CDC Determination: IRB Approval is Not Required

Print Date: 2/15/23

Title:

Generic Information Collection - environmental health and land reuse (EHLR) training

Project Id:

0900f3eb8207f2a6

Accession #:

NCEH-CESIS-1/6/23-7f2a6

Project Contact:

Laurel A Berman

Organization:

NCEH/ATSDR/OCDAPS/CESIS

Status:

Pending Regulatory Clearance

Intended Use:

Project Determination

Estimated Start Date:

03/01/2023

Estimated Completion Date:

09/29/2023

CDC/ATSDR HRPO/IRB Protocol #:
0923-0047

OMB Control #:

Determinations
Determination

Justification

Completed

Entered By & Role

2/15/23

De Leon Salazar_Alfonsina (wvg4) CIO HSC

Not Research / Other
HSC:
Does NOT Require HRPO
Review

45 CFR 46.102(l)
Program Evaluation
Quality Assurance / Improvement

PRA:
PRA Applies

2/15/23

De Leon Salazar_Alfonsina (wvg4) CIO OMB / PRA

Description & Funding
Description
Priority:

Standard

Date Needed:

02/17/2023

Determination Start Date:

01/06/23

Description:

ATSDR's Land Reuse Program (OCDAPS/CESIS) has expanded the "EHLR Basic" 10-hour training of 5 modules into a 20-hour
training, "EHLR Immersive" training focused on three modules: Community Engagement (8 hours), Evaluating Environmental and
Health Risks (8 hours), and Communicating Environmental and Health Risks (4 hours). ATSDR will be delivering 2-4 pilot-level
trainings of EHLR Immersive content. This requires a registration process and voluntary knowledge assessment surveys. Minimal
personally identifiable information, aka "business PII" will be collected using the REDCap system (federally-approved survey
system). OMB Control # 0923-0047

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

ATSDR#s Land Reuse Program has developed a suite of environmental health and land reuse (EHLR) trainings. The overarching
goal of the trainings is to increase the capacity of the environmental health workforce and the communities they serve to engage in
health-focused land reuse. The first part of the training is published on the Land Reuse website and is called EHLR Basic. It
consists of five, 1- to 2-hour modules and is freely available for download or conference presentation. Through a long-standing
partnership and a FY 2023 cooperative agreement, the National Environmental Health Association (NEHA) collaborates on EHLR
training and since 2020 has offered their own comparable EHLR Basic online training as well as issues certificates of completion
and continuing education units for EHLR trainings in general. The Land Reuse Program collaborated with NEHA to produce a more
immersive version of EHLR Basic training, called EHLR Immersive (i.e., EHLR Immersion) training. The EHLR Immersive training
expands the first three modules of EHLR Basic: 1.) Community Engagement, 2) Evaluating Environmental and Health Risks, and 3)
Communicating Environmental and Health Risks (Risk Communication).

Objective:

Based on a 2016 NEHA survey, the environmental health workforce has limited capacity to engage in land reuse. The EHLR
training focuses on building capacity and skills among this population and the communities they serve. Preliminary evaluation
indicated that EHLR Basic met this goal. Objective 1: Continue to improve capacity and skills of the EH workforce in land reuse
overall. Objective 2: Provide certificates of completion for immersive training to build and assess competencies in three EHLR
areas: community engagement, evaluation of environmental and health risks, and communication of environmental and health risks.

Does this project include interventions, services, or Yes
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:

Not Selected

Measuring Disparities:

Yes

Studying Social Determinants of Health (SDOH):

Yes

SDOH Economic Stability:

Yes

SDOH Education:

Yes

SDOH Health Care Access:

Yes

SDOH Neighborhood and Environment:

Yes

SDOH Social and Community Context:

Yes

SDOH Indices:

Reduce the proportion of people living in poverty - SDOH-01 Increase employment in working-age people - SDOH2 Reduce
household food insecurity and hunger - NWS-01 Increase interprofessional prevention education in health professions trianing ECBP-D08 Increase preventive health care - AHS-08 Increase cancer screenings (all) - C-03,-05, -07, etc. Neighborhood and Built
Environment - General (all indicators under this category) Social and Community Context - Health Communication (HCHIT-04)
Health literacy - HCHIT-R01 Health IT LGBT Nutrition People with Disabilities.

