SUPPLEMENTARY INFORMATION:

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

The OMB is particularly interested in comments that will help:

1. 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;

2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

3. Enhance the quality, utility, and clarity of the information to be collected;

4. 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 submissions of responses; and

5. Assess information collection costs.

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)—Extension—National Center for Emerging and 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 an Extension or the 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).

An estimated one in six Americans each year becomes ill with a foodborne disease. Foodborne outbreaks of cyclosporiasis, caused by the parasite Cyclospora cayetanensis, have been reported in the United States since the mid-1990s and have been linked to various types of fresh produce. During the 15-year period of 2000-2014, 31 U.S. foodborne outbreaks of cyclosporiasis were reported; the total case count was 1,562. 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. In recent years, from 2018 onward the number of cases reported annually to CDC has increased substantially to over 2,000 cases; notably, in 2025, more than 2,800 cases were reported.

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 ( printed page 32973) Standardized National Hypothesis Generating Questionnaire (SNHGQ). However, not all of the data elements in the SNHGQ are relevant to the parasite Cyclospora ( e.g., questions about consumption of meat and dairy products); on the other hand, additional data elements not included in the SNHGQ are needed to capture information pertinent to Cyclospora and to fresh produce vehicles of infection. Therefore, the Cyclosporiasis National Hypothesis Generating Questionnaire (CNHGQ) has been developed, by using core data elements from the SNHGQ and incorporating modifications pertinent to Cyclospora.

The core data elements from the SNHGQ were developed by a series of working groups comprised of local, state, and federal public health partners. Subject matter experts at CDC developed the CNHGQ by modifying the SNHGQ to include and focus on data elements pertinent to Cyclospora/cyclosporiasis. Input also was solicited from state public health partners. Because relatively few data elements in the SNHGQ needed to be modified, a full vetting process was determined not to be necessary. The CNHGQ has been designed for administration over the telephone by public health officials (or their proxies), to collect data elements from case-patients. Collected data will be pooled and analyzed at CDC, to generate hypotheses about potential vehicles/sources of infection.

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 (typically, during spring and summer months). In part because molecular typing methods for C. cayetanensis cannot independently identify genetically linked clusters, it is important to interview all case-patients identified during periods of increased reporting, to help determine if their cases could be part of an outbreak(s).

CDC requests OMB approval for an estimated 2,100 total annualized burden hours (approximately 2,800 individuals interviewed x 45 minutes/response). There will be no costs to respondents other than their time.

91 FR 32972