CDC Determination: IRB Approval is Not Required

Att 4 Research Determination_20220324.pdf

Evaluation Reporting Template for the National and State Tobacco Control Program

CDC Determination: IRB Approval is Not Required

OMB: 0920-1390

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Project Determination
Evaluation Reporting Template for National and State Tobacco Control
Program
Project ID:

0900f3eb81e5fa9d

Accession #:

NCCDPHP-ET-12/10/21 -39abd

Project Contact:

Emilia Pasalic

Organization:

OS/OS/OSI

Status:

Pending Regulatory Clearance

Intended Use:

Project Determination

Estimated Start Date:

04/29/22

Estimated Completion Date:

04/29/25

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

ICR in process

Description
Priority
Urgent

Date Needed
01/25/22

Priority Justification
The intention of this STARS entry is to initiate an HSR determination. HSR determination is needed to publish a 30-day FRN. A 60day FRN has been published to
submit this project to OMB for information

Determination Start Date
01/11/22

Description

The goal of this project is to collect standard program evaluation-related information from funding recipients of CDC-RFA-DP20-2001: National and State Tobacco
Control Program, using a standardized data collection template titled ”Evaluation Reporting Template for National and State Tobacco Control Program” (provided in
Supporting Info).

IMS/CIO/Epi-Aid/Chemical Exposure Submission
No

IMS Activation Name
Not selected

Select the primary priority of the project
Not selected

Select the secondary priority(s) of the project
Not selected

Select the task force associated with the response
Not selected

CIO Emergency Response Name
Not selected

Epi-Aid Name
Not selected

Assessment of Chemical Exposure Name
Not selected

Goals/Purpose
The goal of this project is to collect evaluation-related information from funding recipients of CDC-RFA-DP20-2001: National and State Tobacco Control Program.
Information will be used for measuring the progress made by National and State Tobacco Control programs and to respond to inquiries from the Department of
Health and Human Services (HHS), the U.S. Congress, and other sources about outcomes of funding. This information collection project supports the NTCP state
and territorial tobacco program managers, administrators, and evaluators by specifying which information should be included in their annual evaluation reports.
Furthermore, the information collected via this form will allow CDC’s OSH to monitor and evaluate program performance; document facilitators and barriers,
lessons learned, and promising practices; establish processes to support continuous program improvement and development; and assess the effectiveness and
outcomes of the NTCP.

Objective
CDC uses the information collected to evaluate each National and State Tobacco Control Program awardee’s program implementation process and impact.
Evaluation activities by OSH staff also allow CDC to provide oversight of the use of federal funds, as well as to identify and disseminate information about
successful prevention and control strategies implemented by awardees. These functions are central to NCCDPHP’s broad mission of reducing the burden of chronic
diseases.

Does this project include interventions, services, or policy change work aimed at improving the health of groups who have been
excluded or marginalized and/or decreasing disparities?
No

Project does not incorporate elements of health equity science
Not selected

Measuring Disparities
Yes

Studying Social Determinants of Health (SDOH)
Not selected

Assessing Impact
Yes

Methods to Improve Health Equity Research and Practice
Not selected

Other
Not selected

Activities or Tasks
New Collection of Information, Data, or Biospecimens; Programmatic Work

Target Population to be Included/Represented
Other-Other- state tobacco control program staff

Tags/Keywords
Tobacco; Program Evaluation

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
Other - program evaluation; mixed methods

Methods
The data entered into the Evaluation Reporting Template will be imported into Microsoft Access for data management. Data will be analyzed using descriptive
statistics and qualitative thematic analysis.

Collection of Info, Data, or Bio specimens
50 US States, DC, Guam, and Puerto Rico receive DP20-2001 NTCP cooperative agreement funding to implement evidence-based tobacco control strategies and
activities. CDC plans to collect information related to each of the 53 recipients’ evaluation findings. Funding recipients will be asked to complete the template once

per year for 3 years. Information will be collected through the following Microsoft Word-based data collection tool: Evaluation Reporting Template for National and
State Tobacco Control Program.

