MTEC-23-07-WWSDP_RPP Amendment 02.pdf

Request for Project Proposals MTEC-23-07-WWSDP Number W81XWH-15-9-0001

Request for Project Proposals

Solicitation Number: MTEC-23-07-WWSDP

“Wounded Warrior Service Dog Program (WWSDP)”

Issued by:

Advanced Technology International (ATI), MTEC Consortium Manager (CM) 315 Sigma Drive

Summerville, SC 29486 for the

Medical Technology Enterprise Consortium (MTEC)

Request Issue Date: April 5, 2023 Amendment No. 01 Issue Date: April 28, 2023 Amendment No. 02 Issue Date: May 8, 2023

Proposal Due Date: May 15, 2023

Noon Eastern Time

Amendment No. 01 does the following:

Extends the proposal due date from May 8, 2023 to May 15, 2023.

Revises Language in Section 2.2 for funding availability Revises Language in Section 2.6 for Task 2 Offerors

Amendment No. 02 does the following:

Revises Language in Section 2.6 regarding offeror eligibility

All other terms and conditions remain unchanged.

Table of Contents

1 Executive Summary

1.1. The Medical Technology Enterprise Consortium

1.2. Purpose

2 Administrative Overview

2.1. Request for Project Proposals (RPP)

2.2. Funding Availability and Period of Performance

2.3. Acquisition Approach

2.4. Proposers Conference

2.5. Proprietary Information

2.6. Offeror Eligibility

2.7. Cost Sharing Definition

2.8. Cost Sharing Requirements

2.9. MTEC Assessment Fee

2.10. Intellectual Property and Data Rights

2.11. Expected Award Date

2.12. Proposal Selection Notification

3 Technical Requirements

3.1. Background

3.2. Solution Requirements

3.3. Potential Follow-on Tasks

3.4. Restrictions on Animal and Human Subjects

3.5. Guidance Related to DoD-Affiliated Personnel for Participation in research

4 Proposal Preparation

4.1. General Instructions

4.2. TASK 1 Instructions for the Preparation & Submission of the Stage 1 Proposals

4.3. TASK 2 Instructions for the Preparation & Submission of the Stage 1 Proposals

4.4. Stage 2: Cost Proposal (for Only Those Offerors Recommended for Funding)

4.5. Proposal and Cost Proposal Preparation Costs

4.6. Freedom of Information Act (FOIA)

4.7. Telecommunications and Video Surveillance

5 Selection 6 Points-of-Contact 7 Acronyms/Abbreviations 8 TASK 1 ONLY - Enhanced White Paper Template Addendum 1 – Cost Share Definitions Addendum 2 – Statutory Requirements for the Use of Other Transaction Authority Addendum 3 – Intellectual Property and Data Rights Assertions Addendum 4 – Prototype Guidelines Addendum 5 – Privacy Protocols Addendum 6 – TASK 1 ONLY: Statement of Work and Milestone Payment Schedule Addendum 7 – Warranties and Representations Template

Addendum 8 – TASK 2 ONLY: Task 2 Application Form Addendum 9 – TASK 2 ONLY: Budget Narrative Addendum 10 – TASK 2 ONLY: Cost Proposal Format Addendum 11 – Stage 2 Evaluation Criteria Addendum 12 – BIDS Instructions

1 Executive Summary

1.1. The Medical Technology Enterprise Consortium

The Medical Technology Enterprise Consortium (MTEC) is an enterprise partnership in collaboration with industry and academia to facilitate research and development activities, in cooperation with the Department of Defense (DoD) U.S. Army Medical Research and Development Command (USAMRDC) and other Government agencies in the biomedical sciences (including but not limited to drugs, biologics, vaccines, medical software and medical devices) to protect, treat and optimize the health and performance of U.S. military personnel. MTEC is a nonprofit corporation with the following principal objectives:

(a) engage in biomedical research and prototyping;

(b) exploration of private sector technology opportunities;

(c) technology transfer; and

(d) deployment of intellectual property (IP) and follow-on production.

MTEC is a broad and diverse biomedical consortium that includes representatives from large businesses, small businesses, contract research organizations, “nontraditional” defense contractors, academic research institutions and not-for-profit organizations; for more information on the MTEC mission, see the MTEC website at https://mtec-sc.org/.

MTEC operates under an Other Transaction Agreement (OTA) for prototype projects with USAMRDC. In accordance with 10 USC 4022, the MTEC OTA enables the Government to carry out prototype projects that are directly relevant to enhancing the mission effectiveness of military personnel and the supporting platforms, systems, components, or materials proposed to be acquired or developed by the Department of Defense, or to improvement of platforms, systems, components, or materials in use by the armed forces. As defined in the DoD OTA Guide dated November 2018, a prototype project addresses a proof of concept, model, reverse engineering to address obsolescence, pilot, novel application of commercial technologies for defense purposes, agile development activity, creation, design, development, demonstration of technical or operational utility, or combinations of the foregoing. A process, including a business process, may be the subject of a prototype project. Although assistance terms are generally not appropriate in OT agreements, ancillary work efforts that are necessary for completion of the prototype project, such as test site training or limited logistics support, may be included in prototype projects. A prototype may be physical, virtual, or conceptual in nature. A prototype project may be fully funded by the DoD, jointly funded by multiple federal agencies, cost-shared, funded in whole or part by third parties, or involve a mutual commitment of resources other than an exchange of funds. Proposed prototype projects should not be exploratory in nature and do require a foundation of preliminary data.

