[Federal Register Volume 86, Number 140 (Monday, July 26, 2021)]
[Notices]
[Pages 40047-40048]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-15790]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-21-21DI]
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 CryptoNet Case Report Form 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 March 8, 2021 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
CryptoNet Case Report Form--New--National Center for Emerging and
[[Page 40048]]
Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
Cryptosporidium are a genus of parasites that cause the diarrheal
disease cryptosporidiosis. As part of Cryptosporidium case and outbreak
investigations, it is common for state and local health departments to
conduct comprehensive interviews with cases and contacts to identify
how individuals became sick with cryptosporidiosis, to identify
individuals who could have come into contact with an individual sick
with cryptosporidiosis, and to identify strategies to control the
disease spread. Since cryptosporidiosis can be transmitted through
numerous modes, it can be challenging to identify how individuals could
have become ill. As a result, comprehensive case report forms focused
on a range of settings, activities, and potential modes of transmission
are needed to guide prevention and control activities.
The CryptoNet case report form (CRF) was developed to meet the
needs of CDC's case surveillance experts and local officials. The CRF
includes a set of data elements that can be used to identify exposure
trends in outbreak- and non-outbreak-associated Cryptosporidium cases,
to generate hypotheses about the source(s) of infection in clusters or
outbreaks, and to identify strategies to prevent and control
Cryptosporidium cases, clusters, or outbreaks. CryptoNet is meant to
supplement existing cryptosporidiosis case surveillance data reported
through the National Notifiable Diseases Surveillance System (NNDSS)
(OMB No. 0920-0728, Exp. 3/31/2024). Current cryptosporidiosis case
surveillance through NNDSS lacks information on key exposures proposed
to be captured by CryptoNet. Notably, information proposed to be
collected as part of CryptoNet serves as the foundation for the
recently developed foodborne and diarrheal diseases message mapping
guide--cryptosporidiosis tab (FDD MMG). The FDD MMG is the latest
revision to NNDSS that aims to increase the amount of exposure data
collected on each cryptosporidiosis case. Upon nationwide
implementation of the FDD MMG, NCEZID anticipates that the CryptoNet
Case Report form will be retired.
Administration of the CRF is to conduct surveillance on exposures
associated with Cryptosporidium cases to better inform prevention and
control strategies for these infections. There are no research
questions addressed. Standardized data will be compiled on recent
exposures related to cryptosporidiosis with the intention to inform
disease prevention and control activities and will not be used to
inform generalizable knowledge. CDC's CryptoNet staff and the Case
Surveillance node in CDC's Waterborne Disease Prevention Branch (WDPB)
will oversee data collection, data management, and analyses and
dissemination of data collected with the CRF during cryptosporidiosis
investigations. The data collected from the CRF will be used to inform
exposure trends among cases, clusters, or outbreaks with the intention
to identify and implement prevention and control strategies and
recommendations.
The CRF data elements and form were designed for administration via
telephone interview with cases of cryptosporidiosis or their proxies.
This method was chosen to reduce the overall burden on respondents
because it allows for the assessment team to ask for clarification from
participants during the interview, and this limits the need for
additional follow-up. The data collection instrument was designed to
collect the minimum information necessary for the purposes of this
project.
Based on the annual number of laboratory specimens collected by the
Cryptosporidium laboratory at CDC, it is expected that an average of
500 CryptoNet CRFs will be collected each year. OMB approval is
requested for three years. Participation is voluntary and there are no
costs to respondents other than their time. The total estimated
annualized burden is 125 hours.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondent Form name Number of responses per per response
respondents respondent (in hours)
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Individuals ill with CryptoNet Case Report 500 1 15/60
Cryptosporidiosis, or their Form.
designated proxy.
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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. 2021-15790 Filed 7-23-21; 8:45 am]
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