Agency Forms Undergoing Paperwork Reduction Act Review

Published date13 September 2023
Record Number2023-19708
Citation88 FR 62791
CourtCenters For Disease Control And Prevention,Health And Human Services Department
SectionNotices
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]
                =======================================================================
                -----------------------------------------------------------------------
                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
                

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