1.2. Purpose

This solicitation, issued by the MTEC Consortium Manager (CM), Advanced Technology International (ATI), represents a Request for Project Proposals (RPP) for MTEC in support of the Uniformed Services University of the Health Sciences (USU). Proposals selected for award as a https://mtec-sc.org/ result of this RPP will be awarded under the authority of 10 U.S.C. § 4022. Strategic oversight for the award(s) supported by this RPP will be provided by USU.

This RPP aims to advance and optimize a benchmark for the training and matching of service dogs with disabled service members and veterans (henceforth referred to as “SM”). This prototype is based on existing federal regulations, industry best practices, and lessons learned from the prior administration of the Wounded Warrior Service Dog Program (WWSDP) at the USU. This RPP focuses on the following two tasks (see Section 3 for details):

• TASK 1 – Integrator capable of acquiring, collating, and analyzing data for the development of the benchmark.

• TASK 2 – Performers capable of integrating, testing and evaluating the components of the benchmark related to the training and matching of service dogs and SM.

Offerors shall address only ONE of the Tasks listed above and are limited to a single proposal submission.

2 Administrative Overview

2.1. Request for Project Proposals (RPP)

The following sections describe the formats and requirements for proposal submission. Offerors are instructed to review the proposal submission requirements closely as this RPP is tailored to the needs of the WWSDP and do not follow standard RPP requirements.

Offerors who submit Proposals in response to this RPP should submit by the date on the cover page of this RPP. Proposals may not be considered under this RPP unless received on or before the due date specified on the cover page.

Each MTEC Proposal submitted must be in accordance with the mandatory formats provided in this RPP. Proposals that fail to follow the mandatory formats may be eliminated from the competition during the CM’s preliminary screening stage (see Section 5 of this RPP for more details on the Selection process). The Government reserves the right to award Proposals received from this RPP on a follow-on prototype OTA or other stand-alone OTAs as necessary to meet mission requirements.

2.2. Funding Availability and Period of Performance

The U.S. Government (USG) Department of Defense (DoD) USU has approximately $14.1 million to be made available for awards in Fiscal Year 2023. It is expected that MTEC will make a single award to fund a single qualified Offeror for Task 1 AND fund multiple qualified Offerors for Task 2 of this effort to accomplish the scope of work. The maximum allowable budget requested by Task 1 Offerors is $2,000,000. The maximum allowable budget requested by each Task 2 Offeror is $2,000,000. The Government reserves the right to request adjustments to proposed budgets as a condition of award. Award and funding from the Government is contingent upon the availability of federal funds for this program.

The period of performance (PoP) shall not exceed 12 months.

Past WWSDP recipients ARE ELIGIBLE to apply and compete for WWSDP awards through this MTEC RPP. However, please note that this RPP is neither suitable for renewal applications nor supplementation of awards that have been made outside of MTEC.

Note that the Government reserves the right to make final evaluation and award decisions based upon, among other factors, programmatic relevancy and overall best value solutions determined to be in the Government’s best interest. This interest includes, but is not limited to, the safety of the service dog, SM, and the public.

2.3. Acquisition Approach

This RPP will be conducted using a modified Enhanced White Paper approach. In Stage 1, Task 1 Offerors are invited to submit Enhanced White Papers and Task 2 offerors are invited to submit a Task 2 Application Forms (see Section 4.2 of this RPP for description of required documents for submission). The Government will evaluate all submissions and will select those that represent the best value using the evaluation criteria in Section 5 of this RPP.

It is the intent of this program that those Task 2 Offerors that are recommended for award will be required to team with the Task 1 Offeror selected for award, where the Task 1 Offeror will serve as the prime contractor and the multiple Task 2 Offerors will serve as subcontractors.

Upon recommendation for award, the selected Task 1 Offeror will then be invited to submit a full cost proposal in Stage 2, which incorporates the selected Task 2 Offerors as subcontractors for award. MTEC will introduce the selected Task 2 Offerors to the selected Task 1 Offeror at that time. Notification letters will contain specific Stage 2 proposal submission requirements.

Pending successful completion of the total effort, the Government may issue a non-competitive follow-on production contract or transaction pursuant to 10 U.S.C. § 4022 section f.

The Government-selected prototype project(s) awarded as a result of this solicitation will be funded under the Other Transaction Agreement for prototype projects (OTA) Number W81XWH- 15-9-0001 with MTEC administered by the CM, ATI. The CM will negotiate and execute a Base Agreement with the Task 1 Offeror recommended for award (if not yet executed). The same provisions will govern this Base Agreement as the OTA for prototype projects between the Government and MTEC. Subsequently, any proposal that is selected for award will be funded through a Research Project Award (RPA) issued under the member’s Base Agreement. The MTEC Base Agreement can be found on the MTEC website (within the Documents Library:

https://www.mtec-sc.org/documents-library/) and Members-Only website at www.mtec-sc.org.

At the time of the submission, Task 1 Offerors that have not yet executed a Base Agreement must certify on the cover page of their Proposal that, if selected for award, they will abide by the terms and conditions of the latest version of the MTEC Base Agreement. If the Offeror https://www.mtec-sc.org/documents-library/ http://www.mtec-sc.org/ already has executed an MTEC Base Agreement with the MTEC CM, then the Offeror must state on the cover page of its Proposal that, if selected for award, it anticipates the proposed effort will be funded under its executed MTEC Base Agreement.

