SOLICITATION NOTICE
A -- PREventing Violent Explosive Neurologic Trauma (PREVENT)
- Notice Date
- 3/3/2006
- Notice Type
- Solicitation Notice
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Other Defense Agencies, Defense Advanced Research Projects Agency, Contracts Management Office, 3701 North Fairfax Drive, Arlington, VA, 22203-1714
- ZIP Code
- 22203-1714
- Solicitation Number
- BAA06-24
- Response Due
- 4/26/2006
- Archive Date
- 4/27/2006
- Description
- PREventing Violent Explosive Neurologic Trauma (PREVENT) SOL BAA 06-24, DUE: April 26, 2006, TECHNICAL POC: Dr. Geoffrey Ling, DARPA/DSO, Ph: (571) 218-4974, Email: baa06-24@darpa.mil; URL: www.darpa.mil/dso. Website Submission: http://www.sainc.com/dso0624/ DESCRIPTION The Defense Sciences Office is interested in new proposals for PREventing Violent Explosive Neurologic Trauma (PREVENT). This will be a highly aggressive program aimed at protecting our warfighters from traumatic brain injury (TBI) resulting from explosions, such as those from an improvised explosive device (IED). The first phase will be a six month period with the goal of identifying the mechanisms, physical and biological, which cause the injury. The second phase will include development of medical treatments and protective countermeasures that directly address the cause of injury as well as further refinement of the models predicting the injury. BACKGROUND The focus of this program is on traumatic brain injuries that result from non-kinetic explosive effects resulting in non-penetrating brain injuries. Although previous efforts to understand such injuries have focused on a single explanation, blast overpressure, it appears that IED- induced injuries in Iraq cannot be completely explained by blast overpressure alone. Thus, proposals must fully consider all physical forces associated with blast exposure that could potential explain the observed pattern of neurologic injuries. Factors which must be considered include, but are not limited to, the following: blast overpressure, electromagnetic pulse (EMP), thermal shock, chemical components, and shockwave. Additionally, proposers must consider the mechanisms of action across multiple biological scales, and the range of injuries incurred from those interactions (for example, apoptosis, cell lysis, edema, gliosis, impaired neurogenesis, and perturbation of biochemical and physical function through disruption of neural signaling and vascular perfusion, etc). Phase I of this program will comprehensively evaluate the physics of interaction between an IED blast and the neurological system and determine which component(s) are causally associated with neurologic injury. Phase I will also establish the general neurological injury mechanisms resulting from blast exposure. It is expected that the development of test systems and predictive models will be required to characterize the modalities, methods and results of interaction subsequent to blast exposure in order to optimize treatment paradigms, explosive blast mitigation, and protective strategies in Phase II. The phase I milestones shall be the description of physical, biological and molecular mechanisms that result in observed neurological injury. Phase II of this program shall focus on prevention of injury and guide the development of passive and active mitigation strategies, the engineering and development of personal protective armor, and therapeutic interventions for those injured. Programs should generate a nominal model in Phase I with the following characteristics: 1. Addresses mechanisms of explosive blast injury at the molecular as well as the macroscopic scales including, but not limited to cellular, tissue level, organ level, and organ system level. 2. Characterizes the injury over the pathophysiological evolution ranging from primary injury resulting directly from the insult, to the consequent secondary pathophysiological cascade, extending beyond biogenic responses into psychogenic outcomes. 3. Isolates the spectrum of physical mechanisms in explosion environments and determine their coupled or potentially uncoupled effects on the central nervous system (CNS) by utilizing appropriate model studies. 