Research Determination

Print Date: 9/25/23

Title:

The Assessment and Implementation of Sewage Surveillance to Inform COVID-19 in the United States

Project Id:

0900f3eb81b8a666

Accession #:

NCEZID-DWASHEPI-7/8/20-8a666

Project Contact:

Jeffrey W Mercante

Organization:

NCEZID/DFWED/WDPB/DWASHEPI

Status:

Project In Progress : PRA Revision

Intended Use:

Project Determination

Estimated Start Date:

07/15/2020

Estimated Completion Date:

12/31/2026

CDC/ATSDR HRPO/IRB Protocol #:
No OMB Control Number issued

OMB Control #:

Determinations
Determination

Justification

HSC:
Does NOT Require HRPO
Review

Not Research - Public Health Surveillance
45 CFR 46.102(l)(2)

Qualifies for a statutory waiver:

21st Century Cures Act - Sec. 3087 (Public Health Emergency)
Justification: PRA applies but is waived by

Completed

Entered By & Role

9/7/23

Harris_DeMoncheri (yfj7) CIO HSC

PRA:
PRA Applies

the PHE waiver. This purpose of this
amendment is to include the collection of
sewershed boundary data, which, when
overlayed with SARS-CoV-2 case data,
provides information on the number of
cases that may contribute to results from
a given sample. This amendment also
adds the collection of SARS-CoV-2
sequencing data to allow for early
tracking and surveillance of variants to
help inform public health policy and
decision makers. How it relates to COVID19: The goal of the project is to collect
and test sewage data for the presence of
SARS-CoV-2 and to characterize SARSCoV-2 variants. These sewage data will
be used to inform estimates of COVID-19
infections and track SARS-CoV-2
variants in the community. Sewage data
will be compared to existing COVID-19
response case-based and syndromicbased data to assess whether sewage
data serve as a leading indicator for other
health indicators, such as cases and
hospitalizations. Statistical methods
review (if any): Wastewater data on
SARS-CoV-2 will be normalized by flow
and/or presence of controls, and trends
estimated using linear regression of the
most recent three and five wastewater
samples. Additionally, wastewater data
will be binned into quintiles for the
sewershed, and percent change of
pathogen or target concentrations for the
past 15 days will be calculated. For
settings where incidence is very low, the
detection proportion (i.e., the proportion
of samples with any target detection over
a defined lookback period of days to
weeks) will be used. To contextualize the
wastewater data, normalized wastewater
data and case data will be visualized on a
timeseries plot by sewershed. Samples
that have been sequenced may be
analyzed to monitor for genetic variants
or targets of concern. Efforts to reduce
duplication of collection: An
environmental scan revealed no known
projects with similar data collection in the
United States. Estimated burden (X
respondents x Y minutes per response =
Z total hours): Therefore, the anticipated
burden per wastewater utility is in the
range: (52 weeks * 1 sample * 2 hours*
43 jurisdictions)=4,472 hours; (52 weeks
* 7 samples * 2 hours * 43 jurisdictions) =

9/7/23

Vice_Rudith (nhr9) OMB / PRA

31,304 Collection instruments
themselves (can be drafts): There are no
additional data collection instruments for
this amendment. Previously approved
instruments are attached.

ICRO:
PRA Applies

OMB Approval date: 9/8/23
OMB Expiration date: 12/31/99

9/8/23

Zirger_Jeffrey (wtj5) ICRO Reviewer

Description & Funding
Description
Priority:

Urgent

Date Needed:

09/12/2023

Priority Justification:

Sewage Surveillance is an urgent priority that supports respiratory virus detection and surveillance activities prioritized for the
upcoming respiratory virus season in Fall and Winter, 2023-2024.

Determination Start Date:

10/05/21

Description:

The project aims to establish a sewage surveillance system to inform the COVID-19 response in the United States. CDC will work
with local wastewater utilities and state and local health departments to evaluate sewage for the presence of SARS-CoV-2 and to
detect SARS-CoV-2 variants to inform public health partners and policymakers actions during the COVID-19 response.

IMS/CIO/Epi-Aid/Lab-Aid/Chemical Exposure
Submission:

No

IMS Activation Name:

Not selected

Primary Priority of the Project:

Not selected

Secondary Priority(s) of the Project:

Not selected

Task Force Associated with the Response:

Not selected

CIO Emergency Response Name:

Not selected

Epi-Aid Name:

Not selected

Lab-Aid Name:

Not selected

Assessment of Chemical Exposure Name:

Not selected

Goals/Purpose

An environmental scan revealed no known projects with similar data collection in the United States. The goal of the project is to
collect and test sewage data for the presence of SARS-CoV-2 and to characterize SARS-CoV-2 variants. These sewage data will
be used to inform estimates of COVID-19 infections and track SARS-CoV-2 variants in the community. Sewage data will be
compared to existing COVID-19 response case-based and syndromic-based data to assess whether sewage data serve as a
leading indicator for other health indicators, such as cases and hospitalizations.