2.4. Proposers Conference

MTEC will host a Proposers Conference that will be conducted via virtual webinar within two weeks after the release of the RPP. The intent of the Proposers Conference is to provide an administrative overview of this RPP process and present further insight into the Technical Requirements outlined in Section 3 of this RPP. All potential Offerors are strongly encouraged to attend these informational sessions. Further instructions will be forthcoming via email. Offerors are advised to check the MTEC website periodically during the proposal preparation period for any clarifications found in Frequently Asked Questions (FAQ) responses.

2.5. Proprietary Information

The MTEC CM will oversee submission of proposals and analyze cost proposals submitted in response to this RPP. The MTEC CM shall take the necessary steps to protect all proprietary proposal information and shall not use such proprietary information for purposes other than the evaluation of an Offeror’s proposal and the subsequent agreement administration if the proposal is selected for award. In accordance with the Proposal Preparation Guide (PPG), please mark all Confidential or Proprietary information as such. An Offeror’s submission of a proposal under this RPP indicates concurrence with the aforementioned CM responsibilities.

Also, as part of MTEC’s mission to incorporate philanthropic donations, MTEC frequently makes contact with private entities (e.g., foundations, investor groups, organizations, individuals) that award grants or otherwise co-fund research, and/or operates in research areas that are aligned with those of MTEC. These private entities may be interested in reviewing certain Proposals within their program areas, allowing opportunities to attract supplemental funding sources.

Therefore, on your Proposal Cover Page, please indicate your willingness to allow MTEC Officers and Directors access to your Proposal for the purposes of engaging in outreach activities with these private entities. MTEC Officers and Directors who are granted proposal access have signed Nondisclosure Agreements (NDAs) and Organizational Conflict of Interest (OCI) statements.

Additionally, these MTEC Officers and Staff represent organizations that currently are not MTEC members, and therefore their parent organizations are not eligible to submit Proposals or receive any research project funding through MTEC. Additionally, all Technical Evaluation Panel participants, which may include contractor support personnel serving as nongovernmental advisors, will agree to and sign a Federal Employee Participation Agreement or a Nondisclosure/Nonuse Agreement, as applicable.

2.6. Offeror Eligibility

Task 1 and Task 2 offerors must be a nonprofit organization that is subject to 26 U.S.C. 501(c)(3) of the tax code.

TASK 1 Offerors: Task 1 offerors must be a nonprofit organization that is subject to 26 U.S.C.

501(c)(3) of the tax code. Task 1 Offerors must be MTEC Members in good standing to be eligible to submit an Enhanced White Paper. Task 1 Offerors submitting Enhanced White Papers as the Prime Performer must be MTEC members of good standing at least 3 days prior to submission of the Enhanced White Papers. To join MTEC, please visit http://mtec-sc.org/how-to-join/.

TASK 2 Offerors: MTEC membership is NOT required for the submission of a Proposal in response to Task 2 of this MTEC RPP. However, to be eligible to receive WWSDP funds, a Task 2 Offeror is required to:

• Be a nonprofit organization that is subject to 26 U.S.C. 501(c)(3) of the tax code;

• Have an active registration in the System for Award Management (SAM);

• Submit the required submission documents by the application deadline;

• Have a proven track record of providing service dogs to disabled SM;

• Provide for all daily and medical needs of the canines before placement with a SM;

• Provide all placement and training services at no cost to the SM. Services include, but not limited to, canine acquisition, canine training, canine veterinary costs, canine certifications, canine grooming and care, SM training, SM public access training, travel, and lodging (for up to 14 days). Moreover, SM may not be solicited to participate in any activity to underwrite costs. This prohibition includes donations, loans, fundraising activities, or favorable considerations of any type for the organization.

• Be able to integrate, test, and evaluate benchmark guidelines.

2.7. Cost Sharing Definition

Cost sharing is defined as the resources expended by the award recipients on the proposed Statement of Work / Milestone Payment Schedule. Cost sharing above the statutory minimum is not required in order to be eligible to receive an award under this RPP. If cost sharing is proposed, then the Offeror shall state the amount that is being proposed and whether the cost sharing is a cash contribution or an in-kind contribution (see Addendum 1 for definitions); provide a description of each cost share item proposed; the proposed dollar amount for each cost share item proposed; and the valuation technique used (e.g., vendor quote, historical cost, labor hours and labor rates, number of trips, etc.).

2.8. Cost Sharing Requirements

In order to be compliant with the statute for awarding prototype projects, Research Projects selected for funding under this RPP are required to meet at least one of the conditions specified in Addendum 2. Beyond that, cost sharing is encouraged, if possible, as it leads to stronger leveraging of Government-contractor collaboration. For more information regarding cost share, please see Addendum 1. Proposals that fail to meet the mandatory statutory conditions with regard to the appropriate use of Other Transaction authority, as detailed in Addendum 2, will not be evaluated and will be determined ineligible for award.

http://mtec-sc.org/how-to-join/

Due to the unique nature of this solicitation and acquisition approach, compliance with the requirements detailed in Addendum 2 will be verified prior to execution of award in lieu of a screening process performed at the time of proposal submission.

2.9. MTEC Assessment Fee

Per Section 3.4 of the Consortium Member Agreement (CMA), the Task 1 recipient of a Research Project Award under the MTEC OTA shall pay MTEC an amount equal to 2% of the total funded value of each research project awarded. Such deposits shall be due no later than 90-days after the Research Project Award is executed. The MTEC Assessment Fee is not allowable as a direct charge to any resulting award or any other contract. Therefore, Offerors shall not include this Assessment Fee as part of their proposed direct costs. Members who have not paid the assessment fee within 90 days of the due date are not “Members in good standing”.