4. Verified against data observed from in vivo specimens. Models should be able to replicate: Histology  apoptosis following initial injury  axonal damage and degradation  microscopic necrosis  indications of microvascular disruption or abnormality Epidemiology  grading the severity of injury at various ranges and levels of exposure Cognitive impairment  appetite  ability to perform cognitive tasks Functional impairment  sleep  gait and movement patterns In addition, models should be able to explain injuries sustained through repeated exposure to indirect forces created by explosion and cognitive deficits that occur even when subjects are directly shielded from the outputs of explosions but still exposed to potentially reflected energies (e.g., behind walls or around corners). Finally, it is critical that models are correlated with clinical observations of injury in military personnel returning from theater. Proposals that do not specifically address the pattern of injuries observed in the warfighter population will not be considered. PROPOSAL PROCESS Programs should be submitted as twenty four month efforts encompassing both Phase I (6 mos.) and an optional phase II (18 mos.). At the end of phase I, there will be a downselect. In order to be considered for phase II, performers must have demonstrated replication of injury specific to the model guidelines provided above. Proposals must include an outline of a both phase I and phase II budgets that includes resources, labor, and material to complete this task. Successful proposals must have an identified systems integrator (SI). The SI will lead a multi-disciplinary team of performers who can meet the milestones, including both the ability to characterize the explosive environment, characterize the injury resulting from exposure to one or more of the components of the explosive environment, develop predictive models and create mitigation and treatment strategies. As such, successful team composition should include, but is not limited to, specialists from the medical and physical sciences as well as the mathematical and engineering sciences. In addition, team members with the capability to innovate, design, and fabricate sophisticated instrumentation, sensors, and material systems may also enable programmatic success. Evaluation of proposals will be accomplished through a technical review of each proposal using the following criteria: 1. SCIENTIFIC AND TECHNICAL MERIT The objective of this criterion is to assess the extent to which the proposer has an innovative, high payoff, and comprehensive technical approach based on sound scientific principles. Proposals will be evaluated as follows: The effort will add to understanding of neuro-trauma resulting from physical forces occurring in an explosion with potential for advances to the prevention and treatment of traumatic brain injury. It will include an exploration and assessment of the current state of the art. The approach matches program objectives. Means of mitigating, preventing, or treating TBI based on the results expected in phase I will be identified and explanation for reduction in injury through these means provided. 2. VALUE TO DEFENSE The objective of this criterion is to assess the extent to which the proposer has a credible and feasible scientific solution that best meets or exceeds the operational vision and provides a path of application of the technology to DoD. They must demonstrate a clear knowledge of desired military capabilities and indicate the manner in which the technology will transition. Proposals will be evaluated as follows: Research has the potential for mitigating, preventing, and assisting in the recovery of the warfighter from blast related traumatic brain injury. Models will be relevant to clinical observations of traumatic brain injury as observed in warfighters returning from theater. 3. CAPABILITY OF THE PERSONNEL AND FACILITIES TO PERFORM THE PROPOSED EFFORT The objective of this criterion is to assess the extent to which the proposer?s team has the requisite experience, skills and resources necessary to perform the proposed program. This includes an assessment of the team?s management construct, key personnel, facilities and past performance in conducting similar efforts of the proposed scope. Proposals will be evaluated as follows: Interdisciplinary composition including biology, engineering, medicine, physics, and mathematics capable of completing proposed work. Systems integrator that is present and responsible for ensuring that the team meets all milestones and metrics and integration of all proposed research. Facilities should be detailed with discussion of any unique capabilities pertinent to the research. 