MTEC-25-07-Pharmacogenomics RPP_Final.pdf

Request for Project Proposals

Solicitation Number: MTEC-25-07-Pharmacogenomics

“Pharmacogenomics (PGx) Testing for Military Readiness Pilot”

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: May 21, 2025

Enhanced White Paper Due Date: June 20, 2025 Noon Eastern Time

Request for Project Proposals MTEC-25-07-Pharmacogenomics Number W81XWH-15-9-0001

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. Offeror Eligibility

2.5. Proprietary Information

2.6. Proposers Conference

2.7. MTEC Member Teaming

2.8. Cost Sharing

2.9. MTEC Assessment Fee

2.10. Intellectual Property and Data Rights

2.11. Expected Award Date

2.12. Anticipated Enhanced White Paper Selection Notification

3. Technical Requirements

3.1. Background

3.2. Technical Objective

3.3. Potential Follow-on Tasks

3.4. Restrictions on Animal and Human Subjects, Human Anatomical Substances, or Human Cadavers

3.5. Reserved

3.6. Guidance for research studies targeting DoD personnel for survey research

3.7. Guidance for research studies targeting military families and children

3.8. Guidance for research studies involving US Army Special Operations Command (USASOC)

3.9. Compensation to DoD-affiliated personnel for participation

3.10. Requirements for the Issuance of Common Access Cards

4. Enhanced White Paper Preparation

4.1. General Instructions

4.2. Instructions for the Preparation & Submission of the Enhanced White Paper

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

4.4. Enhanced White Paper and Cost Proposal Preparation Costs

4.5. Freedom of Information Act (FOIA)

5 Selection

5.1. Preliminary Screening

5.2. Enhanced White Paper (Stage 1) Evaluation

5.3. Adjectival Merit Ratings

5.4. Definition of General Terms Used in Evaluations

6 Points-of-Contact 7 Acronyms/Abbreviations 8 Enhanced White Paper Template Addendum 1 – Stage 2 Evaluation Criteria

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.

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 prototypes with USAMRDC awarded under the authority of 10 U.S.C. § 4022. The term "prototype project" includes a project that addresses (A) a proof of concept, model, or process, including a business process (B) reverse engineering to address obsolescence, (C) a pilot, novel application of commercial technologies for defense purposes, (D) agile development activity, (E) the creation, design, development, or demonstration of operational utility, or (F) any combination of the foregoing. Proposed prototype projects should not be exploratory in nature and do require a foundation of preliminary data. For more information on the prototype definition, please see the Proposal Preparation Guide (PPG) located on the MTEC Site: https://mtec-sc.org/proposal-submit.

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

Defense Health Agency (DHA). Military relevance is a critical component of the Enhanced White Paper submission. Strategic oversight for the award(s) supported by this RPP will be provided by DHA Research & Engineering Directorate.

This RPP is focused on establishing a pilot program to demonstrate the enhanced use of pharmacogenomics (PGx) in the Military Health System (MHS) to aid in the treatment for specific medical conditions and improve healthcare delivery and outcomes.

2 Administrative Overview

2.1. Request for Project Proposals (RPP)

MTEC is utilizing an accelerated approach to award for this RPP. This streamlined approach is anticipated to be a better means to highlight Offeror methodologies and skills required to address the technical requirements described herein. The Enhanced White Paper process requires quick turnaround times by Offerors. The following sections describe the formats and requirements of the Enhanced White Paper.

https://mtec-sc.org/ https://mtec-sc.org/proposal-submit

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

Each Enhanced White Paper submitted must be in accordance with the mandatory format provided in Section 8 of the RPP. Enhanced White Papers that fail to follow the mandatory format may be eliminated from the competition during the CM’s preliminary screening stage (see Section 5 for more details on the Selection process).

*Note that the terms “Enhanced White Paper” and “Proposal” are used interchangeably throughout this RPP.

2.2. Funding Availability and Period of Performance

The U.S. Government (USG) currently has available a total of approximately $2.15 million (M) for this effort, for direct and indirect costs. Dependent on the results and deliverables under any resultant award(s), the USG may, non-competitively, award additional dollars and/or allow for additional time for scope increases and/or follow-on efforts with appropriate modification of the award. The funding estimated for this RPP is approximate and subject to realignment. Award and funding from the Government is contingent upon the availability of federal funds for this program.

