IRB Approval

Print Date: 3/23/23

Title:

Environmental Health and Land Reuse Certification Training PRA Reinstatement with Change Information Collection Request

Project Id:

0900f3eb8208b35b

Accession #:

NCEH-CESIS-2/28/22-a3ec7

Project Contact:

Laurel A Berman

Organization:

NCEH/ATSDR/OCDAPS/CESIS

Status:

Pending Regulatory Clearance : PRA Revision

Intended Use:

Project Determination

Estimated Start Date:

06/05/2023

Estimated Completion Date:

08/04/2026

CDC/ATSDR HRPO/IRB Protocol #:
0923-0060

OMB Control #:

Determinations
Determination

Justification

Completed

Entered By & Role

3/23/23

Davis_Stephanie I. (sgd8) CIO HSC

Not Research / Other
HSC:
Does NOT Require HRPO
Review

45 CFR 46.102(l)
Other - Training administration

PRA:

PRA Applies

ICRO:
PRA Applies

OMB Approval date: 8/14/19
OMB Expiration date: 8/31/22

3/23/23

Davis_Stephanie I. (sgd8) CIO OMB / PRA

3/7/22

Zirger_Jeffrey (wtj5) ICRO Reviewer

Description & Funding
Description
Priority:

Standard

Date Needed:

04/17/2023

Determination Start Date:

01/13/23

Description:

This is a request to publish the 60-day Federal Register Notice (FRN) for #Environmental Health and Land Reuse Certification
Training" (OMB Control No. 0923-0060, discontinued 08/31/2022). ATSDR is requesting PRA clearance for a reinstatement with
change information collection request (ICR). ATSDR is making administrative changes to the training administration that requires
the addition of several forms and the removal of one form. ATSDR is also adjusting the time burden estimation and burden hours
based on the addition of new data collection forms. The EHLR ICR was formerly covered under Project ID 0900f3eb81bf3c9d
(under CDC IRB Protocol #7175). After careful thought, the NCEH/ATSDR Office of Science has determined that this training
program is not research. Going forward, this new non-research project incorporates training collections, such as conference
registrations, self-assessments, and evaluation of training. EHLR participants work toward certification upon successful completion
of each training module.

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 an Environmental Health and Land Reuse Certificate Training. The purpose of the
EHLR Certificate is to educate environmental professionals, planners, and students in environmental/public health in basics of
environmental health in relation to land reuse and redevelopment. Through a cooperative agreement, National Environmental
Health Association (NEHA) is a training and training evaluation partner in this project. ATSDR is hosting a downloadable
"classroom" version of the certificate for those who prefer classroom instruction or may have limited broadband that prevents full

access to course content (e.g., large PDF files). In addition, ATSDR and NEHA propose to offer additional 20-hour immersive
training in three of the five EHLR training modules--community engagement, evaluation of environmental and health risks, and risk
communication--as conference training sessions. NEHA is providing Certificates of Completion and continuing education credits for
participants of the trainings upon verification of eligibility by the ATSDR course director.
Objective:

The overarching objective is to train the target population (primarily environmental professionals) in health-focused land reuse in its
relationship to environmental health.

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:

Not Selected

SDOH Education:

Not Selected

SDOH Health Care Access:

Not Selected

SDOH Neighborhood and Environment:

Yes

SDOH Social and Community Context:

Yes

SDOH Indices:

Not Selected

Other SDOH Topics:

environmental justice

Assessing Impact:

Yes

Methods to Improve Health Equity Research and
Practice:

Yes

Other:

Not Selected

Activities or Tasks:

New Collection of Information, Data, or Biospecimens ; Programmatic Work

Target Populations to be Included/Represented:

General US Population

Tags/Keywords:

Education ; Health Education ; Conference registration ; Self-assessment ; Course evaluation

CDC's Role:

CDC employees will participate as co-authors in presentation(s) or publication(s)

Method Categories:

Other - Conference registration, course registration, self-assessment

Methods:

ATSDR will provide classroom and conference EHLR training with NEHA assistance. In the future ATSDR and NEHA may publish
manuscripts related to environmental health education and the training.
ATSDR collects user information (name, job title, location/address, email address) from registered learners. The ATSDR Land

Collection of Info, Data or Biospecimen:

Expected Use of Findings/Results and their impact:

Reuse PI, Laurel Berman, securely maintains email addresses of learners who request the Classroom EHLR training. Following the
CDC Records Control Schedule (RCS), the PI will delete such data after 7 years. ATSDR completed its feedback survey for the first
cohort of up to 200 people within 6-12 months after the training. Under this reinstatement with change ICR, this survey will be
eliminated, and ATSDR will add additional information collection related to training and its effectiveness, such as job title, voluntary
self-assessments, and participant feedback.
ATSDR and NEHA will use the self-assessments (voluntary), and other input from Classroom and Online EHLR Basic learners to
evaluate the course. We will also rely on data from the proposed immersive EHLR sessions at various conferences to determine
training effectiveness and impact.

