Research Determination

Print Date: 5/19/25

Title:

ATSDR Exposure Investigations Generic Clearance PRA Revision 1

Project Id:

0900f3eb82456d90

Accession #:

NCEH-OCHHA-7/29/21-8f334

Project Contact:

Karen M Scruton

Organization:

NCEH/ATSDR/OCHHA

Status:

Pending Regulatory Clearance : PRA Revision

Intended Use:

Project Determination

Estimated Start Date:

10/01/2024

Estimated Completion Date:

12/31/2025

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

Determinations

0923-0048 (exp 06/30/2025)

Determination

Justification

HSC:
Does NOT Require HRPO
Review

Not Research - Public Health Surveillance

Entered By & Role

10/23/24

Ding_Yan (Shirley) (yad6) CIO HSC

10/23/24

Ding_Yan (Shirley) (yad6) CIO OMB / PRA

10/23/24

Zirger_Jeffrey (wtj5) ICRO Reviewer

45 CFR 46.102(l)(2)

PRA:
PRA Applies

ICRO:
PRA Applies

Completed

OMB Approval date: 6/15/22
OMB Expiration date: 6/30/25

Description & Funding
Description
Priority:

Standard

Priority Justification:
CDC Priority Area for this Project:

Other CDC Priority - Exposure Investigations GenIC package

Determination Start Date:

09/30/24

Description:

This is an extension of an existing Information Collection Request for Exposure Investigations. OMB Control Number 0923-0048
(exp 06/30/2025). This is a request to publish the 60-day Federal Register Notice (FRN).

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

To allow a mechanism for expedited clearance of OMB packages for Exposure Investigations.

Objective:

To extend OMB approval of the Generic Information Collection package for Exposure Investigations

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:

General US Population

Tags/Keywords:

Environmental Exposure

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:

Exposure Investigation

Methods:

ATSDR will conduct exposure investigations at sites where the agency criteria for conducting exposure investigations are met.

Collection of Info, Data or Biospecimen:

Biological or environmental samples, or both, using convenience sampling, and questionnaire data will be collected at sites that
meet agency criteria for conducting exposure investigations.

Expected Use of Findings/Results and their impact:

The data generated from the exposure investigation will be used to assist ATSDR in making recommendations to reduce
environmental exposure within communities. The data may be shared with local, state or federal environmental agencies as
appropriate.

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

Other-EI may be funded via various mechanisms

Pending

Funding #

Original Budget Yr

Regulation and Policy
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

Budget Amount
0.00

HSC Review

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

# Years Award

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
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

Will you be working with an outside Organization or Institution? No
Institutions yet to be added .....

Staff
Staff
Member

SIQT
Exp.
Date

CITI
Biomedical
Exp. Date

CITI Social &
Behavioral Exp.
Date

Karen
Scruton

08/04
/2026

05/01/2017

11/10/2024

CITI Good Clinical
Practice Exp. Date

Data
DMP
Proposed Data Collection Start Date:

7/29/21

Proposed Data Collection End Date:

7/29/25

Proposed Public Access Level:

Public, Non-Public

Non-Public Details:

CITI Good Laboratory
Practice Exp. Date

Staff Role

Email

Phone

Organization

Principal
Investigator

isg3@cdc.
gov

7704881325

OFFICE OF COMMUNITY
HEALTH AND HAZARD
ASSESSMENT

Reason For Not Releasing Data:

Other - Data may have PII - may be shared with other environmental or public health agencies per the consent form.

Public Access Justification:

The public will be provided the results of the exposure investigations biological testing and/or environmental sampling in a summary
form. Detailed data may be shared with environmental and public health agencies per the consent form agreement.

How Access Will Be Provided for Data:

Data will be managed per ATSDR requirements for PII. Data may be shared with other environmental and public health agencies if
stipulated in the consent form.

Plans for Archival and Long Term Preservation:

The data will be retained per federal retention standards.

Spatiality
Country

State/Province

County/Region

Virgin Islands of the United States
United States

Dataset
Dataset
Title

Dataset
Description

Data Publisher
/Owner

Dataset yet to be added...

Supporting Info
No Supporting Info

Public Access
Level

Public Access
Justification

External
Access URL

Download
URL

Type of Data
Released

Collection
Start Date

Collection End
Date