W81XWH-17-R-0040-0001_Questions-&-Answers.pdf

7/14/2017 Number Reference Question Answer Resulting Amendments

1 SF33, p. 7, SOO, Section 3.0, para. 1.

Section 3 of the solicitation (Statement of Objectives) requires that the device be at Technological Readiness Level 6 or greater. Please clarify whether this refers to the TRL currently, or after completion of the contract.

TRL should currently be at TRL 6.

Added the word "currently" to the following sentence: "The device shall currently be at technology readiness level 6 or greater for the purpose of reducing risk and shortening the time between program start and product fielding."

2 SF33, p. 7, SOO, Section 3.0, para. 4.

Please clarify the requirement in the Solicitation SOO (page

7) for the ideal device: “will be a standalone device (no wireless capabilities needed for use)”. Our current device design uses a smartphone for a User Interface, which is wirelessly in communication with the actual sensor worn by the patient. Such a User Interface could be in communication with more than one sensor.

Is this requirement for no wireless capabilities needed because of unreliability of wireless communications in combat regions, or would our current approach be acceptable?

Any wireless capability including "Point to Point" will require compliance to the US Army's Risk Mitigation Framework (RMF) protocol. List current classification of wireless specifications (e.g.: Bluetooth, wide band, etc.) used in your technology in the submission. Wireless capability should not require cloud usage or connection to the Army network.

None.

3 SF33, p. 30, FAR clause 52.209-1.

Please clarify the QUALIFICATIONS REQUIREMENTS clause on page 30. No agency activity is listed for us to contact to obtain requirements.

Upon further review the Government determined that the clause is not applicable. The acquisition is not subject to a qualification requirement because is a research and development effort and not a production effort.

Clause removed.

4 SF33, p. 31, FAR clause 52.209-4.

Please clarify the section on First Article Approval on pages 31-32. In particular, paragraph (a) states that “the testing requirements are specified elsewhere in the contract” and paragraph (c) indicates that costs for additional first articles and testing thereof are to be borne by the Contractor. I was not able to find a specification on the testing requirements.

Also, the Initial Prototype deliverable at 45 days will naturally be the Contractor’s current device design, and it would seem infeasible to make modifications to meet new US Army requirements within such a short time frame. This entire section seems inconsistent with the fact that this will be a contract for Research and Development and not for production units.

Upon further review the Government determined that the clause is not applicable. The acquisition is for a research and development effort to refine an existing product, and is not a production effort.

Clause removed.

5 SF33, pp. 5-7, SOO, Sections 1.0 & 3.0.

Please clarify Section 1.0 on page 6 as to whether the contract requirements include actual environmental testing, particularly those specified in MIL STD 810G and outlined in the description of the Ideal Device in Section 3.0 on page 7.

We assume this applies to design considerations, and that formal tests would done under a later contract, but we are asking for clarification.

Actual environmental testing will not be conducted in this contract, however the ideal device shall meet MIL STD 810G standards listed in Section 3.0 of the SOO.

None.

W81XWH-17-R-0040 Questions

SF33, p. 10, SOO, Section 5.0, para.

5.1.14.

Please clarify the requirement for a Manufacturing Plan in Section 5.1.14 on page 10, which is Deliverable 14. This deliverable is due 6 months after contract award. However the nature of this Research and Development project is such that many details of the final product design and approved vendors will be unknown at that time.

Provide most detailed planned solution your company will follow to achieve the Manufacturing Plan in Section 5.1.14 as requested based on current product platform.

None.

7 SF33, p. 7, SOO, Section 3.0, para. 3.

Above the requirements for the device there is a statement:

“The Government realizes that the ideal goals stated below may not be obtainable within the period of performance of the contract; however, preference for potential future work will be given to Contractors who are closest to achieving these goals.” Several of these goals we believe are aspirational, e.g., the weight <0.5 lbs., and use in unconscious patients.

Will devices be considered that are ~25 lbs., fit in a backpack?

No. None.

8 SF33, p. 7, SOO, Section 3.0, para. 3.

Pursuant to the “may not be obtainable with the period of the contract”: Will a device be considered for this contract if it must be used on conscious patients only?

No, device must work on both conscious and unconscious patients.

The following statement was removed from the list of "ideal device" characteristics and restated in a new paragraph as an absolute requirement: "The device is required to function on both conscious and unconscious SMs. (Reference SF33, Section C, SOO, Section 3.0, new para. 3.)

SF33, pp. 7-8, SOO, Sections 3.0, 4.0, & 5.0.

The timing of the contract is 18 months, however the prototypes are to be delivered in 45 days, the demonstration within 2 weeks of that, and then 17 months are stated for prototype refinement. This is longer than 18 months. It is also stated in the announcement that “The Government realizes that our stated goal may not be obtainable within the period of performance of the initial contract.” Please clarify what this means. Will there be an opportunity to extend this contract? If yes, should costs associated with that extension be in this proposal or will a subsequent proposal need to be submitted?

Prototype refinement for an ideal device is listed in Section

3.0 of the SOO. Refinement should begin as soon as contract is awarded. The initial prototype delivery and demonstration will allow the COR and Government subject matter experts to understand the concept of operation and device use. Within 17 months of contract award, the Contractor shall deliver the refined prototype that satisfies program requirements to the USAMMA COR. No, there will not be an opportunity to extend the contract.

None.

