[Federal Register Volume 88, Number 176 (Wednesday, September 13, 2023)]
[Notices]
[Pages 62791-62793]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-19708]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-23-1198]


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 July 7, 2023, to obtain comments from the 
public and affected agencies. CDC did not receive comments related to 
the previous notice. 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

[[Page 62792]]

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. 9/30/2023)--
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 (CDC) is requesting 
a three-year Paperwork Reduction Act (PRA) clearance for an Extension 
of 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. 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 from 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 
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 1875 hours (approximately 2,500 individuals 
interviewed x 45 minutes/response). There will be no costs to 
respondents other than their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                   Number of      Average burden
         Type of respondents                 Form name           Number of       responses per     per response
                                                                respondents       respondent        (in hours)
----------------------------------------------------------------------------------------------------------------
Ill individuals identified with       Cyclosporiasis                   2,500                 1            45/60
 cyclosporiasis.                       National Hypothesis
                                       Generating
                                       Questionnaire.
----------------------------------------------------------------------------------------------------------------



[[Page 62793]]

Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health 
Ethics and Regulations, Office of Science, Centers for Disease Control 
and Prevention.
[FR Doc. 2023-19708 Filed 9-12-23; 8:45 am]
BILLING CODE 4163-18-P