[Federal Register Volume 82, Number 207 (Friday, October 27, 2017)]
[Notices]
[Pages 49834-49836]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23450]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-3710]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Evaluation of the 
Food and Drug Administration's Education at the Point of Sale Campaign

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 
November 27, 2017.

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 <a href="/cdn-cgi/l/email-protection#117e7863704e6264737c786262787e7f517e7c733f747e613f767e67"><span class="__cf_email__" data-cfemail="3c53554e5d634f495e51554f4f5553527c53515e1259534c125b534a">[email protected]</span></a>. All 
comments should be identified with the OMB control number 0910--NEW and 
title ``Evaluation of FDA's Education at the Point of Sale Campaign.'' 
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, 
<a href="/cdn-cgi/l/email-protection#38686a796b4c595e5e785e5c591650504b165f574e"><span class="__cf_email__" data-cfemail="114143504265707777517775703f7979623f767e67">[email protected]</span></a>.

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.

Evaluation of FDA's Education at the Point of Sale Campaign OMB Control 
Number 0910--NEW

    The 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco 
Control Act) (Pub. L. 111-31) amends the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) to grant FDA authority to regulate the 
manufacture, marketing, and distribution of tobacco products to protect 
public health and to reduce tobacco use by minors. Section 
1003(d)(2)(D) of the FD&C Act (21 U.S.C. 393(d)(2)(D)) supports the 
development and implementation of FDA public education campaigns 
related to tobacco use. Accordingly, FDA is currently developing and 
implementing a tobacco education intervention at the point of sale to 
reduce the public health burden of tobacco use. The campaign features 
advertisements intended to encourage future quit attempts among current 
smokers in stores that sell tobacco products.
    In support of the provisions of the Tobacco Control Act that 
require FDA to protect the public health, FDA requests OMB approval to 
collect information to evaluate the effectiveness of the point of sale 
tobacco education campaign. Data from this outcome evaluation study 
will be used to examine statistical associations between exposure to 
the campaign and specific outcomes of interest, which include awareness 
of the campaign and its messaging, tobacco-related attitudes, beliefs 
and risk perceptions, and motivation to quit smoking.
    Evaluation is an essential organizational practice in public health 
and a systematic way to account for and improve public health actions. 
Comprehensive evaluation of FDA's public education campaigns will be 
used to document whether the intended audience is aware of and 
understands campaign messages, and whether campaign exposure influences 
tobacco-related attitudes, beliefs and risk perceptions, intentions to 
use tobacco, and motivation to quit smoking. Participation in the 
outcome evaluation study will be voluntary. All of the information 
collected is integral to that evaluation.
    Evaluation of the Point of Sale Campaign. This outcome evaluation 
study will consist of four longitudinal data collection periods over 24 
months (approximately every 7 months), with the first survey (Wave 1) 
occurring approximately 3 months after campaign launch. A fourth wave 
of data collection has been added to the three proposed in the 60-day 
notice because the campaign has been extended from 18 to 24 months. The 
additional wave of data collection is necessary to continue to assess 
the impact of the campaign. To reduce the number of participants needed 
to detect the effects of the campaign on outcomes of interest, the 
design of the campaign was changed from two treatment groups and one 
control group to one treatment group and one control group. The 
respondent numbers and burden hours below have been revised to reflect 
the four data collection waves and the change in the number of 
treatment groups.
    Information will be collected from adult cigarette smokers, ages 25 
to 54, about awareness of and exposure to campaign advertisements, 
tobacco use, and knowledge, attitudes, and beliefs related to tobacco 
use. Information will be collected on demographic variables including 
age, sex, race/ethnicity, and primary language. Participants will also 
be offered the option to download a smartphone application that will 
track their exposure to the campaign, and that will ask them to respond 
to a brief survey about every 6 months over 18 months.
    FDA's media contractor identified 37 potential counties for the 
campaign. From this list, FDA's evaluation contractor has selected 30 
counties to be included in the evaluation. Of these, 15 counties will 
receive the intervention (treatment counties), and 15 counties will not 
receive it (control counties). The number of counties has changed since 
the 60-day notice because we changed the experimental design to have 
one treatment group instead of two, which resulted in needing fewer 
counties.
    Data will be collected from a longitudinal cohort that will consist 
of an entirely new sample of adult cigarette smokers. Addresses will be 
randomly selected from postal carrier routes in the 30 selected U.S. 
counties to identify households that contain one or more adult smokers 
between the ages of 25 and 54. Pre-paid pre-addressed paper screening 
surveys will be mailed to approximately 104,541 households. We estimate 
that 27,651 (9,217 annualized respondents) households will return the 
10-minute screener they received by mail, and 26,258 (8,753