2.10. Intellectual Property and Data Rights

Baseline IP and Data Rights for MTEC Research Project Awards are defined in the terms of an awardee’s Base Agreement and, if applicable, specifically-negotiated terms are finalized in any resultant Research Project Award. MTEC reserves the right to assist in the negotiation of IP, royalties, licensing, future development, etc., between the Government and the individual performers prior to final award decision and during the entire award period.

The Offeror shall comply with the terms and conditions contained in their Base Agreement regarding IP and Data Rights, as modified by the specifically-negotiated IP and Data rights terms herein. It is anticipated that anything created, developed, or delivered under this proposed effort will be delivered to the Government with Government Purpose Rights or unlimited data rights unless otherwise asserted in the proposal and agreed to by the Government. Rights in technical data in each Research Project Award shall be determined in accordance with the provisions of MTEC Base Agreement.

See Addendum 3 for more detail. Note that as part of the Stage 1 of the RPP process (submission of an Enhanced White Paper), ALL Offerors shall complete and submit Addendum 3 (Intellectual Property and Data Rights) as an appendix to the proposal with the Signature of the responsible party for the proposing Prime Offeror.

2.11. Expected Award Date

Offerors should plan on the PoP beginning on or about 30 September 2023 (subject to change).

The Government reserves the right to change the proposed PoP start date through negotiations via the CM and prior to issuing a Research Project Award.

2.12. Proposal Selection Notification

As the basis of selections is completed, the Government will forward its selections to the MTEC CM to notify all Offerors. All Proposers will be notified by email from the MTEC CM of the results of the evaluation. Those successful will move forward to the next stage of the process.

Offerors are hereby notified that once proposals have been submitted, neither the Government nor the MTEC CM will discuss evaluation/status until after the Offeror receives the formal notification with the results of this evaluation.

3 Technical Requirements

3.1. Background

The Wounded Warrior Service Dog Act of 2013 (H.R. 2847)1 established a grant program to encourage the matching of disabled SM and service dogs. In 2015, the program was funded using a Defense Health Program appropriation.2 Since then, the program has been managed by USU and increased in budget, scope, and outreach. However, USU has identified several challenges in managing the program. Primarily, the service dog industry is unregulated. There are no required standards or outcome measures. The lack of shared guidelines makes it difficult to evaluate the quality of service dog programs because this quality was never defined. Moreover, a lack of guidelines place the safety of canines, SM, and the public at risk.

To combat these challenges, USU has taken the experience that they have had so far and drafted the foundation of a benchmark for the WWSDP. This prototype (refer to Addendum 4 of this RPP for the Prototype Guidelines) is intended to serve as a starting point for the Awardees to integrate, test, evaluate. This action has urgency as the Defense Health Agency and the United States Department of Veterans Affairs increase funding for service dogs without shared knowledge, standards, or a formal benchmark.

For the purposes of this RPP, the following terms and operational definitions are used:

• Covered Members and Veterans: Any SM who is receiving medical treatment, recuperation, or therapy under chapter 55 of title 10, United States Code; in medical hold or medical holdover status; or covered under section 1202 or 1205 of title 10, United States Code; or any Veteran who is enrolled in the health care system established under section 1705(a) of title 38, United States Code.

• Disability: A physical, sensory, psychiatric, intellectual, or other mental impairment that substantially limits an individual's major life activities.

• Service dog: Any dog that is individually trained to do work or perform tasks for the benefit of an individual with a disability per 28 C.F.R. §35.104 (does not include emotional support/therapy dogs or facility dogs).

• Service member: Active member of any branch of the U.S. Uniformed Services (Army, Navy, Marine Corps, Air Force, Coast Guard, Space Force, Public Health Service Commissioned Corps, National Oceanic and Atmospheric Administration).

• Sponsor: Government/Uniformed Services University.

