2021-04669. 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.

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 CryptoNet Case Report Form. The CryptoNet Case Report Form will be used by federal, state, and local public health officials responsible for conducting interviews with reported cases of cryptosporidiosis in their jurisdiction in order to systematically assess core exposure elements and risk factors among cases of cryptosporidiosis.

DATES:

CDC must receive written comments on or before May 7, 2021.

ADDRESSES:

You may submit comments, identified by Docket No. CDC-2021-0018 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 Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329; phone: [phone]; Email: [e-mail].

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

CryptoNet Case Report Form—New—National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The Waterborne Disease Prevention Branch (WDPB) in the Division of Foodborne, Waterborne, and Environmental Diseases (DFWED) works to prevent domestic and global water, sanitation, and hygiene (WASH) related disease. The WDPB is comprised of four teams, including the Domestic WASH Epidemiology Team, which focuses on the prevention and control of waterborne and WASH-related disease and outbreaks in the United States. One of the diseases included in the team's work is cryptosporidiosis, an acute diarrheal disease caused by infection with Cryptosporidium parasites.

The Case Surveillance node is a sub-unit within the Domestic WASH Epidemiology Team which focuses on the data collection and management activities of six waterborne diseases, including cryptosporidiosis, in the United States. The Case Surveillance node's current scope of work includes modernizing data collection and management, enabling data connections, and improving public data access to aid public health action.

CryptoNet is the first molecular tracking system for Cryptosporidium in the United States. To meet the needs of the CryptoNet, the Case Surveillance node, and the needs of local officials, the CryptoNet case report form (CRF) was developed. 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.

Data from the CRF will be used by federal, state, and local public health officials responsible for conducting interviews with reported cases of cryptosporidiosis in their jurisdiction in order to systematically assess core exposure elements and risk factors among cases of cryptosporidiosis. Collected data will be used by CDC staff to inform cryptosporidiosis sporadic case and cluster and outbreak prevention and control strategies. CRF data elements and the CRF form were designed for administration via telephone interviews with individuals ill with cryptosporidiosis, or their designated proxy.

CDC requests OMB approval for an estimated 125 annual burden hours. Providing information is voluntary, and there are no costs to respondents other than their time.

Estimated Annualized Burden Hours

Type of respondents	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hours)	Total burden (in hours)
Individuals ill with cryptosporidiosis, or their designated proxy	CryptoNet Case Report Form	500	1	15/60	125
Total					125

Jeffrey M. Zirger,

Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention.