Change Request Justifiation (2018)

OMB Change Request:

Cyclosporiasis National Hypothesis Generating Questionnaire (CNHGQ)

OMB Control Number 0920-1198

Expiration Date: 09/30/2020

Date of Request: 3/6/2018

OMB approval is requested by: 4/1/2018

Program Contact

Shannon Cooney

Parasitic Diseases Branch

Division of Parasitic Diseases and Malaria

Center for Global Health

Centers for Disease Control and Prevention

1600 Clifton Road N.E.

Atlanta, Georgia 30329

Phone: 404-718-1057

Fax: 404-471-8812

Email: [email protected]

Summary

Foodborne outbreaks of cyclosporiasis have been reported in the United States since the mid-1990s and have been linked to various types of fresh produce. 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. The Cyclosporiasis National Hypothesis Generating Questionnaire (CNHGQ) was developed to capture information from case-patients that is pertinent to Cyclospora and fresh produce vehicles of infection to aid in the investigation and detection of outbreaks. The CNHGQ is the only nationally representative survey for collecting extended exposure information from cyclosporiasis case-patients. The CNHGQ was initially approved by OMB for use in 2017; modifications to the collection instrument have been made to help streamline interviews and to improve upon how certain data elements are collected.

Change request

We request OMB approval for the revised CNHGQ data collection instrument, Attachment 1. CNHGQ 2018 Revisions. Revisions from the previously approved 2017 version of the questionnaire are summarized in Attachment 2. Crosswalk of Non-substantive changes to 2018 CNHGQ.

The annualized burden hours and cost to reporting jurisdictions to submit these data to CDC do not change from the original estimates. There are no changes to the respondent universe, sampling methods or procedures for the collection of information. We still expect that the CNHGQ will take ~20 minutes to administer, and the total burden for each response to be ~45 minutes (this includes additional time for the collection of laboratory information, data entry, and submission of information to CDC).

Background and justification

This is a nonmaterial/non-substantive change request for OMB No. 0920-1198, expiration date 09/30/2020, for the reporting of Cyclosporiasis National Hypothesis Generating Questionnaire (CNHGQ) data for use during periods in which increased numbers of cyclosporiasis cases are reported (typically, during spring and summer months). The CNHGQ is a tool used during investigations of clusters/outbreaks of cyclosporiasis cases; the data collected using this questionnaire allow CDC to obtain information from state and local public health partners in a consistent manner for analysis. Cyclosporiasis is a nationally notifiable disease and is currently reportable in 45 U.S. public health jurisdictions (43 states, the District of Columbia, and New York City). However, the data received via the National Notifiable Diseases Surveillance System are not sufficient for investigating outbreaks of cyclosporiasis. Rather, information about exposures among case-patients is needed in order to determine whether cases may be part of a cluster or outbreak. Once analyzed, data are shared with pertinent public health partners (e.g., FDA and state/local partners) to aid in ongoing investigations and prevention efforts.

If approved, the proposed modified CNHGQ will be used beginning in May 2018. This request is for the addition of 6 new disease-specific data elements and 1 new optional data element, modifications of 23 data elements, and deletions of 7 data elements. Many of the new and modified data elements constitute minor expansions of questions already in the OMB-approved version of the CNHGQ. The length of the CNHGQ is now shorter rather than longer than the OMB-approved version because we removed (or combined) ~30 questions in the context of revising the CNHGQ to help streamline the interview process. Additionally, the formatting of the questionnaire has been modified to make it easier to administer. The proposed changes were made following discussions with public health partners (from four jurisdictions) who have used the OMB-approved version of the CNHGQ and thought that the modifications would increase the utility of the CNHGQ.

Additional perspective: Some state public health partners asked us to include questions in the CNHGQ to capture intrastate travel (even though data in such regards are not analyzed at the national level) so states that would like to be able to collect this type of information can do so without having to create a separate (additional) form for local use. In response to this request, we have now added questions about intrastate travel. However, we have indicated on the revised CNHGQ that these questions are optional.

The 2018 CNHGQ is provided as Attachment 1. CNHGQ 2018 Revisions.

Changes from the 2017 version of the questionnaire are summarized in Attachment 2. Crosswalk of Non-substantive changes to 2018 CNHGQ.

Requested OMB approval date and rationale

OMB approval is requested by 4/1/2018. Approval by this date will allow for the survey collection instrument to be disseminated to state public health partners in preparation for the 2018 cyclosporiasis outbreak season (typically, May–August). Lead time is requested so that state partners can become familiar with the revised format of the CNHGQ and ask any questions prior to administering the questionnaire to case-patients.

Estimated timeline

4/1/2018 Target date for receipt of OMB change request approval

4/15/2018 Disseminate CNHGQ to state public health partners in preparation for the 2018 outbreak season

5/1/2018 State public health partners begin administering CNHGQ to cyclosporiasis case-patients