1 https://www.congress.gov/bill/113th-congress/house-bill/2847/text?q=%7B%22search%22%3A%5B%22Veterans%27%5C%5C%22%2C%22Affairs%7CHealth%22%5D%7D&r=88&s=1 (Retrieved on 27 September 2022) 2 https://www.congress.gov/bill/113th-congress/house-bill/83 (Retrieved on 27 September 2022) https://protect2.fireeye.com/v1/url?k=2946f67f-76ddcccf-2941f1ab-0cc47a31ce0a-e39f1d0146d340fc&q=1&e=a48faa86-60e6-47f5-be7d-362c7ce790c9&u=https%3A%2F%2Furldefense.us%2Fv3%2F__http%3A%2F%2Fuscode.house.gov%2Fview.xhtml%3Freq%3Dgranuleid%3AUSC-prelim-title10-chapter55-front%26num%3D0%26edition%3Dprelim__%3B%21%21K5Lz-iOWUwiAdw%21IEqsWp1FdkEieP7LTrBYKUzzjaj2Zu_LaSSWR-pg53ObKROygbTr7UL6tVnlqxy2oLL75NcR9VEF80ShRbw7Y9rAiw0A4YOt%24 https://protect2.fireeye.com/v1/url?k=b82a4de8-e7b17758-b82d4a3c-0cc47a31ce0a-0b3116c9cdb99283&q=1&e=a48faa86-60e6-47f5-be7d-362c7ce790c9&u=https%3A%2F%2Furldefense.us%2Fv3%2F__http%3A%2F%2Fuscode.house.gov%2Fquicksearch%2Fget.plx%3Ftitle%3D10%26section%3D1202__%3B%21%21K5Lz-iOWUwiAdw%21IEqsWp1FdkEieP7LTrBYKUzzjaj2Zu_LaSSWR-pg53ObKROygbTr7UL6tVnlqxy2oLL75NcR9VEF80ShRbw7Y9rAi5_kvYIM%24 https://protect2.fireeye.com/v1/url?k=a0db4d6d-ff4077dd-a0dc4ab9-0cc47a31ce0a-7f465f01b190a6e8&q=1&e=a48faa86-60e6-47f5-be7d-362c7ce790c9&u=https%3A%2F%2Furldefense.us%2Fv3%2F__http%3A%2F%2Fuscode.house.gov%2Fquicksearch%2Fget.plx%3Ftitle%3D10%26section%3D1205__%3B%21%21K5Lz-iOWUwiAdw%21IEqsWp1FdkEieP7LTrBYKUzzjaj2Zu_LaSSWR-pg53ObKROygbTr7UL6tVnlqxy2oLL75NcR9VEF80ShRbw7Y9rAi82gbiHH%24 https://protect2.fireeye.com/v1/url?k=00abbff6-5f308546-00acb822-0cc47a31ce0a-4fa6270a6d1e95b7&q=1&e=a48faa86-60e6-47f5-be7d-362c7ce790c9&u=https%3A%2F%2Furldefense.us%2Fv3%2F__http%3A%2F%2Fuscode.house.gov%2Fquicksearch%2Fget.plx%3Ftitle%3D38%26section%3D1705__%3B%21%21K5Lz-iOWUwiAdw%21IEqsWp1FdkEieP7LTrBYKUzzjaj2Zu_LaSSWR-pg53ObKROygbTr7UL6tVnlqxy2oLL75NcR9VEF80ShRbw7Y9rAi9nte1uJ%24 https://www.congress.gov/bill/113th-congress/house-bill/2847/text?q=%7B%22search%22%3A%5B%22Veterans%27%5C%5C%22%2C%22Affairs%7CHealth%22%5D%7D&r=88&s=1 https://www.congress.gov/bill/113th-congress/house-bill/2847/text?q=%7B%22search%22%3A%5B%22Veterans%27%5C%5C%22%2C%22Affairs%7CHealth%22%5D%7D&r=88&s=1 https://www.congress.gov/bill/113th-congress/house-bill/83

• Veteran: Service member who was discharged or released therefrom under conditions other than dishonorable.

3.2. Solution Requirements

The content of the benchmark to be delivered by this program includes identification of best practices for the service dog industry (e.g., minimum requirements for the selection and training of both dog and SM, facilities conditions, and canine care and medical information), establishment of a baseline to compare service dog organizations, creation of a standard for the purpose of Government funding and research, and establishment of minimum guidelines to protect the wellbeing and safety of our SM, service dogs, and the public.

The Government has identified two tasks for funding to support this effort. Proposals shall address only ONE of the Tasks outlined below. Offerors are limited to a single proposal submission. These Tasks are not listed in order of importance.

• TASK 1 – A single integrator capable of acquiring, collating, and analyzing data for the development of the benchmark

• TASK 2 – Multiple performers capable of testing and evaluating the components of the benchmark related to the training and matching of service dogs and SM

It is the intent of this program that those Task 2 Offerors that are recommended for award will be required to team with the Task 1 Offeror selected for award, where the Task 1 Offeror will serve as the prime contractor and the multiple Task 2 Offerors will serve as subcontractors. This structure will allow for unified network or team working towards a shared goal to support this MTEC WWSDP requirement. All award recipients must safeguard the privacy of SM under the purview of this contract (refer to Addendum 5 of this RPP – “Privacy Protocols” - for more information).

3.2.1. Task 1 – Integrator capable of acquiring, collating, and analyzing data for the development of the benchmark. This program shall be led by a centralized point of contact (POC), or a single organization that serves as the “Integrator.” It is expected that the Integrator will assist the Government in managing the WWSDP. The Integrator will serve as a link between the Government and the Task 2 Performers to facilitate the technical, scientific, and program management. The selected Integrator will be ultimately responsible for official communication with Task 2 Performers and all award deliverables. Task 1 Offerors are expected to propose a “mini-consortium” type of structure that is comprised of the necessary qualified personnel, facilities, equipment, supplies, services, subcontractors, and related administrative and information technology support to accomplish the Integrator’s objectives. It is preferred that the Integrator have established experience in the acquisition and analysis of data for the purpose of developing best practices and guidelines. The Offeror for Task 1 shall include the overall Project Management Plan as part of the Enhanced White Paper submission. Furthermore, the Government recognizes that the composition of the team may change as the project requirements evolve over time. The Offeror shall be prepared to work with MTEC to adjust (i.e.

expand) the team, as needed, throughout the period of performance (to include potential follow on efforts). It is encouraged that Task 1 Offerors demonstrate in their Enhanced White Papers their previous experience providing technical, programmatic, financial, and/or scientific solutions to the Government, and specific experience related to the following areas:

• Functional knowledge of quantitative and qualitative data analysis.

• Experience with psychometric assessments.

• Functional knowledge of federal travel regulations and systems.

The Integrator’s role may include (but is not limited to) the following activities:

• Establish an Advisory Committee containing, at minimum, this Government Sponsor Office

Technical Representative (SOTR) and a member of USU faculty that will assist with the data collection and analysis as well as perform site visits. The Offeror is encouraged to recommend others that may add value to the Advisory Committee. Final approval of the composition of the Advisory Board will be provided by the SOTR. The Advisory Committee is expected to convene quarterly and on an as-needed basis for off cycle issues through virtual communications.

