ARPA-H SHARE BAA Final 8-4-23.pdf

CUI

Scaling Health Applications Research for Everyone (SHARE)

Broad Agency Announcement (BAA)

Source Selection Information – See FAR 2.101 and 3.104

The Advanced Research Projects Agency for Health (ARPA-H)

SP4701-23-B-0002

Controlled by: Defense Logistics Agency Controlled by: DCSO CUI Category: PROCURE, CONTRACT Distribution/Dissemination Control: FEDCON POC: mark.sullivan@dla.mil

Source Selection Information – See FAR 2.101 and 3.104

TABLE OF CONTENTS

A. OVERVIEW INFORMATION

B. FULL TEXT OF ANNOUNCEMENT

B.1 Funding Opportunity Description

C. SHARE PROGRAM

C.1 Program Overview C.2 Program Objectives C.3 Scope of Work C.5 Program Deliverables C.6 Areas of Interest (See Attachment B)

D. GENERAL REQUIREMENTS

D.1 Proposing Teams D.2 General Award Information D.3 Contract Type D.4 Eligibility Information D.5 Debriefs D.6 Organizational Conflicts of Interest (OCI) D.7 Subcontracting Plans

E. APPLICATION INSTRUCTIONS AND SUBMISSION INFORMATION

E.1 Markings for Abstracts and Proposals E.2 Content and Form of Application Submission E.3 Abstract Format E.4 Full Proposal Format

F. APPLICATION REVIEW INFORMATION

F.1 Technical Evaluation Criteria F.2 Review of Abstracts and Full Proposals F.3 Adjectival Technical Ratings F.4 Cost and Price Evaluation:

G. AWARD DECISION

G.1 Basis for Contract Award G.2 Basis for Award without Discussion G.3 Basis for No Award

H. AWARD ADMINISTRATION INFORMATION

H.1 Selection Notices and Notifications H.2 Administrative and Policy Requirements H.3 Reporting H.4 Electronic Systems

ATTACHMENT A: PROPOSAL ADEQUACY CHECKLIST

ATTACHMENT B: AREAS OF INTEREST

ATTACHMENT C: REQUIRED DISCLOSURES OF FOREIGN AFFILIATIONS

A. OVERVIEW INFORMATION

Federal Agency Name - Advanced Research Projects Agency for Health (ARPA-H) Document Type: Combined BAA / Synopsis Solicitation Number: SP4701-23-B-0002 Classification Code: A -- Research & Development Set Asides: N/A North American Industry Classification System (NAICS) Codes: 541714 Research and Development in Biotechnology (except Nanobiotechnology) Product Service Code (PSC): AN12, Health R&D Services; Health care services; Applied Research Announcement Type: Initial Announcement Part: U.S. Government Procurements Subpart: Services Contracting Office Address:

DLA Contracting Services Office – Philadelphia (DCSO-P) Attn: Mark Sullivan, Bldg. 6, Station 6D412 700 Robbins Street Philadelphia, PA 19111-5092 Dates:

• Posting Date: August 04, 2023

• Optional Abstract or Proposals Due Date and Time: September 07, 2023 @ 12:00pm Est.

Concise Description of the Funding Opportunity: ARPA-H seeks to adapt Department of Defense (DoD) and other related Government entities health innovations more broadly to all Americans. For example, pediatric and geriatric populations would benefit from many underlying innovations but cannot use them “out of the box.” These branch projects developed for this BAA would identify and address the unique technical challenges inherent in translating this work to include dosage, form factor, and manufacturing capacity. Proposals should demonstrate prior success and detail the specific technical work required to tailor these solutions.

Anticipated Individual Awards: Multiple awards are anticipated.

Potential Award Instruments: Firm Fixed Price or Cost Reimbursement (cost-plus-fixed fee, cost no fee, cost-plus-award-fee) type contracts, or a combination of firm fixed price and cost reimbursement line items.

Point of Contacts (POC) Contracting: Contracting Officer, Mark Sullivan, Email:

Mark.Sullivan@dla.mil, Phone: 215-922-8346, Contract Specialist, Michelle Harrison, Email:

Michelle.Harrision@dla.mil, Phone: 267-432-2731 Submission of Abstracts/Proposals: Please submit all abstracts and proposals to both DCSO-P, R&D Mailbox RandD.DCSO@dla.mil and ARPA-H Mailbox DIGIHEALS@ARPA-H.GOV. Please also send to the Contracting POCs listed above.

mailto:Michelle.Harrision@dla.mil mailto:RandD.DCSO@dla.mil mailto:DIGIHEALS@ARPA-H.GOV

B. FULL TEXT OF ANNOUNCEMENT

B.1 Funding Opportunity Description

This publication constitutes a combined synopsis and Broad Agency Announcement (BAA) for the acquisition of research and development in accordance with Federal Acquisition Regulation (FAR)

35.016. ARPA-H posts this funding opportunity within the framework of a BAA because of its widely recognized use in funding basic and applied research as well as the ability to negotiate multiple contract types in accordance with the FAR. Any resultant award negotiations will follow all pertinent laws and regulations. No other solicitation will be issued. Only the information provided in this notice is available. Requests for other forms of solicitations shall be disregarded.

