NOISH ABLES STARS Determination

Att8b NIOSH ABLES STARS Determination.docx

Blood Lead Surveillance System (BLSS) - NIOSH

NOISH ABLES STARS Determination

OMB: 0920-0931

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Project Determination


Adult Blood Lead Epidemiology and Surveillance & Research Program



Project ID:

0900f3eb81bd3176

Accession #:

NIOSH-HIB-9/2/20-d3176

Project Contact:

Fields_Latasha (npq7)

Organization:

OS/OS/OSI

Status:

Pending Regulatory Clearance

Intended Use:

Project Determination

Estimated Start Date:

10/01/91

Estimated Completion Date:

09/30/22

CDC/ATSDR HRPO/IRB Protocol#:


OMB Control#:

0920-0931





Description

Priority

Standard

Determination Start Date

09/10/20

Description

The Adult Blood Lead Epidemiology and Surveillance (ABLES) program is an ongoing state-based lead exposure surveillance system for identifying and preventing elevated blood lead levels in U.S. adults. The ABLES program provides the public health community with essential information for setting priorities for research and intervention. The purpose of the ABLES program, which is identical to the HP2020 objective, is to collaborate with states and other federal agencies to reduce lead exposures in adults.

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 Adult Blood Lead Epidemiology and Surveillance (ABLES) program goals are to advance the usefulness of surveillance data for researchers and interested stakeholders in labor and industry, improve lead exposure prevention capacities and assist in implementing measures aimed at reducing adult lead exposures.

Objective

The purpose of the ABLES program, which is identical to the HP2020 objective, is to collaborate with states and other federal agencies to reduce lead exposures in adults.

Activities or Tasks

New Collection of Information, Data, or Biospecimens

Target Population to be Included/Represented

General US Population

Tags/Keywords

blood lead levels: lead exposure: Industry: Occupations: Surveillance

CDC's Role

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 is provider of private data/specimens TO an institution: CDC is provider of technical assistance or staff time in the absence of CDC support

Method Categories

Observation: Public Health Assessment: QA/QI: Surveillance Support: Technical Assistance

Methods

The ABLES program is an ongoing surveillance system that collects blood lead level data from states on an annual basis. States have reporting laws requiring laboratories and providers to submit blood lead results to health departments. States then share data with ABLES for monitoring occupational blood lead data and for identifying interventions to reduce or prevent occupational lead exposures. Major ABLES-related activities include: (1) increasing the public’s awareness of adult lead exposures through publications, reports, presentations at national conferences, and the ABLES listserv; (2) sharing lead exposure data with the U.S. Occupational Safety and Health Administration; (3) posting ABLES data on a publicly accessible website, such as Worker Health Charts (WHC) or the ABLES website as a resource for external researchers, (4) providing technical assistance to build state capacity to initiate or improve adult blood lead surveillance programs, and (5) collaborating with National Center for Environmental Health’s Childhood Blood Lead Surveillance program to integrate adult and childhood lead surveillance systems into Healthy Homes Lead Poisoning Surveillance System (HHLPSS).

Collection of Info, Data, or Bio specimens

States participating in the ABLES programs collects blood lead data from local health departments, private health care providers and, public and private laboratories. If necessary, states will follow-ups with physicians, workers and employers to ensure completeness and accuracy of work-related information. Once a year, participating states transmit adult blood lead data to ABLES in electronic format (e.g., Excel spreadsheet, CSV format, Access database) through encrypted FTP sites.

Expected Use of Findings/Results and their impact

Findings and outputs from the ABLES program are disseminated through peer-reviewed and trade journals, the ABLES website, Worker Health Charts, State-based Occupational Health Surveillance Clearinghouse, social media , LISTSERVs (e.g., ABLES, NIOSH e-News, Occupational and Environmental), partner organizations, and presentations (e.g., CSTE annual meeting, national conferences) and educational/informational materials.

Could Individuals potentially be identified based on Information Collected?

No

Will PII be captured (including coded data)?

No

Does CDC have access to the Identifiers (including coded data)?

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 #

Original Fiscal Year

# of Years of Award

CDC Funding Intramural

Adult Blood Lead Epidemiology and Surveillance & Research Program

927ZULU





HSC Review



Regulation and Policy

Do you anticipate this project will be submitted to the IRB office:

No



Institutions






Institution

FWA #

FWA Exp. Date

IRB Title

IRB Exp. Date

Funding #

Center for Construction Research and Training (CPWR)






Occupational Safety and Health Administration (OSHA)






Council of State and Territorial Epidemiologists (CSTE)








Staff









Staff Member

SIQT Exp. Date

Citi Biomedical Exp. Date

Citi Social and Behavioral Exp. Date

Citi Good Clinical Exp. Date

Staff Role

Email

Phone #

Organization/

Institution

David Wall

12/18/2022




Co-Investigator

[email protected]

513-841-4331

HEALTH INFORMATICS BRANCH

John Lu

08/17/2023


11/07/2021


Co-Investigator

[email protected]

513-841-5

HEALTH INFORMATICS BRANCH

Rebecca Tsai

12/14/2021


12/16/2022


Project Officer

[email protected]

513-841-4398

HEALTH INFORMATICS BRANCH

Scott Henn

03/04/2022

11/06/2021



Co-Investigator

[email protected]

513-841-4173

HEALTH INFORMATICS BRANCH



DMP


Proposed Data Collection Start Date

10/01/91

Proposed Data Collection End Date

09/30/22

Proposed Public Access Level

Restricted

Data Use Type

Memorandum of Understanding

Data Use Type Data Use Type URL

Aggregated data are available via the NIOSH Workers Health Charts and the ABLES website. https://wwwn.cdc.gov/NIOSH-WHC/

Data Use Contact

External investigators can request aggregated data by contacting [email protected]

Public Access justification

Restricted: Since the project data contain indirect identifiers, project data can only be released in aggregate format that preserve the privacy of participants. Some data providers (State Department of Health) may require a written agreement restricting third party data release before releasing data to us. Hence, any request for data will be re-directed to the data provider.

How Access Will Be Provided for Data

Only aggregate data will be shared publicly. Any requests for non-aggregated data will be redirected to primary data providers.

Plans for archival and long-term preservation of the data

The data collection does not qualify as a System of Records and is not covered under the Privacy Act. Please see HIB’s Privacy Impact Assessment of the system for more detail. Data are stored on CDC facilities, using CDC data network within CDC’s firewalls. The CDC network is located in a limited access server room in a building secured with guards, id badges, key cards and closed circuit TV. Access to project data is granted to badged staff assigned to the project and on a need to know basis. User access is removed upon transfer or termination. The ABLES program follows CDC’s record schedule for epidemiological studies, NIOSH Epidemiological Studies, 2-79b, Non-Mortality and Morbidity Studies, where data will be transfer to the Federal Records Center 3 years after study is initially closed and destroy 20 years after study closes.



Spatiality (Geographic Location)



Country

State/Province

County/Region

United States







Determinations

Determination

Justification

Completed

Entered By & Role

HSC:
Does NOT Require HRPO Review

Not Research - Public Health Surveillance

45 CFR 46.102(l)(2)

09/25/20

Luckhaupt_Sara E. (pks8) Division HSC

PRA:
PRA Applies


09/28/20

Sawyer Deloney_Tamela (tqs7) OMB / PRA

ICRO:
Returned with No Decision


09/28/20

Zirger_Jeffrey (wtj5) ICRO Reviewer



File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorLuckhaupt, Sara E. (CDC/NIOSH/DFSE)
File Modified0000-00-00
File Created2021-03-15

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