• Verify that Task 2 Performers integrate, test, and evaluate the prototype guidelines.

• Manage communications among Task 2 Performers and USU, including arranging and conducting site visits to the Task 2 Performers sites.

• Manage the distribution of funds in accordance with the milestones/deliverables identified for each Task 2 Performer.

• Assist Task 2 Performers in meeting deliverable deadlines.

• Develop and distribute periodic surveys to Task 2 Performers to track and evaluate the effectiveness of the prototype benchmark.

• Acquire or develop any necessary questionnaires or additional assessment tools required to evaluate or refine the prototype benchmark.

• Facilitate or conduct associated research activities to articulate best practices.

• Organize at least one focus group meeting for Task 2 Performers to evaluate and validate the prototype benchmark. This would be a 1-2 day event held at USU in Bethesda, MD with accommodations and travel to and from the event for one member of each of the Task 2 Performers to be coordinated by the Task 1 Integrator. This focus group meeting should take place towards the end of the PoP.

• Deliver quarterly reports to USU that summarize data and conclusions from the testing and validation of the prototype benchmark. It is anticipated that the Task 1 Integrator would work with the government during the PoP to standardize a reporting format for this effort

• Conduct data synthesis to articulate meaningful trends, limitations, and next steps.

• Translate data into actionable information to enable the optimization of prototype guidelines

• In the event that additional funding becomes available for follow-on work, the Government may instruct the Integrator to work solely with MTEC to collect project information papers from Task 2 Offerors (including organizations not part of the program during the initial 12-month PoP). If the MTEC Request for Project Information (RPI) process is utilized (either for continued prototype development or for program expansion as follow-on work), the selected Integrator will work with MTEC to draft the necessary RPI. MTEC will use its standard processes to post the RPI and collect the project information paper submissions. USU will evaluate project information papers. All prototype projects will require approval by USU prior to addition to the Integrator’s award.

3.2.2. Task 2 – Performers capable of testing and evaluating the prototype benchmark. Multiple service dog organizations will be selected to incorporate the benchmark into their own training of service dogs and disabled SM, and report the test and evaluation data back to the Task 1 Integrator. Task 2 Performers shall work with the Task 1 Integrator, as needed, to meet contract deliverables and requirements.

Each Task 2 Performer’s role includes (but is not limited to) the following activities:

• Host USU officials for scheduled site visits to the Task 2 Performer sites. Each site visit may require 4-6 hours to inspect the facility, handling of dogs, veterinary care, and record keeping. In addition, the site visits afford both the USG and the performing organizations an opportunity to brainstorm best practices, challenges, and opportunities to improve the benchmark. Offerors must include the costs of such a visit, if any, in their proposals.

• Integrate the prototype benchmark into their own training of service dogs and SM with disabilities.

• Assess the level of burden, scope, and practicality of the prototype benchmark.

• Complete periodic surveys to test and evaluate the effectiveness of the benchmark.

• Assist the Integrator (Task 1 Performer) in articulating best practices to improve dog and

SM training and minimize training attrition, which will contribute to the optimization of the benchmark.

• Participate in at least one 1-2 day focus group meetings organized by the Integrator.

• Tabulate and report dog and SM training data to the Task 1 Integrator (e.g., demographics, hours).

PREFERRED: In addition to the above stated requirements, the Government will consider factors that protect the safety of the service dogs, SM, and the public. The Government will also evaluate the aptitude of Offerors to engage in a robust academic debate related to the benchmark guidelines.

3.3. Potential Follow-on Tasks

There is potential for award of one or more follow-on tasks based on the success of any resultant Research Project Award(s) (subject to change depending upon Government review of work completed). Examples of follow-on work may include studies required to validate and/or optimize the benchmark. Note that any potential follow-on work may be awarded non-competitively to resultant project awardee(s).

3.4. Restrictions on Animal and Human Subjects

Proposals must comply with the following restrictions and reporting requirements for the use of animal and human subjects, to include research involving the secondary use of human biospecimens and/or human data. The Awardee shall ensure local Institutional Animal Care and Use Committee (IACUC) and Institutional Review Board (IRB) approvals, continuing review (in the intervals specified by the local IRB, but at a minimum, annually), and approval by the USAMRDC Office of Human and Animal Research Oversight (OHARO) Office of Human Research Oversight (OHRO). Offerors shall include IRB and OHRO review and approval in the SOW/Milestones Table submitted with the Proposal, as applicable.

Research Involving Humans: All DoD-funded research involving new and ongoing research with human anatomical substances, human subjects, or human cadavers must be reviewed and approved by the USAMRDC OHRO prior to research implementation. This administrative review requirement is in addition to the local IRB or Ethics Committee review. Allow a minimum of 2 to 3 months for OHRO regulatory review and approval processes.

Research Involving Animals: All DoD-funded research involving new and ongoing research with animals must be reviewed and approved by the USAMRDC OHARO Animal Care and Use Review Office (ACURO), in addition to the local Institutional Animal Care and Use Committee (IACUC) of record. Allow at least 3 to 4 months for ACURO regulatory review and approval processes for animal studies.

These restrictions include mandatory Government review and reporting processes that will impact the Offeror’s schedule.

The USAMRDC OHRO will issue written approval to begin research under separate notification.

Written approval to proceed from the USAMRDC OHRO is also required for any Research Project Awardee (or lower tier subawards) that will use funds from this award to conduct research involving human subjects. Offerors must allow at least 30 days in their schedule for the ORP review and authorization process.

