2023-23856. 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 “National Wastewater Surveillance System for SARS–CoV–2 and Other Infectious Disease Targets of Public Health Concern” 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 July 7, 2023 to obtain comments from the public and affected agencies. CDC received 4,476 comments related to this 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

National Wastewater Surveillance System for SARS–CoV–2 and Other Infectious Disease Targets of Public Health Concern—New—National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The Centers for Disease Control and Prevention (CDC) seeks to continue and expand existing information collection by the National Wastewater Surveillance System for COVID–19 currently approved under the COVID–19 Public Health Emergency (PHE) PRA waiver. This information collection request is for three years.

The COVID–19 pandemic demonstrated the need for timely, actionable surveillance data to inform disease prevention and control activities. The genetic material of SARS–CoV–2, the virus that causes COVID–19, is detectable in the feces of infected individuals, regardless of their symptom status. Therefore, sampling and testing wastewater provides a means to assess SARS–CoV–2 infection trends in the community independent of clinical testing or other healthcare indicators. This public health surveillance approach can be used for other infectious diseases or targets of public health concern, such as mpox, influenza, and antimicrobial resistance.

The National Wastewater Surveillance System (NWSS) was originally established to support the CDC COVID–19 response, and now, NWSS serves as a public health tool to provide community-level disease trends. NWSS was designed to permit the addition or exchange of targets for wastewater infectious disease testing. This built-in flexibility will allow jurisdictions to adapt wastewater testing to changing public health needs, enable rapid responses to outbreaks or emergencies, and support broad capacity to detect future, emerging disease threats. Wastewater data have provided impactful information to local public health authorities to confirm trends observed in testing or hospitalization rates, and 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. Together with CDC-funded national-level wastewater testing by commercial partners, jurisdictions across the US have submitted data to NWSS that represents an estimated 141 million individuals, or 41% of the US population. Wastewater data collection will be coordinated by STLT health departments through close collaboration with wastewater utilities. CDC will coordinate national-level testing contracts that cover up to 500 wastewater testing sites. Once collected, wastewater data will be submitted to the Data Collation and Integration for Public Health Event Response (DCIPHER) platform for participants to view and analyze in near real-time.

There are three data components comprising this collection request. For data collection Component 1, wastewater utilities or partners will collect metadata and samples from wastewater influent lines or at other points in the collection stream at regular intervals twice a week, or at irregular intervals as needed. The wastewater samples will be shipped, along with their associated sampling metadata, to STLT health departments where pathogen- or target-specific RNA or DNA will be quantified for up to 40 targets ( e.g., SARS–CoV–2, mpox, influenza, antibiotic resistance, etc.). Data collection for specific infectious diseases or targets will be based on public health need and input from the NWSS Advisory Council comprised of subject matter experts from across CDC. For some wastewater samples, target sequencing will be conducted to help public health officials monitor infectious disease variant trends ( e.g., SARS–CoV–2). STLT health departments will compile, review, and submit testing data to CDC through the NWSS DCIPHER platform, or national contract laboratories will submit data directly to the CDC. Four forms are to be submitted for this data component, with four documents used as reference.

For data collection Component 2, STLT health departments will work with participating utilities to obtain geographic boundary data of the wastewater utility service areas, also called a sewershed. These sewershed boundary data files (also referred to as spatial files) will be uploaded by jurisdiction health departments into the NWSS DCIPHER platform. No forms are to be submitted for this data component, only spatial files, with one document used as reference.

For data collection Component 3, STLT health departments may choose to develop a line list of reported cases of specific infections ( e.g., COVID–19, mpox, influenza, antibiotic resistant infections, etc.) associated with the participating wastewater utility service areas, for which wastewater testing data is also being collected. The STLT health department will submit to CDC the line list of deidentified cases into the NWSS DCIPHER platform. Two forms are to be submitted for this data component, with two documents used as reference.

Based on previous pilot data collection and additional estimates from 2022–2023 US case numbers in the CDC National Notifiable Disease Surveillance System, we estimate that 166,400 wastewater samples and 3,664,607 sewershed-level case data file identifiers will be collected and reported to NWSS each year, while 1,100 sewershed spatial files will only need to be submitted once during the three-year period. In total, the estimated annual burden for all data collection components for this request is 695,941 hours.

Estimated Annualized Burden Hours

Type of respondents	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hours)
State, tribal, local, territorial health department staff	Component 1 Forms: Component-1 BioSample_ww_template_v1.9_NWSS; Component-1 SRA_ww_template_v5.7_NWSS; Component-1 NWSS_DCIPHER_Wastewater_Data_CSV_Upload_Template_v3_1_All Fields	55	2,080	1
Wastewater Utilities Staff	Component 1 Forms: Component-1 NWSS_DCIPHER_Wastewater_Data_CSV_Upload_Template_v3_1_All Fields	1,100	104	80/60
Contract laboratory	Component 1 Forms: Component-1 BioSample_ww_template_v1.9_NWSS; Component-1 SRA_ww_template_v5.7_NWSS; Component-1 NWSS_DCIPHER_Wastewater_Data_CSV_Upload_Template_v3_1_All Fields; Component-1 NWSS_Sequencing_Manifest_Template	1	52,000	140/60
State, tribal, local, territorial health department staff	Component 2 Forms: Sewershed spatial files, no form required	55	20	5/60
Wastewater utility staff	Component 2 Forms: Sewershed spatial files, no form required	1,100	1	2
State, tribal, local, territorial health department staff	Component 3 Forms: Component-3 NWSS_DCIPHER_CaseData_CSVUpload_Template; Component-3 NWSS_DCIPHER_Sewershed_Name_Crosswalk_CSV_Upload_Template	55	66,629	5/60

Jeffrey M. Zirger,

Lead, Information Collection Review Office, Office of Public Health Ethics and Regulations, Office of Science, Centers for Disease Control and Prevention.