NOISH ABLES STARS Determination

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