Cost sharing, including cash and in kind (e.g., personnel or product) contributions are strongly encouraged, have no limit, and are in addition to the Government funding to be provided under the resultant award(s).

MTEC expects to make a single award to a qualified Offeror to accomplish the scope of work.

However, if a single proposal is unable to sufficiently address the entire scope of the RPP, several Offerors may be asked to work together in a collaborative manner or the Government may award to multiple Offerors if an optimal team is not identified and multiple awards are deemed to be in the Government’s best interest. See the “MTEC Member Teaming” section below for more details.

The Period of Performance (PoP) is not to exceed 36 months.

2.3. Acquisition Approach

This RPP will be conducted using the Enhanced White Paper approach.

• Stage 1 – Enhanced White Paper: Current MTEC members are invited to submit Enhanced White Papers using the mandatory format contained in this RPP (see Section 8 of this RPP). The Government will evaluate Enhanced White Papers and will make a selection based on the solution(s) that best meets its current technology priorities using the criteria in Section 5 of this RPP. The Offeror(s) whose proposed solution is selected for further consideration based on the Enhanced White Paper evaluation will be invited to Stage 2.

The Notification letter(s) will contain specific Stage 2 proposal submission requirements.

• Stage 2 – Cost Proposal: Submission of a full cost proposal. Additionally, based upon the results of the technical evaluation, the Offeror(s) may be required to submit additional documentation or supplemental information such as the example(s) listed under Section 4.2).

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 OTA for prototype projects Number W81XWH-15-9-0001 with MTEC administered by the CM, ATI. The CM will negotiate and execute a Base Agreement with MTEC members (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 and Members-Only website at https://mtec-sc.org/.

At the time of the submission, if Offerors have not yet executed a Base Agreement, then Offerors must certify on the cover page of their Enhanced White Paper 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 already has executed an MTEC Base Agreement with the MTEC CM, then the Offeror must state on the cover page of its Enhanced White Paper that, if selected for award, it anticipates the proposed effort will be funded under its executed MTEC Base Agreement.

2.4. Offeror Eligibility

Offerors must be MTEC Members in good standing to be eligible to submit an Enhanced White Paper. 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 .

Subcontractors (including all lower tier subawardees) do not need to be MTEC members. To join MTEC, please visit https://mtec-sc.org/join. A UEI entity ID and CAGE code are also required for submission of an enhanced white paper. For more information, please visit: https://mtec-sc.org/proposal-submit.

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.

https://mtec-sc.org/ https://mtec-sc.org/join

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.

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.

2.6. Proposers Conference

MTEC intends to host a Proposers Conference that will be conducted via virtual webinar on June 2, 2025, at 12:00pm (Noon) EST. The intent of the Proposers Conference is to provide an administrative overview of this RPP process to award and present further insight into the

Technical Requirements outlined in Section 3 of this RPP. To register for this conference, please use this link: https://ati.zoomgov.com/webinar/register/WN_SZXJ8HqiRGiRPOVnHy2jlw

2.7. 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.

MTEC’s new website features a new functionality to assist members in team building. MTEC’s New Member Profiles can help you identify potential teaming partners among other MTEC members, including innovators, service providers, and MTEC M-Corps [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]. It can be accessed via the https://mtec-sc.org/members.

If you are in need of additional teaming assistance, then you are encouraged to reach out to the points of contact listed herein.

2.8. Cost Sharing

Cost sharing is defined as the non-Federal resources expended by the award recipients on the proposed statement of work (SOW). Cost sharing above the statutory minimum is not required in order to be eligible to receive an award under this RPP. In order to be compliant with 10 U.S.C.

https://ati.zoomgov.com/webinar/register/WN_SZXJ8HqiRGiRPOVnHy2jlw https://mtec-sc.org/members

§4022, Research Projects selected for funding under this RPP are required to meet at least one of the conditions specified in Section 3 of the PPG. Proposals that fail to meet the mandatory statutory conditions with regard to the appropriate use of Other Transaction authority, as detailed in Section 3 of the PPG, will not be evaluated and will be determined ineligible for award.

