BRACE Project Summary and Research Determination

project-summary-0900f3eb81dee74b-5-5-2022-14_12_23.pdf

The Performance Measures Project: Improving Performance Measurement and Monitoring by CDC Programs

BRACE Project Summary and Research Determination

OMB: 0920-1282

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Print Date: 5/5/22

Title:

Building Resilience Against Climate Effects (BRACE) Performance Measures

Project Id:

0900f3eb81dee74b

Accession #:

NCEH-AEVALT-10/12/21-ee74b

Project Contact:

Megan M L McLaughlin

Organization:

NCEH/ATSDR/DEHSP/ACHB/AEVALT

Status:

Pending Regulatory Clearance

Intended Use:

Project Determination

Estimated Start Date:

10/01/2022

Estimated Completion Date:

10/01/2025

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

Determinations
Determination

Justification

Completed

Entered By & Role

11/19/21

Lawler_Tameka (giq3) CIO HSC

Not Research / Other
HSC:
Does NOT Require HRPO
Review

45 CFR 46.102(l)
Program Evaluation
Quality Assurance / Improvement

PRA:
PRA Applies

11/19/21

Lawler_Tameka (giq3) CIO OMB / PRA

Description & Funding
Description
Priority:

Standard

Determination Start Date:

10/13/21

Description:

This is a request to obtain PRA clearance for Building Resilience Against Climate Effects: Implementing and Evaluating Adaptation
Strategies that Protect and Promote Human Health (CDC-RFA-EH21-2101). The purpose of this information collection is to continue
CHP's monitoring of recipient programs' planning and delivery of public health activities and adaptation strategies under this new
cooperative agreement.

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

Information will be used for multiple purposes: 1) demonstrate program achievements, including positive effects on community or
population health; 2) build stronger evidence base for adaptations to climate change; 3) demonstrate adaptation applicability and
effectiveness across different populations, settings, and contexts; and 4) drive continuous improvement of funded recipients#
adaptation actions and implementation.

Objective:

The National Center for Environmental Health#s Climate and Health Program (CHP) supports U.S. cities and states to build and
enhance resilience to the health impacts of climate change. CDC#s CHP has funded state and local health departments or their
agents as they prepare for and respond to the health effects that a changing climate will bring to the communities they serve.

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

Not Selected

equity science:
Measuring Disparities:

Not Selected

Studying Social Determinants of Health (SDOH):

Yes

SDOH Economic Stability:

Not Selected

SDOH Education:

Not Selected

SDOH Health Care Access:

Yes

SDOH Neighborhood and Environment:

Not Selected

SDOH Social and Community Context:

Yes

SDOH Indices:

Not Selected

Other SDOH Topics:

Not Selected

Assessing Impact:

Yes

Methods to Improve Health Equity Research and
Practice:

Not Selected

Other:

Not Selected

Activities or Tasks:

New Collection of Information, Data, or Biospecimens

Target Populations to be Included/Represented:

Children ; Pregnant Women ; American Indian or Alaska Native ; Asian ; Black or African American ; Hispanic or Latino ; Native
Hawaiian or Other Pacific Islander ; Older adults > 64 years ; Healthcare Provider

Tags/Keywords:

Climate Change ; Health Equity ; Adaptation strategies

CDC's Role:

CDC employees will provide substantial technical assistance or oversight

Method Categories:

Other - Performance Measures

Methods:

We propose to collect performance measure (PM) data from the recipients of the award on an annual basis.

Collection of Info, Data or Biospecimen:

Recipients will submit standardized PM data via a newly developed electronic reporting tool a CDC-supported secure data collection
and management system called REDCap. The REDCap PM data collection instrument was created to allow recipients to
electronically input information for PMs.

Expected Use of Findings/Results and their impact:

Information will be used for multiple purposes: 1) demonstrate program achievements, including positive effects on community or
population health; 2) build stronger evidence base for adaptations to climate change; 3) demonstrate adaptation applicability and
effectiveness across different populations, settings, and contexts; and 4) drive continuous improvement of funded recipients#
adaptation actions and implementation.

