Agency Forms Undergoing Paperwork Reduction Act Review
| Citation | 88 FR 62791 |
| Published date | 13 September 2023 |
| Record Number | 2023-19708 |
| Court | Centers For Disease Control And Prevention,Health And Human Services Department |
| Section | Notices |
Federal Register, Volume 88 Issue 176 (Wednesday, September 13, 2023)
[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
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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 2,500 1 45/60
cyclosporiasis. National Hypothesis
Generating
Questionnaire.
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[[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]
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