Research Determination

Print Date: 8/28/23

Title:

APPLETREE Performance Measures and ICRs PRA Revision 1

Project Id:

0900f3eb8215d7a0

Accession #:

NCEH-DCHI-11/13/19-61974

Project Contact:

Audra E Henry

Organization:

NCEH/ATSDR/OCDAPS

Status:

Pending Regulatory Clearance : PRA Revision

Intended Use:

Project Determination

Estimated Start Date:

10/01/2023

Estimated Completion Date:

09/30/2026

CDC/ATSDR HRPO/IRB Protocol #:
0923-0057

OMB Control #:

Determinations
Determination

Justification

HSC:
Does NOT Require HRPO
Review

Not Research / Other

PRA:
PRA Applies

Completed

Entered By & Role

11/15/19

Davis_Stephanie I. (sgd8) CIO HSC

6/15/23

De Leon Salazar_Alfonsina (wvg4) CIO OMB / PRA

45 CFR 46.102(l)

ICRO:
PRA Applies

OMB Approval date: 9/28/20
OMB Expiration date: 9/30/23

6/16/23

Zirger_Jeffrey (wtj5) ICRO Reviewer

Description & Funding
Description
Priority:

Standard

Date Needed:

06/30/2023

Determination Start Date:

05/16/23

Description:

APPLETREE performance measures and Information Collection forms to be submitted for the 60-day Federal Register Notice and
to OMB for approval in accordance with the Paperwork Reduction Act.

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

Demonstrate, through regular reporting, the impact and effectiveness of APPLETREE recipients' work to reduce, eliminate, or
prevent harmful chemical exposures in the environment.

Objective:

Collect information from APPLETREE recipients to inform performance measures, demonstrate impact, and report progress.

Does your project measure health disparities among Not Selected
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?:

Not Selected

Does your project propose, implement, or evaluate

Not Selected

an action to move towards eliminating health
inequities?:
Activities or Tasks:

New Collection of Information, Data, or Biospecimens

Target Populations to be Included/Represented:

Other - Awardee Program Managers

Tags/Keywords:

APPLETREE ; Program Evaluation ; Mandatory Reporting

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:

Other - Required reporting under cooperative agreement

Methods:

Data will be reported on various forms developed by ATSDR

Collection of Info, Data or Biospecimen:

Data will consist of programmatic activity tracking, event reporting, and process measurement.

Expected Use of Findings/Results and their impact:

ATSDR will compile information collected to report attainment of programmatic performance measures. Achieving programmatic
goals will result in a demonstration of the return on investment and positive impact on public health.

Could Individuals potentially be identified based on
Information Collected?

No

Funding

Funding Type

Funding Title

Funding #

CDC Cooperative
Agreement

ATSDRs Partnership to Promote Local Efforts to Reduce Environmental Exposure
(APPLETREE)

TS-230001

HSC Review

HSC Attributes
Quality Assurance / Improvement

Yes

Original Budget
Yr

# Years
Award

Budget
Amount

2023

5

69800000.00

Regulation and Policy
Do you anticipate this project will need IRB review
by the CDC IRB, NIOSH IRB, or through reliance on
an external IRB?
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
Institutions yet to be added .....

Staff
Staff
Member

SIQT
Exp.
Date

Audra
Henry

Trent
Lecoultre

CITI Biomedical
Exp. Date

CITI Social &
Behavioral Exp. Date

CITI Good Clinical
Practice Exp. Date

Staff
Role

Email

Phone

Organization

03/13
/2026

Program
Lead

ate1@cdc.
gov

7704883758

OFFICE OF CAPACITY DEVELOPMENT AND
APPLIED PREVENTION SCIENCE

12/17
/2023

Program
Lead

tll7@cdc.
gov

7704883799

DIVISION OF COMMUNITY HEALTH
INVESTIGATIONS

Data
DMP
Proposed Data Collection Start Date:

10/1/23

Proposed Data Collection End Date:

9/30/26

Proposed Public Access Level:

Public, Restricted

Restricted Details:
Data Use Type:
Data Use Type URL:
Data Use Contact:
Public Access Justification:

This data can be made available upon request. The data will be aggregated and summarized to be used in public-facing reports.

How Access Will Be Provided for Data:

This data can be made available upon request. The data will be aggregated and summarized to be used in public-facing reports. No
PII, confidential information, secure information, or intellectual property will be collected.

Plans for Archival and Long Term Preservation:

Data will be stored in ATSDR's Request Management System and in files held by the Project Officer.

