SOLICITATION NOTICE
A -- Atherosclerosis Risk in Communities (ARIC) Study - Lab Center
- Notice Date
- 10/27/2009
- Notice Type
- Presolicitation
- NAICS
- 541711
— Research and Development in 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-HC-11-07
- Point of Contact
- Kristiane E Cooper, Phone: 301-435-0345, Elizabeth Zoller, Phone: 301-435-0374
- E-Mail Address
-
cooperke@mail.nih.gov, zollere@mail.nih.gov
(cooperke@mail.nih.gov, zollere@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Heart, Lung, and Blood Institute (NHLBI), NIH intends to negotiate on a non-competitive, sole source basis with the Baylor College of Medicine, the Lab Center for the Atherosclerosis Risk in Communities (ARIC) study to award a follow-up study. The cited authority is 41 U.S.C. 252(c)(1), as set forth in FAR 6.302-1. This effort will be a six-year follow-up of the ARIC participants and continued community surveillance for cardiovascular disease. This contractor has been involved in the recruitment, follow-up, collection and analysis of data, and reporting of results on 15,792 participants selected from four communities in the United States. The incumbent contractor has the unique capability to provide these required services to NHLBI for the follow-up of the study. Inherent duplication of cost to the Government and unacceptable delays in completing the project make competition unfeasible for this study. The background and objectives of the study are detailed below. Background and Purpose of the ARIC study: ARIC is a prospective epidemiologic study conducted in four U.S. communities: Washington County, MD; Forsyth County, NC; Jackson, MS; and Minneapolis, MN. The study is designed to monitor the trends in incidence and mortality of coronary heart disease (CHD) and heart failure in communities, and to investigate the etiology and natural history of subclinical and clinical cardiovascular disease. Accordingly, ARIC includes a Community Surveillance Component and Cohort Study Component. In the community surveillance, the four communities are investigated to determine the community-wide occurrence of hospitalized myocardial infarction and CHD deaths in approximately 470,000 men and women aged 35-84 years. Starting in 2006, surveillance of inpatient (ages 55 years and older) and outpatient heart failure (ages 65 years and older) is included for the events beginning in 2005. In the cohort study, approximately 4,000 individuals aged 45-64 years were recruited by probability sampling from each of the four communities under surveillance. A total of 15,792 participants (11,478 whites, 4,266 African Americans, and 48 other) received an extensive baseline examination in 1987-1989. Three repeat examinations were conducted in 1990-92, 1993-95, and 1996-98, with a response rate of 93%, 86%, and 80%, respectively. The examinations collected information on demographics, psychosocial and behavioral factors, dietary intakes, physical measurements, and biological and genetic markers. Follow-up occurs yearly by telephone to maintain contact with participants and to assess health status of the cohort. Retention rate remains to be high (92%). There were approximately 13,000 participants alive as of December 2008. To capitalize and expand upon the resources of data, specimens, and infrastructure developed over 20 years in ARIC, this follow-up study aims to: 1) re-examine the ARIC cohort to characterize heart failure stages in the community and identify genetic and environmental factors leading to ventricular dysfunction and vascular stiffness; 2) enhance the ARIC study with cardiovascular outcomes research to assess quality and outcomes of medical care for heart failure and heart failure risk factors; 3) assess longitudinal changes in pulmonary function and identify determinants of pulmonary function decline; 4) continue cohort follow-up for outcomes measures such as CHD, atrial fibrillation, heart failure, and stroke; and for the study of factors related to progression of subclinical to clinical CVD; 5) continue community surveillance to monitor long-term trends in hospitalized MI, CHD deaths, and heart failure; and 6) provide a population laboratory platform for ancillary studies in cardiovascular and other areas. The study will serve as a valuable national resource for training young investigators. The Lab Center’s expected responsibilities that will continue during the follow-up phase include (but are not limited to): 1) work cooperatively with other ARIC investigators and the NHLBI Project Office, and participate in Steering Committee, Lab Committee, and other appropriate subcommittees to develop and implement coordinated plans to achieve study objectives; 2) develop and perform laboratory analyses of blood, urine, and DNA samples collected from the ARIC examinations 1-5 to test new hypotheses regarding biochemical and genetic markers and their associations with development and progression of atherosclerosis and other cardiovascular diseases; 3) propose and justify new measurements, and develop new assays based on the latest scientific and technical advances; 4) develop and maintain a quality assurance program for laboratory-based procedures to include but not be limited to a Manual of Operations for the field centers containing written standard operating procedures for laboratory collections, database development and maintenance, transmittal to the Coordinating Center, specimen tracking, and quality control procedures; 5) serve as a repository for all biological samples from the ARIC examinations 1-5; ensure confidentiality and security of the lab data files; transmit results of laboratory analyses and quality control assessments at all phases of the study to the Coordinating Center on a regular and timely basis; 6) participate in data analyses, make presentations at scientific meetings, and submit publications to peer-reviewed journals; and 7) prepare and submit technical and financial reports as specified herein. This notice of intent expires 15-days from its posting. This is not a request for proposals (RFP). The estimated award date is November 1, 2010. All responsible sources may submit written capability statements demonstrating their ability to perform this research effort on the same study participants. Any interested parties in this or potential subcontracting opportunities may contact either Kristiane Cooper, Contracting Officer, cooperke@nhlbi.nih.gov, 301-435-0345 or Elizabeth Zoller, Contract Specialist, zollere@mail.nih.gov, 301-435-0345.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-HC-11-07/listing.html)
- Place of Performance
- Address: Office of Acquisitions, 6701 Rockledge Drive, RKL2 / 6100, MSC 7902, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN01992854-W 20091029/091027234847-449938ac65ab4904517dfc3346dce82d (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |