ASPR_Next_BAA_8-29-19_FINAL.pdf

BAA-19-ASPR NEXT-SOL-75A50119R00044

Office of the Assistant Secretary for Preparedness and Response (ASPR)

Broad Agency Announcement (BAA)

Title: ASPR Next BAA

Office of Resource Management (ORM)

200 C Street SW

Washington, DC 20201

I.Contents

II. Introduction ............................................................................................................ iii III. Overview ............................................................... Error! Bookmark not defined.

IV. Areas of Interest (AOI) ...........................................................................................ix

V. Reporting Requirements and Deliverables ...........................................................xx VI. Special Considerations ....................................................................................... xxii VII. Stage 1: White Paper Instructions ..................................................................... xxiii VIII. Stage 2: Full Proposal Instructions .................................................................... xxv VIII. Stage 1 and Stage 2 Evaluation ............................................................................ xli

II. Introduction

This Broad Agency Announcement (BAA), which sets forth research and development (R&D), prototyping and procurement areas of interest (AOIs) for the Office of the Assistant Secretary for Preparedness and Response (ASPR), is issued under paragraph 6.102(d)(2)(i) of the Federal Acquisition Regulation (FAR). Proposals selected for award are considered to be the result of full and open competition and in full compliance with 41 U.S.C. § 3301. A formal Request for Proposal will not be issued. Paper copies of this announcement will not be issued. The U.S.

Government (Government) reserves the right to select for award and fund all, some, or none of the proposals in response to this announcement. All proposals will be treated as sensitive competitive information and the contents only disclosed for the purposes of evaluation.

The Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S.

Department of Health and Human Services (HHS) seeks to develop novel solutions to enhance ASPR’s preparedness and response mission to “Save Lives, Protect Americans against 21st Century Health Security Threats.” ASPR is responsible for securing our nation from chemical, biological, radiological, and nuclear (CBRN) threats, pandemic influenza and emerging infectious diseases and natural disasters.

ASPR also supports the transition of medical countermeasures such as vaccines, drugs, diagnostics, and medical devices from research through advanced development towards consideration for approval by the Food and Drug Administration (FDA) and inclusion into the Strategic National Stockpile (SNS). The SNS is the nation’s largest supply of potentially life-saving pharmaceuticals and medical supplies for use in a public health emergency severe enough to cause local supplies to run out. The SNS ensures the right medicines and supplies are available when and where needed to save lives. When state, local, tribal, and territorial responders request federal assistance to support their response efforts, the stockpile ensures that medicine and supplies get to those who need them most during an emergency. Organized for scalable response to a variety of public health threats, the repository contains enough supplies to respond to multiple large-scale emergencies, simultaneously.

Additionally, ASPR supports health care systems in developing resilience to 21st Century threats through leadership, public/private partnerships, and technical and medical support to state, local, territorial, and tribal partners with the Office of Emergency Management and Medical Operations (EMMO). The divisions within this office (Readiness, Field Operations and Response) serve as the core for ASPR’s regional components to ensure a robust supporting presence throughout the cycle of an incident.

In many cases, major challenges with addressing 21st Century health security threats require breakthrough solutions. ASPR, under HHS, is charged with accelerating the research, development, and availability of transformative countermeasures to protect Americans from natural and intentional health security threats.

Additional Information on ASPR can be found at https://www.phe.gov https://www.phe.gov/

III. Overview

A. Agency Name:

Department of Health and Human Services (HHS), Office of the Secretary (OS) Office of the Principal Deputy Assistant Secretary for Preparedness and Response (ASPR) 200 C Street SW, Washington, DC, 20201

B. Issuing Office:

Department of Health and Human Services (HHS), Office of the Secretary (OS) Office of the Assistant Secretary for Preparedness and Response (ASPR),Office of Resource Management (ORM) 200 C Street SW, Washington, DC, 20201

C. Development Opportunity Objective:

This ASPR Next BAA aims to accelerate the research, development, and availability of transformative countermeasures to protect Americans from natural and intentional health security threats by soliciting revolutionary innovations in health security. The projects awarded under the ASPR Next BAA will develop solutions that vary from early to late stages of technological readiness. ASPR is interested in projects that span the entire spectrum of research, development, manufacturing, deployment, operations, sustainment and final disposition.

ASPR is soliciting innovative proposals to investigate approaches that enable revolutionary advances in science, technologies, or systems. Specifically excluded is basic science, research, development, prototype and process development, data science, clinical studies, and other activities that primarily results in evolutionary improvements to the existing state of the art.

ASPR is seeking approaches that are outside the mainstream, challenge assumptions, and have the potential to radically change established practice, lead to extraordinary outcomes, and create entirely new fields and commercial market disruptions with wide-ranging impact that will protect Americans from 21st Century Health Threats.

