Federal Register / Vol. 89, No. 44 / Tuesday, March 5, 2024 / Notices 15875 

Affected Public: State Governments; 

Number of Respondents: 19; Total 

Annual Responses: 399; Total Annual 

Hours: 5,549. (For policy questions 

regarding this collection contact Lina 

Rashid at 301–492–4193.) 

William N. Parham, III 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–04591 Filed 3–4–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–0894] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; The Real Cost 

Monthly Implementation Assessment 

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: 

Æ Engagement with the stimuli. 

Æ Main message comprehension. 

Æ 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 


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15876 Federal Register / Vol. 89, No. 44 / Tuesday, March 5, 2024 / Notices 

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 hours 

Parent Screener .......................................................... 2,338,560 1 2,338,560 0.05 (3 minutes) ..... 116,928 

Parent Permission ....................................................... 1,753,920 1 1,753,920 0.05 (3 minutes) ..... 87,696 

Invitation Emails (Respondents ages 18–20) ............. 54,096 1 54,096 0.02 (1 minute) ...... 1,082 

Youth Assent ............................................................... 27,936 1 27,936 0.05 (3 minutes) ..... 1,397 

Young Adult Consent .................................................. 20,064 1 20,064 0.05 (3 minutes) ..... 1,003 

Online Survey .............................................................. 48,000 1 48,000 0.42 (25 minutes) .. 20,160 

Reminder Emails ......................................................... 48,000 1 48,000 0.20 (12 minutes) .. 9,600 

Total ...................................................................... ........................ ........................ ........................ ................................ 237,866 

1There 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Request for Information: Nomination 

and Evidence-Based Review Process 

of the Advisory Committee on 

Heritable Disorders in Newborns and 

Children 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice of request for public 

comment. 

SUMMARY: At the request of the Advisory 

Committee on Heritable Disorders in 

Newborns and Children (ACHDNC or 


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