IRB determination

Print Date: 7/18/22

Title:

National Environmental Assessment Reporting System (NEARS) OMB Package

Project Id:

0900f3eb81ecc76a

Accession #:

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

Project Contact:

Erin D Moritz

Organization:

NCEH/ATSDR/DEHSP/WFEHSB/FT

Status:

Pending Regulatory Clearance

Intended Use:

Project Determination

Estimated Start Date:

09/01/2022

Estimated Completion Date:

08/31/2025

CDC/ATSDR HRPO/IRB Protocol #:

N/A

OMB Control #:

0920-0980

Determinations
Determination

Justification

Completed

Entered By & Role

3/25/22

Abel_Jason A. (jza5) CIO HSC

Not Research / Other
HSC:
Does NOT Require HRPO
Review

45 CFR 46.102(l)
Quality Assurance / Improvement

PRA:

3/25/22

PRA Applies

Abel_Jason A. (jza5) CIO OMB / PRA

Description & Funding
Description
Priority:

Standard

Date Needed:

04/08/2022

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: 08/31/2022. 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

Primary Priority of the Project:

Not selected

Secondary Priority(s) of the Project:

Not selected

Task Force Associated with the Response:

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 this project include interventions, services, or No
policy change work aimed at improving the health of
groups who have been excluded or marginalized and
/or decreasing disparities?:
Project does not incorporate elements of health
equity science:

Yes

Measuring Disparities:

Not Selected

Studying Social Determinants of Health (SDOH):

Not Selected

Assessing Impact:

Not Selected

Methods to Improve Health Equity Research and
Practice:

Not Selected

Other:

Not Selected

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 be submitted to
the IRB office

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 HIPPA 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
behavioral outcome

No Selection

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
Institutions yet to be added .....

Staff
Staff
Member

SIQT
Exp. Date

CITI Biomedical
Exp. Date

CITI Social &
Behavioral Exp. Date

Adam
Kramer

04/05
/2025

12/31/2022

Beth
Wittry

12/29
/2023

Erin
Mortiz

Laura
Brown

Phone

Organization

CoInvestigator

4044981228

FOOD

12/19/2021

CoInvestigator

7704887333

FOOD

12/27
/2024

12/31/2021

CoInvestigator

4044982756

FOOD

01/25
/2025

12/20/2021

Principal
Investigator

770488-2

WATER FOOD AND ENVIRONMENTAL
HEALTH SERVICES BRANCH

Data
DMP
Proposed Data Collection Start Date:

9/1/22

Proposed Data Collection End Date:

8/31/25

CITI Good Clinical
Practice Exp. Date

Staff Role

Email

nrj8@cdc.
gov

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

Data Publisher
/Owner

Public Access
Level

Public Access
Justification

External
Access URL

Download
URL

Type of Data
Released

Collection
Start Date

Dataset yet to be added...

Supporting Info
Current

CDC Staff
Member and
Role
Moritz_Erin
(nrj8)
PRA Reviewer

Davis_Stephanie
I. (sgd8)
PRA Reviewer

Date Added

Description

Supporting Info Type

Supporting Info

07/15/2022

Zip file containing the revised 30
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

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

Collection End
Date

registration to match the NCEZID
DFWED OES PIA system
description.

Current

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

04/27/2022

The updated compressed file
contains: Supporting Statement A,
Supporting Statement B,
attachments and appendix
documents, the 30 day FRN, and
the 30 day FRN Publication
Request Form.

Paperwork Reduction Act Form

Submit to STARS 04272022.zip

03/17/2022

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.

Paperwork Reduction Act Form

NEARS OMB Package.zip

Moritz_Erin
(nrj8)
Project Contact

Moritz_Erin
(nrj8)
Project Contact