SOLICITATION NOTICE
A -- Radiation Biodosimetry (RaBid)
- Notice Date
- 4/10/2007
- 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, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- BAA07-29
- Response Due
- 7/9/2007
- Archive Date
- 4/10/2008
- Description
- Radiation Biodosimetry (RaBiD) SOL BAA 07-29 WHITE PAPERS DUE: May 11, 2007, no later than 4:00PM ET; FULL PROPOSALS DUE: July 9, 2007, no later than 4:00PM ET; TECHNICAL POC: Dr. Mildred Donlon, DARPA/DSO; Ph: (703) 696-2289, Email: BAA07-29@darpa.mil; URL: www.darpa.mil/dso/solicitations/solicit.htm; Website Submission: http://www.sainc.com/dsobaa DESCRIPTION The Defense Sciences Office (DSO) of the Defense Advanced Research Projects Agency (DARPA) is seeking proposals for new technologies for rapid, high-throughput, portable and low-cost biodosimeters to determine radiation dose to individuals after acute radiation exposure. This technology would provide rapid identification of individuals who have been exposed to high-dose radiation in order to accurately assess radiation exposure levels. The vision of the Radiation Biodosimetry (RaBiD) Program is to create a portable biodosimeter capable of rapid (less than 10 min) assessment of a biological sample with a goal of rapid high-throughput screening of a large population in order to correctly determine the exposure. This revolutionary detection system must be portable, low cost (less than 10 dollars/test), and able to detect and classify radioactive exposure levels within specific quartiles (0 ? 100 cGy, 100 ? 300 cGy, 300 ? 600 cGy, greater than 600 cGy corresponding to less than LD5, LD30 ? LD50, LD50 ? LD70, and greater than LD70 for humans). In addition, this technology must be relatively non-invasive. The RaBiD Program will consider a wide range of biodosimetry technologies. In summary, the technology must be non- or minimally-invasive, rapid, accurate, inexpensive, and portable in order to realize the vision of the program. All proposers to this BAA must provide evidence of a competent team capable of developing a new radiation biodosimetry technology meeting all program objectives and milestones. Successful proposals will address the program goals and specifications outlined in this BAA. For more details, a Proposer Information Pamphlet (PIP) is available at www.darpa.mil/dso/solicitations/solicit.htm and also on FedBizOpps and Grants.gov, and includes information on the submission process, format for white papers and full proposals, as well as dates for all deadlines. If there is any conflict, the published BAA 07-29 takes precedence over the PIP. PROGRAM OVERVIEW The Radiation Biodosimetry (RaBiD) Program is a single phase, 15-month program with a goal of revolutionizing radiation exposure detection. The first 12 months consist of scientific research and development during which the proposer will develop a non- or minimally-invasive radiological biodosimeter and demonstrate accurate radiological detection from biological samples into quartiles of doses for humans (0 ? 100 cGy, 100 ? 300 cGy, 300 ? 600 cGy, greater than 600 cGy) with a detection time less than 10 minutes. This will include radiological dose/detection curves (to validate the linearity, standard error, and range of the detector), as well as multipoint data regarding decay of biological signal as a function of time after radiation exposure. A successful proposal will demonstrate a clear path to these deliverables, including a timeline for technology development, experimentation, and delivery of results. In addition, data describing the onset and rate of decay of the biological signal must be provided. Performers also need to demonstrate clear extrapolation between dose measured by the technology and the absorbed dose. This is important particularly if the biological signal being tested degrades rapidly and could result in an ambiguous calculation of the original dose based on elapsed time. For example, if the signal degrades, performers need to clearly show whether a measured dose of 50 cGy corresponds to a 75 cGy dose received 24 hours earlier or a 100 cGy dose received 36 hours earlier. The technology must be validated in an animal model or in patients undergoing radiation therapy during the 12-month period of research and development. At the end of the 12-month scientific research and development period, the technologies will undergo a down-select based upon experimental data and the ability of the technology to meet the milestones outlined in BAA 07-29. Selected technologies will have one additional month for transition and training to the Armed Forces Radiobiology Research Institute (AFFRI) of their prototype biodosimeter to be used in a coordinated test at AFRRI. Devices will be tested for their speed, accuracy, ease of use, and cost/sample. A successful proposal must demonstrate a plan to re-locate the biodosimeter to the AFRRI testing facility (Bethesda, MD) including expected cost for full time equivalents (FTEs) for consultation, travel, and materials during the two months of additional testing. The RaBiD Program goal of a rapid, portable, inexpensive, and accurate biodosimetry detector is an aggressive effort with an aggressive timeline. A successful proposal will thoroughly cover all details for meeting the milestones set forth for the first 12 months. At the end of the 12-month period, the team?s performance will be evaluated based on experimental data and the technology?s ability to meet the milestones. Performers that are selected to continue will be asked to teach their procedures to AFRRI scientists, either at AFRRI or at the performer's facility, to ensure proper use and maintenance of the technology. This technology is expected to be used in a forward