Research Determination

Status: Original and derived artifacts are available for this document.

Download: pdf

Print Date: 8/25/26

Title:

Enhanced public health surveillance for cyclosporiasis in the United States

Project Id:

0900f3eb821e6c67

Accession #:

CGH-ET-8/15/23-e6c67

Project Contact:

Kimberly Y Won

Organization:

CGH/DPDM/PDB/ET

Status:

Project In Progress

Intended Use:

Project Determination

Estimated Start Date:

08/28/2023

Estimated Completion Date:

09/30/2026

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

Determinations

0920-1198

Determination

Justification

HSC:
Does NOT Require HRPO
Review

Not Research - Public Health Surveillance

Entered By & Role

5/4/26

Peterson_James M. (iyr1) CIO HSC

5/4/26

Daymude_Thomas (qkh7) OMB / PRA

5/6/26

Zirger_Jeffrey (wtj5) ICRO Reviewer

45 CFR 46.102(l)(2)

PRA:
PRA Applies

ICRO:
PRA Applies

Completed

OMB Approval date: 10/27/23
OMB Expiration date: 10/31/26

Description & Funding
Description
Priority:

Standard

Priority Justification:
CDC Priority Area for this Project:

Not selected

Determination Start Date:

08/15/23

Description:

Cyclosporiasis is a nationally notifiable diseases in the United States. In jurisdictions where cyclosporiasis is reportable, healthcare
providers and laboratories are required to report cases of illness to their state or local health department. The Cyclosporiasis
National Hypothesis Generating Questionnaire (CNHGQ) is used by health officials at the state or local health department to
interview patients with reported cases of cyclosporiasis. The CNHGQ collects details on clinical and travel history, produce
consumption, and restaurant and grocery store exposures. Health departments notify CDC of cases of nationally notifiable and
reportable diseases so that CDC can compile national-level data for the United States. CDC uses this data to monitor, measure,
and alert healthcare providers, public health partners, and the public to outbreaks and other public health threats and collaborates
with the US Food and Drug Administration (FDA) to conduct traceback investigations for implicated food vehicles. This protocol
does not describe a specific study. Instead, it describes how epidemiologists receive and use cyclosporiasis surveillance data
through a CDC-designed questionnaire: the CNHGQ.

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

Cyclosporiasis is a nationally notifiable diseases in the United States. In jurisdictions where cyclosporiasis is reportable, healthcare
providers and laboratories are required to report cases of illness to their state or local health department. The Cyclosporiasis
National Hypothesis Generating Questionnaire (CNHGQ) is used by health officials at the state or local health department to
interview patients with reported cases of cyclosporiasis. The CNHGQ collects details on clinical and travel history, produce
consumption, and restaurant and grocery store exposures. Health departments notify CDC of cases of nationally notifiable and
reportable diseases so that CDC can compile national-level data for the United States. CDC uses this data to monitor, measure,
and alert healthcare providers, public health partners, and the public to outbreaks and other public health threats and collaborates
with the US Food and Drug Administration (FDA) to conduct traceback investigations for implicated food vehicles.

Objective:

Public health surveillance data collected about confirmed and probable cases of cyclosporiasis shows where and how often the
disease occurs in a particular area, who is affected (demographic, clinical, and epidemiological characteristics), how they are
affected (course of clinical illness and care received), and how they were potentially infected (produce consumption and restaurant
and grocery store exposures). This information enables state and local health officials and CDC to understand where cyclosporiasis
is occurring, how cyclosporiasis can be prevented, which groups are most heavily impacted, identify outbreaks, identify disease
trends and, work with partner agencies (e.g., FDA) and other external stakeholders to implement measures to mitigate and control
the spread of disease.

