Research Determination

Print Date: 8/15/23

Title:

Public Health Emergency Management Capacity Assessment Tool (PHEM Tool)

Project Id:

0900f3eb820df056

Accession #:

CPR-EMTA-1/11/23-869b3

Project Contact:

Wendy P Smith

Organization:

CPR/DEO/GEMCD/EMTA

Status:

Pending Regulatory Clearance

Intended Use:

Project Determination

Estimated Start Date:

02/28/2023

Estimated Completion Date:

09/30/2025

CDC/ATSDR HRPO/IRB Protocol #:

Not Applicable

OMB Control #:

Not Applicable

Determinations
Determination

Justification

Completed

Entered By & Role

3/4/23

Garcia_Albert D. (asg9) CIO HSC

Not Research - Public Health Surveillance
45 CFR 46.102(l)(2)
HSC:
Does NOT Require HRPO
Review

Not Research / Other
45 CFR 46.102(l)

Program Evaluation
Other - PH Emergency Preparedness

Qualifies for a statutory waiver:

Justification: # Project Title: Public Health
Emergency Management Capacity
Assessment Tool (PHEM Tool) # POC
(Project Officer/Principle Investigator):
Wendy Smith # Estimated date of project
completion: 9/9/025 # Priority Topics
(relationship to COVID-19 response): To
create an easy to use and
comprehensive PHEM Program and
PHEOC assessment tool for use in
Global Health Security Agenda as well as
USG/ CDC priority countries. # Efforts
made to assess duplication of data
collection efforts: The organization of the
PHEM Tool avoids duplication of
questions or redundancy as relates to
programs and projects outside of the
scope of PHEM. # Statistical methods
review: PHEM Tool data will be used to
tailor technical assistance and
programmatic activities in participant
countries. # Estimated Burden hours (#
Respondents x Time/Response = TOTAL
Burden Hours): 20 x hours Program
plans on submitting ICR to cover
information collection after PHE PRA
terminates

PRA:
PRA Applies

ICRO:
PRA Applies

21st Century Cures Act - Sec. 3087 (Public Health Emergency)

OMB Approval date: 3/21/23
OMB Expiration date: 12/31/99

3/6/23

Garcia_Albert D. (asg9) OMB / PRA

3/21/23

Zirger_Jeffrey (wtj5) ICRO Reviewer

Description & Funding
Description
Priority:

Urgent

Date Needed:

03/16/2023

Priority Justification:

Due to COVID-19, GEMCD is requested to provide technical assistance (TA) to GHSA countries for PHEM and PHEOC areas. The
Tool is needed to perform systematic assessment, to guide TA support.

Determination Start Date:

03/06/23
The Global Emergency Management Capacity Development (GEMCD) Team provides technical assistance to Global Health

Description:

Security Agenda priority countries to assist them in developing and maintaining public health emergency management (PHEM)
programs and public health emergency operations centers (PHEOCs). The Public Health Emergency Management Capacity
Assessment Tool (PHEM Tool) is intended to provide a systematic approach to collecting data pertaining to PHEM programs and
PHEOCs in countries where technical support is being provided. Data collected Data collected will help GEMCD identify
programmatic and PHEOC strengths and weaknesses to guide short and long term technical assistance and project planning.

IMS/CIO/Epi-Aid/Lab-Aid/Chemical Exposure
Submission:

Yes

IMS Activation Name:

2019 Novel Coronavirus Response

Primary Priority of the Project:

Prevention, mitigation, and intervention strategies

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

The goal of the PHEM Tool is to provide an easy to use but comprehensive questionnaire to assess public health emergency
management (PHEM) program capacity and public health emergency operations centers' (PHEOC) capabilities, for the purpose of
identifying areas of technical assistance support.

Objective:

1. To create an easy to use and comprehensive PHEM Program and PHEOC assessment tool for use in Global Health Security
Agenda as well as USG/ CDC priority countries. 2. To use data collected using the tool to identify focus areas for programmatic
activities and Technical Assistance. 3. To use tool each program year to document improvements or decreases in public health
emergency management and/ or Public Health Emergency Operations Center capabilities.

