SOLICITATION NOTICE
A -- Vascular Interventions/Innovations and Therapeutic Advances (VITA) Stage-A (Concept to Proof of Principle) & Stage B (Proof of Principle to IND or IDE)
- Notice Date
- 5/15/2012
- 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
- BAA-NHLBI-CSB-HV-2013-02-JS
- Archive Date
- 6/13/2012
- Point of Contact
- Jennifer Swift, Phone: 3014350358, Cornelius Moore, Phone: (301) 435-0343
- E-Mail Address
-
swiftje@mail.nih.gov, mooreco@nhlbi.nih.gov
(swiftje@mail.nih.gov, mooreco@nhlbi.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Heart, Lung, and Blood Institute anticipates issuance of a Broad Agency Announcement BAA-NHLBI-CSB-HV-2013-02-JS on or about May 29, 2012 to acquire the services of a program coordinating center (PCC) for the Vascular Interventions/Innovations and Therapeutic Advances (VITA) Program. 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 term "product candidate", as it concerns the VITA Program, is also 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. This solicitation will seek proposals for two (2) different study stages e.g. concept to proof of principle (POP) [Stage-A] and proof of principle to investigational new drug (IND) or Investigational Device Exemption (IDE) [Stage-B]. Up to six (6) contracts (with up to 3-year duration each) are planned for the Stage-A awards and up to three (3) contracts (with up to 3-year duration each) are planned for the Stage-B awards. A total of $5.8M is available for this BAA round. 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 synopsized in a separate pre-solicitation notice (RFP-NHLBI-CSB-HV-2013-04-JS). Interested Offerors are highly encouraged to locate and review it elsewhere in the FEDBIZOPPS and to review the resulting solicitation. Contract proposals for the BAA and the RFP solicitations will be due in late August 2012. Awards are planned for August 2013. This announcement is not a request for proposals (RFP) and the Government is not committed to award a contract pursuant to this announcement. The solicited requirement will cover 36 months and Cost-Reimbursement-Completion type contracts with options pricing are being considered. The ultimate contract type and funding mechanism will be determined by the NHLBI, based on what best fits the project's goals and the available funding. The BAA solicitation will be available on the FEDBIZOPPS website at http://fedbizopps.gov. Potential Offerors are responsible for downloading the BAA and any/all attachments. It is also Offerors' responsibility to monitor the FEDBIZOPPS for any amendments to the BAA. This acquisition has been designated as full and open competition under the North American Industry Classification System (NAICS) code 541712.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/BAA-NHLBI-CSB-HV-2013-02-JS/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
- SN02749166-W 20120517/120516000844-65232b5dc8cbdf265a863dc37662d3f8 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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