[[Page 49835]]

annualized respondents) households will complete a 10-minute in-person 
field screener conducted by trained field interviewers. Field 
interviewers will attempt to conduct field screeners for all households 
that return the mail screener and appear to have one or more eligible 
participants in the household, and a subsample of the households that 
do not return the screener. At 10 minutes per screening, the potential 
burden hours for the mail screener are 4,701 hours (1,567 annualized). 
At 10 minutes per screening, the potential burden hours for the field 
screener are 4,464 hours (1,488). The process for locating and 
screening participants has been updated since the 60-day notice to 
better reflect the study design.
    Accounting for nonresponse, we estimate that the mail and field 
screenings will result in 4,282 (1,427 annualized) adults who meet 
criteria for participation and complete the full Wave 1 questionnaire. 
The Wave 1 questionnaire will be completed during an in-person visit to 
the home, immediately after the field screening is completed, assuming 
the selected participant is available to complete the questionnaire at 
that time. If the participant is not available at that time, the 
interviewer will schedule a time to return to the household and 
complete the evaluation questionnaire in person. We estimate that the 
Wave 1 questionnaire will take 40 minutes to complete, resulting in 
2,869 (956 annualized) burden hours. Adjusting for loss to follow-up 
between waves, we anticipate that 3,426 (1,142 annualized) participants 
will complete the Wave 2 questionnaire, which will take 40 minutes and 
result in 2,295 (765 annualized) burden hours, that 2,912 (971 
annualized) participants will complete the Wave 3 questionnaire, which 
will take 40 minutes and result in 1,951 (650 annualized) burden hours, 
and that 2,475 (825 annualized) participants will complete the Wave 4 
questionnaire, which will take 40 minutes and result in 1,658 (553 
annualized) burden hours. The Waves 2, 3, and 4 questionnaires will be 
completed online or in person by trained interviewers, depending on 
participant preference. The total burden hours for Waves 2 to 4 
evaluation questionnaires will be 5,904 (1,968 annualized).
    We anticipate that approximately 54 percent of the participants 
(2,308 people (769 annualized)) who complete the Wave 1 questionnaire 
will download a smartphone application that will deliver brief app-
based questionnaires to them in between the four waves of evaluation 
data collection. These participants will complete three questionnaires 
lasting 5 minutes each (every 6 months over the course of 18 months), 
resulting in 554 (185 annualized) burden hours. The app will also use 
geolocation technology to record participants' visits to convenience 
stores as a measure of passive campaign exposure.
    In addition, over the course of the study, telephone verification 
questionnaires will be conducted with a small portion of participants. 
The purpose of these questionnaires is to ensure that information 
obtained by field interviewers is correct, to evaluate the performance 
of field interviewers, to avoid fraud, and to ensure that all relevant 
incentives were delivered. Trained staff will administer a 5-minute 
verification questionnaire to a random sample of 10 percent of 
participants who completed the in-person screening but not the Wave 1 
questionnaire (2,198 individuals (733 annualized)), and a random sample 
of 10 percent of participants who completed the Waves 1 to 4 
questionnaires (1,308 individuals (436 annualized)). At 5 minutes per 
verification questionnaire, this results in 177 burden hours (59 
annualized) for the field screener telephone verifications and 105 
burden hours (35 annualized) for the four evaluation questionnaire 
telephone verifications. Some telephone verification questionnaires may 
be administered in person if it is not possible to reach the individual 
by phone. This verification process has been added to the information 
collection request since the 60-day notice to prevent fraudulent data 
entry by interviewers.
    In addition to the telephone verification survey, we will also 
audio record (with participants' consent) interviews with a random 
sample of approximately 10 percent of respondents to the Wave 1 
questionnaire and a random 10 percent of the Waves 2, 3, and 4 
respondents who complete the questionnaire in person as an additional 
quality control measure. These recordings will be used to measure 
interviewer compliance with study procedures and will be destroyed 
after they are reviewed. This procedure does not affect participant 
burden.
    The total burden hours for the mail and field screeners, four 
outcome evaluation questionnaires, three app-based questionnaires, and 
four telephone verification questionnaires is 18,773 (6,258 
annualized).
    In the Federal Register of November 15, 2016 (81 FR 80075), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Two comments were received; however, only 
one was PRA-related.
    Comment: One comment stated that requiring or compelling retailers 
to display ``anti-smoking or anti-tobacco advocacy'' is prohibited 
under the First Amendment. If the campaign is deemed unconstitutional, 
then there is no need for the information collection.
    Response: The comment misunderstands how FDA intends to carry out 
this public education campaign. FDA intends to purchase advertising 
space from retailers on a voluntary basis and will not require that 
retailers participate in the campaign. Therefore, the comment raises an 
issue that is outside the scope of this proposed information 
collection.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                 Number of
                                                                    Number of    responses      Total
          Type of respondent                     Activity          respondents      per         annual       Average burden  per response    Total hours
                                                                                 respondent   responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Households (adults 18 and up).........  Mail screener............        9,217            1        9,217  0.17 (10 minutes)................        1,567
                                        Field screener...........        8,753            1        8,753  0.17 (10 minutes)................        1,488
                                        Telephone verification,            733            1          733  0.08 (5 minutes).................           59
                                         field screener.
Adult smokers, ages 25 to 54..........  Wave 1 questionnaire.....        1,427            1        1,427  0.67 (40 minutes)................          956
                                        Wave 2-4 questionnaires..        2,938            1        2,938  0.67 (40 minutes)................        1,968
                                        Telephone verification,            436            1          436  0.08 (5 minutes).................           35
                                         questionnaires 1-4.
Study participants (opt in)...........  App-based questionnaire..          769            3        2,308  0.08 (5 minutes).................          185
                                                                  --------------------------------------------------------------------------------------
    Total.............................  .........................  ...........  ...........  ...........  .................................        6,258
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.



[[Page 49836]]

    Dated: October 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-23450 Filed 10-26-17; 8:45 am]
 BILLING CODE 4164-01-P


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