Research determination

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Print Date: 7/20/21

Title:

Environmental Health Specialists Network (EHS-Net) Program OMB Generic Package

Project Id:

0900f3eb81c8e66b

Accession #:

NCEH-WFEHSB-2/2/21-8e66b

Project Contact:

Laura G Brown

Organization:

NCEH/ATSDR/DEHSP/WFEHSB

Status:

Pending Clearance : PRA Revision

Intended Use:

Project Determination

Estimated Start Date:

09/01/2021

Estimated Completion Date:

08/31/2024

CDC/ATSDR HRPO/IRB Protocol #:
OMB Control #:

0920-0792

Determinations
Determination

Justification

Completed

Entered By & Role

HSC:
Does NOT Require HRPO
Review

Research Not Involving Human Subjects

7/20/21

Davis_Stephanie I. (sgd8) CIO HSC

PRA:
PRA Applies

3/19/21

Abel_Jason A. (jza5) CIO OMB / PRA

ICRO:
Returned with No
Decision

3/19/21

Zirger_Jeffrey (wtj5) ICRO Reviewer

45 CFR 46.102(e)

Description & Funding
Description
Priority:

Standard

Date Needed:

04/01/2021

Determination Start Date:

06/25/21

Description:

This is the OMB package for the EHS-Net food safety research program generic clearance. Generic clearance is the
OMB terminology for a 'blanket' clearance for several studies. Our 8 EHS-Net funded sites conduct 2 or 3 multisite
data collections in restaurants per funding cycle. This generic clearance allows for a shortened clearance process
(i.e., 6 months) for these data collections. If we did not obtain generic clearance for these EHS-Net studies,
clearance for each individual study would take at least 12 months, compared to the 6 months it would take with a
generic clearance. The current generic clearance expires 8/31/2021.

IMS/CIO/Epi-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

Assessment of Chemical Exposure Name:

Not selected

Goals/Purpose

The goal of this food safety research program (called EHS-Net) is to collect data in retail food establishments that
will identify and address environmental factors (e.g., manager food safety certification, equipment condition, etc.)
associated with retail-related foodborne illness and outbreaks.

Objective:

The information collected from establishments will be used by CDC to develop food safety prevention and
intervention recommendations for environmental public health/food safety programs and the retail food
establishment industry.

Does this project include interventions,
services, or policy change work aimed at
improving the health of groups who have

Not Selected

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been excluded or marginalized and/or
decreasing disparities?:
Project does not incorporate elements of
health equity science:

Not Selected

Measuring Disparities:

Not Selected

Studying Social Determinants of Health
(SDOH):

Not Selected

Assessing Impact:

Not Selected

Methods to Improve Health Equity Research Not Selected
and Practice:
Other:

Not Selected

Activities or Tasks:

New Collection of Information, Data, or Biospecimens

Target Populations to be
Included/Represented:

Businesses

Tags/Keywords:

food safety

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

Method Categories:

Individual Interview (Quantitative); Observation

Methods:

interviews/assessments with restaurant staff; observations of restaurant kitchen environments and food workers
preparing food

Collection of Info, Data or Biospecimen:

interviews/assessments with restaurant staff; observations of restaurant kitchen environments and food workers
preparing food

Expected Use of Findings/Results:

The information collected from establishments will be used by CDC to develop food safety prevention and
intervention recommendations for environmental public health/food safety programs and the retail food
establishment industry.

Could Individuals potentially be identified
based on Information Collected?

No

Funding

Funding Type

Funding Title

CDC Cooperative
Agreement

Environmental Health Specialists Network - $1,540,000
annually

Funding
#

Original Budget
Yr

# Years
Award

EH-20-001

2020

5

Budget
Amount

HSC Review

HSC Attributes
Non-Human/Non-Animal Material

Yes

Regulation and Policy
Do you anticipate this project will be
submitted to the IRB office

Yes

Estimated number of study participants

376 restaurants per study

Population - Children

N/A

Population - Minors

N/A

Population - Prisoners

N/A

Population - Pregnant Women

N/A

Population - Emancipated Minors

N/A

Suggested level of risk to subjects Minimal Do you anticipate this project will be exempt research or non-exempt research Exempt
Category 1: Educational Practices

No Selection

Category 2: Educational tests, surveys,
No Selection
interviews, or observation of public behavior
Category 3: Benign Behavioral Interventions No Selection
and Collection of Information

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Category 4: Secondary Research for Which
Consent is not Required

No Selection

Category 5: Research and Demonstration
Projects

No Selection

Category 6: Taste and Food Quality
Evaluation and Consumer Acceptance
Studies

No Selection

Category 7: Storage or Maintenance for
Secondary Use for Which Broad Consent is
Required

No Selection

Category 8: Secondary Research for Which
Broad Consent is Required

No Selection

Institutions & Staff
Institutions
Name

FWA #

FWA Exp Date

IRB Title

IRB Exp Date

Funding #

Harris County, Texas Department of Health

EH-20-001

Franklin County, OH Department of Health

EH-20-001

Fund for Public Health NY

FWA00023694

12/09/20

New York City Dept of Hlth & Mental Hygiene IRB #1

08/06/23

EH-20-001

Minnesota Department of Health

FWA00000072

03/24/22

EH-20-001

New York State Dept of Hlth

FWA00003700

03/11/26

EH-20-001

Rhode Island Department of Health

FWA00006141

09/09/25

RHODE ISLAND STE DEPT HLTH IRB #1

04/03/22

EH-20-001

Southern Nevada Health District

FWA00023704

10/23/24

U of Nevada, Las Vegas IRB #1 -- Biomedical Sciences

01/03/23

EH-20-001

Tennessee Department of Health

FWA00000379

02/07/22

EH-20-001

Staff
Staff
Member

SIQT Exp.
Date

Laura
Brown

12/20/2021

CITI Biomedical
Exp. Date

CITI Social &
Behavioral Exp.
Date

CITI Good
Clinical Practice
Exp. Date

Staff
Role

Program
Lead

12/20/2021

Email

Phone

Organization

[email protected]

770488-2

WATER FOOD AND
ENVIRONMENTAL HEALTH
SERVICES BRANCH

Data
DMP
Proposed Data Collection Start Date:

1/1/22

Proposed Data Collection End Date:

8/31/24

Proposed Public Access Level:

Public

Public Access Justification:

These data will be anonymous so can be shared.

How Access Will Be Provided for Data:

We will release data files from the studies with our publications through CDC Stacks.

Plans for Archival and Long Term
Preservation:

We will archive for 10 years in CDC Stacks.

Spatiality
Country

State/Province

County/Region

United States

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

Collection
End Date

Dataset yet to be added...

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