Agency Forms Undergoing Paperwork Reduction Act Review

Issuing agencies

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<title>Federal Register, Volume 91 Issue 197 (Wednesday, October 14, 2026)</title>
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[Federal Register Volume 91, Number 197 (Wednesday, October 14, 2026)]
[Notices]
[Pages 65215-65216]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-20906]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-27-1198]


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 June 2, 2026, to obtain comments from the 
public and affected agencies. CDC received four public comments. 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 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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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. 10/31/2026)--
Revision--The National Center for Emerging and

[[Page 65216]]

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 a Revision to 
the approved 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).
    Foodborne outbreaks of cyclosporiasis have been reported in the 
United States since the mid-1990s and have been linked to various types 
of imported fresh produce, including raspberries, basil, snow peas, 
mesclun lettuce, cilantro, and parsley. During the 15-year period of 
2000-2014, 31 U.S. foodborne outbreaks of cyclosporiasis were reported; 
the total case count was 1,562. Outbreaks were reported during 12 of 
the 15 years. Overall, a median of two outbreaks was reported per year, 
with a median of 20 reported cases per outbreak (range, three to 582 
cases). However, 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.
    From 2015-2025, the numbers of reported cases steadily increased 
and larger multistate outbreaks were reported. For example, an 
estimated 2,299 laboratory-confirmed, domestically acquired cases among 
persons who became ill from May to August, the typical timeframe of the 
cyclosporiasis ``season'' in the United States, were reported in 2018. 
This total was markedly higher than the numbers of cases reported for 
the same time period in 2016 (174) and 2017 (623). The number of 
reported cases continued to increase, reaching 2,717 laboratory-
confirmed cases in 2024. As of April 30, 2026, a total of 2,862 
laboratory-confirmed seasonal cases were reported to CDC.
    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). The 
CNHGQ was based on the SNHGQ but was modified to address the exposure 
period of interest for Cyclospora, to delete questions about food items 
that are not considered biologically plausible for transmission of this 
parasite (e.g., meat and dairy products), and to expand the data 
elements regarding fresh produce exposures (e.g., include more detailed 
information about grocery stores and restaurants).
    The CNHGQ was designed for administration over the telephone by 
public health officials, to collect data elements from case-patients or 
their proxies. Public health officials can use the CNHGQ or a locally 
developed form that includes CNHGQ data elements to collect 
information. The CNHGQ data elements and form will continue to improve 
the timeliness of hypothesis-generating analyses during outbreak 
investigations. This will be accomplished through the use of the CNHGQ 
to collect and submit data elements that will be maintained centrally 
for rapid pooling and analysis. There are no changes to the CNHGQ since 
the previous approval.
    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. 
Many foods investigated in outbreaks have multiple produce ingredients, 
like salsa or salads, making it difficult to narrow down to a single 
food item. The Cyclospora parasite is harder to track than many 
bacteria like Salmonella because whole genome sequencing is not 
available for this pathogen. Molecular typing methods for Cyclospora 
were developed in 2018 to determine genetic relatedness of cases 
associated with epidemiologic clusters. However, these methods cannot 
yet be used to identify new clusters of infection independent of 
epidemiologic data. Therefore, all temporally associated patients in 
whom cyclosporiasis is diagnosed must be interviewed to help determine 
if their case of infection could be part of an outbreak.
    The CNHGQ is not expected to entail substantial burden for 
respondents. The estimated total annualized burden associated with 
administering the CNHGQ is 2100 hours (approximately 2,800 individuals 
interviewed x 45 minutes/response). There are no costs to respondents 
other than their time to participate.

                                        Estimated Annualized Burden Hours
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                                                                                     Number of    Average burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
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Ill individuals identified with         Cyclosporiasis National            2,800               1           45/60
 cyclosporiasis.                         Hypothesis Generating
                                         Questionnaire.
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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. 2026-20906 Filed 10-13-26; 8:45 am]
BILLING CODE 4163-18-P


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