Research Determination

Print Date: 6/26/20

Title:

OMB 0920-1215 Awardee Lead Profile Assessment (ALPA)

Project Id:

0900f3eb81b58ce0

Accession #:

NCEH-LPPEHTB-5/27/20-58ce0

Project Contact:

Ruckart_Perri A. (afp4)

Organization:

NCEH/ATSDR/DEHSP/LPPEHTB

Status:

Pending Clearance

Intended Use:

Project Determination

Estimated Start Date:

02/01/2021

Estimated Completion Date:

01/31/2024

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

Determinations
Determination

Justification

Completed

Entered By & Role

6/26/20

Davis_Stephanie I. (sgd8) CIO HSC

Not Research / Other
HSC:
Does NOT Require HRPO
Review

45 CFR 46.102(l)
Program Evaluation
Quality Assurance / Improvement

PRA:
PRA Applies

6/26/20

Davis_Stephanie I. (sgd8) CIO OMB / PRA

Description & Funding
Description
Priority:

Standard

Date Needed:

06/05/2020

Determination Start Date:

05/28/20

Description:

This is a revision request of a currently approved OMB protocol #0920-1215 (Expiration Date 02/28/2021). The Awardee Lead
Profile Assessment (ALPA) data collection instrument will be used to: 1) identify common characteristics of funded childhood lead
poisoning prevention programs and 2) inform guidance, resource development, and technical assistance activities conducted by the
CDC Childhood Lead Poisoning Prevention Program (CLPPP) in support of the ultimate goal, which is blood lead elimination in
children. Assessment findings will be shared on the CDC CLPPP website and in response to inquiries by the public, press, and
Congress. The dissemination of results will support the ability for both funded and non-funded jurisdictions to: 1) identify policies
and other factors that support or hinder childhood lead poisoning prevention efforts, 2) understand what strategies are being used
by funded state and local governments (or their bona fide fiscal agents) to implement childhood lead poisoning prevention activities,
and 3) use this knowledge to develop and apply similar strategies to support the national agenda to eliminate childhood lead
poisoning. Changes included modifying survey questions with text box answers to gateway questions with multiple choice answer
options. Additionally, specific terms and phrases were revised for conciseness and clarification and questions about primary
prevention and lead elimination were added to the survey.

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 purpose of this annual assessment under the cooperative agreement is to identify: 1) jurisdictional legal frameworks governing
CDC-funded childhood lead poisoning prevention programs in the United States and 2) strategies for implementing childhood lead
poisoning prevention activities in the United States.

Objective:

The ALPA information collection will serve to 1) identify common characteristics of awarded childhood lead poisoning prevention
programs and 2) inform guidance and resource development in support of the ultimate elimination goal. The dissemination of results
obtained from this information collection will enable jurisdictions to 1) identify policies and other factors that support or hinder
childhood lead poisoning prevention efforts; 2) understand what strategies are being used by funded state and local governments
(or their bona fide fiscal agents) to implement childhood lead poisoning prevention activities; and 3) use this knowledge to develop
and apply similar strategies to support the national agenda to eliminate childhood lead poisoning. Both funded and non-funded
jurisdictions will be able to apply these principles to their childhood lead poisoning prevention programs. Findings will be shared on
CDC#s CLPPP website and in response to inquiries by the public, press, and Congress.

Activities or Tasks:

New Collection of Information, Data, or Biospecimens

Target Populations to be Included/Represented:

Other

Tags/Keywords:

Lead Poisoning

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:

Survey

Methods:

Each recipient has one project manager for lead poisoning prevention activities. Each project manager will complete the
questionnaire in his or her official capacity. The ALPA questionnaire will use the EpiInfo functionality as the primary method for
respondents to complete the information. The link will be sent via an invitation email by a CDC staff member to the attention of all
project managers of the funded programs approximately 150 days before the end of the annual budget period. A follow-up email will
be sent to the attention of all project managers approximately 130 days before the end of the annual budget period. Respondents
who do not want to complete the online web questionnaire will be able to complete the Word questionnaire that will be emailed to
them by a CDC staff member.

Collection of Info, Data or Biospecimen:

Via survey that will have a web-based on paper-based option

Expected Use of Findings/Results:

Assessment findings will be shared on the HHLPPP CDC CLPPP website and in response to inquiries by the public, press, and
Congress. The dissemination of results will support the ability for both funded and non-funded jurisdictions to: 1) identify policies
and other factors that support or hinder childhood lead poisoning prevention efforts, 2) understand what strategies are being used
by funded state and local governments (or their bona fide fiscal agents) to implement childhood lead poisoning prevention activities,
and 3) use this knowledge to develop and apply similar strategies to support the national agenda to eliminate childhood lead
poisoning.

Could Individuals potentially be identified based on
Information Collected?

No

Funding

Funding Type

Funding Title

Funding #

CDC Cooperative
Agreement

Childhood Lead Poisoning Prevention Projects, State and Local Childhood Lead Poisoning Prevention and
Surveillance of Blood Lead Levels in Children

CDC Cooperative
Agreement

Lead Poisoning Prevention- Childhood Lead Poisoning Prevention

HSC Review

Original
Budget Yr

# Years
Award

CDC-RFA-EH181806

2018

3

CDC-RFA-EH171701PPHF17

2017

4

HSC Review

HSC Attributes
Program Evaluation

Yes

Quality Assurance / Improvement

Yes

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

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 & Staff
Institutions
Institutions yet to be added .....

Staff
Staff Member

SIQT
Exp.
Date

Kelly Dyke

03/12
/2021

Perri Ruckart

05/02
/2021

Rio
Schondelmeyer

05/27
/2023

CITI
Biomedical
Exp. Date

11/07/2020

CITI Social &
Behavioral Exp.
Date

CITI Good Clinical
Practice Exp. Date

11/20/2020

Data
DMP
Proposed Data Collection Start Date:

6/1/21

Proposed Data Collection End Date:

6/28/24

Proposed Public Access Level:

Public, Restricted

Restricted Details:
Data Use Type:
Data Use Type URL:
Data Use Contact:

Data Sharing Agreement

Staff
Role

Email

Phone

Organization

Data
Owner

nfn8@cdc.
gov

4044981215

PROGRAM SERVICES

Program
Official

afp4@cdc.
gov

7704883808

LEAD POISONING PREVENTION AND
ENVIRONMENTAL HEALTH TRACKING BRANCH

Data Use
Contact

prw8@cdc.
gov

4044982797

PROGRAM DEVELOPMENT, COMMUNICATIONS
AND EVALUATION

Public Access Justification:

de-identified data can be shared

How Access Will Be Provided for Data:

aggregate data will be publicly available on CDC CLPPP website and additional data may be shared upon request for approved
purposes via data use agreement

Plans for Archival and Long Term Preservation:

Spatiality

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

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