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Use of the Cyclosporiasis National Hypothesis Generating Questionnaire (CNHGQ) During Investigations of Foodborne Disease Clusters and Outbreaks
Supporting Statement A

Request for OMB Revision
OMB Control No. 0920-1198, expiration 10/31/2026





















Program Contact:
Kimberly Won, PhD
The National Center for Emerging and
Zoonotic Infectious Diseases (NCEZID)
Health Scientist
Centers for Disease Control and Prevention
1600 Clifton Road N.E.
Atlanta, Georgia 30329
Phone: 404-718-4137
Email: [email protected]

Submitted: September 25, 2026

Table of Contents
1. Circumstances Making the Collection of Information Necessary	3
2. Purpose and Use of Information Collection	5
3. Use of Improved Information Technology and Burden Reduction	6
4. Efforts to Identify Duplication and Use of Similar Information	7
5. Impact on Small Businesses or Other Small Entities	7
6. Consequences of Collecting the Information Less Frequently	7
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5	8
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency	8
9. Explanations of Any Payment or Gift to Respondents	8
10. Protection of the Privacy and Confidentiality of Information Provided by Respondents	8
11. Institutional Review Board (IRB) and Justification for Sensitive Questions	9
12. Estimates of Annualized Burden Hours and Costs	9
13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers	11
14. Annualized Cost to the Government	11
15. Explanation for Program Changes or Adjustments	11
16. Plans for Tabulation and Publication and Project Time Schedule	11
17. Reason(s) Display of OMB Expiration Date is Inappropriate	12
18. Exceptions for Certification for Paperwork Reduction Act Submissions	12







List of Attachments
A. Authorizing Legislation- Section 301 of the PHS Act (42 U.S.C. 241)
B. Cyclosporiasis National Hypothesis Generating Questionnaire - PDF fillable
C. 60-Day Federal Register Notice
D. 60-Day Public Comment Responses
E. Cyclosporiasis National Hypothesis Generating Questionnaire - Data Elements
F. Determination of Non-Applicability of Human Subjects Regulations





Cyclosporiasis National Hypothesis Generating Questionnaire (CNHGQ)

This is a request for revision of an OMB-approved Questionnaire to facilitate the collection of standard data during investigations of multistate outbreaks of cyclosporiasis.

A. Justification

1. Circumstances Making the Collection of Information Necessary

The Centers for Disease Control and Prevention (CDC) is requesting a three-year Paperwork Reduction Act (PRA) clearance for this revision information collection request (ICR) titled “Use of the Cyclosporiasis National Hypothesis Generating Questionnaire (CNHGQ) During Investigations of Foodborne Disease Clusters and Outbreaks” expiration October 31, 2026.  Cyclosporiasis is a gastrointestinal illness caused by the microscopic parasite Cyclospora. People can become infected with Cyclospora by consuming food or water contaminated with the parasite. Symptoms of cyclosporiasis begin an average of 7 days (range, 2 days to ≥2 weeks) after ingestion of the infective form of the parasite, and may include watery diarrhea, loss of appetite, weight loss, cramping, bloating, increased gas, nausea or fatigue. Although cyclosporiasis is usually not life threatening, if not treated, symptoms can persist for several weeks or longer.

 CDC works with state, local, and federal partners to combine patient interviews, food traceback through the supply chain, and laboratory testing to find the source of multistate outbreaks. This helps investigators prioritize traceback and other actions to stop more illnesses.

Foodborne outbreaks of cyclosporiasis have been reported in the United States since the mid-1990s and have been linked to various types of imported fresh produce, including raspberries, basil, snow peas, mesclun lettuce, cilantro, and parsley. During the 15-year period of 2000–2014, 31 U.S. foodborne outbreaks of cyclosporiasis were reported; the total case count was 1,562. Outbreaks were reported during 12 of the 15 years. Overall, a median of two outbreaks was reported per year, with a median of 20 reported cases per outbreak (range, 3 to 582 cases). However, it is likely that more cases (and outbreaks) occurred than were reported; in addition, because of insufficient data, many of the reported cases could not be directly linked to an outbreak or to a particular food vehicle. From 2015-2025, the numbers of reported cases steadily increased and larger multistate outbreaks were reported. For example, an estimated 2,299 laboratory-confirmed, domestically acquired cases among persons who became ill from May to August (the typical timeframe of the cyclosporiasis “season” in the United States) were reported in 2018.  This total was markedly higher than the numbers of cases reported for the same time period in 2016 (174) and 2017 (623). The number of reported cases continued to increase, reaching 2,717 laboratory-confirmed cases in 2024. As of April 30, 2026, a total of 2,862 laboratory-confirmed cases who became ill between May and August 2025 were reported to CDC.  