The Government reserves the right to award all, some, or none of the proposals submitted. The BAA will open for an initial round of abstract and proposal submissions on August 4, 2023, and close on September 7, 2023 @ 12:00pm est. Future openings for abstract and proposal submissions will be determined at a later date and an amendment to this BAA will be posted on SAM.gov specifying the dates and areas of interest. During the open period, offerors may submit optional abstracts or proposals up until the closing date and time listed above.

The mission of ARPA-H is to accelerate better health outcomes for all Americans by advancing innovative research that addresses society's most challenging health problems. Awardees will develop groundbreaking new ways to tackle health-related challenges through high potential, high-impact biomedical and health research. For this BAA, ARPA-H seeks proposals that will transform health innovations into healthcare solutions that can be adapted to health systems (e.g., medical devices or health records systems) or scaled to larger application areas.

ARPA-H specifically excludes:

1) Proposals that represent an evolutionary or incremental advance in the current state of the art (e.g., it is NOT sufficient to merely apply the same technology to new populations; instead contractors should highlight the unique extensions required to transition technology to a new population / health system or expand the scale of the application);

2) Proposals that fail to address the objectives of the program;

3) Proposals directed towards policy changes, traditional education and training, or center coordination and construction of physical infrastructure, which are outside the scope of the ARPA-H mission (note that infrastructure required to perform the proposed research will be considered on a case-by-case basis and must be essential to the goals of the research effort);

4) Basic research proposals where the link to improved health outcomes or improvements in the reliability of health systems is unclear.

C. SHARE PROGRAM

C.1 Program Overview

Source Selection Information – See FAR 2.101 and 3.104

ARPA-H's mission is to accelerate better health outcomes for all Americans. This solicitation, “Scaling Health Applications Research for Everyone (SHARE),” seeks to capitalize on and expand existing government R&D investments. Those innovations are often, but not limited to, those developed by the Department of Defense (DoD). Inside DoD, the Defense Research Projects Agency (DARPA) is an exemplar model for this type of innovation.

SHARE extends health innovations—or innovations from other domains that could be adapted to health—to accelerate better health outcomes more broadly. In the DoD context, these innovations are developed to support a specific population: the warfighter. Under SHARE, these technologies would be adapted to other populations, such as pediatric and geriatric. Proposals to the SHARE program may align with the four ARPA-H thrust areas (Health Science Futures, Proactive Health, Scalable Solutions, or Resilient Health Systems), and contractors may leverage services provided by the ARPA-H Project Accelerator Transition Innovation Office (PATIO), including:

• Building trust with target communities

• Increasing accessibility so these solutions would be available to as many Americans as possible

• Decreasing cost so Americans can afford these solutions

• Testing of minimum viable products (MVPs)

• Clinical trial support, to include readiness and ensuring diverse and representative populations

• Regulatory support

• Entrepreneurship education

C.2 Program Objectives

The purpose of this program is to increase the probability of adapting and scaling high-risk and potentially disruptive new technologies and solutions across the full spectrum of health-related applications. Projects will focus on adapting, scaling, and transition challenges associated with the underlying technology. These can be related to technology integration, manufacturing, and proving efficacy, building capacity, and adapting the technology to the health sector. The specific objectives of the program are to develop proven demonstrations of efficacy in civilian populations or civilian health infrastructure, receive regulatory approvals, eliminate barriers to manufacturing or distribution, secure key partnerships with commercial entities, user-groups, and other stakeholders, and to attract outside investment.

Building on the groundbreaking successes achieved by DARPA, DIU, and other government entities, this program aims to translate these achievements into transformative civilian healthcare solutions.

Applicants MUST demonstrate three things:

1. Technical Feasibility. Prior success within a DoD/USG context, substantiated by advancements like verified progress towards FDA approval, independent verification and validation, or successful operational prototypes.

2. An “ARPA-H/ard” Pivot & Target Population and/or Health Application. An R&D plan for a compelling, innovative prototype that adapts existing technology to the unique physiological

Source Selection Information – See FAR 2.101 and 3.104 and psychosocial considerations of pediatric and geriatric populations, other identifiable beneficiary, or health-related system.

3. Clear Mission Alignment. Alignment with the ARPA-H mission and one or more ARPA-H Focus Areas (Health Science Futures, Scalable Solutions, Proactive Health, Resilient Health Systems)

C.3 Scope of Work

The successful contractor(s) will:

• Leverage the critical groundwork laid by any DoD/USG like DARPA project while clearly articulating the specific R&D effort required to adapt these innovations to civilian healthcare settings.

• Conduct an in-depth feasibility study that appreciates the unique clinical, physiological, and social considerations of broad populations or health systems.

• Develop a prototype or pilot program through rigorous R&D that transforms existing DoD or other USG funded technology to the specific needs of these new demographics or health infrastructure.

• Develop a plan to commercialize or scale the prototype or technology, incorporating successful strategies for transitioning technologies from demonstration to market-readiness.

• Establish a collaborative framework with relevant stakeholders, ensuring a comprehensive approach to adaptation and implementation.

• Conduct ongoing evaluation and quality improvement activities to ensure the technology meets the needs of the target populations and maintains high standards of care.

