[Federal Register Volume 85, Number 106 (Tuesday, June 2, 2020)]
[Notices]
[Pages 33683-33684]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-11798]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-20-1198]


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 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 February 25, 2020 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 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

[[Page 33684]]

(CNHGQ) During Investigations of Foodborne Disease Clusters and 
Outbreaks (OMB Control No. 0920-1198, Exp. 9/30/2020)--Revision--Center 
for Global Health (CGH), Centers for Disease Control and Prevention 
(CDC).

Background and Brief Description

    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 of 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. During the intervening years (i.e. 2015-2019), 
the numbers of reported cases have steadily increased and larger 
multistate outbreaks have been reported. For example, there were an 
estimated 2,299 laboratory-confirmed, domestically acquired cases among 
persons who became ill during May to August (the typical timeframe of 
the cyclosporiasis ``season'' in the United States) reported in 2018. 
This was markedly higher than the numbers of cases reported for the 
same time period in 2016 (174) and 2017 (623). In 2019, as of November 
13, there were an estimated 2,408 laboratory-confirmed cases reported 
for the same time period.
    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) (see 
OMB No. 0920-0997). 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, in consultation with public health partners at 
the local, state, and federal level, CDC developed the Cyclosporiasis 
National Hypothesis Generating Questionnaire (CNHGQ) using core data 
elements from the SNHGQ and incorporating modifications pertinent to 
Cyclospora. The CNHGQ facilitates data collection about exposures of 
potential relevance that an individual had during the period of 
interest (typically, for ill persons, the two week period before onset 
of symptoms). The CNHGQ also facilitates information collection about 
other factors that may be pertinent to multistate outbreaks of 
cyclosporiasis, including the individual's travel history, 
hospitalization status, consumption of fresh produce, and points of 
service for food items consumed at home or away from home. Use of the 
CNHGQ reduces delays in information collection that would occur if 
state and local health departments had to develop new forms for each 
outbreak investigation. The CNHGQ also promotes a common data framework 
for analysis of pooled data across jurisdictions and better 
understanding of potential vehicles/sources of Cyclospora infection.
    The CNHGQ has been designed for administration over the telephone 
by public health officials. State or local health departments may use a 
web-based version of the CNHGQ to facilitate information collection and 
transmission to CDC. Health departments that prefer to complete a 
fillable PDF version of the CNHGQ may submit forms to CDC by email.
    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). In some circumstances, a parent, guardian, household 
member or other proxy may participate in the interview on behalf of the 
case-patient.
    OMB approval is requested for three years. There are no changes to 
data collection content, data collection procedures, or the estimated 
burden per response of 45 minutes per interview. The only change is an 
increase in the estimated number of respondents based on projected use 
of the CNHGQ. Participation is voluntary and there are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 1,875.

                                        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 as part of   Cyclosporiasis National            2,500               1           45/60
 an outbreak investigation.              Hypothesis Generating
                                         Questionnaire.
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2020-11798 Filed 6-1-20; 8:45 am]
 BILLING CODE 4163-18-P