Many foods investigated in outbreaks have multiple produce ingredients, like salsa or salads, making it difficult to narrow down to a single food item. The Cyclospora parasite is harder to track than many bacteria like Salmonella because whole genome sequencing isn't available for this pathogen. Molecular typing methods for Cyclospora were developed in 2018 to determine genetic relatedness of cases associated with epidemiologic clusters. However, these methods cannot yet be used to identify new clusters of infection independent of epidemiologic data. Therefore, all temporally associated patients in whom cyclosporiasis is diagnosed must be interviewed to help determine if their case of infection could be part of an outbreak.  

In some previous outbreak investigations, insufficient data were available to link domestically acquired cases of cyclosporiasis to each other or to particular food vehicles/sources. Consistent use of the Cyclosporiasis National Hypothesis Generating Questionnaire (CNHGQ) has improved data collection and quality.  For example, from 2020-2025, information collected by jurisdictional partners through the CNHGQ led to the identification of at least one multistate outbreak each year. Continued use of the CNHGQ will increase the likelihood that future outbreaks will be recognized and that vehicles/sources will be identified (implicated).  Epidemiologic data collected via the CNHGQ also inform efforts to optimize molecular typing methods currently in use.

During outbreak investigations, if cases from multiple jurisdictions are identified, CDC may coordinate the investigations to help ensure data are collected consistently and to analyze aggregate data. Once sufficient epidemiologic data have been collected to identify a suspect vehicle for the pertinent outbreak, the appropriate regulatory agencies become involved to determine whether ill persons can be linked via product traceback to a common (i.e., the same) source. If a common source is identified, CDC, state and local health departments, and the appropriate regulatory agencies work collaboratively to control ongoing outbreaks. Of note, more than one outbreak may occur during the same time frame, and data collected via the CNHGQ enables differentiation.

With the development of the CNHGQ, the CDC has established data elements that are used for hypothesis generation during periods of increased numbers of reported cases of cyclosporiasis (typically, during spring and summer months). The CNHGQ was based on CDC’s Standardized National Hypothesis Generating Questionnaire (SNHGQ; OMB No. 0920-0997) but was modified to address the exposure period of interest for Cyclospora, to delete questions about food items that are not considered biologically plausible for transmission of this parasite (e.g., meat and dairy products), and to expand the data elements regarding fresh produce exposures (e.g., include more detailed information about grocery stores and restaurants).

The CNHGQ has been and will continue to be administered over the telephone by state and local public health officials to patients or their proxies and data submitted to CDC. In the event of a large outbreak, CDC staff may help in administering the survey if requested by state partners. Public health officials could use the CNHGQ or a locally developed form that includes CNHGQ data elements to collect information. The CNHGQ data elements and form will continue to improve the timeliness of hypothesis-generating analyses during outbreak investigations. This will be accomplished through the use of the CNHGQ to collect and submit data elements that will be maintained centrally for rapid pooling and analysis (described in Supporting Statement B). The only change since the previous approval is a slight increase in the number of respondents.

The primary audiences for the CNHGQ include (1) state and local public health partners (foodborne epidemiologists, public health nurses, and other interviewers) and (2) CDC. The maintenance of the CNHGQ will be coordinated by CDC; data collected using this tool will be maintained by the pertinent public health jurisdictions and CDC.

Authorizing Legislation comes from Section 301 of the Public Health Service Act (42 U.S.C. 241) (Attachment A. Section 301 of the PHS Act).

2. Purpose and Use of Information Collection

 Since 2017, CDC and state and local public health partners have used the CNHGQ to identify likely infection sources and link cases sharing common exposures. Federal, state, and local officials will continue using the questionnaire to interview cyclosporiasis patients in their jurisdictions. This will provide a standard method for capturing core exposure information of temporally associated cases during periods of increased reporting, typically the spring and summer months.

Without the CNHGQ, each jurisdiction would need to design its own hypothesis-generating questionnaire for every investigation, delaying data collection, analysis, and ultimately outbreak response. This would limit the ability to identify a likely vehicle(s) and take timely public health action. The CNHGQ improves timeliness during the hypothesis-generating phase and can shorten the time needed to determine how and where contamination occurred.

Just as important, the CNHGQ's standardized core variables ensure that all patients are asked the same questions regardless of jurisdiction. This consistency allows the CDC Cyclosporiasis surveillance program to assess exposures nationwide and detect signals of multistate outbreaks. Without it, comparing exposures across states would be difficult or impossible, risking missed multistate outbreaks, or, at best, significant delays in identifying them.

