A -- BASIC AND APPLIED MEDICAL RESEARCH IN CASUALTY CARE AND MANAGEMENT

Notice Date

February 20, 2001

Contracting Office

Office of Naval Research, 800 North Quincy St., Arlington, VA 22217-5660

ZIP Code

22217-5660

Solicitation Number

01-009

Response Due

March 30, 2001

Point of Contact

Dr. J Majde-Cottrell, (703) 696-4055, E-mail majde@onr.navy.mil

Description

(1) General Statement of Research Need The Office of Naval Research (ONR) is soliciting preproposals and proposals directed at basic and applied medical research focusing on combat casualty care, particularly the treatment of major blood loss, combined blood loss and head trauma, and traumatic shock. Of specific interest are approaches to acute pain control; methods for inducing metabolic down-regulation; methods for hemostasis and simultaneous antibiosis of large wounds; oxygen-carrying materials that substitute for red cells and are stable to storage under ambient temperature conditions; and portable systems for manufacturing injectable water in the field. Especially meritorious submissions pertaining to hemorrhagic shock mechanisms and therapeutics; and non-invasive diagnostics suitable for use in the field may be considered. The goals of the ONR Casualty Care and Management program are presented in more detail on the Internet at http://www.onr.navy.mil/sci_tech/personnel/ and below. The following aspects of acute trauma care are of particular interest: (1) products that control pain without cognitive and motor impairment; (2) novel approaches to metabolic down-regulation that facilitate casualty transport; and (3) treatments for physiological sequelae of induced whole-body hypothermia or torpor. With respect to hemostasis and oxygen delivery, products with the following capabilities are sought: (4) hemostatic agents or devices that are affordable and capable of achieving hemostasis and antibiosis of large extremity and soft tissue wounds; (5) lyophilized red cells that can be stored long-term with minimal refrigeration; (6) red cell substitutes free of vasoactivity and immunosuppressant activity that function without exogenous oxygen support. With respect to hemorrhagic shock, the following areas may be expanded: (7) mechanisms of the shock response to trauma, especially neural, neuroendocrine, endocrine or immune mediators stimulated by hemorrhagic shock; (8) novel therapeutic interventions for shock; (9) design, testing, evaluation and side-by-side comparison of both FDA-approved volume replacement fluids and fluids with other therapeutic benefit in hemorrhage; (10) drug substitutes for large volume fluids that maintain cardiovascular function or additives for conventional resuscitation fluids that reduce volume requirements; and (11) improved delivery of fluids to hypotensive casualties. With respect to non-invasive diagnostics, (12) lightweight, portable technologies for enhanced diagnosis of injuries in the combat casualty by minimally trained personnel are desired. In addition to the above areas, any novel approaches that may save lives on the battlefield or maintain functionality of the casualty will be considered, especially those that identify risk, protract or mitigate adverse sequelae, or enable mission completion without medical consequence. Techniques and technologies suitable for use by first responders or limited license practitioners are a priority. Decision support system integration into diagnostic and therapeutic technologies is important. Technical POC: Dr. J. Majde-Cottrell, 703-696-4055, E-mail: majdej@onr.navy.mil. It is not the intent of this solicitation to establish new facilities; investigators should be able to demonstrate the required research capability and the necessary facilities. Preproposals whose main objectives are to conduct analyses, literature reviews, or program evaluations are not encouraged. (2) Instructions for Preparation of Preproposals and Proposals Offerors are invited to submit five (5) copies of a preproposal formatted as described on the Internet at http://www.onr.navy.mil/sci_tech/personnel/. The preproposal (technical only) should not exceed three pages of text. In addition, an estimate of overall costs (including indirect) for a three year effort and a curriculum vitae of the principal investigator(s) (PI) should be appended together with the three-page technical preproposal along with any supporting information, such as reprints or preprints, that will assist in the evaluation of the preproposal. Offerors submitting the most promising preproposals will be invited to submit a full technical and cost proposal on all or part of their preproposal submission. However, any such invitation does not assure a subsequent award. Any offeror may submit a full proposal even if its preproposal was not identified as promising or if no preproposal is submitted; however any full proposal submission would be made without the benefit of feedback prior to full proposal submission. The initial deadline for preproposals will be 16:00 EST (4:00 PM), 30 March 2001 for the next funding cycle that begins 1 October 2001. Formal proposals prepared in accordance with the Research Proposal Format Instructions at the above Web site will be required by 16:00 EST (4:00 PM), 01 June 2001. When animals are to be employed, a completed DoD Animal Use Protocol with supporting documentation (copies of AAALAC approval, IACUC approval, research literature database searches, and the two most recent USDA inspection reports) must be submitted with the Proposal. Similarly, any proposal that involves the experimental use of human subjects must include approval by the organization's committee for protection of human subjects (Institutional Review Board, IRB), and documentation of a Multiple Project Assurance that covers the proposed human subjects study or a DoD Single Project Assurance for that work. Please see section "N" of the Research Proposal Format Instructions for further details and forms. Offerors must state in their preproposals and full proposals that the submission is in response to this BAA. Preproposals received after 16:00 EST (4:00 PM), 30 March 2001, or proposals received after 16:00 EST (4:00 PM), 01 June 2001, may still be considered for the next funding cycle if funds are available. This BAA provides no funding for preproposals or subsequent proposal development purposes. All preproposals will be acknowledged. Preproposals will not be returned after evaluation. (3) Criteria for Selecting Proposals, their Relative Importance, and the Method of Evaluation Preproposal and full proposal submissions will be evaluated on the 1) overall basis of innovation and scientific merit; 2) programmatic relevance of the proposal; 3) the qualifications and experience of the proposed principal investigator and key personnel; 4) the offeror's capabilities, related experience, facilities, techniques or unique combinations of these that are integral factors for achieving the proposal objectives; 5) socio-economic merits of the proposal and 5) realism of the proposed cost and availability of funds. Awards may take the form of a contract, cooperative agreement, grant, or other agreement. For awards made as contracts, the socio-economic merits of each proposal will be evaluated based on the extent of commitment in providing meaningful subcontracting opportunities for small business, HUB zone small business, small disadvantaged business, woman-owned small business concerns, veteran-owned small businesses and historically black colleges and universities and minority institutions (HBCU/MI). The North American Industry Classification System (NAICS) code is 54171 with the small business size standard of 500 employees. In addition, contract proposals that exceed $500,000 submitted by all but small businesses must be accompanied by a Small Business Subcontracting Plan in accordance with FAR 52.219-9. HBCU/MI's, as determined by the Secretary of Education to meet requirements of 34 CFR Section 608.2 and 10 U.S.C. Paragraph 2323(a)(1)(C), are particularly encouraged to participate, though no portion of this BAA has been set aside. Preproposals and proposals should be submitted by the due dates cited in the BAA to Ms. Catherine Bagaglio at the Office of Naval Research 341, Room 823, 800 N. Quincy St., Arlington, VA 22217-5660. Ms. Bagaglio's phone number, 703-696-0369, should be used for express mail purposes. Questions regarding contractual matters relating to this BAA should be directed to: Office of Naval Research, Attention Bona Tilahun (Code 252), Room 720, 800 N. Quincy St., Arlington, VA 22217-5660, (703) 696-2591, or by e-mail to tilahub@onr.navy.mil.

Record

Loren Data Corp. 20010222/ASOL005.HTM (W-051 SN50E0F3)