230 Federal Register / Vol. 80, No. 2 / Monday, January 5, 2015 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–2294] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Evaluation of the 

Food and Drug Administration’s 

Multicultural Youth Tobacco 

Prevention Campaigns 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

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 evaluation of FDA’s multicultural 

youth tobacco prevention campaigns. 

DATES: Submit either electronic or 

written comments on the collection of 

information by March 6, 2015. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

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. 

Evaluation of FDA’s Multicultural 

Youth Tobacco Prevention Campaigns 

(OMB Control Number—0910–New) 

The 2009 Family Smoking Prevention 

and Tobacco Control Act (Tobacco 

Control Act) (Pub. L. 111–31) amended 

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 youth-targeted public 

education campaigns to help prevent 

tobacco use among multicultural youth 

and thereby reduce the public health 

burden of tobacco. The campaigns will 

feature events, advertisements on 

television and radio and in print, digital 

communications including social 

media, and other forms of media. 

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 

needed to evaluate FDA’s multicultural 

youth tobacco prevention campaigns. 

Comprehensive evaluation of FDA’s 

public education campaigns is needed 

to ensure campaign messages are 

effectively received, understood, and 

accepted by those for whom they are 

intended. Evaluation is an essential 

organizational practice in public health 

and a systematic way to account for and 

improve public health actions. 

FDA plans to conduct two studies to 

evaluate the effectiveness of each of its 

multicultural youth tobacco prevention 

campaigns: (1) An outcome evaluation 

study and (2) a media tracking survey. 

The timing of these studies will be 

designed to follow the multiple, discrete 

waves of media advertising planned for 

the campaigns. 

Outcome Evaluation Studies 

The outcome evaluation studies 

consist of baseline surveys of 

multicultural youth aged 12 to 18 before 

each campaign’s launch. The baseline 

will be followed by three cross-sectional 

surveys of the target audience of youth 

at approximate 6-month intervals after 

the campaign’s launch. Information will 

be collected about youth awareness of 

and exposure to campaign events and 

advertisements and about tobaccorelated knowledge, attitudes, beliefs, 

intentions, and use. Information will 

also be collected on demographic 

variables including age, sex, race/

ethnicity, grade level, and primary 

language. 

Media Tracking Surveys 

The media tracking surveys consist of 

assessments of youth aged 13 to 18 

conducted at 3, 9, and 15 months 

postcampaign launch—timing that 

complements the outcome evaluation’s 

timing. The media tracking surveys will 

assess awareness of the campaigns and 

receptivity to campaign messages. These 

data will provide critical evaluation 

feedback to the campaigns and will be 

conducted with sufficient frequency to 

match the cyclical patterns of events 

and media advertising and variation in 

exposure to allow for midcampaign 

refinements. 

All information will be collected 

through in-person and Web-based 

questionnaires. Youth respondents will 

be recruited from four sources: (1) A 

sample drawn from 30 U.S. media 

markets gathered using an addressbased postal mail sampling of U.S. 

households for the outcome evaluation 

studies, (2) an Internet panel for the 

media tracking surveys, (3) intercepts at 

various locations (e.g., mall, events), 

and (4) targeted social media (e.g., 

Facebook). Participation in the studies 

is voluntary. 

The information collected is 

necessary to inform FDA’s efforts and 

measure the effectiveness and public 

health impact of the campaigns. Data 

from the media-tracking surveys will be 

used to estimate awareness of and 

exposure to the campaigns among youth 

in target markets where the campaigns 

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Federal Register / Vol. 80, No. 2 / Monday, January 5, 2015 / Notices 231 

are active. Data from the outcome 

evaluation studies will be used to 

examine statistical associations between 

exposure to the campaigns and 

subsequent changes in specific 

outcomes of interest, which will include 

knowledge, attitudes, beliefs, and 

intentions related to tobacco use. 

FDA’s burden estimate is based on 

prior experience with in-person and 

Internet panel studies similar to the 

Agency’s plan presented in this 

document. To obtain the target number 

of completed surveys (completes) for the 

outcome evaluation studies, 48,000 

youth respondents and their parent or 

legal guardian will be contacted through 

a screening and consent process. The 

estimated burden per response is 5 

minutes, for a total of 4,000 hours. An 

estimated 16,800 surveys will be 

completed in the baseline and 3 

postcampaign cross-sectional surveys. 

The estimated burden per response is 35 

minutes for each survey wave, for a total 

of 9,800 hours. 

To obtain the target number of 

completes for the media tracking survey, 

a total of 90,000 respondents will be 

contacted for the 3 survey waves 

through an online invitation. The 

estimated burden per response is 2 

minutes, for a total of 3,000 hours for all 

waves of the Media Tracking Screener. 

An estimated 2,000 youth will be 

recruited to complete each of the 3 

waves of the media tracking survey. The 

estimated burden per response is 30 

minutes for each questionnaire, for a 

total of 3,000 hours for all of the three 

waves of the Media Tracking 

Questionnaire. 

The total number of respondents is 

160,800. The total estimated burden is 

19,800 hours. 

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 hours 

General Population.Screener and Consent Process 

(Youth and Parent)—Baseline/

Wave 1—outcome study.

12,000 1 12,000 0.0833 (5 min.) ...... 1,000 

General Population.Screener and Consent Process 

(Youth and Parent)—Wave 2— 

outcome study.

12,000 1 12,000 0.0833 (5 min.) ...... 1,000 

General Population.Screener and Consent Process 

(Youth and Parent)—Wave 3— 

outcome study.

12,000 1 12,000 0.0833 (5 min.) ...... 1,000 

General Population.Screener and Consent Process 

(Youth and Parent)—Wave 4— 

outcome study.

12,000 1 12,000 0.0833 (5 min.) ...... 1,000 

Multicultural 

Youth aged 

12–18 in select 

media markets.

Baseline (Wave 1) youth outcome evaluation questionnaire.4,200 1 4,200 0.5833 (35 min.) .... 2,450 

Wave 2 youth outcome evaluation questionnaire.4,200 1 4,200 0.5833 (35 min.) .... 2,450 

Wave 3 youth outcome evaluation questionnaire.4,200 1 4,200 0.5833 (35 min.) .... 2,450 

Wave 4 youth outcome evaluation questionnaire.4,200 1 4,200 0.5833 (35 min.) .... 2,450 

Multicultural 

youth aged 

13–18 in the 

select media 

markets.

1st Media Tracking Screener ...... 30,000 1 30,000 0.03333 (2 min.) .... 1,000 

1st Media Tracking Questionnaire.2,000 1 2,000 0.5 (30 min.) .......... 1,000 

2nd Media Tracking Screener ..... 30,000 1 30,000 0.03333 (2 min.) .... 1,000 

2nd Media Tracking Questionnaire.2,000 1 2,000 0.5 (30 min.) .......... 1,000 

3rd Media tracking Screener ....... 30,000 1 30,000 0.03333 (2 min.) .... 1,000 

3rd Media Tracking Questionnaire.2,000 1 2,000 0.5 (30 min.) .......... 1,000 

Total ............ ...................................................... 160,800 ........................ ........................ ................................ 19,800 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Dated: December 29, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–30808 Filed 1–2–15; 8:45 am] 

BILLING CODE 4164–01–P 

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