Spatiality
Country

State/Province

County/Region

United States

Dataset
Dataset
Title

Dataset
Description

Data Publisher
/Owner

Public Access
Level

Public Access
Justification

External
Access URL

Download
URL

Type of Data
Released

Collection
Start Date

Collection End
Date

Dataset yet to be added...

Supporting Info
Current

CDC Staff
Member and Role

Date Added

Description

Supporting Info Type

Supporting Info

Zirger_Jeffrey
(wtj5)
ICRO Reviewer

06/16/2023

NOA 0923=0057 (2020)

Notice of Action

NOA 0923-0057.pdf

De Leon
Salazar_Alfonsina
(wvg4)
CIO OMB / PRA

06/15/2023

60-day FRN documents reviewed
by OS and ready for ICRO review

Other

0923-0057 60D FRN files to ICRO.zip

De Leon
Salazar_Alfonsina
(wvg4)
CIO HSC

06/15/2023

60-day FRN documents reviewed
by OS and ready for ICRO review

Other

0923-0057 60D FRN files to ICRO.zip

Henry_Audra L.
(ate1)
Project Contact

06/13/2023

Appletree 2023 Revision 60-day
FRN request documents rev by
OS.

Other

Appletree OMB package rev OS for 60D FRN.zip

Henry_Audra L.
(ate1)
Project Contact

06/13/2023

Draft 60-day FRN notice

Paperwork Reduction Act Form

0923-0057 APPLETREE Revision 60Day_FRN_20190801.docx

Henry_Audra L.
(ate1)
Project Contact

06/13/2023

Supporting Statement A

Paperwork Reduction Act Form

SSA APPLETREE PMs 103019.docx

Henry_Audra L.
(ate1)
Project Contact

06/13/2023

ICR package forms for 60-day
notice

Other

Clean Copies to upload to STARS for 60 days - Copy.zip

Henry_Audra L.
(ate1)
Project Contact

06/13/2023

60-day FRN package - clean copy

Other

Clean copies for 60 day.zip

Henry_Audra L.
(ate1)
Project Contact

06/13/2023

Notice of Funding Opportunity

Notice of Funding Opportunity

Foa_Content_of_CDC-RFA-TS-23-0001 (1) (1).pdf

Henry_Audra L.
(ate1)
Project Contact

06/13/2023

Supporting Statement B

Paperwork Reduction Act Form

SSB APPLETREE PMs 103019.docx

Henry_Audra L.
(ate1)
Project Contact

06/13/2023

Appletree 2020 Revision Wrksht1
and wrksht2.

Other

Appletree 2020 revision Wrksh1 Wrksh2s.zip

Henry_Audra L.
(ate1)
Project Contact

06/13/2023

Appletree 2023 Revision 30-day
FRN request documents rev by
OS.

Other

Appletree OMB package rev OS for 30D FRN.zip

De Leon
Salazar_Alfonsina
(wvg4)
CIO HSC

05/19/2023

Appletree 2023 Revision 60-day
FRN request documents rev by
OS.

Other

Appletree OMB package rev OS for 60D FRN.zip

De Leon
Salazar_Alfonsina
(wvg4)
CIO HSC

05/19/2023

Appletree 2020 Revision Wrksht1
and wrksht2.

Other

Appletree 2020 revision Wrksh1 Wrksh2s.zip

De Leon
Salazar_Alfonsina
(wvg4)
CIO HSC

05/19/2023

Appletree 2023 Revision 30-day
FRN request documents rev by
OS.

Other

Appletree OMB package rev OS for 30D FRN.zip

Henry_Audra L.
(ate1)
Project Contact

05/16/2023

ICR package forms for 60-day
notice

Other

Clean Copies to upload to STARS for 60 days - Copy.zip

Henry_Audra L.
(ate1)
Project Contact

05/16/2023

Notice of Funding Opportunity

Notice of Funding Opportunity

Foa_Content_of_CDC-RFA-TS-23-0001 (1) (1).pdf

Henry_Audra L.
(ate1)
Project Contact

05/16/2023

ICR package forms for 60-day
notice

Other

Clean Copies to upload to STARS for 60 days - Copy.zip

LeCoultre_Trent
D (tll7)
Project Contact

11/15/2019

Draft 60-day FRN notice

Paperwork Reduction Act Form

0923-0057 APPLETREE Revision 60Day_FRN_20190801.docx

LeCoultre_Trent
D (tll7)
Project Contact

11/15/2019

Supporting Statement A

Paperwork Reduction Act Form

SSA APPLETREE PMs 103019.docx

LeCoultre_Trent
D (tll7)
Project Contact

11/15/2019

Supporting Statement B

Paperwork Reduction Act Form

SSB APPLETREE PMs 103019.docx