C.5 Program Deliverables

Specific deliverables will be determined at contract award. Example deliverables include:

• R&D Plan and Scale-Up Strategy Report

• Feasibility study report for different or broader populations

• Prototype development or pilot program plan

• Stakeholder engagement strategy

• Ongoing evaluation and quality improvement plan

C.6 Areas of Interest (See Attachment B)

The Areas of Interest for this BAA are listed in Attachment B. ARPA-H may amend Attachment B as needed to add, modify, or remove Areas of Interest. Amendments modifying Attachment B will be posted to the government-wide Contract Opportunities portal at https://www.SAM.gov.

D. GENERAL REQUIREMENTS

D.1 Proposing Teams https://www.sam.gov./

It is expected proposals will involve teams with the expertise needed to achieve the goals of the areas of interest stated above. Specific content, communications, networking, and team formation are the sole responsibility of the contractor. Contractors must submit a single, integrated proposal led by a Principal Investigator (PI), under a single prime awardee2 that addresses all program Phases, as applicable.

Contractors may only submit one proposal as the prime contractor.

D.2 General Award Information

Multiple awards are anticipated. The resources made available under this BAA, and number of awards made will depend on the quality of the proposals received and the availability of funds. ARPA-H with the assistance of the DLA Contracting Services Office – Philadelphia (DCSO-P) reserves the right to make multiple awards, a single award, or no awards.

The Government reserves the right to select for negotiation all, some, one, or none of the proposals received in response to this BAA and to make awards without negotiations with contractors. The Government also reserves the right to conduct negotiations if it is later determined to be necessary.

Additionally, ARPA-H reserves the right to accept proposals in their entirety or to select only portions of proposals for negotiation and award. The Government reserves the right to fund proposals in phases, including as optional phases, as applicable.

Proposals identified for negotiation are expected to result in a Firm Fixed Price or Cost Reimbursement contract type. Selection of contract type will be based upon consideration of the nature of the work proposed, the required degree of interaction between parties, and other factors. The Government may request additional necessary documentation, tailored to the individual proposals once it makes the award instrument determination. The Government reserves the right to remove proposals from award consideration should the parties fail to reach agreement on award terms, conditions, and/or cost/price within a reasonable time, and/or if the contractor fails to timely provide requested additional information.

D.3 Contract Type

ARPA-H intends to award FFP or cost-reimbursement (FAR Subpart 16.3) contracts under this BAA.

ARPA-H will consider proposals based on cost (cost-plus-fixed-fee, cost (no fee), cost-plus-award-fee, cost-plus-fixed-fee completion, or cost-sharing), or fixed-price, including FFP or FFP Level of Effort (LOE) (FAR Subpart 16.2) contracts, but reserves the right to award other contract types when ARPA- H in its sole discretion deems such award to be in the best interests of the Government. Submittals based on contract types other than those listed above, may be rejected and may not be reviewed or evaluated at the government’s discretion.

D.4 Eligibility Information

All responsible sources capable of satisfying the Government's needs may submit a proposal. However, to be eligible for award, all prospective offerors must meet certain minimum standards pertaining to

Source Selection Information – See FAR 2.101 and 3.104 financial resources, adequacy of accounting systems, ability to comply with performance schedules, prior record of past performance, integrity, organization structure, experience, operational controls, technical skills facilities and equipment. For additional information and guidance concerning qualifications and standards for responsibility of prospective contractors, please refer to Part 9 of the Federal Acquisition Regulation (FAR).

Federally Funded Research and Development Centers (FFRDCs) and Government Entities

FFRDCs FFRDCs are subject to applicable direct competition limitations and cannot propose to this BAA in any capacity unless they meet the following conditions. (1) FFRDCs must clearly demonstrate that the proposed work is not otherwise available from the private sector. (2) FFRDCs must provide a letter, on official letterhead from their sponsoring organization, that (a) cites the specific authority establishing their eligibility to propose to Government BAAs and compete with industry, and (b) certifies the FFRDC’s compliance with the associated FFRDC sponsor agreement’s terms and conditions. These conditions are a requirement for FFRDCs proposing to be awardees or subcontractors.

Government Entities Government Entities (e.g., Government/National laboratories, military educational institutions, etc.) are subject to applicable direct competition limitations. Government Entities must clearly demonstrate that the work is not otherwise available from the private sector and provide written documentation citing the specific statutory authority and contractual authority, if relevant, establishing their ability to propose to Government BAAs and compete with industry. This information is required for Government Entities proposing to be awardees or subcontractors.

Other Applicants ARPA-H will prioritize awards in accordance with Public Law No. 117-328 (Section 499A(n) of the PHSA). Without limiting the foregoing ARPA-H will prioritize awards to domestic entities (organization and/or individuals) that will conduct funded work in the US. However, non-US entities may participate to the extent such participants comply with nondisclosure agreements, security regulations, export control laws, and other governing statutes applicable under the circumstances. Non- US entities are encouraged to collaborate with domestic US entities. In no case will awards be made to entities organized under the laws of a covered foreign country (as defined in section 119C of the National Security Act of 1947 (50 U.S.C. § 3059)) or entities suspended or debarred from business with the Government.

D.5 Debriefs

No debrief after review of abstracts will be provided as no award can result from an abstract.

D.6 Organizational Conflicts of Interest (OCI)

Contractors are required to identify and disclose all facts relevant to potential OCIs involving the contractor’s organization and any proposed team member (proposed subcontractor) as prescribed in FAR subpart 9.5. Regardless of whether the contractor has identified potential OCIs under this section, Source Selection Information – See FAR 2.101 and 3.104 the contractor is responsible for providing a disclosure with its proposal. The disclosure must include the contractors, and as applicable, proposed team members’ OCI mitigation plans. The OCI mitigation plan(s) must include a description of the actions the contractor has taken, or intends to take, to prevent the existence of conflicting roles that might bias the contractor’s judgment and to prevent the contractor from having unfair competitive advantage. The OCI mitigation plan will specifically discuss the disclosed OCI in the context of each of the OCI limitations outlined in FAR 9.505-1 through FAR 9.505-4. The disclosure and mitigation plan(s) do not count toward the page limit (see sections E.3 and E.4).

Agency Supplemental OCI Policy In addition, ARPA-H restricts contractors from concurrently providing professional support services, including, Advisory and Assistance Services or similar support services, and being a technical performer. Therefore, as part of the FAR 9.5 disclosure requirement above, a contractor must affirm whether the contractor or any proposed team member (proposed subcontractor, etc.) is providing professional support services to any ARPA-H office(s) under: (a) a current award or subaward; or (b) a past award or subaward that ended within one calendar year prior to the proposal’s submission date.

If any professional support services are being or were provided to any ARPA-H office(s), the proposal must include:

• The name of the ARPA-H office receiving the support;

• The prime contract number;

• Identification of proposed team member (proposed subcontractor) providing the support; and

• An OCI mitigation plan in accordance with FAR 9.5.

Government Procedures The Government will evaluate OCI mitigation plans to avoid, neutralize, or mitigate potential OCI issues before award and to determine whether it is in the Government’s interest to grant a waiver. The Government will only evaluate OCI mitigation plans for proposals determined selectable under the BAA evaluation criteria and funding availability.

The Government may require contractors to provide additional information to assist the Government in evaluating the OCI mitigation plan.

If the Government determines a contractor failed to fully disclose an OCI; or failed to provide the affirmation of ARPA-H support as described above; or failed to reasonably provide additional information requested by the Government to assist in evaluating the contractor’s OCI mitigation plan, the Government may reject the proposal and withdraw it from consideration for award.

D.7 Subcontracting Plans

For proposed contract awards exceeding $750,000.00 large businesses and non-profits (including educational institutions) shall provide a Small Business Subcontracting Plan that contains all elements required by the most recent versions of FAR 19.704, FAR 52.219-9 and DFARS 252.219-7003. The Plan must be submitted as an attachment to the Proposal Adequacy Checklist and will not be included

Source Selection Information – See FAR 2.101 and 3.104 in the page count. If a company has a Master or Individual Subcontracting Plan, as described in FAR

19.701 or a Comprehensive Subcontracting Plan described in DFARS 219.702, a copy of the Plan shall also be submitted as an attachment to the Proposal Adequacy Checklist in attachment A.

Plans will be reviewed for adequacy, ensuring that the required information, goals, and assurances are included. If an apparent successful offeror fails to negotiate a Plan acceptable to the contracting officer within the time limit prescribed by the contracting officer, the offeror will be ineligible for award.

Offerors shall propose a plan that ensures small businesses (inclusive of SDBs, WOSBs, HUBZone, VOSBs and SDVOSBs) will have the maximum practicable opportunity to participate in contract performance consistent with efficient performance.

As a baseline, Offerors shall, to the best extent possible, propose realistic goals to ensure small business participation in accordance with the current or most recent fiscal year subcontracting goals found on the DoD Office of Small Business Program website at: https://business.defense.gov/About/Goals-and- Performance/. Please refer to the website for most accurate list of goals. If proposed goals are below the statutory requirements, then the offeror shall include in the Plan a viable written explanation as to why small businesses are unable to be utilized and what attempts were taken to ensure that small business were given the opportunity to participate in the effort to the maximum extent practicable.

a. Subcontracting Resources - Subcontracting can be a good way to participate in the contracting process. The following is a list of potential resources that may assist in locating potential subcontracting partners/opportunities/resources:

*Companies Participating in DoD Subcontracting Program Report -https://business.defense.gov/Acquisition/Subcontracting/Subcontracting-For-Small-Business/ *DoD OSBP Prime Contractors and Subcontractors with Subcontracting Plans -https://business.defense.gov/Acquisition/Subcontracting/Subcontracting-For-Small-Business/ *DefenseLink ≥ $7.0 M Award Notices - https://www.defense.gov/News/Contracts/ *SBA Dynamic Small Business Search - https://web.sba.gov/pro-net/search/dsp_dsbs.cfm *Electronic Subcontracting Reporting System (eSRS) - https://www.esrs.gov/ *DLA SBIR/STTR Search – Website or Brochure -https://www.dla.mil/Portals/104/Documents/SmallBusiness/Small%20Business%20- %20SBIP%20-%20January%202020.pdf?ver=2019-12-27-081121-487 *DoD Procurement Technical Assistance Centers (PTAC) - https://www.aptac-us.org/ *U.S. Small Business Administration (SBA) Subcontracting Opportunities Directory -https://www.sba.gov/document/support-directory-federal-government-prime-contractors-subcontracting-plans *U.S. Small Business Administration Subcontracting Network (SubNet) -https://eweb1.sba.gov/subnet/client/dsp_Landing.cfm