3.5. Guidance Related to DoD-Affiliated Personnel for Participation in research Please note that compensation to DoD-affiliated personnel for participation in research while on duty is prohibited with some exceptions. For more details, see Department of Defense Instruction (DODI) 3216.02, Protection of Human Subjects and Adherence to Ethical Standards in DoD- Conducted and -Supported Research. You may access a full version of the DODI by accessing this link: https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/321602p.pdf

4 Proposal Preparation

4.1. General Instructions

Proposals should be submitted by the date and time specified on the cover page using BIDS:

https://ati2.acqcenter.com/ATI2/Portal.nsf/Start?ReadForm. Include the MTEC Solicitation https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/321602p.pdf https://ati2.acqcenter.com/ATI2/Portal.nsf/Start?ReadForm

Number (MTEC-23-07-WWSDP) on each proposal submitted. See Addendum 12 for further information regarding BIDS registration and submission.

The Proposal formats provided in this MTEC RPP are mandatory for all Offerors. Please note that this RPP includes proposal templates that are specific to Task 1 or Task 2.

Note that only a Task 1 Offeror selected for Stage 2 of this effort will be required to submit a Full Cost Proposal, incorporating the selected Task 2 Offerors as subcontractors using the information provided in their submitted Cost Proposals.

Offerors are encouraged to contact the POCs identified herein up until the Proposal due date/time to clarify requirements (both administrative and technical in nature).

All eligible Offerors may submit Proposals for evaluation according to the criteria set forth herein.

Offerors are advised that only ATI as the MTEC’s CM, with the approval of the DoD Agreements Officer, is legally authorized to contractually bind MTEC into any resultant awards.

4.2. TASK 1 Instructions for the Preparation & Submission of the Stage 1 Proposals Offerors submitting an Enhanced White Paper, inclusive of a Rough Order of Magnitude cost/price estimate, in response to Task 1 this RPP shall prepare all documents in accordance with the following instructions:

Offerors should submit files in Microsoft Office formats or Adobe Acrobat (PDF – portable document format) as indicated below. ZIP files and other application formats are not acceptable.

All files must be print-capable, searchable, and without a password required. Filenames must contain the appropriate filename extension (.docx, .doc, .pptx, .ppt .xlsx, .xls or .pdf). Filenames should not contain special characters. Apple users must ensure the entire filename and path are free of spaces and special characters.

An automated BIDS receipt confirmation will be provided by email. Offerors may submit in advance of the deadline. Neither MTEC nor ATI will make allowances/exceptions for submission problems encountered by the Offeror using system-to-system interfaces. If the Offeror receives errors and fails to upload the full submission prior to the submission deadline, the submission may not be accepted. It is the Offeror’s responsibility to ensure a timely and complete submission.

Required Submission Documents for TASK 1 (4): Submitted via BIDS (5MB or lower per document)

• Enhanced White Paper: one PDF document (See Section 8)

• Intellectual Property and Data Rights Assertions: one Word or PDF document (See

Addendum 3)

• Statement of Work (SOW)/Milestone Payment Schedule (MPS): one Word or PDF document (See Addendum 6)

• Warranties and Representations: one Word or PDF document (See Addendum 7)

Page Limitation: The Enhanced White Paper is limited to ten (10) pages (including cover page).

The following Appendices are excluded from the page limitation: (1) Warranties and Representations, (2) Statement of Work, and (3) Intellectual Property and Data Rights Assertions.

The Enhanced White Paper and its Appendices must be in 12-point font (or larger), single-spaced, single-sided, 8.5 inches x 11 inches. Smaller type may be used in figures and tables but must be clearly legible. Margins on all sides (top, bottom, left, and right) should be at least 1 inch.

Enhanced White Papers and Appendices exceeding the page limitations and/or the file size specified above may not be accepted.

Section 8 of this RPP provides additional information related to each of the required documents for the proposal submission. Offerors are encouraged to contact MTEC with any questions so that all aspects are clearly understood by both parties.

FOR INFORMATION ONLY: Please note a full Cost Proposal will be requested if the Enhanced White Paper is recommended for funding (see Section 4.3 for additional details). Additionally, the Government may request additional information in the form of supplementary attachments/appendices (henceforth referred to as supplemental information) to this proposal submission after completion of the technical evaluation to include the following:

• Human Subject Recruitment and Safety Procedures which details study population, inclusion/exclusion criteria, description of the recruitment process, description of the informed consent process, etc.

• Letter(s) of Support, as applicable, if the prototype project will require access to active-duty military patient populations and/or DoD resource(s) or database(s).

The exact requirements of any such attachment/appendix are subject to change and will be provided at the time (or immediately following) the technical evaluation summary is provided (as part of the Selection Notification described in Section 2.12 of this RPP).

4.3. TASK 2 Instructions for the Preparation & Submission of the Stage 1 Proposals

Offerors submitting a Proposal in response to Task 2 of this RPP shall prepare all documents in accordance with the following instructions. Offerors are encouraged to contact MTEC with any questions so that all aspects are clearly understood by both parties.

Offerors should submit files in Microsoft Office formats or Adobe Acrobat (PDF – portable document format) as indicated below. ZIP files and other application formats are not acceptable.

All files must be print-capable, searchable, and without a password required. Filenames must contain the appropriate filename extension (.docx, .doc, .pptx, .ppt .xlsx, .xls or .pdf). Filenames should not contain special characters. Apple users must ensure the entire filename and path are free of spaces and special characters.