Additionally, Section 7.4 of the PPG contains information on cost share definitions and directions for inclusion.

2.9. MTEC Assessment Fee

Per the Consortium Member Agreement, each recipient of an RPA 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 RPA 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 RPAs are defined in the terms of an awardee’s Base Agreement and, if applicable, specifically negotiated terms are finalized in any resultant RPA.

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 RPA shall be determined in accordance with the provisions of MTEC Base Agreement.

See Attachment 6 of the PPG for more detail. Note that as part of Stage 1 of the RPP process (submission of an Enhanced White Paper), Offerors shall complete and submit Attachment 6 of the PPG (Intellectual Property and Data Rights) as an appendix to the Enhanced White Paper with the Signature of the responsible party for the proposing Prime Offeror.

For more information, the CM has published a resource for Offerors entitled, “Understanding Intellectual Property and Data Rights” on the MTEC members-only website.

2.11. Expected Award Date

Offerors should plan on the period of performance beginning September 2025 (subject to change). The Government reserves the right to change the proposed Period of Performance start date through negotiations via the CM and prior to issuing an RPA.

2.12. Anticipated Enhanced White Paper Selection Notification As the basis of selections is completed, the Government will forward its selection(s) to the MTEC CM to notify 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 an Enhanced White Paper has 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

DHA Research & Engineering Directorate is requesting proposals for a PGx pilot program to aid and improve military readiness and clinical care for military personnel in response to the FY24 DoD Appropriations Act. The pilot program will develop and demonstrate the standards and processes that will result in MHS protocols for routine PGx testing in applicable military cohorts and report PGx testing results that can provide actionable information to MHS providers for medical treatment of the Active-Duty population. The pilot will leverage the Electronic Health Record (EHR) patient information and patient outcomes to determine and report optimal healthcare delivery.

Results from this program will demonstrate the feasibility of utilizing PGx as an impactful and cost-effective solution to improve the personalization, safety, and efficacy of medication for Active-Duty service members (ADSM).

The intent of the PGx pilot program is to demonstrate the impact PGx can have on the ADSMs by preventing adverse drug reactions, optimizing drug dosing, and reducing the use of non-effective medications, as well as demonstrating the cost benefit, quality, and outcomes of treatment.

The PGx pilot program scope will include development of appropriate PGx processes (e.g.

enrollment) relevant to military populations at DoD site(s), tracking outcomes after medical treatment, and performing analyses to determine treatment efficacy based on PGx testing.

3.2. Technical Objective

Proposed solutions are expected to include (but are not limited to) the following characteristics and activities:

1. Collaborate with Military Treatment Facilities (already identified by the Government

Sponsor) to identify approaches and/or strategies to maximize the use and/or integration of precision medicine in clinical care for ADSMs.

Note: The sites identified by the Government are those that currently have PGx capabilities. The specific site information will be shared with the Offeror selected for award.

This does not preclude Offerors from proposing an additional MTF site(s) within the Enhanced White Paper. However, a letter of support should be provided for any Offeror-identified/proposed site(s). See Section 4.2. below for information related to Letter(s) of Support.

2. Establish a process for the integration of PGx into clinical care. This will include development of an Application Programming Interface within the MHS EHR within the DoD secured server under strict data and national security requirements in accordance with National Institute of Standards and Technology 8582 and DFARS 239.7602-2(a).

3. Identify, establish, and execute programmatic tasks of the pilot program. These may include, but are not limited to:

a. Document pilot processes for Clinical PGx and tele-PGx platform within the MHS through the EHR, for PGx consultation, education, and fluency across the MHS community.

b. Conduct data collection, and data analysis, to include the measurement of effectiveness of PGx processes.

c. Measure treatment efficacy with respect to:

i. reductions in adverse drug reactions and use of non-effective medications;

ii. treatment outcomes;

iii. informing long-term medication management for improvements in clinical health conditions; and

iv. cost related to testing, treatment, and ADSM return to duty

d. Ensure the use of all appropriate Clinical Pharmacogenetics Implementation

Consortium guidelines, where appropriate.

e. Develop progress and final reports with recommendations based on data analysis

Requirements for the Proposed Team:

The following are the anticipated requirements to consider when forming a team and are considered necessary to ensure the successful development of the project.

