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Pre-Solicitation NICHD-22-244

INTRODUCTION

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A

CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION.

The National Institutes of Health, National Institute of Child Health and Development (NICHD), in support of the National Institute on Minority Health and Health Disparities (NIMHD) intends to award a firm-fixed price purchase order to include option year(s) without providing for full and open competition to EMORY UNIVERSITY for Scientific and Technical Consulting Services to support a Longitudinal and Cross-Sectional Cohort Data Analyses Study.

BACKGROUND

The Lab in the Population and Community Health Sciences Branch at the National Institute on Minority Health and Health Disparities (NIMHD) focuses on the socio-spatial determinants of cardiovascular disease (CVD) risk factors contributing to disparities in racial and ethnicity, income, geography for cardiovascular outcomes. One area of particular focus is using geospatial methods, including geographic information systems (GIS), to objectively quantify exposures to neighborhood social contexts that promote adverse cardiovascular-related outcomes and risk factors among multi-ethnic, population-based cohorts. Our laboratory projects utilize data from such objectively measured population-based cohorts to elucidate the mechanism by which certain neighborhood social factors impact CVD events and risk factors. A consulting epidemiologist with specific expertise in complex analyses, a thorough understanding of pathomechanisms of complex diseases, and health outcomes research using geospatial measures, and utilizing large, population-based datasets with complex sampling methods has been required to conduct statistical analyses for the Lab projects. These analyses specifically involve but are not limited to the cohorts from the Jackson Heart Study (JHS), the Multi-Ethnic Study of Atherosclerosis (MESA), the UK Biobank, the NIH American Association of Retired Persons (AARP) Diet and Health Study, and the NEXT Generation Health Study and Next Plus, a population-based longitudinal cohort data among adolescents. Expertise with these specific population-based datasets and with complex statistical analyses using neighborhood measures is not available within the Population and Community Health Sciences Branch at the NIMHD.

JUSTIFICATION

Understanding the impact of neighborhood measures on cardiovascular disease (CVD) risk and CVD-related outcomes (such as physical activity, sedentary behaviors, diabetes, and sleep) is extremely understudied in the minority populations in the United States. To further elucidate the mechanism by which specific adverse neighborhood social environments influence CVD risk factors and outcomes, we need to apply complex statistical techniques to examine such longitudinal associations using well-established large cohort datasets. Based on market research and our knowledge, EMORY UNIVERSITY has been identified as the only source capable of providing a candidate which is a formally trained epidemiologist with expertise in clinical medicine and expertise related to study design, methodology, and complex data analysis of largescale epidemiological projects. They have led numerous large-scale surveillance studies, including those

PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS

with linkage across multiple health data systems, with a primary focus on studying the association of modifiable risk factors with the incidence of diabetes and its associated complications. Their research focuses on health outcomes research, clinical/translational research, biomarker discovery, and health disparities. Their research is guided by an overarching interest in describing and understanding pathophysiology, identifying biomarkers, the possible mediating pathway of protein-based biomarkers by which adverse neighborhood and housing conditions are linked with the risk of adverse health outcomes geospatial measures, and utilizing large, population-based datasets with conducting statistical analysis using complex sampling methods. Their unique skillsets in three disparate research areas (i.e., complex epidemiological analysis, pathophysiology, and neighborhood environment) make them an ideal candidate to meet all of our requirements. They have also published over 50 articles in high-impact factor journals and have published 4 high-impact articles with the NIH investigators. They have studied the association of various adipokines and inflammatory biomarkers with chronic diseases by leveraging various databases. These unique skillsets and background ideally position EMORY UNIVERSITY’s candidate to offer the needed services and expertise critical to our research in deciphering the mediating role of novel biomarkers with sub-clinical and clinical vascular diseases and significantly contribute to the goals of the lab at the NIMHD, NIH. To our knowledge, no other source is capable of providing a candidate to perform these highly specialized services at the level of performance required.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 541690 with business size standard of $16.5m.

REGULATORY AUTHORITY

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Regulation (FAR) Federal Acquisition Circular (FAC) 2022-06 effective 5/26/2022. This acquisition is conducted under the procedures as prescribed in FAR Part 13 - Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($250,000), FAR Part 12 - Acquisition of Commercial Items, and FAR Subpart 17.2 - Options.

STATUTORY AUTHORITY

This acquisition is conducted under the authority of FAR 13.106(b)(1) Soliciting from a single source - For purchases not exceeding the simplified acquisition threshold.

PLACE OF DELIVERY

NIH/NIMHD

3 Center Dr.

Bethesda, MD, 20892

DESCRIPTION OF REQUIREMENT

We have a requirement for a base year and option year(s) for Scientific and Technical Consulting Services to support a Longitudinal and Cross-Sectional Cohort Data Analyses Study:

• Conduct complex statistical analyses for the JHS to better understand how neighborhood social factors impact CVD events and risk factors, including physical activity, sedentary behaviors, depressive symptoms, sleep health, and diabetes among African American adults living in Jackson, Mississippi.

