Defense Advanced Research Projects Agency (DARPA), Contracts Management Office (CMO), 3701 N. Fairfax Dr., Arlington, VA 22203-1714

A -- ADVANCED DIAGNOSTICS FOR PATHOGENS SOL BAA98-24 DUE 081298 POC Stephen Morse- Technical; Tom Baranoski- Contractual; FAX (843) 974-5445 BROAD AGENCY ANNOUNCEMENT (DARPA BAA 98-24): ADVANCED DIAGNOSTICS FOR PATHOGENS. POC for technical matters is Stephen S. Morse, Ph.D., fax: (843) 974-5445; e-mail: BAA9824@ spawar.navy.mil. POC for contractual matters is Mr. Tom Baranoski at; fax: (843) 974-5445; e-mail: BAA9824@spawar.navy.mil. The Defense Advanced Research Projects Agency (DARPA) is soliciting proposals for the development and demonstration of innovative advanced diagnostics for pathogens, which will be a key component of DARPA's programs in Biological Warfare Defense. All aspects of the DARPA program are for defensive purposes only. This BAA pertains only to the Advanced Diagnostics portion of the overall DARPA program and excludes environmental detection, environmental modeling and simulation, decontamination and external protection, medical informatics, and therapeutics. Therapeutics and decontamination are included under a complementary DARPA BAA #98-25, Pathogen Countermeasures. PROGRAM OBJECTIVES AND DESCRIPTION: The most sinister offensive biological warfare scenario employs surprise, immediate proximity, and rapidly lethal, persistent agents in overwhelming quantities. Under these circumstances, real-time sensing, donning of physical protection, and conventional non-medical countermeasures are only marginally effective, and the first indication of an attack with a biological agent may be the appearance of sick military personnel. Immediate diagnosis, and the ability to identify those who have been exposed but have not yet developed signs or symptoms, will be essential for effective response. Disease caused by different biological agents will require different courses of action, but may often begin with the same vague initial symptoms, which may also be caused by a variety of natural infections. The capability to identify hitherto unknown natural infections and bio-engineered agents will also be essential. Time constraints require the ability to test appropriate samples with minimal or no preparation. Because military operations can occur in virtually any locale, diagnostics should be able to function under extreme environmental conditions. By contrast, current methods for pathogen identification often require specialized skills and reagents and may take hours or days to complete. This could lead to potentially disastrous delays in responding appropriately to the threat or to the possibility of inappropriate action based on inadequate information. The goal of the Advanced Diagnostics Program is to provide the capability to detect in real time, in the absence of recognizable signs and symptoms and when pathogen numbers are still low, the presence of infection by any significant pathogen in the body (or exposure to the pathogen), under any environmental conditions. The focus of this solicitation is the development of innovative, broad spectrum diagnostic measures for significantly pathogenic micro-organisms and/or their pathogenic products (including toxins). DARPA is not interested in diagnostics for single biological threats. The flexibility to rapidly incorporate new probes or tests, at minimal additional development cost, is also desirable. Issues of sample acquisition (including suitable sample type for assay) and preparation should be addressed. In general, it is most desirable to have little or no manual sample preparation. Specific areas of interest include, but are not limited to: (1) Multi-agent diagnostics capable of simultaneously identifying a broad range of pathogens and/or their products in clinical samples or in the body; (2) Strategies for identifying both known and presently unknown or bio-engineered pathogens (e.g., diagnostic approaches based upon fundamental, critical mechanisms of pathogenesis, targets shared by classes of pathogens, or early host responses to infection); (3) Detection and identification of biosignatures or biomarkers that could serve usefully to indicate exposure or infection and provide useful diagnostic or prognostic information, especially early in infection; (4) Capabilities for continuous monitoring or immediate recognition of infection in the body; and (5) Wearable diagnostics for noninvasive broad-spectrum detection of infection in the body. DARPA is planning to expand its efforts in the development of advanced medical diagnostic technology for immediate rapid detection of infection or exposure in fiscal years 1999 through 2001. Therefore, we are seeking proposals for 1-3 years of funding. Several parallel research and development projects are likely to be conducted. PRE-PROPOSAL: Proposers having the technical and management capabilities, facilities, and experience necessary to conduct all or portions of this program are invited to submit a brief pre-proposal describing their technical approach (including any preliminary data), major technical challenges, participants, principal research topics and milestones, and approximate funding level versus time. Teaming is strongly encouraged, as appropriate, but not a requirement for a successful selection. Submission of a pre-proposal before the proposal is strongly encouraged. DARPA will encourage the bidders with the most promising pre-proposals to submit complete Technical and Cost proposals for full evaluation. This initial screening is intended to save bidders the time and expense of developing a detailed proposal that has little chance for award. DARPA will not provide a de-brief of pre-proposals. FORMAT AND INFORMATION: Proposers should obtain the Proposer Information Pamphlet (PIP) BAA 98-24, Advanced Diagnostics for Pathogens. This document provides details of the pre- proposal format. Proposals not meeting this format may not be reviewed. Within ten business days, DARPA will acknowledge receipt of submission of the pre-proposal and assign a BAA control number that should be used in all further correspondence. CLOSING AND SUBMISSION: All pre-proposals are due no later than 4 PM ET 27 May 1998. Offerors should submit 1 original and 7 copies of the pre-proposal to: SPAWARSYSCEN Charleston, 1639 Ave. B North, North Charleston, SC 29405-1639, Attn.: BAA #98-24/Code 544. Early submission of pre-proposals is strongly encouraged. DARPA intends to respond to pre-proposals, within approximately thirty-five (35) calendar days of the pre-proposal closing date of 27 May 1998, with a recommendation to propose or not propose. Regardless of the recommendation, the decision to submit a proposal is the responsibility of the Proposer. All proposals submitted by the due