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 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2016-N-3710]
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Notice.
 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 
                        *oira_submission@omb.eop.gov.*
                         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, 
                        *PRAStaff@fda.hhs.gov.*


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 
                    ( print 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
Type of respondent
Activity
Number of
                             respondents
Number of
                             responses per  
                             respondent
Total annual responses
Average burden 
                             per response
Total hoursHouseholds (adults 18 and up)
Mail screener
9,217
1
9,217
0.17 (10 minutes)
1,567Field screener
8,753
1
8,753
0.17 (10 minutes)
1,488Telephone verification, field screener
733
1
733
0.08 (5 minutes)
59Adult smokers, ages 25 to 54
Wave 1 questionnaire
1,427
1
1,427
0.67 (40 minutes)
956Wave 2-4 questionnaires
2,938
1
2,938
0.67 (40 minutes)
1,968Telephone verification, questionnaires 1-4
436
1
436
0.08 (5 minutes)
35Study participants (opt in)
App-based questionnaire
769
3
2,308
0.08 (5 minutes)
185Total





6,2581
                         There are no capital costs or operating and maintenance costs associated with this collection of information.
 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