Research Determination

Print Date: 10/1/24

Title:

Annual Progress Reports for Injury Control Research Centers (ICRC) OMB Package

Project Id:

0900f3eb823b76db

Accession #:

NCIPC-PIEB-5/20/24-9e2d9

Project Contact:

Megan C Barry

Organization:

NCIPC/DIP/PIEB

Status:

Pending Regulatory Clearance

Intended Use:

Project Determination

Estimated Start Date:

05/20/2024

Estimated Completion Date:

12/13/2024

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

Determinations

Determination

Justification

Completed

Entered By & Role

6/4/24

Ferdon_Corinne (djz4) CIO HSC

6/5/24

Ferdon_Corinne (djz4) OMB / PRA

Not Research / Other
HSC:
Does NOT Require HRPO
Review

45 CFR 46.102(l)
Program Evaluation

PRA:
PRA Applies

Description & Funding
Description
Priority:

Standard

Date Needed:

06/17/2024

Priority Justification:
CDC Priority Area for this Project:

Not selected

Determination Start Date:

06/05/24

Description:

This is an Office of Management and Budget (OMB) package for the Injury Control Research Centers (ICRCs) annual progress
reports (APRs) and success stories template. Successful clearance of the OMB package will allow the ICRC unit to collect valuable
data that will be used to monitor the performance of 11 grantees funded under Grants for Injury Control Research Centers (CDCRFA-CE24-001). APR data, publications, and success stories will be collected via the web-based Cooperative Agreement
Management Platform (CAMP). The documents in this OMB package are: 1) The OMB Supporting Statement (SS) A form provides
a justification for the OMB package, including information about why the information data collection is necessary and how improved
information technology is used to reduce grantee burden. 2) The OMB Supporting Statement B form elaborates on important details
for collections of information employing statistical methods. 3) Attachment 1: Authorizing Legislation, Section 301 of the Public
Health Service Act, which authorizes information collection as a means for states to advance public health across the lifespan and
reduce health disparities. 4) Attachment 2: List of Grantees is a placeholder document for the grantee list that will accompany the
30-day OMB package. 5) Attachment 3. ICRC CAMP Screenshots provides 8 screenshots of the ICRC APR on CAMP. 6)
Attachment 4: Crosswalk of ICRC Program Evaluation Questions and Indicators helps to explain how the evaluation questions map
onto the ICRC indicators. 7) Attachment 5a: ICRC APR is the primary document for this information collection. Grantees will
complete the APR annually, as required by their grant. The APR is divided into 4 sections: research, outreach, training and
education, and the publication table. 8) Attachment 5b: Publication Table is a part of the APR, but grantees will download it as an
Excel sheet, re-upload, and submit via CAMP. 9) Attachment 5c: Success Stories Template is not a part of the APR but will be
housed on CAMP for grantees to submit successful research, outreach, and training activities that they would like to share with
CDC and have displayed on the CDC website. 10) Attachment 6: APR guidance provides grantees with helpful information as they
fill out their APR. It includes information about what to include in each section of the APR, what to include when describing
accomplishments, etc. Additionally, the SSA and SSB documents reference attachments 7 (Federal Register Notice), 8 (NCIPC-CIO
Privacy Act applicability), and 9 (NCIPC Research Determination). These documents will be finalized while the 60-day OMB

package clears and are not included in the current project determination package, although placeholder language to be cleared is in
the documents.
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 of this project determination is to get OMB clearance for the ICRC APR and related guidance, as well as the Success
Stories template. The 11 new grantees for the ICRC 2024 funding cycle will begin funding on August 1, 2024. We hope to receive
approval from OMB in early 2025 so we can finalize the APR on CAMP. We will open the ICRC APR for data collection of year 1
progress reports on CAMP on July 1, 2025. The year 1 APR will close on October 31, 2025.

Objective:

The objectives of this project are to submit and clear an OMB package for 1) an APR 2) a Publication Table, and 3) their associated
guidance, and for 4) a Success Stories Template for CDC-RFA-CE24-001 grantees.

