Determination

Print Date: 9/16/25

Title:

U.S. National Authority for Containment of Poliovirus Data Collection Tools

Project Id:

0900f3eb8225c620

Accession #:

-CPR-11/1/23-5cf7f

Project Contact:

Albert D Garcia

Organization:

ORR

Status:

Pending Regulatory Clearance

Intended Use:

Project Determination

Estimated Start Date:

11/01/2023

Estimated Completion Date:

11/01/2027

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

Determinations

0920-1424

Determination

Justification

Completed

Entered By & Role

11/1/23

Garcia_Albert D. (asg9) CIO HSC

11/1/23

Garcia_Albert D. (asg9) OMB / PRA

12/16/24

Zirger_Jeffrey (wtj5) ICRO Reviewer

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

Not Research / Other

Review
45 CFR 46.102(l)
Environmental Sampling
PRA:
PRA Applies

ICRO:
PRA Applies

OMB Approval date: 12/19/23
OMB Expiration date: 12/31/26

Description & Funding
Description
Priority:

Standard

Date Needed:

11/11/2023

Priority Justification:
CDC Priority Area for this Project:

Not selected

Determination Start Date:

11/01/23

Description:

The goal of the project is to collect data in the event of a poliovirus breach of containment - as well as to understand the biosafety
practices of facilities working on poliovirus and mitigations strategies in place to reduce risks. These goals are in line with World
Health Organization#s Global Action Plan (GAP) for Poliovirus containment efforts.

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

This information will assist with meeting the goals of the Section 361 of the Public Health Service (PHS) Act (42 U.S.C. 264) and
prevents the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions,
or from one State or possession into any other State or possession.

Objective:

The goal of the project is to collect data in the event of a poliovirus breach of containment - as well as to understand the biosafety
practices of facilities working on poliovirus and mitigations strategies in place to reduce risks. These goals are in line with World
Health Organization#s Global Action Plan (GAP) for Poliovirus containment efforts.

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 - Poliovirus Essential Facilities

Tags/Keywords:

Poliovirus ; Personal Protective Equipment ; Containment of Biohazards

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:

Needs Assessment; Survey

Methods:

The Facility Incident Reporting Forms for Poliovirus Release and Potential Exposure and Theft and Loss, the Global Action Plan
(GAP) Poliovirus Containment Poliovirus-Essential Facility Assessment Checklist, the Global Action Plan (GAP) Poliovirus
Containment Poliovirus-Essential Facility Questionnaire, and the Poliovirus Containment Sampling Points and Sanitation
Assessment Form for Wastewater (WW) Systems Supporting a Poliovirus-Essential Facility (PEF) in the United States will be in a
fillable form and include a paper and electronic based format. The NAC-NIOSH Personal Protective Equipment Survey for
Laboratories will be a web based electronic survey using an anonymous REDCap survey.
The Facility Incident Reporting Forms for Poliovirus Release and Potential Exposure and Theft and Loss, the Global Action Plan
(GAP) Poliovirus Containment Poliovirus-Essential Facility Assessment Checklist, the Global Action Plan (GAP) Poliovirus
Containment Poliovirus-Essential Facility Questionnaire, and the Poliovirus Containment Sampling Points and Sanitation

Collection of Info, Data or Biospecimen:

Assessment Form for Wastewater (WW) Systems Supporting a Poliovirus-Essential Facility (PEF) in the United States will be in a
fillable form and include a paper and electronic based format. The NAC-NIOSH Personal Protective Equipment Survey for
Laboratories will be a web based electronic survey using an anonymous REDCap survey.

Expected Use of Findings/Results and their impact:

# Data captured on the Facility Incident Reporting Form for Poliovirus Release and Potential Exposure will be used in the U.S. NAC
risk assessments and guide federal emergency response efforts. # Data captured on the Facility Incident Reporting Form for
Poliovirus Theft and Loss will be used in the U.S. NAC risk assessments and guide federal emergency response efforts. # The
information collected in the Personal Protective Equipment Survey for Laboratories will assist the Centers for Disease Control and
Prevention (CDC), U.S. NAC and National Institute for Occupational Safety and Health (NIOSH) with developing guidance and
recommendations for PPE selection and use in support of poliovirus containment as well as identify laboratory PPE commonly used
to evaluate laboratory PPE performance characteristics in testing studies. # Information collected in the Global Action Plan (GAP)
Poliovirus Containment Poliovirus-Essential Facility Assessment Checklist will aid U.S. facilities in preparing for an audit to obtain a
poliovirus certificate of containment. # Data collected from the Global Action Plan (GAP) Poliovirus Containment PoliovirusEssential Facility Questionnaire will collect additional information on poliovirus materials held by a U.S. facility, their work activities,
and facility features. # The Poliovirus Containment Sampling Points and Sanitation Assessment Form for Wastewater (WW)
Systems Supporting a Poliovirus-Essential Facility (PEF) in the United States will collect information to assess poliovirus essential
facility#s wastewater system, the primary safeguards to reduce and control the release of poliovirus from the facility. In addition, it
will verify the safeguards of local wastewater utilities that receive wastewater from the PEF.

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 (including
coded data)?:

Yes

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
Environmental Sampling

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

Lia
Haynes

08/23
/2026

Suganthi
Suppiah

10/07
/2027

CITI
Biomedical
Exp. Date

CITI Social &
Behavioral Exp.
Date

CITI Good Clinical
Practice Exp. Date

10/15/2024

CITI Good Laboratory
Practice Exp. Date

Staff Role

Email

Phone

Organization

Program
Official

loh5@cdc.
gov

4047184639

OFFICE OF THE CHIEF
MEDICAL OFFICER

Principal
Investigator

kpe9@cdc.
gov

4047183461

NATIONAL AUTHORITY FOR
CONTAINMENT OF POLIOVIRUS

Data
DMP
Proposed Data Collection Start Date:

11/1/23

Proposed Data Collection End Date:

11/1/27

Proposed Public Access Level:

Non-Public

Non-Public Details:
Reason For Not Releasing Data:

Other - Data is used to mitigate release of poliovirus and has no utility to the public.

Public Access Justification:

Data is used to mitigate release of poliovirus and has no utility to the public.

How Access Will Be Provided for Data:

Access to the data will be protected via access to the CDC server. The U.S. NAC may share information about the incident to
poliovirus containment oversight bodies and CDC Incident Response leadership to ensure appropriate measures are implemented.

Plans for Archival and Long Term Preservation:

CDC/CPR/OD/NAC is the steward for the data. Data collected will be stored on a shared drive within CDC#s secured environment
with restricted access.

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

Landing
Page URL

Direct
Download URL

Type of Data
Released

Collection
Start Date

Collection
End Date

Current

CDC Staff
Member and
Role

Date Added

Description

Supporting Info Type

Supporting Info

Zirger_Jeffrey
(wtj5)
ICRO Reviewer

12/16/2024

NOA 0920-1424 (2023)

Notice of Action

NOA 0920-1424_2023.pdf

Current

Garcia_Albert
D. (asg9)
Project Contact

11/01/2023

PPE Lab Survey

Data Collection Form

Att7 - _Personal Protective Equipment Survey for
Laboratories_Final.pdf

Current

Garcia_Albert
D. (asg9)
Project Contact

11/01/2023

GAP Questionnaire

Data Collection Form

Att6 - Global Action Plan (GAP) Poliovirus Containment
Poliovirus-Essential Facility Questionnaire_Final.pdf

Current

Garcia_Albert
D. (asg9)
Project Contact

11/01/2023

GAP PEF Assessment

Data Collection Form

Atth 5-Global Action Plan (GAP) Poliovirus Containment
Poliovirus-Essential Facility Assessment Checklist_Final.
pdf

Current

Garcia_Albert
D. (asg9)
Project Contact

11/01/2023

Release or Potential Exposure

Data Collection Form

Current

Garcia_Albert
D. (asg9)
Project Contact

11/01/2023

Wastewater Assessment

Data Collection Form

Att8_Poliovirus Containment Sampling Points and
Sanitation Assessment Form for Wastewater_Final.pdf

Current

Garcia_Albert
D. (asg9)
Project Contact

11/01/2023

Theft or Loss

Data Collection Form

Att4 - Facility Incident Reporting Form for Poliovirus
Theft or Loss_Final.pdf

Att3 - Facility Incident Reporting Form for Poliovirus
Release or Potential Exposure_final.pdf