[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]
BILLING CODE 4163-18-P