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 #

CDC Cooperative
Agreement

National Environmental Health Association Brownfields Project (Year 4 Activity at $75,000 and
proposed Year 5 at $85,000))

CDC-RFAOT18- 1802

HSC Review

HSC Attributes

Original
Budget Yr

# Years
Award

Budget
Amount

2020

5

85000.00

Other - Training administration

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

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 #
CDC-RFA-OT18- 1802

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

Michael
Lewin

05/25
/2025

Rebecca
Labbo
Sharon
Unkart

Phone

Organization

n/a

CoInvestigator

gbare@neha.
org

National Environmental Health Association

n/a

Contract
Official

[email protected]

National Environmental Health Association

Principal
Investigator

3128867476

COMMUNITY ENGAGEMENT SCIENCES
& INTERVENTION SECTION

07/09/2023

Statistician

7704883812

RESEARCH ACTIVITIES TEAM

08/07
/2022

07/09/2023

Statistician

rlabbo@neha.
org

National Environmental Health Association

08/07
/2022

07/09/2023

CoInvestigator

sdunkart@neha.
gov

National Environmental Health Association

10/29/2022

Data
DMP
Proposed Data Collection Start Date:

7/31/23

Proposed Data Collection End Date:

8/1/25

Proposed Public Access Level:

Public

Public Access Justification:

Results of training, such as self-reported competency increases or aggregated self-assessment data may be used in publications by
ATSDR and NEHA. All individuals will be de-identified and no PII will be released. Because we are reviewing literature and
presenting the summaries of our findings, no people will be named or identified. The data may also summarize public environmental
regulations, policies, and practices. Our focus geographic areas are N. America, European Union states, and non-EU Eastern
European regions.

How Access Will Be Provided for Data:

All PII (person identifiers) will be removed from data.

Plans for Archival and Long Term Preservation:

Personally identifiable information will be stored in NEHA's secured learning management system or in ATSDR secured PI's files
and will be relevant to issuing of certificates of completion and CEUs (by NEHA). ATSDR will not store PII for more than three years
and typically only 2-3 months after NEHA issues a certificate of completion. ATSDR's Land Reuse Team Lead will follow federal
records procedures for training health professionals (i.e., destroy records after 7 years). In terms of any collaborative trainings and
related publications, there is not a need for data storage indirectly related to training results but may result in saving published
journal articles or citing publicly available federal/state/regional website content.

Spatiality
Country

State/Province

County/Region

United States
Romania

Bihor

Dataset
Dataset
Title

Dataset
Description

Dataset yet to be added...

Supporting Info

Data Publisher
/Owner

Public Access
Level

Public Access
Justification

External
Access URL

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

Davis_Stephanie
I. (sgd8)
CIO OMB / PRA

03/23/2023

EHLR 60-day FRN publication
request package

Paperwork Reduction Act Form

EHLR 60D FRN Rqst to ICRO.zip

Berman_Laurel
A. (fjq0)
CIO HSC

03/23/2023

Zipped file with corrections to FRN
documents, SSA, etc.

Paperwork Reduction Act Form

Revised-FRN-docs-SSA-B-listAtt.zip

Berman_Laurel
A. (fjq0)
Project Contact

03/23/2023

Clean versions of the corrected
60D FRN publication request and
60D FRN for EHLR certification
are zipped and supplemented by
updated SSA (burden table), SSB,
and list of attachments.

Paperwork Reduction Act Form

Revised-FRN-docs-SSA-B-listAtt.zip

Davis_Stephanie
I. (sgd8)
CIO HSC

03/23/2023

OS comments to 60D publication
request package

Paperwork Reduction Act Form

EHLR 60D Rqst Reinstate w Chng.zip

Berman_Laurel
A. (fjq0)
CIO HSC

03/22/2023

Zipped forms for latest revisions.

Paperwork Reduction Act Form

EHLR-PRA-Reinst-032223.zip

Berman_Laurel
A. (fjq0)
Project Contact

03/22/2023

This zipped package contains
clean and updated requested
documents: DRAFT 60DFRN,60D
publication request form, all data
collection instruments in burden
table, SS-A (and SS-B), list of
attachments.