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:

International

Tags/Keywords:

Public Health Emergency Management

CDC's Role:

CDC employees will provide substantial technical assistance or oversight

Method Categories:

Needs Assessment

Methods:

GEMCD team emergency management technical advisors (EMTAs) will use the PHEM Tool to assess the public health emergency
management program capabilities in targeted Global Health Security Agenda and USG/ CDC priority countries. The PHEM Toll will
be administered to CDC Country Office staff and/ or Ministry of Health (MoH) staff. Data will be collected in excel and analyzed to
determine strengths and weaknesses of PHEM programs and PHEOCs, using criteria consistent with the WHO Joint External
Evaluation (JEE) Tool, the gold standard in achieving the International Health Regulations (IHR) requirements. Using the findings
collected via the from PHEM Tool, EMTAs will create project plans to provide countries' with programmatic support and technical
assistance. The DEO Information Technology (IT) Team#s CDCReady will host the PHEM Tool. The IT Team will provide technical
support to GEMCD such as summary reports of PHEM Tool findings, for each country and for combinations of countries, over time.
The IT Team will act as the Data Manager (DM) for the PHEM Tool data, ensuring that it is maintained over time and providing
recommendations on the use of CDCReady analytic and visualization tools. GEMCD team members will collect data via excel and
submit to data manager directly or through specified mechanism. Standard reports will be generated on demand for the GEMCD
Team but special reports will require 2-4 weeks to create, based upon IT Team availability.

Collection of Info, Data or Biospecimen:

GEMCD Team EMTAs will use the PHEM Tool to guide interviews with key informants at CDC country offices and/ or Ministries of
Health. Duration of the interview is anticipated to be less than one day. Additional time may be required if key informants choose to
provide corroborating plans to support their responses to survey questions. Excel based data will be managed through the DEO
Information Technology Team and CDCReady portal. GEMCD requests the PRA waiver for COVID-19 as we continue to assess its
impact on PHEM capacity in countries. The PHEM Tool as described herein will continue to be used once the waiver has expired
and we will address PRA coverage beyond the timeframe of the current waiver. The point of contact for the activity is Sharanya
Krishnan, noted in the application. The organization of the PHEM Tool avoids duplication of questions or redundancy as relates to
programs and projects outside of the scope of PHEM. The administration of the PHEM Tool may be accomplished in a matter of 4
hours, but longer, up to one full day for the GEMCD team member and one or more respondents from the CDC Country Office or
the MOH for 4-8 hours. The data collected will yield descriptive statistics, analyzed using excel.

Expected Use of Findings/Results and their impact:

PHEM Tool data will be used to tailor technical assistance and programmatic activities in participant countries. PHEM Tool data will
be available to participant CDC country teams, in report form. In addition, these reports may be shared with Ministry of Health
officials, at the discretion of the CDC Country or Regional Teams. GEMCD may use data collected using the PHEM Tool to develop
reports for programmatic use, internal to DEO, CPR, of Global Health. Aggregated or de-identified PHEM Tool data may also be
used in publications pertaining to emergency management, capacity development, public health workforce development, etc.
Publications external to CDC will reference country specific data in an anonymous format or as one of many represented in the case
of regional comparisons. PHEM Tool data for use in external publications or presentations will be submitted through CDC#s
approval and clearance process.

Could Individuals potentially be identified based on
Information Collected?

Yes

Will PII be captured (including coded data)?

No

Is this project covered by an Assurance of
Confidentiality?

No

Does this activity meet the criteria for a Certificate
of Confidentiality (CoC)?

No

Is there a formal written agreement prohibiting the
release of identifiers?

No

Funding

Funding yet to be added .....

HSC Review

HSC Attributes
Program Evaluation

Yes

Other - PH Emergency Preparedness

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

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
Institutions yet to be added .....

