of total 
health and in relation to all the diseases and health-related 
conditions associated with the use of tobacco products (section 
911(h)(1) of the FD&C Act). The proposed research will inform the 
Agency's efforts to implement the provisions of the FD&C Act related to 
MRTPs.
    FDA proposes conducting a study to assist in determining 
appropriate methods for gathering information about how consumers 
perceive and understand modified risk information. The study would 
develop and validate measures of consumer perceptions of health risk 
from using tobacco products. Moreover, the study would test how 
participants' responses on these measures are affected by viewing 
modified risk labeling or advertising, participants' characteristics 
such as prior beliefs about the harmfulness of tobacco products, 
current use of tobacco products, and sociodemographic characteristics. 
Finally, the study would examine factors that may influence the 
effectiveness of debriefing at the end of a consumer perception study 
to ensure that people read and recall key information about the study. 
This research is significant because it will validate methods that can 
be used in studies of the impact of labels, labeling, and advertising 
on consumer perceptions and understanding of the risks of product use.
    Measures of consumer health risk perception will be developed and 
validated by conducting a study on two product types: Moist snuff 
smokeless tobacco products and electronic cigarette (e-cigarette) 
products. For each product type, we will assess individual-level 
factors that may moderate the impact of modified risk information on 
consumer responses. Potential moderating factors under study include: 
Beliefs (prior to viewing the modified risk information) about the 
harmfulness of tobacco products, and the strength with which those 
beliefs are held; current tobacco use behaviors; and sociodemographic 
characteristics including age and educational attainment. For each 
product type, participants will be randomized to view one of two 
conditions: Tobacco product labeling and advertising that either does 
or does not contain modified risk claims about a product. The labeling 
will consist of a product package. The

[[Page 23466]]

advertising will consist of a print advertisement. The study will 
assess participants' perceptions of various health risks from using the 
product, as well as their perceptions of health risk from using the 
product compared to smoking cigarettes, using nicotine replacement 
therapies, and quitting all tobacco and nicotine products. The study 
will also assess participants' intentions to use the product and their 
level of doubt about whether tobacco products are harmful to users' 
health. Measures of intentions and doubt will be used to help assess 
the validity of the measures of health risk perception.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
            Activity                 Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Invitation: Young Adults (Ages            29,000               1          29,000            0.02             580
 18-25).........................
Invitation: Adults (Ages 26+)...          29,000               1          29,000            0.02             580
Consent and Screener: Young               11,000               1          11,000            0.10           1,100
 Adults (Ages 18-25)............
Consent and Screener: Adults              16,500               1          16,500            0.10           1,650
 (Ages 26+).....................
Study: Young Adults (Ages 18-25)           3,300               1           3,300            0.33           1,089
Study: Adults (Ages 26+)........           3,300               1           3,300            0.33           1,089
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           6,088
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA's burden estimate is based on prior experience with research 
that is similar to this proposed study. Approximately 58,000 people 
will receive a study invitation, estimated to take 1 minute to read 
(approximately 0.02 hours), for a total of 1,160 hours for invitations. 
Approximately 27,500 people will complete the informed consent and 
screener to determine eligibility for participation in the study, 
estimated to take 6 minutes (0.10 hours), for a total of 2,750 hours 
for informed consent and screening activities. Approximately 6,600 
people will complete the full study, estimated to take 20 minutes 
(approximately 0.33 hours), for a total of 2,178 hours for study 
completion activities. The estimated total hour burden of the 
collection of information is 6,088 hours.

    Dated: May 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10723 Filed 5-18-18; 8:45 am]
 BILLING CODE 4164-01-P