Does your project measure health disparities among No
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?:

Yes

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

No

Activities or Tasks:

Secondary Data or Specimen Analysis

Target Populations to be Included/Represented:

No Human Population

Tags/Keywords:

Program Evaluation ; Office of Management and Budget (OMB) package ; Injury Control Research Centers (ICRC) ; Annual
Progress Report ; performance monitoring ; Cooperative Agreement Management Platform (CAMP) ; improved information
technology ; burden reduction ; timely response
Activity originated and designed by CDC staff, or conducted at the specific request of CDC, or CDC staff will approve study design

CDC's Role:

and data collection as a condition of any funding provided

Method Categories:

Survey

Methods:

For this OMB package, the documents will be sent to the National Center for Injury Prevention and Control (NCIPC) OMB team on
May 20th, 2024 to submit for 60-day review. While the package is open for 60-day review, we will continue to refine the package
with the NCIPC OMB team. Also on May 20th, 2024, the package will be submitted for to check for Privacy Act related review. Once
we receive comments from the 60-day, we will revise and reassemble the packaging, including attachments 7 (Federal Register
Notice), 8 (NCIPC-CIO Privacy Act applicability), and 9 (NCIPC Research Determination), and submit for 30-day review. OMB
approval will be for 3 years, so we will need to renew the package in the middle of our grant cycle, so that it will cover the last few
APRs. ICRC grantees will report progress and activity information to CDC on an annual schedule using a web-based CAMP. As
necessary, grantees will also submit Success Stories. Data collection will include 100% of ICRC grantees; therefore no
subpopulation will be studied and sampling methods will not be used. No research design or human subjects will be involved. CDC
will not use statistical methods for analyzing information. Most data will be qualitative and therefore will include case and Success
Story descriptions. In certain limited cases, count data is collected (e.g., number of trainees, number of publications, etc.); however,
most of these data are used to better understand ICRC productivity and activities. Furthermore, the information in the APR and
Publication templates will allow for CDC staff to monitor program activities and implementation and provide technical assistance to
grantees after an internal qualitative review has been completed.

Collection of Info, Data or Biospecimen:

APR and Success Stories data will be collected via CAMP. This data is self-reported by ICRC grantees as part of their funding
requirements. Collecting this APR data with an electronic template on CAMP allows CDC to quickly generate a variety of routine
and customizable reports that describe activities about individual and across all funded ICRCs.

Expected Use of Findings/Results and their impact:

CDC will use OMB clearance to collect APR data and Success Stories from 11 grantees. CDC will use the APR data and Success
Stories to monitor program goals, identify grantee technical assistance needs, and to respond to inquiries from the HHS, the White
House, Congress and other stakeholders about ICRC program activities and their impact on public health. The grantee Success
Stories are particularly helpful for CDC to succinctly showcase the valuable work of ICRCs. These functions are central to the
NCIPC#s broad mission of protecting Americans from violence and injury threats. The information collection will allow CDC to
monitor the increased emphasis on strategies that affect health outcomes and impact, and is expected to reduce duplication of
effort, enhance program impact, and maximize the use of federal funds.

Could Individuals potentially be identified based on
Information Collected?

No

Funding

Funding Type

Funding Title

Funding #

Original Budget Yr

# Years Award

Budget Amount

CDC Grant

Grants for Injury Control Research Centers

CDC-RFA-CE24-001

2024

5

11000000.00

HSC Review

HSC Attributes
Program 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 #:

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? No
Institutions yet to be added .....