Objective:

The objective of this project is to develop a surveillance system to identify an early indicator for increasing COVID-19 infections in a
community. Earlier information on COVID-19 infections in a community will allow public health and other policymakers to implement
more effective prevention and control measures to limit COVID-19 spread within the community.

Does your project measure health disparities among No
populations/groups experiencing social, economic,
geographic, and/or environmental disadvantages?:
Does your project investigate underlying
contributors to health inequities among populations
/groups experiencing social, economic, geographic,
and/or environmental disadvantages?:

No

Does your project propose, implement, or evaluate
an action to move towards eliminating health
inequities?:

No

Activities or Tasks:

New Collection of Information, Data, or Biospecimens ; Secondary Data or Specimen Analysis

Target Populations to be Included/Represented:

General US Population

Tags/Keywords:

Sewage ; Sentinel Surveillance ; Biosurveillance

CDC's Role:

Activity originated and designed by CDC staff, or conducted at the specific request of CDC, or CDC staff will approve study design
and data collection as a condition of any funding provided ; CDC employees or agents will obtain or use anonymous or unlinked
data or biological specimens ; CDC employees will participate as co-authors in presentation(s) or publication(s) ; CDC employees
will provide substantial technical assistance or oversight ; CDC is recipient of private data/specimens FROM an institution

Method Categories:

Biomonitoring; Outbreak Investigation; Secondary Data Analysis; Surveillance Support

Methods:

All methods proposed in this project have been reviewed extensively by CDC environmental microbiologists and engineers. Data
collection activities will obtain sufficient information to inform standardization and normalization of samples across the country.
Sewage data collection and testing: Wastewater utilities will collect routine grab or composite sewage samples from their respective
sewershed. Samples collected by the utilities will be sent to academic, industry, or public health laboratories for processing and
testing, and in some cases for sequencing of SARS-CoV-2, if the utility does not possess testing capabilities. A standard set of
collection and testing data elements in addition to the sample testing results will be collected by the wastewater utilities and testing
partners to ensure comparability of sewage data across sampling sites and testing laboratories. Participants: Wastewater utilities
will collect and provide sewage samples to testing laboratories, and will also collect and provide sewershed boundary data to the
CDC. State and local health departments will interview cases and identify cases residing or admitted to hospitals within sewershed
boundaries. Participation in the data collection activities is voluntary. Recruitment: Interested wastewater utilities will be identified
and invited to participate by CDC. Officials at the state and local public health departments within the communities served by
participating wastewater utilities will contact COVID-19 cases to conduct the interviews. Sewage Data: The sewage data contain
questions in the following content areas that would allow for comparison of sewage data across sampling sites and testing
laboratories. This includes: 1) wastewater utility details, including sewershed boundary data, 2) wastewater utility sampling details,
3) wastewater utility collection details, 4) sample processing, 5) sample quantification and/or characterization methods, 6) sample
normalization, 7) sample testing conditions, and 8) sample results, including PCR or sequencing results. The sewage data do not
include any personally identifiable information (PII). Sampling: Sewage samples will be collected on a regular interval. Officials in
state and local public health departments contact all COVID-19 cases for interviews. However, only cases residing in participating

sewersheds or who were hospitalized at a hospital in a participating sewershed will be included in data provided to CDC for this
project. Incentives: No incentives will be provided to wastewater utilities or state and local health departments submitting data to
CDC for this project.

Collection of Info, Data or Biospecimen:

Data collection: Wastewater utilities will oversee and perform sewage sample collection and sewershed boundary data collection.
Results of this data collection will be provided to CDC for analyses. No sewage data collection activities will place a burden on the
American public. Existing case data will be obtained from DCIPHER and HHS Protect. These data were voluntarily collected from all
COVID-19 cases by state and local health departments. There are no research questions addressed through this data collection
activity. Standardized data will be compiled on recent health outcomes related to COVID-19 in the context of the national response.
Data will be used to evaluate model estimate validity and to assess whether sewage data provide an early indication of future case
data. Specimen collection: Wastewater utilities will collect routine grab or composite sewage samples from a representative sample
of their sewershed. Samples will be processed and tested at the wastewater utility, if they have the testing capacity, or will be
provided to an academic, industry, or public health laboratory for testing, and in some cases, SARS-CoV-2 sequencing. We
anticipate sewage data collection will occur at least weekly but likely more often than once sample per week per wastewater utility.
Therefore, the anticipated burden per wastewater utility is in the range: 52 weeks * 1 sample * 2 hours = 104 hours 52 weeks * 7
samples * 2 hours = 728 hours

Expected Use of Findings/Results and their impact:

Aggregated summaries of findings to describe the utility of sewage data as a predictor of case outcomes and the ability of the
sewage model to estimate COVID-19 prevalence will be shared as part of COVID-19 response communications, including calls with
non-CDC public health agencies, wastewater utilities, and academic partners and at internal CDC meetings. Additionally,
aggregated summaries of findings may be shared externally through conference presentations and peer-reviewed journal articles to
describe the ability of COVID-19 sewage data to inform COVID-19 response and prevention efforts.