D. Announcement Type and Date:

Broad Agency Announcement, August 29, 2019, as: BAA-19-ASPR NEXT-SOL- 75A50119R00044

This BAA is being issued by ASPR. ASPR is interested in attracting revolutionary advancements in health security products, technologies and innovations, specifically to invigorate operations, response, recovery and medical countermeasure development and deployment activities. Amendments to this BAA will be posted. Interested parties are encouraged to check www.FBO.gov periodically for updates and amendments. In addition, Special Instructions will be posted as amendments to the BAA when they become apparent.

Please monitor this solicitation for future special instructions.

http://www.fbo.gov/

E. Eligible Offerors:

This BAA is open to all responsible sources. Offerors may include single entities or teams from private sector organizations, Government laboratories, and academic institutions.

To be eligible for award, a prospective recipient must meet certain minimum standards pertaining to financial resources, ability to comply with the performance schedule, prior record of performance, integrity, organization, experience, operational controls, technical controls, technical skills, facilities, and equipment.

Federally Funded Research and Development Centers (FFRDCs) and Government entities (Government/National laboratories, military educational institutions, etc.) are subject to applicable direct competition limitations and cannot propose to this BAA in any capacity unless they address the following conditions:

FFRDCs must clearly demonstrate that the proposed work is not otherwise available from the private sector AND must provide a letter on letterhead from their sponsoring organization citing the specific authority establishing their eligibility to propose to government solicitations and compete with industry, and compliance with the associated FFRDC sponsor agreement and terms and conditions.

This information is required for FFRDCs proposing to be primes or subcontractors.

ASPR will consider eligibility submissions on a case-by-case basis; however, the burden to prove eligibility for all team members rests solely with the Offeror.

Historically Black Colleges and Universities (HBCU), Minority Institutions (MI), Small Business concerns, Small Disadvantaged Business concerns, Women-Owned Small Business concerns, Veteran-Owned Small Business concerns, Service-Disabled Veteran-Owned Small Business concerns, and HUB Zone Small Business concerns are encouraged to submit proposals and to join other entities as team members in submitting proposals.

In accordance with federal statutes, regulations, and HHS policies, no person on grounds of race, color, age, sex, national origin, or disability shall be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity receiving financial assistance from the HHS.

The ORM is publishing this solicitation on behalf of the HHS/OS/ASPR.

F. Number of Awards:

Multiple awards of various values are anticipated, inclusive of seedling (less than $750,000) and full programs (greater than $750,000), and are dependent upon technical importance to agency, and availability of funds. It is anticipated that there will be many submissions, but only a small number of awards.

G. Types of Award:

Awards under this BAA may utilize Cost-Reimbursement, including Cost (C), Cost-Sharing (CS), Cost-Plus-Incentive-Fee (CPIF), and Cost-Plus-Fixed-Fee (CPFF) Contracts, Firm-Fixed-Price (FFP) Contracts; and Other Transaction Agreements (OTA), as authorized for ASPR under 10 USC 2371 and Sections 319L(c) (4) (B).

If cost sharing is proposed, the amount of cost participation should depend on the extent to which the effort or results are likely to enhance the Offerors expertise, capability, or competitive position. If an Offeror does not believe that a Cost-Sharing contract (see FAR 16.303) (or Cost contract [see FAR 16.302]) is appropriate, then the Offeror should provide the reason in writing under “B. Basic Cost/Price Information” of the Cost Proposal (Part VI, Stage 2, Volume II – Cost Proposal Attachments). The reason should include an explanation (i) as to why there is no probability that the Offeror would receive any present or future benefits from an award, (ii) of the R&D expected to be of only minor value to the Offeror, or (iii) of a statute that precludes the use of cost sharing.

If the Government contemplates the award of a cost-reimbursement type contract, the Offeror must demonstrate prior to award that its approved Cost Accounting Standards, per FAR 30.001 and accounting system are adequate for administering a cost-reimbursement contract. Offerors should propose the type of arrangement they believe best satisfies the requirement.

The costs of preparing responses to this BAA are not considered an allowable direct charge on any resultant award.

H. Summary of the Submission Process:

For complete details on this submission process, see Parts VI and VII of this BAA.

There are two (2) stages to the submission process.

Stage 1 is the submission of a White Paper and must completed before Stage 2. Stage 2 is the submission of a full proposal. Before preparing a white paper, potential Offerors are advised to read this full BAA, and to visit the ASPR website (https://www.phe.gov) for more information on the ASPR mission, solicitations and program manager contact information.

The Two (2) Stages are as follows:

Stage 1 – White Paper

Stage 2 – Full Proposal Volume I – Technical Proposal

Volume I – Technical Proposal Attachments Volume II – Cost Proposal Volume II – Cost Proposal Attachments

Stage 1 – White Paper: Offerors are required to submit a White Paper before they may submit a full proposal. Offerors must submit their White Paper in accordance with the instructions provided in Part VI. The White Paper should describe the effort in succinct but sufficient detail to allow a review of the concept's technical merit and its potential contribution to the ASPR mission. ASPR will review White Papers based on the criteria provided in Part VIII.

Offerors whose White Paper receives a favorable review will be invited to submit a Full Proposal. Offerors whose White Paper did not receive a favorable review will be notified and provided with information on technical issues and concerns that ASPR has regarding the proposed effort. This written feedback is the only response that will be provided to unsuccessful https://www.phe.gov/

Stage 1 Offerors.

Stage 2 – Full Proposals: If the White Paper is deemed acceptable, Offerors will receive a letter of invitation to submit a Full Proposal. Full Proposals must be submitted in accordance with the instructions provided in this BAA and in the invitation letter. Full Proposals will be evaluated against criteria as described in Part VIII. Proposals that do not conform to the requirements outlined in the BAA or to the instructions provided in the invitation letter will be considered non-responsive and not viewed for further action.

I. Submission Deadlines and Government Response Time:

Table 1: Submission Deadlines and Government Response Time

Proposal Stage Deadline for Submission* Government Response

Stage 1: White Paper A White Paper may be submitted on any day during the open period of the

BAA.

However, all submissions will be held until the review deadline for that quarter, at which time all papers received during that quarter will be reviewed and responses prepared.

The first such quarterly deadline for review of submitted white paper/slide summary is September 30, 2019.

Others are:

December 31, 2019 March 31, 2020 June 30, 2020

This is a rolling BAA announcement and final deadline for White Paper submissions for this BAA is June 30, 2020.

A receipt confirmation will be sent within one week.

A decision will be made within 90 calendar days of the submission.

Stage 2: Full Proposal As defined in the Invitation Letter. A receipt confirmation will be sent within one week.

*Submissions must be made no later than 4:30 PM Eastern Standard Time for each due date.

J. Contact and Submission Information:

All inquiries and submissions regarding this BAA must be sent to: ASPRNext@hhs.gov

Learn more about ASPR: www.phe.gov Technical Point of Contact: ASPR Innovation – ASPRInnovation@hhs.gov Contracting Point of Contact: Tasha McMillian – Tasha.McMillian@hhs.gov mailto:ASPRNext@hhs.gov mailto:ASPRInnovation@hhs.gov mailto:Tasha.McMillian@hhs.gov

K. Limitation on Communication after Submission:

Be advised that while you are encouraged to contact the Technical Points of Contact named in this BAA before submitting a White Paper (or Full Proposal), the opposite is true after a White Paper (or Full Proposal) has been submitted. After that point, all communications related to that submission must be through the Contracting Office (CO) only, to ASPRNext@HHS.GOV.

Communications following the Government response to a White Paper or Full Proposal submission must be through the CO identified in the response letter.

When submitting a Full Proposal following your receipt of White Paper Invitation Letter from the CO, submit the Full Proposal to ASPRNext@HHS.GOV, carbon copy (Cc) the CO, and reference the Response Letter in the first paragraph of the email.

Do not Cc or blind carbon copy (Bcc) the technical POCs or any other individuals within Program during submission of either a White Paper or Full Proposal. Similarly, do not Cc or Bcc the technical POCs or any other individuals within Program when sending inquires directly to the

CO.

L. Preliminary Inquiries:

The Government realizes that the preparation of a proposal often represents a substantial investment of time and effort by the Offeror. In an attempt to minimize this burden, ASPR encourages organizations and individuals interested in submitting proposals to make preliminary inquiries as to the general need for the type of R&D effort contemplated before expending extensive effort in preparing a detailed proposal or submitting proprietary information.

M. Special Instructions:

Special instructions will be advertised via the BAA as they become apparent. These additional instructions would be tailored to specific AOI and may have unique submission due dates. The information requested in these instructions should be used along with Part VI and VII of the BAA to format and prepare the Technical (Volume I) and Cost (Volume II) Proposals. Offerors shall follow the instructions in Part VI and VII of the BAA, and include the information requested therein.

N. Proposal Handling and Submission Information:

Treatment of Submission Documents: All proposals are treated as the Offerors proprietary information prior to award and the contents are disclosed only for the purpose of evaluation. The Offeror must indicate any limitation to be placed on disclosure of information contained in the proposal in accordance with the instructions as set forth in FAR 52.215- 1(e) “Restrictions on disclosure and use of data.” Offerors are responsible for marking relevant pages as proprietary.

Classified Submissions: Classified proposals will not be accepted. All submissions must be Unclassified.

Use of Color Proposals: All proposals received shall be stored as electronic images.

Electronic color images require a significantly larger amount of storage space than black-and-mailto:ASPRNext@HHS.GOV white images. As a result, Offerors use of color in proposals should be minimal and used only when necessary for details. Do not use color unless necessary.

Post-Employment Conflict of Interest (COI): There are certain post-employment restrictions on former federal officers and employees, including special government employees (Section 207 of Title 18, U.S.C.). If a prospective Offeror believes a conflict of interest may exist, the situation should be emailed to the appropriate Contracting Officer, prior to expending time and effort in preparing a proposal. The appropriate HHS personnel will discuss any conflict of interest with prospective Offeror.