• Conduct the statistical analyses to investigate the longitudinal and cross-sectional analyses on the associations between adverse neighborhood social environments and CVD-related outcomes. Perform statistical analyses for the MESA cohort to further clarify the mechanism by which environmental and socio-economic factors impact lifestyle-related behaviors and chronic diseases.

• Use sophisticated statistical techniques to examine the longitudinal and cross-sectional mediation analyses on the associations between exposures to environmental and social factors and chronic disease outcomes.

• Conduct statistical analyses for the UK Biobank, a biological and epidemiologic study of longitudinal data designed to investigate the role of genetic ancestry on the associations between adverse neighborhood measures and CVD events among UK adults.

• Examine the incidence and prevalence of CVD outcomes among the UK Biobank cohort. This work is being done in collaboration with a principal investigator at the NIMHD.

• Perform statistical analyses for the NEXT cohorts to examine longitudinal associations between changes in neighborhood-built environment factors and changes in CVD risk factors among adolescents and apply statistical methods to examine the longitudinal and cross-sectional analyses using R software.

• Perform cross-sectional and longitudinal analyses of population-based large cohort data with R software.

• Perform cross-sectional and longitudinal mediation modeling of CVD risk factors in relation to neighborhood environment factors and psychosocial factors with R software.

• Finalize complex statistical analyses using physical environmental measures as mediators of the relationships between neighborhood deprivation and CVD risk in the cohort studies.

• Write and edit manuscripts and statistical analysis plan for the articles and present the findings.

• Conduct weekly phone meetings to discuss analysis results from projects and the next steps for analyses.

• Provide reproducible statistical results (in R notebooks) for publication in peer-reviewed journals.

Expertise Critical to the Success of the Project

• Minimum of 10 years of related work experience (Required)

• Doctoral degree in Epidemiology or related fields (Required)

• Experience working with NIH Investigators (Preferred)

• Working knowledge of complex analyses (Required)

• Thorough understanding of pathomechanisms of complex diseases

• Experience in health outcomes research using geospatial measures

• Experience in utilizing large, population-based datasets with complex sampling methods

• Familiarity with the Jackson Heart Study (JHS), the Multi-Ethnic Study of Atherosclerosis

(MESA), and the UK Biobank among other large prospective cohor studies. (Preferred)

CLOSING STATEMENT

This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability in response to this notice and may submit a capability statement, which shall be considered by the agency. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement that includes management, technical data and cost information in sufficient detail and with convincing evidence that clearly demonstrates the capability to perform the required work. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.

All respondents must have an active registration in the System for Award Management (SAM) www.sam.gov. All responses to this notice shall be submitted electronically by 6:00 PM Eastern Standard Time, on 8/18/2022, to jacob.balenson@nih.gov and shall include Pre-Solicitation NICHD-22-244 in the subject line.

http://www.sam.gov/ mailto:jacob.balenson@nih.gov

INTRODUCTION
JUSTIFICATION
Understanding the impact of neighborhood measures on cardiovascular disease (CVD) risk and CVD-related outcomes (such as physical activity, sedentary behaviors, diabetes, and sleep) is extremely understudied in the minority populations in the United S...
with linkage across multiple health data systems, with a primary focus on studying the association of modifiable risk factors with the incidence of diabetes and its associated complications. Their research focuses on health outcomes research, clinical...
NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE
REGULATORY AUTHORITY
STATUTORY AUTHORITY
PLACE OF DELIVERY
DESCRIPTION OF REQUIREMENT
Conduct statistical analyses for the UK Biobank, a biological and epidemiologic study of longitudinal data designed to investigate the role of genetic ancestry on the associations between adverse neighborhood measures and CVD events among UK adults.
Examine the incidence and prevalence of CVD outcomes among the UK Biobank cohort. This work is being done in collaboration with a principal investigator at the NIMHD.
Perform statistical analyses for the NEXT cohorts to examine longitudinal associations between changes in neighborhood-built environment factors and changes in CVD risk factors among adolescents and apply statistical methods to examine the longitudi...
Perform cross-sectional and longitudinal analyses of population-based large cohort data with R software.
Perform cross-sectional and longitudinal mediation modeling of CVD risk factors in relation to neighborhood environment factors and psychosocial factors with R software.
Finalize complex statistical analyses using physical environmental measures as mediators of the relationships between neighborhood deprivation and CVD risk in the cohort studies.
Write and edit manuscripts and statistical analysis plan for the articles and present the findings.
Conduct weekly phone meetings to discuss analysis results from projects and the next steps for analyses.
Provide reproducible statistical results (in R notebooks) for publication in peer-reviewed journals.
Expertise Critical to the Success of the Project
Minimum of 10 years of related work experience (Required)
Doctoral degree in Epidemiology or related fields (Required)
Experience working with NIH Investigators (Preferred)
Working knowledge of complex analyses (Required)
Thorough understanding of pathomechanisms of complex diseases
Experience in health outcomes research using geospatial measures
Experience in utilizing large, population-based datasets with complex sampling methods
Familiarity with the Jackson Heart Study (JHS), the Multi-Ethnic Study of Atherosclerosis (MESA), and the UK Biobank among other large prospective cohor studies. (Preferred)

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