# Proposed Data Collection Submitted for Public Comment and Recommendations
**AGENCY:**
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
**ACTION:**
Notice with comment period.
**SUMMARY:**
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Use of the Cyclosporiasis National Hypothesis Generating Questionnaire (CNHGQ) During Investigations of Foodborne Disease Clusters and Outbreaks. This data collection is used to collect standardized data during investigations of outbreaks of cyclosporiasis, thereby increasing the likelihood that outbreaks will be recognized, and sources will be identified.
**DATES:**
CDC must receive written comments on or before September 5, 2023.
**ADDRESSES:**
You may submit comments, identified by Docket No. CDC-2023-0056 by either of the following methods:
• *Federal eRulemaking Portal: www.regulations.gov.* Follow the instructions for submitting comments.
• *Mail:* Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS H21-8, Atlanta, Georgia 30329.
*Instructions:* All submissions received must include the agency name and Docket Number. CDC will post, without change, all relevant comments to *www.regulations.gov.*
*Please note:* Submit all comments through the Federal eRulemaking portal ( *www.regulations.gov* ) or by U.S. mail to the address listed above.
**FOR FURTHER INFORMATION CONTACT:**
To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS H21-8, Atlanta, Georgia 30329; Telephone: 404-639-7570; Email: *[email protected].*
**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. 9/30/2023)—Extension—Global Health Center (GHC), 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 the Extension of Use of the Cyclosporiasis National Hypothesis Generating Questionnaire (CNHGQ) During Investigations of Foodborne Disease Clusters and Outbreaks (OMB Control No. 0920-1198, Expiration Date 09/30/2023).
An estimated one in six Americans per 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 (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. 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 1,000 cases; notably, in 2018 and again in 2019 over 2,000 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 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 (besides those 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, to collect data elements from case-patients or their proxies. The data that are collected 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 are not yet available for *C. cayetanensis,* 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). The CNHGQ is not expected to entail substantial burden for respondents. The estimated total annualized burden associated with administering the CNHGQ is 1,875 hours. There will be no costs to respondents other than their time.
| Type of respondents | Form name | Number of | Number of | Average | Total burden |
| --- | --- | --- | --- | --- | --- |
| Ill individuals identified with cyclosporiasis | Cyclosporiasis National Hypothesis Generating Questionnaire | 2,500 | 1 | 45/60 | 1,875 |
| Total | | | | | 1,875 |
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health Ethics and Regulations, Office of Science, Centers for Disease Control and Prevention.