RFP for Burn Wound Imaging Technology.pdf

75A50123R00002 Burn Wound Imaging Technology

NOTE TO OFFERORS

The information in SECTION A - Solicitation/Contract Form, contains important information for any Offeror interested in responding to this solicitation. Any contract resulting from this solicitation will include in its SECTION A - Solicitation/Contract Form, accounting, appropriation and general information applicable to the contract award.

If your proposal is not received by the Contracting Officer (CO) or his/her designee at the time and place specified, it will be considered late and handled in accordance with the Federal Acquisition Regulation (FAR), FAR 52.215-1 (Instructions to Offerors – Competitive Acquisition), the Health and Human Services Acquisition Regulation (HHSAR)

Potential Offerors must be registered in the System for Award Management (SAM) prior to award of a contract.

The contract schedule, set forth in SECTIONS B through H, contains contractual information pertinent to this solicitation. It is not an exact representation of the contract document that may be awarded as a result of this solicitation. The contract cost or price and other contractual provisions unique to the Offeror's proposal may be included in the resultant contract.

The contract schedule is intended to provide the Offeror with information to aid in understanding the likely terms and conditions of any resultant contract.

The cutoff date for all questions on this RFP is August 1, 2023, at 12:00 PM ET. All questions shall be submitted via e-mail to Kevin.Dean1@hhs.gov and Jonathan.Gonzalez@hhs.gov. The due date for all proposal submissions is September 1, 2023, at 4:00 PM ET. All proposals must be submitted via email to Jonathan.Gonzalez@hhs.gov and Kevin.Dean1@hhs.gov. The submission email must include business and technical proposal documents as separate documents.

mailto:Kevin.Dean1@hhs.gov mailto:Jill.Johnson@hhs.gov

PART I – THE SCHEDULE

SECTION B – SUPPLIES OR SERVICE AND PRICE / COST

B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

Treatment and care for burn injuries is both resource and labor intensive. The national capacity is typically limited and presents a significant limitation to when a sudden surge capacity is required in a burn mass casualty incident (BMCI). A BMCI in a geographic area could overwhelm a regional existing capacity and present to substantial resource constraints. To mitigate this challenge, BARDA has collaboratively worked with the burn care community to identify areas of improvement in the delivery of this care. This collaboration has identified numerous area which BARDA has systematically addressed over the years. However, to date, a systemic capability within burn care to provide early, accurate assessment of burn size and the ability to provide clinical guidance on prognosis of burn wound healing largely does not exist. Building these two important capabilities within the burn care treatment paradigm would be expected to have cascading effects across the burn care continuum. For example, the current standard of care for these assessments largely relies on visual clinical judgement based on the experience of the care providers. Studies have shown that even trained burn specialists have only modest 70% accuracy in their visual clinical judgement, while the frontline emergency physicians though relatively broadly trained but inexperienced in burn care function with just 50% accuracy in their capability. Experts believe this gap has big implications even in cost of routine care and efficiency within the healthcare but passes of relatively undetected due to the lack of alternatives and the inability to track the cost of poor judgements. However, in a BMCI it would cause significant bottleneck and disruption in the ability to deliver proper burn care. The ability to properly triage burn patients who need timely surgical care or discharged would be critical in use of valuable resources and management of surgical burden.

Even in routine care, it would transform the efficiency in delivery of care from reduction in unnecessary transfers to management of precious burn care resources.

Based on this background, the objective of this RFP is to support development of a novel burn wound imaging technology (BWIT). Development and systematic integration within the care system (emergency departments and burn care centers) would enable building a national infrastructure where the capability for assessment of burn injury size and healing potential would be slowly adopted and integrated as a standard of care. We hope to accomplish this by supporting pivotal studies and advanced development of imaging devices with enhanced artificial intelligence (AI-algorithms). This technology is envisioned as a non-invasive imaging device to rapidly assist emergency physicians on the need to triage patients to more specialized burn centers. It will also help inform burn specialists on the areas of burn injury in need of interventional treatment to achieve definitive healing. Further, with placement of these devices and training users in initial and definitive burn care settings will expand adoption. Under this RFP, BARDA will support advanced development of the imaging devices, manufacturing capability as well as execution of pivotal clinical studies to achieve FDA approval. Additional post-marketing studies if required as well as placement of devices in additional initial and definitive care settings to enhance market penetration are included as defined in the scope. Such tasks may also include future enhancements based on insights gained from users that could provide value. Procurement strategies would include use of device lease agreements and maintenance contracts covering the period of performance and the need for transition agreements for placement of devices in initial and definitive burn care settings for routine use. With this strategy, BARDA aims to achieve both availability and familiarity of this BWIT as a MCM to build national preparedness against a BMCI as well as transform the standard of burn care in US.

B.2. PRICES / COSTS

The final contract will contain the price/cost provisions agreed upon by the Government and the Offeror. It is anticipated that the final contract will consist of a base period of performance up to three (3) years and a total contract period of performance (base plus option periods) up to 7 years (but not to exceed 10 years) with the exercise of options.