1. The team should include clinical pharmacists trained in PGx, especially those with practical experience in implementing PGx with therapeutic conditions in one or more of the following medical conditions prioritized in the MHS: behavioral health, pain management, cardiology, infectious diseases, gastrointestinal disorders, and sleep disorders, etc. Other clinical conditions may be proposed as appropriate.

2. Members of the team shall be able to satisfy requirements to receive access to government furnished equipment (i.e., computer) and obtain a government common access card (see Section 3.10 for additional information). Final requirements and the decision to issue government furnished equipment is to be determined by DHA data access approval authority. This is anticipated in order to access electronic health records (de-identified) to determine the health outcomes from pharmacogenomics testing.

3. The vendor/contractor MUST be willing and able to partner with Defense Health Agency clinical subject matter experts (to be specified post award) to ensure timely approval and access to DoD populations and medical data, to fulfill data security requirements, and maximize translation of findings to the MHS.

4. The Offeror shall include travel to four sites (determined in coordination with the Government Sponsor) for access to the PGx capability.

3.3. Potential Follow-on Tasks

Under awards resulting from this RPP, there is the potential for award of one or more non-competitive follow-on tasks based on the success of the project (subject to change depending upon Government review of completed work and successful progression of milestones). Potential follow-on work may be awarded based on the advancement in prototype maturity during the initial PoP. Follow-on work may include, but are not limited to, expansion of pilot program to include additional ADSM, scaling the pilot program to multiple additional sites, reviewing data collected to refine pharmacogenomic testing, improve efficiency and reproducibility of pilot program, and advanced testing in relevant or simulated operational environments.

3.4. Restrictions on Animal and Human Subjects, Human Anatomical Substances, or Human

Cadavers

3.4.1. 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 Office of Human and Animal Research Oversight’s (OHARO) Office of Human Research Oversight (OHRO) prior to research implementation. This administrative review requirement is in addition to the local Institutional Review Board (IRB) or Ethics Committee review. Allow a minimum of 2 to 3 months for OHRO regulatory review and approval processes.

If the proposed research is cooperative (i.e., involving more than one institution), a written plan for single IRB review arrangements must be provided at the time of award negotiation. The lead institution responsible for developing the master protocol and master consent form should be identified and should be the single point of contact for regulatory submissions and requirements.

3.4.2. 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.

Proposals must comply with the above-mentioned 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 IACUC and IRB approvals, continuing review (in the intervals specified by the local IRB, but at a minimum, annually), and approval by the USAMRDC OHARO. Offerors shall include IRB and OHARO review and approval in the SOW/Milestones Payment Schedule submitted in Stage 1 of the RPP process, as applicable.

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

Written approval to proceed from the OHARO 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 USAMRDC OHARO review and authorization process.

3.5. Reserved

3.6. Guidance for research studies targeting DoD personnel for survey research

Protocols that target DoD personnel for research in which the primary data collection tool is a survey require additional administrative review per Department of Defense Instruction (DODI)

1100.13. Investigators will need to coordinate with OHARO to identify current submission requirements.

3.7. Guidance for research studies targeting military families and children In accordance with DODI 1402.5 and Army Directive 2014-23, Child Care National Agency Check and Inquiries background investigations are required for all individuals who have regular contact with military dependents under 18 years of age. All individuals who regularly interact with children under 18 years of age in Army sponsored and sanctioned programs are required to undergo specific initial background checks and periodic re-verifications. Investigators who propose work involving contact with military dependents under 18 years of age should plan for the additional time and funds required for such investigations.

Per Department of Defense Education Activity (DODEA) Administrative Instruction 2071.3, DODEA approval is required for research studies involving DODEA school personnel, school facilities, students, sponsors, and/or data. Investigators proposing to conduct any research activities involving DODEA schools should plan for the additional time (~3-6 months) and effort required to obtain approval from DODEA to conduct such activities. Procedures and requirements for the review and approval of a research study request can be found at-http://www.dodea.edu/datacenter/research/requests.cfm

Research studies that address Army Family Advocacy Program concerns will need to be coordinated with the Family Advocacy Research Subcommittee per Army Regulation 608-18.

