Research Determination

Print Date: 9/9/22

Title:

Evaluation of the 2022 National Tobacco Education Campaign

Project Id:

0900f3eb81ccd0c4

Accession #:

NCCDPHP-OSHHCB-3/16/21-cd0c4

Project Contact:

Lauren Boyle-Estheimer

Organization:

NCCDPHP/OSH/OSHHCB

Status:

Project In Progress

Intended Use:

Project Determination

Estimated Start Date:

08/31/2021

Estimated Completion Date:

08/30/2024

CDC/ATSDR HRPO/IRB Protocol #:
OMB Control #:

Determinations
Determination

Justification

Completed

Entered By & Role

3/31/21

Redmond Leonard_Joan (jrl3) CIO HSC

Not Research / Other
HSC:
Does NOT Require HRPO
Review

45 CFR 46.102(l)
Program Evaluation

PRA:

PRA Applies

3/31/21

Still-LeMelle_Terri (cse6) OMB / PRA

ICRO:
Returned with No Decision

3/31/21

Zirger_Jeffrey (wtj5) ICRO Reviewer

Description & Funding
Description
Priority:

Standard

Date Needed:

03/19/2021

Determination Start Date:

03/17/21

Description:

Efforts for this performance work statement will focus on developing and implementing an evaluation plan that follows CDC#s
Framework for Evaluation to evaluate the National Education Campaign Tips From Former Smokers in 2022. This is a new project
/task order that falls under CDCs National Tobacco Education Campaign Evaluation contract, the information collection component
is approved by OMB (OMB # 0920-1083). The contractor may submit this project to their IRB.

IMS/CIO/Epi-Aid/Lab-Aid/Chemical Exposure
Submission:

No

IMS Activation Name:

Not selected

Primary Priority of the Project:

Not selected

Secondary Priority(s) of the Project:

Not selected

Task Force Associated with the Response:

Not selected

CIO Emergency Response Name:

Not selected

Epi-Aid Name:

Not selected

Lab-Aid Name:

Not selected

Assessment of Chemical Exposure Name:

Not selected

Goals/Purpose

The purpose of this proposed contract is to evaluate the impact of the 2022 National Tobacco Education Campaign, Tips for Former
Smokers#. The primary goal of the 2022 campaign is to encourage smokers to quit. The objectives will be to encourage quitting use
of cigarettes among smokers ages 18 to 54; raise awareness of the immediate health damage caused by cigarette smoking and
exposure to secondhand smoke; direct people to free resources to help them quit; and encourage nonsmokers to protect
themselves and their families from exposure to secondhand smoke. The campaign will potentially be on air nationally for
approximately 24 weeks.

Objective:

The Contractor shall propose evaluation approaches for a campaign with an average exposure of 1,200 Gross Rating Points
(GRPs) per quarter over the course of the campaign. Ad placement and duration will vary, and it may be necessary to conduct
tailored evaluations for media buys focused in various regions, states, and designated market areas. CDC/OSH areas of interest
and priority for targeted evaluations include, digital media advertising, impact on demographic subgroups with high smoking

prevalence (when feasible) and subgroups by non-demographic similarities (i.e., rural/urban, geographic location). Final decisions
regarding the 2022 campaign will be shared with the Contractor as they become available upon award of the contract. The intention
of this contract is to evaluate the 2022 NTEC campaign.
Does this project include interventions, services, or Not Selected
policy change work aimed at improving the health of
groups who have been excluded or marginalized and
/or decreasing disparities?:
Project does not incorporate elements of health
equity science:

Not Selected

Measuring Disparities:

Not Selected

Studying Social Determinants of Health (SDOH):

Not Selected

Assessing Impact:

Not Selected

Methods to Improve Health Equity Research and
Practice:

Not Selected

Other:

Not Selected

Activities or Tasks:

New Collection of Information, Data, or Biospecimens

Target Populations to be Included/Represented:

Other - 18-54 year old adults, smokers and nonsmokers

Tags/Keywords:

Tobacco Use Cessation

CDC's Role:

Activity originated and designed by CDC staff, or conducted at the specific request of CDC, or CDC staff will approve study design
and data collection as a condition of any funding provided

Method Categories:

Survey

Methods:

The sample for the data collection may originate from two sources: (1) An online longitudinal cohort of smokers and nonsmokers,
sampled randomly from postal mailing addresses in the United States (address-based sample, or ABS); and (2) the existing Ipsos
Knowledge Panel, an established long-term online panel of U.S. adults. The ABS-sourced longitudinal cohort may consist of
smokers and nonsmokers who have not previously participated in any established online panels to reduce potential panel
conditioning bias from previous participation. The ABS cohort may be recruited by Ipsos, utilizing similar recruitment methods that
are used in the recruitment of Knowledge Panel. All surveys, regardless of sample source, will be conducted via the Ipsos
Knowledge Panel web portal for self-administered surveys. Surveys will be administered in English and Spanish. Once enrolled in
the first wave of data collection, participants will be re-contacted for follow-up at subsequent data collection waves. We estimate
there will be 2 waves of data collection with a total of 8,000 smoker respondents and 4,000 nonsmoker respondents. The contractor
may submit this project to their IRB.

Collection of Info, Data or Biospecimen:

All online surveys, regardless of sample source, will be conducted via the GfK/Ipsos KnowledgePanel Web portal for selfadministered surveys. All information will be collected by online surveys.

Expected Use of Findings/Results and their impact:

This data will be used to inform program planning and to evaluate the Tips campaign. This will be done through a variety of
mechanisms that may include presentations, peer-reviewed journal articles, and other reports.

Could Individuals potentially be identified based on
Information Collected?

No

Funding

Funding yet to be added .....

HSC Review

HSC Attributes
Program Evaluation

Yes

Regulation and Policy
Do you anticipate this project will be submitted to
the IRB office

No

Estimated number of study participants

Population - Children

Protocol Page #:

Population - Minors

Protocol Page #:

Population - Prisoners

Protocol Page #:

Population - Pregnant Women

Protocol Page #:

Population - Emancipated Minors

Protocol Page #:

Suggested level of risk to subjects
Do you anticipate this project will be exempt
research or non-exempt research

Requested consent process waviers
Informed consent for adults

No Selection

Children capable of providing assent

No Selection

Parental permission

No Selection

Alteration of authorization under HIPPA Privacy
Rule

No Selection

Requested Waivers of Documentation of Informed Consent
Informed consent for adults

No Selection

Children capable of providing assent

No Selection

Parental permission

No Selection

Consent process shown in an understandable language
Reading level has been estimated

No Selection

Comprehension tool is provided

No Selection

Short form is provided

No Selection

Translation planned or performed

No Selection

Certified translation / translator

No Selection

Translation and back-translation to/from target
language(s)

No Selection

Other method

No Selection

Clinical Trial
Involves human participants

No Selection

Assigned to an intervention

No Selection

Evaluate the effect of the intervention

No Selection

Evaluation of a health related biomedical or
behavioral outcome

No Selection

Registerable clinical trial

No Selection

Other Considerations

Exception is requested to PHS informing those
bested about HIV serostatus

No Selection

Human genetic testing is planned now or in the
future

No Selection

Involves long-term storage of identfiable biological
specimens

No Selection

Involves a drug, biologic, or device

No Selection

Conducted under an Investigational New Drug
exemption or Investigational Device Exemption

No Selection

Institutions & Staff
Institutions
Institutions yet to be added .....

Staff
Staff
Member

SIQT Exp.
Date

Robert
Rodes

02/28/2023

CITI Biomedical
Exp. Date

CITI Social & Behavioral
Exp. Date

12/30/2021

Data
DMP
Proposed Data Collection Start Date:

8/31/21

Proposed Data Collection End Date:

8/30/24

Proposed Public Access Level:

Restricted

Restricted Details:

CITI Good Clinical Practice
Exp. Date

Staff Role

Email

Phone

Organization

Program
Lead

rur9@cdc.
gov

770-4885748

HEALTH COMMUNICATIONS
BRANCH

Other - Data Shared by Request

Data Use Type:
Data Use Type URL:
Data Use Contact:

Public Access Justification:

Data will be shared and disseminated publicly upon request. The designated e-mail address (e.g., tobaccomediacampaign@cdc.
gov) to request data will be located on our Tips# website. We calculate that it will be more cost-efficient for us to provide one-on-one
technical assistance to interested users than to create full documentation and host the dataset on a website. In addition, data will be
distributed or released publicly as summarized and aggregated in evaluation reports, research manuscripts and other dissemination
products.

How Access Will Be Provided for Data:

A request for data may be made through a designated e-mail address (e.g. [email protected]) located on our Tips#
website that is monitored daily. OSH will accommodate all requests for data. We are planning for OSH to receive the requests,
communicate with the requestors to understand their needs within 5 business days of receipt of request, and coordinate with the
contractor to provide the data files and technical assistance to the requestor to ensure their orientation to the data.

Plans for Archival and Long Term Preservation:

The data collection is ongoing and there is not a current archive plan at this time.

Spatiality

Spatiality (Geographic Locations) yet to be added .....

Dataset
Dataset
Title

Dataset
Description

Data Publisher
/Owner

Public Access
Level

Public Access
Justification

External
Access URL

Download
URL

Type of Data
Released

Collection
Start Date

Dataset yet to be added...

Supporting Info
Current

CDC Staff
Member and Role
Boyle-

Date Added

Description

Adding the Performance Work

Supporting Info Type

Supporting Info

Collection End
Date

Estheimer_Lauren
(yjw7)
Project Contact
BoyleEstheimer_Lauren
(yjw7)
Project Contact

03/17/2021

03/17/2021

Statement (PWS) which describes
the project in detail, for reviewer
reference.

Statement of Work

Approved Concept Clearance form
in eClearance.

Other-Approved Concept
Clearance Form

Performance Work Statement_NTECEVAL_2022_3-1121_clean.docx

FINAL_APPROVED_CONCEPT CLEARANCE
FORM FROM ECLEARANCE_17MAR2021_FOR
STARS SUBMISSION.pdf