The Base Period consists of one Cost-Plus Fixed Fee (CPFF) CLIN (0001) to support product development activities, limited manufacturing and building commercial readiness, execution of clinical studies as required by the FDA. Initial procurement of imaging devices required for the clinical studies, training, back up devices etc. are part of this CLIN. Post-approval, studies if required or justifiable are part of two additional but distinct Cost-Sharing optional CLINs (0003 and 0005) to support product optimization. Post-approval studies would require a pre-negotiated cost-share.

Post-approval two distinct Firm Fixed Price (FFP) optional CLINs (0002 and 0004) support future product procurements in a staggered fashion to allow for wider placement into more burn care hospital settings (burn centers and emergency departments) across a greater geographical distribution for increased BMCI preparedness. Procurement strategies (especially post-approval) would include use of device lease agreements and maintenance contracts covering the period of performance and the need for transition all agreements for placement of devices in initial and definitive burn care settings for routine use.

B.2.1. BASE PERIOD

Base Period Cost-Plus-Fixed-Fee CLIN

Anticipated Period of

Performance CLIN Supplies/Services Quantity Unit Price

($) Total ($)

09/29/2023- 09/28/2026 0001

(Base)

Development of BWIT, clinical studies, manufacturing readiness, health economics and initial procurement of up to 30 units devices to support clinical trial

(CPFF)

B.2.2. OPTIONS

Optional Cost-Sharing and Firm-Fixed-Price CLINs

Anticipated Period of

Performance CLIN Supplies/Services Quantity Unit Price

($) Total ($)

09/27/2026 – 09/26/2028

(Option 1)

Additional Procurement (potential to lease) up to 30 units (FFP) 1

09/27/2026 – 09/26/2028

(Option 2) Additional Development (Cost-Sharing) 1

09/25/2028 – 09/24/2030

(Option 3)

Additional Procurement (potential to lease) up to 140 units (FFP) 1

09/25/2028 – 09/24/2030

(Option 4) Additional Development (Cost-Sharing) 1

Total Cost for CPFF CLIN 0001 Total Cost for Cost-Sharing CLINs 0003, 0005 Total Cost for FFP CLINs 0002, 0004

GRAND TOTAL

B.3. ADVANCE UNDERSTANDINGS

The final contract may contain advance understandings between the Government and the Offeror.

Specific elements of cost, which normally require prior written approval of the Contracting Officer before incurrence of the cost will be included in this Section if the Contracting Officer has granted his/her approval prior to contract award.

a. Person-in-Plant

With seven (7) days advance notice to the Contractor in writing from the Contracting Officer, the Government may place a man-in-plant in the Contractor’s or Subcontractor’s facility, who shall be subject to the Contractor’s or Subcontractor’s policies and procedures regarding security and facility access at all times while in the Contractor’s or Subcontractor’s facility. The Government’s representative shall be provided reasonable access, during normal business hours, of the production areas being utilized in performance on the Contract. As determined by federal law, no Government representative shall publish, divulge, disclose, or make known in any manner, or to any extent not authorized by law, any information coming to him in the course of employment or official duties, while stationed in a contractor or subcontractor plant.

An article substantially similar to this Person-in-Plant article shall be incorporated into any subcontract for experimental or manufacturing work.

b. Security

A security plan will be required as part of the contract.

c. Subcontracts

Prior written consent from the Contracting Officer in the form of Contracting Officer Authorization (COA) is required for any subcontract that:

• Is of the cost-reimbursement type and exceeds $250,000; or

• Is of the fixed price type and exceeds $250,000 or 5% of the contract, whichever is less.

The Contracting Officer shall request appropriate supporting documentation in order to review and determine authorization, pursuant with FAR Clause 52.244-2, Subcontracts.

After receiving written consent of the subcontract by the Contracting Officer, the Contractor shall provide a copy of the signed, executed subcontract and consulting agreement to the Contracting Officer within ten (10) calendar days.

Note: Consulting services are treated as subcontracts and subject to the ‘consent to subcontract’ provisions set forth in this Section.

d. Overtime Compensation

No overtime (premium) compensation is authorized under the subject contract.

e. Sharing of contract deliverables within United States Government (USG)

In an effort to build a robust medical countermeasure pipeline through increased collaboration, the Government may share technical deliverables with Government entities responsible for Medical Countermeasure Development. In accordance with recommendations from the Public Health Emergency Medical Countermeasure Enterprise Review, agreements established in the Integrated Portfolio Advisory Committee (PAC) Charter, and agreements between BARDA and the Department of Defense, the National Institutes of Health, the Centers for Disease

Control, and the Food and Drug Administration, BARDA may share technical deliverables and test results created in the performance of this Contract with colleagues within the Integrated Portfolio.