Other SDOH Topics:

Reduce violence/crime; reduce environmnetal injustice.

Assessing Impact:

Yes

Methods to Improve Health Equity Research and
Practice:

Yes

Other:

Not Selected

Activities or Tasks:

Programmatic Work

Target Populations to be Included/Represented:

General US Population

Tags/Keywords:

Education, Professional, Retraining ; Environment and Public Health ; Environmental Exposure ; Environmental Health ;
Environmental Issues ; Environmental Monitoring ; Environmental Pollution ; Environmental Policy

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:

Survey

Methods:

ATSDR's Land Reuse Program will collect and securely maintain course registration information, including name, job title, and
email. ATSDR will provide a list of participants to NEHA, who will issue certificates and store the names in their secure learning
management system. In addition, ATSDR will use voluntary, anonymous knowledge assessment surveys to evaluate the
effectiveness of the training.

Collection of Info, Data or Biospecimen:

Voluntary knowledge assessment surveys that are anonymous will be collected through the federally approved REDCap system
survey. The knowledge assessments will take less than 15 minutes to complete. The questions ask job title (checkbox), and general
questions to estimate how much (using a Likert scale of great extent, good extent, moderate extent, no extent, N/A) expertise,
capacity to apply concepts, and how much confidence increased from the particular module. Questions on specific questions are
also included, with responses on the same Likert scale, such as whether or not an overview was helpful, how much concepts may
have been synthesized, the usefulness of tools that were highlighted, the usefulness of a particular session and/or tools they
practiced with was for their work. The Registration forms take less than 3 minutes to complete and will be collected in order to issue
Certificates of Completion through NEHA. Registration is not required (e.g., people can opt out or participate in training but opt to
not receive a certificate). The registration form asks job title, name, and email address, and asks the participant to check the box for
the type of training they are registering for (e.g., which module). NEHA will provide to ATSDR#s Land Reuse Program lead PDF
Certificates of Completion that contain the participants# names. The program lead (Laurel Berman) will email the certificates to the
participants and store the certificates in their secure ATSDR laptop. The certificates will be managed as records and disposed of
/transferred to the federal records center according to the appropriate schedule (e.g., after 2 years). NEHA will follow their own data
management plan and schedule for maintaining the participants' name and email address, and a copy of their certificate.

Expected Use of Findings/Results and their impact:

ATSDR will use the knowledge assessments to adjust the course content based on feedback. For example, the course content
relies on numerous practice tools for community engagement, key messaging, and site assessment activities. This content could be
tailored to specific audiences, such as having participants provide an environmental issue they are working on to use as practice.

Could Individuals potentially be identified based on
Information Collected?

Yes

Will PII be captured (including coded data)?

Yes

Does CDC have access to the identifiers (including
coded data)?:

Yes

Is this project covered by an Assurance of
Confidentiality?

No

Does this activity meet the criteria for a Certificate
of Confidentiality (CoC)?

No

Is there a formal written agreement prohibiting the
release of identifiers?

No

Funding

Funding Type

Funding Title

Funding #

Original Budget
Yr

# Years
Award

Budget
Amount

CDC Cooperative
Agreement

National Environmental Health Association Brownfields Project (Year 5 Activity at
$85,000)

HSC Review

HSC Attributes
Program Evaluation

Yes

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

CDC-RFA-OT181802

2023

5

85000.00

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

No Selection

future
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
Name

FWA #

FWA Exp Date

Centers for Disease Control & Prevention

FWA00001413

07/30/26

National Environmental Health Association

FWA00030382

11/16/25

IRB Title

IRB Exp Date

Funding #

Centers for Disease Control & Prevention IRB #2 - B

10/08/24

CDC-RFA-OT18- 1802

Staff
Staff
Member

SIQT
Exp.
Date

CITI Biomedical
Exp. Date

CITI Social &
Behavioral Exp. Date

CITI Good Clinical
Practice Exp. Date

Staff Role

Email

Gina
Bare

n/a

n/a

n/a

Jesse
Bliss

n/a

n/a

n/a

Laurel
Berman

10/09
/2023

n/a

CoInvestigator

gbare@neha.
org

n/a

Contract
Official

[email protected]

