[Federal Register Volume 85, Number 37 (Tuesday, February 25, 2020)]
[Notices]
[Pages 10698-10699]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03656]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-20-1198; Docket No. CDC-2020-0014]
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 effort to reduce public burden and maximize the
utility of government information, invites the general public and other
Federal agencies the opportunity to comment on a proposed and/or
continuing information collection, as required by the Paperwork
Reduction Act of 1995. This notice invites comment on a proposed
information collection project titled ``Cyclosporiasis National
Hypothesis Generating Questionnaire''. The Cyclosporiasis National
Hypothesis Generating Questionnaire (CNHGQ) facilitates the collection
of standard data during investigations of outbreaks of cyclosporiasis,
thereby increasing the likelihood that outbreaks will be recognized and
sources will be identified.
DATES: CDC must receive written comments on or before April 27, 2020.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2020-
0014 by any of the following methods:
Federal eRulemaking Portal: Regulations.gov. Follow the
instructions for submitting comments.
Mail: Jeffrey M. Zirger, 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. CDC will post, without change, all relevant comments
to Regulations.gov.
Please note: Submit all comments 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 Jeffery M. Zirger, 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].
[[Page 10699]]
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 the OMB for approval. To
comply with this requirement, we are publishing this notice of a
proposed data collection as described below.
The OMB is particularly interested in comments that will help:
1. 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;
2. Evaluate the accuracy of the agency's estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to
be collected; and
4. 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
submissions of responses.
5. Assess information collection costs.
Proposed Project
Cyclosporiasis National Hypothesis Generating Questionnaire (OMB
Control No. 0920-1198 Exp. 9/30/2020)- Revision--Centers 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.
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 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 (in Total burden (in
respondents respondent hours) hours)
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Ill individuals identified as part of an Cyclosporiasis National 2,500 1 45/60 1875
outbreak investigation. Hypothesis Generating
Questionnaire.
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total................................... .............................. ................. ................. ................. 1875
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2020-03656 Filed 2-24-20; 8:45 am]
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