RFI - Attachment 1 - PWS Updated_12.2.24.docx

SECTION 1.0: GENERAL INFORMATION

1.1 Objective

To support biomedical research application evaluation for the Congressionally Directed Medical Research Programs (CDMRP) and U.S. Army Medical Research and Development Command (USAMRDC). In addition, other federal organizations may be approved through the CDMRP COR and the USAMRAA Contracting Officer of the base-level IDIQ to use this mechanism on a case-by-case basis.

1.2 Background

The United States Congress has directed the Department of Defense (DoD) to manage appropriations totaling over $19.7 Billion, since fiscal year 1992 (FY92) to foster novel approaches to biomedical research in response to the expressed needs of the American public, the military, and Congress. The CDMRP is an office within the USAMRDC that implements funding and serves as the executive management agent for many of the biomedical research programs directed by Congress in addition to providing support for the core (presidential budget) DoD medical research program areas.

Hallmarks of the CDMRP include investing in groundbreaking research; targeting critical gaps; reviewing applications using a two-tier formal review with no standing peer review panels and no “pay line;” involving consumer advocates throughout the program cycle; supporting both the next generation of researchers and established scientists; funding the full pipeline of research development, including basic, translational, and clinical research; and fostering collaboration and synergy.

The CDMRP strives to transform health care for Service Members, Veterans, their Families, and the American public through innovative and impactful research. While individual programs are unique in their focus, all the programs managed by the CDMRP share the common goal of advancing paradigm shifting research, solutions that will lead to cures or improvements in patient care, or breakthrough technologies and resources for clinical benefit. For more information on the CDMRP, go to https://cdmrp.health.mil.

1.3 Key Personnel

Key Personnel are identified below for the performance of the required services. Substitutions of proposed Key Personnel shall not be allowed for a period of six months after award, except under extreme circumstances. Any substitution or replacement of Key Personnel shall have qualifications equal to or greater than the individuals proposed. For temporary and/or permanent replacement of Key Personnel, the Contractor shall provide a resume for each individual to the base COR. Resumes shall be provided five business days (or as mutually agreed upon) prior to making any personnel changes. The Government reserves the right to pre-approve any replacement or substitutions of Key Personnel. Contractor personnel must submit necessary information to start the clearance review process at least ten business days prior to reporting for performance.

The Government has identified the following positions to be filled by Key Personnel.

Position Title:

Project Director Deputy Project Director Scientific Review Manager Consumer Reviewer Administrative Manager Program Support Coordinator

1.4 Quality Control Plan

The Quality Control Plan (QCP) is developed by the Contractor to describe how the Contractor will meet the performance standards and acceptable quality levels outlined in the QASP. The QCP shall identify the Contractor’s methods of quality surveillance, performance standards, roles and responsibilities, and ways of identifying potential risks along with a plan to address them if/when they arise. The QCP will be finalized within 45 calendar days after the start date and updated as needed after changes are identified.

Subsequent QCP will be finalized within several calendar days of the change.

SECTION 2.0: GOVERNMENT-FURNISHED PROPERTY AND BUSINESS SYSTEMS

2.1 General Information

The Government will not provide physical space at Fort Detrick to support this effort.

2.2 Government Furnished Property

All Government Furnished Property (GFP) data/records will be uploaded and maintained in the Procurement Integrated Enterprise Environment (PIEE) GFP module at https://piee.eb.mil. (Additional information can be found at: https://dodprocurementtoolbox.com, click “Government Furnished Property”). The Government will issue personal laptop computers to Contractor personnel requiring network access and email. The GFP provided to the Contractor will be determined at the task order level. Any GFP issued on task orders will be administered at the base IDIQ level.

The Government will make available access to a web-based tool (optional usage) to assist in effectively locating experts, based on their field of study and qualifications, and to assign reviewers for specific grant applications.

2.3 Government Business Systems

The CDMRP utilizes a custom developed research administration platform consisting of two applications, the Electronic Biomedical Research Application Portal (eBRAP) and the Electronic Grants System (EGS). A process map is provided in the Data Flow attachment.

2.3.1 The eBRAP

The eBRAP is a government-owned custom developed system, which allows for research proposal application submission and processing, document collection, and information dissemination. It serves as the front-end portal for the worldwide research community with the CDMRP, USAMRDC and other DoD organizations. eBRAP’s primary functionality in in the area of submission of pre-applications, direct submission of intramural DOD proposals, interface with Grants.gov for retrieval, and processing of extramural/intramural applications and administrative review for compliance. It is also the system for submission of award management information and files (e.g. invoices, regulatory documents, technical reports, quad charts) over the lifetime of research awards; eBRAP also interfaces with the back-end business system, EGS (a CDMRP/USAMRDC Government-owned, contractor-operated system). The eBRAP currently supports 70,000 users from 110 countries, most of whom are members of the public scientific community including researchers, study personnel and research administrators. On an annual basis, over 150 solicitations for research proposals are released in eBRAP, approximately 15,000-20,000 pre-applications and 8,000-12,000 proposal applications are received.