3. Use of Improved Information Technology and Burden Reduction

The CNHGQ data elements and form have been designed for administration via telephone interviews with persons who have cyclosporiasis or their proxies. The CNHGQ will be available as a fillable PDF (Attachment B. Cyclosporiasis National Hypothesis Generating Questionnaire - fillable). Data can be transferred electronically to CDC in a variety of ways including direct data entry to a secure server, bulk upload (e.g., REDCap extract), and HL7 message mapping. The use of the electronic platforms limits the burden that otherwise would be associated with entering data from a paper-based form. 

All CNHGQ data will be uploaded and stored in the System for Enteric Disease Response, Investigation, and Coordination (SEDRIC), a secure, cloud-based platform that integrates multiple data streams and is available to CDC and jurisdictional partners. Data collected using the CNHGQ will be analyzed descriptively, primarily through univariate analyses of food exposures among patients interviewed (further description of analyses is provided in Supporting Statement B). Data analysis software (e.g., SAS) will be used to further analyze data to aid in outbreak investigation (e.g., to determine proportions of patients who reported consumption of particular food items).
4. Efforts to Identify Duplication and Use of Similar Information

CDC has conferred with internal and external staff to avoid duplication of data collection and surveillance efforts. The CNHGQ typically should not lead to collection of duplicate information. 

Cyclosporiasis national surveillance, via the Nationally Notifiable Disease Surveillance System (NNDSS), occurs year-round. Data collected through NNDSS include generic core data elements, such as state and county of residence, age, sex, race, ethnicity, etc. However, NNDSS does not collect detailed travel history, fresh produce exposures, or restaurant or grocery store exposures. The CNHGQ will be used to supplement NNDSS data during periods of increased numbers of reported cases. If a case is reported through NNDSS (during a period of increased numbers of reported cases), CDC will initiate follow-up with the public health department to obtain CNHGQ data. Health departments could prepopulate a case-patient’s CNHGQ with the relatively few generic data elements (e.g., basic demographic information) that also are collected via NNDSS. The CNHGQ will allow CDC to make hypotheses about vehicles of infection and clusters or outbreak of cases; data obtained through NNDSS are not sufficient to make these hypotheses. 

The function provided by CDC’s Standardized National Hypothesis Generating Questionnaire (SNHGQ; OMB No. 0920-0997) for bacterial foodborne outbreaks is similar to the intended function of the CNHGQ for cyclosporiasis. However, as noted in Section A-1, the SNHGQ has been modified to be relevant to cyclosporiasis; the SNHGQ has not been used during (and is not appropriate for) investigations of outbreaks of cyclosporiasis. 
5. Impact on Small Businesses or Other Small Entities

No small businesses will be involved in this data collection.

6. Consequences of Collecting the Information Less Frequently

Lack of a standard data collection instrument would slow down epidemiologic investigations and limit the ability of public health officials to identify the likely vehicle of infection (e.g., a particular produce item) and to take public health action (e.g., issue an import alert).

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

This request is consistent with the general information collection guidelines of 5 CFR 1320.5(d)(2). No special circumstances apply.

8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency

A. Federal Register 60-day Notice was published on June 2, 2026, vol. 91 pg 32972 (Attachment C. 60-Day Federal Register Notice). CDC received 4 comments. Responses to public comments are in Attachment D.

B. The CNHGQ, when originally developed, was based on the SNHGQ, which was developed in collaboration with public health partners through OutbreakNet, a national voluntary network of epidemiologists and other public health officials who investigate outbreaks of foodborne illnesses in the United States. OutbreakNet members include local, state, federal, and regulatory partners. The CNHGQ was developed from the SNHGQ, with input from external public health and internal CDC partners.  In 2018 and 2021, the CNHGQ was revised and updated based on feedback received from state partners; this renewal request utilizes the most recent version of the CNHGQ.

9. Explanations of Any Payment or Gift to Respondents

There will be no remuneration to respondents.

10. Protection of the Privacy and Confidentiality of Information Provided by Respondents 

Respondents will be assured of the privacy of their replies under Section 934(c) of the Public Health Service Act, 42 USC 299c-3(c). They will be told why and for what purposes the information is being collected and that, in accordance with this statute, any identifiable information about them will not be used or disclosed for any other purpose without their prior consent, unless required by law upon the demand of a court or other governmental authority.

The CNHGQ data elements and collection tool will ascertain information from respondents, including data regarding exposures (food and other) that preceded the onset of symptoms from cyclosporiasis (Attachment E. Cyclosporiasis National Hypothesis Generating Questionnaire - Data Elements). The CNHGQ will not collect any information that could be used to identify individual patients. Local or state public health officials with jurisdictional responsibility will maintain the respondent’s name, telephone number, and other personally identifiable information. This information will not be included in the data collection tool, and no identifying information will be transmitted to CDC.

