N0017315RBA01_Amendment_01.pdf

Solicitation No.: N00173-15-R-BA01

Amendment 0001

Whereas the Naval Research Laboratory Contracting Officer received questions from potential offerors, the purpose of this amendment is to provide answers to questions received, modify the response date, provide an addition question and answer period, revise the white paper page limits and modify the Anticipated Period of Performance.

Q1. Would it be acceptable to propose two separate multiplexes for Tier1 evaluation? We envision one for biothreat organisms and one for arthropod-transmitted diseases; however, there could be a single point of whole blood sample application.

A1) No, only one multiplex should be offered for Tier 1 evaluation. In Tier 1, NRL will benchmark the performance of the offeror's technology with the best assay that most closely matches the desired product. Any performance characteristic not demonstrated by the proposed Tier 1 assay, for example operation from a whole blood matrix, would need to have its development path specifically addressed in the proposal text. Note that for Tier 1 it could be acceptable to demonstrate the technology's performance with a disease not listed in the Broad Area Announcement, for example influenza.

Q2. Alternatively, is it acceptable to propose two different multiplexed assays?

A2) Yes, the proposal of two different multiplexed assays will be considered for Tier 2 and Tier 3. Full consideration should be given to the cost/benefit of having two tests, including work flow, ease of use, reagent usage and storage, etc. Please include an explanation in the proposal text.

Q3. How do the Tiered phases work? Should the product be ready to go – or can additional pathogens be added in Tier 2 for example. Looks like the technology needs to be at TRL4 to begin with.

A3) Technologies accepted in to Tier 1 do not have to be fully compliant with Tier 2 and

Tier 3 performance characteristic at the time of the proposal. The Tier 2 development phase is designed to allow the offeror to customize, add to, and improve both/either their device and/or assay so that the technology meets the desired performance characteristics by the end of Tier 2.

Q4. Is there more information regarding field testing in Tier 3?

A4) Field testing will be performed at field sites across four continents. All field sites are in remote locations and/or in the developing world and are in tropical climates. Exact field testing will depend on the offeror's proposed panel of febrile diseases - matching disease panels to the location with the highest likelihood of exposure.

Q5. We would like clarification on timelines. Is it expected that whitepaper submission, invitation for full proposal, and submission of full proposal all be completed by June 17? If awarded, would the August 31 deadline for Tier 1 evaluation be adjusted based on the date that award is actually made?

A5) White paper submissions are due by the response date, now revised to June 25, 2015.

Following white paper review, full proposals will be requested from selected technologies. The calendar provided in the Broad Area Announcement is an anticipated period of performance, adjustments in schedule are possible if deemed necessary.

Q6. What is the total budget? Should we just propose a most reasonable number?

A6) Budget should be reflective of the work needed to advance the offeror's technology to meet performance characteristics. Both cost and cost reality will be evaluated. Multiple awards are expected.

Q7. On page 3 of the solicitation it states "The first Tier will be no more than 5 months".

However in the timeline just below it states "31 August 2015: Tier1 testing complete". Given that White Papers are due on June 17, it would appear that the actual performance period can only be about 2 months. Can you resolve for us which timing is accurate to your intentions?

A7) The description of the Anticipated Period of Performance, including the anticipated timeline, has been revised to clarify the intentions. Tier 1 will commence following white paper, proposal, and a contractual agreement between the offeror and NRL. In Tier 1, technology evaluation will be performed by NRL personnel with the technology provided by the offeror. The calendar provided in the Broad Area Announcement is an anticipated period of performance, adjustments in schedule are possible if deemed necessary.

Q8. On a related note, if the timeframe for Tier 1 is 5 months we can attempt an n=3 multiplex demonstration, but if only 2 months we would be limited to an n=2 demonstration. Do we understand correctly that the Tier 1 demonstration does NOT require demonstration of multiplexing of 3 or greater? (We are prepared to deliver multiplex of 5 in Tier 2).

A8) The Tier 1 evaluation does not require multiplexing of three diseases. In Tier 1, NRL will benchmark the performance of the offeror's technology with the best assay that most closely matches the desired product. Any performance characteristic not demonstrated by the proposed Tier 1 assay, for example operation from a whole blood matrix or multiplexing of three diseases, would need to have its development path specifically addressed in the proposal text. Note that for Tier 1 it could be acceptable to demonstrate the technology's performance with a disease not listed in the Broad Area Announcement, for example influenza.

Q9. The timeline does not reflect decision and funding dates for Tier 1. Can you provide this information?

A9) Only white paper submissions are due on June 25th. Following white paper review, full proposals will be requested from selected technologies. Once there is a contractual agreement between the offeror and NRL, then Tier 1 will commence. The calendar provided in the Broad Area Announcement is an anticipated period of performance, adjustments in schedule are possible if deemed necessary.

Q10. Can you provide any direction on funding limits or expectations under the various Tiers?

This would help us to make sure our proposal is appropriate to your expectations.

A10) The budget should be reflective of the work needed to advance the offeror's technology to meet performance characteristics. Both cost and cost reality will be evaluated. Multiple awards are expected.