Could Individuals potentially be identified based on
Information Collected?

No

Funding

Funding yet to be added .....

HSC Review

Regulation and Policy
Do you anticipate this project will need IRB review
by the CDC IRB, NIOSH IRB, or through reliance on
an external IRB?

No

Estimated number of study participants

Population - Children

Protocol Page #:

Population - Minors

Protocol Page #:

Population - Prisoners

Protocol Page #:

Population - Pregnant Women

Protocol Page #:

Population - Emancipated Minors

Protocol Page #:

Suggested level of risk to subjects
Do you anticipate this project will be exempt
research or non-exempt research

Requested consent process waviers
Informed consent for adults

No Selection

Children capable of providing assent

No Selection

Parental permission

No Selection

Alteration of authorization under HIPPA Privacy
Rule

No Selection

Requested Waivers of Documentation of Informed Consent
Informed consent for adults

No Selection

Children capable of providing assent

No Selection

Parental permission

No Selection

Consent process shown in an understandable language
Reading level has been estimated

No Selection

Comprehension tool is provided

No Selection

Short form is provided

No Selection

Translation planned or performed

No Selection

Certified translation / translator

No Selection

Translation and back-translation to/from target

No Selection

language(s)
No Selection

Other method

Clinical Trial
Involves human participants

No Selection

Assigned to an intervention

No Selection

Evaluate the effect of the intervention

No Selection

Evaluation of a health related biomedical or
behavioral outcome

No Selection

Registerable clinical trial

No Selection

Other Considerations
Exception is requested to PHS informing those
bested about HIV serostatus

No Selection

Human genetic testing is planned now or in the
future

No Selection

Involves long-term storage of identfiable biological
specimens

No Selection

Involves a drug, biologic, or device

No Selection

Conducted under an Investigational New Drug
exemption or Investigational Device Exemption

No Selection

Institutions & Staff
Institutions
Institutions yet to be added .....

Staff
Staff
Member

Amy Kirby

SIQT
Exp. Date

01/21

CITI Biomedical
Exp. Date

08/25/2026

CITI Social &
Behavioral Exp. Date

CITI Good Clinical
Practice Exp. Date

Staff Role

Email

Phone

Organization

Program

agk1@cdc.

404718-

Environmental Microbiology and

/2024

Jeffrey
Mercante

08/25
/2026

08/25/2026

Lead

gov

3161

Engineering Lab Team

Project
Coordinator

wyh5@cdc.
gov

4046390263

DIVISION OF PREPAREDNESS AND
EMERGING INFECTIONS

Data
DMP
Proposed Data Collection Start Date:

7/15/20

Proposed Data Collection End Date:

12/31/26

Proposed Public Access Level:

Public

Public Access Justification:

Data are anonymized and collected during the COVID-19 response. Data are collected using taxpayer dollars and do not contain
any private or other sensitive information.

How Access Will Be Provided for Data:

Sewage data, sewershed boundary data, and sequencing data will be collected by wastewater utilities and testing laboratories.
Testing laboratories will directly enter sewage data using a secure Epi Info Web Survey, upload data via a secure file transfer site,
or will share via a laboratory information management system (LIMS) connection with the Data Collation and Integration for Public
Health Event Response (DCIPHER) system. Data exported from DCIPHER will be stored in secure shared folders behind the CDC
firewall on secure, access-restricted CDC servers only for analytic purposes.

Plans for Archival and Long Term Preservation:

Spatiality
Country

State/Province

County/Region

United States

Dataset
Dataset
Title

Dataset
Description

Data Publisher
/Owner

Public Access
Level

Public Access
Justification

External
Access URL

Download
URL

Type of Data
Released

Collection
Start Date

Collection End
Date

Dataset yet to be added...

Supporting Info
Current

CDC Staff
Member and Role

Date Added

Description

Supporting Info Type

Supporting Info

Zirger_Jeffrey
(wtj5)
ICRO Reviewer

09/08/2023

Amendment to activity approved
under PHE (COVID) PRA Waiver

Notice of Action

PHE PRA Waiver Approval COVID.docx

Mercante_Jeffrey
(wyh5)
Project Contact

09/07/2023

Determination memo of nonresearch public health
surveillance.

HS Research Determination Memo

071320ZM-NR-signed.pdf

Mercante_Jeffrey
(wyh5)
Project Contact

09/07/2023

PDF version of email documenting
review and approval of amended
Sewage Surveillance Project
Determination by Nicole
Fehrenbach, Branch Chief of the
Rapid Response, Research and
Surveillance Branch (R3SB).

