Human Subjects Determination

Print Date: 10/25/21

Title:

Performance Monitoring of CDCs Core State Injury Prevention Program

Project Id:

0900f3eb81d460c4

Accession #:

NCIPC-ET-5/3/21-150f6

Project Contact:

Stacey A Willocks

Organization:

NCIPC/DIP/PIEB/ET

Status:

Pending Regulatory Clearance

Intended Use:

Project Determination

Estimated Start Date:

09/01/2021

Estimated Completion Date:

07/31/2026

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

Determinations
Determination

Justification

Completed

Entered By & Role

6/2/21

Angel_Karen C. (idy6) CIO HSC

Not Research / Other
HSC:
Does NOT Require HRPO
Review

45 CFR 46.102(l)
Program Evaluation
Other - Program monitoring and evaluation

PRA:
PRA Applies

6/2/21

Angel_Karen C. (idy6) OMB / PRA

Description & Funding
Description
Priority:

Standard

Date Needed:

06/16/2021

Determination Start Date:

06/02/21

Description:

This Notice of Funding Opportunity (CDC-RFA-CE21-2101) supports health department infrastructure, data and partnerships to
identify and respond to existing and emerging injury threats with data-driven public health actions. These actions are intended to
increase protective factors and reduce risk factors using the best available evidence for injuries and death. Such an approach
includes engaging in robust data and surveillance, strengthening strategic collaborations andpartnerships, and conducting
assessment and evaluation. The overall goal of this approach is to inform public health action for injury prevention. An enhanced
funding component is available for recipients to implement and evaluate prevention strategies while incorporating novel surveillance
activities, with the goal of contributing practice-based evidence to strengthen the overall evidence base for injury prevention. While
all recipients will focus their strategic efforts on prevention of traumatic brain injury (TBI), transportation-related injury, and Adverse
Childhood Experiences (ACES), recipients are also encouraged to examine their data and flex up to 25% of their award to address
identified priority injury topics of local concern (i.e. drowning, older adult falls, or suicide). This project determination is specific to the
Core SIPP performance monitoring only. The NOFO has already been cleared.

IMS/CIO/Epi-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

Assessment of Chemical Exposure Name:

Not selected

Goals/Purpose

The goal is to collect performance monitoring data via a web-based Partners Portal. This data is needed to monitor cooperative
agreement program funded under the Core State Injury Prevention Program (Core SIPP) (CDC-XXX-XX).

Objective:

The objectives are to: monitor recipients' progress in implementing the Core SIPP, identify challenges to inform CDC technical
assistance support to recipients, and to provide accountability to DIP and NCIPC leadership, as well as congress for the funds
administered though this NOFO.

Does this project include interventions, services, or Yes
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:

Yes

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:

Programmatic Work

Target Populations to be Included/Represented:

No Human Population

Tags/Keywords:

Capacity Building

CDC's Role:

CDC employees will provide substantial technical assistance or oversight ; CDC is providing funding

Method Categories:

QA/QI

Methods:

Awardees will report progress and activity information to CDC on an annual schedule using a web-based Partners' Portal. No
research design or human subjects involved.

Collection of Info, Data or Biospecimen:

Awardees will enter programmatic information into a web-based Partners' Portal.

Expected Use of Findings/Results:

Data will be used to monitor the cooperative agreement program funded under the Core State Violence and Injury Prevention
Program (Core SIPP) (CDC-XXX-XX).

Could Individuals potentially be identified based on
Information Collected?

No

Funding

Funding Type

Funding Title

Funding #

Original Budget Yr

# Years Award

CDC Cooperative Agreement

Core State Violence and Injury Prevention Program (Core SIPP)

CDC-RFA-CE21-2101

2021

5

HSC Review

Budget Amount

HSC Review

HSC Attributes
Program Evaluation

Yes

Other - Program monitoring and 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
Population - Minors
Population - Prisoners
Population - Pregnant Women
Population - Emancipated Minors

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 & Staff
Institutions
Name

FWA #

FWA Exp Date

IRB Title

IRB Exp Date

Funding #

CoAg recipient organizations

Staff
Staff
Member

SIQT
Exp. Date

Sally
Thigpen

08/08
/2022

CITI Biomedical
Exp. Date

CITI Social &
Behavioral Exp. Date

10/19/2024

CITI Good Clinical
Practice Exp. Date

Staff Role

Email

Phone

Organization

Project
Coordinator

sti9@cdc.
gov

770-4883892

PROGRAM IMPLEMENTATION AND
EVALUATION BRANCH

Data
DMP
Proposed Data Collection Start Date:

9/1/21

Proposed Data Collection End Date:

7/31/26

Proposed Public Access Level:

Public

Public Access Justification:

The purpose of the performance monitoring data is to enable CDC to monitor programmatic progress for funding accountability and
also to inform CDC technical assistance provision to awardees.

How Access Will Be Provided for Data:

The data set will not be shared publicly; however, reports based on aggregate-level data (at the recipient or program level) will be
shared externally. No PII will be collected.

Plans for Archival and Long Term Preservation:

Spatiality
Country

State/Province

County/Region

United States

Dataset
Dataset
Title

Dataset
Description

Dataset yet to be added...

Data Publisher
/Owner

Public Access
Level

Public Access
Justification

External
Access URL

Download
URL

Type of Data
Released

Collection
Start Date

Collection End
Date