Organizational Conflict of Interest (OCOI) Organizational conflict of interest means that because of other activities or relationships with other persons, a person is unable or potentially unable to render impartial assistance or advice to the Government, or the person’s objectivity in performing the contract work is or might be otherwise impaired, or a person has an unfair competitive advantage.

Unsuccessful Proposal Disposition: Proposals will not be returned. The original of each proposal received will be retained by ASPR pursuant to FAR 4.805 and all other non-required copies destroyed.

Government Notice for Handling and Submitting Proposals: Refer to Attachment 6 for inclusion requirement of the Government notice.

IV. Areas of Interest (AOI)

Major challenges with addressing 21st Century health security threats require breakthrough solutions. ASPR, under HHS, is charged with accelerating the research, development, and availability of transformative countermeasures to protect Americans from natural and intentional health security threats.

Pursuant to that, ORM on behalf of ASPR soliciting proposals for advanced research and development, prototyping and procurement of revolutionary health security products, technologies and innovations in order to increase our capability and capacity to respond to national security health threats. MHFC is soliciting proposals that have an emphasis on revolutionary advancements in health security products, technologies and solutions, specifically to invigorate operations, response, recovery and medical countermeasure manufacture, deployment and dispensing activities. ASPR anticipates that activities awarded under this BAA will enter the award or arrangement at any stage of maturity. Some candidates may be more advanced and an award under this BAA will serve to continue the candidate product or technology toward ultimate licensure or approval by the U.S. Food and Drug Administration (FDA) and/or procurement of mature solutions for field use. For other candidates, an award might provide support in the early stages of research or development. This BAA will also serve to advance the knowledge and scientific understanding of candidates’ research, platform technologies, inventions, modeling and forecasting, and visual analytics.

Proposed research should investigate leading edge approaches that enable revolutionary advances in science, technologies, or systems to support ASPR steady-state, response and recovery operations. Offerors should emphasize revolutionary approaches over incremental improvements to the existing state of the art or current progress in the field. ASPR seeks novel approaches that may not have been applied to the field previously, these could include approaches that are outside the mainstream, challenge assumptions, and have the potential to radically change established practice, lead to extraordinary outcomes, and create entirely new fields.

Awards resulting from this BAA may also benefit from multiple core services that ASPR already provides and will provide in the future. These core services include an animal study network, flexible manufacturing facilities, technical expertise in development, manufacturing, regulatory affairs, quality systems, and clinical studies.

Authorities:

The Pandemic and All Hazard Preparedness Act Pub. L. No. 109-417, 42 U.S.C. § 241 et seq. (PAHPA) and

The Pandemic and All Hazard Preparedness Reauthorization Act Pub. L. No. 113-51, (PAHPRA).

The 21st Century Cures Act (H.R. 34)

The Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (S.

1379)

Section 319 of the Public Health Service Act

AOI-1: Priority Medicines on Demand

Development of transformational devices for end-to-end pharmaceutical, vaccine and/or biologics production in small-scale, modular, continuous manufacturing platforms.

ASPR is also interested in developing technologies that can transform drinking water to water for sterile injection, complete with physiological additives suitable for infusion, for production at point-of-delivery.

AOI-1 – Background and Need:

Currently, ASPR, and the public at large, are beholden to market influences on, and global availability of, the constituents that make up of the small molecule drugs and biologics purchased, stored and distributed within the Strategic National Stockpile. The need to shift to distributed, point-of-need manufacture is paramount to ensuring that these products are available in final form, during a disaster or pandemic response effort.

The impacts on sterile saline production are still felt from the impacts of hurricane Maria.

Sterile infusion products are consistently on the FDA shortage list, and additional capacity needs to be built in a highly-distributed fashion to ensure adequate and stable supply during steady-state as well as during a pandemic. The ASPR Priority Medicines on Demand effort seeks to disrupt the current market influences, production and distribution paradigms, to ensure the availability of saline small molecule, and biologics products at point-of-use.

AOI-1 – Goals:

Develop transformational devices for end-to-end pharmaceutical, vaccine and/or biologics production in small-scale, modular, continuous manufacturing platforms. Develop sterile http://www.gpo.gov/fdsys/pkg/PLAW-109publ417/pdf/PLAW-109publ417.pdf http://www.gpo.gov/fdsys/pkg/PLAW-113publ5/pdf/PLAW-113publ5.pdf https://www.congress.gov/114/bills/hr34/BILLS-114hr34enr.pdf https://www.congress.gov/bill/116th-congress/senate-bill/1379 http://uscode.house.gov/view.xhtml?path=/prelim@title42/chapter6A&edition=prelim infusion product manufacturing capabilities. Inform process design for future project calls.

Focus on production of small molecule active pharmaceutical ingredients, final formulation of small molecule products, intravenous injection solutions, inclusive of Ringer’s Lactate, 0.9N Saline, D5W and D10W, as well as biologics (including, but not limited to, recombinant proteins, tissues, genes, cells, blood components, and vaccines) at point of need. Identify commercialization, production, and regulatory strategies that will ensure availability when these products are needed the most.