Paperwork Reduction Act Form

EHLR-PRA-Reinst-032223.zip

Davis_Stephanie
I. (sgd8)
CIO HSC

02/06/2023

ICR reviewed by OS

Paperwork Reduction Act Form

Files rev OS.zip

Berman_Laurel
A. (fjq0)
CIO HSC

02/06/2023

All PRA Reinstatement documents
zipped in one file.

Paperwork Reduction Act Form

PRA-Reinst-All-Files-zip-020623.zip

Berman_Laurel
A. (fjq0)
Project Contact

02/06/2023

All PRA Reinstatement files and
forms are zipped within as one
package.

Paperwork Reduction Act Form

PRA-Reinst-All-Files-zip-020623.zip

Berman_Laurel
A. (fjq0)
CIO HSC

02/06/2023

This zipped package contains the
3survey instruments: Atts 4a-e adn
5a-c.

Paperwork Reduction Act Form

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

Berman_Laurel
A. (fjq0)
CIO HSC

02/06/2023

This zipped package contains the
PIA and IRB closure memo.

Paperwork Reduction Act Form

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

Berman_Laurel
A. (fjq0)
CIO HSC

02/06/2023

This zipped package contains the
30-day, SSA, SSB, Privacy Act
Checklist, FRN Publication Notice.

Paperwork Reduction Act Form

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

Berman_Laurel
A. (fjq0)
CIO HSC

02/06/2023

This zipped package contains
Worksheets: Wksht1 and all
Wksht2s.

Paperwork Reduction Act Form

Wrksht1-2-all-CLN-020423.zip

Berman_Laurel
A. (fjq0)
CIO HSC

02/06/2023

This zipped package contains the
List of Attachments, Att 1, Att 2, Att
3,3a-b

Paperwork Reduction Act Form

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

02/06/2023

This zipped package contains the
Worksheets for the PRA packet the overall training (Wksht1) and
registration and survey form
Wrkshts 2s. I submitted this on 2/4
/23, but the files do not appear as
submitted, so resubmitting.

Paperwork Reduction Act Form

Wrksht1-2-all-CLN-020423.zip

02/06/2023

This zipped package contains the
survey instruments for EHLR Basic
and Immersion (4a-e and 5a-c). I
submitted this on 2/4/23, but the
files do not appear as submitted,
so resubmitting.

Paperwork Reduction Act Form

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

02/06/2023

This zipped package contains the
List of Attachments, Att1, 2, 3, 3a,
3b (3ab - registration and opt out) I
submitted this on 2/4/23, but the
files do not appear as submitted,
so resubmitting.

Paperwork Reduction Act Form

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

02/06/2023

This zipped package contains the
30-day, SSA, SSB, Privacy Act
Checklist, FRN Publication Notice.
I submitted this on 2/4/23, but the
files do not appear as submitted,
so resubmitting.

Paperwork Reduction Act Form

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

02/06/2023

This zipped package contains the
Privacy Assessment and IRB
Closure Notice. I submitted this on
2/4/23, but the files do not appear
as submitted, so resubmitting.

Paperwork Reduction Act Form

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

Berman_Laurel
A. (fjq0)
Project Contact

Berman_Laurel
A. (fjq0)
Project Contact

Berman_Laurel
A. (fjq0)
Project Contact

Berman_Laurel
A. (fjq0)
Project Contact

Berman_Laurel
A. (fjq0)
Project Contact

Davis_Stephanie
I. (sgd8)
CIO HSC

01/18/2023

ZIpfile of reinstatement with
change ICR with OS comments

Paperwork Reduction Act Form

Files rev OS.zip

Berman_Laurel
A. (fjq0)
Project Contact

01/13/2023

Att4 through Att 5: EHLR Basic
and Immersion Knowledge
Assessments zipfile 010523

Paperwork Reduction Act Form

Att4-Att5-Basic-Immers-KnowledgeAssessm-010523.zip

Berman_Laurel
A. (fjq0)
Project Contact

01/13/2023

Att 3c - emailed registration form
(Word)

Paperwork Reduction Act Form

Att3c-EHLR Emailed Online Registration Form
(classroom)-12-2022.docx

Berman_Laurel
A. (fjq0)
Project Contact

01/13/2023

All EHLR worksheets zipfile
010523

Paperwork Reduction Act Form

Worksheets-EHLR-all-010523.zip

Berman_Laurel
A. (fjq0)
Project Contact

01/13/2023

EHLR Registration Forms: 3, 3a,
3b, 3c1 (opt-out form), zipfile
010523

Paperwork Reduction Act Form

EHLR-RegistrationForms-3-3a-3b-3c-3c1-010523.zip

Berman_Laurel
A. (fjq0)
Project Contact

01/13/2023

Package contains Authorization
(Att1), 30-day, Att 6, PIA, SSA,
SSB, List of attachments, zipfile
dated 10523

