SOLICITATION NOTICE
A -- Validate II: Vascular Aging-The Link that Bridges Age to Atherosclerosis
- Notice Date
- 11/18/2011
- 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 Institute on Mental Health, Contracts Management Branch, 6001 Executive Blvd, Rm 8154, MSC 9661, Bethesda, Maryland, 20892-9661
- ZIP Code
- 20892-9661
- Solicitation Number
- NIH-AG-2011-157
- Point of Contact
- Sara Mclaurin, Phone: 301-443-2696
- E-Mail Address
-
mclaurinsm@mail.nih.gov
(mclaurinsm@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Institutes of Health (NIH), National Institute on Aging (NIA) intends to negotiate, under authority of FAR 6.302-1(a) (2) and in accordance with 41 U.S.C. 253(c)(1) as set forth in FAR 15, on a noncompetitive, sole source basis with Johns Hopkins University for a project entitled "Validate II: Vascular Aging: The Link that Bridges Age to Atherosclerosis." This notice of intent is not a request for competitive proposals. However, responsible sources may express their interest by submitting a capability statement or proposal. All capability statement/proposals received within fifteen days after date of publication of this synopsis will be considered by the government. 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. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. This effort will be for a two (2) year period of performance. In spite of unprecedented advances in the diagnosis and management of atherosclerotic cardiovascular disease, it remains the leading cause of morbidity and mortality in the United States. This disease disproportionately affects older individuals and its incidence, prevalence, and severity all markedly increase with age. The VALIDATE study is a seminal research initiative designed by the NIA to address the critical questions of why and how aging is associated with an increased prevalence of atherosclerotic disease. The study was begun seven years ago and has successfully studied 498 participants. The purpose of this contract is to complete the remaining "second visits" for 294 participants. These participants were first seen in VALIDATE I in order to examine the longitudinal changes in vascular properties and body composition by enhanced vascular EBCT and MRI in Baltimore Longitudinal Study on Aging (BLSA) participants. Johns Hopkins University (JHU) is uniquely qualified to perform this work due to its unique access to this cohort of subjects. Since JHU began this study seven (7) years ago, successfully studying 498 participants, they have established relationships with the participants who are part of the BLSA study, of which the average age of whom is 71. In addition to having an established relationship with JHU, these elderly participants are familiar with the procedures required under the study and with JHU's study location. A second, final visit is necessary in order to complete the study for the remaining 294 participants; however, there is a potential risk of study participants discontinuing participation in the study if a different contractor is used. Any attempt to secure services from other than JHU could significantly reduce the response rates for interviews and required scans, and thus jeopardize the scientific aims and productivity of the research. Therefore, it is not feasible or cost effective to have another contractor go through the process of establishing new working relationships in order to complete the research. Also of concern is that any contractor completing this study must have the identical CT scanning equipment, Toshiba Aquilion One, 320 slice scanner, that was used for the participants' initial visits, so that longitudinal changes can be directly assessed without the need to perform a comparability evaluation. The incumbent contractor has this equipment and has used it for the first scans. In addition, by using the same set of clinical readers, inter-reader variability can be removed as a source of potential error when evaluating the study results. If another contractor were to complete the study, a significant increase in the period of performance would be required, along with additional costs, for another contractor to enroll new participants in order to maintain the cohort size, to accomplish both the initial scans for new participants, and the second scans required. A new contractor would be unable to meet the same efficiency levels that Johns Hopkins University has established at this stage of completion of the study. Finally, as the incumbent contractor, Johns Hopkins has the required experience performing EBCT and safety practices associated with radioactive studies. Levels of expertise in these clinical and administrative areas must be commensurate with that of the readers for the first portion of the study so that the two are comparable. JHU meets these criteria. Under the requirements of 41 U.S.C. 253[c](1) and FAR 6.302-1, JHU is the only source capable of meeting the requirements of this project. The requirements of VALIDATE II are as follows: The contractor shall perform high resolution, non-contract CT images of the heart, coronary arteries, and proximal great vessels and provide Agatston calcium volume scores, and use the data obtained to construct a chronologic age/calcium score relationship and physiologic vascular age/calcium score relationship. Facilitate comparison of the participant data obtained in the "first visit" under the predecessor contract (VALIDATE), with data obtained during the "second visit" under this requirement (VALIDATE II) in order to determine the rate of progression of coronary artery calcification. Support analysis of contrast-enhanced magnetic resonance imaging of the common and internal carotid arteries conducted in the predecessor contract and integration of this data into measures of body composition. Measure serologic markers and determine genetic polymorphisms in the study cohort that may influence the physiologic vascular measurements and the development of atherosclerosis. This proposed acquisition was previously publicized under sources sought notices HHS-NIH-NIDA(AG)-RDSS-11-157 and HHS-NIH-NIDA(AG)-SBSS-11-157. The estimated contract award date will be on or about March 1, 2012.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIMH/NIH-AG-2011-157/listing.html)
- Place of Performance
- Address: Contracting Office Address:, Contracts Management Branch, 6001 Executive Blvd., Room 8154, MSC 9661, Bethesda, MD 20852, Bethesda, Maryland, 20852, United States
- Zip Code: 20852
- Zip Code: 20852
- Record
- SN02626147-W 20111120/111118234537-e0dca4ef094bbaf87e10b75320ac7e80 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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