SOLICITATION NOTICE
A -- NHLBI Vascular Innovations/Interventions and Therapeutic Advances (VITA)
- Notice Date
- 6/18/2015
- 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-CSB-HV-2017-01-JS
- Archive Date
- 10/20/2015
- Point of Contact
- Jennifer Swift, Phone: 3014350358, Kelli Malkin,
- E-Mail Address
-
Jennifer.Swift@nih.gov, Kelli.Malkin@nih.gov
(Jennifer.Swift@nih.gov, Kelli.Malkin@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Pre-Solicitation Notice NHLBI Vascular Innovations/Interventions and Therapeutic Advances (VITA) Stage-A & Stage-B, Round 2 The National Heart, Lung, and Blood Institute (NHLBI) is seeking contractors for the Vascular Innovations/Interventions and Therapeutic Advances (VITA) program. The purpose of this announcement is to provide a Presolicitation Notice for the release of Solicitation NHLBI-CSB-HV-2017-01-JS. THIS IS A SYNOPSIS. THIS IS NOT A SOLICITATION. The overall objective of the VITA Program is to enable and accelerate the development of promising diagnostic and therapeutic modalities for certain diseases within the purview of the National Heart, Lung, and Blood Institute (NHLBI). In that context the NHLBI has identified two "opportunity gaps" in the early stages of the development process by which new medical research is translated into new medical products. The first gap occurs between the conceptualization of potential medical advances and the experimental validation of those concepts as medical product candidates (designated as the "Concept to Proof-of-Principle" stage or Stage-A). The second gap resides between the demonstration of proof of principle and the completion of studies required for the assessment of a product candidate in human clinical trials (designated as the "Proof-of-Principle to IND/IDE" stage or Stage-B). The VITA Program has been conceptualized as a policy tool to provide resources to help resolve these early stage product development opportunity gaps. These resources include direct funding, regulatory advice, product management training, and construction of a "product development environment" (direct meetings, website, and webinars) that will cultivate specific product development projects in the near term and broader collaborative networks in the long term. The term "product candidate" as it concerns the VITA Program, is used to refer to new diagnostics, new therapeutic interventions (agents or devices), or novel applications of existing therapeutic interventions. The product candidate(s) under study and development can include, but are not limited to: small molecules, small peptides, proteins or antibodies, devices, diagnostic tests, imaging probes, genetic markers, and cell or gene agents. The VITA Program will provide support for early-stage translational development of product candidates in the fields of vascular disorders, thrombotic diseases, and pulmonary hypertension. Proposed project areas of interest may include peripheral arterial disease, aortic aneurysms and dissections, pulmonary vascular disorders, venous and arterial thrombosis, thromboembolic disorders, and disorders of the lymphatic system. Not included as specific topics in this program are diseases of the coronary and intracranial arteries. The VITA program intends to utilize a Broad Agency Announcement (BAA) to solicit proposals for each of the two product development stages. There are two planned rounds of solicitations for this BAA. The first was in FY-2014 and second will be in FY-2017. A Program Coordinating Center (PCC) contract was acquired via a Request for Proposal (RFP). The PCC contract was awarded for six years beginning in FY-2014. The PCC has provided support to the contracts awarded under this FY-2014 Round-1 (Stages-A and B) acquisition and will provide services to the planned Round-2 (Stages-A and B) to be acquired in FY-2017. It is anticipated that multiple awards will be made under both stages for a total period of performance of three (3) years. A BAA is not eligible for any small business set-aside program. This is not the Broad Agency Announcement (BAA) 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 BAA will be available on the FedBizOpps Web page at http://www.fedbizopps.gov. Prospective offerors are responsible for downloading the BAA and all attachments. The offeror is responsible for monitoring the FedBizOpps Web page for the release of the solicitation and any amendments. The BAA will be available from the FedBizOpps on or about July 7, 2015.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-CSB-HV-2017-01-JS/listing.html)
- Record
- SN03769682-W 20150620/150618235729-e6d6d361ea4cc94722e359cd45449b9d (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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