Proposals that include only improvements to compounding, or iterative improvements to small molecule, biologics or sterile infusion product manufacture will be considered unresponsive. Proposals that focus only on developing cell banks or foundational components of small molecule and sterile infusion product manufacture will be considered unresponsive.

AOI-1 – Program Metrics:

In order for the Government to evaluate the effectiveness of a proposed solution in achieving the stated program goals, proposers should note that the Government hereby promulgates the following program metrics that may serve as the basis for determining whether satisfactory progress is being made to warrant continued funding of the program. Although the following program metrics are specified, proposers should note that the Government has identified these goals with the intention of bounding the scope of effort, while affording the maximum flexibility, creativity, and innovation in proposing solutions to the stated goals.

AOI-1 – For All AOI-1 Applicants

AOI-1 – Within the first Six (6) months:

Should be able to demonstrate a working prototype that can produce sterile infusion products, small molecule APIs and biologics at point of need.

Should be able to demonstrate that the solutions produced meet U.S. Pharmacopeia Standards for Water for Injection.

Should be able to demonstrate current good manufacturing practices for production of small molecules (inclusive of API synthesis, workup, isolation, and drug product modules), sterile infusion products and biologics within a production footprint that is less than 500 square feet.

Should be able to demonstrate safety and efficacy of the product either in-vivo or on animal models.

AOI-1 – Ideally within the Period of Performance (POP):

Final design build including all components, reagents, materials

Reduce and optimize process development activities for large scale transfer and/or economically feasible demonstration at scale

Should be able to demonstrate production of FDA accepted product through appropriate field testing as a proof of concept of the technology through the appropriate surrogate testing model.

Provide final design product for transition into advanced development, manufacturing and commercialization.

AOI-2: Dialysis Care in Disaster Settings

Development of next-generation, portable technologies for hemodialysis in disaster settings.

AOI-2 – Background and Need:

To address the needs of ASPR to support frail populations affected by natural and intentional disasters, and ensure that populations can be cared for in a manner that reduces the burden of transport, the development and inclusion of current and next-generation portable hemodialysis capabilities need to be incorporated into Federal Medical System and Disaster Medical Assistance Team response efforts. A typical response requires the relocation/airlift of approximately 100 dialysis outpatients and comes with significant cost burden to HHS.

AOI-2 – Goals:

Development of dialysis platforms that can create dialysate from potable water sources, require low power to operate (less than 2KW per system) and ensure the safety of patients using the technology at home or in a temporary outpatient care facility. Development of novel interface solutions that simplify use of platform technologies and reduce the amount of needed training for front-line healthcare providers in disaster settings. Development of novel hemodialysis care platforms and blood treatment sets (BTS) for portable dialysis care. Support a materiel and training program for ASPR Teams to deliver dialysis care in or near disaster zones with next-generation portable dialysis technologies, and allow transition of these patients to in-home dialysis care.

Proposals that include portable dialysis technologies that do not produce their own dialysate from potable water sources, have a simplified interface for patients and healthcare providers, do not include advanced safety features to improve patient health outcomes, and require greater than 2KW of power per system to operate will be considered non-responsive.

AOI-2 – Program Metrics

In order for the Government to evaluate the effectiveness of a proposed solution in achieving the stated program goals, proposers should note that the Government hereby promulgates the following program metrics that may serve as the basis for determining whether satisfactory progress is being made to warrant continued funding of the program. Although the following program metrics are specified, proposers should note that the Government has identified these goals with the intention of bounding the scope of effort, while affording the maximum flexibility, creativity, and innovation in proposing solutions to the stated goals.

AOI-2 – For All AOI-2 Applicants

AOI-2 – Within the first 12 months:

Identify design concepts, identify available technologies, and consider regulatory strategy to outline principal user and functional requirements.

Specify appropriate interfaces for hemodialysis systems to support the selected populations

Should be able to demonstrate a working prototype that can produce dialysate from potable water sources

Should be able to demonstrate individualized use of next-generation blood treatment sets by hemodialysis patients on portable dialysis platforms that can be operated in-center or in-home.

AOI-2 – Ideally within the period of performance:

Final design build including all components, reagents, materials

Reduce and optimize process development activities for large scale transfer and/or economically feasible demonstration at scale

Should be able to demonstrate support of up to 100 dialysis patients in-center and in-home.

AOI-3: Medical Countermeasure Deployment and Dispensing

Development of capabilities to ensure rapid deployment and dispensing of medical countermeasures or other materials to emergency response locations. This is inclusive of, but not limited to, alternate delivery methods and dispensing solutions and the development of alternative delivery platforms for pharmaceutical, vaccine and biologic administration.

