Agency Forms Undergoing Paperwork Reduction Act Review

In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled “Use of the Cyclosporiasis National Hypothesis Generating Questionnaire (CNHGQ) During Investigations of Foodborne Disease Clusters and Outbreaks” to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on June 2, 2026, to obtain comments from the public and affected agencies. CDC received four public comments. This notice serves to allow an additional 30 days for public and affected agency comments.

CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:

(a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(c) Enhance the quality, utility, and clarity of the information to be collected;

(d) Minimize the burden of the collection of information on those who are to respond, including, through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and

(e) Assess information collection costs.

To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570. Comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/​public/​do/​PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide written comments within 30 days of notice publication.

Proposed Project

Use of the Cyclosporiasis National Hypothesis Generating Questionnaire (CNHGQ) During Investigations of Foodborne Disease Clusters and Outbreaks (OMB Control No. 0920-1198, Exp. 10/31/2026)—Revision—The National Center for Emerging and ( printed page 65216) Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The Centers for Disease Control and Prevention is requesting a three-year Paperwork Reduction Act (PRA) clearance for a Revision to the approved information collection request (ICR) Use of the Cyclosporiasis National Hypothesis Generating Questionnaire (CNHGQ) During Investigations of Foodborne Disease Clusters and Outbreaks (OMB Control No. 0920-1198, Exp. 10/31/2026).

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, three 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 seasonal cases were reported to CDC.

Collecting the requisite data for the initial hypothesis-generating phase of investigations of multistate foodborne disease outbreaks is associated with multiple challenges, including the need to have high-quality hypothesis-generating questionnaire(s) that can be used effectively in multijurisdictional investigations. Such a questionnaire was developed in the past for use in the context of foodborne outbreaks caused by bacterial pathogens; that questionnaire is referred to as the Standardized National Hypothesis Generating Questionnaire (SNHGQ). The CNHGQ was based on the SNHGQ 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 was designed for administration over the telephone by public health officials, to collect data elements from case-patients or their proxies. Public health officials can 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. There are no changes to the CNHGQ since the previous approval.

CDC requests OMB approval to collect information via the CNHGQ from persons who have developed symptomatic cases of Cyclospora infection during periods in which increased numbers of such cases are reported. 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 is not 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.

The CNHGQ is not expected to entail substantial burden for respondents. The estimated total annualized burden associated with administering the CNHGQ is 2100 hours (approximately 2,800 individuals interviewed × 45 minutes/response). There are no costs to respondents other than their time to participate.