Expected Use of Findings/Results and their impact
Information will be used for measuring the progress made by National and State Tobacco Control programs and to respond to inquiries from the Department of
Health and Human Services (HHS), the U.S. Congress, and other sources about outcomes of funding. For example, consolidated information can be used to answer
questions about the effectiveness and outcomes of tobacco cessation efforts for various racial/ethnic populations related to the national tobacco education
campaign. The information collection is designed to address specific outcomes outlined in the National State-Based Tobacco Control Programs (NTCP) cooperative
agreement. The NTCP aims to achieve four national goals: 1) prevent initiation of tobacco use among youth and young adults, 2) promote quitting among adults
and youth, 3) eliminate exposure to secondhand smoke, and 4) advance health equity by identifying and eliminating commercial tobacco product-related inequities
and disparities. CDC uses the results of this information collection to evaluate the model for future program efforts.

Could Individuals potentially be identified based on Information Collected?
No

Funding
Funding Type

Funding Title

Funding #

Original Fiscal
Year

# of Years
of Award

Budget
Amount

CDC Cooperative

National and State Tobacco Control Program

CDC-RFA-DP20-2001

2020

5

8570000.00

Veritas Management Group Evaluation

CONTRACT NO: 200-2020-

2020

5

26703.94

Contract ce on Smoking and Health

09680

Agreement
CDC Contract

Evaluation Technical Services

HSC Review
HSC Attributes
Program Evaluation
Yes

Regulation and Policy
Do you anticipate this project will be submitted to the IRB office
No

Institutions
Institution

FWA #

FWA Exp.
Date

IRB Title

IRB Exp. Date

Veritas Management Group,

Funding #
CONTRACT NO: 200-2020-09680

Inc.

Staff
Staff Member

SIQT Exp.
Date

Citi
Biomedical
Exp. Date

Citi Social
and
Behavioral
Exp. Date

Citi Good
Clinical Exp.
Date

Staff Role

Email

Phone #

Organization/
Institution

Debra Holden

n/a

n/a

n/a

n/a

Project

Debbie@ve

Veritas

Coordinator

ritasmanag

Management

ementgrou

Group, Inc.

p.com
Emilia Pasalic
Nikki Hawkins

08/21/2023

01/15/2022

12/20/2022

Technical

kse0@cdc.g

404-498-

EVALUATION

Monitor

ov

1531

TEAM

Contract Officer

cyt4@cdc.g

770-488-

EPIDEMIOLOGY

Representative

ov

4229

BRANCH

DMP
Proposed Data Collection Start Date

04/29/22

Proposed Data Collection End Date

04/29/25

Proposed Public Access Level

Non-Public

Reason for not Releasing the Data

Other- We are collecting program data from state health departments for project monitoring and
evaluation purposes.

Public Access justification

If we release these data, information would be reported in aggregate format with no identifying
information included.

How Access Will Be Provided for Data

The Evaluation Reporting Template for National and State Tobacco Control Program will only collect
organizational or institutional information. No information about individuals or households will be
collected. All data will be reported in aggregate form, with no identifying information included.
Because data is maintained in a secure, password protected system, and information will be

reported in aggregate form, there is no impact on respondent privacy. The Evaluation Reporting
Template will be provided in Microsoft Word format. The completed templates will be uploaded to a
secure web-based Awards Management Platform (AMP). Aggregated information will be stored on
an internal CDC platform subject to CDC's information security guidelines. The online platform and
database undergo security certification and accreditation through CDC's Office of the Chief
Information Security Officer. CDC staff, evaluation and technical assistance, and training contractors
will have varying levels of access to the system with role-appropriate security training, based on the
requirements of their position(s). While consent is not required to report aggregate data, recipient
consent will be obtained if specific state data is used for publications, reports or other publicly
disseminated information.

Plans for archival and long-term preservation of

Aggregated information will be stored on an internal CDC platform subject to CDC's information

the data

security guidelines. The online platform and database undergo security certification and
accreditation through CDC's Office of the Chief Information Security Officer.

Spatiality (Geographic Location)
Country

State/Province

County/Region

United States

Determinations
Determination

Justification

Completed

Entered By & Role

HSC:

Not Research / Other

01/11/22

Redmond Leonard_Joan (jrl3) CIO HSC

01/11/22

Still-LeMelle_Terri (cse6) OMB / PRA

Does NOT Require HRPO
Review

45 CFR 46.102(l)

Program Evaluation
PRA:
PRA Applies


File Typeapplication/pdf
AuthorPasalic, Emilia Sigrid (CDC/DDNID/NCCDPHP/OSH)
File Modified2022-03-25
File Created2022-03-24

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