4. COST REALISM The objective of this criterion is to assure that proposed cost is consistent with proposed effort. The proposed cost will be evaluated as follows: Proposals will be evaluated as follows: Costs are justified in relation to the scope of the proposed program. Other funding sources and activities are taken into account. A budget for an optional second phase is provided and includes justification of all costs. TEAMING AND INFORMATION SESSION Teaming is encouraged, especially where interdisciplinary approaches to a problem are required. A teaming and information session will be held on March 26, 2006 at the Westin Arlington Gateway. This day will provide an opportunity for those interested in proposing to seek clarification on the proposal and partnerships critical to programmatic success. A full announcement detailing meeting specifics can be found at http://www.darpa.mil/baa/sn06-20.htm. In addition, for those unable to attend the session, notes, posters, and presentations will be made available at http://www.preventblast.com upon completion of the meeting. This will also serve as a teaming website for all interested parties. Registration is required in order to view information presented at the Teaming and Information Session website. PROPOSAL SUBMISSION AND DEADLINES Proposals may be submitted and received at any time until the final proposal deadline of April 28, 2006, at 4:00 PM, ET. Proposals will be evaluated against the criteria set forth in this solicitation, and a proposer will be notified either that: (1) the proposal has been selected for funding, or (2) the proposal has not been selected for funding. Proposers may elect to have their proposal withdrawn from consideration at any time during the evaluation process. If a formal request is not made, DARPA will assume that continued evaluation is desired. One copy only of proposals that are not selected for funding will be retained for administrative purposes. The Government reserves the right to select for award all, some, or none of the proposals received in response to this announcement, including those that do not strictly adhere to the division of technical and cost sections. The Government also reserves the right to fund proposals in phases with options for continued work at the end of one or more of the phases. Proposals identified for funding may result in a procurement contract, grant, cooperative agreement, or "Other Transaction," depending upon the nature of the work proposed, the required degree of interaction between parties, and other factors. The proposer must submit a separate list of all technical data or computer software that will be furnished to the Government with other than unlimited rights (see DFARS Part 227). FORMAT AND CONTENT OF FULL PROPOSAL The descriptions contained in this section are to help proposers ensure that proposals have sufficiently detailed information to be evaluated. Proposals not conforming to the instructions of this section may not, at the discretion of the Government, be evaluated. Full proposals shall consist of two volumes, technical and cost. A website http://www.sainc.com/dso0624 has been established to facilitate the submission of full proposals electronically. This site will allow proposers to fill in contact information and upload a full proposal created with the requirements listed below in either Word or PDF format. Note: if the website is not used, please use the U.S. mail system or the BAA e-mail account BAA06-24@darpa.mil. If submitting via e-mail, the body of the e-mail and the attachment must include name, mailing address, phone number, and fax number of the proposer. If this information is not contained in the body, the e-mail will be returned for inclusion of that information. If proposers choose to submit by U.S. mail, they should submit one (1) original and three (3) copies of the full proposal to the address shown below. Proposals will not be accepted by way of facsimile transmissions. Both volumes should be included as a single document when uploading to the website. Volume 1: Technical The technical volume is limited to a maximum of 30 pages including all figures, references, tables, charts, cover sheet, and appendices and consists of the following sections: a) Executive Summary (two pages or less); b) Technical section that clearly describes the innovation of the work to be accomplished, specific metrics for the effort, the risks to achieving those metrics and approaches for mitigation of those risks. All milestones should be clearly delineated, especially phase I milestones (6 mos.) critical to demonstration of the concept or approach. Supporting rationale for performance enhancements should be included. The perceived need for this research and the potential impact on the DoD should be described, and a Statement of Work (SOW) that summarizes critical tasks to be accomplished should be presented; c) Time-phased schedule-milestone chart; d) Summary of relevant prior work; e) Brief description of applicable facilities and equipment; f) Short resumes of key individuals. The level of effort and specific roles and qualifications of key individuals should be included. If the team is large (greater than 3 separate entities), a management plan for coordination of the effort should also be included; and g) Current and pending support (award title, amount, period of performance, and degree of overlap with this proposal). Proposers are cautioned