[Federal Register Volume 88, Number 129 (Friday, July 7, 2023)]
[Notices]
[Pages 43351-43353]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-14413]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-23-23GL; Docket No. CDC-2023-0055]


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 and other infectious disease targets of public 
health concern. The proposed information collection project aims to 
collect pathogen and public health target concentration in wastewater, 
wastewater target variant sequencing data, sewershed spatial files, and 
associated sewershed-level case data from participating jurisdictions 
in the United States to inform infectious disease prevention and 
control efforts.

DATES: CDC must receive written comments on or before September 5, 
2023.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2023-
0055 by either of the following methods:
     Federal eRulemaking Portal: www.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 H21-8, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to www.regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (www.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 H21-8, Atlanta, Georgia 30329; Telephone: 404-639-7570; 
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

[[Page 43352]]

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 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

    This information collection request is built upon a project 
currently approved under the COVID-19 Public Health Emergency (PHE) PRA 
Waiver. This expanded information collection request is for three 
years. The COVID-19 pandemic has 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, has been detected 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, such as mpox, influenza, and 
antimicrobial resistance. Recommendations for wastewater data 
collection for specific infectious diseases will be based on public 
health need and input from the NWSS Advisory Council comprised of 
subject matter experts from across CDC.
    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 
wastewater surveillance of SARS-CoV-2 infections. In 2022, NWSS was 
expanded to include environmental surveillance of mpox infections. 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 disease threats. 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. Together with CDC-funded national-level 
wastewater testing, jurisdictions across the U.S. have submitted data 
to NWSS that represents approximately 138 million individuals, or 41% 
of the U.S. population. Data are input to the Data Collation and 
Integration for Public Health Event Response (DCIPHER) platform for 
participants to view and analyze in near real time.
    Wastewater surveillance provides aggregated, anonymized data at the 
community level to indicate trends in infections. These data can be 
especially impactful 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 
additional surveillance data to assess community-level infection 
trends. Wastewater data collection will be coordinated by health 
department jurisdictions through close collaboration with wastewater 
utilities, testing laboratories, and by CDC through national-level 
testing contracts that cover up to 500 wastewater utility sites. There 
are three data components comprising this collection request. For data 
collection Component 1, wastewater utilities or partners will collect 
single time point, time-weighted composite, or flow-weighted composite 
samples from wastewater influent lines or at other points in the 
collection stream at regular intervals, such as once a week. The 
wastewater samples will be shipped, along with their associated 
sampling metadata, to testing laboratories where pathogen- or target-
specific RNA or DNA will be quantified for up to 30 targets (e.g., 
SARS-CoV-2, mpox, influenza, antibiotic resistance, etc.). For some 
wastewater samples, target sequencing will be conducted to help public 
health officials monitor infectious disease variant trends (e.g., SARS-
CoV-2). The testing laboratory will deliver wastewater sample 
collection and laboratory testing data to the jurisdiction health 
department, or directly to the CDC from national-level testing, to 
compile, review, and submit to CDC through the NWSS DCIPHER platform.
    For data collection Component 2, 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.
    For data collection Component 3, health department jurisdictions 
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. The health department jurisdiction will submit to CDC 
the line list of deidentified cases into the NWSS DCIPHER platform.
    The proposed data collection will occur over three years. Based on 
previous pilot data collection and additional estimates from 2022-2023 
U.S. case numbers in the CDC National Notifiable Disease Surveillance 
System (NNDSS), it is estimated that 166,400 wastewater samples and 
2,198,736 sewershed-level case data files 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 571,013 hours.

[[Page 43353]]



                                        Estimated Annualized Burden Hours
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                                                                                          Average       Total
                                                           Number of       Number of     burden per     annual
       Type of respondents              Form name         respondents    responses per    response      burden
                                                                          respondent     (in hours)     hours
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State, tribal, local, territorial  Component 1 Forms:               55           2,080       139/60      265,026
 health departments.                NWSS Data
                                    Dictionary v5.0.0;
                                    CDC Seq Manifest
                                    Data Dictionary;
                                    BioSample_WW
                                    Template v1.9; SRA
                                    Template v5.7
                                    NWSS; NCBI DCIPHER
                                    Crosswalk_Data
                                    Dictionary;
                                    NWSS_DCIPHER
                                    Wastewater Data
                                    CSV Upload
                                    Template;
                                    Component 1-2-3
                                    NWSS DCIPHER CSV
                                    Bulk Upload Tool.
Private laboratory...............  Component 1 Forms:                1          52,000       139/60      120,467
                                    Component; NWSS
                                    Data Dictionary
                                    v5.0.0; CDC Seq
                                    Manifest Data
                                    Dictionary;
                                    BioSample WW
                                    Template v1.9; SRA
                                    WW Template v5.7;
                                    NCBI DCIPHER
                                    Crosswalk Data
                                    Dictionary; NWSS
                                    DCIPHER Wastewater
                                    Data CSV Upload
                                    Template v3;
                                    Component 1-2-3
                                    NWSS DCIPHER CSV
                                    Bulk Upload Tool.
State, tribal, local, territorial  Component 2 Forms:               55              20         5/60           92
 health departments.                Sewershed Spatial
                                    Files (No Form);
                                    Component 1-2-3
                                    NWSS DCIPHER CSV
                                    Bulk Upload Tool.
Wastewater utilities.............  Component 2 Forms:            1,100               1            2        2,200
                                    Sewershed Spatial
                                    Files (No Form);
                                    Component 1-2-3
                                    NWSS DCIPHER CSV
                                    Bulk Upload Tool.
State, tribal, local, territorial  Component 3 Forms:               55          39,977         5/60      183,228
 health departments.                NWSS COVID Case
                                    Data Dictionary;
                                    NWSS DCIPHER Case
                                    Data CSV Upload
                                    Template; NWSS
                                    DCIPHER Sewershed
                                    Name Crosswalk CSV
                                    Upload Template;
                                    Component_1-2-3
                                    NWSS DCIPHER CSV
                                    Bulk Upload Tool.
                                                       ---------------------------------------------------------
    Total........................  ...................  ..............  ..............  ...........      571,013
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health 
Ethics and Regulations, Office of Science, Centers for Disease Control 
and Prevention.
[FR Doc. 2023-14413 Filed 7-6-23; 8:45 am]
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