[Federal Register Volume 88, Number 129 (Friday, July 7, 2023)]
[Notices]
[Pages 43350-43351]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-14414]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-23-1198; Docket No. CDC-2023-0056]


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.

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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

[[Page 43351]]

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.

                                        Estimated Annualized Burden Hours
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                                                                                       Average
                                                        Number of       Number of     burden per   Total burden
      Type of respondents             Form name        respondents    responses per    response     (in hours)
                                                                       respondent     (in hours)
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Ill individuals identified with  Cyclosporiasis               2,500               1        45/60           1,875
 cyclosporiasis.                  National
                                  Hypothesis
                                  Generating
                                  Questionnaire.
                                                    ------------------------------------------------------------
    Total......................  ..................  ..............  ..............  ...........           1,875
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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. 2023-14414 Filed 7-6-23; 8:45 am]
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