HDTRA1-17-S-0001_--_QA_-_Final.xlsx
XLSX spreadsheet 24 KB Posted
- Attached to
- Chemical/Biological Technologies FY2017 Program Build DTRA BAA Federal contract opportunity
- Solicitation number
- HDTRA1-17-S-0001
- Issued by
- Defense Threat Reduction Agency
About this file
This document contains a question and answer file related to a Defense Threat Reduction Agency Broad Agency Announcement soliciting proposals for chemical and biological defense technologies. The solicitation seeks proposals for detection, information systems, protection, hazard mitigation, threat agent science, medical pre-treatments, diagnostics, therapeutics, and threat surveillance technologies. Proposals must address one of the topics presented and will be evaluated based on technical merit, transition potential, and cost. The document provides answers to clarifying questions on proposal formatting and submission requirements, evaluation criteria, intellectual property provisions, and applicable regulations.
HDTRA1-17-S-0001 -- Questions and Answers
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Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| HDTRA1-17-S-0001_Conformed_Copy.pdf | ||
| HDTRA1-17-S-0001_--_Amendment_2.pdf | ||
| ATTACHMENT_4_-_Cost_Spreadsheet.xlsx | XLSX spreadsheet | |
| HDTRA1-17-S-0001_--_Amendment_1.pdf | ||
| ATTACHMENT_1_TRL_Definitions.pdf | ||
| ATTACHMENT_5_-_Reps_and_Certs.pdf | ||
| ATTACHMENT_3_-_SF1408.pdf | ||
| ATTACHMENT_2_-_SOW_Template.pdf | ||
| HDTRA1-17-S-0001.pdf | ||
| ATTACHMENT_3_-_SF1408.docx | DOCX document | |
| ATTACHMENT_5_-_Reps_and_Certs.docx | DOCX document | |
| ATTACHMENT_4_-_Cost_Spreadsheet.xlsx | XLSX spreadsheet | |
| ATTACHMENT_2_-_SOW_Template.docx | DOCX document | |
| HDTRA1-17-S-0001.docx | DOCX document | |
| ATTACHMENT_1_TRL_Definitions.docx | DOCX document |
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Sheet1
| Question | Answer |
| Q1. May an Offeror submit multiple proposals for one topic? | A1. Yes. |
| Q2. May an academic institution apply for this research program? | A2. Please refer to Section 2.1 and 2.2 of the BAA solicitation. |
| Q3. What is the maximum budget for awards made under this BAA? | A3. Budgets for awards under this BAA have not been estimated with the exception of Topic Areas CBS-01 and CBS-02. |
| Q4. What is the maximum period of performance for awards made under this BAA? | A4. Please refer to Section 1.5.3 of the BAA solicitation. |
| Q5. How many grants will be funded by this BAA? | A5. Please refer to Section 1.5 of the BAA solicitation. |
| Q6. Would a Compact Portable UV Raman Spectroscope be of interest to the Government? | A6. DTRA is seeking optimum approaches to meet the technology objectives in Section 7 of the BAA. It is the Offeror's responsibility to demonstrate how their proposed technology addresses the topic requirement. |
| Q7. Section 2.1: Is a DOE sponsor letter required for Phase I Submission? | A7. No. |
| Q8. May an Offeror still submit a proposal for a technology that does not relate to a specific topic but, in the Offeror's opinion, falls directly in line with a research goal listed in para. 1.3.3 of the BAA? | A8. No. |
| Q9. Does the Government think these tasks match the BAA well: a) Development of a system to support interactive exploration, analytics, and visualization on large-scale social media data such as Twitter to help commanders in chemical and biological defense. It supports massive amounts of data using parallel computing. An example live prototype on Zika is available at [2]. |
b) Development of a system to support interactive, declarative, and GUI-based text analytics on data from various information sources. Supported operations include NLP, information extraction, and machine learning methods.
