1. Supporting Statement A_NWSS_v_final_3_final

Goal of the study: The goal of the National Wastewater Surveillance System (NWSS) data collection is to provide community-level trends of COVID-19 and data on other infectious disease targets of concern.
Intended use of the resulting data: Data from wastewater will be used to track infection trends or disease presence in communities where samples are collected, and serve to inform the general public of disease risks, and as an independent data source to alert public health officials and professionals.
Methods to be used to collect: Wastewater utilities or other public health partners will collect wastewater sample metadata and sewershed information, as well as samples from wastewater influent or effluent lines, or from upstream collection sites or along the treatment pathway. Samples will be tested in-house or forwarded to state, tribal, local, or territorial (STLT) health departments for processing and analysis, and data then submitted to CDC along with deidentified case linking data. In some cases, contract laboratories will collect, test, and submit all data directly to CDC.
The subpopulation to be studied: United States communities, including, but not limited to states, counties, cities, territories, and tribal communities where participating wastewater utilities or public health partners are conducting wastewater sampling.
How data will be analyzed: Data will be analyzed for the presence of and/or changes in the concentration (either normalized or unnormalized) of one or more wastewater targets. Trend calculations may be used to analyze wastewater target changes, including, but not limited to linear regression analysis or statistical weighting, and where applicable, trends may be classified based on duration and direction.

Circumstances Making the Collection of Information Necessary

This is a new Information Collection Request (ICR) for an existing collection currently approved under the COVID-19 public health emergency PRA waiver. The request is to approve 3 years of information collection from date of approval.

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 trends for SARS-CoV-2 and mpox infections. 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 NWSS that represents ~141 million individuals, or ~41% of the US population. 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 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.

Authorizing legislation: Section 301 of the Public Health Service Act (42 U.S.C. 241) (Attachment 1)

Purpose and Use of Information Collection

The purpose of the National Wastewater Surveillance System (NWSS) data collection is to provide community-level trends of COVID-19 and data on other infectious disease targets of concern to better inform public health action. Data from wastewater will be used to estimate infection trends or disease presence in the communities in which samples are collected. Wastewater surveillance is a public health tool that captures a pooled community sample of relevant infectious disease data even in communities with asymptomatic infections or individuals who do not seek health care. Wastewater data can also provide important disease prevalence information in areas with limited clinical testing capacity, helping affirm public health actions (such as community outreach, healthcare provider alerts, or vaccination campaigns), and indicate when further public health interventions may be necessary. Past studies have demonstrated that wastewater surveillance may provide a 4-to-6-day lead time on COVID-19 clinical case increases; this provides valuable time for resource allocation and communication with public health entities. Wastewater data on other infectious disease targets of concern, such as influenza or antibiotic resistance, may provide additional public health value.

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, was 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 of public health concern, such as mpox, influenza, and antimicrobial resistance. Not having the information from this collection request would mean that there would be less advanced warning of impending public health disease threats, hindering the ability of public health professionals to make rapid, timely decisions to protect public health through outreach, communication, and resource allocation. Some future public health threats may even be missed without wastewater surveillance data collection. Not having wastewater surveillance would remove a critical US surveillance system that is independent of healthcare seeking behavior, thus creating difficulty in verifying disease trends seen in clinical surveillance systems. Not having this wastewater information would also decrease the public awareness of important changes in community disease prevalence, removing a crucial data source from which individuals can gauge risk and help make personal decisions that affect their health.

The National Wastewater Surveillance System (NWSS) was originally established to support the CDC COVID-19 response. 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. NWSS has supported jurisdictions throughout the United States to implement wastewater surveillance, and together with CDC-funded national-level wastewater testing by commercial partners, jurisdictions across the US have submitted data to NWSS that represents ~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, such as twice a week. 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., targets listed in the “Value Sets” tab of Attachment 12). 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 ) (Attachment 17). 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. 4 submission forms are to be used for this data component (Attachments 4, 5, and 9, 17), with 4 documents used as reference (Attachments 3, 6, and 7, 12).