In accordance with FAR 5.206 Notices of Subcontracting Opportunities, the following entities may transmit a notice to the GPE to seek competition for subcontracts, to increase participation by qualified HUBZONE small business, small, small disadvantaged, women-owned small business, veteran-owned small business, and service-disabled veteran-owned small business concerns, and to meet established subcontracting plan goals:

https://business.defense.gov/Acquisition/Subcontracting/Subcontracting-For-Small-Business/ https://business.defense.gov/Acquisition/Subcontracting/Subcontracting-For-Small-Business/ https://www.defense.gov/News/Contracts/ https://web.sba.gov/pro-net/search/dsp_dsbs.cfm https://www.esrs.gov/ https://www.dla.mil/Portals/104/Documents/SmallBusiness/Small%20Business%20-%20SBIP%20-%20January%202020.pdf?ver=2019-12-27-081121-487 https://www.dla.mil/Portals/104/Documents/SmallBusiness/Small%20Business%20-%20SBIP%20-%20January%202020.pdf?ver=2019-12-27-081121-487 https://www.aptac-us.org/ https://www.sba.gov/document/support-directory-federal-government-prime-contractors-subcontracting-plans https://www.sba.gov/document/support-directory-federal-government-prime-contractors-subcontracting-plans https://eweb1.sba.gov/subnet/client/dsp_Landing.cfm

(1) A contractor awarded a contract exceeding the simplified acquisition threshold that is likely to result in the award of any subcontracts.

(2) A subcontractor or supplier, at any tier, under a contract exceeding the simplified acquisition threshold, that has a subcontracting opportunity exceeding $15,000.

The notices must describe:

• The business opportunity

• Any prequalification requirements; and

• Where to obtain technical data needed to respond to the requirement

In addition, another place prime contractors may post solicitations or sources sought notices for small business is the U.S. SBA SUB-Net: https://eweb.sba.gov/gls/dsp_sbabanner.cfm. The SUB- Net database provides a listing of subcontracting solicitations and opportunities posted by large prime contractors and other non-federal organizations.

E. APPLICATION INSTRUCTIONS AND SUBMISSION INFORMATION

E.1 Markings for Abstracts and Proposals

Contractors are responsible for clearly identifying proprietary information. Submissions containing proprietary information must have the cover page and each page containing such information clearly marked with a label such as “Proprietary.” Research and Development is considered CUI. In accordance with the Department of Defense (DoD) phased CUI Program, any form of communication or documentation containing CUI must carry the appropriate markings, i.e., header and footer identifying the document as “CUI” and a completed CUI Designation Indicator.

Proposals shall include all proprietary claims to results, prototypes, or systems supporting or necessary for the use of the research, results, or prototypes. If there are no proprietary claims, then the proposal must include a statement to that effect. Do not put proprietary data or markings in the Statement of Work (SOW). Proposals containing data that is not to be disclosed to the public for any purpose or used by the Government except for review purposes shall include the following sentences in accordance with FAR 52.215- 1e(1) and (2) on the cover page) Mark the title page with the following legend:

This proposal includes data that shall not be disclosed outside the Government and shall not be duplicated, used, or disclosed-in whole or in part-for any purpose other than to evaluate this proposal. If, however, a contract is awarded to this offeror as a result of-or in connection with-the submission of this data, the Government shall have the right to duplicate, use, or disclose the data to the extent provided in the resulting contract. This restriction does not limit the Government's right to use information contained in this data if it is obtained from another source without restriction. The data subject to this restriction are contained in sheets [insert numbers or https://eweb.sba.gov/gls/dsp_sbabanner.cfm

Source Selection Information – See FAR 2.101 and 3.104 other identification of sheets]; and

Mark each sheet of data it wishes to restrict with the following legend:

Use or disclosure of data contained on this sheet is subject to the restriction on the title page of this proposal.

In accordance with FAR 3.104-4, your company is required to mark all material that may be Source Selection Information as described at paragraph (10) of the “Source Selection Information” definition in FAR 2.101, to include the cover page and each page that may contain source selection information, with the legend “Source Selection Information – See FAR 2.101 and 3.104”. Although the information in paragraphs (1) through (9) of the definition in 2.101 is considered to be Source Selection Information whether or not marked, all reasonable efforts must be made to mark such material with the same legend.

If you are unsure if particular information is Source Selection Information as defined in FAR 2.101, consult the Contracting Officer POC listed in the BAA. In addition, your company is required to mark all material that may be procurement sensitive, or defense covered information with the legend “Controlled Unclassified Information” (CUI). If the information is also source selection information both markings must be present.

Note: Source Selection markings are required for all documents submitted in response to this BAA, which includes Abstracts and Technical/Price Proposals (when applicable).

NOTE: “Confidential” is a classification marking used to control the dissemination of U.S.

Government National Security Information as dictated in Executive Order 13526 and should not be used to identify proprietary business information.

This announcement and any references to external websites herein constitute the total solicitation. If contractors cannot access the referenced material posted in the announcement found at https://www.sam.gov/, please contact the contracting officer listed in Section A of the BAA.

