RAPIID_TA3_Attachment_A_Technical_Management_Proposal.docx

Attachment A: DARPA-PA-26-09 Technical and Management Proposal Competition Sensitive

DARPA-PA-26-09: RAPIID TA-3

Technical and Management Proposal (TMP) Use of this template is mandatory for all TA-3 proposal submissions to this Program Announcement (PA). This document must include all components described herein.

Proposals not meeting the format prescribed herein may not be reviewed. All submissions must be written in English, and all pages shall be formatted for printing on 8-1/2 by 11- inch paper with 1-inch margins on all sides. Text must be single-spaced and size 11 Calibri font with the exception that size 9 font may be used for captions on figures, tables, and charts. The TMP must be submitted in .pdf, .doc, .docx, or .odx formats.

The Government will not consider TMP submissions in excess of 10 pages. Proposals with fewer than the maximum number of pages will not be penalized. Additional information that directly supports concepts and assertions in the TMP may be included in the optional Appendix (TMP Section 12).

Proposers are encouraged to submit concise, but descriptive, proposals. Specific examples of problems, approaches, or goals are preferred to qualitative generalities.

Proposals must be submitted per the instructions outlined herein (guidance provided in blue text below) and received by DARPA no later than the due date and time listed in Section III of the PA. Proposals received after this time and date may not be reviewed.

Please refer to Section III of the PA for all submission guidance.

COVER SHEET

[PRIME ORGANIZATION LOGO]

Proposal Title

Proposer Organization

Proposer Reference Number, if any

Address:

Telephone:

Email:

Address:

Telephone:

Email:

Place(s) of Performance

Period(s) of Performance

Months

Organization:

Organization Type:

Year 2: $ Year 3: $ Total: $

SAM.gov Unique Entity ID (UEI)[footnoteRef:2] [2: The SAM-generated UEI becomes the official identifier for doing business with the U.S. Government. This replaces DUNS. ]

Taxpayer identification number (TIN)[footnoteRef:3] [3: See https://www.irs.gov/individuals/international-taxpayers/taxpayer-identification-numbers-tin for information on requesting a TIN. Note, requests may take from 1 business day to 1 month depending on the method (online, fax, mail).]

Commercial and Government Entity (CAGE) code[footnoteRef:4] [4: A CAGE Code identifies companies doing or wishing to do business with the Federal Government. ]

Administration Office POC at Defense Contract Management Agency (DCMA)[footnoteRef:5] or Office of Naval Research (ONR)[footnoteRef:6], if known [5: https://pubapp.dcma.mil/CASD/CasdSearch.do] [6: http://www.onr.navy.mil/Contracts-Grants/Regional-Contacts.aspx]

Name:

Address:

Telephone:

Audit Office POC at Defense Contract Audit Agency (DCAA)[footnoteRef:7], if known [7: http://www.dcaa.mil/Home/Locator?title=Locator]

Name:

Address:

Telephone:

Date Proposal was Prepared

Proposal Validity Period (minimum 120 days)

Official Transmittal Letter [Attach the official transmittal letter from the prime proposer organization.

Preclinical Evaluation Capabilities [Describe your organization’s ability, approach, and facilities to conduct preclinical safety and efficacy studies for TA-1 components and TA-2 devices using in vitro, small animal, and large animal models. Please also address the following:

· Explain your experience with combination testing of products from multiple sources as well as testing of companion diagnostics/devices. Describe how multiple products will be tested simultaneously to inform decision making and how you will ensure unbiased, independent assessment. This can be via in vitro and/or in vivo studies.

· Detail your access to, or direct control of, Good Laboratory Practice (GLP)-compliant large-animal models relevant to trauma and hemorrhagic shock, either via in-house, CRO-like capabilities or under tightly managed partnership with an external CRO. Proposals must address an expedited pathway to GLP compliance during the RAPIID Phase 1 timeline if not conducted in-house.

· Describe your approach to coordinating with TA-1 and TA-2 performers for timely receipt and testing of components/devices.

Proposers are encouraged to provide supporting documentation for this section as an appendix at the end of the TMP which will not count towards the page limit.] Clinical Trials Capabilities [Describe your experience, approach, and facilities for designing and managing multi-site, rapid, and efficient clinical trials of pre-market investigational products (including utilizing Exception from Informed Consent (EFIC)). Please also address the following:

· Highlight expertise in clinical and regulatory affairs, Institutional Review Board (IRB) management, interactions with the U.S. Food and Drug Administration (FDA) on novel clinical trials, Investigational New Drug (IND)/Investigational Device Exemption (IDE) submissions, and patient enrollment/consent strategies (including EFIC, when appropriate).

