IRB Determination

Print Date: 6/9/25

Title:

Performance Monitoring of CDCs Core State Injury Prevention Program

Project Id:

0900f3eb81d150f6

Accession #:

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

Project Contact:

Angela Deokar

Organization:

NCIPC/DIP/PIEB/ET

Status:

Project In Progress

Intended Use:

Project Determination

Estimated Start Date:

09/01/2021

Estimated Completion Date:

07/31/2026

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

Determinations

0920-1369

Determination

Justification

Completed

Entered By & Role

6/2/21

Angel_Karen C. (idy6) CIO HSC

6/2/21

Angel_Karen C. (idy6) OMB / PRA

1/10/23

Zirger_Jeffrey (wtj5) ICRO Reviewer

Not Research / Other
HSC:
Does NOT Require HRPO
Review

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

PRA:
PRA Applies

ICRO:
PRA Applies

OMB Approval date: 9/14/22
OMB Expiration date: 9/30/25

Description & Funding
Description
Priority:

Standard

Date Needed:

05/10/2021

Priority Justification:
CDC Priority Area for this Project:

Not selected

Determination Start Date:

05/03/21

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/Lab-Aid/Chemical Exposure
Submission:

No

IMS Activation Name:

Not selected

Submitted through IMS Clearance Matrix:

Not selected

Primary Scientific Priority:

Not selected

Secondary Scientific Priority (s):

Not selected

Task Force Responsible:

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 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 your project measure health disparities among Not Selected
populations/groups experiencing social, economic,
geographic, and/or environmental disadvantages?:
Does your project investigate underlying
contributors to health inequities among populations
/groups experiencing social, economic, geographic,
and/or environmental disadvantages?:

Not Selected

Does your project propose, implement, or evaluate
an action to move towards eliminating health
inequities?:

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 and their impact:

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

HSC Attributes
Program Evaluation

Yes

Other - Program monitoring and evaluation

Yes

Regulation and Policy
Do you anticipate this project will require review by
a CDC IRB or HRPO?

No

Estimated number of study participants

Population - Children

Protocol Page #:

Population - Minors

Protocol Page #:

Population - Prisoners

Protocol Page #:

Population - Pregnant Women

Protocol Page #:

Budget Amount

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 HIPAA 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

Will you be working with an outside Organization or Institution? Yes
Institution

FWA #

FWA Exp Date

Funding

Funding Restriction Amount

CoAg recipient organizations

Institution

Funding Restriction Percentage

Funding Restriction Reason

Funding Restriction has been Lifted

CoAg recipient organizations

Institution
CoAg recipient organizations

Institution Role(s)

Institution Project Title

Institution Project Tracking #

Prime Institution

Institution

Regulatory Coverage

IRB Review Status

CoAg recipient organizations

Institution

Registered IRB

IRB Registration Exp. Date

IRB Approval Status

CoAg recipient organizations

Institution

IRB Approval Date

IRB Approval Exp. Date

Relying Institution IRB

CoAg recipient organizations

Staff
Staff
Member

SIQT
Exp.
Date

Sally
Thigpen

08/01
/2026

CITI
Biomedical
Exp. Date

CITI Social &
Behavioral Exp.
Date

CITI Good Clinical
Practice Exp. Date

11/26/2027

CITI Good Laboratory
Practice Exp. Date

Staff Role

Email

Phone

Organization

Project
Coordinator

sti9@cdc.
gov

7704883892

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

Data Publisher
/Owner

Public Access
Level

Public Access
Justification

External
Access URL

Download
URL

Type of Data
Released

Collection
Start Date

Collection End
Date

Dataset yet to be added...

Supporting Info
Current

CDC Staff
Member and
Role
Zirger_Jeffrey
(wtj5)
ICRO Reviewer

Willocks_Stacey
(xcz9)
Project Contact

Date Added

Description

Supporting Info Type

Supporting Info

01/10/2023

NOA 0920-1369 (2022)

Notice of Action

NOA 0920-1369.pdf

05/03/2021

This is the web-based reporting
format in the Partners' Portal for
awardees to enter their
programmatic data annually.

Data Collection Form

Attachment D_Core SIPP Partners Portal reporting
platform.pptx