NCEH CBLS STARS Determination

Print Date: 9/29/20

Title:

Blood Lead Surveillance System (BLSS) -- OMB No. 0920-0931

Project Id:

0900f3eb81bcf99b

Accession #:

NCEH-LPPEHTB-8/31/20-cf99b

Project Contact:

Courtney_Joseph (hzc2)

Organization:

NCEH/ATSDR/DEHSP/LPPEHTB

Status:

Pending Regulatory Clearance

Intended Use:

Project Determination

Estimated Start Date:

08/31/2020

Estimated Completion Date:

09/30/2020

CDC/ATSDR HRPO/IRB Protocol #:
0920-0931

OMB Control #:

Determinations
Determination

Justification

HSC:
Does NOT Require HRPO
Review

Not Research - Public Health Surveillance

PRA:
PRA Applies

Completed

Entered By & Role

9/29/20

Lawler_Tameka (giq3) CIO HSC

9/29/20

Lawler_Tameka (giq3) CIO OMB / PRA

45 CFR 46.102(l)(2)

Description & Funding
Description
Priority:

Standard

Date Needed:

09/30/2020

Determination Start Date:

09/02/20

Description:

This CDC information collection request (ICR) includes two data collection systems that provide a coordinated, comprehensive, and
systematic public health approach to the surveillance and monitoring of blood lead levels (BLLs) for children and occupationally
exposed adults in the U.S. We are requesting an extension for the current OMB approval which expires on May 31, 2021 (# 09200931).

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

We are requesting an extension for the current OMB approval for BLSS which expires on May 31, 2021.

Objective:

The overarching goal of this information collection is to continue the blood lead surveillance collection for children and
occupationally-exposed adults in the U.S.

Activities or Tasks:

Secondary Data or Specimen Analysis

Target Populations to be Included/Represented:

Children, Other

Tags/Keywords:

Lead Poisoning, Nervous System, Childhood, Lead Poisoning, Nervous System, Adult, Public Health Surveillance

CDC's Role:

CDC employees or agents will obtain or use anonymous or unlinked data or biological specimens, CDC employees will provide
substantial technical assistance or oversight, CDC is providing funding

Method Categories:

Surveillance Support

Methods:

State and local health departments submit standardized Childhood Blood Lead Surveillance (CBLS) data on a quarterly basis via
the CDC#s Secure Access Management System#s (SAMS) Secure Data eXchange#s (SDX) integrated Managed File Transfer
(MFT) Platform. CDC staff import and store the CBLS data on a secure CDC network drive for processing, analysis, and generation
of reports. State health and labor departments submit Adult Blood Lead Epidemiology and Surveillance (ABLES) data on an annual
basis through secure encrypted FTP sites. ABLES data are stored on secure CDC network drives for processing, analysis, and
generation of reports.
CDC does not collect these data directly, they are submitted by the states and local programs as described in the Methods above.
CBLS collects all laboratory and clinician-reported blood lead levels (BLLs) test results on individual children reported to
participating state or local CLPPPs. The de-identified, individual-level case management and follow-up data are forwarded to CDC,

Collection of Info, Data or Biospecimen:

Expected Use of Findings/Results:

imported into CBLS, and a consistent #case# definition is then applied. The Adult Blood Lead Epidemiology and Surveillance
(ABLES) program, a part of CDC#s NIOSH, compiles state surveillance data for adults 16 years of age or greater, most of whom
are occupationally exposed.
Data generated and analyzed from these two programs provide critical information to monitor trends in BLLs over time. This
information is used for program implementation, policy development, and to target population-based interventions to children at high
risk for lead exposure and adults who may be exposed to lead in the workplace.

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?

No

Is an assurance of confidentiality in place or
planned?

No

Is a certificate of confidentiality in place or planned? No
Is there a formal written agreement prohibiting the
release of identifiers?

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

Regulation and Policy

Original
Budget Yr

# Years
Award

CDC-RFA-EH181806 SUPP20

2018

1

CDC-RFA-EH171701SUPP20

2017

1

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

Benjamin

03/18

CITI
Biomedical
Exp. Date

CITI Social &
Behavioral Exp.
Date

CITI Good Clinical
Practice Exp. Date

Staff
Role

Email

Phone

Technical

yhp5@cdc.

770488-

Organization

OFFICE OF FINANCIAL INFORMATION SYSTEMS

Bina

/2023

Monitor

gov

2093

David Wall

12/18
/2022

Technical
Monitor

dkw0@cdc.
gov

5138414331

HEALTH INFORMATICS BRANCH

John Lu

08/17
/2023

Technical
Monitor

czl5@cdc.
gov

513841-5

HEALTH INFORMATICS BRANCH

Joseph
Courtney

08/31
/2023

Program
Lead

hzc2@cdc.
gov

4044983282

LEAD POISONING PREVENTION AND
ENVIRONMENTAL HEALTH TRACKING BRANCH

KATHRYN
EGAN

03/25
/2022

Technical
Monitor

nky9@cdc.
gov

4047185778

EPIDIMIOLOGY AND SURVEILLANCE

Marie
Haring
Sweeney

11/22
/2022

Program
Lead

mhs2@cdc.
gov

5138414102

HEALTH INFORMATICS BRANCH

Monica
Leonard

08/31
/2023

Program
Lead

zgf7@cdc.
gov

4044981826

DIVISION OF ENVIRONMENTAL HEALTH
SCIENCE AND PRACTICE

Qaiyim
Harris

06/09
/2023

Technical
Monitor

qah3@cdc.
gov

7704887115

EPIDIMIOLOGY AND SURVEILLANCE

Rebecca
Tsai

12/14
/2021

Technical
Monitor

vht5@cdc.
gov

5138414398

HEALTH INFORMATICS BRANCH

Scott Henn

03/04
/2022

Technical
Monitor

ajn4@cdc.
gov

5138414173

HEALTH INFORMATICS BRANCH

Stella Chuke

08/31
/2023

Technical
Monitor

slc7@cdc.
gov

7704883475

EPIDIMIOLOGY AND SURVEILLANCE

Data
DMP

11/07/2021

11/30/2021

12/16/2022

11/06/2021

Proposed Data Collection Start Date:

6/1/21

Proposed Data Collection End Date:

5/31/24

Proposed Public Access Level:

Public

Public Access Justification:

This is a publicly funded program to help state and local programs collect important data. Sharing the aggregate data with the public
is an important part of the process.

How Access Will Be Provided for Data:

Both the CBLS and ABLES data will be disseminated on program websites and in MMWR Surveillance Reports. Because CBLS
datasets include some required variables with potentially personally identifiable information (PII) (e.g., age, race, sex, county of
address) which may present privacy concerns due to small numbers for some of the variables, small cell sizes (counts <5) will be
redacted from all datasets or summary tables that are disseminated in any way.

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