ATTACHMENT 1

DRAFT PERFORMANCE WORK STATEMENT

Biomedical Research Application Evaluation and Support

2.3.2 The EGS

The EGS is a government-owned, contractor-operated mission-support business system designed to address core functions of biomedical research portfolio and awards management needs for CDMRP and other organizations. It stores biomedical research proposal and award data as well as files including contracting, regulatory, administrative, and other relevant information. EGS has many functional components designed to automate administrative processes including proposal management, awards management, regulatory review, program management, and program evaluation. A number of system-to- system interfaces facilitate interactions and data transfers with external systems owned and operated by contractors and other agencies. It supports multiple electronic/online workflows, including progress report reviews, award negotiations, regulatory review and approval, product management, and website data management. EGS currently supports 550 users and contains 152,000 proposal records, 26,000 award records and over 10,000 regulatory protocols. On an annual basis, an average of 10,000 new proposals are created, 9,800 active awards are managed with 1,000 new awards initiated.

SECTION 3.0: CONTRACTOR REQUIREMENTS

3.1 Contractor Personnel Minimum Requirements

3.1.1 For appropriate Contractor and subcontractor personnel, a Common Access Card (CAC) will be issued before beginning work on the contract, which requires a favorable T1 security investigation. Before CAC issuance, the Contractor personnel requires, at a minimum, a favorably adjudicated National Agency Check with Inquiries (NACI). The Contractor personnel will be issued a CAC only if duties involve 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. If Contractor personnel are unable to receive a favorable NACI, that individual may not provide support services to CDMRP under this requirement.

3.1.2 Each Contractor and subcontractor personnel shall be a United States citizen and able to obtain the appropriate level security investigation and clearance as needed. The CDMRP will initiate the process with the appropriate security personnel at Fort Detrick for the appropriate Contractor personnel.

3.1.3 All Contractor personnel, and associated subcontractor personnel with access to Government information, must agree to and sign an “Acceptable Use Policy” (AUP). The CDMRP Training Coordinator will upload a copy of the AUP to the Contractor personnel’s ATCTS account.

3.1.4 All Contractor and sub-Contractor personnel shall comply with applicable installation, facility, and area commander installation and facility access and local security policies and procedures. The Contractor shall also provide all information required for background checks to meet installation access requirements accomplished by the installation Security Office. The Contractor workforce must comply with all personnel identity verification requirements (FAR clause 52.204-9, Personal Identity Verification of Contractor Personnel) as directed by DOD, Headquarters, Department of the Army (HQDA), and local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in Contractor security matters or processes.

3.1.5 Contractor personnel shall be designated as “Automated Data Processing (ADP) Level III (non- sensitive positions) at a minimum as defined by Department of Defense Regulation 5200.02 DoD Personnel Security Program (for reference, review https://www.cac.mil/Portals/53/Documents/52000.2R.pdf).

3.2 Training Requirements

3.2.1 All Contractor personnel and associated subcontractor personnel requiring access to a government information system shall complete mandatory trainings. Course names and website links are outlined in the table below. An in-processing guide with further instructions will be provided to Contractor personnel at the start of the contract. Additional required trainings may be added in the future as determined by the USAMRDC. The Contractor and associated subcontractor personnel shall submit certificates of completion for each affected Contractor and subcontractor personnel to the CDMRP Training Coordinator upon completion. The Government estimates it will take ten (10) hours to complete all required trainings.

Available

Initial and Annual training requirements for CAC holders only.

Cyber Awareness Challenge

Available

https://www.cdse.edu/Training/eLearning/IF011/ Non-CAC Option Available

https://www.cdse.edu/Training/eLearning/GS130.16/ Non-CAC Option Available

Available

Available

https://learn.atis.army.mil CAC Enabled Only

Available

Available

Initial and Annual training requirements for CAC holders requiring network access.

Non-CAC Trainings: Complete within 30 calendar days after contract start date or effective date of incorporation into the contract, whichever is applicable, and annually thereafter.