date and time will be reviewed regardless of the disposition of the pre-proposal. PROPOSAL: The objective of a successful proposal is a feasibility demonstration of the technology proposed for development. Proposers must describe in detail the technical and scientific basis of the diagnostic methodology or instrument under development (Phase 1) and the details of the technology demonstration using clinically relevant sample types and/or suitable animal models (Phase 2). All programs must culminate in a significant end-point demonstration of solutions to crucial problems within the initial period of support.Excluded for the purposes of this solicitation are proposals for paper studies and/or evaluations. Such proposals will be judged to be non-responsive. FORMAT AND INFORMATION: Proposers should obtain the Proposer Information Pamphlet (PIP) BAA 98-24, Advanced Diagnostics for Pathogens. This document provides details of the proposal format. Proposals not meeting this format may not be reviewed. Within ten business days, DARPA will acknowledge receipt of submission of the proposal and assign a BAA control number that should be used in all further correspondence. CLOSING AND SUBMISSION: All proposals are due no later than 4 PM ET, 12 August 1998. Offerors should submit 1 original and 7 copies of the proposal to: SPAWARSYSCEN Charleston, 1639 Ave. B North, North Charleston, SC 29405-1639, Attn.: BAA #98-24/Code 544. Early submission of proposals is strongly encouraged. Selections for awards may be made at any time during the evaluation process. The PIP for BAA 98-24 may be obtained by accessing the World Wide Webat URL address -- http://www.darpa.mil/DSO/solicitations -- and downloading the information for storage and/or printing. Those individuals without access to the Internet or who are unable to obtain the pamphlet in this manner should submit a request in writing via fax or e-mail to fax: (843) 974-5445; e-mail: BAA9824@spawar.navy.mil. This CBD notice itself constitutes the Broad Agency Announcement as contemplated by Federal Acquisition Regulation (FAR) 6.102(d)(2). A formal Request For Proposal (RFP) or other solicitation regarding this announcement will not be issued. Requests for same will be disregarded. Evaluation and selection of proposal(s) for award will be made to those Offerors whose proposals are considered most advantageous to the Government. The Government reserves the right to fund selected tasks from proposals, and to select for award any, all or none of the proposals received in response to this announcement. Proposals identified for funding may result in a contract, grant, cooperative agreement, or "other transaction" agreement, depending on the nature of the work proposed, the required degree of interaction among parties, and other factors. All responsible sources capable of satisfying the Government's needs may submit pre-proposals and proposals. No portion of this BAA will be set aside for Historically Black College and University (HBCU) and Minority Institution (MI) participation because of the impracticality of reserving discrete or serverable areas of development for exclusive competition among these entities. These entities are encouraged to apply. EVALUATION CRITERIA: All pre-proposals and proposals will be opened and processed for administrative and logistic purposes by SPAWARSYSCEN Charleston, which is a Department of the Navy Government activity. Relevant SPAWARSYSCEN Charleston personnel and SPAWARSYSCEN Charleston contractor support personnel will have signed and will have on file with DARPA and SPAWARSYSCEN Charleston appropriate non-disclosure and conflict of interest certifications before handling either pre-proposals or proposals. Pre-Proposals and proposals will be evaluated by a peer review panel that may consist of both government and non-government experts. Proposers who object to having their submissions reviewed and evaluated by non-government personnel must so state in writing at the time of making their submissions. Both government and non-government personnel will have signed and will have on-file with DARPA appropriate non-disclosure and conflict of interest certifications before commencing any evaluation. Evaluation of the proposals and pre-proposals will be based on the following four criteria, in decreasing order of importance: (1) the scientific and technical merits of the proposed effort including the feasibility of the approach and the relevance of the proposed goals to the DARPA program objective; (2) the quality of the demonstration, synergy in effectively leveraging or significantly advancing the current state-of-the-art, and the adequacy of the technical tasks proposed to reach this demonstration within the timeframe of the program; (3) the qualifications of the principal investigator and other key research personnel, their record of past performance, and the adequacy of current and planned equipment and facilities to accomplish the research objectives; and (4) cost realism. Note: Cost realism will only be significant in proposals that have significantly under or over estimated the cost to complete their effort. The final decision for funding a proposal will be made by the cognizant DARPA program manager. When the proposal evaluation is completed, the Offeror will be notified of selectability or non-selectability. Selectable proposals will be considered for funding; non-selectable proposals will be destroyed. (One copy of non-selectable proposals may be retained for file purposes). Not all proposals deemed selectable may be funded. Decisions to fund selectable proposals will be based on funds available, scientific and technical merit, contribution to program goals, and overall program balance. Proposals receiving a letter of selection may be considered for funding for a period of up to one year. Awards made under this BAA are subject to the provisions of the FAR Subpart 9.5, Organizational Conflict of Interest. All Offerors and proposed subcontractors must state in writing, at the time of proposal submission, whether they are supporting any DARPA technical office(s) through an active contract or subcontract. All affirmations must state which office(s) the Offeror supports, and identify the prime contract number. All facts relevant to the existence or potential existence of organizational conflicts of interest, as that term is defined in FAR 9.501, must be disclosed. This disclosure shall include a description of the action the Proposer has taken, or proposes to take, to avoid, neutralize or mitigate such conflict. Questions regarding this BAA must be submitted in writing, via fax or e-mail. Please submit BAA questions to fax: (843) 974-5445; e-mail: BAA9824@spawar.navy.mil. (0114)

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