SOLICITATION NOTICE
A -- Atherosclerosis Risk in Communities (ARIC) Study – Coordinating Center (CC)
- Notice Date
- 7/23/2015
- Notice Type
- Presolicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-ECB-HV-2017-02-TK
- Archive Date
- 8/22/2015
- Point of Contact
- Amrana Ali, Phone: (301) 435-0338, Tara Knox, Phone: 301-402-0834
- E-Mail Address
-
Amrana.Ali@nih.gov, knoxt@nhbli.nih.gov
(Amrana.Ali@nih.gov, knoxt@nhbli.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Heart, Lung, and Blood Institute (NHLBI) is seeking a Coordinating Center (CC) for a five year renewal of the program entitled "The Atherosclerosis Risk in Communities (ARIC) Study". The purpose of this announcement is to provide a Pre-Solicitation Notice for the release of Solicitation NHLBI-ECB-HB-2017-02-TK. The intended procurement is classified under NAICS code 541712 with a Size Standard of 500 employees. THIS IS A SYNOPSIS. THIS IS NOT A SOLICITATION. Background and Program Objectives The National Heart, Lung, and Blood Institute (NHLBI) is planning a competitive renewal for the Atherosclerosis Risk in Communities (ARIC) Study. The ARIC Study is a study of the risk factors for and natural history of atherosclerosis and development of clinical atherosclerosis in a biracial population-based sample of men and women who were aged 45-64 years at inception of the study (https://www2.cscc.unc.edu/aric/ ). Fifteen thousand, seven hundred ninety-two (15,792) black and white participants were recruited from four (4) Field Centers during 1987-1989 (Forsyth County, NC; Jackson, MS; suburbs of Minneapolis, MN; and Washington County, MD). The goal of this acquisition is to maximize use of data and samples amassed in ARIC over 29 years to address new questions about the development and progression of clinical cardiovascular disease (CVD) and related conditions. The scientific objectives are to (1) enhance statistical power to perform analyses of predictors of clinical events, particularly in informative subgroups; (2) study the progression of subclinical to clinical cardiovascular disease (CVD); (3) identify new risk factors or interactions among factors that inform disease pathophysiology; and (4) evaluate the feasibility and validity of surveillance for myocardial infarction (MI) and heart failure (HF) using electronic health record (EHR) technology. The operational goals are to (1) support continued cohort follow-up and data collection on clinical events; (2) continue to foster scientific collaborations; (3) support conduct of a limited clinical examination of the ARIC participants as a platform for ancillary study examination components. This program will fund one (1) coordinating center (CC) to support up to four (4) field centers. A separate synopsis will be released to procure up to four (4) ARIC field centers, one (1) field center within one of the following four geographical areas of the ARIC study: Forsyth County, NC; Jackson, MS; suburbs of Minneapolis, MN; and Washington County, MD. Under this solicitation, the Government anticipates the award of one (1) Indefinite Delivery, Indefinite Quantity (IDIQ) contract with cost-reimbursement task orders for a period of approximately five years with an estimated award date of November 15, 2016. Project Requirements The important overall technical requirements associated with the Atherosclerosis Risk in Communities (ARIC) Study - Coordinating Center include the following: • Provide appropriate senior personnel with expertise in cardiovascular disease epidemiology, clinical cardiovascular disease, longitudinal studies management, biostatistics, bioinformatics, medical informatics, EHR systems, human genetics and genomics, administrative and biorepository management. • Develop and maintain a web-based data collection system for and provide other services as necessary to enable regular follow-up contacts of participants by field centers. The computer systems and software shall meet the requirements of Section 508 of the Rehabilitation Act. More information is available on the Web at: http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards • Develop and maintain a web-based data collection system for and provide other services as necessary to enable abstraction of data from medical records, death certificates, and other relevant materials; and conduct expert review and classification thereof. The computer systems and software shall meet the requirements of Section 508 of the Rehabilitation Act. More information is available on the Web at: http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards • Develop and maintain a public and private web site for the ARIC program. The public website designed under this contract shall meet the requirements of Section 508 of the Rehabilitation Act. More information is available on the Web at: http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards • Support a re-examination of ARIC participants, including developing and maintain a data collection system for Visit 6. • Design and implement appropriate quality assurance and quality control programs. • Perform administrative, operational, and technical duties to support productive collaboration among the study personnel at all ARIC centers, outside researchers collaborating with ARIC, and the NHLBI Project Office. • Establish and maintain study databases, including updating the databases with data from newly ascertained events and ancillary studies both for internal use and for posting on BioLINCC (https://biolincc.nhlbi.nih.gov) and other NIH databases, such as dbGaP (http://www.ncbi.nlm.nih.gov/gap), as appropriate. • Establish and manage a biological specimen repository. • Conduct a feasibility and calibration study of community surveillance for MI and HF using digitally transmitted data from Electronic Health Record (EHR) systems of the hospitals in the ARIC study catchment areas. The study will assess the feasibility of obtaining the EHR data from community hospitals and determine how to access the numeric and text digital data and will be followed by a calibration study comparing incidence estimates from data from the traditional ARIC data collection process for MI and HF and with estimates from data obtained via digital transmission of EHR for MI and HF. • Coordinate and participate collaboratively in study committees to provide a transparent committee process, open access to study documents, clear policies for access to data and materials, and an approval process for proposed manuscripts and ancillary studies that is fair and balanced. • Arrange for and manage annual meetings of an NHLBI-appointed Observational Studies Monitoring Board (OSMB) as directed by the NHLBI Project Office. • Conduct statistical analyses and prepare scientific publications and presentations. • Perform activities related to study closeout as directed by the NHLBI Project Office. • Work cooperatively with all study investigators and staff, the NHLBI Project Office, and any subcontractors and consultants in all relevant aspects of the study. • Prepare final limited access data sets. The data sets shall include data with full documentation, prepared in accordance with NHLBI policies available at: http://www.nhlbi.nih.gov/research/funding/human-subjects/set-preparation-guidelines.htm • Plan for a smooth and seamless transition of Coordinating Center's responsibilities from the existing Coordinating Center Contractor, if necessary, including the following: * obtain IRB approval with appropriate consideration for conditions that have been established and existing in the previous contract (including informed consent conditions agreed to by the participants, and existing IRB approved conditions at the original Field Centers); * transition of all data and biospecimens from the existing Contractor, including plans for confidentiality and security of all data as necessary; * transition of all existing protocols, documents, minutes, and reports from the current Contractor as necessary; and * transition of the internal and public use web sites. This is not a Request for Proposal (RFP) and the Government is not committed to award a contract pursuant to this announcement. This advertisement does not commit the Government to award a contract. The RFP will be available on the FedBizOpps Web page at http://www.fedbizopps.gov. Prospective offerors are responsible for downloading the RFP and all attachments. The offeror is responsible for monitoring the FedBizOpps Web page for the release of the solicitation and any amendments. The RFP will be available from the FedBizOpps on or about August 27, 2015.
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