E.2 Content and Form of Application Submission

NOTE: Non-conforming submissions that do not follow BAA instructions may be rejected without further review at any stage of the process.

All submissions must be written in English with type not smaller than 12-point font. Smaller font may be used for figures, tables, and charts. Documents submitted must be clearly labeled with the ARPA-H BAA number, contractor organization, and proposal title/proposal short title.

Proposal prices and all other terms and conditions must remain valid for 180 days from the submission date of the proposal. Information in the technical proposal that is deemed by the Respondent to be proprietary must be clearly marked as proprietary information.

This announcement and any references to external websites herein constitute the total solicitation. If contractors cannot access the referenced material posted in the announcement found at https://www.sam.gov/ https://www.sam.gov/, please contact the contracting officer listed in Section A of the BAA.

E.3 Abstract Format

Contractors are not required to but are welcome to submit an abstract in advance of a full proposal submission to minimize effort and reduce the potential expense of preparing an out-of-scope proposal.

While not required, abstracts are intended for contractors to receive a recommendation from ARPA-H to submit or not submit a full proposal. Based on evaluation of the abstract, ARPA-H may recommend contractors not submit a full proposal. The cover sheet should be clearly marked “ABSTRACT,” and the total length should not exceed 3 pages in length. The maximum page count excludes the cover page and the Rough Order of Magnitude. The Government will not review pages beyond 3; and any abstract submitted that exceeds 3 pages will only be reviewed at ARPA-H’s discretion. Official transmittal letter is not required.

E.3.1 Cover Page The cover page should follow the same format as the full proposal format, as detailed below in Volume I, Technical and Management Proposal. The cover page does not count towards the abstract 3-page limit.

E.3.2 Concept Summary Describe the proposed concept with minimal jargon and explain how it addresses the topic area(s) of the BAA.

E.3.3 Innovation and Impact

Clearly identify the health outcome(s) sought and/or the problem(s) to be solved with the proposed technology concept. Describe how the proposed effort represents an innovative and potentially revolutionary solution to the technical challenges posed by the BAA. Explain the concept’s potential to be disruptive compared to existing or emerging technologies. Describe how the concept will have a positive impact on at least one of ARPA-H's mission areas.

To the extent possible, provide quantitative metrics in a table that compares the proposed technology concept to current and emerging technologies and includes:

• State of the art / emerging technology “baseline”

• Target for proposed technology in its final, commercializable form

• Target for proposed technology at the end of the proposed ARPA-H project

E.3.4 Proposed Work

Describe the final deliverable(s) for the project, one or two key interim milestones, and the overall technical approach used to achieve project objectives. Discuss alternative approaches considered, if any, and why the proposed approach is most appropriate for the project objectives.

Describe the background, theory, simulation, modeling, experimental data, or other sound engineering and scientific practices or principles that support the proposed approach. Provide https://www.sam.gov/

Source Selection Information – See FAR 2.101 and 3.104 specific examples of supporting data and/or appropriate citations to the scientific and technical literature. Identify commercialization challenges to be overcome for the proposed technology to be successful in the health market.

Describe why the proposed effort is a significant technical challenge and the key technical risks to the project. At a minimum, the abstract should address:

• Does the approach require one or more entirely new technical developments to succeed?

• How will technical risk be mitigated?

E.3.5 Team Organization and Capabilities

Indicate the roles and responsibilities of the organizations and key personnel that comprise the Project Team. Provide the name, position, and institution of each key team member and describe in 1-2 sentences the skills and experience they bring to the team.

E.3.6 Rough Order of Magnitude (ROM)

Please include a ROM estimate of timeline and federal funds requested, as well as the total project cost. The ROM should also include a breakdown of the work by direct labor, labor rates, subcontracts, materials, equipment, other direct costs (e.g., travel), indirect costs, profit, and any other relevant costs. The below table may be used for this breakdown:

Cost Category Amount Direct Labor Indirect Costs Subcontractors Materials Equipment Travel Other Direct Costs Indirect Costs Profit Total

However, contractors should ensure the ROM encompasses all applicable costs and should modify the above to best reflect the contractor’s expected costs. The ROM does not count toward the page limit.

E.4 Full Proposal Format

Proposals must be in the format given below. The typical proposal should express a consolidated effort in support of one or more related technical concepts or ideas. Disjointed or unrelated efforts should not be included in a single proposal. Proposals shall consist of two volumes: 1) Volume I, Technical and

Source Selection Information – See FAR 2.101 and 3.104

Management Proposal (composed of 3 parts), and 2) Volume II, Cost Proposal. The Cover Page shall be no more than 1 page in length. The page limitation includes all figures, tables, and charts. All pages shall be formatted for printing on 8- 1/2 by 11- inch paper. Margins must be 1-inch on all sides. Copies of all documents submitted must be clearly labeled with the ARPA-H BAA number, contractor organization, and proposal title/proposal short title. Volume I, Technical and Management Proposal, may include an attached bibliography of relevant technical papers or research notes (published and unpublished) which document the technical ideas and approach upon which the proposal is based.

Copies of not more than three relevant papers may be included with the submission. The bibliography and attached papers are not included in the page counts given below. The submission of other supporting materials along with the proposals is strongly discouraged and will not be considered for review. The maximum page count for Volume 1 is 30 pages; excluding the Statement of Work (SOW).