Staff
Staff Member

Sharanya
Krishnan

SIQT Exp.
Date

CITI Biomedical Exp.
Date

CITI Social & Behavioral
Exp. Date

11/02/2023

Data
DMP
Proposed Data Collection Start Date:

3/1/23

Proposed Data Collection End Date:

10/1/27

Proposed Public Access Level:

Non-Public

Non-Public Details:

CITI Good Clinical Practice
Exp. Date

Staff Role

Email

Phone

Organization

Program
Lead

eug9@cdc.
gov

404-4263313

EMTA TEAM
1

Reason For Not Releasing Data:

Other - Data are sensitive and relate to critical infrastructure.

Public Access Justification:

Data collected through the PHEM Tool regarding jurisdictional capabilities are sensitive and inappropriate for public distribution
unless appearing in a de-identified or aggregate form.

How Access Will Be Provided for Data:

The DEO Information Technology (IT) Team#s CDCReady will host excel based data that are collected using the PHEM Tool. The
IT Team will act as the Data Manager (DM) for the PHEM Tool data, ensuring that it is maintained over time in the CDCReady
platform, available to specific, role based programmatic staff.

Plans for Archival and Long Term Preservation:

PHEM Tool data will be managed by the DEO IT Team, ensuring that it is maintained over time in the CDCReady platform. Data
archived in the system will be maintained indefinitely.

Spatiality
Country
Republic of Kenya
Republic of Tajikistan
Republic of South Africa
Republic of Sierra Leone
Republic of India
Republic of Senegal
Republic of Panama
Republic of Nicaragua
Republic of Mozambique
Republic of Mali
Republic of Malawi
Republic of Honduras
Republic of Costa Rica
Dominican Republic
Republic of Zambia

State/Province

County/Region

Republic of Zimbabwe
South Sudan
United Republic of Tanzania
Republic of Uganda
Republic of the Philippines
Republic of Peru
Republic of Guinea
Republic of Ghana
Lao People's Democratic Republic
Democratic People's Republic of Korea
Republic of Azerbaijan
Republic of Armenia
Republic of Liberia
Mexico
Islamic Republic of Pakistan
Republic of Indonesia
Republic of Rwanda
Belize
Jamaica
Guadeloupe
Republic of El Salvador
Kingdom of Cambodia

Independent State of Papua New Guinea
Turkmenistan
Republic of Haiti
Republic of Djibouti
Republic of Botswana
Plurinational State of Bolivia
Libya
Bangladesh
Republic of Cote d'Ivoire
Republic of Cameroon
Republic of Angola
Islamic Republic of Mauritania
Malaysia
Kingdom of Lesotho
Kingdom of Eswatini
Burkina Faso
Republic of Uzbekistan
Federal Republic of Nigeria
Federal Democratic Republic of Ethiopia
Democratic Republic of the Congo
Kyrgyz Republic
Federative Republic of Brazil
Socialist Republic of Vietnam

Ukraine
Kingdom of Thailand
Republic of Kazakhstan
Republic of Colombia
Georgia

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

Current

CDC Staff
Member and
Role

Date Added

Description

Supporting Info Type

Supporting Info

Zirger_Jeffrey
(wtj5)
ICRO Reviewer

03/21/2023

Activity approved under PHE PRA
Waiver. A 60d FRN and PRA
package will need to be submitted.

Notice of Action

PHE PRA Waiver Approval COVID.docx

Smith_Wendy
P (wvj7)
Project Contact

03/16/2023

Please see attached, revised
PHEM Tool, including additional
COVID-19 focused questions.

Data Collection Form

PHEM Tool Additional C19 _16 MAR 23.xlsx

Smith_Wendy
P (wvj7)
Project Contact

02/09/2023

Attached is draft PHEM Tool for
review and revision, as
recommended.

Data Collection Form

PHEM Tool Draft UAZ3 12 DEC 22.xlsx