AOI-3 – Background and Need:

ASPR needs to ensure that every American has access to life-saving medical countermeasures (MCMs) during a public health emergency. ASPR has the role of supporting state and local public health authorities, who have responsibility to distribute MCMs to the affected populations.

Time to dispense MCMs during incidents, such as a chemical, biological, radiological or nuclear attack, is critical to saving lives. While planning efforts have been underway in this area for over a decade, concerns still surround the ability to get MCM to citizens and residents in a timely manner.

AOI-3 – Goals:

Deliver lifesaving medications and medical countermeasures in austere environments with limited or no communication and transportation solutions. Provide medical supplies in events where main commercial providers are unavailable or intermittent. Identify alternative methods for delivery of medical countermeasures to large populations affected by disasters – this is also inclusive of novel vaccine/biologic or drug dispensation and delivery solutions.

Proposals that only include incremental improvements for the distribution of MCMs to affected populations, incremental improvements to transportation and delivery systems or incremental improvements to vaccine/biologic or drug administration will be considered non-responsive.

AOI-3 – Program Metrics

In order for the Government to evaluate the effectiveness of a proposed solution in achieving the stated program goals, proposers should note that the Government hereby promulgates the following program metrics that may serve as the basis for determining whether satisfactory progress is being made to warrant continued funding of the program. Although the following program metrics are specified, proposers should note that the Government has identified these goals with the intention of bounding the scope of effort, while affording the maximum flexibility, creativity, and innovation in proposing solutions to the stated goals.

AOI-3 – For All AOI-3 Applicants

AOI-3 – Within the first 12 months:

Identify design concepts, identify available technologies, and consider regulatory strategy to outline principal user and functional requirements.

Specify appropriate systems and interfaces to develop capabilities to distribute medical countermeasures to large populations (500K +)

Should be able to demonstrate a working prototype that can deliver medical countermeasures in a distributed fashion across a population of (100K +)

AOI-3 – Ideally within the Period of Performance (POP):

Near final design build including all components and materials

Reduce and optimize process development activities for large scale transfer and/or economically feasible demonstration at scale

Demonstrate distribution of identified items to a population of 500K or more where communications and transportation infrastructure is diminished.

AOI-4: Real-Time Healthcare System Capacity Reporting

Develop capabilities that enable secure, confidential and controlled means to track healthcare provider capacity to respond to disasters in a dynamic and timely fashion.

AOI-4 – Background and Need:

Identifying healthcare system capacity to match demand during a public health emergency or mass casualty incident is a consistent challenge due to the proprietary nature of the information shared, and the additional burden that gleaning this information places on healthcare systems and State and Local partners. These challenges are further complicated by cumbersome permissions and confidentiality controls that allow sharing of proprietary information in a secure, verifiable manner. ASPR needs solutions that will allow for real-time reporting of bed availability, as well as capacity that could be made available, in near-real time, should a public health emergency or mass casualty event occur. The system must be protected to ensure reporting facility information is not compromised.

AOI-4 – Goals:

Realize dynamic, seamless, low-burden and secure methods for identifying healthcare system capacity to match demand during a public health emergency or mass casualty incident.

Establish a secure reporting platform and active processes for the data owner to allow audit and control who has access to proprietary information.

Proposals including solutions that cannot gather information in near real-time, or establish low-burden secure methods to permission, provision and manipulate healthcare system information at scale, and do not include platforms with open standards and architectures will be considered unresponsive.

AOI-4 – Program Metrics

In order for the Government to evaluate the effectiveness of a proposed solution in achieving the stated program goals, proposers should note that the Government hereby promulgates the following program metrics that may serve as the basis for determining whether satisfactory progress is being made to warrant continued funding of the program. Although the following program metrics are specified, proposers should note that the Government has identified these goals with the intention of bounding the scope of effort, while affording the maximum flexibility, creativity, and innovation in proposing solutions to the stated goals.

AOI-4 – For All AOI-4 Applicants

AOI-4 – Within the first 12 months:

Identify design concepts, identify available technologies, and consider regulatory strategy to outline principal user and functional requirements.

Specify appropriate systems and interfaces to develop capabilities that will allow secure, provisioned sharing of healthcare system capacity.

Should be able to deliver a functional platform that can provide near real-time availability of healthcare system capacity in at least 100 large healthcare provider systems.

AOI-4 – Ideally within the Period of Performance (POP):

Final design and delivery of all system components, and/or ancillary devices

Conduct full feasibility demonstration at scale (400+ healthcare systems and/or coalitions).

AOI-5: Disaster Response and Recovery Intelligence

Develop capabilities that bring together deep learning, Artificial Intelligence (AI) and Machine Learning (MI) applications to forecast disaster impacts and automate replenishment of supplies during disasters.

AOI-5 – Background and Need:

While inventory management systems are robust in their ability to track and manage materiel for disaster responses, the current processes involve labor-intensive tracking and management of supplies in the field, estimates that may fall short of actual need and multiple steps from recognition of need to realization of solution. ASPR is seeking to develop novel tools for inventory tracking and management for disasters, inclusive of advanced analytical methods and artificial intelligence driven tools to track assets in an automated fashion, forecast need and automate ordering and approval processes for materiel deployed in disaster responses.