Could Individuals potentially be identified based on
Information Collected?

No

Funding

Funding Type

Funding Title

Funding #

CDC Cooperative
Agreement

Building Resilience Against Climate Effects - Implementing and Evaluating Adaptation
Strategies that Protect Human Health

CDCRFA0EH21-2101

HSC Review

HSC Attributes
Program Evaluation

Yes

Quality Assurance / Improvement

Yes

Regulation and Policy
Do you anticipate this project will be submitted to
the IRB office

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

Original
Budget Yr

# Years
Award

Budget
Amount

2021

5

20000000.00

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
Name

FWA #

FWA Exp Date

IRB Title

IRB Exp Date

Funding #

Wisconsin Department of Health Services

CDC-RFA0EH21-2101

State of Vermont

CDC-RFA0EH21-2101

County of Santa Clara

CDC-RFA0EH21-2101

Oregon Health Authority

CDC-RFA0EH21-2101

NYS Health Research, Inc

CDC-RFA0EH21-2101

North Carolina Department of Health and Human Services

CDC-RFA0EH21-2101

Maine Department of Health and Human Services

CDC-RFA0EH21-2101

State of Connecticut Department of Public Health

CDC-RFA0EH21-2101

California Department of Public Health

CDC-RFA0EH21-2101

Arizona Department of Health Services

CDC-RFA0EH21-2101

San Francisco Dept of Public Hlth

FWA00000162

03/05/23

CDC-RFA0EH21-2101

Staff
Staff Member

SIQT
Exp.
Date

CITI
Biomedical
Exp. Date

CITI Social &
Behavioral Exp. Date

CITI Good Clinical
Practice Exp. Date

Staff Role

Email

Amanda Clark

n/a

n/a

n/a

Evan Mallen

n/a

n/a

n/a

Heather
Joseph

Phone

Organization

n/a

CoInvestigator

[email protected]

n/a

Project
Officer

[email protected]

10/08
/2023

Project
Officer

[email protected]

Jared Ulmer

10/08
/2023

CoInvestigator

jared.ulmer@vermont.
gov

State of Vermont

Jonathan
Meiman

10/08
/2023

CoInvestigator

jonathan.meiman@dhs.
wisconsin.gov

Wisconsin Department of Health
Services

Julie Sifuentes

10/08
/2023

CoInvestigator

julie.sifuentes@dhsoha.
state.or.us

Oregon Health Authority

Lauren Thie

10/08
/2023

CoInvestigator

[email protected].
gov

North Carolina Department of
Health and Human Services

Linda Helland

10/08
/2023

CoInvestigator

[email protected].
gov

California Department of Public
Health

Matt Wolff

10/08
/2023

CoInvestigator

[email protected]

San Francisco Dept of Public Hlth

Matthew
Roach

10/08
/2023

CoInvestigator

matthew.roach@azdhs.
gov

Arizona Department of Health
Services

Megan
McLaughlin

10/08
/2023

Project
Officer

[email protected]

Neil
Muscatiello

10/08
/2023

CoInvestigator

neil.muscatiello@health.
ny.gov

Rebecca

10/08

Co-

State of Connecticut Department
of Public Health

4046392636

ASTHMA EVALUATION TEAM

NYS Health Research, Inc

Maine Department of Health and

Lincoln

/2023

Investigator

[email protected]

Human Services

Rhonda
McClintonBrown

10/08
/2023

CoInvestigator

[email protected]

County of Santa Clara

Data
DMP
Proposed Data Collection Start Date:

10/1/22

Proposed Data Collection End Date:

10/31/25

Proposed Public Access Level:

Public

Public Access Justification:

The data will potentially be summarized or aggregated and shared on CDC website and with recipients. Data will be shared if data
sharing agreement is confirmed.

How Access Will Be Provided for Data:

Recipients will have unique access to their data collection site and will choose who should have access to enter data and access
information.

Plans for Archival and Long Term Preservation:

Spatiality

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

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


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File Created2022-05-05

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