For data collection component 2, STLT 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. No forms are to be submitted for this data component, only spatial files, with 1 document used as a submission reference (Attachment 7).

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 deidentified case linking data into the NWSS DCIPHER platform . 2 submission forms are to be used for this data component (Attachments 10 and 11), with 2 documents used as reference (Attachments 7 and 8).

Use of Improved Information Technology and Burden Reduction

The collection of information submitted to the CDC will occur using a real-time, secure electronic public health data platform called Data Collation and Integration for Public Health Event Response (DCIPHER) hosted at the CDC where participating jurisdictions will store, analyze, and display wastewater data and analyses. Data may also be uploaded to CDC using an application programing interface (API) to further automate and reduce the burden of data collection and submission. Data sent to CDC will not contain individually or personably identifiable information. The data collection instruments are designed to minimize the data elements required for analysis while providing relevant and complete sample data, metadata, and case information for public health action.

Efforts to Identify Duplication and Use of Similar Information

CDC is not aware of the availability of any similar information, including any nationally standardized wastewater surveillance being conducted outside of the efforts proposed in this data collection by the National Wastewater Surveillance System (NWSS). NWSS has developed a federal partnership framework for wastewater surveillance (https://www.cdc.gov/nwss/federal-coordination.html) to coordinate efforts and ensure no duplication of work or data collection. As part of this framework, HHS and CDC convened the National Sewage Surveillance Interagency Leadership (NSSIL) Committee, composed of representatives from CDC, HHS, EPA, NIH, USGS, NSF, DHS, FDA, DHS, DoD and VA to facilitate this goal. NWSS also works closely with public health oriented non-governmental organizations (APHL, ASTHO, CSTE, NACCHO, NEHA, WEF and WRF) to help harmonize partner support efforts and avoid duplication of work or data collection.

To avoid duplicative reporting of case data, NWSS requests a minimal set of case data (unique case identifier, local case identifier, reporting jurisdiction, and residential wastewater utility service area name) to link with existing, submitted case data already at the CDC. This linking provides NWSS with a complete record of identified infectious disease cases but only requires the reporting jurisdiction to compile a list of simplified identifiers.

Impact on Small Businesses or Other Small Entities

This data collection will not involve or impact small businesses or other small entities.

Consequences of Collecting the Information Less Frequently

Wastewater surveillance is a leading indicator of infectious disease trends and provides a 4-to-6-day advanced warning on COVID-19 clinical case increases. Wastewater surveillance may provide similar benefits for other infectious diseases, which affords valuable time for resource allocation, communication with public health entities, focusing additional testing and surveillance efforts and public health information campaigns.

Collecting this information less frequently will mean that advanced warning provided by wastewater surveillance will be severely decreased, thus lessening the value of this data collection to public health officials and the general public, and decreasing awareness of public health threats. Less frequent data collection will also mean that important changes in trends in infectious diseases will also be missed which will hinder the ability of public health professionals to make rapid, timely decisions to protect public health.

Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

This request fully complies with the regulation 5 CFR 1320.5.

Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency

A. A 60-day Federal Register Notice was published in the Federal Register on July 7, 2023, vol. 88, No. 129, pp. 43351-43353 (Attachment 2). CDC received 4,476 comments (Attachment 14 and 15) related to this notice. A large majority of comments (N=4353, 97.25%) were supportive of wastewater surveillance, while only 6 comments (0.13%) were in opposition to wastewater surveillance. Of the 529 within-scope or substantive comments, only 1 comment expressed a concern related to participant burden, estimate accuracy, validity, or collection costs. Comments were grouped into 4 general categories and CDC responses were developed for each category. Comment categories and CDC responses are as follows:

Category 1: Comments out-of-scope/non-substantive, supportive of wastewater surveillance, (N=3835, 85.68%);

CDC Response: The current notice by the CDC National Wastewater Surveillance System (NWSS) is intended to inform the public of a proposed public health data collection and solicit feedback and comment. This notice is not intended to notify of a decrease in funding or closure of the NWSS program. NWSS appreciates the widespread support demonstrated in comments to this notice.