| A9. DTRA is seeking optimum approaches to meet the technology objectives in Section 7 of the BAA. It is the Offeror's responsibility to demonstrate how their proposed technology addresses the topic requirement. | |
| Q10. Is there anyone an Offeror can talk to in order to get initial feedback in order to prepare a good proposal? | A10. The Government will not provide initial feedback to any Offeror. It is the responsibility of the Offeror to prepare their proposal in accordance with the BAA Solicitation. |
| Q11. Are small fonts allowed for figure legends, figures, footnotes and tables? | A11. No. |
| Q12. Are subcontracting goals still required if submitting a Subcontracting Master Plan? | A12. Yes, small business subcontracting goals are still required. |
| Q13. May Offerors add tabs within the Cost Spreadsheet for subcontractors? | A13. Yes. |
| Q14. What is the percentage of indirect costs that can be requested? | A14. There is no specific limit. |
| Q15. In the background section, it states that "Previously developed real-time polymerase chain reaction (PCR) diagnostic assays (amplification of pathogen target genes) for both brucellosis and epidemic typhus were terminated due to multi-center clinical trial performance below acceptance criteria." I was wondering if you could elaborate on why the tests failed to meet the acceptance criteria so that this could be addressed in the proposal. | A15. As noted in the topic description, research efforts funded under this topic will ultimately support the Joint Program Executive Office (JPEO) Medical Countermeasure Systems (MCS) Diagnostics program to develop sensitive and specific diagnostic tests for acute brucellosis, epidemic typhus and arboviral encephalitis. It should be noted that these are clinical disease states, not pathogens. Previous efforts have demonstrated that for a variety of acute diseases, analytical sensitivity/specificity is not equivalent to clinical sensitivity/specificity. As such, in addition to analyte identification methodologies, it is also critical to address appropriate sample matrices and diagnostic windows. |
| Q16. Is there is a specific limit to the direct costs or total costs we can apply for under this BAA per year, or per total period of performance? | A16. See A3 and A4. |
| Q17. Topic CBA-04: Will existing data from BSVE be available to the team during the project execution? Is there a known time-frame to gain approval after requesting access to the site? | A17. Yes, existing data within the BSVE can and should be utilized during project execution. Approval for BSVE access is dependent upon the need and citizenship and can be executed in a matter of hours. |
| Q18. Topic CBA-04: Please comment if generating our own data is encouraged during the project execution (and if possible, adding to the BSVE data)? | A18. Unique datasets which become integrated data sources within the BSVE during the course of project execution is encouraged. Data sharing agreements should allow for widespread collaboration opportunities with all partners within the BSVE when possible. |
| Q19. Topic CBA-04: Does DTRA have simulated and/or measured datasets for operational scenarios that may be used to validate anomaly detection algorithms? | A19. Yes. The Government is also interested in new validation datasets and approaches. |
| Q20. Topic CBA-04: Is it appropriate to propose tasks that involve collecting/analyzing data from newly developed (TRL 7-9) sensors in order to enrich relevant content? | A20. Yes, especially if the sensor has a planned acquisition by the Department of Defense. |
| Q21. Topic CBMB-01: Is it DTRA's intent that the proposals submitted for this particular topic include activities/tasks up to and including registration (as per the FDA's Animal rule [21 CFR 314.600 through 314.650]) of the investigational drug product for one or more of the following antibiotic resistant (MDR) pathogens of biodefense interest. pseudomallei, F. tularensis,B. anthracis,Y. pestis and/orC.burnetii? Or is it the intention of this BAA to support development of the investigation drug product to a defined milestone such as demonstration of in vivo activity? | A21. In general, the JSTO missions space carries development through approximately phase I clinical trials. However, the maturity expected at the conclusion of a program is clearly contingent on the starting maturity and the developmental plan. As such, our portfolio includes programs from discovery to proof of concept in vivo activity as well as programs to advance a preclinical candidate into the clinic. It is critical to note that, although work with clinical pathogens will likely be critical for the regulatory path of a broad-spectrum antibacterial, the ChemBio Defense Program is appropriated to develop products to combat biological weapons exclusively. It is further recommended that offerors consult the topic in the BAA to determine the requisite level of maturity to be responsive to the topic. In particular, the topic stipulates "a lead candidate will have demonstrated feasibility of manufacturing, in vitro and in vivo evidence of efficacy against biothreat bacterial agents, and sufficient characterization to allow the development of a draft Target Product Profile (TPP)." |