Activities or Tasks:

Programmatic Work

Target Populations to be Included/Represented:

General US Population

Tags/Keywords:

Cyclosporiasis ; Public Health Surveillance ; Foodborne Diseases

CDC's Role:

CDC employees or agents will obtain or use anonymous or unlinked data or biological specimens

Method Categories:

Outbreak Investigation; Surveillance Support

Methods:

Public health surveillance for cyclosporiasis is ongoing. In states where cyclosporiasis is reportable, cases of cyclosporiasis are
reported to the state or local health department. Participants (patients diagnosed with cyclosporiasis) are then interviewed at least
once by state or local public health officials, although follow up with patients involved in an outbreak or other public health
investigation may be necessary. State or local health officials may be contacted by CDC epidemiologists for additional information
depending on the course of the investigation; CDC staff do not directly contact or interview patients. Analysis of surveillance data
collected via the CNHGQ is also continual and includes both descriptive analyses and exploratory studies where exposure
information is re-analyzed as new cases are reported to identify potentially emerging signals that may indicate a particular produce
item or point of sale/service as a source of illness. The study population are U.S. residents diagnosed with cyclosporiasis. The
cyclosporiasis case definition was determined by the Council for State and Territorial Epidemiologists (CSTE). Cases are identified
by electronic laboratory reporting of positive test results to the state or local health department; physicians may also report cases to
their state or local health department. The number of cases reported will vary by location and over time. Patients diagnosed with
cyclosporiasis are interviewed by state or local public health officials in jurisdictions where the disease is reportable using the
CNHGQ or a state-adapted version of it. That information is then transmitted to CDC electronically via the System for Enteric
Disease Response, Investigation, and Coordination (SEDRIC) platform. CDC epidemiologists receive and compile reported case
data for further analysis. Key variables that are collected include demographic, clinical and travel history, and exposure data. The
data are analyzed continually, utilizing both descriptive and exploratory methods to determine both national level disease estimates

(e.g., case counts by year, state, sex, race/ethnicity, age) and identify trends in disease occurrence. Data are stored electronically in
SEDRIC with restricted access only for staff working with and granted access to that data. Patients diagnosed with cyclosporiasis
are assigned a unique case ID by their state or local health department and this case ID is provided on data sent to CDC. Data are
stored electronically in SEDRIC with restricted access only for staff working with and granted access to the data. Electronic data are
retained indefinitely.
Collection of Info, Data or Biospecimen:

Patients diagnosed with cyclosporiasis are interviewed by state or local public health officials in jurisdictions where the disease is
reportable using the CNHGQ or a state-adapted version of it. That information is then transmitted to CDC electronically.

Expected Use of Findings/Results and their impact:

Key variables that are collected include demographic, clinical and travel history, and exposure data. The data are analyzed
continually, utilizing both descriptive and exploratory methods to determine both national level disease estimates (e.g., case counts
by year, state, sex, race/ethnicity, age) and identify trends in disease occurrence. Surveillance data are compiled and shared or
discussed with state and local health departments depending on the needs of the jurisdiction or investigations that may be occurring
at the time. During the cyclosporiasis season (typically May through August, although cases can be reported as late as September),
a weekly epidemiological update is compiled and distributed via email to state and local health departments as well as FDA and
internal CDC partners (e.g., Division of Foodborne Waterborne and Environmental Diseases/Outbreak Response and Prevention
Branch). Surveillance data may be compiled and published as surveillance summaries or summaries of notable events.
Cyclosporiasis surveillance data may be combined with other data (e.g., Cyclospora genotyping data) to better understand the
occurrence of disease in the United States. Any of these analyses may be published in the scientific literature or presented at
scientific conferences.

Could Individuals potentially be identified based on
Information Collected?

No

Dual Use Research potential?:

Funding

Funding yet to be added .....

HSC Review

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

No Selection

language(s)
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? Yes
Institutions yet to be added .....

