Notice2023-23856
Agency Forms Undergoing Paperwork Reduction Act Review
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
October 30, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 88 Issue 208 (Monday, October 30, 2023)</title>
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[Federal Register Volume 88, Number 208 (Monday, October 30, 2023)]
[Notices]
[Pages 74189-74190]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-23856]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-24-23GL]
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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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
[[Page 74190]]
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
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Average
Number of Number of burden per
Type of respondents Form name respondents responses per response
respondent (in hours)
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State, tribal, local, territorial Component 1 Forms: Component-1 55 2,080 1
health department staff. BioSample_ww_template_v1.9_NW
SS; Component-1
SRA_ww_template_v5.7_NWSS;
Component-1
NWSS_DCIPHER_Wastewater_Data_
CSV_Upload_Template_v3_1_All
Fields.
Wastewater Utilities Staff............. Component 1 Forms: Component-1 1,100 104 80/60
NWSS_DCIPHER_Wastewater_Data_
CSV_Upload_Template_v3_1_All
Fields.
Contract laboratory.................... Component 1 Forms: Component-1 1 52,000 140/60
BioSample_ww_template_v1.9_NW
SS; 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_Temp
late.
State, tribal, local, territorial Component 2 Forms: Sewershed 55 20 5/60
health department staff. spatial files, no form
required.
Wastewater utility staff............... Component 2 Forms: Sewershed 1,100 1 2
spatial files, no form
required.
State, tribal, local, territorial Component 3 Forms: Component-3 55 66,629 5/60
health department staff. NWSS_DCIPHER_CaseData_CSVUplo
ad_Template; Component-3
NWSS_DCIPHER_Sewershed_Name_C
rosswalk_CSV_Upload_Template.
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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. 2023-23856 Filed 10-27-23; 8:45 am]
BILLING CODE 4163-18-P
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