Paperwork Reduction Act Form

Att1Auth-30Day-Att6-PIA-SSA-SSB-ListAttach01052023.zip

Berman_Laurel
A. (fjq0)
Project Contact

01/06/2023

Attachment 7: Research
Redetermination IRB Closure

Other

Att7- Research Re-determination IRB Closure Memo12152022.pdf

Berman_Laurel
A. (fjq0)
Project Contact

01/06/2023

Zip File: EHLR Basic and
Immersion Knowledge
Assessments (Atts 4a,b,c,d,3 #
Basic and Atts 5a,b,c # Immersion)

Other

Att4-Att5-Basic-Immers-KnowledgeAssessm-010523.zip

Berman_Laurel
A. (fjq0)
Project Contact

01/06/2023

Zip File: EHLR PRA Worksheets

Other

Worksheets-EHLR-all-010523.zip

Berman_Laurel
A. (fjq0)
Project Contact

01/06/2023

Zip File: EHLR Registration #
Basic and Immersion (Classroom)
(Att3), EHLR Conference
Registration (Att3a), EHLR Online
Registration Form (Att 3b), EHLR
Emailed Registration form (Att3c),
EHLR Online Regist form opt out
(Att3c1)

Other

EHLR-RegistrationForms-3-3a-3b-3c-3c1-010523.zip

Berman_Laurel
A. (fjq0)
Project Contact

01/06/2023

Zip File: Authorization, 30-day,
SSA, SSB, List of Attachments,
and the Att 6 PIA

Other

Att1Auth-30Day-Att6-PIA-SSA-SSB-ListAttach01052023.zip

Zirger_Jeffrey
(wtj5)
ICRO Reviewer

03/07/2022

NOA 0923-0060 (2019)

Notice of Action

NOA 0923-0060.pdf

03/02/2022

CLEAN Word document. Also
loaded as supporting info in
STARS tab. Marked version is in
comments.

Other

fjq0_0900f3eb81ea3ec7-CLEAN-030222.docx

Berman_Laurel
A. (fjq0)
CIO HSC

03/02/2022

60D FRN documents
(registrations, pre- and post-test,
self-assessments, NEHA Online
evaluation)

Other

0923-0060 EHLR Crtfctn Trng 60-day FRN-forSTARS.
zip

Current

Berman_Laurel
A. (fjq0)
Project Contact

03/02/2022

CLEAN version of the file
(comments/Marked version are
within STARS comments tab)

Other

fjq0_0900f3eb81ea3ec7-CLEAN-030222.docx

Current

Berman_Laurel
A. (fjq0)
Project Contact

03/02/2022

Correct zip file containing the PRA
documents for burden (registration
forms, per- and post-test, selfassessment, NEHA online
evaluation)

Other

0923-0060 EHLR Crtfctn Trng 60-day FRN-forSTARS.
zip

02/28/2022

Zipped file containing all
documents related to 60-day FRN
and activities requiring PRA
approval (e.g., conference
registrations, pre- and post-tests,
training registrations, selfassessment, online course
evaluation)

Other-Enter new type

Modules-1-3-files-022322.zip

Berman_Laurel
A. (fjq0)
CIO HSC

Berman_Laurel
A. (fjq0)
Project Contact

Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES

Centers for Disease Control
and Prevention (CDC)

Memorandum
Date

May 10, 2022

From

Jerrell Little
IRB-Committee Administrator
Human Research Protection Office

Subject

Closure of CDC Protocol 7175 “Environmental Health and Land Reuse Certification.”

To

LAUREL BERMAN, PhD, MS
ATSDR/OCDAPS
On behalf of the CDC Human Research Protection Office (HRPO), I have reviewed the request
to close protocol 7175 “Environmental Health and Land Reuse Certification.” The study stopped
for reasons other than risk or noncompliance. Study received IRB/HRPO approval and
completed the terms of the approved protocol. NCEH/ATSDR Office of Science has reviewed
the protocol and has made a determination that this activity is not research. The request for
closure is associated with STARS project ID 0900f3eb81bf3c9d. No study data has been
collected. Data have not yet been collected. No biospecimens have been stored. This includes the
case where none were collected.
Please update your records accordingly.
If you have any questions, please contact your National Center Human Subjects Contact or the
CDC Human Research Protection Office at (404) 639-7570 or by e-mail at [email protected]).
cc: NCEH/ATSDR HS mailbox (CDC)