Q11. Can you confirm that the page limit for the white paper due on June 17 is 2 pages? We have seen 2 sets of instructions. We believe the 2 page request supersedes another set of instructions which shows a 30 page limit.

A11) The solicitation has been revised to clearly state white papers may be up to 4 pages in length.

Therefore, based on answers provided, the following changes are made to the solicitation:

1. Revised response date:

From: June 17, 2015 4:00pm EST

To: June 25, 2015 4:00pm EST

2. Questions and Answers:

Questions may be submitted to NRLProposals and must be received by June 16, 2015

12:00pm EST.

3. Modified White paper and Proposal Preparation instructions:

FROM: Interested offerors must first submit a white paper (WP). The purpose of a WP is to preclude unwarranted effort on the part of an offeror whose proposed work is not of interest to NRL. White papers should be no more than 2 pages and include information on the device type (Role 0 or Role 1), the current detection capabilities, and a statement of the offeror’s

R&D capabilities.

Cost estimates in WPs for stand-alone subsets of efforts are encouraged. Offerors of those

WPs found to be consistent with the intent of the BAA may be invited to submit a formal proposal. An invitation does not assure an offeror of a subsequent contract award. If selected for a full proposal addition guidance will be provided.

mailto:%20nrlproposal@nrl.navy.mil

Submit one original of each WP to NRLProposals. The subject of the email shall be "Subj:

BAA number, Topic # and Topic Title".

TO: Interested offerors must first submit a white paper (WP). The purpose of a WP is to preclude unwarranted effort on the part of an offeror whose proposed work is not of interest to NRL. White papers should be no more than 4 pages and include information on the device type (Role 0 or Role 1), the current detection capabilities, and a statement of the offeror’s R&D capabilities.

Cost estimates in WPs for stand-alone subsets of efforts are encouraged. Offerors of those

WPs found to be consistent with the intent of the BAA may be invited to submit a formal proposal. An invitation does not assure an offeror of a subsequent contract award. If selected for a full proposal addition guidance will be provided.

Submit one original of each WP to NRLProposals. The subject of the email shall be "Subj:

BAA number, Topic # and Topic Title".

4. Modified Anticipated Period of Performance:

From: It is anticipated that the Development of Field Forward Diagnostics and Tiered

Evaluation program shall provide up to two years of funding for research and development through competitive prototyping. The timeline will be divided into three Tiers. The first Tier will be no more than 5 months and benchmark the performance of the offerors technology with the assay that best matches the stated diagnostic needs. An optional second Tier can be activated that engages the offeror in research development of the technology to meet the specific needs outlined with a performance period up to 12 months. Following the performance period, the developed technology will be benchmarked by NRL. Finally, an optional third Tier of 3-9 months can be activated for the field deployment of the developed technology. These Tiers include device development, testing and demonstration, evaluation, reporting, and selection activities. Selection of device candidates to be advanced into Tier 2 and Tier 3 will be based on specific parameters and metrics being successfully met in demonstration exercises. The government shall provide technical data and support for demonstrations, as well as facilitate interaction with relevant DoD and Interagency stakeholders. The following presents a timeline that lists the anticipated sequence of major milestones for this program.

31 August 2015: Tier 1 testing complete

7 September 2015: Down selection, initiate Tier 2

1 July – 1 October 2016: Tier 2 development complete

1 November 2016: Tier 2 testing complete

30 November 2016: Down selection, initiate Tier 3

To: It is anticipated that the Development of Field Forward Diagnostics and Tiered

Evaluation program shall provide up to two years of funding for research and development through competitive prototyping. The timeline will be divided into three Tiers. The first Tier will be to benchmark the performance of the offeror’s current technology with the assay that best matches the stated diagnostic needs. Technology and assay(s) provide in Tier 1 do not have meet all aspects of the final diagnostic to be considered, but must have the ability to reach those performance criteria during the program. The offeror will provide their technology and best assay to NRL staff, which will perform a benchmark evaluation. Any performance characteristic not demonstrated by the proposed Tier 1 assay, for example operation from a whole blood matrix or multiplexing of three diseases, would need to have its development path specifically addressed in the proposal text. An optional second Tier can be activated that engages the offeror in research development of the technology to meet the specific needs outlined with a performance period up to 12 months. During this time period the offeror will make improvements and alterations to meet final performance criteria.

Following the performance period, the developed technology will be evaluated by NRL staff. Finally, an optional third Tier of 3-9 months can be activated for the field deployment of the developed technology. These Tiers include device development, testing and demonstration, evaluation, reporting, and selection activities. Selection of device candidates to be advanced into Tier 2 and Tier 3 will be based on specific parameters and metrics being successfully met in demonstration exercises. The government shall provide technical data and support for demonstrations, as well as facilitate interaction with relevant DoD and

Interagency stakeholders. The following presents a timeline that lists the anticipated sequence of major milestones for this program.

11 September 2015: Tier 1 testing complete

18 September 2015: Down selection, initiate Tier 2

1 July – 1 October 2016: Tier 2 development complete

1 November 2016: Tier 2 testing complete

30 November 2016: Down selection, initiate Tier 3

End of Amendment 0001.