However, for all sections, ARPA-H encourages conciseness to the maximum extent practicable.

Volume I should include the following components:

E.4.1 Volume I, Technical and Management Proposal

Technical Proposals shall consist of three parts:

Section I – Administration Section II – Summary of Proposal Section II – Detailed Proposal Information

Section I: Administrative

Cover Page

1. BAA number;

2. Technical area;

3. Proposal title;

4. Prime Awardee/entity submitting proposal;

5. Type of organization, selected among the following categories: LARGE BUSINESS, SMALL DISADVANTAGED BUSINESS, OTHER SMALL

BUSINESS”, Historically Black Colleges and Universities (HBCUs), Minority Institution (MI), OTHER EDUCATIONAL, OR OTHER NONPROFIT (including non-educational government entities) (NOTE: The Small Business Administration’s (SBA) size standards determine whether or not a business qualifies as small.). Size standards may be found here: https://www.ecfr.gov/current/title-13/chapter-I/part- 121#121.201

6. Date of submission;

7. Other team members (if applicable) and type of organization for each;

8. Proposal title;

9. Technical point of contact (POC) to include: salutation, last name, first name, street address, city, state, zip code, telephone, email;

10. Administrative POC to include: salutation, last name, first name, street address, city, state, zip code, telephone, email; and

11. Total dollar amount of proposal https://www.ecfr.gov/current/title-13/chapter-I/part-121#121.201 https://www.ecfr.gov/current/title-13/chapter-I/part-121#121.201

Source Selection Information – See FAR 2.101 and 3.104

Section II: Summary of Proposal

Proposal Content

A. Technical rationale, technical approach, and constructive plan for accomplishment of technical goals in support of innovative claims and deliverable creation. (In the full proposal, this section should be supplemented by a more detailed plan in Section III of the Technical and Management Proposal.)

B. Innovative claims for the proposed research. This section is the centerpiece of the proposal and should succinctly describe the uniqueness and benefits of the proposed approach relative to the current state-of-art alternate approaches.

C. Deliverables associated with the proposed research and the plans and capability to accomplish technology transition and commercialization. Include in this section all proprietary claims to the results, prototypes, intellectual property, or systems supporting and/or necessary for the use of the research, results, and/or prototype. If there are no proprietary claims, this should be stated. See the section entitled intellectual property for more information.

D. General discussion of other research in this area. Contractors must disclose current and previous research and development (R&D) efforts related to the proposed research and identify any challenges associated with such efforts, including any scientific or technical barriers encountered in the course of such efforts or challenges in securing sources of funding, as applicable.

E. A clearly defined organization chart for the program team. Please also include information describing (1) the programmatic relationship of team member; (2) the unique capabilities of team members; (3) the task of responsibilities of team members;

(4) the teaming strategy among the team members; and (5) the key personnel along with the amount of effort to be expended by each person during each year.

Section III: Detailed Proposal Information

A. Executive Summary:

Provide a synopsis of the proposed project, including answers to the following questions:

• What is the proposed work attempting to accomplish or do?

• How is the proposed work leading to improved health outcomes or improvements in the reliability of health systems?

• How is it done today, and what are the limitations?

• What is innovative in your approach?

• What are the key technical challenges in your approach, and how do you plan to overcome these?

• Who or what will be affected, and what will be the impact if the work is successful?

Source Selection Information – See FAR 2.101 and 3.104

• How much will it cost, and how long will it take?

B. Goals and Impact:

Clearly describe what the team is trying to achieve and the difference it will make (qualitatively and quantitatively) if successful. Describe the innovative aspects of the project in the context of existing capabilities and approaches, clearly delineating the uniqueness and benefits of this project in the context of the state of the art, alternative approaches, and other projects from the past and present. Describe how the proposed project is revolutionary and how it significantly rises above the current state-of-the-art. Describe the deliverables associated with the proposed project and any plans to commercialize the technology, transition it to a customer, or further the work.

C. Technical Plan:

Outline and address technical challenges inherent in the approach and possible solutions for overcoming potential problems. This section should provide appropriate measurable milestones (quantitative if possible) at intermediate stages of the program to demonstrate progress, a plan for achieving the milestones, and a simple process flow diagram of the final system concept.

The technical plan should demonstrate a deep understanding of the technical challenges and present a credible (even if risky) plan to achieve the program goal. Discuss mitigation of technical risk.

D. Technical Factors

D.1 Overall Scientific and Technical Merit

Contractors must explain the proposed technical approach is innovative, feasible, achievable, and complete. Task descriptions and associated technical elements provided must be complete and in a logical sequence with all proposed deliverables clearly defined such that a final outcome that achieves the goal can be expected as a result of award. The proposal identifies major technical risks and planned mitigation efforts are clearly defined and feasible.

D.2 Past Performance, Contractor’s Capabilities and/or Related Experience

Contractors must show that the technical team has the expertise and experience to accomplish the proposed tasks. The contractor's prior experience in similar efforts clearly demonstrates an ability to deliver products that meet the proposed technical performance within the proposed budget and schedule. The proposed team has the expertise to manage the cost and schedule. Similar efforts completed/ongoing by the contractor in this area are fully described including identification of other Government entities.