Staff
Staff
Member

SIQT
Exp.
Date

Ekta
Choudhary

07/25
/2026

CITI
Biomedical
Exp. Date

CITI Social &
Behavioral Exp.
Date

CITI Good Clinical
Practice Exp. Date

CITI Good Laboratory
Practice Exp. Date

Staff Role

Email

Phone

Organization

CoInvestigator

gnr0@cdc.
gov

7704883825

PROGRAM
IMPLEMENTATION AND
EVALUATION BRANCH

Data
DMP
Proposed Data Collection Start Date:

7/1/25

Proposed Data Collection End Date:

10/31/25

Proposed Public Access Level:

Public

Public Access Justification:

These data are collected with federal appropriations and will be used to develop publicly available documents (such as Success
Stories, a Program Impact Report, etc.). Thus, data will be made available to anyone who requests it. However, some of the
intellectual property or copyright restrictions may apply.

How Access Will Be Provided for Data:

The data will be provided upon request.

Plans for Archival and Long Term Preservation:

APR data will be stored on NCIPCs Data Lake. A PDF version of the APR data will be stored in the grantee file on GrantSolutions.

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

Dataset
Dataset
Title

Dataset
Description

Dataset yet to be added...

Supporting Info

Data Publisher
/Owner

Public Access
Level

Public Access
Justification

External
Access URL

Download
URL

Type of Data
Released

Collection
Start Date

Collection End
Date

Current

Current

Current

CDC Staff
Member and
Role
Barry_Megan
(pxo4)
Project Contact

Barry_Megan
(pxo4)
Project Contact

Date Added

Description

Supporting Info Type

Supporting Info

05/20/2024

A placeholder document for the
grantee list that will accompany
the 30-day OMB package.

Other-List of grantees

Att 2. List of Grantees.docx

05/20/2024

The primary document for this
information collection. Grantees
will complete the APR annually, as
required by their grant. The APR is
divided into 4 sections: research,
outreach, training and education,
and the publication table

Data Collection Form

Att 5a. ICRC APR.docx

Other-APR Guidance document

Att 6. ICRC APR Guidance.docx

Current

Barry_Megan
(pxo4)
Project Contact

05/20/2024

Provides grantees with helpful
information as they fill out their
APR. It includes information about
what to include in each section of
the APR, what to include when
describing accomplishments, etc.

Current

Barry_Megan
(pxo4)
Project Contact

05/20/2024

A part of the APR, but grantees
will download it as an Excel sheet,
re-upload, and submit via CAMP.

Data Collection Form

Att 5b. Publication Table.xlsx

Current

Barry_Megan
(pxo4)
Project Contact

05/20/2024

Elaborates on important details for
collections of information
employing statistical methods.

Other-OMB SSB document

SSB_ICRC_May 2024.docx

Current

Barry_Megan
(pxo4)
Project Contact

05/20/2024

Provides 8 screenshots of the
ICRC APR on CAMP.

Other-Enter new type

Att 3. ICRC CAMP Platform Screenshots.docx

Current

Barry_Megan
(pxo4)
Project Contact

05/20/2024

Helps to explain how the
evaluation questions map onto the
ICRC indicators.

Other-Crosswalk of indicators and
evaluation questions

Att 4. Crosswalk of Indicators and Evalutation Questions.
docx

Current

Barry_Megan
(pxo4)
Project Contact

05/20/2024

Funding determination document
from ERPO

Other-Funding Determination

CE24001_Funding Determination_5.11.2022.docx

05/20/2024

Provides a justification for the
OMB package, including
information about why the
information data collection is
necessary and how improved
information technology is used to
reduce grantee burden.

Other-OMB SSA form

SSA_ICRC_May 2024.docx

Current

Barry_Megan
(pxo4)
Project Contact

Current

Current

Barry_Megan
(pxo4)
Project Contact

Barry_Megan
(pxo4)
Project Contact

05/20/2024

Section 301 of the Public Health
Service Act, which authorizes
information collection as a means
for states to advance public health
across the lifespan and reduce
health disparities.

Other-Authorizing legislation

Att 1. Authorizing Legislation.doc

05/20/2024

Not a part of the APR but will be
housed on CAMP for grantees to
submit successful research,
outreach, and training activities
that they would like to share with
CDC and have displayed on the
CDC website.

Data Collection Form

Att 5c. Success Stories Template.docx