This advance understanding does not authorize the Government to share financial information outside of the United States Government, except as required under law. The Contractor is advised to review the terms of FAR 52.227-14, Rights in Data – General, regarding the government’s rights to deliverables submitted during performance as well as the government’s rights to data contained within those deliverables.

f. Approval of Human and Animal Protocols

The Contractor shall submit all human and animal protocols and human informed consent documents as referenced under this Contract to the COR for review and approval prior to seeking other approvals (Institutional Review Board, Human Use Committee, Institutional Animal Care and Use Committee) unless the contractor already had such approvals prior to contract award. The Government requires no fewer than eight (8) business days to perform a review. The Contractor shall take this review time into account and submit protocols as early as possible to avoid delays. The Government’s comments and feedback shall be addressed prior to approval. The COR will review and provide approval of protocols. Human informed consents shall also be submitted and reviewed with any human protocol.

g. Rights in Data

The contract will incorporate the FAR Clause 52.227-14, Rights in Data—General. The Contractor is advised to review the terms of FAR 52.227-14, Rights in Data, regarding the government’s rights to deliverables submitted during performance as well as the government’s rights to data contained within those deliverables.

h. Invoice Submission during end of Fiscal Year

The government will not accept invoices for processing from Sep 6th through Oct 5th because of end of year fiscal requirements. Any invoices received from September 6th through October 5th will be canceled and returned to the Contractor for resubmission beginning on October 6th.

h.1. Travel Costs

a) Total expenditures for travel (transportation, lodging, subsistence, and incidental expenses) incurred in direct performance of this contract during the Base Period (CLIN 0001) shall not exceed $96,000 (to be determined at the time of award) without the prior written approval of the Contracting Officer. Costs must be consistent with Federal Acquisition Regulations (FAR) 52.247-63 – Preference for U.S. Air Flag carriers.

b) Subject to a dollar limitation of $96,000 the Contactor shall invoice and be reimbursed for all travel costs in accordance with Federal Acquisition Regulation (FAR) 31.2 – Contracts with Commercial Organizations, Sub-Section 31.205- 46, Travel Costs.

c) If foreign travel is necessary, a Contracting Officer Authorization (COA) will be required.

Expenditures for foreign travel (transportation, lodging, subsistence, and incidental expenses) incurred in direct performance of this contract shall not exceed the amount specified in each approved COA, without the prior written approval of the Contracting Officer. For an organization located outside Canada, the United States and its territories and possessions, foreign travel means travel outside that country. Foreign travel must be billed separately from domestic travel.

Requests for foreign travel must be submitted at least four weeks in advance and shall contain the following:

a. Meeting(s) and place(s) to be visited, with costs and dates; name(s) and title(s) of Contractor personnel to travel and their functions in the contract project;

b. Contract purposes to be served by the travel;

c. How travel of Contractor personnel will benefit and contribute to accomplishing the contract project, or will otherwise justify the expenditure of BARDA contract funds;

d. How such advantages justify the costs for travel and absence from the project of more than one person if such are suggested; and

e. What additional functions may be performed by the travelers to accomplish other purposes of the contract and thus further benefit the project.

B.4 ORGANIZATIONAL CONFLICT OF INTEREST

a. General: For the purpose of this provision/clause, “consultant” is defined as a company, firm, LLC, sole proprietor, joint venture member, independent contractor, subcontractor, affiliate, or similar entity that is not an employee of the Contractor.

b. Disclosure: The Contractor shall report contacts with consultants who are paid to furnish advice, information, direction, or assistance to the Contractor or any subcontractor in support of the preparation or submission of the Contractor’s business or technical proposal. The report shall include the following information:

a. The name, title, and contact information for the consultant, including the name and contact information for his/her company/firm/etc.

b. The name, title, and contact information for a Contractor point of contact, including the name and contact information for the prime contractor if the consulting services were received by a subcontractor.

c. The nature of the consulting services received.

c. Resolution: The responsible Contracting Officer will review the Contractor’s disclosure to determine whether an actual or appearance of a conflict of interest exists based on the information disclosed by the Contractor and/or from other sources. The framework for the Contracting Officer’s review will be FAR Subpart 9.5, Organizational and Consultant Conflicts of Interest. If an actual or appearance of a conflict of interest exists, the Contracting officer will take action which may include, but is not limited to, requesting a mitigation plan from the Contractor.

B.5. PROVISIONS TO APPLICABLE COSTS

This section prohibits or restricts the use of contract funds which includes the following items (costs unallowable unless otherwise approved by the Contracting Officer):

a) Acquisition, by purchase or lease, of any interest in real property.

b) Rearrangement or alteration of facilities.

c) Purchase of lease of any item of general-purpose office furniture or office equipment regardless of dollar value.

d) Accountable Government Property.

e) Overtime

f) General scientific meetings/conferences.

g) Travel costs including foreign travel.

h) Costs incurred in the performance of any cost-reimbursement type subcontract (including consulting agreements).

i) Costs to be paid for the performance of a fixed-price subcontract that exceeds $250,000.00;

j) Refreshments and Meal Expenditures.

k) Promotional Items

l) Printing

SECTION C – DESCRIPTION / SPECIFICATIONS / WORK STATEMENT

C.1. STATEMENT OF OBJECTIVES

BACKGROUND and PURPOSE

Treatment and care for burn injuries is labor intensive and influenced by the unique properties of each case with complicating factors including patient age, pre-existing health conditions, burn wound size, depth, and location. The challenges of providing definitive burn care are heightened when delivering treatment after a mass casualty event in a resource strained environment. The anticipated high number of injured in a mass casualty incident especially in a geographical area would pose significant limitations on the ability to provide conventional standards of care for victims.