AOI-5 – Goals:

Realize dynamic, seamless, low-burden and secure methods for forecasting disaster impacts on a location. Establish a predictive capability to forecast supply needs and real-time tracking and management of supplies in the field. Develop advanced analytical methods and artificial intelligence driven tools to track assets in an automated fashion, forecast need and automate ordering and approval processes for materiel deployed in disaster responses.

Proposals that detail incremental approaches to forecasting disaster impacts and do not include secure, scalable ledgering solutions for tracking assets throughout response and recovery efforts will be considered unresponsive. Proposals that do not include advanced application of artificial intelligence and/or deep learning tools will be considered unresponsive.

AOI-5 – Program Metrics

In order for the Government to evaluate the effectiveness of a proposed solution in achieving the stated program goals, proposers should note that the Government hereby promulgates the following program metrics that may serve as the basis for determining whether satisfactory progress is being made to warrant continued funding of the program. Although the following program metrics are specified, proposers should note that the Government has identified these goals with the intention of bounding the scope of effort, while affording the maximum flexibility, creativity, and innovation in proposing solutions to the stated goals.

AOI-5 – For All AOI-5 Applicants

AOI-5 – Within the first 12 months:

Identify design concepts, identify available technologies, and consider regulatory strategy to outline principal user and functional requirements.

Specify appropriate systems and interfaces to develop capabilities that will allow secure, automated forecasting, ordering and tracking of materiel for disasters. Proposers will be considered unresponsive if they present concepts associated with only inventory management or only business analytics. Demonstrate ability to perform under a FedRAMP approved environment.

Demonstrate ability to leverage cloud development, operations, and sustainment environments to the greatest extent possible.

Demonstrate ability for system resiliency to cyber-attacks, human, and environmental factors that can impact system security, stability, and up-time.

Demonstrate ability to successfully apply for required Authority to Operate (ATO) approvals, meeting HHS and ASPR requirements.

Should be able to deliver a functional system that can forecast the impact of a disaster on affected populations, critical infrastructure and health systems.

Should be able to deliver a functional system that can provide the ability to track, forecast and automate ordering of materiel for disasters.

https://www.fedramp.gov/

AOI-5 – Ideally within the Period of Performance (POP):

Final delivery, including all modules and/or ancillary equipment.

AOI-6: Advanced Medical Interventions

Develop capabilities to address advanced health security vulnerabilities, establish trusted data platforms to secure health-related information and investigate linkages between clinical manifestation of disease and multi-omic indicators within dedicated US-based facilities to open new pipelines for medical countermeasure discovery.

AOI-6 – Background and Need:

The US Health system is vulnerable to encroachment, patient data is managed in disparate ways, and biotechnology and precision medicine discovery relies on siloed provider-based services for sequencing and synthetic biology product realization. ASPR is seeking to address health system vulnerabilities and develop novel, robust discovery pipelines to improve the discovery and transition of medical countermeasures and bolster the US Bio-economy. ASPR is seeking to develop programs that will secure, provision and integrate patient data towards enabling discovery using artificial intelligence and deep learning tools, develop new secure pipelines for multiomics discovery and create a data research ecosystem that will drive the development of novel medical countermeasures and interventions to improve the level of care following a natural or intentional disaster.

AOI-6 – Goals:

Establish trusted data platforms to secure health-related information and investigate linkages between clinical manifestation of disease and multi-omic indicators within dedicated US-based facilities. Combine disparate data sets of EHR and multi-omic information in a central secure location to advance the state of U.S. health and wellness through identified biological expression circuits. Create transformative analysis pipelines to yield greatest health outcomes, leveraging US-based infrastructure, to open new pipelines for medical countermeasure discovery. Establish revolutionary analytical methods that improve the understanding of pathogenesis within the human host and hold application to chronic disease indications.

Develop new approaches for capturing and analyzing complex health data sets, including new approaches to patient assessment, and developing new tools and methods to better correlate multi-omic data to health records and patient outcomes.

Proposals that detail incremental approaches and do not include secure, scalable ledgering solutions will be considered unresponsive. Proposals that address only one of these topic areas, and do not include application of artificial intelligence and/or deep learning solutions will be considered unresponsive. Proposals that do not include application of secure ledgering solutions to better enable health discovery and only include concepts associated with only secure sharing of patient data will be considered unresponsive.

AOI-6 – Program Metrics

In order for the Government to evaluate the effectiveness of a proposed solution in achieving the stated program goals, proposers should note that the Government hereby promulgates the following program metrics that may serve as the basis for determining whether satisfactory progress is being made to warrant continued funding of the program. Although the following program metrics are specified, proposers should note that the Government has identified these goals with the intention of bounding the scope of effort, while affording the maximum flexibility, creativity, and innovation in proposing solutions to the stated goals.