Category 2: Comments out-of-scope/non-substantive, opposing or not supportive of wastewater surveillance, (N=5, 0.11%);

CDC Response: The National Wastewater Surveillance System appreciates your comment and concerns, and NWSS will continue to build value through a robust network providing real-time data that supports individual and public health decision making.

Category 3: Comments within-scope/substantive, related to the accuracy of burden estimation, minimization of burden, or collection costs (N=9, 0.2%);

CDC Response: The National Wastewater Surveillance System provides community-level disease infection data on ~41% of the US population. This extremely large representation is possible because wastewater is an already existing, highly pooled and anonymous sample. Burden to respondents for this data collection is minimized by requesting a nominal set of data elements as well as provision of data support services, such as automated API-based data uploads, to respondent jurisdictions for data submission. Burden is further minimized through CDC coordination of respondent activities and distribution of information introducing and reinforcing collaborative jurisdictional relationships.

Category 4: Comments within-scope/substantive, related to the necessity of data collection or data quality (N=520, 11.57%);

CDC Response: During the COVID-19 pandemic, data from the National Wastewater Surveillance System (NWSS) were proven to be a reliable leading indicator of SARS-CoV-2 infections in participating communities. Research also shows that wastewater surveillance can accurately detect other infectious diseases in wastewater in a similar fashion, thus enabling surveillance for multiple diseases or public health targets. Wastewater data is collected and submitted to CDC NWSS from a widely distributed US network encompassing 50 US states, 2 territories, and 5 major cities. NWSS currently provides community-level disease infection data on ~41% of the US population. This data collection and submission is entirely voluntary and there is no requirement or mandate for participation by respondent jurisdictions. The CDC NWSS has and continues to build a robust disease surveillance network through voluntary partnering and collaboration with interested jurisdictions to support impactful public health needs and goals.

B. No consultations outside of CDC occurred.

Explanation of Any Payment or Gift to Respondents

CDC will not provide remuneration or incentives to participants.

Protection of the Privacy and Confidentiality of Information Provided by Respondents

Activities do not involve the collection of Personally Identifiable Information (PII). CDC’s Information Systems Security Officer reviewed this submission and determined that the Privacy Act does not apply (Attachment 16).

Institutional Review Board (IRB) and Justification for Sensitive Questions

Institutional Review Board (IRB)

NCEZID’s Human Subjects Advisor has determined that this information collection is not research involving human subjects. IRB approval is not required (Attachment 13)

The project was determined to be non-research public health surveillance.

Justification for Sensitive Questions

No sensitive questions are asked.

Estimates of Annualized Burden Hours and Costs

Estimated annualized burden hours for collecting wastewater data for SARS-CoV-2 and other infectious disease or public health targets of concern were determined, in part, based on a pilot study with three state participants conducted during the COVID-19 response where pilot states submitted bi-weekly SARS-CoV-2 wastewater sample data to the CDC NWSS DCIPHER data system. “Respondents” include an estimated 55 state, tribal, local, and territorial (STLT) public health departments, 1100 wastewater utilities, and a contract laboratory.