not to submit supporting material (articles, CDs, etc.) as these will not be used in evaluation of the proposal. Volume 2: Cost The cost volume shall contain the following: a) Cover sheet to include: (1) BAA number; (2) Technical area; (3) Lead organization submitting proposal; (4) Type of business (Lead organization), selected among the following categories: LARGE BUSINESS, SMALL BUSINESS, SMALL DISADVANTAGED BUSINESS, 8A, OTHER SMALL BUSINESS, EMERGING SMALL BUSINESS, VETERAN-OWNED SMALL BUSINESS, SERVICE-DISABLED VETERAN OWNED, OTHER VETERAN, WOMAN-OWNED BUSINESS, HUBZONE, JWOD PARTICIPATING NONPROFIT AGENCY, OTHER NONPROFIT, HOSPITAL, FOREIGN CONCERN OR ENTITY, DOMESTIC FIRM PERFORMING OUTSIDE U.S., HISTORICALLY BLACK COLLEGE OR UNIVERSITY (HBCU), MINORITY INSTITUTION (MI), OTHER EDUCATIONAL; (5) Contractors reference number (if any); (6) Other team members (if applicable) and type of business for each; (7) Proposal title; (8) Technical point of contact to include: salutation, last name, first name, street address, city, state, zip code, telephone, fax (if available), electronic mail (if available); (9) Administrative point of contact to include: salutation, last name, first name, street address, city, state, zip code, telephone, fax (if available), and electronic mail (if available); (10) Award instrument requested: cost-plus-fixed-fee (CPFF); cost-contract--no fee; cost sharing contract--no fee; or other type of procurement contract (specify), grant, cooperative agreement, or other transaction; (11) Place(s) and period(s) of performance; (12) Total proposed cost separated by basic award and option(s) (if any); (13) Name, address, and telephone number of the proposers cognizant Defense Contract Management Agency (DCMA) administration office or Office of Naval Research; (14) Name, address, and telephone number of the proposers cognizant Defense Contract Audit Agency (DCAA) audit office; (15) Date proposal was prepared; (16) DUNS, TIN, CAGE CODE; and (17) All subcontractors proposal backup documentation to include items 1-16 above, as applicable and available. b) Detailed cost breakdown to include: (1) total program cost broken down by major cost items (direct labor, subcontracts, materials, travel, other direct costs, overhead charges, etc.), and (2) an itemization of major subcontracts (labor, travel, materials and other direct costs) and equipment purchases. Where the effort consists of multiple portions that could reasonably be partitioned for purposes of funding, these should be identified as options with separate cost estimates for each. c) Supporting cost and pricing information in sufficient detail to substantiate the summary cost estimates in b) above. Include a description of the method used to estimate costs and supporting documentation. Note: cost or pricing data as defined in the Federal Acquisition Regulation (FAR) Subpart 2.101 shall be required if the proposers proposal is for a procurement contract award of $550,000 or greater unless the proposer requests an exception from the requirement to submit cost or pricing data. Cost or pricing data is not required if the proposer proposes an award instrument other than a procurement contract (e.g., a grant, cooperative agreement, or other transaction). The requirements for submission of cost or pricing data are specified in FAR Subpart 15.403-4 (see http://www.arnet.gov/far). OTHER RELEVANT INFORMATION FOR PROPOSAL SUBMISSION TEAM COMPOSITION Proposals may include, or be led by, foreign firms and/or personnel provided all export control laws and U.S. national security requirements are adhered to in the conduct of the effort and that the work relating to the foreign firm or personnel is unclassified. The onus of understanding and complying with export control rests with the proposer, not the Government. Small Disadvantaged Businesses, Historically Black Colleges and Universities (HBCUs), and Minority Institutions (MIs) are encouraged to submit proposals and join others in submitting proposals. However, no portion of this BAA will be set aside for Small Disadvantaged Businesses, HBCU, and MI participation due to the impracticality of reserving discrete or severable areas of this research for exclusive competition among these entities. Awards made under this BAA are subject to the provisions of the FAR Subpart 9.5, Organizational Conflicts of Interest. Consequently, all proposers and proposed subcontractors must, therefore, affirm whether they are providing scientific, engineering and technical assistance (SETA) or similar support to any DARPA technical office(s) through an active contract or subcontract. All affirmations must state which office(s) the proposer supports and identify the prime contract numbers. Affirmations should be furnished at the time