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 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2023-N-0894]
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Notice.
 SUMMARY: The Food and Drug Administration (FDA or we) 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: Submit written comments (including recommendations) on the collection of information by April 4, 2024.
 ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to 
                        *https://www.reginfo.gov/​public/​do/​PRAMain.*
                         Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the search function. The title of this information collection is “The Real Cost Monthly Implementation Assessment.” Also include the FDA docket number found in brackets in the heading of this document.
 FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
                        *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. The Real Cost Monthly Implementation Assessment OMB Control Number 0910-NEW This information collection supports the development and implementation of FDA public education campaigns related to tobacco use. To reduce the public health burden of tobacco use in the United States and educate the public—especially young people—about the dangers of tobacco use, the FDA Center for Tobacco Products (CTP) is developing and implementing multiple public education campaigns. FDA launched “The Real Cost” in February 2014, seeking to reduce tobacco use among at-risk teens ages 12-17 in the United States who are open to smoking cigarettes and/or using electronic nicotine delivery systems (ENDS) products, or who have already experimented with cigarettes and/or ENDS products. Complementary evaluation studies, including the “Evaluation of FDA's Public Education Campaign on Teen Tobacco,” were implemented to measure awareness of “The Real Cost” paid media campaign among teens ages 12-17 in the United States, and to understand how awareness is related to change in key outcomes. Although outcome evaluation studies of “The Real Cost” have and continue to assess the impact of awareness on outcomes, no studies have sought to assess the implementation of “The Real Cost.” As FDA continues to increase the presence of “The Real Cost” on digital channels (
                    *e.g.,*
                     Hulu, YouTube, Instagram), the need for an implementation evaluation has become clear as these messages are received by the target audience on digital channels differently compared to how the messages are received on broadcast channels. Before the migration of campaign ads to digital channels, ads from “The Real Cost” were primarily aired on broadcast TV. In the broadcast space, for people to avoid receiving the message, they needed to be proactive (
                    *e.g.,*
                     finding the remote to change the channel or leaving the room). In the digital space, however, people need to be proactive to watch the full message, like stopping scrolling on social media or watching the full ad on YouTube. Assessment of this information is integral to understanding self-reported ad awareness levels, as well as how our audience experiences and processes the ads as they are airing in a digital setting. Therefore, we propose a study to help us understand, in a digital setting, how teens experience the messages, how they engage with messages, the extent to which teens report being exposed to messages, and how teens process the messages. Data gathered from this assessment will also provide the necessary and timely information to optimize campaign messages, the digital media buy (
                    *i.e.,*
                     where, how, and when ads are shown), and creative rotations (
                    *i.e.,*
                     which ads are shown). “The Real Cost” Monthly Implementation Assessment (MIA) is a repeated cross-sectional survey that will be conducted using web-based surveys that are self-administered on personal computers or web enabled mobile devices to collect rapid data on “The Real Cost” stimuli. Data from up to 2,000 teens in the United States will be collected each month for up to 24 months. To be eligible, participants must be between the ages of 12-20 and have not taken the MIA survey within the past 3 months. We will use an Ipsos Knowledge Panel to collect data on “The Real Cost” stimuli. This design offers flexibility to assess new stimuli messages, as they air across various digital platforms, examine their performance over time, as well as the ability to pivot and add new survey measures as necessary. Monthly data will also allow us to obtain timely information on stimuli awareness, perceived effectiveness, as well as on teen attention and processing of the stimuli. The purpose of FDA's “The Real Cost” is to evaluate the following key components about “The Real Cost” stimuli: Awareness of “The Real Cost” stimuli.
                Attention behaviors when seeing “The Real Cost” stimuli.
                Processing of “The Real Cost” stimuli, including: ○ Engagement with the stimuli. ○ Main message comprehension. ○ Acceptance and/or rejection of the stimuli. Perceived effectiveness of “The Real Cost” stimuli.