Data Collection Component 1:

The average number of responses and burden estimate per year from wastewater utilities for component 1 of data collection, which includes the time to collect and record the wastewater samples and prepare the samples for transport to the STLT public health department, based on the original pilot study, was estimated to be 104 responses (2 samples per week X 52 weeks) averaging 80 minutes per response, for a maximum burden of 152,533 hours. The average number of responses and burden estimate per year from STLT health departments, which includes the time to extract and quantify or sequence a wastewater target, compile the laboratory results, and submit resulting data to the NWSS DCIPHER platform, based on the original pilot study plus extrapolated time estimates of laboratory high throughput sequencing protocols, was estimated to be 2,080 response (40 samples per week per jurisdiction X 52 weeks) averaging 60 minutes per response, for a maximum burden of 114,400 hours. Based on these values, the average number of responses and burden estimate per year from contract laboratories is estimated to be 52,000 responses (500 sampling locations X 2 samples per week X 52 weeks) averaging 140 minutes per response, for a maximum burden of 121,333 hours.

Data Collection Component 2:

The average number of responses and burden estimate per year from wastewater utilities for component 2 of data collection, which includes the time to locate and verify the accuracy of sewershed geographic boundary data and convert these data files to the requested format, based on the original pilot study, was estimated to be 1 response averaging 2 hours per response, for a maximum burden of 2,200 hours. The average number of responses and burden estimate per year from STLT public health departments, which includes the time to submit formatted sewershed boundary data file (also known as the spatial file) to the NWSS DCIPHER platform, based on the original pilot study, was estimated to be 20 responses (20 wastewater treatment plants per STLT jurisdiction) averaging 5 minutes per response, for a maximum burden of 92 hours. Component 2 data collection is only required once and not required in subsequent years.

Data Collection Component 3:

The average number of responses and burden estimate per year from STLT public health departments for component 3 of data collection, which includes the time to collect and submit case data to the CDC NWSS DCIPHER platform, based on the original pilot study plus estimates of additional case rates from existing CDC clinical surveillance networks, was estimated to be 66,629 responses, averaging 5 minutes per response, for a maximum burden of 305,383 hours. The component 3 response estimate was, in part, extrapolated from case numbers on 18 infectious disease and antibiotic resistance surveillance targets as recorded in CDC National Notifiable Disease Surveillance System estimates from 2022-2023.

The estimated maximum annual burden for all potential data collection (components 1 + 2 + 3), is 695,941 hours.

Please note that NWSS data collection is composed of 3 separate components (see above) with multiple, different respondents contributing to or utilizing the same instruments in collection component 1 and component 2. Therefore, rows of the table below list the estimated burden associated with the instruments requested from each type of respondent for every data component.

Table A: Estimated Annualized Burden Hours

Type of Respondents	Form Name	No. of Respondents	No. of Responses per Respondent	Average Burden per Response (in hours)	Total Annual Burden Hours
State, tribal, local, territorial health department staff	Component 1 Forms: Attachment-04_ Component-1_BioSample_ww_template_v1.9_NWSS.csv Attachment-05_ Component-1_SRA_ww_template_v5.7_NWSS.csv Attachment-09_ Component-1_NWSS_DCIPHER_Wastewater_Data_CSV_Upload_Template_v3_1_All Fields.csv	55	2,080	1	114,400
Wastewater Utilities Staff	Component 1 Forms: Attachment-09_ Component-1_NWSS_DCIPHER_Wastewater_Data_CSV_Upload_Template_v3_1_All Fields.csv	1100	104	80/60	152,533
Contract laboratory	Component 1 Forms: Attachment-04_ Component-1_BioSample_ww_template_v1.9_NWSS.csv Attachment-05_ Component-1_SRA_ww_template_v5.7_NWSS.csv Attachment-09_ Component-1_NWSS_DCIPHER_Wastewater_Data_CSV_Upload_Template_v3_1_All Fields.csv Attachment-17_Component-1_NWSS_Sequencing_Manifest_Template	1	52,000	140/60	121,333
State, tribal, local, territorial health department staff	Component 2 Forms: Sewershed spatial files, no form required	55	20	5/60	92
Wastewater utility staff	Component 2 Forms: Sewershed spatial files, no form required	1100	1	2	2,200
State, tribal, local, territorial health department staff	Component 3 Forms: Attachment-10_ Component-3_NWSS_DCIPHER_CaseData_CSV_Upload_Template.csv Attachment-11_ Component-3_NWSS_DCIPHER_Sewershed_Name_Crosswalk_CSV_Upload_Template.csv	55	66,629	5/60	305,383
Total					695,941

