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Attachment 10 - Research Determination Form

Print Date: 2/12/20

Title:

Asthma Information Reporting System (AIRS) Revision ICR

Project Id:

0900f3eb81a32f63

Accession #:

NCEH-DEHSP-10/1/19-32f63

Project Contact:

Etheredge_Alisha (epq5)

Organization:

NCEH/ATSDR/DEHSP

Status:

Project In Progress

Intended Use:

Project Determination

Estimated Start Date:

10/01/2019

Estimated Completion Date:

10/01/2023

CDC/ATSDR HRPO/IRB Protocol #:
0920-0853

OMB Control #:

Determinations
Determination

Justification

Completed

Entered By & Role

HSC:
Does NOT Require HRPO
Review

Not Research

10/3/19

Davis_Stephanie I. (sgd8) CIO HSC

10/3/19

Davis_Stephanie I. (sgd8) CIO OMB / PRA

PRA:
PRA Applies

ICRO:
Returned with No Decision

2/4/20

Zirger_Jeffrey (wtj5) ICRO Reviewer

Description & Funding
Description
Priority:

Standard

Date Needed:

10/15/2019

Determination Start Date:

10/01/19

Description:

The purpose of this information collection (IC) is to continue CDC#??s monitoring of funded programs#?? planning and delivery of
public health activities and the programs#?? collaboration with health care systems. AIRS is the system by which state asthma
programs report their progress on National Asthma Control Program developed performance measures (PM), as well as state-level
asthma emergency department (ED) visit and hospital discharge (HD) data. Recipients receive funding to implement a variety of
public health strategies and activities. CDC collects information related to each recipient's strategies and activities, and the process
and outcome PM outlined by the cooperative agreement program.

Goals/Purpose

The National Center for Environmental Health#s National Asthma Control Program (NACP) supports state, local and territorial
health departments to better understand the impact of asthma and to encourage a comprehensive public health approach to asthma
control. The purpose of this information collection (IC) is to continue NACP#s monitoring of recipient programs# planning and
delivery of public health activities and the programs# collaboration with health care systems under a new cooperative agreement
(EH19-1902). CDC collects information related to each recipient#s strategies and activities, and the process and outcome PMs
outlined by the cooperative agreement program. NACP-funded asthma programs report their progress on NACP developed
performance measures (PMs), as well as state-level asthma emergency department (ED) visit and hospital discharge (HD) data. A
new PM electronic reporting tool has been developed, which will allow recipients to report PM information. Recipients receive
funding to implement a variety of public health strategies and activities.

Objective:

The objective of this information collection is to 1) monitor state and national progress toward achieving the outcomes identified in
the National Asthma Control Program#s logic model; 2) facilitate aggregate reporting of outcomes to state and national
stakeholders; 3) identify and respond to technical assistance needs; and 4) promote continuous quality improvement at the state
program and CDC level.

Activities or Tasks:

New Collection of Information, Data, or Biospecimens

Target Populations to be Included/Represented:

Awardee Program Managers

Tags/Keywords:

Asthma, AIRS

CDC's Role:

CDC is providing funding, CDC is recipient of materials/services FROM an institution

Method Categories:

Other

Methods:

Respondents include up to 30 cooperative agreement recipients (state, local, and territorial health departments). Information will be
collected from recipients on an annual basis.
Recipients will submit standardized PM data on an annual basis via a newly developed electronic reporting tool in SharePoint. The

Collection of Info, Data or Biospecimen:

Expected Use of Findings/Results:

Could Individuals potentially be identified based on
Information Collected?

SharePoint site was created to allow recipients to electronically input information for eight core PMs. State-level ED visit and HD
surveillance data will be submitted electronically by recipients to a dedicated electronic mailbox.
Information will be used for multiple purposes: 1) monitoring state and national progress toward achieving the outcomes identified in
the National Asthma Control Program#s logic model; 2) facilitating aggregate reporting of outcomes to state and national
stakeholders; 3) identifying and responding to technical assistance needs; and 4) promoting continuous quality improvement at the
state program and CDC level.
Yes

Funding

Funding Type

Funding Title

Funding #

CDC Cooperative
Agreement

A Comprehensive Public Health Approach to Asthma Control through Evidence-Based
Interventions

CDC-RFA-EH191902

Original Budget
Yr

# Years
Award

2019

5

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

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

Alisha
Etheredge

12/26
/2021

03/10/2019

CITI Social &
Behavioral Exp. Date

CITI Good Clinical
Practice Exp. Date

Staff
Role

Email

Phone

Organization

Project
Officer

epq5@cdc.
gov

7704887884

DIVISION OF ENVIRONMENTAL HEALTH
SCIENCE AND PRACTICE

Data
DMP
Proposed Data Collection Start Date:

10/1/20

Proposed Data Collection End Date:

10/1/23

Proposed Public Access Level:

Public

Public Access Justification:

Data will be made accessible to the public.
Aggregate, de-identified performance measures data will be shared with the public (posted on CDC webpage) and presented at the
American Evaluation Association conference. The hospitalizations and emergency departments visits data is publicly available data

previously collected by the recipient, not at the request of CDC. This de-identified data is shared with the public on the CDC
website.

How Access Will Be Provided for Data:

Plans for Archival and Long Term Preservation:

The data will be stored within the SharePoint site for at least ten years. Each state, local and territorial asthma program recipient
has access to its own information and surveillance data. The state, local, or territorial cooperative agreement recipient decides the
level of access for each user, and to what extent local partners may access that information. State, local, and territory cooperative
agreement recipients are required to report periodically as a condition of their award from CDC. The information collected will be
neither sensitive nor proprietary in nature. Reporting spreadsheets containing emergency department visit and hospitalization data
will be uploaded and stored on the ACHB#s SharePoint site for at least ten years.

Spatiality

Spatiality (Geographic Locations) yet to be added .....

Dataset
Dataset Title

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