· Demonstrate your track record as Sponsor of Record for multisite trauma clinical trials, including trials conducted under EFIC and site monitoring approaches.

· Describe your institutional capability to hold INDs, IDEs, and Emergency Use Authorizations (EUA) as Sponsor of Record with the FDA. This should include a recent record of peer-reviewed publications from completed multisite trauma trials, with timelines compatible with EUA and Biologics License Application (BLA) decision-making.

· Explain your plan for integrating TA-1 components and TA-2 devices into system-level clinical trials.

· Describe your approach to statistical input for study design, statistical analysis planning, data management, statistical oversight, and trial result reporting.

Proposers are encouraged to provide supporting documentation for this section as an appendix at the end of the TMP which will not count towards the page limit.] Other Relevant Organizational Capabilities, Part Performance, and Key Personnel [not to exceed two (2) pages]

· [Summarize additional organizational capabilities relevant to TA-3, such as experience with medical countermeasures, trauma trials, regulatory oversight of clinical trials, and clinical practice guideline (CPG) development.

· Demonstrate previous engagement with the Joint Trauma System (JTS), Committee on Tactical Combat Casualty Care (CoTCCC), and/or Service medical leadership for the development of CPGs.

· Identify key personnel, their qualifications, and expected level of effort. It is strongly recommended that the PI dedicate at least 20% effort to this project.

· Provide an organizational chart and project management plan, including coordination among any subawardees or consultants.] Team Member Identification [Use and expand the following table to provide a list of all team members including the prime, subawardee(s), and consultant(s), as applicable. Identify whether any are a non-US organization or individuals. Note: Consultants (e.g., 1099s) are considered subperformers and must be listed.

Please note that Federally Funded Research and Development Centers (FFRDCs), University Affiliated Research Centers (UARCs), and Government entities, including National Laboratories, are not eligible to propose to this PA or be subawardees or consultants.] Prime

Non-U.S. Individual: ☐Yes ☐No

Subawardees/Consultants

Non-U.S. Individual: ☐Yes ☐No

Non-U.S. Individual: ☐Yes ☐No

Conflict of Interest Affirmations and Disclosure [In accordance with the requirements of the PA, provide the following information:]

a. Have any of the proposed individuals, employees, consultants, affiliates, or subawardee(s) applied to the RAPIID TA-1 and TA-2 solicitation? ☐ No ☐ Yes [If Yes, please explain.]

b. Have any of the proposed organizations and personnel, including all divisions, subsidiaries, affiliates, and parent entities, previously assisted or currently assist in the development, commercialization, and/or have a financial interest in any TA-1 or TA-2 performer, product, or technology? This includes consultants, affiliates, and subawardee(s) on the proposal. ☐ No ☐ Yes [If Yes, please explain.]

c. Does the proposing organization or subawardee(s) (including all divisions, subsidiaries, affiliates, and parent entities as well as consultants, affiliates, and subawardee(s)) certify that their organization’s expertise, experience, and capabilities in EFIC trauma trials, regulatory sponsorship, and blood product development are not dependent on any team member who is currently involved in the development, commercialization, or has a financial, advisory, or commercialization interest in any TA-1 or TA-2 performer, product, or technology? ☐ No ☐ Yes [If No, please explain.]

d. Does the proposing organization’s ability to meet the eligibility criteria and perform the required work depend on any individual or team that has a conflict of interest with TA-1 and/or TA-2? (See Section 2.6.4 in the PA) ☐ No ☐ Yes [If Yes, please explain.] Organizational Conflict of Interest Affirmations and Disclosure [In accordance with the requirements of Section 2.6.5 in the PA, provide the following information:]

a. Are any of the proposed individual team members or their respective organizations (whether prime or subawardee or consultant) currently providing SETA, A&AS or similar support to DARPA? ☐ No ☐ Yes

b. Did any of the proposed individual team members or their respective organizations (whether prime or subawardee or consultant) provide SETA, A&AS or similar support to DARPA within one calendar year of this proposal submission? ☐ No ☐ Yes [If Yes to 6.a OR 6.b, provide the following information for each applicable team member:

· The name of the DARPA office receiving the support;

· The prime contract number;

· Identification of proposed team member (subawardee, consultant) providing the support; and

· An OCI mitigation plan in accordance with FAR 9.5.]

c. Are there any other potential Organizational Conflicts of Interest involving any of the proposed individual team members or their respective organizations (whether prime or subawardee or consultant)? ☐ No ☐ Yes [If Yes, provide the following information for each applicable team member:

· Identification of applicable team member; and

· An OCI mitigation plan in accordance with FAR 9.5.] Novelty of Proposed Work Has the proposed work been submitted to any other Government solicitation?