B. Estimated Annualized Burden Costs

The annualized cost to respondents were based upon mean hourly wage rates for water and wastewater treatment plant and system operators, epidemiologists, biological technicians information published on the Bureau of Labor Statistics-May 2022 National Occupational Employment and Wage Estimates website, https://www.bls.gov/oes/current/oes_nat.htm.

Type of Respondent	Form Name	Total Burden Hours	Hourly Wage Rate	Total Respondent Costs
State, tribal, local, territorial health department staff	Component 1 Forms: Attachment-04_ Component-1_BioSample_ww_template_v1.9_NWSS.csv Attachment-05_ Component-1_SRA_ww_template_v5.7_NWSS.csv Attachment-09_ Component-1_NWSS_DCIPHER_Wastewater_Data_CSV_Upload_Template_v3_1_All Fields.csv	114,400	$41.29	$4,723,576
Wastewater Utilities Staff	Component 1 Forms: Attachment-09_ Component-1_NWSS_DCIPHER_Wastewater_Data_CSV_Upload_Template_v3_1_All Fields.csv	152, 533	$26.78	$4,084,833.74
Contract laboratory Staff	Component 1 Forms: Attachment-04_ Component-1_BioSample_ww_template_v1.9_NWSS.csv Attachment-05_ Component-1_SRA_ww_template_v5.7_NWSS.csv Attachment-09_ Component-1_NWSS_DCIPHER_Wastewater_Data_CSV_Upload_Template_v3_1_All Fields.csv Attachment-17_Component-1_NWSS_Sequencing_Manifest_Template	121,333	$25.75	$3,124,324.75
State, tribal, local, territorial health department staff	Component 2 Forms: Sewershed spatial files, no form required	92	$41.29	$3,798.68
Wastewater utility staff	Component 2 Forms: Sewershed spatial files, no form required	2,200	$26.78	$58,916
State, tribal, local, territorial health department staff	Component 3 Forms: Attachment-10_ Component-3_NWSS_DCIPHER_CaseData_CSV_Upload_Template.csv Attachment-11_ Component-3_NWSS_DCIPHER_Sewershed_Name_Crosswalk_CSV_Upload_Template.csv	305,383	$41.29	$12,609,264.07
Total				$24,604,713.24

Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers

There are no costs to respondents other than their time to participate.

Annualized Cost to the Government

The estimated cost for the federal government is calculated to be approximately one GS-14, 6 GS-13, two GS-12, and 4 GS-11 federal government employee salaries at the Atlanta, GA locality based on the OPM General Schedule wage table (https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/2023/general-schedule), in addition to contracts and other expenses.

Expense Type	Role	Estimated Annualized Cost
Direct Cost to the Federal Government; Federal employees	6 GS-13 FTEs	$624,048.00
	2 GS-12 FTE	$174,932.00
	4 GS-11 FTE	$291,896.00
	1 GS-14 FTE	$122,907.00
Contracts and other expenses	NWSS DCIPHER Licensing Cost	$4,000,000.00
	NWSS DCIPHER Platform Development, Operations, and Maintenance	$750,000.00
	NWSS DCIPHER Data Management	$871,708.20
	NWSS DCIPHER Onboarding and Customer Support	$191,665.67
	Contract Laboratory	$12,000,000.00
Total		$19,027,157.87

Explanation for Program Changes or Adjustments

This is a new information collection.