Other

R3SB Approval of NWSS Amended Project
Determination.pdf

Mercante_Jeffrey
(wyh5)
Project Contact

09/07/2023

Activity will be conducted under
the PHE PRA Waiver.

Notice of Action

PHE PRA Waiver Approval.docx

09/07/2023

PDF version of email documenting
review and approval of amended
Sewage Surveillance Project
Determination by Amy Kirby,
NWSS Team Lead, in the Rapid
Response, Research and
Surveillance Branch (R3SB).

Other

Kirby_NWSS Approval of NWSS Amended Project
Determination.pdf

09/07/2023

Sewage Surveillance to Inform
COVID-19 amended project with
track changes for reference
comparison to original document.

Other

Sewage Surveillance to Inform COVID19_Amended_Track_Changes_Final.docx

Mercante_Jeffrey
(wyh5)
Project Contact

Mercante_Jeffrey
(wyh5)
Project Contact

PDF version of email documenting
review and approval of amended

Current

Mercante_Jeffrey
(wyh5)
Project Contact

09/07/2023

Mercante_Jeffrey
(wyh5)
Project Contact

08/28/2023

Mercante_Jeffrey
(wyh5)
Project Contact

Sewage Surveillance Project
Determination by Amy Kirby,
NWSS Team Lead, in the Rapid
Response, Research and
Surveillance Branch (R3SB).

Other

Kirby_NWSS Approval of NWSS Amended Project
Determination.pdf

Determination memo of nonresearch public health
surveillance.

HS Research Determination Memo

071320ZM-NR-signed.pdf

08/28/2023

PDF version of email documenting
review and approval of amended
Sewage Surveillance Project
Determination by Nicole
Fehrenbach, Branch Chief of the
Rapid Response, Research and
Surveillance Branch (R3SB).

Other

R3SB Approval of NWSS Amended Project
Determination.pdf

Mercante_Jeffrey
(wyh5)
Project Contact

08/28/2023

Activity will be conducted under
the PHE PRA Waiver.

Notice of Action

PHE PRA Waiver Approval.docx

Mercante_Jeffrey
(wyh5)
Project Contact

08/28/2023

Sewage Surveillance to Inform
COVID-19 amended project with
track changes for reference
comparison to original document.

Other

Sewage Surveillance to Inform COVID19_Amended_Track_Changes_Final.docx

08/28/2023

Sewage Surveillance to Inform
COVID-19 amended project with
track changes for reference
comparison to original document.

Other

Sewage Surveillance to Inform COVID19_Amended_Track_Changes_Final.docx

Mercante_Jeffrey
(wyh5)
Project Contact

08/28/2023

PDF version of email documenting
review and approval of amended
Sewage Surveillance Project
Determination by Nicole
Fehrenbach, Branch Chief of the
Rapid Response, Research and
Surveillance Branch (R3SB).

Other

R3SB Approval of NWSS Amended Project
Determination.pdf

Mercante_Jeffrey
(wyh5)
Project Contact

08/25/2023

Sewage Surveillance to Inform
COVID-19 amended project with
track changes for reference
comparison to original document.

Other

Sewage Surveillance to Inform COVID19_Amended_Track_Changes.docx

Mercante_Jeffrey
(wyh5)
Project Contact

08/25/2023

Wastewater Surveillance amended
project with track changes for
reference comparison to original
document.

Other

Project Determination_NWSS_Track_Changes.docx

Mercante_Jeffrey
(wyh5)
Project Contact

Zirger_Jeffrey

Activity will be conducted under

(wtj5)
ICRO Reviewer

10/06/2021

the PHE PRA Waiver.

Notice of Action

PHE PRA Waiver Approval.docx

Marsh_Zachary
(ksf6)
Project Contact

10/04/2021

Survey of states for NWSS

Data Collection Form

Wastewater Surveillance Data Landscape Survey
Questions.docx

Daymude_Thomas
(qkh7)
Project Contact

09/29/2021

Survey of states for NWSS

Data Collection Form

Wastewater Surveillance Data Landscape Survey
Questions.docx

Daymude_Thomas
(qkh7)
Project Contact

09/29/2021

Survey of states for NWSS

Data Collection Form

Wastewater Surveillance Data Landscape Survey
Questions.docx

Peterson_James
M. (iyr1)
CIO HSC

07/13/2020

Determination memo of nonresearch public health
surveillance.

HS Research Determination Memo

071320ZM-NR-signed.pdf

Marsh_Zachary
(ksf6)
Project Contact

07/09/2020

This is a data schematic describing
the anticipated minimum data
elements the sewage surveillance
project will need to collect.

Other-Enter new type

SewageSurveillanceDiagram.pdf