PEDIATRIC CIRCULATORY SUPPORT RELEASE DATE: November 19, 2002 NOTICE: NOT-HL-03-004 National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov) RFP/BAA: NHLBI-HV-04-01 Letter of Intent Receipt Date: March 21, 2003 Proposal Receipt Date: May 21, 2003 RESEARCH OBJECTIVES The Division of Heart and Vascular Diseases (DHVD), National Heart, Lung, and Blood Institute (NHLBI) intends to release a Broad Agency Announcement (BAA) entitled "Pediatric Circulatory Support" for basic and applied research to develop novel circulatory assist devices or other bioengineered systems for infants and children with congenital and acquired cardiovascular disease who experience cardiopulmonary failure and circulatory collapse. This announcement is released under NAICS code 541710, for research and development contracts. The applicable size standard is 500 employees. The primary objective of the BAA is to develop novel circulatory assist devices including left and right ventricular assist devices, extracorporeal gas exchange systems, and other bioengineered systems for infants and children with congenital and acquired cardiovascular disease. Offerors are encouraged to propose basic physiological and bioengineering studies necessary for the design and evaluation of novel pediatric assist devices. This may include pre-clinical and clinical studies that explore innovative strategies to meet the circulatory needs of the pediatric patient population. Each offeror is expected to focus on overcoming the physiological and bioengineering hurdles that currently impede development of extracorporeal and implantable assist devices for infants and small children. Systems must be, for example, appropriately sized, but capable of providing adequate cardiac output for the infant or child, while avoiding complications associated with the patient's small size, such as vascular injury or thrombosis. It is not anticipated that every offeror will propose a program that includes clinical testing within the five contract years, although each proposal should include the design and evaluation of devices with a clear potential for future clinical application. The contractors will need to have considerable medical/scientific expertise in order to carry out the work to achieve the highly sophisticated research and technical objectives of this program, using biomedical staff including materials science and bioengineering, pediatric cardiologists and surgeons, and facilities involved in cardiovascular surgical treatment of infants and children. This is not a solicitation for contract proposals. The solicitation will be posted on the NHLBI Home Page, which can be accessed through the NIH Website (http://www.nih.gov). At the NIH Home Page select "Grants and Funding Opportunities," then select "Research Contracts"; from the listing select "National Heart, Lung, and Blood Institute (NHLBI)." Offerors with Internet access may go directly to http://www.nhlbi.nih.gov/funding/inits/index.htm#rfp and search by BAA number or title. ELIGIBILITY REQUIREMENTS Awards under this solicitation will be made to offerors located in the continental United States, Alaska and Hawaii. Foreign awards may be considered. MECHANISM OF SUPPORT The NHLBI anticipates awarding approximately four to eight (4-8) contracts based on technical merit, available funds, and programmatic balance. The total project period for the BAA will not exceed five years. The anticipated award date is February 15, 2004. This will be a best value acquisition based primarily on technical merit.
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