Determination

Print Date: 8/31/23

Title:

Enhanced public health surveillance for cyclosporiasis in the United States

Project Id:

0900f3eb821e6c67

Accession #:

CGH-ET-8/15/23-e6c67

Project Contact:

Anne Straily

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 #:
0920-1198

OMB Control #:

Determinations
Determination

Justification

HSC:
Does NOT Require HRPO
Review

Not Research - Public Health Surveillance

PRA:
PRA Applies

Completed

Entered By & Role

8/22/23

Abel_Jason A. (jza5) CIO HSC

8/31/23

Abel_Jason A. (jza5) OMB / PRA

45 CFR 46.102(l)(2)

ICRO:
PRA Applies

OMB Approval date: 9/30/20
OMB Expiration date: 9/30/23

8/31/23

Zirger_Jeffrey (wtj5) ICRO Reviewer

Description & Funding
Description
Priority:

Standard

Date Needed:

08/28/2023

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 and collects 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
may 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, rather it describes the receipt and use of cyclosporiasis surveillance data by epidemiologists at CDC that was collected using
the CDC-designed CNHGQ.

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

: 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 and collects 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
may 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.

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:

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 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 reanalyzed 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 stateadapted version of it. That information is then transmitted to CDC electronically. CDC epidemiologists receive and compile reported
case data into a database using a specially designed R-shiny tool 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 a secured folder by disease 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 a secure folder
by disease with restricted access only for staff working with and granted access to the data. Electronic data are retained indefinitely.
Any paper forms received are entered into that disease#s electronic database and the paper copy destroyed.
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

Funding

Funding yet to be added .....

HSC Review

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?
Estimated number of study participants

No

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

SIQT Exp.
Date

Anne Straily

07/21/2026

Lauren Ahart

07/05/2026

CITI Biomedical
Exp. Date

CITI Social & Behavioral
Exp. Date

CITI Good Clinical Practice
Exp. Date

Staff Role

Email

Phone

Organization

06/02/2024

Principal
Investigator

yzv2@cdc.
gov

404-7181422

Epidemiology
Team

09/05/2025

Co-Investigator

nox7@cdc.
gov

404-7183207

Epidemiology
Team

Marion Rice

01/30/2026

12/10/2024

Susan
Montgomery

06/26/2026

06/24/2024

01/13/2026

Co-Investigator

lnv1@cdc.
gov

404-7186865

Epidemiology
Team

Program Lead

zqu6@cdc.
gov

404-7184731

Epidemiology
Team

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.

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

Supporting Info
Current

Date Added

Description

Supporting Info Type

Supporting Info

Zirger_Jeffrey
(wtj5)
ICRO Reviewer

08/31/2023

NOA 0920-1198 (2020)

Notice of Action

NOA 0920-1198_2020.pdf

Current

Straily_Anne
(yzv2)
Project Contact

08/30/2023

Updated protocol with correct OMB
control number.

Protocol

Protocol for CNHGQ_updated.docx

Current

Straily_Anne
(yzv2)
Project Contact

08/15/2023

CNHGQ

Data Collection Form

CNHGQ 2021_fillable.pdf

Current

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

Current

CDC Staff
Member and
Role