| Q22. In order to adequately estimate the budget, does this BAA require that service providers external to the offeror be limited to US based companies or are international service providers acceptable? | A22. Offerors may subcontract with international service and supply providers, subject to FAR and DFARS restrictions such as those found at FAR 25.7 and DFARS 225.7. |
| Q23. Topic CBA-02: Please define what constitutes a “high level of exposure”. Is the individual symptomatic? If not, what is the time frame between presumptive exposure and onset of symptoms of a “long latency” compound for exposure to be considered a “high level”? | A23. The significance of relative levels of exposure is agent-dependent. However, in general, a high level of exposure to a CWA will result in acute toxic effects resulting in incapacitation or death within a time frame of seconds to a few days, although the display of symptoms is not always immediate. The lag time between presumptive exposure and onset of symptoms is dependent on a number of factors including nature of the CWA, amount of CWA, exposure route, and peculiarities of the exposed individual. The offeror should describe the range of scenarios for which their proposed device would be useful to the military by adding decision capability in the battlefield environment. |
| Q24. Topic CBA-02: Is a “high level of exposure” considered as resulting from a single exposure event or from multiple/long term exposure over time causing bioaccumulation? | A24. High level of exposure is considered as resulting from a single exposure event. |
| Q25. Topic CBA-02: Does the term “low burden trigger” refer to a low level of exposure or a device/test that is easy to use? | A25. This phrase refers to a device/test that is lightweight and easy to use, and yet provides sufficient confidence to reliably inform subsequent course of action. Specifically, the phrase in the BAA is "low burden trigger to treat" which refers to a device that would reliably inform the selection of appropriate medical treatments. |
| Q26. Topic CBA-02: Does the term “high threat scenario” refer to the imminent biological effects of the agent if the individual is not treated or more like an open combat setting? | A26. High threat scenario refers to a situation in which there is a reasonable probability of that CW might be deployed. |
| Q27. Topic CBA-02: What are the restrictions and limitations associated with a “high threat scenario”? | A27. There are no particular restrictions or limitations defined by the topic for a "high threat scenario". This language is simply intended to convey a scenario in which there is a reasonable probability that a CW might be deployed. |
| Q28. Topic CBA-02: What is an acceptable time frame between the presumptive exposure and agent exposure testing? | A28. The time frame between presumptive exposure and agent exposure testing will vary depending on the particular scenario. The most useful device would be one which could be deployed within a range of scenarios in as short a time frame as possible once presumptive exposure is recognized, but which would also provide sufficient confidence to reliably inform response. |
| Q29. Topic CBA-02: What is the difference between contexts (a) and (c)? The wording appears identical in the BAA. | A29. There is no difference between contexts (a) and (c). Context (c) under this topic will be deleted. |
| Q30. Is a Contractor permitted to submit multiple proposals to a given Topic with multiple Parts, where each proposal would be specific to one Part of the Topic? | A30. Yes. However, each proposal must be submitted independently in accordance with BAA Section 3.5 requirements. Additionally, each proposal must be stand-alone and independently executable. |
| Q31. Topic CBA-02: Does “low burden trigger to treat” refer to the weight, logistics chain, etc. of the diagnostic device (i.e., burden to the medic), or does it refer to the threshold of biomarker concentration that must be detected in order to trigger treatment? | A31. It refers to the former of these. |
