[Federal Register Volume 88, Number 208 (Monday, October 30, 2023)]
[Notices]
[Pages 74189-74190]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 www.reginfo.gov/public/do/PRAMain. 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
----------------------------------------------------------------------------------------------------------------
                                                                                                        Average
                                                                          Number of      Number of    burden per
          Type of respondents                       Form name            respondents   responses per   response
                                                                                        respondent    (in hours)
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------


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