SOURCES SOUGHT
A -- Vascular Intervention/Innovations and Therapeutics Advances Program (VITA) Stage-1 (Concept to Proof of Principles) & Stage-2 (Proof of Principle to IND or IDE)
- Notice Date
- 3/29/2012
- Notice Type
- Sources Sought
- 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-2013-02-PDM
- Archive Date
- 4/28/2012
- Point of Contact
- Cornelius Moore, Phone: (301) 435-6674, Paul D McFarlane, Phone: 301-435-0350
- E-Mail Address
-
mooreco@mail.nih.gov, pmcfarlane@mail.nih.gov
(mooreco@mail.nih.gov, pmcfarlane@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- BACKGROUND 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). 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). 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. ACQUISITION PLAN This acquisition will employ a Broad Agency Announcement (BAA) solicitation to seek proposals for two (2) different study stages e.g. concept to proof of principle (POP) and proof of principle to investigational new drug (IND) or Investigational Device Exemption (IDE). This BAA will be repeated in a second round in FY-2016. Although, the same number of awards and funding are planned in the second round, the NHLBI reserves the right to revisit this issue based on the results of the first BAA round. Up to six (6) contracts (with, up to 3-year duration each) are planned for the Stage-1 awards and up to three (3) contracts (with, up to 3-year duration each) are planned for the Stage-2 awards. A total of $10.8M is available for these two (2) BAA rounds (i.e. $5.4M in FY-2013 and $5.4M in FY-2016). A BAA is not eligible for any small business set-aside program. Companion to this BAA solicitation, is a request for proposals (RFP) solicitation for a Program Coordinating Center (PCC) to award a single contract to provide project management, meeting coordination, and regulatory advice for the awarded BAA contractors that require such services. The RFP solicitation for the VITA PCC is being synopsized in a separate Sources Sought Notice. Interested Offerors should look for it elsewhere in the FEDBIZOPPS. The BAA and the RFP solicitations are planned for issuance in late May 2012, with proposals due in late August 2012. Awards are planned for September 2013. Further details regarding the VITA program may be found at: http://www.nhlbi.nih.gov/funding/inits/faq-NHLBIVITA.htm EVALUATION PLAN Awards for the BAA solicitation will be made based on weighted evaluation factors of technical merit, programmatic balance, and funds availability. Individual award amounts are expected to vary depending on the scope and capacity of the technical objectives and statements of work proposed by the Offerors.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-CSB-HV-2013-02-PDM/listing.html)
- Place of Performance
- Address: Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland 20892-7902, United States
- Zip Code: 20892-7902
- Zip Code: 20892-7902
- Record
- SN02708878-W 20120331/120329235158-1e3b2a3c8459a7e040f023ad9090e630 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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