deployment scenario, and therefore, an important consideration during testing will be portability, accuracy, and ease of use. PROGRAM PHASES/MILESTONES The RaBiD Program is aimed at reducing cost and testing time while increasing throughput and portability of radiation biodosimeters. The milestones that will be used as the selection criteria for the down-select at the end of the 12 months of scientific research and development are as follows: a. Ability to resolve irradiated animal samples or samples from patients undergoing radiation therapy into quartiles: less than 100 cGy; 100 - 300 cGy; 300 - 600 cGy; greater than 600 cGy (human equivalent dose) corresponding to less than LD5, LD5 - LD30, LD30 - LD70, and greater than LD70 for humans. b. 100 percent sensitivity with 95 percent confidence accuracy for determination of original exposed dose. c. Once sample has been obtained, ability to resolve radiation exposed dosage into one of four quartiles in 10 minutes or less. d. Non- or minimally-invasive: collecting blood through a finger-prick test, and collecting urine, breath, hair and toe and finger nails, as well as scanning teeth, eyes, bones, etc. are all examples of minimally invasive protocols. DELIVERABLES Performers will provide: a. A radiation biodosimetry prototype technology that meets the program milestones at the end of the 12-month research and development period. b. Quarterly reports describing progress, initial results, and analysis. c. A final report containing all procedures, results, and analysis, including: 1. Dose detection curves for animals irradiated at 0, LD5, LD30, LD50, LD70, and LD90. Dose detection curves will be performed out to 72 hours with frequency of data sampling performed at the discretion of the performer and relevant to the rate of decay of the signal. 2. Multi-point data curve showing decay of biological signal as a function of time after radiation exposure with multiple data points in each quartile (0 - 100, 100 - 300, 300 - 600, greater than 600 cGy, human equivalent dose). 3. A clear method for extrapolating measured dose to the original exposed dose. TEAM ORGANIZATION The aggressive goals of the RaBiD Program require that each proposal include a team with demonstrated (or established) capability. At a minimum, proposers are expected to possess expertise or demonstrate collaboration with professionals in the following areas: a. Radiation Biologist/Radiation Oncologist--with expertise in radiation exposure to animal models. b. Engineering--with developmental expertise needed to translate biological sampling to radiation readout. Strong, competent team leadership is essential for successful implementation of the elements of this program. For this reason, it is critical that the research team be organized around an integration partner or Systems Integrator (SI) who has the responsibility of overall program management and who will maintain a focus on the RaBiD objectives. DARPA will evaluate proposals based on the composite expertise and experience of the teams, their understanding of the challenges, current data, access to facilities to conduct the proposed work, and most importantly, a clear plan to achieve the specific milestones of the program. It is left to the discretion of the proposer to construct their team from the private, academic, and commercial parties that will be necessary to achieve the milestones. 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. All responsible sources capable of satisfying the Government's needs may submit a proposal that shall be considered by DARPA. 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 BAA 07-29 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. NOVEL MITIGATION TECHNOLOGIES In addition to radiation biodosimeter technologies, DARPA is also interested in pushing the envelope of novel radiation mitigation technologies that can be administered 12 hours or more post irradiation and provide better than 90 percent survivability to humans that would receive in excess of 200 cGy. Performers are required to demonstrate their results in an animal model. DARPA will accept proposals on novel radiation mitigation technologies. While still part of the overall RaBiD program, these proposals must be clearly delineated from those proposals concerning radiation biodosimetry technologies. This will be done by stating ?Novel Mitigation Technologies? both at the top of the white paper and under the ?Technical Area? of the full proposal as instructed in the ?Submission Process? section of the PIP. White papers are encouraged and can be submitted in the area of novel radiation mitigation technologies as outlined in the ?White Paper Guidelines? and ?Full Proposal Process? sections of this BAA and in the ?Submission Process? section of the PIP. Full proposals should reflect a 12-month period of performance and will not participate in further testing. Therefore, proposed costs should be calculated for a 12-month period of research and development only. WHITE PAPER GUIDELINES It is STRONGLY ENCOURAGED that a white paper be submitted to determine the acceptability of the proposed concept to BAA 07-29. WHITE PAPERS ARE DUE NO LATER THAN 4:00PM ET, May 11, 2007. The Government anticipates that all white papers will be reviewed no later than May 25, 2007, and recommendations for full proposals will be provided at that time. See the PIP for further details on white paper content and the submission process. FULL PROPOSAL PROCESS Proposals may be submitted and received at any time until the final proposal deadline of 4:00PM ET, July 9, 2007. See the PIP for further details on full proposal content and the submission process. COST PROPOSAL Proposals to this process for radiation biodosimetry