To mitigate some of these challenges BARDA has collaboratively worked with the burn care community to identify areas to improve the delivery of care and treatment procedures. Two major areas where enhanced medical countermeasures (MCM) can provide a meaningful difference are in the triage of initial care and in a definitive burn care setting.

The objective of this RFP is to build a reliable infrastructure for a non-invasive imaging technology as an MCM within both the initial care (such as emergency departments (ED) as well as definitive care settings (such as burn care centers). Our work in partnership with the burn care community has identified that accurate assessment of burn depth and the ability to provide guidance on prognosis of burn wound healing are two important factors in both initial and definitive care. Health care professionals (HCPs) in EDs do not see the caseloads to be experienced in their ability to assess burn size and depth. In routine ED settings, inaccurate assessments of burn depth and estimation of the burn size have been measured at 50% accuracy. This often results in excess or inappropriate transfer of patients to burn centers for advanced treatments. Or conversely, patients are discharged home who should have been referred to a burn center. Similarly, trained burn care professionals such as burn surgeons are approximately 70% accurate in their assessments on burn depth. This can result in incorrect decisions on the care pathway for their patients. Surgeons have reported situations when surgical interventions were either unnecessary or delayed. Given this data concerning degree of inaccuracy in initial burn wound assessment during routine care, the current standards of care for burn wound depth assessment and burn size are inadequate and would result in significant triage challenges in a burn mass casualty.

Under this RFP, BARDA plans to establish a deployed vendor-managed inventory (VMI) system to accelerate the integration of the newly developed technology within the health care system. A deployed vendor-managed inventory requires the vendor (Offeror or subcontractor) to deploy the device units procured by BARDA at various locations (such as ED or burn centers) where these units could be integrated into routine care use. The vendor remains responsible for the management, maintenance of its full functional performance of such deployed inventory. Upon FDA clearance, additional device procurements and training studies would be required. The additional real world performance data shall continue to drive and further enhance the predictive capability of the underlying algorithm as well as improve user familiarity and functionality. In combination with other efforts, this device will enhance the overall capability of burn care specialists and emergency physicians to provide better overall burn care reliably and effectively. It will also help both in build national preparedness in the event of a burn mass casualty incident.

SCOPE

This RFP focuses on supporting late-stage development leading to the Offeror achieving marketing clearance for a non-invasive burn wound imaging device from the FDA. Critical attributes of the device shall include the capability to provide guidance on estimating size as well as its healing potential (based on characteristics such as depth severity and data driven prognosis). The following areas of work are considered within the overall scope of this RFP:

a) Advanced development work may include both device and software development to achieve reliable performance metrics of the underlying technology, advancements in hardware, design, imaging and encoding the machine learning AND predictive algorithms. The device shall achieve reliable and robust demonstratable capability to provide superior and reliable guidance to HCPs in their respective care settings such as the ED and burn care centers.

b) All required clinical studies to demonstrate the technological superiority over the current standard of care such as by clinical validation studies or bench-top testing and/or other analyses as part of the FDA approval process.

c) Limited clinical-scale manufacturing of commercial-ready devices as well as technology transfer processes to scale-up the manufacturing and release of devices.

d) Operational regulatory and (QSR) quality management infrastructure.

e) Distinct health economic studies to establish the value proposition and cost effectiveness to a healthcare setting from integration of the device shall be assessed.

f) Execution of post-marketing requirements and commitments or other studies deemed valuable to enable product integration and adoption in routine care.

g) Capability development for manufacturing at commercial scale to support additional procurements and integration in health care. Such capabilities shall also include product support and service functions, continued oversight over the product life cycle, continued algorithm refinements and system/firmware upgrades or bug-fixes.

h) The device must be ready for additional functionalities of injury / disease condition evaluations which are critical for market sustainability of the product but not directly funded under this potential award. Examples of such market sustainable indications include but are not limited to detection of diabetic foot ulcers, ischemic injury, or lower extremity amputation guidance.

To meet the scope outlined above, Offeror shall address the objectives outlined in the following six sections. Note that section 6 is not a Contract Option and has required objectives for all options.

