Determination: IRB Approval Not Required

Print Date: 5/12/21

Title:

Public Health Emergency Preparedness Cooperative Agreement Operational Readiness Review 2.0

Project Id:

0900f3eb81b1f212

Accession #:

CPR-PSB-4/13/20-1f212

Project Contact:

Molly Sanborn

Organization:

CPR/DSLR/PIB

Status:

Project In Progress

Intended Use:

Project Determination

Estimated Start Date:

07/01/2021

Estimated Completion Date:

07/01/2024

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

Determinations
Determination

Justification

Completed

Entered By & Role

5/19/20

Garcia_Albert D. (asg9) CIO HSC

Not Research / Other
HSC:
Does NOT Require HRPO
Review

45 CFR 46.102(l)
Program Evaluation

PRA:

PRA Applies

5/29/20

Garcia_Albert D. (asg9) OMB / PRA

HRPO:
Returned with No Decision

5/29/20

Logan_Marinda D. (mwl8) HRPO Reviewer

ICRO:
Returned with No Decision

5/29/20

Zirger_Jeffrey (wtj5) ICRO Reviewer

Description & Funding
Description
Priority:

Standard

Date Needed:

06/01/2021

Determination Start Date:

04/13/20

Description:

To help evaluate the country's public health emergency preparedness and response capacity, the Centers for Disease Control and
Prevention's Division of State and Local Readiness (DSLR) administers the Public Health Emergency Preparedness (PHEP)
cooperative agreement. The PHEP program is a critical source of funding for 62 state, local, and territorial jurisdictions to build and
strengthen their ability to respond to and recover from public health emergencies. The Operational Readiness Review (ORR) is a
rigorous, evidence-based assessment used to evaluate PHEP recipients' planning and operational functions. The previous version
of the ORR evaluated a jurisdiction'??s ability to execute a large emergency response requiring medical countermeasure (MCM)
distribution and dispensing. The purpose of this new ORR 2.0 is to expand measurement and evaluation to all 15 Public Health
Emergency Preparedness and Response Capabilities, which serve as national standards for public health preparedness planning.

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 purpose of this ICR is to expand the ORR to include all 15 PHEP capabilities so DSLR can better monitor program impact and
support program analysis and improvement across all hazards impacting public health.

Objective:

The ORR 2.0 will have three modules: descriptive, planning, and operational, which will allow DSLR to analyze the data for the
development of descriptive statistics and to monitor the progress of each recipient towards performance goals. It is intended to
promote accountability, track recipient progress towards achieving desired programmatic outcomes, and provide key insights into
recipients# planning and operational strengths, areas of improvement, and technical assistance needs.

Does this project include interventions, services, or Not Selected
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:

Not Selected

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:

New Collection of Information, Data, or Biospecimens

Target Populations to be Included/Represented:

No Human Population

Tags/Keywords:

Public Health Emergency Preparedness and Response

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:

As part of the PHEP cooperative agreement, the 62 recipients are required to submit information via the ORR that will describe their
activities and progress towards defined preparedness goals/standards. This information will be submitted via forms housed in the
ORR online system.

Collection of Info, Data or Biospecimen:

The information will be submitted via the ORR online system or fillable PDF forms.

Expected Use of Findings/Results:

The findings will be collected to analyze how recipients are progressing towards defined program goals/objectives. The findings will
be aggregated to create an annual public health preparedness and response national snapshot that presents aggregated national
data and specific recipient data.

Could Individuals potentially be identified based on
Information Collected?

Yes

Will PII be captured (including coded data)?

Yes

Does CDC have access to the identifiers?

Yes

Is an assurance of confidentiality in place or
planned?

Yes

Is a certificate of confidentiality in place or planned? No
Is there a formal written agreement prohibiting the
release of identifiers?

No

Funding

Funding Type

Funding Title

Funding #

Original Budget Yr

# Years Award

CDC Cooperative Agreement

Public Health Emergency Preparedness Cooperative Agreement

CDC-RFA-TP19-1901

2019

5

HSC Review

HSC Attributes
Program 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

Budget Amount

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
Institutions yet to be added .....

Staff
Staff
Member

SIQT Exp.
Date

Molly
Sanborn

03/22/2023

CITI Biomedical
Exp. Date

CITI Social & Behavioral
Exp. Date

CITI Good Clinical Practice
Exp. Date

Staff Role

Email

Phone

Organization

Program
Official

qbo4@cdc.
gov

404-7185058

DLSR PROGRAM SERVICES
BRANCH

Data
DMP
Proposed Data Collection Start Date:

7/31/21

Proposed Data Collection End Date:

7/31/24

Proposed Public Access Level:

Public

Public Access Justification:

An annual public health preparedness and response national snapshot occurs each year that presents aggregated national data
and specific recipient data. This will continue and will reflect data collected in the proposed system.

How Access Will Be Provided for Data:

Although CDC will collect some individually identifiable information (IIF) related to the official roles of respondents, including name,
phone number, email, and PHEP awardee jurisdiction, all information will be kept on the HHS Secure Access Management Services

(SAMS) system and will only be accessible to project team members.
Plans for Archival and Long Term Preservation:

Recipient data will be kept on the HHS Secure Access Management Services (SAMS) system.

Spatiality
Country

State/Province

United States

Montana

United States

Nebraska

United States

Nevada

United States

New Hampshire

United States

New Jersey

United States

New Mexico

United States

New York

United States

Alabama

United States

Alaska

United States

Arizona

United States

Arkansas

United States

California

United States

Colorado

United States

Connecticut

United States

Delaware

United States

Florida

United States

Georgia

United States

Hawaii

County/Region

United States

Idaho

United States

Illinois

United States

Indiana

United States

Iowa

United States

Kansas

United States

Kentucky

United States

Louisiana

United States

Maine

United States

Maryland

United States

Massachusetts

United States

Michigan

United States

Minnesota

United States

Mississippi

United States

Missouri

United States

North Carolina

United States

North Dakota

United States

Ohio

United States

Oklahoma

United States

Oregon

United States

Pennsylvania

United States

Rhode Island

United States

South Carolina

United States

South Dakota

United States

Tennessee

United States

Texas

United States

Utah

United States

Vermont

United States

Virginia

United States

Washington

United States

Washington, D.C.

United States

West Virginia

United States

Wisconsin

United States

Wyoming

United States

New York

New York

United States

Illinois

Cook

United States

California

Los Angeles

American Samoa
Guam
Micronesia
Northern Mariana Islands
Puerto Rico
Palau
Marshall Islands
U.S. Virgin Islands

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