technologies should include a cost estimate that is divided into two sections: 1) The 12 months of scientific testing, including all personnel, materials, facilities, and any other aspects of the proposed research project should be outlined, and 2) A one-month period of transition and training to AFRRI in case of selection with two months of additional testing at AFRRI. To reiterate, cost proposals for the 12-month period of research and development will be calculated and submitted and costs for a one month period of transition and training to AFFRI and two months of additional testing as outlined in the PIP under the section: ?Format and Content of Full Proposal, Volume 2,? should be submitted. Proposals to this process for novel mitigation technologies should include a cost estimate for 12 months of scientific testing including all personnel, materials, facilities, and any other aspects of the proposed research project. There will not be a one-month period of transition or testing associated with novel mitigation technologies. 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/). PROPOSAL EVALUATION Proposals will not be evaluated against each other, since they are not submitted in accordance with a common work statement. For evaluation purposes, a proposal is the document described in Proposal Format. Other supporting or background materials submitted with the proposal will be considered for the reviewer's convenience only and not considered as part of the proposal. DARPA reserves the right to request an oral presentation of proposals. If such a request is made, it is expected that, to the extent possible, all key personnel on the team will be present. The request for an oral presentation, or lack thereof, should not be construed as either a positive or negative assessment of the 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. Evaluation of proposals will be accomplished through a technical review of each proposal using the following criteria, in descending order of importance: 1. SCIENTIFIC AND TECHNICAL MERIT Proposers must demonstrate that their proposal is scientifically sound with feasibility for meeting the milestones. Proposers are encouraged to avoid obscure language and indeterminate measures of success as these will not help the application. 2. VALUE TO DEFENSE DARPA's vision is to develop technologies that will enable the Department of Defense to mount a rapid medical response to radiation events based on timely and accurate dose information of potentially affected personnel. Such a rapid, high-throughput, portable, and low-cost capability is in sharp contrast to current radiation dosimetry and biodosimetry technology that is time consuming (2-5 days), low-throughput (less than 100 samples/day), expensive (greater than 500 dollars/test), and non-portable (generally requiring a laboratory). 3. CAPABILITY OF THE PERSONNEL AND FACILITIES TO PERFORM THE PROPOSED EFFORT Proposers must demonstrate that their team has the necessary background and experience to perform this project, including a radiation biologist or radiation oncologist. 4. COST REALISM AND REASONABLENESS Costs of the proposal must be reasonable and provide a high value to the Government. Reasonable accounting of consumable reagents, facility costs, detailed budgets from subcontractors and personnel should be provided. The Government reserves the right to select all, some, or none of the proposals received in response to this solicitation and to make awards without discussions with proposers; however, the Government reserves the right to conduct discussions if the Source Selection Authority later determines them to be necessary. Proposals identified for funding may result in a 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. If warranted, portions of resulting awards may be segregated into pre-priced options. GENERAL INFORMATION Proposals that fail to conform to the format described in the PIP may not be reviewed. Proposals MUST NOT be submitted by fax; any so sent will be disregarded. This notice, in conjunction with the BAA07-29 Federal Business Opportunity Announcement and the grants.gov posting, along with all references, constitutes the entire announcement. If there is any conflict, the published BAA 07-29 takes precedence. No additional information is available, nor will a formal Request for Proposal (RFP) or other solicitation regarding this announcement be issued. Requests for same will be disregarded. Only unclassified proposals will be accepted in response to this BAA. A website http://www.sainc.com/dsobaa/ has been set up to facilitate the submission of white papers and full proposals electronically. This site will allow submission of contact information and uploading of a white paper or full proposal in either Word or PDF format. Proposers will be able to select to submit to BAA 07-29, and must provide all contact information, as well as an abstract, in order to properly submit. Submissions may also be made by attachment to an e-mail sent to BAA07-29@darpa.mil. If submitting electronically via e-mail, the body of the e-mail AND the attachment must include the Proposer's name, mailing address, phone number, fax number, as well as the cost of the proposed work and duration (in months) of proposed work. 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 listed under the Full Proposal Submission and Deadlines section in the PIP. White papers and full proposals will not be accepted by way of facsimile transmissions. In all correspondence, reference BAA 07-29. POINT OF CONTACT Dr. Mildred Donlon, DARPA Program Manager, DSO; Phone: (703) 696-2289, Fax: (703) 741-3896, Email: Mildred.Donlon@darpa.mil.
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