Proposals will be evaluated by the USG on their ability to meet these objectives as described below:

Section 1: Late-stage Product Development Objectives and Initial Product Procurement for Placement in Clinical Sites (CLIN 1) Section 2: [Contract Option] Post-Approval Procurement Objectives (CLIN 2) Section 3: [Contract Option] Post-Marketing Commitments and/or Requirements (CLIN 3) Section 4: [Contract Option] Additional Procurements (CLIN 4) Section 5: [Contract Option] Additional Development (CLIN 5) Section 6: Program Management and Risk Mitigation Objectives (All CLINs)

1) Late-stage Product Development Objectives (CLIN 1) Independently, and not as an agent of the USG, the Offeror shall furnish all the necessary services, qualified personnel, materials, supplies, equipment, facilities, transportation, and travel not otherwise provided by the USG as required to fulfill the programmatic objectives.

a) General Product Development Objectives

i) Critical attributes of the device shall include the capability to provide guidance on estimating size as well as its healing potential (based on characteristics such as depth severity and data driven prognosis).

ii) The product shall at minimum be in an active clinical Phase development ready for execution of pivotal studies with data available to support the intended purpose (defined in section 1).

The Offeror shall demonstrate sufficient advancement in device development, capability in software development and algorithm development for image processing as well as management of clinical study data to support the product’s intended indication. The Offeror should have discussed the product development and regulatory strategy with the FDA.

iii) The product shall have the potential for use in both adults and special populations (pediatrics, immunocompromised, elderly). It would be acceptable for the Offeror with a product under development to have only limited data but with a plan for addressing the needs for special populations.

iv) The Offeror must describe how the proposed product function would:

(1) Address the problems identified in the purpose and challenges within the burn care system.

(2) Enhance the adoption for use in routine care within the burn care community in different care settings such as in EDs and burn centers.

(3) Enhance the national capacity and readiness to treat burn patients in a mass casualty event. Enhancements in readiness shall be demonstrable based on the product’s attributes. Other potential indirect impacts resulting from largescale adoption of the product could be documented separately as well. Some aspects relevant to enhancing national preparedness include:

• Better triage and transfer process in delivery of burn care

• Decrease in resource burden and increased capacity to deliver care

• Decrease in the length of hospital stay as compared to standard of care.

• Better management /reduction in the needs for surgical infrastructure resources

• Reduction in the need for surgical personnel trained for burn care

• Reduction in the need for autografting or other definitive care products as compared to SOC

• Reduction in patient morbidity and use of pain medication

• Ability to achieve wound closure and healing when compared to SOC.

• Improved functional and /or cosmetic outcome

• Product sustainability data such as integration of product into current procedures and compatible with current clinical skills

• Potential to reduce the overall cost of burn care for the patient

v) As part of the product development plan, the Offeror shall conduct Health Economics and Outcomes Research (HEOR) studies to assess the impact on the cost of care compared to the alternative or SOC to demonstrate the value proposition of the product in burn care. Such studies shall lead to modeling the cost-effectiveness analysis (CEA) and budget impact modeling to enable product adoption in the different care settings.

vi) The Offeror shall demonstrate applicability of their product for other indications in the commercial market sector, the development status, and the potential organizational and financial wherewithal to achieve success.

b) Regulatory and Quality Systems for Execution of Software Development and Clinical

Objectives

i) The Offeror shall submit a Quality Management System (QMS) [ Ref. QMS; 21 CFR Part 820; ISO 13485:2016 (optional)] plan led by an adequately resourced team of qualified, competent personnel to execute the program.

ii) The Offeror shall provide a clear and comprehensive regulatory master plan for obtaining product approval/ clearance. (See item viii)

iii) The statement of work must include a Risk Management Plan (ISO 14971) for risk evaluation of various aspects of the overall product development and execution as proposed. Such aspects should specifically address outstanding items identified by the FDA as well as others identified including but not limited to, clinical studies, performance metrics, software / algorithm development and manufacturing activities, as appropriate. The appropriate milestones for regulatory activities must be included in an overall Gantt chart.

iv) The Offeror shall work collaboratively with BARDA for all regulatory actions and inform BARDA of all communications with the FDA for the specific product under development.

v) The Offeror shall conduct all clinical studies trials following in Good Clinical Practice (GCP) compliance as well with all applicable local, state, and federal rules and regulations and other FDA guidance.

vi) The Offeror is anticipated to be ready to execute pivotal studies. Preliminary studies only required by the FDA or justifiable to de-risk the pivotal study to attain targeted outcomes may be considered. The Offeror shall also provide and be responsible for entire clinical study infrastructure which includes but is not limited to:

(1) Clinical device development and current Good Manufacturing Practice (cGMP) compliant manufacturing and insured delivery to sites and oversight for a fully functional device at the study site throughout the contract period of performance.

(2) Conduct studies in sufficient clinical sites as well as management of subcontractors required for study operations and management of data and statistical services, clinical monitoring, site initiations and electronic data capture, verification of source data and other required steps.

(3) Engagement and partnership with leading investigators from the burn care community.

