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The Medical Technology Enterprise Consortium (MTEC) is excited to post this pre-announcement for an Other Transaction (OT) for prototype projects Request for Project Proposals (RPP) which aims to adva... The Medical Technology Enterprise Consortium (MTEC) is excited to post this pre-announcement for an Other Transaction (OT) for prototype projects Request for Project Proposals (RPP) which 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 Uniformed Services University (USU). ____________________________________________________________________________________ BACKGROUND: The Wounded Warrior Service Dog Act of 2013 (H.R. 2847) established a grant program to encourage the matching of disabled SM and service dogs (see attachment for further details regarding H.R. 2847). In 2015, the program was funded using a Defense Health Program appropriation (see attachment for further details regarding this appropriation). 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, lack of guidelines places the safety of canines, SM, and the public at risk. To overcome these challenges, USU has taken the experience that they have had so far and drafted the foundation of a benchmark for the WWSDP. This draft benchmark is intended to serve as a starting point for the Awardee to test, validate, and improve upon. This action has urgency as the Defense Health Agency (DHA) and the United States Department of Veterans Affairs (VA) increase funding for service dogs without shared benchmarks, standards, or a formal benchmark. SOLUTION REQUIREMENTS: The content of the benchmark to be delivered by this program under the upcoming RPP 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 – Integrator capable of acquiring, collating, and analyzing data for the development of the benchmark TASK 2 – 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. 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: Establishing 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. Managing communications among Task 2 Performers and USU, including arranging and conducting site visits to the Task 2 Performers sites. Managing the distribution of funds in accordance to the milestones/deliverables identified for each Task 2 Performer. Assisting Task 2 Performers in meeting deliverable deadlines. Developing and distributing periodic surveys to Task 2 Performers to track and evaluate the effectiveness of the prototype benchmark. Acquiring or developing any necessary questionnaires or additional assessment tools required to evaluate or refine the prototype benchmark. Facilitating or conducting associated research activities to articulate best practices. Organizing 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/Bethesda 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. It is preferred that this focus group meeting take place towards the end of the Period of Performance (PoP). Delivering 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. Conducting data synthesis to articulate meaningful trends, limitations, and next steps. Translating data into products and providing an optimized benchmark prototype to the Government. 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. 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: Integrating the prototype benchmark into their own training of service dogs and SM with disabilities. Assessing the level of burden, scope, and practicality of the prototype benchmark. Completing periodic surveys to test and evaluate the effectiveness of the benchmark. Assisting 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. Participating in at least one 1-2 day focus group meetings organized by the Integrator. Tabulating and reporting dog and SM training data to the Task 1 Integrator (e.g., demographics, hours). REQUIRED: To be eligible to receive WWSDP funds, a Task 2 Offeror must: Have an active registration in the System for Award Management (SAM); Submit the required submission documents by the application deadline (template will be provided in the upcoming RPP); Demonstrate 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; Ensure that all service dogs to be placed with SM pass a public access test administered by an industry-recognized third-party (e.g., ADI, AKC); Ensure that SM applying for participation submit a copy of Certificate of Release or Discharge from Active Duty (DD 214); 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 incorporate, test, and evaluate the benchmark. 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. TERMS & DEFINITIONS For the purposes of this pre-announcement, 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. Veteran: Service member who was discharged or released therefrom under conditions other than dishonorable. POTENTIAL FUNDING AVAILABILITY AND PERIOD OF PERFORMANCE: The U.S. Government (USG) Department of Defense (DoD) USU has up to $15,000,000 to be made available for awards in 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 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 anticipated start of the PoP is September 2023. The PoP is not to exceed 12 months. Past WWSDP recipients ARE ELIGIBLE to apply and compete for WWSDP awards through this upcoming MTEC RPP. This upcoming RPP is neither suitable for renewal applications nor supplementation of awards that have been made outside of MTEC. ACQUISITION APPROACH: This RPP will be conducted using the Enhanced White Paper approach. In Stage 1, Offerors are invited to submit Proposals using the mandatory format contained in the RPP. The Government will evaluate all submissions and will select those that represent the best value using the evaluation criteria contained in the 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. This upcoming RPP will be posted to the MTEC website (mtec-sc.org) and SAM.gov to notify interested parties. The RPP is expected to be released as soon as possible and will have a short proposal preparation period (approximately 30 days). MTEC membership is required for the submission of an Enhanced White Paper in response to Task 1 of this MTEC RPP. However, membership will NOT be required for Offerors responding to Task 2 of this MTEC RPP. Subcontractors (including all lower tier subawardees) do not need to be MTEC members. To join MTEC, please visit http://mtec-sc.org/how-to-join/. MTEC MEMBER TEAMING: While teaming is not required for this effort, Offerors are encouraged to consider teaming during the proposal preparation period (prior to Enhanced White Paper submission) if they cannot address the full scope of technical requirements of the RPP or otherwise believe a team may be beneficial to the Government. The following resources may help Offerors form a more complete team for this requested scope of work. The MTEC M-Corps is a network of subject matter experts and service providers to help MTEC members address the business, technical, and regulatory challenges associated with medical product development. M-Corps offers members a wide variety of support services, including but not limited to: business expertise [i.e., business development, business and investment planning, cybersecurity, finance, intellectual asset management, legal, logistics/procurement, pitch deck coaching, transaction advisory], and technical expertise [i.e., chemistry, manufacturing and controls, clinical trials, concepts and requirements development, design development and verification, manufacturing, process validation, manufacturing transfer quality management, regulatory affairs]. Please visit https://www.mtec-sc.org/m-corps/ for details on current partners of the M-Corps. MTEC Database Collaboration Tool to help identify potential teaming partners among other MTEC members. The Database Collaboration Tool provides a quick and easy way to search the membership for specific technology capabilities, collaboration interest, core business areas/focus, R&D highlights/projects, and technical expertise. Contact information for each organization is provided as part of the member profile in the collaboration database tool to foster follow-up conversations between members as needed. The Collaboration Database Tool can be accessed via the “MTEC Profiles Site” tab on the MTEC members-only website (https://private.mtec-sc.org/). A dedicated chat forum has been established to facilitate direct interaction amongst MTEC members in relation to this active funding opportunity. The chat forum can be accessed via the “Discuss Portal” on the MTEC members-only website - https://private.mtec-sc.org/. MTEC: The MTEC mission is to assist the U.S. Army Medical Research and Development Command (USAMRDC) by providing cutting-edge technologies and supporting life cycle management to transition medical solutions to industry that protect, treat, and optimize Warfighters’ health and performance across the full spectrum of military operations. MTEC is a biomedical technology consortium collaborating with multiple government agencies under a 10-year renewable Other Transaction Agreement (OTA), Agreement No. W81XWH-15-9-0001, with the U.S. Army Medical Research Acquisition Activity (USAMRAA). MTEC is currently recruiting a broad and diverse membership that includes representatives from large businesses, small businesses, “nontraditional” defense contractors, academic research institutions and not-for-profit organizations. POINT OF CONTACT: For inquiries regarding this pre-announcement, please direct your correspondence to Dr. Chuck Hutti, MTEC Research Associate, chuck.hutti@ati.org.