Research determination

Print Date: 9/26/25

Title:

National Environmental Assessment Reporting System (NEARS) OMB Package

Project Id:

0900f3eb81e72adc

Accession #:

NCEH-FT-1/25/22-72adc

Project Contact:

Laura G Brown

Organization:

NCEH/ATSDR/DEHSP/WFEHSB/FT

Status:

Project In Progress

Intended Use:

Project Determination

Estimated Start Date:

03/01/2026

Estimated Completion Date:

02/28/2029

CDC/ATSDR HRPO/IRB Protocol #:

N/A

OMB Control #:

0920-0980

OMB Discontinuation Date:

Determinations

Determination

Justification

Completed

Entered By & Role

9/22/25

Ding_Yan (Shirley) (yad6) CIO HSC

9/22/25

Ding_Yan (Shirley) (yad6) CIO OMB / PRA

9/22/25

Zirger_Jeffrey (wtj5) ICRO Reviewer

Not Research / Other
HSC:
Does NOT Require HRPO
Review

45 CFR 46.102(l)
Quality Assurance / Improvement

PRA:
PRA Applies

ICRO:
PRA Applies

OMB Approval date: 2/6/23
OMB Expiration date: 2/28/26

Description & Funding
Description
Priority:

Standard

Date Needed:

09/30/2025

Priority Justification:
CDC Priority Area for this Project:

Readiness and Response

Determination Start Date:

03/25/22

Description:

This package requests a three-year Paperwork Reduction Act (PRA) clearance for the National Environmental Assessment
Reporting System (NEARS), OMB Control No. 0920-0980, Expiration Date: 02/28/2026. This includes revision of a previously
approved information collection request (ICR).

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

No

IMS Activation Name:

Not selected

Submitted through IMS Clearance Matrix:

Not selected

Primary Scientific Priority:

Not selected

Secondary Scientific Priority (s):

Not selected

Task Force Responsible:

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

The goal of NEARS is to continue to improve public health practice by providing a standardized, detailed reporting system for food
safety programs, to collect foodborne outbreak environmental assessment data, and to establish a sound epidemiological basis for
disease prevention activities.

Objective:

The foodborne outbreak environmental assessment data reported to NEARS will be used to characterize data on food vehicles and
monitor trends; identify contributing factors and their environmental antecedents; generate hypotheses, guide planning, and
implementation; evaluate food safety programs; and ultimately assist to prevent future outbreaks.

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

Target Populations to be Included/Represented:

Businesses

Tags/Keywords:

Foodborne Diseases ; Outbreak investigation ; Public Health Surveillance

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 will participate as co-authors in presentation(s) or
publication(s) ; CDC employees will provide substantial technical assistance or oversight ; CDC is providing funding

Method Categories:

Individual Interviews (Qualitative); Observation; Outbreak Investigation; Technical Assistance

Methods:

During foodborne illness outbreak investigations, environmental health specialists collect detailed environmental data by conducting
environmental assessments. These data identify how and why the food became contaminated with pathogens, and how and why
these pathogens were not eliminated before ingestion. When reported to CDC via NEARS, this information provides an opportunity
to systematically monitor and evaluate environmental factors, which can then be used to develop effective foodborne illness
outbreak response and preventative controls.

Collection of Info, Data or Biospecimen:

Data from foodborne outbreak environmental assessments are collected by environmental health professionals responding to
foodborne outbreaks at retail food establishments. Data are collected through direct observations at the establishment, and through
manager interviews or pen-and-paper at the establishment. Participating food safety programs then enter their data into a secured
web-based system designed to make data entry easy for respondents.

Expected Use of Findings/Results and their impact:

The information collected through NEARS is primarily used by the CDC to identify and understand environmental factors
(contributing factors and environmental antecedents) associated with foodborne illness outbreaks. Data collected through NEARS
will also be used to describe outbreaks and outbreak responses, describe environmental factors associated with outbreaks, and
describe the associations between environmental antecedents and specific contributing factors.

Could Individuals potentially be identified based on
Information Collected?

No

Funding

Funding Type

Funding Title

Funding #

Original Budget Yr

# Years Award

Budget Amount

CDC Cooperative Agreement

Environmental Health Specialists Network

RFA-EH-20-001

2020

5

1540700.00

HSC Review

HSC Attributes
Quality Assurance / Improvement

Yes

Regulation and Policy
Do you anticipate this project will require review by
a CDC IRB or HRPO?

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 HIPAA 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
language(s)

No Selection

Other method

No Selection

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

No Selection

behavioral outcome
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

Will you be working with an outside Organization or Institution? Yes
Institutions yet to be added .....

Staff

Staff
Member

SIQT
Exp.
Date

CITI
Biomedical
Exp. Date

CITI Social &
Behavioral Exp.
Date

Adam
Kramer

08/07
/2026

12/23/2025

Beth
Wittry

08/16
/2026

Erin
Mortiz

Laura
Brown

CITI Good Clinical
Practice Exp. Date

CITI Good Laboratory
Practice Exp. Date

Staff Role

Email

Phone

Organization

CoInvestigator

4044981228

FOOD

10/31/2026

CoInvestigator

7704887333

FOOD

08/28
/2026

02/21/2028

CoInvestigator

4044982756

FOOD

08/07
/2026

07/18/2025

Principal
Investigator

770488-2

WATER FOOD AND
ENVIRONMENTAL HEALTH
SERVICES BRANCH

nrj8@cdc.
gov

Data
DMP
Proposed Data Collection Start Date:

9/1/22

Proposed Data Collection End Date:

8/31/25

Proposed Public Access Level:

Public

Public Access Justification:

Data will be released publicly with each publication.