(4) Establishment of oversight advisory boards.

vii) The Offeror shall retain the required capability for continued development and upgrades to the machine-learning algorithms based on data and support the resultant AI-enabled product functionality.

viii)The Offeror shall be the product sponsor for all regulatory activities ultimately leading to FDA approval and marketing clearance. Such activities include but are not limited to the following:

(1) Establishment of a regulatory strategy and periodic review and realignment.

(2) Communications with the FDA and all required filings after concurrence with BARDA.

(3) Periodic audits of clinical sites and device manufacturers in partnership with BARDA’s Clinical and Quality group following QMS principles.

(4) Adherence to all processes which govern the establishment of safety and effectiveness of the device for marketing readiness including human factor testing and evaluation with a full range of qualified end-users.

(5) Independent oversight into software development following Good Machine Learning Practice (GMLP) and validation and requirements in compliance with FDA regulations.

(6) Independent oversight into management and handling of HIPAA compliant patient data, interfaces with electronic data generated under study with Electronic Health Records (EHR) systems that meet or exceed cybersecurity standards and related risk assessment requirements.

c) Clinical Evaluation

i) The Offeror shall provide a detailed Clinical Development Plan (CDP) which describes the requisite studies (by phase, size, geographies, duration, comparators, etc.) to gain approvals from target regulatory authorities.

ii) The Offeror shall provide an appropriate Statistical Analysis Plan (SAP) detailing primary and secondary endpoints, analysis methods, primary analysis set, pre-defined comparisons and significance levels, exploratory analyses, trial maturity, data sources, population studied, statistical methodology, etc. (as applicable).

iii) The Offeror shall propose adequate implementation and oversight methods by themselves or appropriate sub-contracted vendors to ensure patient safety, data integrity and regulatory compliance.

iv) The Offeror shall demonstrate how the CDP supports the proposed Target Product Profile (TPP) and regulatory filing strategies.

v) The Offeror shall provide a reasonable high level future marketing and commercialization plan to ensure market adoption.

d) Initial Product Procurement (Placement in Clinical Sites for Validation Studies)

i) The Offeror shall partner with a qualified device manufacturer and complete the development of a commercial imaging device ready to enter the validation studies. The device must have the full functionalities to meet the objectives set forth in this document.

ii) The device must be ready for additional functionalities of injury / disease condition evaluations which are critical for market sustainability of the product but not directly funded under this potential award. (See section 2 item h).

iii) The Offeror shall conduct adequate diligent oversight for the device manufacturer in partnership with Quality to ensure readiness for shipment to clinical sites for validation.

iv) The Offeror is solely responsible for ensuring the clinical site readiness including study documentation, execution of the study as well as device training to certify specific users at the site on the use of the device for validation studies. Upon placement of the devices at the clinical sites for validation, the Offeror shall ensure full functionality and qualify of the device including verification that the site personnel are trained and ready to execute the clinical validation study.

v) A critical aspect of this procurement would include the potential to lease the imaging device versus purchasing. The Offeror should present both options and highlight any relevant differences to enable the calculation of life-cycle costs. Post-approval, Offeror shall ensure the devices at the initial clinical sites are ready for commercial use including system upgrades and training requirements.

2) OPTION 1: Post-Approval Procurement Objectives (CLIN 2)

Towards the original goals for preparedness set forth in the SOO, BARDA may consider procurement of additional imaging devices under deployed VMI and establish them into new sites for delivery of burn care. Such sites may be a combination of burn centers and EDs in different settings than the initial sites during the development phase (CLIN 1).

For this Option, the Offeror shall provide a proposal which addresses the following objectives:

a) Initial Procurement and Placement for Delivery of Care

i) When the product achieves 510(k) Clearance for marketing from FDA, BARDA may procure up to an additional 30 device units.

ii) It is anticipated the units would be placed in about 20 to 30 different sites. Some hospitals may have a unit placed in the ED as well as the burn center.

iii) The Offeror is responsible for all technical support for installation and training of the site personnel responsible for delivery of care. Other requirements for fully operational sites include routine maintenance, such as system software updates, troubleshooting and service calls throughout the contract period of performance.

iv) A critical aspect of this procurement would include the potential to lease the imaging device versus purchasing. The Offeror should present both options and highlight any relevant differences to enable the calculation of life-cycle costs

3) OPTION 2: Post-Marketing Commitments and/or Requirements (CLIN 3)

a) Additional Development for Market Integration:

It is anticipated that during pivotal studies development additional product refinements which provide value to the end-users will become apparent. While they may not be critical for the product marketing clearance, they may be important to enhance product adoption in care. During the FDA 510 (k) clearance process, the FDA could require or suggest follow-up studies such as post-marketing commitments. The clinical sites under CLIN 1 as well sites for procurements triggered under CLIN 2 could support additional development activities.