3.8. Guidance for research studies involving US Army Special Operations Command

(USASOC)

Per USASOC policy 24-18, studies involving USASOC as human subjects require additional review by the USASOC Research Advisory Committee and Human Subjects Research Board.

3.9. Compensation to DoD-affiliated personnel for participation 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 3216.02, Protection of Human Subjects and Adherence to Ethical Standards in DoD-Conducted and -Supported Research. The full version of the DODI can be accessed at the following link:

https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/321602p.pdf.

3.10. Requirements for the Issuance of Common Access Cards

Before CAC issuance, the employee(s) of the selected Offeror (i.e., “contractor employee”) requires, at a minimum, a favorably adjudicated National Agency Check with Inquiries (NACI) or an equivalent or higher investigation in accordance with Army Directive 2014‐05. The contractor employee will be issued a CAC only if performance of the prototype project involves one of the following: (1) Both physical access to a DoD facility and access, via logon, to DoD networks on‐ site or remotely; (2) remote access, via logon, to a DoD network using DoD‐approved remote access procedures; or (3) physical access to multiple DoD facilities or multiple non‐DoD federally controlled facilities on behalf of the DoD on a recurring basis for a period of 6 months or more.

At the discretion of the sponsoring activity, an initial CAC may be issued based on a favorable review of the FBI fingerprint check and a successfully scheduled NACI at the Office of Personnel Management.

Additional details related to the CAC Request Process will be provided, if determined necessary, after award of any Research Project Award.

4. Enhanced White Paper Preparation

4.1. General Instructions

Enhanced White Papers should be submitted by the date and time specified on the cover page using BIDS: https://submissions2.ati.org/ATI2/Portal.nsf/Start?ReadForm. See Attachment 7 of the PPG for further information regarding BIDS registration and submission. The Offeror shall include MTEC Solicitation Number (MTEC-25-07-Pharmacogenomics) in the Enhanced White Paper.

The Enhanced White Paper format provided in this MTEC RPP (Section 8) is mandatory. Note that

Cost Proposals are only required for Stage 2 and are not part of the initial Enhanced White Paper submission. Offerors are encouraged to contact the Points-of-Contact (POCs) identified herein up until the Enhanced White Paper due date/time to clarify requirements (both administrative and technical in nature).

All eligible Offerors may submit Enhanced White Papers 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.

https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/321602p.pdf https://submissions2.ati.org/ATI2/Portal.nsf/Start?ReadForm

4.2. Instructions for the Preparation & Submission of the Enhanced White Paper Offerors submitting an Enhanced White Paper in response to 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 (5): Submitted via BIDS (5MB or lower per document)

1. Enhanced White Paper: one Word or PDF document. The Enhanced White Paper is limited to ten (10) pages including cover page. (Section 8 of the RPP)

2. Warranties and Representations: one signed Word or PDF document (Attachment 3 of the PPG)

3. Statement of Work (SOW)/Milestone Payment Schedule (MPS): one Word or PDF document (Attachment 4 of the PPG)

4. Current and Pending Support: one Word or PDF document (Attachment 5 of the PPG) summarizing other sponsored research for each person who will contribute significantly to the proposed prototype project. The information for previous support should include the past five (5) years, unless otherwise specified in the request.

5. Intellectual Property and Data Rights Assertions: one signed Word or PDF document (Attachment 6 of the PPG)

Optional Submission Documents (1): Submitted via BIDS (5MB or lower)

1. Letter(s) of Support (as applicable and as one PDF document) if the prototype project will require access to active-duty military patient populations and/or DoD resource(s) or database(s). There is no required format for the Letter(s) of Support. Please combine all supporting documents and Letter(s) of Support as one PDF submission. This optional submission document is excluded from the Enhanced White Paper page limitation.

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

References may be included in the Enhanced White Paper and are excluded from the page limitation. The following Appendices are excluded from the page limitation: (1) Warranties and

Representations, (2) Statement of Work/Milestone Payment Schedule, (3) Current and Pending Support, and (4) 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 0.5 inch.

Enhanced White Papers and Appendices exceeding the page limitations and/or the file size specified above may not be accepted. Each document shall be uploaded to BIDS separately (see Attachment 7 of the PPG for BIDS instructions).