An automated BIDS receipt confirmation will be provided by email. Offerors may submit in advance of the deadline. Neither MTEC nor ATI will make allowances/exceptions for submission problems encountered by the Offeror using system-to-system interfaces. If the Offeror receives errors and fails to upload the full submission prior to the submission deadline, the submission may not be accepted. It is the Offeror’s responsibility to ensure a timely and complete submission.

Required Submission Documents for TASK 2 (4): Each document (5MB or lower per document) will be uploaded to BIDS separately (see Addendum 13 of RPP for BIDS instructions).

• Task 2 Application Form (PMR Form): one Word or PDF document (See Addendum 8).

The application form is designed to establish a profile for each applicant. Organizations must complete accurate and contemporary, as opposed to prospective, information.

• Task 2 Budget Narrative: one Word or PDF document (See Addendum 9). This narrative is designed to justify the requested financial support outlined in the Cost Formats. This justification must explain how funds will be used to integrate, test, and evaluate prototype guidelines (e.g., canine medical requirements, testing, trainer accreditation, home visits, etc.).

• Task 2 Cost Proposal Format: one Excel or PDF document (See Addendum 10). This form is designed to provide the necessary information for the selected Task 1 Integrator to submit a full cost proposal.

• Intellectual Property and Data Rights Assertions: one Word or PDF document (See Addendum 3). The Offeror shall comply with the terms and conditions defined in the Base Agreement regarding Data Rights. It is anticipated that anything delivered under this proposed effort would be delivered to the Government in accordance with Section 2.10 of the RPP unless otherwise asserted in the proposal and agreed to by the Government.

If this is not the intent, then you should discuss any restricted data rights associated with any proposed deliverables/milestones. If applicable, complete the table within the referenced attachment for any items to be furnished to the Government with restrictions.

FOR INFORMATION ONLY: Please note, additional attachments/appendices (referred to above as “supplemental information”) to this proposal submission may be requested after completion of the technical evaluation. Examples of such supplemental information are provided in Section 4.2.

above. The exact requirements of any such attachment/appendix will be provided at the time (or immediately following) the technical evaluation summary is provided (as part of the Selection Notification described in Section 2.12 of this RPP).

4.4. Stage 2: Cost Proposal (for Only Those Offerors Recommended for Funding) Offerors that are recommended for funding will receive notification letters which will serve as the formal teaming request between the Task 1 Integrator and Task 2 Performers. The request will require the selected Task 1 Integrator to submit a full Cost Proposal, including all selected Task 2 Performers as subcontractors. All Offerors may receive an additional request at this time for Enhanced White Paper revisions and/or supplemental information, such as those examples listed in the section above, based on the results of the technical evaluation). This request will contain specific submission requirements if there are any changes to those contained in this RPP.

However, it is anticipated that the Task 1 Integrator will be required to submit:

Required Submission Documents (2): Submit to mtec-contracts@ati.org

• Section I: Cost Proposal Narrative: one Word or PDF document

• Section II: Cost Proposal Format: one Excel or PDF document

See below for additional instructions. Also refer to Addendum 11 of this RPP for details on how the full Stage 2 Cost Proposals will be evaluated.

The selected Task 1 Offeror is encouraged to use their own cost format such that the necessary detail is provided. MTEC will make cost proposal formats available on the Members-Only MTEC website. The Cost Proposal formats provided in the MTEC website and within the PPG are NOT mandatory.

Each cost proposal should include direct costs and other necessary components as applicable, for example, fringe, General & Administrative Expense (G&A), Facilities & Administrative (F&A), Other Direct Costs (ODC), etc. Offerors shall provide a breakdown of material and ODC costs as applicable. Refer to the MTEC PPG for additional details.

Those Offerors invited to submit a Cost Proposal are encouraged to contact the MTEC CM and/or Government with any questions so that all aspects of the Stage 2 requirements are clearly understood by both parties.

4.5. Proposal and Cost Proposal Preparation Costs

The cost of preparing Proposals and Cost Proposals in response to this RPP is not allowable as a direct charge to any resulting award or any other contract. Additionally, the MTEC Assessment Fee (see Section 2.9 of this RPP) is not allowable as a direct charge to any resulting award or any other contract.

4.6. Freedom of Information Act (FOIA)

To request protection from FOIA disclosure as allowed by 5 U.S.C. §552, Offerors shall mark business plans and technical information with a legend identifying the documents as being submitted on a confidential basis. For more information, please refer to Section 6.1.1 of the MTEC PPG or contact the POCs identified herein up until the Proposal due date/time to clarify.

4.7. Telecommunications and Video Surveillance

As stated in Section 6.1.2 of the MTEC PPG, per requirements from the Acting Principal Director of Defense Pricing and Contracting dated 13 August 2020, the provision at FAR 52.204-24, “Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment” is incorporated in this solicitation. If selected for award, the Task 1 Offeror must complete and provide the representation, as required by the provision, to the CM.

5 Selection

5.1 Preliminary Screening

The CM will conduct a preliminary screening of submitted proposals to ensure compliance with the RPP requirements. As part of the preliminary screening process, Proposals that do not meet the requirements of the RPP may be eliminated from the competition or additional information may be requested by the CM. Additionally, the Government reserves the right to request additional information or eliminate proposals that do not meet these requirements from further consideration.

5.2 Stage 1 Proposal Evaluation

The CM will distribute all Proposals that pass the preliminary screening (described above) to the Government for full evaluation. Evaluation of Proposals will be based on an independent, comprehensive review and assessment of the work proposed against the stated source selection criteria and evaluation factors.