Notice2023-14413
Proposed Data Collection Submitted for Public Comment and Recommendations
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 7, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 129 (Friday, July 7, 2023)</title>
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[Federal Register Volume 88, Number 129 (Friday, July 7, 2023)]
[Notices]
[Pages 43351-43353]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">www.regulations.gov</a>. Follow
the instructions for submitting comments.
<bullet> 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 <a href="http://www.regulations.gov">www.regulations.gov</a>.
Please note: Submit all comments through the Federal eRulemaking
portal (<a href="http://www.regulations.gov">www.regulations.gov</a>) 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: <a href="/cdn-cgi/l/email-protection#83eceee1c3e0e7e0ade4ecf5"><span class="__cf_email__" data-cfemail="3956545b795a5d5a175e564f">[email protected]</span></a>.
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.
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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]
BILLING CODE 4163-18-P
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