Plans for Tabulation and Publication and Project Time Schedule

Data will be collected and analyzed on a weekly basis with no stated collection/activity end date. Three years of clearance are requested for this recurring data/information collection. Data and analyses will be reported through the NWSS DCIPHER system and through NWSS public facing dashboards on a weekly basis. Publication is not expected to be a routine reporting tool for this data collection, but publications describing development of the NWSS data system and collection, along with occasional analytical descriptions of data and findings (e.g., journal manuscripts) are expected approximately every year.

Reason(s) Display of OMB Expiration Date is Inappropriate

The OMB 3-line header and Burden Statement are not found in the individual data collection instruments and elements referenced because all data submissions to NWSS are conducted through electronic transfers using bulk upload template files that do not accommodate notations or input other than data entry and data communication. CDC requests approval to place the PRA burden statement and OMB header on the CDC NWSS Wastewater Surveillance Data Reporting and Analytics webpage (https://www.cdc.gov/nwss/reporting.html). Respondents can navigate to the list of required data elements and instruments from this central location.

Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.

Attachments

Authorizing Legislation
- Attachment 1- Attachment 1_Authorizing Legislation_Section 301 of the Public Health Service Act (42 USC 241)
60-Day FRN
- Attachment 2- Published 60-Day FRN_NWSS
Information Collection Instruments
- Attachment 4-Component-1_BioSample_ww_template_v1.9_NWSS
- Attachment 5-Component-1_SRA_ww_template_v5.7_nwss
- Attachment 9-Component-1_NWSS_DCIPHER_Wastewater Data_CSV Template_v3_1_All Fields
- Attachment 10-Component-3_NWSS_DCIPHER_CaseData_CSV_Upload_Template
- Attachment 11- Component-3_NWSS_DCIPHER_SewershedName_Crosswalk_CSV_Upload_Template
- Attachment 17-Component-1_NWSS_Sequencing_Manifest_Template
Supplemental Reference Documents
- Attachment 3-Component-1_ref-CDC_seq_manifest_data_dict
- Attachment 6-Component-1_ref-NCBI_DCIPHER_Crosswalk_DataDictionary
- Attachment 7-Component-1-2-3_ref-NWSS_DCIPHER_BulkUploadTool_screenshot
- Attachment 8-Component-3_ref-NWSS COVID Case Data Dictionary_v1_0_0
- Attachment 12-Component-1_ref-NWSS Data Dictionary_v5.0.0Attachment 13
Human Subjects Determination
- Attachment 13-Human Subjects Determination
60-day Public Comments
- Attachment 14- NWSS_60day_Comments
- Attachment 15- 60-day-FRN-Summary_Comments
Privacy Impact Assessment
- Attachment 16-Privacy Impact Assessment

File Type	application/vnd.openxmlformats-officedocument.wordprocessingml.document
Author	Samuel, Lee (CDC/OID/NCEZID)
File Modified	0000-00-00
File Created	2023-11-01

1. Supporting Statement A_NWSS_v_final_3_final

1. Supporting Statement A_NWSS_v_final_3_final.docx

[NCEZID] National Wastewater Surveillance System for COVID-19 and other Infectious Disease Targets of Public Health Concern

OMB: 0920-1422

Request for OMB approval of New Collection

October 12, 2023

Supporting Statement A

Table of Contents

Circumstances Making the Collection of Information Necessary

Purpose and Use of Information Collection

Use of Improved Information Technology and Burden Reduction

Efforts to Identify Duplication and Use of Similar Information

Impact on Small Businesses or Other Small Entities

Consequences of Collecting the Information Less Frequently

Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency

Explanation of Any Payment or Gift to Respondents

Protection of the Privacy and Confidentiality of Information Provided by Respondents

Institutional Review Board (IRB) and Justification for Sensitive Questions

Estimates of Annualized Burden Hours and Costs

Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers

Annualized Cost to the Government

Explanation for Program Changes or Adjustments

Plans for Tabulation and Publication and Project Time Schedule

Reason(s) Display of OMB Expiration Date is Inappropriate

Exceptions to Certification for Paperwork Reduction Act Submissions

Attachments