IRB Determination

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Form Version Date Nov. 2016

NCIPC Determination
General Information
Project Title
DELTA Impact Annual Progress Report (APR) Tool and Prevention Infrastructure Assessment

Science Officer(s)Lindsey Barranco

Telephone: (404) 498-5221

Division: DVP

Ethics verification number: 18982

E-mail yzi9@cdc.gov
Project Officer(s)Jessica Crowell

Division: DVP

Telephone:
Ethics verification number:

E-mail wuz6@cdc.gov

Proposed Project Dates:
03/02/2018 Ending: 03/01/2022
Start:
Ex: MM/DD/YYYY

Ex: MM/DD/YYYY

Funding Mechanism
• Cooperative Agreement #:
• Grant #:
• Contract#:
• No funding (Specify):

Funding FOA#: CE18-1801
Funding FOA#:

Describe the purpose, methods, and outcomes of the project

PURPOSE: CDC has developed the Annual Progress Report (APR) tool and Prevention Infrastructure Assessment
for DELTA Impact Recipients. The goal of this information collection effort is to collect data related to
implementation and performance monitoring from DELTA Impact recipients and to allow CDC to assess the
impact of the program across the program recipients. METHODS: The ten recipients will complete the APR tool
annually using a Microsoft-based fillable electronic tool that will be submitted to CDC project officers and
evaluation officers as part of their required annual reporting and continuation application. The Prevention
Infrastructure Assessment will be collected via a web-based survey tool that will be emailed to recipients in years
1, 3 and 5. OUTCOMES: CDC will use the information collected to monitor recipient's progress and to identify
facilitators and barriers to program implementation and achievement of outcomes. In addition, CDC will look at
the aggregate impact of program activities on program outcomes across grantees.
Describe the roles and responsibilities of CDC and any partner organizations (e.g., grantee, contractor).
CDC will develop the APR tool, with help from an IT contractor, and will pre-populate as much information as possible before
sending to the recipient to complete 120 days before the end of their first year of funding. After year 1, the recipients (10 state
domestic violence coalitions) will continue to complete the tool on an annual basis and send to CDC. CDC and the IT
contractor will then import the data from the tool into an integrated database.
CDC will send the Prevention Infrastructure Assessment to the Executive Director of each of the 10 state domestic violence
coalitions one time in Years 1, 3 and 5 via a web-based survey tool. There will be one response per coalition. CDC will use the
survey tool to aggregate and download the raw data which will be analyzed internally by CDC staff working on the project.
CDC will provide guidance and technical assistance to recipients around the completion of both the APR tool and the
Infrastructure Assessment Tool and will be available to answer any questions that recipients have.

CDC 0.1485 (E), January 2017, CDC Adobe Acrobat DC, S508 Electronic Version, January 2017

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Form Version Date Nov. 2016

NCIPC Determination
Project Title:
DELTA Impact Annual Progress Report (APR) Tool and Prevention Infrastructure Assessment

Proposed Project Dates:
03/02/2018
Start:

Ending:

03/01/2022

Applicability of Human Subjects Regulations
Please check appropriate category:
✔

I. Activity is not research. Primary intent is public health practice: disease/injury control, surveillance,
improvement of programs or services. Objectives focused on a specific population.
___ A. Epidemic/endemic disease/injury control activity; collected data directly relate to immediate disease
control needs (e.g., epi-aid).
___ B. Routine disease/injury surveillance activity; data used for disease control program or policy purposes
for a specific health condition/disease in a specific population and setting. (Includes disease reporting)
✔ C. Program evaluation/monitoring activity; data are used primarily for assessing, monitoring or
___
improving a program, policy, or a communications activity (e.g., message testing) in a specific
population/setting.
___ D. Purchase orders or contracts for services or equipment.
-ORII. Activity is research but does NOT involve human subjects. Primary intent is to develop or contribute to
generalizable knowledge, but data is obtained solely from non-human sources or not living individuals, or anonymous
existing data collected for another purpose are being analyzed:
___ A. Activity is research involving collection/analysis of data about health facilities or other
organizations or units, which are not individual persons
___ B. Activity is research using existing unlinked or anonymous data previously collected for another purpose.
___C. Activity is research involving data and/or specimens from deceased persons.

-ORIII. Activity is research involving human subjects but CDC is not engaged. CDC employees including visiting
scientists, fellows, and on-site contractors (but not off-site contractors or other collaborators
*Will NOT obtain consent or data by intervening or interacting with participants
*Will NOT have access to identifiable (including coded) private data or biological specimens
NOTE: Once local IRB approval has been obtained please forward a copy (electronic preferred) to the NCIPC Human
Subjects Coordinator for records keeping purposes.
-ORIV. Activity is research involving human subjects but exempt according to the categories specified in the
regulations 45 CFR 46.101(b). Educational practices, Educational tests, surveys, interviews, or observation of
public behavior. Existing data, documents, records (e.g., not identifiable, publicly available). Demonstration
projects.
-ORV. Activity is research involving human subjects, CDC is engaged, and CDC IRB approval will be sought.

CDC 0.1485 (E), January 2017, CDC Adobe Acrobat DC, S508 Electronic Version, January 2017

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Form Version Date Nov. 2016

Required Signatures

Digitally signed by
Kimberley E. Freire -S
Date: 2017.10.19
13:31:11 -04'00'
Branch/Team Official (e.g., Branch chief or Team Lead)

Kimberley
E. Freire -S

signed by
Kathleen C. Digitally
Kathleen C. Basile -S
Date: 2017.10.19
Basile -S
17:03:25 -04'00'
Division Official (e.g., ADS, Director)

Human Subjects Coordinator

10/19/2017
Date

10/19/2017
Date

Date

Office Use Only

CDC 0.1485 (E), January 2017, CDC Adobe Acrobat DC, S508 Electronic Version, January 2017

Next Page

Previous Page

Form Version Date Nov. 2016

NCIPC Determination

Project Title:

DELTA Impact Annual Progress Report (APR) Tool and Prevention Infrastructure Assessment

Proposed Project Dates:
Start:
03/02/2018

Ending:

03/01/2022

Applicability of OMB-PRA Regulations
Please check appropriate category:
I. Does the activity involve collecting identical information from 10 or more respondents within a one year period
Including evaluation/monitoring (Examples of collections: Surveys & Interviews (Phone & On-line) - Focus groups –
Surveillance – Program evaluation- Program monitoring).
No
✔

Yes - Type of collection:
On-site questionnaire
Mail-back questionnaire
Testing/assessment form ✔ Web-based survey
Evaluation
Observation
Comment card
✔ Other (Explain) Email APR Tool to Project Officer

Personal interview
Focus groups
Workshop

Telephone survey
Record abstractions
Discussion group

II. Is NCIPC Sponsoring the data collection? Check all that apply.
✔

✔
✔

✔

✔
✔

A. NCIPC will initiate or request a data collection.
B. NCIPC will develop or design the data collection.
C. NCIPC will manage or own the data collection.
D. NCIPC will be directing the data collection.
E. NCIPC staff will interact/intervene participants.
F. NCIPC is requesting specific data reports.
G. NCIPC will disseminate the data as an official report or study.
H. NCIPC is not conducting any of the above activities and therefore is not sponsoring the data
collection.

CDC 0.1485 (E), January 2017, CDC Adobe Acrobat DC, S508 Electronic Version, January 2017

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