Att6-Human Subject Research Determination

Print Date: 4/1/24

Title:

Workplan Templates for Ten Regional Centers to Enhance Public Health Preparedness and Response

Project Id:

0900f3eb823544e8

Accession #:

-ORR-4/1/24-544e8

Project Contact:

Albert D Garcia

Organization:

ORR

Status:

Pending Regulatory Clearance

Intended Use:

Project Determination

Estimated Start Date:

04/01/2024

Estimated Completion Date:

04/01/2029

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

Determinations
Determination

Justification

Completed

Entered By & Role

4/1/24

Garcia_Albert D. (asg9) CIO HSC

Not Research / Other
HSC:
Does NOT Require HRPO
Review

45 CFR 46.102(l)
Other - Cooperative agreement performance measure

PRA:

4/1/24

PRA Applies

Garcia_Albert D. (asg9) OMB / PRA

Description & Funding
Description
Priority:

Standard

Date Needed:

04/01/2024

Determination Start Date:

04/01/24

Description:

This project aims to establish up to 10 centers across the designated Health and Human Services (HHS) regions for public health
preparedness and response (PHPR). The goal is to improve PHPR practices by increasing the uptake of evidence-based strategies
and interventions (EBSIs) that align with the needs of the communities involved. This will be achieved through 1) the development
of a five-year workplan that covers known strategies or interventions, plans to implement each strategy or intervention, or the
development and evaluation of new approaches in PHPR, 2) the use of a Cooperative Agreement Work Plan Template to monitor
performance of activities throughout the funding period and 3) the use of an Evaluation Work Plan Template to support evaluation of
implemented work plan activities.

IMS/CIO/Epi-Aid/Lab-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

Lab-Aid Name:

Not selected

Assessment of Chemical Exposure Name:

Not selected

Goals/Purpose

This project aims to establish up to 10 centers across the designated Health and Human Services (HHS) regions for public health
preparedness and response (PHPR). The goal is to improve PHPR practices by increasing the uptake of evidence-based strategies
and interventions (EBSIs) that align with the needs of the communities involved. This will be achieved through 1) the development
of a five-year workplan that covers known strategies or interventions, plans to implement each strategy or intervention, or the
development and evaluation of new approaches in PHPR, 2) the use of a Cooperative Agreement Work Plan Template to monitor
performance of activities throughout the funding period and 3) the use of an Evaluation Work Plan Template to support evaluation of
implemented work plan activities.

Objective:

To support regional centers# creation of a five-year work plan addressing 1) focus areas and objectives across State, Tribal, Local,
and Territorial (STLT) and relevant partners that would benefit from use of new or enhanced PHPR EBSIs, 2) activities to meet
objectives, 3) prioritized EBSIs to implement, 3) capability and capacity of STLT health departments and relevant partners to

implement and evaluate activities, and 4) regional sustainability for implementation of evidence-based practice beyond the five-year
period.
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?:

No

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

No

Activities or Tasks:

New Collection of Information, Data, or Biospecimens

Target Populations to be Included/Represented:

Other - HHS Regional Coordinator

Tags/Keywords:

Regional Health Planning

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:

Survey

Methods:

Contractors will collect information from the 10 HHS regional Strategic Coordinators to support development, implementation, and
evaluation of activities outlined in individualized work plans for their respective regions. The aim is to increase the implementation of
EBSIs for PHPR activities. Focus areas, objectives, and activities supporting the work plans will be developed based on collective
work and decisions of a regional coordinating body of applicable state, tribal, local, and territorial health departments and officials,
health care facilities, and health care coalitions, academic, public, and private partners. In addition, two other collection instruments
will be used including 1) a Cooperative Agreement Work Plan Template serving as a performance monitoring instrument for project
tracking through the performance period and 2) an Evaluation Work Plan Template that provides background information needed to
understand approaches in evaluating selected strategies or intervention activities.

Collection of Info, Data or Biospecimen:

Information will be collected via word document templates

Expected Use of Findings/Results and their impact:

To support regional centers# creation of a five-year work plan addressing 1) focus areas and objectives across State, Tribal, Local,
and Territorial (STLT) and relevant partners that would benefit from use of new or enhanced PHPR EBSIs, 2) activities to meet
objectives, 3) prioritized EBSIs to implement, 3) capability and capacity of STLT health departments and relevant partners to
implement and evaluate activities, and 4) regional sustainability for implementation of evidence-based practice beyond the five-year
period.

Could Individuals potentially be identified based on
Information Collected?

Funding

No

Funding
Type

CDC Contract

Funding Title

Funding
#

Establishing Workplans for Ten Regional Centers to Enhance Public Health Preparedness and
Response

HSC Review

HSC Attributes
Other - Cooperative agreement performance
measure

Yes

Regulation and Policy
Do you anticipate this project will need IRB review
by the CDC IRB, NIOSH IRB, or through reliance on
an external IRB?

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

Original Budget
Yr

# Years
Award

Budget
Amount

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

Mimisha
Kothari

04/24
/2026

Robin
Soler

12/03
/2024

Tracy
Thomas

08/07
/2026

Data

CITI Biomedical
Exp. Date

CITI Social &
Behavioral Exp. Date

CITI Good Clinical
Practice Exp. Date

Staff Role

Email

Phone

Organization

CoInvestigator

puu7@cdc.
gov

404-4983125

SCIENTIFIC EVIDENCE AND
IMPLEMENTATION TEAM

12/27/2021

Principal
Investigator

dqx4@cdc.
gov

770-4885103

SCIENCE TEAM

11/03/2025

CoInvestigator

tct5@cdc.
gov

770-4881570

SCIENTIFIC EVIDENCE AND
IMPLEMENTATION TEAM

DMP
Proposed Data Collection Start Date:

11/1/24

Proposed Data Collection End Date:

11/1/27

Proposed Public Access Level:

Non-Public

Non-Public Details:
Reason For Not Releasing Data:

Other - information collected has no public utility as it is used for program planning

Public Access Justification:

information collected has no public utility as it is used for program planning

How Access Will Be Provided for Data:

Activities do not involve the collection of sensitive or individually identifiable information (IIF). Although the contact information is
obtained for each funded recipient (i.e. contractor), the contact person provides information about the organization, not personal
information. No system of records will be created under the Privacy Act. Information will be kept secure in a shared file system with
access limited to project team members. No IIF will be distributed. CDC only includes aggregate and summary information in
reports and does not include information that may identify respondents.

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...

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

Supporting Info
No Supporting Info