Technical
Monitor

Michael
Lewin

05/25
/2025

07/09/2023

Rebecca
Labbo

05/25
/2025

07/09/2023

10/29/2022

Phone

Organization

[email protected]

3128867476

COMMUNITY ENGAGEMENT SCIENCES
& INTERVENTION SECTION

Statistician

[email protected]

7704883812

RESEARCH ACTIVITIES TEAM

Statistician

rlabbo@neha.
org

Sharon
Unkart

05/25
/2025

CoInvestigator

07/09/2023

sdunkart@neha.
gov

Data
DMP
Proposed Data Collection Start Date:

3/1/23

Proposed Data Collection End Date:

9/29/23

Proposed Public Access Level:

Non-Public

Non-Public Details:
Reason For Not Releasing Data:

Other - ATSDR and extramural partners will not release personally identifiable information (PII). It is not needed for this project.

Public Access Justification:

Participant data, including name and email, will not be made public. It is not needed for this project and participants can remain
completely anonymous. ATSDR may summarize participant job title (e.g., environmental health professional or environmental
science student) and may publish this data along with summaries of knowledge assessments as part of routine training evaluation.
Despite summarizing job title and knowledge assessment data, no individuals will be identified in this process. ATSDR's Land
Reuse Program lead typically removes all PII from EHLR training data by assigning, e.g., a number instead of a name and a code
for job category, e.g., S for student, EP for environmental health/environmental professional.

How Access Will Be Provided for Data:

ATSDR may summarize job titles and knowledge assessments (voluntary) of participants in publications or presentations. No
participants will be identified. In previous similar evaluations of EHLR Basic (the shorter course) training, ATSDR removed
participant names and emails from data summarized in Excel worksheets prior to sharing summary results with NEHA. Future
publications or presentations related to EHLR Immersion training may include NEHA partners. However, participant names and
emails will be removed from any shared data. In addition, NEHA may have access to job titles provided by ATSDR or signup name
and email of participants who opt to receive their Certificate of Completion. NEHA will store this information in their secure Learning
Management System, which is a routine activity for NEHA's online learners. ATSDR and NEHA will not release any personally
identifiable information, namely the participants' names and email addresses. However, ATSDR may collaborate with NEHA on the
presentation or publication of summarized job titles and summarized knowledge assessments.

Plans for Archival and Long Term Preservation:

Registration data will be stored by the land reuse Program Lead (Laurel Berman) in a secure computer, who will follow the
appropriate storage and transfer as records.

Spatiality
Country
United States

State/Province

County/Region

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

Date Added

Description

Supporting Info Type

Supporting Info

02/15/2023

Zipped file with updated Gen IC for
EHLR Training.

Paperwork Reduction Act Form

EHLR-GEN-IC-021523.zip

Berman_Laurel A.
(fjq0)
Project Contact

02/15/2023

The zip file contains corrected,
clean copies of files, per REV by
OS file comments. 1. No Privacy
Act Checklist included (realize that
was done with the Gen IC
originally), 2. RedCap Survey
forms - changes made and active,
combined as PDF and exported to
Word (note, some format is off on
Word documents, mostly at page
break), 3. Worksheet 2 - changes
made.

Paperwork Reduction Act Form

EHLR-GEN-IC-021523.zip

De Leon
Salazar_Alfonsina
(wvg4)
CIO HSC

02/13/2023

Revised OS files for GenIC.

Other

Files from PGM - rev by OS.zip

Berman_Laurel A.
(fjq0)
CIO HSC

02/10/2023

All GEN IC files enclosed.

Paperwork Reduction Act Form

GENIC-AllForms-021023.zip

Berman_Laurel A.
(fjq0)
CIO HSC

Collection End
Date

Berman_Laurel A.
(fjq0)
Project Contact

02/10/2023

Updated GEN IC files for EHLR
Training Pilots.