It can be contemplated that significant refinements could lead to an entirely new generation of devices including portability considerations. Additional 510 (k) clearances are supported under this objective. For this Option the Offeror shall provide a proposal which addresses the following objectives:

i) Follow-on development work to be conducted at sites for product refinement and expansion of product functionality. Such functionalities may include portability, imaging, image processing, improved visualization, etc.

ii) All technical support for the corresponding changes to the software / machine learning algorithms as required.

iii) Regulatory and Quality support for compliance as specified above including filing with the

FDA.

iv) Continue HEOR studies including assessment of impact from real-world data.

4) OPTION 3: Additional Procurement Objectives (CLIN 4)

Towards the original goals for preparedness set forth in the SOO, BARDA may consider procurement of additional imaging devices under deployed VMI and establish them into new sites for delivery of burn care. Such sites may be a combination of burn centers and EDs in different settings than in CLIN 1 and CLIN 2. For this Option, the Offeror shall provide a proposal which addresses the following objectives:

a) Additional Procurements and Placement for Delivery of Care

i) BARDA may procure up to an additional 140 device units. A critical aspect of this procurement would include the potential to lease the imaging device versus purchasing. The Offeror should present both options and highlight any relevant differences to enable the calculation of life-cycle costs.

ii) It is anticipated the units would be placed in about 140 different sites. Some hospitals may have a unit placed in the ED as well as the burn center.

iii) The Offeror is responsible for all technical support for installation and training of the site personnel responsible for delivery of care. Other requirements for a fully operational site include routine maintenance such as system software updates, troubleshooting and service calls throughout the contract period of performance.

5) OPTION 4: Additional Development (CLIN 5)

a) Guiding Principles

i) It is contemplated that additional product refinements which provide value to the end-users will continue to be identified. Such enhancement could range from single changes or combinations of factors from camera lenses, imaging, software, algorithm development, ability to project onto the wound to better portable design to name a few areas.

ii) Such refinements could lead to an entirely new generation of devices Additional 510 (k) clearances are supported under this objective.

b) Requirements

For this Option the Offeror shall provide a proposal which addresses the following objectives:

i) Follow-on development work to be conducted at sites for product refinement and expansion of product functionality. Such functionalities may include portability, imaging, image processing, improved visualization etc.

ii) All technical support for the corresponding changes to the software / machine learning algorithms as required.

iii) Regulatory and Quality support for compliance as specified above and filing with the FDA

iv) Continue HEOR studies including assessment of impact from real-world data.

6) Project Management & Risk Mitigation Objectives (All CLINs)

The Offeror is directed towards details provided in the section on Reporting Requirements. The work here is intended to be performed in the Base period as well as all the Options (if and when they are triggered). Hence, all SOW generated for the Base and Option periods shall have a Project Management and Risk Mitigation section covering objectives in this CLIN.

a) Project Management Plan and Tracking Budget

i) The Offeror shall provide a master Project Plan (including tabular and Gantt forms) to BARDA that clearly indicates the critical path to support product approval. The master Project Plan shall outline key, critical path milestones, with "Go/No Go" decision criteria and a contract Work Breakdown Structure.

ii) The Offeror shall submit updates to master project plans working in coordination with BARDA’s project officer.

iii) Tools for visual representation of project activities, alignment of work breakdown structures and budgets for tracking are recommended.

b) Tracking Project Risk Management Objectives

i) As part of the project management objectives the Offeror shall consolidate the efforts to develop and maintain a risk management plan and the risk matrix as referenced in other task objectives above.

ii) The Offeror shall participate in regular meetings to coordinate and oversee the contracting effort.

iii) The Offeror shall provide a list of individuals to serve as primary and secondary points of contact who will be available 24 hours a day, seven days a week, for the purpose of a public health emergency notification.

iv) The Offeror shall provide a security plan that includes physical and information technology (IT) security associated with all aspects of manufacture of product, process, storage, and inventory of the critical assets such as devices or components when under the Offeror’s direct control. The Security plan shall cover the ability to ensure security of the devices installed at external locations.

C.2. REPORTING REQUIREMENTS

See Section F for specific reporting requirements.

Performance of the contract will be monitored by the CO/COR on a regular basis. The Contracting Officer will be responsible for inspection and acceptance of deliverables and services. Monitoring of the contract will be based on periodic reporting by the Offeror.

C.3. MEETINGS / SITE VISITS

The Contractor and BARDA/CMA shall participate in regular meetings to coordinate and oversee the contracting effort as requested by the Contracting Officer (CO)/Contracting Officer’s Representative (COR). Such meetings may include, but are not limited to, a kickoff meeting to be held at a location determined by the COR, status update meetings and/or teleconferences, site visits to the Contractor’s and/or subcontractor’s facilities, and meetings with individual Contractors and other HHS officials to discuss the technical, regulatory, and contractual aspects of the program. The Contractor shall provide data, reports, and presentations to USG personnel and USG-contracted subject matter experts as required by the CO/COR facilitating review of activities.

The purpose of the kickoff meeting will be to orient the Contractor to HHS/BARDA and review contract requirements. This meeting usually occurs within a month after contract award. Bi-weekly or monthly status update meetings/teleconferences will be held. The schedule for these meetings will be established by the CO and COR.