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). Furthermore, additional attachments/appendices (henceforth referred to as supplemental information) to this proposal submission may be requested after completion of the technical evaluation to include the following:

• Biographical Sketches: Information for each individual identified who will contribute significantly to the proposed prototype project that complies with separate instructions but includes identifying information, organization and location, professional preparation (e.g., education and training), appointments and positions, and a list of products that demonstrate the individual’s qualifications to carry out the project as proposed.

The exact requirements of any such supplemental information 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 2.13).

4.3. 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 request for a full Cost Proposal (and may contain a request 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). These letters will contain specific submission requirements if there are any changes to those contained in this RPP. However, it is anticipated that the following will be required:

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

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

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

See below for additional instructions. Also refer to Addendum 1 of this RPP for details on how the full Cost Proposals will be evaluated:

The Cost Proposal shall be submitted in two separate sections. One Word (.docx or .doc) or PDF file for Section I: Cost Proposal Narrative and one Excel (.xlsx or .xls) or PDF file for Section II:

Cost Proposal Formats is required.

Offerors are encouraged to use their own cost formats 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 on the MTEC website and within the PPG are NOT mandatory.

Each Stage 2: Cost Proposal submitted must be in accordance with the requirements of the PPG found on the MTEC website, https://mtec-sc.org/proposal-submit. Those Offerors invited to submit a Cost Proposal are encouraged to contact the MTEC CM with any questions.

4.4. Enhanced White Paper and Cost Proposal Preparation Costs The cost of preparing Enhanced White Papers 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 2.10 of this RPP) is not allowable as a direct charge to any resulting award or any other contract.

4.5. Freedom of Information Act (FOIA)

To request protection from FOIA disclosure as allowed by 10 U.S.C. §4021(i), 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.

5 Selection

5.1. Preliminary Screening

The CM will conduct a preliminary screening of submitted Enhanced White Papers to ensure compliance with the RPP requirements. As part of the preliminary screening process, Enhanced White Papers that do not meet the requirements of the RPP and/or the statutory requirements for the appropriate use of Other Transaction Authority (described within Section 3 of the PPG) 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 Enhanced White Papers that do not meet these requirements from further consideration.

5.2. Enhanced White Paper (Stage 1) Evaluation

The CM will distribute all Enhanced White Papers that pass the preliminary screening (described above) to the Government for full evaluation. Evaluation of Enhanced White Papers will be based on an independent, comprehensive review and assessment of the work proposed against the stated source selection criteria and evaluation factors. The Government will evaluate each Enhanced White Paper against the evaluation factors detailed below and assign adjectival ratings to the non-cost/price factor(s) consistent with those defined in Table 1 (General Merit Rating Assessments). The Offeror shall clearly state how it intends to meet and, if possible, exceed the RPP requirements. Mere acknowledgement or restatement of a RPP requirement is not acceptable. The overall award decision will be based upon a best value determination by considering factors in addition to cost/price.

The evaluation factors and evaluation criteria are described below in descending order of importance.

Evaluation Factors

1. Programmatic and Technical Relevance

2. Personnel and Team

Evaluation Factor #1 – Programmatic and Technical Relevance:

The Offeror’s proposal will be assessed for the degree to which the Offeror demonstrates a strong solution to the defined unmet military medical need consistent with Section 3 of the RPP. The proposal will also be assessed for relevancy, thoroughness, and completeness of the proposed approach (i.e., the technical merit). The Government’s evaluation of this factor may include the degree to which the following are addressed and demonstrated:

• Clear and appropriate objectives that describe a feasible solution supported by preliminary data and/or sound scientific rationale;

• Focused and detailed methodologies to address the Technical Objectives outlined in Section 3.2;

• Thorough, complete, and reasonable SOW and ROM Cost Estimate; and,

• Whether the proposal includes a realistic, achievable performance schedule with a plan to address potential risks that could delay or otherwise impact performance.

Evaluation Factor #2 – Personnel and Team:

This factor will evaluate the strength of the organization/team, including the Offeror’s resources, expertise, and experience of proposed personnel. As part of this evaluation factor, the Government may also consider the project management plan and the ability for the technical and management team to execute the proposed SOW in an efficient and effective manner. Key personnel will be assessed based on the relevant qualifications demonstrated (i.e., ability to support this effort) to include those listed under “Requirements for the Proposed Team” under

3.2. above. The Government may also consider whether the proposal includes strategies to address potential risks that could delay or otherwise impact performance.

