Research determination

Attachment 6. ACE Research Determination

Print Date: 8/12/20

Title:

Assessment of Chemical Exposures (ACE) Investigations (OMB No.09230051)

Project Id:

0900f3eb81b8c0ed

Accession #:

NCEH-EHSB-7/9/20-8c0ed

Project Contact:

Orr_Maureen F. (mco0)

Organization:

NCEH/ATSDR/DTHHS/EHSB

Status:

Pending Regulatory Clearance

Intended Use:

Project Determination

Estimated Start Date:

03/31/2021

Estimated Completion Date:

03/31/2024

CDC/ATSDR HRPO/IRB Protocol #:

n/a

OMB Control #:

09230051

Determinations
Determination

Justification

HSC:
Does NOT Require HRPO
Review

Not Research - Public Health Surveillance

PRA:
PRA Applies

Completed

Entered By & Role

8/12/20

Davis_Stephanie I. (sgd8) CIO HSC

8/12/20

Davis_Stephanie I. (sgd8) CIO OMB / PRA

45 CFR 46.102(l)(2)

Description & Funding
Description
Priority:

Standard

Date Needed:

07/23/2020

Determination Start Date:

07/21/20

Description:

ATSDR is requesting a continuation of the OMB Gen IC for the Assessment of Chemical Exposures (ACE) investigations (OMB No.
09230051) for an additional 3 years. The ACE toolkit is a modifiable set of surveys and databases used to conduct an epidemiologic
assessment after a chemical incident. The existing surveys have been shortened and field data entry will be implemented. The part
of the toolkit formerly the ACE short form has been renamed Epidemiologic Contact Assessment Symptom Exposure (Epi CASE).
We would like to expand the collection to include not just chemical incidents but working with our partners (NCEH and NIOSH)
include a broader range of environmental incidents including nuclear, radiological, natural disasters, and explosions. Due to this
there will be an increase in requested burden hours of 180.3.

IMS/CIO/Epi-Aid/Chemical Exposure Submission:

No

IMS Activation Name:

Not selected

CIO Emergency Response Name:

Not selected

Epi-Aid Name:

Not selected

Assessment of Chemical Exposure Name:

Not selected

Goals/Purpose

The ACE program helps state and local health departments conduct an epidemiologic assessment after an environmental exposure
incident.

Objective:

Generally these are the objectives, each state/local health department sets their own. To better understand the impact of an
environmental incident on the community and make recommendations to fulfil their needs. To assess the public health response
and impact of the incident and make recommendations to improve. To understand the cause of the incident and make
recommendations to prevent similar incidents from happening. To define a group of individuals who may need follow up for potential
mental and physical health effects in the future.

Activities or Tasks:

New Collection of Information, Data, or Biospecimens

Target Populations to be Included/Represented:

General US Population

Tags/Keywords:

Disasters

CDC's Role:

Activity originated and designed by non-CDC staff (awardee or external collaborator), CDC employees or agents will obtain data by
intervening or interacting with participants, CDC employees or agents will obtain or use identifiable (including coded) private data or
biological specimens, CDC employees will participate as co-authors in presentation(s) or publication(s), CDC employees will
provide substantial technical assistance or oversight, CDC is NOT a recipient or provider of private data, specimens, materials or
services, CDC is provider of technical assistance or staff time in the absence of CDC support

Method Categories:

Exposure Investigation; Individual Interview (Quantitative); Record Review

Methods:

The ACE toolkit contains modifiable individual as well as household level surveys. It contains a survey for the hospital staff as well
as medical chart abstraction forms. There are epi info databases to enter and analyze the data. WE are developing filed data entry
screens. Most data analysis are descriptive. GIS modeling is often used to try to identify the area of exposure. I have listed
exposure investigation, but it is not the traditional ATSDR Exposure investigation (EI).

Collection of Info, Data or Biospecimen:

Surveys are usually collected door to door in an affected community. If the size of the affected community is large and the time to
collect the data are limited, sampling may be employed using the CASPER model. GRASP generally assists us to identify the
affected area to interview. Surveys of responders or workers are generally conducted at their workplace. If we are unable to do in
person interview, phone interviews may be done to catch those we were unable to interview in person. we consult with the NCEH
labs and toxicologists to determine if we should consider biomonitoring. If it is indicated, then we will work with the NCEH labs to
collect and test specimens.

Expected Use of Findings/Results:

Data are used to help the community. It will determine any resources they may need, to improve the communities emergency
response procedures and prevent future similar incidents. Results are often published in the MMWR or other journals.

Could Individuals potentially be identified based on
Information Collected?

No

Funding

Funding Type

Funding Title

Technical assist-CDC not reimbursed

EPi Aid

Funding #

Original Budget Yr

# Years Award

HSC Review

Additional Ethical Considerations
The ACE Investigations are public health surveillance activities designed to assess population exposures to chemical releases in affected communities, and at the request of the state or local
public health agency.

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 documents 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

No Selection

Other method

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

Maureen
Orr

02/28/2023

CITI Biomedical
Exp. Date

CITI Social & Behavioral
Exp. Date

01/16/2022

CITI Good Clinical
Practice Exp. Date

Staff
Role

Email

Phone

Organization

Program
Lead

mco0@cdc.
gov

770-4883806

ENVIRONMENTAL HEALTH
SURVEILLANCE BRANCH

Data
DMP
Proposed Data Collection Start Date:

3/31/21

Proposed Data Collection End Date:

3/31/24

Proposed Public Access Level:

Non-Public

Non-Public Details:
Reason For Not Releasing Data:

Country/Jurisdiction owns the data with protections under their laws and regulations

Public Access Justification:

CDC/ATSDR does not own the data, it is the state or county who requested the ACE assistance.

How Access Will Be Provided for Data:

this is up to the states regulations.

Plans for Archival and Long Term Preservation:

this is up to the states regulations.

Spatiality
Country

State/Province

County/Region

United States

Dataset
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