[Federal Register Volume 81, Number 246 (Thursday, December 22, 2016)]
[Notices]
[Pages 93937-93939]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-30778]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-17-17IM; Docket No. CDC-2016-0120]


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 efforts to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies to take this opportunity to comment on proposed and/or 
continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on Use of the 
Cyclosporiasis National Hypothesis Generating Questionnaire (CNHGQ) 
during Investigations of Foodborne Disease Clusters and Outbreaks. CDC 
seeks to request Office of Management and Budget (OMB) approval to 
collect information via the CNHGQ from persons who have developed

[[Page 93938]]

symptomatic cases of Cyclospora infection during periods in which 
increased numbers of such cases are reported (typically, during spring 
and summer months).

DATES: Written comments must be received on or before February 21, 
2017.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2016-
0120 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE., MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.
    Please note: All public comment should be submitted through the 
Federal eRulemaking portal (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 the Information Collection Review Office, 
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
D74, Atlanta, Georgia 30329; phone: 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 OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; (d) ways to 
minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services 
to provide information. Burden means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; to develop, acquire, 
install and utilize technology and systems for the purpose of 
collecting, validating and verifying information, processing and 
maintaining information, and disclosing and providing information; to 
train personnel and to be able to respond to a collection of 
information, to search data sources, to complete and review the 
collection of information; and to transmit or otherwise disclose the 
information.

Proposed Project

    Use of the Cyclosporiasis National Hypothesis Generating 
Questionnaire (CNHGQ) during Investigations of Foodborne Disease 
Clusters and Outbreaks--New--Center for Global Health (CGH), Centers 
for Disease Control and Prevention (CDC).

Background and Brief Description

    An estimated 1 in 6 Americans per year become 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.
    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 have 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 750 hours (approximately 1,000 individuals 
interviewed x 45 minutes/response). There will be no costs to 
respondents other than their time.

[[Page 93939]]



                                        Estimated Annualized Burden Hours
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                                                                     Number of      Avg. burden
     Type of  respondents           Form name        Number of    responses  per   per response    Total burden
                                                    respondents      respondent      (in hrs.)       (in hrs.)
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Individuals...................  Cyclosporiasis             1,000               1           45/60             750
                                 National
                                 Hypothesis
                                 Generating
                                 Questionnaire.
                               ---------------------------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             750
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Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific 
Integrity, Office of the Associate Director for Science, Office of the 
Director, Centers for Disease Control and Prevention.
[FR Doc. 2016-30778 Filed 12-21-16; 8:45 am]
 BILLING CODE 4163-18-P