10 SF33, p. 2.

What does it mean on p. 2 of the solicitation “Offerors’ proposals shall remain open for a minimum of 120 days from the date of submission”? Does this mean that proposals can be modified or added to in that 120 day time period after the August 7th submission? Given decisions are to be made on September 15th this is likely not the case. Please clarify.

This means that the Offeror will accept an award from the Government in accordance with the solicitation terms and conditions, and the Offeror's proposal, within a minimum of 120 days from the date that the Offeror submits the proposal.

"The Government intends to award without discussions.

Offerors shall provide their best, complete proposal upon initial submission. If discussions are required they will be conducted with Offerors in the competitive range to the extent deemed necessary by the Contracting Officer in accordance with FAR 15.306. Discussions will be conducted on the content of the proposal and, if discussions have been conducted, a Final Revised Proposal (FRP) will be solicited from those Offerors within the competitive range. A common cut-off date will be established for receipt of all FRPs."

(Reference SF33, Section M.)

SF33, p. 5, USAMRAA

Instruction, CMR.

The contract is to be awarded on September 15th, however the CMR time period is from October 1 through September 30th. Does this mean that all labor hours should be reported from October 1 onward, not September 15th, i.e., should we be awarded a contract we should not begin work until October 1st? If yes, is the 45 day deadline for prototype delivery November 3rd (45 days from September 15) or November 17th (~45 days from September 30th) or another date?

Please specify the date for delivery of the prototype device.

Work should commence on the contract period of performance (POP) start date; labor hours should be reported when the contract POP begins. The deadline for the prototype delivery is 45 calendar days after the contract POP start date.

The following references to "contract award" have been changed to "the POP start date". (Reference SF33, Section C, SOO, paragraphs 2.3, 2.4, 2.7, 4.0, 5.1.3, 5.1.8, 5.1.10, 5.1.15, and Table 1 deliverables 1, 3, 7, 10, 11, 12, 14, & 15.)

SF33, p. 8, SOO, Section 5.0, para.

5.1.1.

Is the 45 day deadline the ship by date or the receipt of prototype date? The 45 day deadline is receipt of prototype date.

The following definition was added to the SOO: "NOTE: For this requirement “deliver” means that the USAMMA COR is in possession of the deliverable." (Reference SF33, Section C, SOO, Section 5.0.)

13 SF33, pp. 5-13, SOO.

The FDA clinical trial could be performed on the device that will be used in the field, or the initial prototype. The field device will not be completed until prototype refinement is finished, which is potentially at the end of this contract.

Should we plan on conducting the FDA clinical trial subsequent (on the refined prototype) or in parallel (on the unrefined prototype) to this prototype refinement 17 month period? Either can be done but it would be helpful to know what the expectation is for the FDA clinical trial.

Plan on conducting the FDA clinical trial subsequent (on the refined prototype). None.

14 SF33, pp. 5-13, SOO.

Safety testing of the device should occur before FDA submission. Is safety testing considered to be part of the 17 months “prototype refinement” phase or should it be performed after.

Safety testing should be considered to be part of the 17 months "prototype refinement" phase. None.

Solicitation Attachment 3, Cost/Pricing Template.

Can full time employee salaries be included in the budget for this proposal if they are working full time on the prototype and/or clinical trial? Can a portion of a full time salary be paid for by this contract?

Offerors shall propose based on the level of effort (LOE). None.

16 SF33, p. 6, SOO, Section 2.0, para. 2.7.

We assume the full cost of FDA pre-submission, meetings, interactions, and clinical trials should be included in this contract. Please confirm.

Only the cost of FDA pre-submission, meetings, and interactions that will occur during the contract's period of performance should be included in this contract. A clinical trial is out of scope of the current solicitation W81XWH-17-R- 0040.

None.

17 SF33, pp. 101-102.

The solicitation requires that the Offeror’s proposal contain a Quality Control Approach and a Quality Control Plan. Please clarify your requirements for these sections, and particularly whether these documents are intended to govern the Research and Development project or future anticipated production operations. We suggest that these requirements, as stated, may more appropriately be part of a production or pre-production contract.

The Quality Control Approach and Quality Control Plan are intended to govern the research and development project being executed under the resulting contract. The requirements for these sections are stated in Section L of the

SF33.

18 SF33, p. 2.

Per the solicitation, Section A, General Information, Proposal Submission, “each proposal volume should be a separate attachment.” Should Volume II(a) be prepared as a separate volume from Volume II(b) or is it okay to combine?

Please follow the instructions outlined in the SF33, Section L:

"One electronic copy shall be submitted for each proposal volume. Each proposal volume should be a separate attachment." Also, please note the special formatting and submission instructions for the Statement of Work (SOW) in Section L, Proposal Submission, para. 2.

None.

19 SF33, p. 2. What is the total amount set aside for the 5 awards you intend to make for this solicitation?

This information is internal to the Government and will not be disclosed for this acquisition. Disclosure of this information is common in a grant environment but not in a contract environment.

None.

20 SF33, p. 2.

What is the expected size of a successful award in terms of budget, and/or what is the range of budget you would consider reasonable?

This information is internal to the Government and will not be disclosed for this acquisition. Disclosure of this information is common in a grant environment but not in a contract environment.

None.

21 SF33, pp. 5-13, SOO. What is you target time to complete an assessment for a single patient?

≤ 1 minute (including patient prep time). This is included on the list of Essential Characteristics identified in the SOO. None.