This activity has been classified as non-research, and it has been determined that IRB review is not required for this data collection (Attachment F. Human Subjects Determination).


Privacy Impact Assessment Information

Overview of the Data Collection System

Collection of the CNHGQ data elements will employ quantitative and qualitative methods, including telephone interviews, designed to elicit core element exposures from respondents. No research questions will be addressed; data will be compiled regarding recent food exposures and risk factors relevant to cyclosporiasis, in the context of responding to potential and documented outbreaks.

Description of Information to be Collected

•	Responses to interview questions (i.e., CNHGQ data elements)
•	No individually identifiable information will be collected on the CNHGQ

11. Institutional Review Board (IRB) and Justification for Sensitive Questions 

This activity has been classified as non-research, per the National Center for Emerging, Zoonotic, and Infectious Diseases determined human subjects coordinator; IRB review is not required for this data collection (Attachment F. Determination of Non-Applicability of Human Subjects Regulations).

No questions of a sensitive nature will be asked. During the introduction to the interview, respondents will be informed that their participation is voluntary and that they can refuse to answer any question and stop the interview at any time.

12. Estimates of Annualized Burden Hours and Costs

A. Interviews will be conducted with case-patients identified. On the basis of previous years’ case counts, it is estimated that the CNHGQ would be administered to approximately 2,800 individual respondents across all jurisdictions each year, although the actual number may fluctuate from year to year.  This estimate was revised from the previous ICR based on data collected since the last revision.

Exhibit 1 shows the estimated annual burden hours associated with administering the CNHGQ. The estimated total annual burden for all organizations combined is 2100 hours.

Exhibit 1: Estimated Annual Burden Hours

Type of respondents
Form Name
No. of Respondents
No. of Responses per Respondent
Avg. Burden per Response (in hrs)
Total Burden (in hrs)
Ill individuals identified as part of an outbreak investigation
Cyclosporiasis National Hypothesis Generating Questionnaire
2,800
1
45/60
2100
Total
2100

B. We used the 2025 mean hourly wage for all occupations in the United States. This wage (i.e., $33.54) was obtained from the Bureau of Labor Statistics (Occupational Employment and Wage Statistics).

Exhibit 2 shows the estimated aggregate annual cost burden associated with the interviewees’ time to participate. The estimated burden in hours is provided in Exhibit 1. The total annual cost burden was calculated by multiplying the mean hourly wage by the burden in hours. The estimated total annual cost burden is $140,868.00.


Exhibit 2. Estimated Annual Cost Burden to Respondents
Respondent Category
Average Hourly Wage
Burden (in hours)
Cost Burden
Wage Rate Multiplier
Fully loaded Cost Burden
All occupations in the United States
$33.54
2100
$70,434.00
x2
$140,868.00
Total


$70,434.00
x2
$140,868.00

13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers

There will be no direct costs to respondents other than their time to participate in the outbreak investigation (i.e., to be interviewed).

14. Annualized Cost to the Government

The estimated total cost to the Federal Government per year of data collection is $302,080.60. Exhibit 3 lists the components of the estimated total annual cost.

Exhibit 3. Estimated Costs to Federal Government
Cost Component (including CDC staff time)*
Total Cost (in dollars)
Wage Rate Multiplier
Fully loaded Wage Rate
Project Management (0.5 FTE)
$56,630.00
x2
$113,260.00
Data Collection Activities (0.33 FTE)
$37,780.30
x2
$75,560.60
Data Analysis (0.5 FTE)
$56,630.00
x2
$113,260.00
Total
$151,040.30
x2
$302,080.60
*Costs based on 2026 General Schedule Pay Tables for Atlanta, hourly rate, GS 13-1 (SALARY TABLE 2026-ATL).


15. Explanation for Program Changes or Adjustments

This is a request for an revision of a previously approved data collection instrument.    The data collection instrument has not been changed since the most recent revision that was approved by OMB in 2023.  The number of respondents has increased by 300 since the previous approval.

16. Plans for Tabulation and Publication and Project Time Schedule


Activity
Estimated time schedule following OMB clearance
Conduct interviews using the CNHGQ during multistate outbreak investigations
Months 1–36
Ongoing data analysis
Months 1–36

The analysis plan for data collected using the CNHGQ is to conduct descriptive analyses, primarily univariate analyses of food exposures among patients interviewed as part of outbreak investigations (further description of analyses is provided in Supporting Statement B). Data analysis software (e.g., SAS) will be used to determine the proportions of patients who reported consumption of particular food items and thereby to generate hypotheses about potential food vehicles. Dissemination of results occurs continuously, as CDC analyzes the data in real-time and shares these results with partners on an on-going basis.


17. Reason(s) Display of OMB Expiration Date is Inappropriate

None.


18. Exceptions for Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.