5.3. Adjectival Merit Ratings

Table 1 explains the adjectival merit ratings that will be used for the Evaluation Factors.

TABLE 1 - GENERAL MERIT RATING ASSESSMENTS

RATING DESCRIPTION

Upon review and evaluation of the Proposals, the Government sponsor will perform proposal source selection. This will be conducted using the evaluation factors detailed above. The

Government will conduct an evaluation of all qualified proposals. The Source Selection Authority may:

1. Select the proposal (or some portion of the proposal) for award

2. Place the proposal in the Basket if funding currently is unavailable; or

3. Reject the proposal (will not be placed in the Basket)

In rare cases, the following recommendation may be provided: “Recommendation Undetermined.” This is reserved for situations in which additional information/documentation is needed by the Government evaluators before finalizing a recommendation to one of those listed above and is intended to facilitate the release of all evaluator comments within the BIDS System.

The RPP review and award process may involve the use of contractor subject matter experts

(SMEs) serving as nongovernmental advisors. All members of the technical evaluation panel, to include contractor SMEs, will agree to and sign a Federal Employee Participation Agreement or a Nondisclosure/Nonuse Agreement, as appropriate, prior to accessing any proposal submission to protect information contained in the Enhanced White Paper as outlined in Section 2.5.

5.4. Definition of General Terms Used in Evaluations

OUTSTANDING

Proposal meets requirements and indicates an exceptional approach and understanding of the requirements. Strengths far outweigh any weaknesses. Risk of unsuccessful performance is very low.

GOOD

Proposal meets requirements and indicates a thorough approach and understanding of the requirements. Proposal contains strengths which outweigh any weaknesses. Risk of unsuccessful performance is low.

ACCEPTABLE

Proposal meets requirements and indicates an adequate approach and understanding of the requirements. Strengths and weaknesses are offsetting or will have little or no impact on contract performance. Risk of unsuccessful performance is no worse than moderate.

MARGINAL

Proposal does not clearly meet requirements and has not demonstrated an adequate approach and understanding of the requirements. The proposal has one or more weaknesses which are not offset by strengths.

Risk of unsuccessful performance is high.

UNACCEPTABLE

Proposal does not meet requirements and contains one or more deficiencies. Proposal is not awardable.

Significant Strength – An aspect of an Offeror's proposal that has appreciable merit or appreciably exceeds specified performance or capability requirements in a way that will be appreciably advantageous to the Government during award performance.

Strength – An aspect of an Offeror’s proposal that has merit or exceeds specified performance or capability requirements in a way that will be advantageous to the Government during award performance.

Weakness – A flaw in the proposal that increases the risk of unsuccessful award performance.

Significant Weakness – A flaw that appreciably increases the risk of unsuccessful award performance.

Deficiency – A material failure of a proposal to meet a Government requirement or a combination of weaknesses in a proposal that increases the risk of unsuccessful award performance to an unacceptable level.

The following terms may be used to evaluate the Rough Order of Magnitude (ROM) cost/price estimate as part of Evaluation Factor #1 – Programmatic and Technical Relevance:

Sufficient - The ROM estimate is within the available funding limits and considered appropriate to successfully complete the proposed project

Insufficient - The ROM estimate is lower than what is considered appropriate and/or realistic to successfully complete the proposed project

Excessive - The ROM estimate is higher than what is considered appropriate to successfully complete the proposed project and may be outside of the available funding limits.