Periodic site visits shall occur on an ad hoc basis (anticipate at least twice a year).

Within thirty (30) calendar days of an FDA audit of Contractor or subcontractor facilities, the Contractor shall provide copies of the audit findings, final report, and a plan for addressing areas of nonconformance to FDA regulations and guidance for GLP, GMP or GCP guidelines as identified in the final audit report.

Other U.S. Government Audits The USG reserves the right to conduct an audit of the Contractor with 48 hours advance notice. The USG reserves the right to accompany the Contractor on routine and for-cause site-visits/audits of subcontractor(s). At the discretion of the USG and independent of testing conducted by the Contractor, BARDA reserves the right to conduct site visits/audits and collect samples of product held by the Contractor and subcontractor(s).

Pre-award site visits may be made with short notice. Contractors are expected to guarantee the availability of key staff or other staff determined by the Government as essential for purposes of this site visit.

SECTION D – PACKAGING, MARKING AND SHIPPING

D.1. METHOD OF DELIVERY

Unless otherwise specified by the Contracting Officer, all deliverable items to be furnished to the Government under this contract (including invoices) shall be made by first class mail, overnight carrier, or email as described in SECTION F.3.

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and Contractor’s name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

D.2. FOB DESTINATION DELIVERIES AND SET UP

The Offeror shall describe the FOB Destination and transportation conditions for the product, specifically noting the precautions, acceptable environmental conditions, and protection to sensitive parts of the product’s calibrations, and integrity of data systems. The Offeror shall be responsible for product shipment, installation, qualifications, and certifications required for full functional use of the product at all sites where the product is deployed. Certification of testing, calibration, and full functionality including data transmission at all every individual site of deployment would be required to complete the acceptance of product by the USG prior to invoicing. The Offeror shall carry the required insurance to cover accidental loss prior to product acceptance at a site. The product acceptance process applies to products purchased or under comprehensive lease agreements which cover its routine maintenance, timely updates, repairs, replacements, and restoration of full functionality in the shortest allowable times.

SECTION E – INSPECTION AND ACCEPTANCE

E.1. INSPECTION AND ACCEPTANCE

Inspection and acceptance of the product, services, and documentation called for herein shall be accomplished by the Contracting Officer or a duly authorized representative. Technical inspection and acceptance will take place at the site of deployment of the units.

Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duty authorized representative within 30 days of receipt.

E.2. FEDERAL ACQUISITION REGULATION CLAUSES INCORPORATED BY REFERENCE

This contract incorporates the following clauses by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available.

FAR 52.246-2, Inspection of Supplies – Fixed-price (August 1996) CLINs 2 and 4

FAR 52.246-5, Inspection of Services - Cost-Reimbursement (April 1984) CLINs 1, 3 and 5

FAR 52.246-8, Inspection of Research and Development – Cost-reimbursement (May 2001)

FAR 52.246-16, Responsibility for Supplies (April 1984)

SECTION F – DELIVERIES OR PERFORMANCE

F.1. PERIOD OF PERFORMANCE

The base period of performance of this contract is anticipated for thirty-six (36) months from the date of award. The period of performance may be extended up to 84 months with the exercise of option(s), structured as CLINs, as set forth in SECTION B. The contract may be extended for up to 120 months with approval from the Contracting Officer.

F.2. DELIVERIES

Successful performance of the final contract shall be deemed to occur upon performance of the work described in SECTION C of this RFP and upon delivery and acceptance of the items described in SECTION F.3 by the Contracting Officer or their duly authorized representative.

F.3. CONTRACT DELIVERABLES AND REPORTING REQUIREMENTS

F.3.1. Submission of Contract Deliverables

Documents shall be delivered electronically via email to the Contracting Officer (CO), jonathan.gonzalez@hhs.gov and the Contracting Officer Representative (COR) Julio Barrera-Oro, Julio.Barrera-Oro@hhs.gov. No hard copies will be accepted.

F.3.2. Reporting Requirements

In addition to those reports required by other terms of this RFP, the Contractor shall submit to the CO and the COR technical progress reports as identified in any potential resultant contract. These reports shall be subject to the technical inspection and requests for clarification by the COR, and approval by the CO/COR. These reports shall be brief, factual, and prepared in accordance with the following format:

A. Monthly Progress Report

This report shall include a description of the activities during the reporting period and the activities planned for the ensuing reporting period. The first reporting period consists of the first full month of performance plus any fractional part of the initial month. Thereafter, the reporting period shall consist of each calendar month.

The Contractor shall submit a Monthly Progress Report on or before the 15th calendar day following the last day of each reporting period and shall include the following:

Title Page: The title page for this report shall include the contract number and title; the type of report and period that it covers; the Contractor's name, address, telephone number, fax number, and e-mail address; and the date of submission.

Distribution List: A list of individuals receiving the Technical Progress report.

Progress:

SECTION I - An introduction covering the purpose…