22 SF33, pp. 5-13, SOO. What is the skill level of the medic that will be using the device?

The medic using the device goes through 10 weeks of basic combat training and 16 weeks of advanced individual training including practice in-patient care. Some of the skills learned are patient-care techniques, emergency medical techniques, advanced medical care, plaster-casting techniques. (Source:

https://www.goarmy.com/careers-and-jobs/browse-career-and job-categories/medical-and-emergency/combat-medic-specialist.html)

None.

23 SF33, pp. 5-13, SOO. Do you believe that HRV [heart rate variability] by itself is sufficiently sensitive and specific?

Describe how heart rate variability (HRV) can be used to interpret vitality of brain function and provide actionable information to a medic. Reference scientific papers to back up claims.

None.

24 SF33, p. 5, SOO, Section 1.0, para. 3. Is intracranial pressure alone sufficient? Yes. None.

25 SF33, pp. 5-13, SOO. Is pulse pressure of value?

Describe how pulse pressure can be used to interpret vitality of brain functions. Reference scientific papers to back up claims.

None.

26 SF33, p. 2. Is there a response due on July 14th as well? Or is the proposal due date August 7?

Questions were due on 14 Jul 2017 but no other response was required. None.

27 SF33, p. 7, SOO, Section 3.0, para. 4.

The restrictive specs of the desired system (<0.5 pounds, volume of less than 11in3, minimum of 150 assessments on one battery life, etc.) means that each system will have a single function out of those desired in this RFP (intracranial pressure, cerebral blood flow, cerebral oxygenation, heart rate variability, electrocortical activity, extra-vascular blood volume, and blood pressure). Will those specs be different if the suggested system can measure several of those parameters in a single device?

No, but keep in mind, these are ideal essential characteristics and the Government realizes that these may not be achievable in the stated timeframe for all devices.

None.

28 SF33, p. 5, SOO, Section 1.0, para. 1.

Just to clarify: While the RFP talks about prolonged field care, the system engineered for this effort should focus on field triage capabilities and not on field monitoring?

The device should inform both triage and treatment decisions that are made by a medic dealing with a casualty that has experienced a moderate to severe Traumatic Brain Injury

(TBI).

None.

29 SF33, p. 2.

Could you please let me know if there are any pre-application requirements for this solicitation? Or, do we just submit the proposal on or before August 7, 2017?

No, there are no pre-application requirements for the solicitation. Offerors will just submit the proposal on or before the proposal due date.

None.

30 SF33, p. 2.

On page 2 of the solicitation it states, “Alternate Proposals:

Only one proposal from each Offeror will be evaluated by the government.” Does this mean that the University [...] as the institution (therefore the ‘Offeror’) can only submit one proposal or does this mean that the P.I. can only submit one proposal?

If the University has multiple PI's working on multiple devices each PI may submit a proposal; however only one proposal per device will be accepted.

None.

31 SF33, pp. 5-13, SOO.

Does the Government require a device that provides an indication of the change in the patient's status based on the physiologic data measured by the device, or just that the device collects and displays the physiologic data itself?

The device should collect and display the physiologic data itself. The data should be easy to interpret by a medic to inform triage and treatment decisions.

None.

Solicitation Attachment 3, Cost/Pricing Template.

The instructions indicate to use a cost template that asks for loaded rate without profit and fully loaded rate. Could you please provide me with more information concerning how to calculate those rates.

Please refer to the following for additional information: FAR Part 31 (for commercial entities), OMB Circular A-122 (for Non-Profits), or OMB Circular A-21 (for Educational Institutions).

None.

Solicitation Attachment 3, Cost/Pricing Template.

Do you have a spreadsheet or template you could share as a guide to preparing the time phased breakdown of labor? No. None.

Solicitation Attachment 3, Cost/Pricing Template.

Also, I need a listing of labor categories for the cost pricing template.

The Offeror should propose the personnel required to complete the effort in accordance with the Offeror's own statement of work (SOW).

35 SF33.

I am unclear regarding how we can complete the SF33 since it is in .pdf. I presume that we are supposed to complete the middle of the form as ‘offeror’. However, the form is in .pdf and we are unable to complete the information.

In MS Word page 1 of the SF33 is an image and cannot be manipulated. Offerors generally utilize the 'add text' feature of Adobe to complete the page 1 sections, or, print and write directly on the form, then scan it in as a PDF for submission.

None.

36 SF33.

Could you please provide a checklist of information you require for the first application?

• Is it just financial details you need at this stage?

• I don't see any area for supporting information regarding the company, plans etc. Do we/ can we produce a supporting document and is there a preferred format to this?

All of the documentation required for the submission of a complete proposal package is shown in the table in Section L of the SF33, Proposal Submission. Additional details regarding the specific documents are provided in the Non- Cost/Price Proposal Content Instructions. Financial details are not solely what is required, we require all items shown on the aforementioned table. The Government will perform the evaluation on the requested documentation and in accordance with Section M of the SF33.

None.

37 SF33, p. 80, FAR clause 52.204-8. Does the company applying have to be 1000 employees big? No. None.

38 SF33, pp. 5-13, SOO.

Target population:

• Please define the target population of “moderate to severe TBI” (e.g., prior long-term LOC, currently unconscious, etc.) at the time of evaluation.

• Would a device intended for a population with a GCS of 7 to 12 best meet the requirements as opposed to a higher GCS?

• How important, if at all, would this device be for a patient population with a GCS below 7?

• Would inclusion of a GCS of 13-15 be helpful for the device?

1) The chart at the following URL shows classification of TBI.

(URL: https://www.fallenheroesfund.org/getdoc/c6ec7636- 1bfb-4dd0-b212-9f24ff56acd1/tbi.aspx) NOTE: The chart has also been included at the end of this document. 2) This effort is focused on Moderate to Severe TBI. 3) Very important. 4) Inclusion of GCS 13-15 is currently out of scope of this effort.

None.

39 SF33, pp. 5-13, SOO.

How would you rate the importance to the military for each of the below (Very High, High, Medium, Low, Very Low)

• An initial, objective marker after injury that indicates the likelihood of a service member being CT+.

• An objective marker that indicates the level of functional impairment.

• Progression over time of likelihood of being CT+.

• Improvement/worsening over time of functional impairment.

1) Very High

2) Medium

3) Very High

4) Medium

None.

40 SF33, pp. 5-13, SOO.

How would you rate the importance to the military of multi-modality of physiological parameters (Very High, High, Medium, Low, Very Low)

• Benefit of independently-displayed physiological parameters.

• Benefit of combined physiological parameters shown as a unique measure.

1) Very High

2) Medium None.

41 SF33, pp. 5-13, SOO.

Interval measurement vs. continuous monitoring.

• Is there preference for interval measurements vs.

continuous monitoring?

• If repeated measurements, what is the minimum frequency of (shortest interval between) measurements?

1) Continuous monitoring is preferred. Decision of interval measurement vs. continuous monitoring should be made based on meeting target essential characteristics shown in section 3.0 of the SOO including but not limited to weight, size, number of assessments, etc.

2) Clinical practice guideline states that patient will be remeasured once every hour. A prolonged care scenario can last over 72 hours in duration.

None.

42 SF33, pp. 5-13, SOO.

How important is the requested ability to measure/monitor during transportation? (Very High, High, Medium, Low, Very Low)

High None.

43 SF33, pp. 5-13, SOO.

What form of transmission/communication is the RFP referring to given that the device should not emit any radiofrequency signatures? Does this mean that any such transmission capability would be needed, and if so would it require a non-wireless mechanism?

Any wireless capability including "Point to Point" will require compliance to the US Army's Risk Mitigation Framework (RMF) protocol. List current classification of wireless specifications (e.g.: Bluetooth, wide band, etc.) used in your technology in the submission. Wireless capability should not require cloud usage or connection to the Army network.

None.

SF33, p. 8, SOO, Section 5.0, para.

5.1.1.

Within 45 days an initial prototype demo is required. What is the expected readiness level for the Deliverable 1 as described in the solicitation? If the system includes estimation of a clinically-relevant parameter based on correlation to other directly measured parameters, is it expected that the correlation is fully developed for the initial prototype?

Technology Readiness Level 6; Correlation should be fully developed for the initial prototype. None.

45 SF33, pp. 5-13, SOO.

A device for TBI assessment based on derived parameters will require a certain level of sophistication and more importantly clinical data to 1) prove the technical hypothesis and 2) define and refine a final algorithm. Would inclusion of such a clinical study in the proposed program be acceptable?

Yes. None.

46 SF33. Is there a budget cap on the proposal or is there a total budget for this entire solicitation?

This information is internal to the Government and will not be disclosed for this acquisition. Disclosure of this information is common in a grant environment but not in a contract environment.

None.

47 SF33, pp. 5-13, SOO.

Will the medic have another device which can be loaded with controller software and attached to the POI device to control it? Is it acceptable to run a cable controlling/reading from the POI device to said controller device?

The entire system should meet the size and weight essential characteristics in section 3.0 of the SOO. The medic will only be provided a controller if it is a part of the system which you are proposing. Yes, a cable is acceptable for this purpose.

48 SF33, pp. 5-13, SOO. Is it acceptable to have it require battery charging and if so, are there requirements for charging?

Yes this is acceptable. If using only rechargeable batteries, the device should still meet the essential characteristics in section 3.0 of the SOO (150 assessments on one charge).

None.

49 SF33, p. 7, SOO, Section 3.0, para. 4.

Please clarify 11in^3, do you mean 11" x 11" x 11”, or a total volume of 11in^3 (i.e. 2" x 2" x 2.75").

Total volume of 11 in^3 (approximately the size of a smartphone as a reference point).

The SF33, Section C, SOO, section 3.0 has been revised as follows: "• have a volume of less than 11in3 (approximately the size of a smartphone) stored or expanded for use;".

50 SF33.

Does the proposer need to include a subcontractor build up?

If required, please provide an address for the subcontractor to send a sealed package with their proprietary rates.

The Offeror does not need to include a subcontractor buildup;

however the Offeror should perform their own analysis of the subcontractor's price. The Offeror is required to complete the Cost/Pricing Template. Tab 2 (Other Direct Costs) of the template requires the Offeror to identify the subcontractor, the task(s) the subcontractor will perform, the price, and the Offeror's basis for determining the subcontractor's price to be fair and reasonable.

None.

51 SF33, p. 2. Is there a reason for fixed price instead of cost plus fixed fee for this activity?

Yes. The Government determined that a firm fixed price (FFP) contract was suitable for the requirement. None.

52 SF33.

Is this announcement aimed at companies that have already have a working device that just needs some modification? Or would it be appropriate for a team such as ours that would have to create a new device based on our existing technology?

This announcement is aimed at companies that already have a working device that just needs some modification. System should currently be at technology readiness level 6.

Added the word "currently" to the following sentence: "The device shall currently be at technology readiness level 6 or greater for the purpose of reducing risk and shortening the time between program start and product fielding." (Reference SF33, Section C, SOO, Section 3.0, para. 1.)

53 SF33. Is there an approximate funding ceiling that is associated with this contract?

This information is internal to the Government and will not be disclosed for this acquisition. Disclosure of this information is common in a grant environment but not in a contract environment.

None.

54 SF33, pp. 5-13, SOO. You do want the device to be compliant with FDA QSR and ISO 13485? Yes.

Added the following statement to the SOO: "The device shall be compliant with the FDA Quality System Regulation (QSR) and International Organization for Standardization (ISO) 13485." (Reference, SF33, Section C, SOO, Section 3.0, new para. 3.)

55 SF33, p. 7, SOO, Section 3.0, para. 4.

The desired volume stated in the solicitation is for the volume of the product to be less than 11 in3. Just to be clear, are you saying the desire is for the product to be along the lines of 2”x 2”x 2.75” (as opposed to 11“x 11” x 11”)?

Total volume should be 11 in^3 (approximately the size of a smartphone as a reference point).

The SF33, Section C, SOO, section 3.0 has been revised as follows: "• have a volume of less than 11in3 (approximately the size of a smartphone) stored or expanded for use;".

56 SF33, p. 7, SOO, Section 3.0, para. 4.

If the volume is to be less than 11 cubic inches, is it acceptable for the device to be stored at this size and then expanded for use (such as a cap or headband) or must the unit be essentially a hand-held device?

Acceptable for the device to be stored at this size then expanded for use.

The SF33, Section C, SOO, section 3.0 has been revised as follows: "• have a volume of less than 11in3 (approximately the size of a smartphone) stored or expanded for use;".

57 SF33, p. 7, SOO, Section 3.0, para. 4.

Could you be more specific on what is meant by “does not emit a radio frequency signature”? Would using an RF absorbing material to minimize RF propagation be acceptable? Is the requirement for zero radio frequency signature or is there some defined distance where a low level of RF signal could be tolerated? In other words, is any RF-based technology unacceptable?

Any wireless capability including "Point to Point" will require compliance to the US Army's Risk Mitigation Framework (RMF) protocol. List current classification of wireless specifications (e.g.: Bluetooth, wide band, etc.) used in your technology in the submission. Wireless capability should not require cloud usage or connection to the Army network.

None.

58 SF33, p. 7, SOO, Section 3.0, para. 4.

Battery life is to be for a minimum of 150 assessments. Can you please clarify your definition of assessments? Are you talking about (a) 150 samples read, (b) assessments of 150 patients (which may include multiple samples per patient) or

(c) where a TBI has been determined to be present in 150 patients (which may involve multiple patients who have a negative diagnosis for TBI) or (d) some other measure?

150 samples read.

The SOO has been revised as follows: "• can conduct a minimum of 150 assessments (i.e. samples read) on one battery life;". (Reference SF33, Section C, SOO, section 3.0, para. 5).

59 SF33, p. 7-8, SOO, Section 3.0, para. 4.

What is meant by “have the ability to be calibrated by a DoD Biomedical Equipment Specialist in the field”? Are you talking about a repair depot away from the fighting field, or potentially during combat operations?

During combat operations. None.

60 SF33, p. 7-8, SOO, Section 3.0, para. 4.

On the requirement that “[c]alibration does not require any specialized equipment”; could you clarify what is meant by specialized equipment? For example, would standard laboratory equipment such as oscilloscopes and RF spectrum analyzers be considered specialized equipment?

Please list all equipment required to validate device readings and required to calibrate the device in your proposal. None.

61 SF33, pp. 5-13, SOO.

Is the intent to have an FDA approved item at the end of the 18 months, including any clinical trials that might be required?

If so, can the costs of such trials to be included in the proposal? In the event the FDA requires a trial that lasts longer than 18 months, or takes longer to approve the product, would that be considered non-performance?

No the intent is not to have an FDA approved item at the end of the 18 months. The intent is for device refinement to meet the stated essential characteristics in section 3.0 of the SOO.

None.

62 SF33, p. 102-103, Section 'Volume III', b.

For some services, we plan on using sub-contractors with specific relative experience. Can the experience and references for these sub-contractors be included in the “past performance” evaluation or must such performance be specific to the offering organization?

"Offerors shall submit no more than 3 references for its own performance and no more than 2 references for each subcontractor performing 30% or more of the overall effort."

Complete past performance criteria can be found in the SF33, Section L, Proposal Submission, section 'Volume III - Past Performance', b. Past Performance References.

SF33, p. 7, SOO, Section 3.0, para. 1.

SF33, p. 28, FAR clause 52.227-11, -11 Alt I, & -11 Alt II.

At the end of the 18 month timeline, if the company's product has fulfilled the requirements of TRL-6 (Technical Readiness Level), and the product is not chosen to continue by the U.S.

Army, who maintains ownership of the device, data, and patent? Would the government consider writing a clarification of the relevant policy?

Page 7 in the "Objectives section 3.0

The Contractor will maintain ownership of the device, data, and patent; however, the Contractor should provide data in accordance with CDRL A0001 (Exhibit A) and the contract clauses. The clause cannot be revised.

None.

SF33, p. 28, FAR clause 52.227-11, -11 Alt I, & -11 Alt II.

If contractor files a patent during the contract period, is it required that the government be listed on it? Can patent costs be put in the cost basis of the proposal, or are patent cost considered to be overhead assuming that the information contained in the patent application is for the protection of the proprietary value of the device?

No. Patent costs should not be included in the proposal. None.

65 SF33.

Do written or verbal negotiations by either the company or the government take place after the proposal submission and before starting the contract is awarded? How are these subsequently added to the contract?

"The Government intends to award without discussions.

Offerors shall provide their best, complete proposal upon initial submission. If discussions are required they will be conducted with Offerors in the competitive range to the extent deemed necessary by the Contracting Officer in accordance with FAR 15.306. Discussions will be conducted on the content of the proposal and, if discussions have been conducted, a Final Revised Proposal (FRP) will be solicited from those Offerors within the competitive range. A common cut-off date will be established for receipt of all FRPs."

(Reference SF33, Section M.)

None.

66 SF33. Since this is a fixed price contract, how are add-ons and changes dealt with?

Changes will be handled in accordance with FAR clause 52.243-1 Alt V 'Changes--Fixed Price'; incorporated into the solicitation by reference. (Reference SF33, section I.)

None.

67 SF33, pp. 101-102.

Will a proposal be deemed "Unresponsive" if it contains just a brief Quality Control Plan and Approach and we state that implementation of the plan is contingent on receiving the award?

"The Offeror’s quality control approach will be evaluated for the degree to which it demonstrates the Offeror’s approach as it pertains to quality control. The Offeror’s quality control approach will be evaluated for the degree to which it demonstrates how the Offeror’s approach to quality control identifies processes, procedures, and metrics which are likely to result in a successful outcome at the agreed upon price and on schedule." "The QCP will be evaluated as part of the quality control approach. The Offeror’s QCP will be evaluated for the degree to which it demonstrates their Quality Control approach. The Offeror’s quality control approach will be evaluated for the degree to which the QCP demonstrates the self-inspection plan and the outline of the procedures that the Offeror will use to maintain quality, timeliness, responsiveness, and customer satisfaction." (Reference SF33, Section M.)

68 SF33, p. 5-6, SOO, Section 1.0, para. 4.

How many maximum down select prototype contracts are anticipated? What is the down select criteria for the follow-on contract?

The Government can only answer questions related to this solicitation and cannot address questions related to possible future requirements at this time.

None.

69 SF33, p. 6, SOO, Section 2.0, para. 2.4.

Will the Government provide written details of the desired refinements?

Written details of the desired refinements have been provided. See section 3.0 of the SOO (Essential Characteristics).

None.

SF33, p. 8, SOO, Section 5.0, para.

5.1.3 .

Is the consumables supply to be 15 uses per device or 15 total?

The consumables supply should be for 15 uses per device (total of 45 consumables, reference SOO 5.1.3).

The following statement has been revised as follows:

"Consumables, if applicable, shall be sufficient for at least 15 patient uses of each device (total of 45 consumables for this deliverable)." (Reference SF33, Section C, SOO, Section 5.0, para. 5.1.3.)

SF33, p. 10, SOO, Section 5.0, para.

5.1.15.

Why does the government need a spend plan for a Firm Fixed Price contract? Does the government intend the contractor to propose a milestone FFP schedule?

The Government uses the Spend Plan to track disbursements and ensure that spending is being executed in accordance with Fiscal law. The Government does not intend the contractor to propose a milestone FFP schedule.

None.

SF33, p. 11, SOO, Table 1, Deliverable 7, Quality Assurance Plan.

Quality Assurance is performed by the Government, assume the intent is for a Quality Control Plan?

Quality Assurance Surveillance is performed by the Government. The intent is for a Quality Assurance Plan (QAP). The Government will use the QAP to develop a Quality Assurance Surveillance Plan (QASP).

None.

SF33, p. 24, USAMRAA clause 'Regulatory Rights in Event of Product Development Failures, para. b.

This provision conflicts with the SOO. The SOO allows that the product not be ready for FDA full marketing approval at the end of this initial contract. Please remove.

The SOO does allow that the product not be ready for the FDA full marketing approval; however, the devices offered may be in varying stages of preparedness for FDA submission/approval.

Changed "expected" to "a possibility" for the following sentence: "It is a possibility that this contract will result in the FDA clearance and commercialization of the Point of Injury Device to Measure and Monitor Physiological Parameters Relevant to Moderate-Severe Traumatic Brain Injury (POI TBI or the “Technology”)."

74 SF33, p. 30, FAR clause 52.209-1. What specific qualifications does this clause refer to?

Upon further review the Government determined that the clause is not applicable. The acquisition is not subject to a qualification requirement because is a research and development effort and not a production effort.

Clause removed.

75 SF33, pp. 31-23, FAR clause 52.209-4.

The clause conflicts with the SOO. The initial prototype submission is to be demonstrated within 45 days of delivery and is not necessarily the final product that would be subject to first article testing. Other paragraphs within this clause also conflict, the First article may be used as part of final contract quantity. First Article testing is normally used for full rate production contracts, not prototypes.

Upon further review the Government determined that the clause is not applicable. The acquisition is for a research and development effort to refine an existing product, and is not a production effort.

Clause removed.

76 SF33, p. 99, Table of Proposal contents.

Table conflicts with SOO deliverable table (pg. 11) for Quality Control Plan (assuming question #5 is correct). Is a QC Plan required with proposal submission or after award?

A Quality Control Plan is required with proposal submission. None.

Solicitation Attachment 1, Small Business Utilization.

The percentage fill-ins in paragraph (a) appear to have three factors, but there are really only two factors, “Percent work by Small Business” and “Percent work by Large Business”

There are two areas that the Government is asking the Offeror to identify. (1) The overall percentage of work that is being performed directly by the Offeror (i.e. the Prime); (2) The percentage of work being performed by subcontractors.

This subcontractor area is then broken down into subcontractors that are small businesses and subcontractors that are large business. In any event, all fill-ins on the attachment should be completed by the Offeror.

None.

Solicitation Attachment 1, Small Business Utilization.

Assume the Small Business Participation will not be evaluated since it is not mentioned in the Basis for Award (Section M) and no socio-economic subcontracting goals were provided. Please confirm.

FAR clause 52.219-8 is included in this solicitation (reference SF33, p. 28). The clause discusses the Government's policy to have small business participation in contracting to the maximum extent practicable and says in part: "The Contractor hereby agrees to carry out this policy in the awarding of subcontracts to the fullest extent consistent with efficient contract performance. The Contractor further agrees to cooperate in any studies or surveys as may be conducted by the United States Small Business Administration or the awarding agency of the United States as may be necessary to determine the extent of the Contractor's compliance with this clause." Small Business Participation is not an evaluation criteria; however, the Government still requires the Offeror to complete and submit Attachment 1. Additionally, the Contractor will be required to comply with FAR clause 52.219- 8 (SF33, Section I).

None.

Solicitation Attachment 3, Cost/Pricing Template, Other Direct Costs tab.

Government Furnished Contractor Acquired Property does not normally apply to Firm Fixed Price contracts. Does the Government intend that equipment purchased for the purpose of completing this contract become the property of the Government, and therefore deliverable to the Government at the conclusion of the contract? What if equipment purchased during the life of this contract and used for the purposes of this contract but is replacement of existing equipment, does that become Government property, and if not how is it accounted for?

The Government does not intend to furnish property under the contract. Due the statutory requirements all clauses related to Government Property must remain in the solicitation.

The Government Furnished Property section has been removed from the Cost/Pricing Template.

SF33, p. 14, SOO, Section 6.0, para. 3.

Solicitation Attachment 3, Cost/Pricing Template, Other Direct Costs tab.

The SOO calls for two trips to Ft Detrick for up to 3 individuals for one day but the Attachment 3 appears to anticipate 3 trips with no designated number of individuals or number of days.

Should the offeror only price out two trips? Also Attachment 3 calls for a justification for the trip, but our understanding is that the purpose of the trip is to demonstrate the device.

Please clarify.

The Offeror should price out two trips. The Offeror should propose the number of Contractor employees (up to 3) and number of days required for the demonstration. The spreadsheet has been revised to align with the trip information in the SOO. While the justification is stated in the SOO, Offerors should fill in the justification on the cost/pricing template to confirm their understanding of the travel requirements.

Deleted the 'Trip 3' column from the spreadsheet. Input '1' for 'No. Trips per Period' for Trip 1 and Trip 2 columns since the Contractor will only make one trip for each of the two demonstrations.

Solicitation Attachment 3, Cost/Pricing Template, Other Direct Costs tab.

Since the Government requires the Travel cost be in accordance with FAR Part 31, can the offeror use the per-diem rates for the Frederick, MD lodging, meals, and incidentals for purposes of proposal pricing? Travel will be a cost reimbursable expense and actual costs may be slightly different at the time of travel.

Yes, the Offeror can use the per-diem rates for Frederick, MD for lodging, meals, and incidentals for purposes of proposal pricing.

None.

Solicitation Attachment 3, Cost/Pricing Template, Other Direct Costs tab.

Does the government require that all subcontractor costs be on a FFP basis between the Prime and the Sub (Line 9 of the template). If the basis for fair and reasonable determination is “competition” (FAR 15.404-1(b)(2)(i)), does the Government need to see the competitive quotes? What documentation does the Government need to see if the Basis is any of the other techniques (FAR 15.404-1(b)(2)(ii) thru (vii).

No, the agreement between the Prime contractor and their subcontractor can be a fixed price type contract or a cost type contract; however, the agreement between the Prime contractor and the Government will be firm fixed price so changes in subcontractor costs/pricing post award will not impact the dollar value of the contract between the Government and Prime contractor.

None.

Solicitation Attachment 3, Cost/Pricing Template, Labor tab.

The instructions say “The subtotal column is intended to provide the rate without profit included so it can be identified as a separate amount in the award.” How does the Government intend to identify the rate without profit in a Firm Fixed Price Contract Line Item? Why would this matter to the Government as long as the overall price can be determined fair and reasonable?

The Government intends to identify the rate without profit in the Contract Line Item Number (CLIN) structure. Comparison of proposed prices with prices obtained through market research is one of the price analysis techniques used by the Government.

None.

Solicitation Attachment 3, Cost/Pricing Template, Labor tab.

The instructions say “The rates in the total column will be used to compare the proposed rates to the base contract maximum rates, which include profit.” To what “base contract” is this referring and what are the “maximum rates”?

This statement was included in error and has been removed.

Deleted: "The rates in the total column will be used to compare the proposed rates to the base contract maximum rates, which include profit."

SF33, p. 17, USARMAA Instruction 'Reports, Manuscripts and Public Releases' para. b.

Provide courtesy copies of Reports, manuscripts and public releases to the COR. Are the “courtesy copies” considered deliverables?

They are not considered "deliverables"; however, the "courtesy copies" are required per the included clause. (ref.

Reports, Manuscripts, and Public Releases (June 2015) (USAMRAA) clause).

None.

SF33, pp. 22-23, 'Prohibition of Use of Human Subjects, para. 2.

USAMRMC ORP “conducts site visits as part of its responsibility for research compliance. Will FDA/USAMRMC ORP conduct site visits during prototype development and production?

FDA/USAMRMC ORP will not conduct site visits during prototype development. And production during this contract period.

None.

SF33, p. 22, USAMRAA Instruction 'Prohibition of Human Research', para. 2. (p.

24??)

Office of Research Protections provides research authorization - “IAW the protocol”; “human research study”. Is the “human research study” a deliverable? It is not currently identified as a deliverable. What contractor reports/data does ORP use to grant research authorization?

The "human research study" is not a deliverable. The second question is not applicable based on the answer to the first question.

SF33, pp. 24-25, USAMRAA Instruction 'Regulatory Rights in Event of Product Development Failures'. SF33, p. 9, SOO, Section 5.0, para. 5.1.9.

The contractor is the sponsor of the Regulatory Application to the US FDA. It appears that the CO requires copies of application documents? They are transferable at the end of the contract, however, are not identified as deliverables. Are they included as attachments to the Regulatory Strategy deliverable (Deliverable 9)?

No, they are not included as attachments to the Regulatory Strategy deliverable (Deliverable 9). These applications are out of scope of this solicitation; however, if regulatory applications to the US FDA occur during this contract period they are required. While not included on the list of deliverables they are required per the contract clause/instruction and should be submitted in accordance with the contract clause/instruction.

None.

SF33, pp. 50-51, DFARS clause 252.227-7013, para.

(a)(8)(ii).

252.227-7013 RIGHTS IN TECHNICAL DATA--

NONCOMMERCIAL ITEMS (FEB 2014) Since this clause is included, does the government expect the contractor’s cost proposal to consider/incorporate these expense determinations? “Private expense determinations should be made at the lowest practicable level.”

No. None.

90 SF33, p. 75, DFARS clause 252.227-7039.

252.227-7039 PATENTS--REPORTING OF SUBJECT

INVENTIONS (APR. 1990) The Contractor shall furnish the Contracting Officer the following: (a) Interim reports every twelve (12) months (or such longer period as may be specified by the Contracting Officer) from the date of the contract, listing subject inventions during that period and stating that all subject inventions have been disclosed or that there are no such inventions. (b) A final report, within three

(3) months after completion of the contracted work, listing all subject inventions or stating that there were no such inventions. Are these reports deliverables?

Yes, while not included on the list of deliverables they are required per the contract clause and should be submitted in accordance with the clause.

None.

SF33, p. 99, Proposal Submission, para. 1.

SF33, p. 102, Section 'Volume II(b)', para. a.

There appears to be conflicting format information in Section L and the SOO. Please clarify:

(Pg. 99) Section L - Instructions, Conditions and Notices to Bidders The proposal shall be submitted in Times New Roman font, size 11, with 1” margins.

(Pg. 102) Statement of Work (SOW): (Tech Volume Attachment) The Offeror shall provide a SOW as an attachment to the Technical Volume. The SOW shall be in Times New Roman font, size 10…with one inch margins.

The differing instructions are intentional. The Contractor's SOW will be incorporated into the contract in full text. The Government's contract writing system is very restrictive in terms of accepted formatting (i.e. font size, font type, page layout, etc.). Section C of the SF33 shows the area reserved for the Contractor's SOW. The rest of the proposal should be submitted in the format stated on page 99 of the SF33, Proposal Submission, para. 1.

SF33, Section L, Proposal Submission, changed "Administrative Format Instructions" to "Proposal Format Instructions". SF33, Section L, Proposal Submission, a second paragraph has been added as follows: "Special formatting and submission instructions for the Statement of Work (SOW): The SOW should be submitted in MS Word 2003 or higher, but not greater than MS Word 2010 format.

The SOW should be in Times New Roman font, size 10 and should not contain a table of contents or any images imbedded into the document. Only basic tables with single, thin borders and no shaded cells created in Microsoft Word are accepted. The font must be black without any highlighting with 1 inch margins. Text must be left-aligned." SF33, Section L, Proposal Submission, Section 'Volume II(b)', para.

a. The following statement has been added to the paragraph:

"The SOW should be submitted in MS Word 2003 or higher, but not greater than MS Word 2010 format."

92 SF33.

We understand it is not the government’s intent to provide access to facilities, but will provide subject matter expertise related to protocol development, monitoring of clinical sites and manufacturing. One of the key items for revision of the prototype will be development of design specifications. It would be enormously important to take into account the workflow, skill sets and working conditions in which the end users will operate.