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 National Wastewater Surveillance System for COVID-19. The proposed information collection project aims to collect SARS-CoV-2 wastewater and associated sewershed-level case data from participating jurisdictions in the United States to inform COVID-19 prevention and control efforts.

DATES:

CDC must receive written comments on or before November 8, 2021.

ADDRESSES:

You may submit comments, identified by Docket No. CDC-2021-0090 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: 404-639-7118; Email: omb@cdc.gov.

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;

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; and

5. Assess information collection costs.

Proposed Project

National Wastewater Surveillance System for COVID-19—New—National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The COVID-19 pandemic has demonstrated the need for timely, actionable surveillance data to inform prevention and control activities. The genetic material of SARS-CoV-2, the virus that causes COVID-19, has been detected in the feces of infected individuals, regardless of their symptom status. Therefore, sampling and testing wastewater provides a means to obtain an assessment of SARS-CoV-2 infection trends in the community independent of health care seeking, or other clinical indicators.

The Waterborne Disease Prevention Branch (WDPB) in the Division of Foodborne, Waterborne, and Environmental Diseases works to prevent domestic and global water, sanitation, and hygiene related disease. In support of the Centers for Disease Control and Prevention (CDC) COVID-19 response, WDPB established the National Wastewater Surveillance System (NWSS). NWSS serves as a public health tool to provide environmental surveillance of SARS-CoV-2 infections. Wastewater data have provided impactful information to local public health authorities, whether to confirm trends observed in testing or hospitalization rates, or to assert the need for increased testing or healthcare resources. NWSS has supported jurisdictions throughout the United States to implement wastewater surveillance, and will continue to support state, tribal, local, and territorial (STLT) partners to collect wastewater data. Data are input to the Data Collation and Integration for Public Health Event Response (DCIPHER) platform for participants to view and analyze their data in near real time.

Wastewater surveillance provides aggregated, anonymized data at the community level to indicate trends in SARS-CoV-2 infections. These data can be particularly useful in underserved populations where clinical testing is limited or health care seeking is reduced. Wastewater data collection could inform locations that require greater resource allocation early in outbreaks and provide health departments with an additional, clinical-testing agnostic surveillance method to assess community-level COVID-19 trends.

Wastewater data collection will be coordinated by health department jurisdictions through close collaboration with wastewater utilities, testing laboratories, and CDC. Wastewater utilities will collect grab, time-weighted composite, or flow-weighted composite samples of wastewater from wastewater influent lines at least once a week. The wastewater samples will be shipped along with their associated sampling metadata to testing laboratories where SARS-CoV-2 RNA will be quantified. The testing laboratory will deliver wastewater sample collection and laboratory testing data to the jurisdiction health department to compile, review, and submit to CDC using the comma separated value (CSV) bulk upload template into the NWSS DCIPHER platform.

In addition to wastewater data, jurisdiction health departments will work with participating utilities to obtain spatial files of the utility service areas, also called a sewershed. These sewershed spatial files will be uploaded by jurisdiction health departments into the NWSS DCIPHER platform. Finally, health department jurisdictions using the sewershed spatial files will develop a line list of COVID-19 cases who reside within the participating wastewater utility service areas. The health department jurisdiction will submit to CDC, the line list of COVID-19 cases using a CSV bulk upload template into the DCIPHER NWSS platform.

The proposed data collection will occur over three years. The data collection involves three data components: (1) SARS-CoV-2 wastewater data, (2) spatial files of the wastewater utility service area (referred to as sewersheds), and (3) COVID-19 sewershed case data. Based on pilot data collection, it is expected that 64,480 wastewater samples, 620 spatial files, and 1,550,000 COVID-19 sewershed cases will be collected and reported to NWSS each year. This will lead to a total annual burden of 238,089 hours (107,682 hours for wastewater data, 1,240 hours for spatial files, and 129,167 hours for COVID-19 sewershed case data). There is no cost to respondents other than their time.