Paperwork Reduction Act Form

GENIC-AllForms-021023.zip

Berman_Laurel A.
(fjq0)
CIO HSC

02/04/2023

This zipped file contains all survey
instruments - 4 - 5 in both REDCap
PDF and in Word

Paperwork Reduction Act Form

ATTS-4a-3-5-a-c-CLN-020423.zip

Berman_Laurel A.
(fjq0)
CIO HSC

02/04/2023

This zipped packed contains 30day documents, SSA and B,
Privacy Act checklist, FRN
publication Request.

Paperwork Reduction Act Form

30-d-SSA-B-PAChklst-FRNPubReq-CLN-020423.zip

Berman_Laurel A.
(fjq0)
CIO HSC

02/04/2023

This zipped packet contains ATT 6
and 7: PIA and OMB closure
forms.

Paperwork Reduction Act Form

Att6-PIA-Att7-IRBclose-CLN-020423.zip

Berman_Laurel A.
(fjq0)
CIO HSC

02/04/2023

This zipped file contains all
Worksheets.

Paperwork Reduction Act Form

Wrksht1-2-all-CLN-020423.zip

Berman_Laurel A.
(fjq0)
CIO HSC

02/04/2023

This zipped file contains the List of
Attachments, and ATT 1, 2, 3s:
Legal authorization, 60 day, and
registration forms.

Paperwork Reduction Act Form

ListAtt-Att1-2-3-3a-3b-CLN-020423.zip

De Leon
Salazar_Alfonsina
(wvg4)
CIO HSC

02/01/2023

GenIC with OS comments

Paperwork Reduction Act Form

Files rev OS.zip

Berman_Laurel A.
(fjq0)
CIO HSC

02/01/2023

First upload failed. This document
contains reviewer comments and
edits, including my responses to
comments.

Paperwork Reduction Act Form

GenIC-EHLR-ImmPilot-OS-REV-MRKD-013123.zip

Berman_Laurel A.
(fjq0)
CIO HSC

02/01/2023

First upload failed. The zipped files
contain clean, updated files.

Paperwork Reduction Act Form

AttA-B-C-EHLR-Imm-Training-PILOTS-013123.zip

Berman_Laurel A.
(fjq0)
Project Contact

01/11/2023

The file contains reviewer
comments with my corrections and
responses.

Paperwork Reduction Act Form

fjq0_0900f3eb8207f2a6-MRKD-RESPS-011123.docx

De Leon
Navarro_Alfonsina
(wvg4)
CIO HSC

01/11/2023

GenIC reviewed by OS

Paperwork Reduction Act Form

PGM Files reviewed by OS.zip

EHLR Immersion Module

Current

Berman_Laurel A.
(fjq0)
Project Contact

01/06/2023

Evaluating Environmental and
Health Risks - voluntary
Knowledge Assessment

Paperwork Reduction Act Form

EHLRImmersionEvaluatingEnviron-12-2022.pdf

Current

Berman_Laurel A.
(fjq0)
Project Contact

01/06/2023

EHLR Risk Communication
module voluntary Knowledge
Assessment

Paperwork Reduction Act Form

EHLRImmersionRiskCommunication-12-2022.pdf

Current

Berman_Laurel A.
(fjq0)
Project Contact

01/06/2023

EHLR Training Registration Form.

Paperwork Reduction Act Form

Att3-EHLR-ALL-TrainingsRegistration_EHLRT (4).pdf

Current

Berman_Laurel A.
(fjq0)
Project Contact

01/06/2023

Generic Information Collection
request for EHLR training pilots.

Paperwork Reduction Act Form

GenIC-EHLR-ImmPilot-Regist-KnowlAssmts-11092022.
docx

Current

Berman_Laurel A.
(fjq0)
Project Contact

01/06/2023

EHLR Immersion Community
Engagement Module Knowledge
Assessment

Paperwork Reduction Act Form

EHLRImmersionCEngKnowledgeAsse-12-2022.pdf