D.3 Potential Contribution and Relevance to the ARPA-H Mission

Contractors must show potential future R&D, commercial, and/or clinical applications of the project proposed, including whether such applications may have the potential to address areas of currently unmet need within biomedicine and improve health outcomes.

Degree to which the proposed project has the potential to transform biomedicine.

Potential for the project to take an interdisciplinary approach. In addition, the evaluation will take into consideration the extent to which the proposed intellectual property (IP) rights structure will potentially impact the Government’s ability to transition the technology.

E. Management Plan:

Provide a summary of expertise of the team, including any subcontractors, and key personnel who will be doing the work. A PI for the project must be identified, along with a description of the team’s organization, including the breakdown by Technical Area. All teams are strongly encouraged to identify a Project Manager/Integrator to serve as the primary POC to communicate with the ARPA-H PM, IV&V team, and Contracting Officer Representative, coordinate the effort across co-performer, vendor, and subcontractor teams, organize regular performer meetings or discussions, facilitate data sharing, and ensure timely completion of milestones and deliverables.

Provide a clear description of the team’s organization including an organization chart that includes, as applicable: the programmatic relationship of team members; the unique capabilities of team members; the task responsibilities of team members, the teaming strategy among the team members; and key personnel with the amount of effort to be expended by each person during each year. Provide a detailed plan for coordination, including explicit guidelines for interaction among collaborators/subcontractors of the proposed effort. Include risk management approaches. Describe any formal teaming agreements required to execute this program.

F. Metrics:

Describe organizational experience in relevant subject area(s), existing intellectual property, specialized facilities, and any Government-furnished materials or information. Describe any specialized facilities to be used as part of the project, the extent of access to these facilities, and any biological containment, biosafety, and certification requirements. Discuss any work in closely related research areas and previous accomplishments.

G. Statement of Work (SOW) NOT INCLUDED IN PAGE COUNT:

The SOW should provide a detailed task breakdown, citing specific tasks for each TA, and their connection to the milestones and program metrics. Each Phase of the program should be separately defined. The SOW must not include proprietary information.

For each task/subtask, provide:

• A detailed description of the approach to be taken to accomplish each defined

Source Selection Information – See FAR 2.101 and 3.104 task/subtask.

• Identification of the primary organization responsible for task execution (prime awardee, subcontractor(s), by name).

• A measurable milestone, i.e., a deliverable, demonstration, or other event/activity that marks task completion. Include completion dates for all milestones. Include quantitative metrics.

• A definition of all deliverables (e.g., data, reports, software) to be provided to the Government in support of the proposed tasks/subtasks.

It is recommended the SOW be developed so that each TA and Phase of the program is separately defined.

H. Schedule and Milestones:

Provide a detailed schedule showing tasks (task name, duration, work breakdown structure element as applicable, performing organization), milestones, and the interrelationships among tasks. The task structure must be consistent with that in the SOW. Measurable milestones should be clearly articulated and defined in time relative to the start of the project.

I. Technology Transfer Plan:

Provide information regarding the types of partners (e.g., government, private industry) that will be pursued and submit a timeline with incremental milestones toward successful engagement.

The plan should include a description of how ARPA-H will be included in the development of potential technology transfer relationships. If the Technology Transfer Plan includes the formation of a start-up company, a business development strategy must also be provided.

E.4.2 Volume II, Cost/Price Proposal

Note: It is expected that the effort will leverage all available relevant prior research to obtain the maximum benefit from the available funding. ARPA-H recognizes that undue emphasis on cost may motivate contractors to offer low-risk ideas with minimum uncertainty and to staff the effort with junior personnel to be in a more competitive posture. ARPA-H discourages such cost strategies.

No page limits apply to the Cost Proposal. The cost proposal shall include total project cost by month. The offeror shall also give a detailed breakdown of the total project costs by each task listed in the technical proposal. If subcontracts are contemplated, the offeror must estimate the total amount of effort to be subcontracted and specify the “burden” or “pass through rate” that will be applied to those subcontracts. Offerors are required to submit certification of current cost or pricing data in accordance with FAR 15.406-2 (Certificate of Current Cost or Pricing Data).

The total cost of each major cost element and the make-up of those costs shall be presented in the offeror's proposal. A statement related to the latest DCAA audit and whether the offeror’s accounting system has been approved by the DCAA shall be included in the Cost Proposal.

State if there are currently negotiated DCAA rates or forward pricing rate agreements and

Source Selection Information – See FAR 2.101 and 3.104 factors being used in the proposal. Include a detailed breakdown of costs by cost category by offeror's calendar or fiscal year:

• Direct Labor - Individual labor categories or person with associated labor hours and unburdened direct labor rates.

• Indirect Costs - Fringe benefit, Overhead, G&A, Cost of Money, etc. (must show base amount and rate)

• Travel - Number of trips, destinations, durations, purpose, etc.

• Subcontracts - A cost proposal is required to be submitted by any proposed subcontractor and “burden” or “pass through rate” shall be clearly stated.

• Materials - Specifically itemized with estimated (or actual) costs.

• Lease Items - Fair market value of lease items and the method used for making such evaluations.

Sufficient information shall be provided in supporting documents to evaluate the reasonableness and realism of these proposed costs.