6 Points-of-Contact

For inquiries, please direct your correspondence to the following contacts:

• Questions concerning contractual, cost or pricing related to this RPP should be directed to the MTEC Contracts Manager, mtec-contracts@ati.org

• Technical and membership questions should be directed to the MTEC Chief Science Officer, Dr. Lauren Palestrini, Ph.D., lauren.palestrini@mtec-sc.org

• All other questions should be directed to the MTEC Program Manager, Mr. Evan Kellinger, mtec-sc@ati.org

7 Acronyms/Abbreviations

ACURO Animal Care and Use Review Office mailto:mtec-contracts@ati.org mailto:lauren.palestrini@mtec-sc.org mailto:mtec-sc@ati.org

ADSM Active-Duty service members ATI Advanced Technology International CM Consortium Manager CMA Consortium Member Agreement

DCAA Defense Contract Audit Agency DCMA Defense Contract Management Agency DHA Defense Health Agency DoD Department of Defense DODEA Department of Defense Education Activity DODI Department of Defense Instruction EHR Electronic Health Record FOIA Freedom of Information Act Government U.S. Government, specifically the DoD IACUC Institutional Animal Care and Use Committee

IP Intellectual Property (e.g., patents, copyrights, licensing, etc.)

IRB Institutional Review Board MHS Military Health System

MPS Milestone Payment Schedule MTEC Medical Technology Enterprise Consortium NDA Nondisclosure Agreement

OCI Organizational Conflict of Interest OHARO Office of Human and Animal Research Oversight OHRO Office of Human Research Oversight OTA Other Transaction Agreement PDF Portable Document Format POC Point-of-Contact PGx Pharmacogenomics PoP Period of Performance PPG Proposal Preparation Guide ROM Rough Order of Magnitude RPA Research Project Award RPP Request for Project Proposals SME Subject Matter Expert SOW Statement of Work

USAMRDC U.S. Army Medical Research and Development Command USASOC US Army Special Operations Command USG U.S. Government

8 Enhanced White Paper Template

Cover Page

[Name of Offeror]

[Address of Offeror]

[Phone Number and Email Address of Offeror]

Unique Entity ID: [UEI] CAGE code: [CAGE code]

[Title of Enhanced White Paper]

[Offeror] certifies that, if selected for award, the Offeror will abide by the terms and conditions of the MTEC Base Agreement.

[Offeror] certifies that this Enhanced White Paper is valid for 3 years from the close of the applicable RPP, unless otherwise stated.

[A proprietary data disclosure statement if proprietary data is included. Sample:

This Enhanced White Paper includes data that shall not be disclosed outside the MTEC Consortium Management Firm and the Government and shall not be duplicated, used, or disclosed, in whole or in part, for any purpose other than to evaluate this Enhanced White Paper and negotiate any subsequent award. If, however, an agreement is awarded as a result of, or in connection with, the submission of this data, the MTEC Consortium Management Firm and the Government shall have the right to duplicate, use, or disclose these data to the extent provided in the resulting agreement. This restriction does not limit the MTEC Consortium Management Firm and the Government's right to use the information contained in these data if they are obtained from another source without restriction. The data subject to this restriction is (clearly identify) and contained on pages (insert page numbers).]

Willingness to allow MTEC Officers access to your Solution Brief for the purposes of engaging in outreach activities with private sector entities: Indicate YES or NO [As part of MTEC’s mission to incorporate philanthropic donations, MTEC frequently makes contact with private sector entities (e.g., foundations, investors, organizations, individuals) that award grants or otherwise co-fund research, and/or operate in research areas that are aligned with those of MTEC. Additional private entities may be interested in reviewing certain Solution Briefs within their program areas, allowing opportunities to attract supplemental funding sources. Please indicate your willingness to allow MTEC access to your Solution Brief for the purposes of engaging in outreach activities with these private sector entities. MTEC staff has signed Nondisclosure Agreements (NDAs) and Organizational Conflict of Interest statements.]

Request for Project Proposals MTEC-26-XX-Pharmacogenomics

[Title of Enhanced White Paper]

Programmatic Relevance

• Provide the background and the Offeror’s understanding of the problem and/or technology gap/process deficiency.

• Describe how the proposed technology meets the needs specified in this RPP.

Scope Statement

• Define the scope of the effort and clearly state the objectives of the project.

Scientific Rationale / Preliminary Data

• Describe the scientific rationale for the project, including a brief description of previous related work data that supports the feasibility of proposed work.

Technical Approach

• Describe the design, methods, and materials required to accomplish the proposed approach. Describe the proposed methodology in sufficient detail to show a clear course of action to address the solution requirements (Section 3.2)

• Offerors are encouraged to provide a rough order magnitude price for each task required to meet the solution requirements

Anticipated Outcomes/Impact

• Provide a description…