☐ No ☐ Yes [If Yes, provide the following information:

· Solicitation number ________________________

· Agency _________________________

· Proposed work has already received funding or a positive funding decision:

☐ No ☐ Yes ☐ Decision pending] Determination of Process Improvements, Creating Value via OT for Research Agreement Vehicle [Proposers are required to provide answers to all of the following questions as part of the TMP.

This Value Assessment is an opportunity for proposers to quantitatively demonstrate the unique value of their solution to the Government, and/or the value that utilization of an OT has afforded your organization. When discussing the value of using an OT agreement, value could refer to a variety of outcomes such as speed, flexibility, or cost savings. This analysis should consider the following:

· Specific, measurable benefits (e.g., cost avoidance, time savings, performance improvements, risk reduction) afforded by utilizing 10 USC 4021 (Authority of the Department of Defense to carry out research OT projects);

· Quantify benefits using empirical metrics, benchmarks, or other objective measures;

· Compare quantified value against reasonable alternatives or status quo approaches;

· Present a clear return on investment calculation or other financial analysis that demonstrates value to the Government;

· Specifically for traditional prime contractors, consideration may include:

· Administrative burden reduction, resulting in changes to indirect, overhead, and G&A rates achieved through more efficient business systems and compliance avoidance;

· Direct cost savings in other processes like property management, subcontracting, and general cost of compliance; and

· Resource allocation improvements, for instance, bypassing regulatory compliance and increasing value engineering opportunities (optimizing the value of a product or service by analyzing its functions and associated costs).

· In addition to the above, proposers may also consider the following:

· If there has been limited prior investment in this technology area, discuss how DARPA's investment could catalyze further development and adoption by other organizations.

· Commerciality review could include potential market size, barriers to entry, potential licensing opportunities, and spin-off potential. Proposers should focus on the most significant commercial opportunities and challenges. This may include unexpected costs and technical challenges; honest and transparent assessments are valued.

Proposers are free to provide further detail outside of the answers to the above questions as to why and how an OT allows the Government to realize cost savings and thereby create added value.] Representations and Certifications [Please download, complete, and submit within this volume “2-SAMPLE OT certifications” available at the following link: DARPA Representations and Certifications] Intellectual Property (IP) [Provide the following information, as applicable. Note: The Government will negotiate intellectual property rights generated under the RAPIID program during contracting.]

a. Technical Data and Computer Software Are you asserting any IP restrictions on any technical data or non-commercial computer software that will be delivered to the Government? ☐ No ☐ Yes [If yes, list all proprietary claims to results, devices/prototypes, deliverables or systems supporting and/or necessary for the use of the proposed research, results, devices/prototypes and/or deliverables. Provide a short summary for each item asserted with less than unlimited rights that describes the nature of the restriction and the intended use of the intellectual property in the conduct of the proposed research. Use the following format for these lists.]

NONCOMMERCIAL

Asserted Rights Category

Name of Person Asserting Restrictions

Are you proposing any commercial software that will be delivered to the Government? ☐ No ☐ Yes [If Yes, please provide licensing terms.]

COMMERCIAL

Asserted Rights Category

Name of Person Asserting Restrictions

b. Patents Does the proposed effort involve using patented inventions that are owned by or assigned to the proposing organization or individual? ☐ No ☐ Yes [If Yes, provide documentation proving ownership or possession of appropriate licensing rights to all patented inventions to be used for the proposed project. If a patent application has been filed for an invention, but it includes proprietary information and is not publicly available, provide documentation that includes: the patent number, inventor name(s), assignee names (if any), filing date, filing date of any related provisional application, and summary of the patent title, with either: (1) a representation of invention ownership; or (2) proof of possession of appropriate licensing rights in the invention (i.e., an agreement from the owner of the patent granting license to the proposer).] Appendix (Optional) [As needed, proposers can provide materials that directly support the plans and assertions made in earlier sections of the TMP. This can include items such as citations, data, reports, contract/agreement documents, and/or other materials. Keep material relevant to the submission requirements and evaluation criteria as specified in Sections III and IV, respectively, of the PA.]