[Federal Register Volume 86, Number 170 (Tuesday, September 7, 2021)]
[Notices]
[Pages 50125-50126]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19160]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-21-21HT; Docket No. CDC-2021-0090]


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.

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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: 
[email protected].

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

[[Page 50126]]

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.

                                        Estimated Annualized Burden Hours
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                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondents           Form name       respondents    responses per   response (in     (in hours)
                                                                    respondent        hours)
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State, tribal, local,           National                  64,480           2,080          100/60         107,682
 territorial health department   Wastewater
 staff.                          Surveillance
                                 System: SARS-
                                 CoV-2
                                 wastewater data
                                 collection.
State, tribal, local,           No form;                     620              20               2           1,240
 territorial health department   provision of
 staff; Wastewater utility       sewershed
 staff.                          spatial files.
State, tribal, local,           National               1,550,000          50,000            5/60         129,167
 territorial health department   Wastewater
 staff.                          Surveillance
                                 System: COVID-
                                 19 sewershed
                                 case data
                                 collection.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............         238,089
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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. 2021-19160 Filed 9-3-21; 8:45 am]
BILLING CODE 4163-18-P