How Access Will Be Provided for Data:

Datasets will be release on the CDC Stacks Public Health Publications website. The sites of the food safety program will be deidentified and free text reviewed to ensure it contains no identifying information available for the restaurant or program. All data are
stored behind the CDC firewall.

Plans for Archival and Long Term Preservation:

Spatiality
Spatiality (Geographic Locations) yet to be added .....

Dataset
Dataset
Title

Dataset
Description

Dataset yet to be added...

Supporting Info

Data Publisher
/Owner

Public Access
Level

Public Access
Justification

Landing
Page URL

Direct
Download URL

Type of Data
Released

Collection
Start Date

Collection
End Date

Current

CDC Staff
Member and
Role

Date Added

Description

Supporting Info Type

Supporting Info

Zirger_Jeffrey
(wtj5)
ICRO Reviewer

09/22/2025

NOA 0920-0980 (2023)

Notice of Action

NOA 0920-0980_2023.pdf

Brown_Laura R
(lrg0)
Project Contact

09/19/2025

This file contains the data
collection forms for this PRA
revision.

Data Collection Form

NEARS data collection forms 9-25.zip

Brown_Laura R
(lrg0)
Project Contact

09/19/2025

This is the 60 day FRN for NEARS
OMB package.

Paperwork Reduction Act Form

0 - 60-day_FRN_NEARS 9-25.docx

Brown_Laura R
(lrg0)
Project Contact

09/19/2025

This is our 60-day FRN request for
the NEARS OMB package.

Paperwork Reduction Act Form

0 - 60-day FRN Publication Request Form 9-25.docx

Current

Brown_Laura R
(lrg0)
Project Contact

09/19/2025

This file contains the data
collection forms for this PRA
revision.

Data Collection Form

NEARS data collection forms 9-25.zip

Current

Brown_Laura R
(lrg0)
Project Contact

09/19/2025

This is the 60 day FRN for NEARS
OMB package.

Paperwork Reduction Act Form

0 - 60-day_FRN_NEARS 9-25.docx

Current

Brown_Laura R
(lrg0)
Project Contact

09/19/2025

This is our 60-day FRN request for
the NEARS OMB package.

Paperwork Reduction Act Form

0 - 60-day FRN Publication Request Form 9-25.docx

Zirger_Jeffrey
(wtj5)
ICRO Reviewer

07/26/2022

NOA 0920-0980 (2019)

Notice of Action

0920-0980_2019.pdf

Davis_Stephanie
I. (sgd8)
PRA Reviewer

07/25/2022

NEARS 30D package

Paperwork Reduction Act Form

NEARS 30D to ICRO 20220725.zip

Moritz_Erin
(nrj8)
PRA Reviewer

07/22/2022

Updated package and associated
documents.

Paperwork Reduction Act Form

NEARS Submitted 7-22-22.zip

Davis_Stephanie
I. (sgd8)
PRA Reviewer

07/18/2022

30D ICR zipfile with comments
/edits.

Paperwork Reduction Act Form

Files rev OS.zip

Paperwork Reduction Act Form

NEARS OMB Submitted 7-15-22.zip

Moritz_Erin
(nrj8)

07/15/2022

Zip file containing the revised 30
day FRN and ICR and supporting

(nrj8)
PRA Reviewer

07/15/2022

day FRN and ICR and supporting
documents.

Paperwork Reduction Act Form

NEARS OMB Submitted 7-15-22.zip

Paperwork Reduction Act Form

NEARS 30D FRN ICR rev OS.zip

Davis_Stephanie
I. (sgd8)
PRA Reviewer

07/12/2022

Zipfile of NEARS 30D FRN and
Revision ICR. Please address
comments and revisions. Add
attachments marked
PLACEHOLDER. I have edited the
burden table to include NEARS
registration to match the NCEZID
DFWED OES PIA system
description.

Moritz_Erin
(nrj8)
PRA Reviewer

07/07/2022

Zip file containing the 30 day FRN
and ICR for the NEARS
surveillance system.

Paperwork Reduction Act Form

NEARS OMB Submitted 7722.zip

Davis_Stephanie
I. (sgd8)
PRA Reviewer

06/24/2022

Zipfile of 30D FRN and ICR
reviewed with comments from OS

Paperwork Reduction Act Form

Files rev OS.zip

Moritz_Erin
(nrj8)
PRA Reviewer

06/22/2022

Compressed file includes
supporting statements A and B,
relevant attachments, the 30-day
FRN, and burden worksheets.

Paperwork Reduction Act Form

NEARS OMB Submitted 06222022.zip

Davis_Stephanie
I. (sgd8)
PRA Reviewer

05/09/2022

30D FRN publication request and
revision ICR files with OS
comments to address.

Paperwork Reduction Act Form

Files rev OS.zip

Paperwork Reduction Act Form

Submit to STARS 04272022.zip

Paperwork Reduction Act Form

NEARS OMB Package.zip

The updated compressed file
contains: Supporting Statement A,
Moritz_Erin
(nrj8)
Project Contact

Moritz_Erin
(nrj8)
Project Contact

04/27/2022

03/17/2022

Supporting Statement B,
attachments and appendix
documents, the 30 day FRN, and
the 30 day FRN Publication
Request Form.
Compressed file contains:
Supporting Statement A,
Supporting Statement B, 10
attachments (including the 60 day
FRN [Attachment 3]), and the 60
day FRN Publication Request
Form.