| Q32. Topic CBA-05: Is there an envisioned timeline and budget for this project? | A32. This paper study should not exceed 24 months but could be accomplished more rapidly depending on the scope and number of pathogens proposed. Proposed funding must be a derivative of project costs. |
| Q33. Topic CBA-05: The announcement states that “this topic seeks to develop a comprehensive reference guide for detection of biothreat targets in body fluid matrices.” Should the effort focus on a limited set of specific threats (to include the four listed) or attempt a more general technical approach that could be adopted for use with other non-listed or not-yet-identified threats? | A33. Efforts should focus on the former. For the purpose of this solicitation, "comprehensive" refers to the “identification of all relevant clinical matrices, identification of the optimal clinical matrix and the clinically relevant diagnostic window.” |
| Q34. Topic CBA-05: All four biothreats called out in this task are bacterial. Are biomarkers for viral biothreats also of interest? | A34. No, viral pathogens are beyond the scope of this topic. |
| Q35. Topic CBA-05: Will there be government-provided access to classified data? | A35. No classified information will be provided by DTRA. Collaborations with Department of Defense and/or National Biocontainment Laboratories/Research Centers with relevant missions/capabilities could possibly be considered at the discretion of these Institutions. |
| Q36. Topic CBA-06: Will the product report (or portions) be allowed to be published in open literature? | A36. Unless the project has been designated as fundamental research without restrictions, contractors must request and receive approval prior to release, in accordance with DFARS 252.204-7000. |
| Q37. Topic CBA-02: Will you consider minimally invasive devices with diagnostic capability that are non-assay based in nature? | A37. The term "assay" as employed in this topic is intended to refer to any diagnostic capability that allows for assessment of presence, amount, or functional activity of a given target, which could include a chemical or biochemical substance, a cellular level response, a tissue-level response, or a system-level response of the subject. More important than whether an approach meets a particular definition of the term "assay" is whether the approach accomplishes the objective of the topic, to provide, in a minimally invasive manner, actionable diagnostic information of warfighters regarding (a) "high levels of exposure to long latency cholinesterase-inhibiting agents for which medical intervention could change the outcome" or which provides "(b) low burden trigger to treat for presumptively exposed personnel without objective signs of exposure in high threat scenarios |
| Q38. Section 3.3.1: Will DTRA consider multiple proposals in response to the same topic area? | A38. Refer to A30. above. |
| Q39. Section 3.3.1: Will submitting multiple proposals in response to the same topic area result in proposals being disqualified? | A39. Refer to A30. above. |
| Q40. Section 3.4.4: May the Offeror include standard front matter (title page, table of contents) as part of the white paper, and should this legend appear as part of that standard front matter? If not, where should the legend appear? | A40. Per the BAA, the White Paper format requirement does not include standard front matter (title page, table of contents). |
| Q41. Section 3.4.4: Will the legend and any standard front matter count toward the white paper’s 6-page limit? | A41. See A40. |
| Q42. Section 3.5.1.2: The project overview included in the white paper is required to describe “How and to what degree the scientific solution is relevant to DOD CBDP program goals.” Can DTRA make available or direct Offerors to the most current information regarding DOD CBDP program goals? | A42. CBD Goals: 1. Equip the force to successfully conduct military operations to prevent, protect, and respond to CBRN threats and effects. 2. Prevent surprise by anticipating CBRN threats and developing new capabilities for the Warfighter to counter emerging threats. 3. Maintain infrastructure to meet and adapt current and future needs for personnel, equipment, and facilities within funding constraints. 4. Lead the Enterprise to integrate and align activities to fulfill the CBD mission. |
| Q43. Topic CBMB-01: While some of the BAA topics included expected award ranges, this one did not. Is there a project base period award range or overall contract award value range that is anticipated for Topic CBMB-01? | A43. There are no present guidelines with regard to periods of performance or total contract value. |
| Q44. Topic CBA-03: What is the expected data volume to keep on hand? | A44. 65 Terabytes. |