of proposal submission. All facts relevant to the existence or potential existence of organizational conflicts of interest, as that term is defined at FAR 9.501, must be disclosed. The disclosure shall include a description of the action the proposer has taken or proposes to take to avoid, neutralize, or mitigate such conflict. TECHNOLOGY TRANSITION Proposals that have currently identifiable commercial or military end-product are strongly encouraged to engage commercial and military end-users and commercial manufacturers. The engagement of these communities also helps ensure that the various technologies being developed will be commercially viable (cost effective, manufacturability, etc.) and available to the military. Thus, proposals are strongly encouraged to include/involve the user-community that intends to bring the technology to practice as a result of this research. This relationship encourages the participation of researchers, end-users and manufacturers as collective contributors to the technology definition, implementation, and performance evaluation. PROPRIETARY INFORMATION All proprietary information should be marked on the full proposal. It is the policy of DARPA to treat all proposals as competitive information and to disclose their contents only for the purpose of evaluation. Standard proprietary disclaimers notwithstanding, proposals may be reviewed by non-Government technical experts who have signed a nondisclosure agreement with DARPA, unless the specific phrase TO BE REVIEWED BY GOVERNMENT EMPLOYEES ONLY appears on the cover sheet. In any case, personnel under exclusive contract with DARPA who have completed the appropriate nondisclosure agreements will handle the proposals for administrative purposes. GUIDANCE FOR CLASSIFIED INFORMATION AND DATA The Government anticipates that proposals submitted under a BAA will be unclassified. In the event that a proposer chooses to submit a classified proposal, the following information is applicable. Proposals may contain classified information or data (up to the level of Top Secret/SCI). HOWEVER, DO NOT SEND CLASSIFIED FULL PROPOSALS BY EMAIL OR VIA ONLINE SUBMISSION SYSTEMS. Proposers that intend to include classified information or data in their proposals should contact DARPA security at (571) 218-4842 (or alternatively, the point-of-contact for this BAA) for guidance and direction in advance of proposal preparation. Proposers must have existing approved capabilities (personnel and facilities) to perform research and development at the classification level they propose. Security Classification guidance on DD Form 254 will not be provided at this time since DARPA is soliciting ideas only. After reviewing the incoming proposals, if a determination is made that the award instrument may result in access to classified information, a DD Form 254 will be issued and attached as part of the award. Proposers choosing to submit a classified proposal must first receive permission from the Original Classification Authority to use their information in applying to this BAA. An applicable classification guide should be submitted to ensure that the proposal is protected appropriately. For instructions on submitting Classified Full Proposals, contact Security & Intelligence Directorate (SID) Classification Management at (571) 218-4842. RESEARCH INVOLVING HUMAN USE Proposals selected for funding are required to comply with provisions of the Common Rule (32 CFR 219) on the protection of human subjects in research (http://www.dtic.mil/biosys/downloads/32cfr219.pdf) and the DoD Directive 3216.2 (http://www.dtic.mil/whs/directives/corres/html2/d32162x.htm). All proposals that involve the use of human subjects are required to include documentation of their ability to follow federal guidelines for the protection of human subjects. This includes, but is not limited to, protocol approval mechanisms, approved Institutional Review Boards (IRB), and Federal Wide Assurances. These requirements are based on expected human use issues sometime during the entire length of the proposed effort. For proposals involving greater than minimal risk to human subjects within the first year of the project, performers must provide evidence of protocol submission to a federally approved IRB at the time of final proposal submission to DARPA. For proposals that are forecasted to involve greater than minimal risk after the first year, a discussion on how and when the proposer will comply with submission to a federally approved IRB needs to be provided in the submission. More information on applicable federal regulations can be found at the Department of Health and Human Services Office of Human Research Protections website (http://www.dhhs.gov/ohrp/).
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