Staff

Staff
Member

SIQT
Exp.
Date

CITI
Biomedical
Exp. Date

CITI Social &
Behavioral Exp.
Date

CITI Good Clinical
Practice Exp. Date

Andreas
Nshala

09/23
/2028

09/18/2028

09/05/2025

Ashley
Payne

06/04
/2029

12/04/2027

12/04/2027

Caitlin
Worrell

06/03
/2028

06/05/2028

Kimberly
Won

08/13
/2029

Lauren
Ahart

Staff Role

Email

Phone

Organization

09/19/2025

CoInvestigator

txx7@cdc.
gov

4046395107

ELIMINATIONS &
CONTROL
EPIDEMIOLOGY TEAM

11/06/2026

CoInvestigator

qzu9@cdc.
gov

4046390335

EPIDEMIOLOGY TEAM

09/05/2025

CoInvestigator

uvz2@cdc.
gov

4047184774

EPIDEMIOLOGY TEAM

12/04/2027

09/05/2025

Principal
Investigator

kfw7@cdc.
gov

404718-7

EPIDEMIOLOGY TEAM

12/31
/2099

12/04/2027

09/05/2025

CoInvestigator

nox7@cdc.
gov

4047183207

Epidemiology Team

Mamadou
Diallo

06/10
/2029

09/03/2025

03/23/2022

CoInvestigator

mod7@cdc.
gov

4046398486

STRATEGIC
INFORMATION TEAM

Marion Rice

11/25
/2028

12/04/2027

01/13/2026

CoInvestigator

lnv1@cdc.
gov

4047186865

Epidemiology Team

Rodriquez
Choice

05/12
/2029

03/08/2027

09/05/2025

CoInvestigator

qhi2@cdc.
gov

4047188228

PARASITIC DISEASES
BRANCH

Susan
Montgomery

03/31
/2029

03/27/2027

09/05/2025

CoInvestigator

zqu6@cdc.
gov

4047184731

Epidemiology Team

Tasneem
Malik

12/31
/2099

03/08/2027

09/05/2025

CoInvestigator

tom2@cdc.
gov

3014584010

ELIMINATIONS &
CONTROL
EPIDEMIOLOGY TEAM

Data

02/28/2028

CITI Good Laboratory
Practice Exp. Date

Data
DMP
Proposed Data Collection Start Date:

8/28/23

Proposed Data Collection End Date:

9/30/26

Proposed Public Access Level:

Public

Public Access Justification:

Case surveillance data for nationally notifiable disease

How Access Will Be Provided for Data:

Data use agreement

Plans for Archival and Long Term Preservation:

Data will be stored electronically.

Supporting Info

Current

CDC Staff
Member and
Role

Date Added

Description

Supporting Info Type

Supporting Info

Zirger_Jeffrey
(wtj5)
ICRO Reviewer

05/06/2026

NOA 0920-1198 (2023)

Notice of Action

NOA 0920-1198_2023.pdf

Current

Won_Kimberly
Y. (kfw7)
Project Contact

05/01/2026

CNHGQ

Data Collection Form

CNHGQ 2021_fillable.pdf

Current

Won_Kimberly
Y. (kfw7)
Project Contact

05/01/2026

NOA 0920-1198 (2020)

Notice of Action

NOA 0920-1198_2020.pdf

Current

Won_Kimberly
Y. (kfw7)
Project Contact

05/01/2026

Protocol_clean

Protocol

Protocol for CNHGQ_updated_01MAY2026_clean.docx

Current

Won_Kimberly
Y. (kfw7)
Project Contact

05/01/2026

Protocol_tracked changes

Protocol

Zirger_Jeffrey
(wtj5)
ICRO Reviewer

08/31/2023

NOA 0920-1198 (2020)

Notice of Action

NOA 0920-1198_2020.pdf

Straily_Anne
(yzv2)
Project Contact

08/30/2023

Updated protocol with correct OMB
control number.

Protocol

Protocol for CNHGQ_updated.docx

Straily_Anne
(yzv2)
Project Contact

08/15/2023

CNHGQ

Data Collection Form

CNHGQ 2021_fillable.pdf

Straily_Anne
(yzv2)
Project Contact

08/15/2023

OMB/PRA template form

Paperwork Reduction Act Form

OMB-PRA template for DPDM_CNHGQ renewal.docx

Straily_Anne
(yzv2)
Project Contact

08/15/2023

Protocol for collection and use of
surveillance data via CNHGQ

Protocol

Protocol for CNHGQ.docx

Straily_Anne
(yzv2)
Project Contact

08/15/2023

DPDM Project determination form

Other-Project determination form

338035-A_DPDM-Proj-Det-Form-4-508_Cyclo
Surveillance.pdf

Protocol for CNHGQ_updated_01MAY2026_tracked
changes.docx