Research Determination

Print Date: 12/10/21

Title:

ATSDR Exposure Investigations Generic Clearance

Project Id:

0900f3eb81d8f334

Accession #:

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

Project Contact:

Karen M Scruton

Organization:

NCEH/ATSDR/OCHHA

Status:

Pending Clearance : PRA Revision

Intended Use:

Project Determination

Estimated Start Date:

07/29/2021

Estimated Completion Date:

07/29/2025

CDC/ATSDR HRPO/IRB Protocol #:
0923-0048 (exp 04/30/2022)

OMB Control #:

Determinations
Determination

Justification

HSC:
Does NOT Require HRPO
Review

Not Research - Public Health Surveillance

PRA:
PRA Applies

Completed

Entered By & Role

7/30/21

Davis_Stephanie I. (sgd8) CIO HSC

7/30/21

Davis_Stephanie I. (sgd8) CIO OMB / PRA

45 CFR 46.102(l)(2)

ICRO:
PRA Applies

OMB Approval date: 4/16/19
OMB Expiration date: 4/30/22

8/2/21

Zirger_Jeffrey (wtj5) ICRO Reviewer

Description & Funding
Description
Priority:

Standard

Determination Start Date:

12/09/21

Description:

This is an extension of an existing Information Collection Request for Exposure Investigations. OMB Control Number 0923-0048
(exp 04/30/2022). This is a request to publish the 60-day Federal Register Notice (FRN).

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

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 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:

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

# Years Award

Budget Amount
0.00

HSC Review

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

No

Estimated number of study participants

Population - Children
Population - Minors
Population - Prisoners
Population - Pregnant Women
Population - Emancipated Minors

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

Karen
Scruton

11/01
/2024

05/01/2017

Peter
Kowalski

12/21
/2021

CITI Good Clinical
Practice Exp. Date

Staff Role

Email

Phone

Organization

11/10/2024

Principal
Investigator

isg3@cdc.
gov

7704881325

OFFICE OF COMMUNITY HEALTH AND
HAZARD ASSESSMENT

04/24/2022

Principal
Investigator

pek2@cdc.
gov

7704880776

EXPOSURE INVESTIGATIONS SECTION

Data
DMP
Proposed Data Collection Start Date:

7/29/21

Proposed Data Collection End Date:

7/29/25

Proposed Public Access Level:

Public

Public Access Justification:

The public will be provided the results of the exposure investigations biological testing and/or environmental sampling.

How Access Will Be Provided for Data:

Data will be managed per ATSDR requirements for PII.

Plans for Archival and Long Term Preservation:

Spatiality
Country
United States

Dataset

State/Province

County/Region

Dataset
Title

Dataset
Description

Dataset yet to be added...

Data Publisher
/Owner

Public Access
Level

Public Access
Justification

External
Access URL

Download
URL

Type of Data
Released

Collection
Start Date

Collection End
Date