                Potential unintended consequences of viewing “The Real Cost” stimuli. In addition to the above components, the survey will ask participants to report on tobacco use and other psychographic and demographic items. The time frame that the survey items will ask about for stimuli awareness (
                    *i.e.,*
                     past 30 days or past week) will depend on several factors, including how long the stimuli was on air. The survey will take an average of approximately 25 minutes to complete per participant. As the survey items are tested, any irrelevant items will be cut as necessary. Stimuli creative for both vaping and cigarette products will be assessed; therefore, two similar surveys (one on ENDS-focused 
                    ( print page 15876)
                    stimuli and one on cigarette-focused stimuli) will be fielded as appropriate, but not within the same month. In support of the provisions of the Tobacco Control Act that require FDA to protect the public health and to reduce tobacco use by minors, FDA requests OMB approval to collect information to evaluate CTP's public education campaign “The Real Cost” through the MIA. In the 
                    **Federal Register**
                     of April 27, 2023 (88 FR 25660), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. 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
                             responses
Average burden per response
Total hoursParent Screener
2,338,560
1
2,338,560
0.05 (3 minutes)
116,928Parent Permission
1,753,920
1
1,753,920
0.05 (3 minutes)
87,696Invitation Emails (Respondents ages 18-20)
54,096
1
54,096
0.02 (1 minute)
1,082Youth Assent
27,936
1
27,936
0.05 (3 minutes)
1,397Young Adult Consent
20,064
1
20,064
0.05 (3 minutes)
1,003Online Survey
48,000
1
48,000
0.42 (25 minutes)
20,160Reminder Emails
48,000
1
48,000
0.20 (12 minutes)
9,600Total




237,8661
                         There are no capital costs or operating and maintenance costs associated with this collection of information.
 Data collection for the MIA will consist of administering a monthly survey to participants ages 12-20 over the course of 2 years (24 months). We expect the screening process (3 minutes per response) to yield an approximate 2.3 to 1 ratio of eligible participants. We will need to screen approximately 97,440 potential parents each month (resulting in 2,338,560 screeners) over the study period. Since the eligible age for data collection is 12 to 20 years old, we intend to screen parents of eligible youth and young adults. Parents of the youth participants determined to be eligible through the screener will provide parent permission (3 minutes per response). We estimate that 1,753,920 of the parents who complete the screener will provide their permission for their youth to complete the online survey (approximately 75 percent of the 2,338,560 screened). In addition to recruiting respondents through parents, we will send direct invitations to young adult panel members (18 to 20 years old). We anticipate that 50 percent of young adults will agree to participate. We will send 508 direct invitations a month to young adult panel members (18 to 20 years old). Eligible youth (1,753,920) will provide their assent (3 minutes per response) to participate in the online survey (25 minutes per response). Participants who are 18 to 20 years old (19 to 20 years old in Alabama and Nebraska in accordance with state law) will provide their consent (3 minutes per response) to participate in the online survey. We estimate that approximately 42 percent of the 48,000 completed surveys will come from young adults aged 18 to 20 (aged 19 to 20 in Alabama and Nebraska). Over the course of the study period, we intend to survey approximately 2,000 teens ages 12-20 per month for 24 months. From completed screeners, we estimate that we will obtain data from approximately 27,936 youth and 20,064 young adults. This will give us a total of 48,000 participants for the study. The survey will be repeated with a new cross-sectional sample approximately every month over a period of 24 months; however, some participants will complete more than one wave. These 48,000 respondents will receive an invitation email with a link to take the survey (4 minutes), 6 reminder emails (3 minutes each), and a thank you email (3 minutes) upon completion of the study for a total of 25 minutes for respondents to read and respond to the emails. Several changes have been made to this information collection request since the 60-day notice was published in the 
                    **Federal Register**
                    . These changes include (a) editing to clarify that the ad campaign is intended for “teens” not just “youth;” (b) removing the focus on video ads since the campaign may use other forms of communication to deliver its message and replacing the term “ad” with “stimuli;” (c) removing the youth screener from the burden table because parents determine the eligibility of their youth aged 12-17 (18-20 in Alabama and Nebraska in accordance with state law); (d) removing the young adult screener from the burden table, which will not be needed because young adult panel members (18-20 years old) will only receive an email invitation to complete the survey; (e) updating the burden table to reflect that we will send direct invitations to young adult panel members (18-20 years old); (f) updating the permission, assent, and consents because of updated information on the expected sample breakdown from the sample vendor for the distribution of the sample who are 12-17 years old and 18-20 years old; and (g) removing the thank you email since that will not be a part of the data collection procedures. In addition to the implementation evaluation described above, we will also assess perceptions to proposed stimuli and potential unintended consequences in order to inform the development of future messaging. Dated: February 28, 2024. Lauren K. Roth, Associate Commissioner for Policy.


[FR Doc. 2024-04526 Filed 3-4-24; 8:45 am] BILLING CODE 4164-01-P