| Q45. Topic CBA-03: What is the current need for data storage and its expected growth? Can you clarify by month? | A45. 65 Terabytes. It is growing at rate of approximately 25 TB per year. |
| Q46. Topic CBA-03: Many organizations have found that legacy systems with closed architectures can be complex to update and keep current with industry leading technologies. To what extent is DTRA willing to alter BSVE’s existing architecture in its effort to broaden and enhance BSVE? For example, would DTRA be willing to integrate with or re-platform to an alternative system? | A46. The Biosurveillance Ecosystem (BSVE) is a virtual, customizable, collaborative system that leverages existing commercial and government technologies. The BSVE architecture supports HTML5, Java, Python, R Shiny, PostgreSQL, MongoDB, and Hadoop. This topic seeks proposals to broaden and enhance the current BSVE architecture and technologies to provide improved CBD situational awareness, a common analytical work bench for users, integration and fusion of a wide array of relevant data sources, and decision support tools for the tactical to strategic level command authorities. |
| Q47. Topic CBA-03: Given increasing limitations with on premise solutions in terms of data processing and storage, is DTRA interested in the solution being hosted as a service? | A47. The BSVE is cloud based, residing in Amazon Web Services. |
| Q48. Topic CBA-03: Will there be a future need for incorporating classified data and/or analytic approaches into the BSVE platform? If so, is there an anticipated timeline? | A48. The Government does not currently plan to incorporate classified data and/or analytic approaches into the BSVE platform. |
| Q49. Topic CBA-03: Is there a requirement to support disconnected or offline operations for end users accessing BSVE in a remote location? | A49. There is not a requirement to support disconnected or offline operations for end users accessing BSVE in a remote location; however, this is certainly a capability of interest to the Government. |
| Q50. Topic CBA-03: In areas where there is sufficient related operational biosurveillance experience, would the Government consider using a fixed price contract which places more risk and responsibility onto the Offeror? | A50. Please refer to Section 1.5.1 of the BAA for available for contract types. |
| Q51. Topic CBA-03: Is there currently an organizational framework or playbook in place for Agile Development? | A51. No. |
| Q52. Topic CBA-04: Is there an interest in proposals that articulate innovative approaches or new capabilities for the process of developing analytic applications? Or, does CBA-04 solely intend to solicit specific topics to support integrated early warning? | A52. The relevant focus areas are listed in Topic CBA-04. The desired end goal of the portfolio is earlier warning to adverse events which affect the Chem Bio Defense equities. |
| Q53. Section 3.1.1: Would the Government consider the addition of a second BPOC for registration to the DTRA Submission Website and any subsequent communications in case of computer, access or system problems with the upload? | A53. The Government will not consider the addition of a second BPOC for registration to the DTRA Submission Website; however, if an Offeror is encountering access or system problems when uploading their proposal, they may contact the DTRA BAA Helpdesk. The Helpdesk's email and phone number are listed on the DTRA Submission Website. |
| Q54. Section 3.5.2.2: The CO could determine in this case that the exception for certified cost and pricing data found in FAR 15.403-1(b)(1) could apply given it is expected that any resulting prices agreed upon would be based on adequate price competition. Has this been considered? | A54. While the BAA incorporates a competitive selection process, as reflected in the evaluation criteria provided in BAA Section 4.0 and the basis for selection provided in BAA Section 4.5, adequate price competition is not achieved. As such, certified cost and pricing data will be required for proposals meeting the requirements of FAR 15.403-4. |
| Q55. Section 4.7: In the notice to unsuccessful bidders, will the minimum required debrief information per FAR 15.505(e) be included in the notice to unsuccessful offerors? | A55. Upon receipt of a timely request for debrief in accordance with FAR 15.505(a)(1), the Government will provide the minimum required debrief information in accordance with FAR 15.505(e). |
| Q56. Section 8.1.6: Please provide the requirements for the DTRA Directive 3216.01 and the DTRA Human Subjects Protection Program so that contractors can confirm compliance. | A56. The requirements for Protection of Human Subjects starts on page 54, paragraph 8.1.6 of the BAA. |
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