AOI-6 – For All AOI-6 Applicants

AOI-6 – Within the first 12 months:

Identify design concepts, identify available technologies, and consider regulatory strategy to outline principal user and functional requirements.

Specify appropriate systems and interfaces to develop capabilities that will allow secure provisioning and ledgering of patient datasets for advanced discovery projects.

Establish a Data Research Organization that will set data use rules and manipulate health system and patient data at grand scale.

Establish clinical cohorts that will apply artificial intelligence tools towards identifying better medical interventions during disasters (sepsis interventions, dialysis patient interventions, environmental toxicant exposures, AMR and others).

Develop an instance of a secure patient record platform throughout a large health system.

Establish a secure, streamlined multi-omics analysis capability to support clinical studies of patient cohorts of 10,000 or more.

Establish precision diagnostics and patient characterization capabilities for disaster medicine applications.

AOI-6 – Ideally within the Period of Performance (POP):

Establish a secure, streamlined multi-omics analysis capability to support clinical studies of patient cohorts of 10,000 or more in more than two large health systems.

Demonstrate advanced diagnostics and patient characterization capabilities for disaster medicine applications.

Develop an instance of a secure patient record platform throughout more than ten large health systems.

Demonstrate functionality of the Data Research Organization and ability to set interim data use rules and manipulate health system and patient data at grand scale.

AOI-7: Telehealth Applications for Response and Recovery

Establish telehealth services for medical professionals and para-professionals to better assist state, local, tribal and territorial health systems during disaster response and recovery. These teams of medical professionals and para-professionals include advanced clinicians (nurse practitioners/physician assistants), medical officers, registered nurses, respiratory therapists, paramedics, pharmacists, safety specialists, logistical specialists, information technologists, communication and administrative specialists.

AOI-7 – Goals:

Realize dynamic, seamless, low-burden and secure methods for providing telehealth services in austere settings during disaster response and recovery efforts. Establish capabilities for medical professionals and para professionals to better deliver care remotely within, or project care into, austere environments during disaster response and recovery efforts. Establish technologies that can integrate ancillary capabilities for patient assessment and aid in diagnosis and treatment.

Specifically excluded are technologies that only establish communication frameworks.

Proposals that do not include capabilities to remotely assess, diagnose and/or treat patients using ancillary devices will also be considered non-responsive.

AOI-7 – Program Metrics

In order for the Government to evaluate the effectiveness of a proposed solution in achieving the stated program goals, proposers should note that the Government hereby promulgates the following program metrics that may serve as the basis for determining whether satisfactory progress is being made to warrant continued funding of the program. Although the following program metrics are specified, proposers should note that the Government has identified these goals with the intention of bounding the scope of effort, while affording the maximum flexibility, creativity, and innovation in proposing solutions to the stated goals.

AOI-7 – For All AOI-7 Applicants

AOI-7– Within the first 12 months:

Identify design concepts, identify available technologies, and consider regulatory strategy to outline principal user and functional requirements.

Specify appropriate systems and interfaces to develop capabilities that will allow secure delivery of care in austere settings.

Establish solutions that will better assess and diagnose patients and provide superior delivery of care during disasters.

Develop an instance of a secure consultative capability and teaming construct for medical professionals and para professionals.

AOI-7 – Ideally within the Period of Performance (POP):

Reduce and optimize process development activities for large scale implementation for simultaneous operations.

Provide final design and all ancillary equipment for full-scale implementation both CONUS and OCONUS.

AOI-8: Health Security Innovation

This Area of Interest seeks revolutionary research ideas for topics not being addressed by ongoing ASPR programs or other published solicitations.

AOI-8 – Background and Need:

HHS/ASPR seeks to develop transformational technologies to enhance ASPR’s preparedness and response mission to “Save Lives, Protect Americans against 21st Century Health Security Threats.”

In the current environment, the rate of technology change, global access to emerging technologies, and increased rate of natural disasters, ASPR is interested in rapid realization of solutions, inclusive of defining Measures of Effectiveness (MOE), cost, schedule, concepts of operation, and reduction of overall risk to meeting ASPR mission requirements with dual-use for commercially sustainable markets. ASPR is interested in the rapid research and development of health security capabilities to support ASPR’s mission, inclusive of a distributed capability to produce sterile solutions suitable for infusion at point-of-need, portable hemodialysis solutions, and additional capabilities to support long-term response and recovery efforts to natural and intentional public health emergencies.

AOI-8 – ASPR is interested in submissions related to the following:

Development of technologies that can reduce the burden associated with transport of water for disasters.

Power generation and capabilities establish a long-term power supply at large scale from multiple fuel sources for major medical centers if the electric grid and back-up generators fail.

Development of novel interface solutions that simplify use of platform technologies and reduce the amount of needed training for front-line healthcare providers in disaster settings.

Solutions that realize significant deployment and/or sustainment savings for the Strategic National Stockpile.

Solutions that enable significant…