3.2.2 Information Assurance (IA)/Information Technology (IT). All contractor personnel working IA/IT functions must complete DoD IA awareness training and comply with DoD and Army training requirements in DoDD 8570.02 located at: https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/520002p.pdf?ver=20 18-05-11- 100552-223, DoD 8570.01-M located at: https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodm/857001m.pdf?ver=2 019-07-08- 101252-253, and AR 25-2 located at https://armypubs.army.mil/epubs/DR_pubs/DR_a/pdf/web/ARN17503_AR25_2_Admin_ FINAL.pdf within six months of appointment to IA/IT functions.

SECTION 4.0: PERFORMANCE OBJECTIVES

The CDMRP requests the Contractor to provide biomedical research application evaluation and support by performing the following tasks. In addition, the Contractor shall provide a secure contractor- owned, contractor-operated web-based electronic system which includes hosting of such system. The system shall support activities and capabilities specific to peer review, including but not limited to: document viewing, facilitation of various meeting formats including virtual meetings, individual reviewer and panel scoring and written evaluations, and conducting concurrent review in multiple meetings and/or panels.

NOTE: Pre-applications and applications are submitted to a Program Announcement (PA); pre- applications/pre-proposals and applications/proposals are submitted to a Broad Agency Announcement (BAA).

The Deliverables required for each task order shall be outlined in the Task Order Deliverables/Receivables Tracking Sheet (D/RTS). These are the minimum deliverables anticipated by the Government in accordance with the PWS. Additional deliverables shall be negotiated at the task order level.

4.1 General Program Support

General support for science administration and management includes support and tasks that are applicable to all CDMRP programs. Program-specific support shall be provided under individual task orders, including but not limited to, scientific review management, project management, and consumer reviewer administration.

4.2 Conduct Compliance Review

To ensure pre- and full applications submitted to a PA and pre- and full applications/proposals submitted to a program-specific BAA are in compliance with FOA requirements, the offeror shall conduct a compliance review. Compliance review requires using the eBRAP automated process to identify compliance issues common across all FOAs (e.g. project narrative page limit) as well as a manual process executed by the offeror for other issues that are FOA-specific.

4.2.1 The offeror shall develop a Compliance Standard Operating Procedure in consultation with CDMRP. The General Application Instructions (GAI) and PA or General Submission Instructions and

BAA (as applicable) shall be used as the authoritative documents for conducting Administrative Action/Compliance Review of pre-applications/proposals and full applications/proposals submitted in response to the funding opportunities.

4.2.2 Original pdf files submitted via government electronic processes (Grants.gov and eBRAP) shall be administratively reviewed to verify that applications include the appropriate components as identified in each respective FOA.

4.2.3 Provide a compliance specification sheet/checklist in accordance with each respective PA or program-specific BAA within ten (10) business days after FOA release.

4.2.4 Conduct a compliance review by identifying compliance issues and administrative modifications for every pre-application/pre-proposal submitted, in accordance with each respective FOA. Using eBRAP, provide a list of the compliance review results for each FOA within the following deadlines: 1) For issues undergoing the eBRAP automated compliance review, provide list within 24 hours following pre-application/pre-proposal receipt; and 2) For other issues undergoing manual compliance review, provide list no later than two (2) business days if 250 pre-applications/pre-proposals or less were received for a specific FOA and no later than four (4) business days if greater than 250 pre- applications/pre-proposals were received for a specific FOA. In situations where compliance is underway for multiple FOAs within the same program or for multiple separate programs, the offeror must be able to implement a scale up strategy to accommodate the workload requirements.

4.2.5 Conduct a compliance review by identifying compliance issues and administrative modifications for every full application/proposal submitted, in accordance with each respective FOA. Using eBRAP, provide the results of the compliance review for each FOA within the following deadlines: 1) For issues identified by the eBRAP automated compliance review, provide list no later than two (2) business days following the verification deadline specified in the FOA; 2) For issues undergoing manual compliance review, provide a list of applications/proposals with compliance issues and administrative modifications no later than the following number of days after the verification deadline in eBRAP: a) within three (3) business days for less than 100 applications/proposals received under a specific FOA; b) within five (5) business days for 101 to 250 applications/proposals received under a specific FOA; and c) no later than seven (7) business days for >250 applications/proposals received under a specific FOA.

4.2.6 Provide a report by research program and FOA of pre-applications/pre-proposals and applications/proposals that contain names of individuals serving on the second tier of review for CDMRP known as programmatic panel members. A list of these members is listed on the CDMRP program pages (in sections other than “References Cited”) to be delivered no later than one (1) business day after compliance review is completed.

4.2.7 Provide a report of all Principal Investigators (PIs) by their respective eBRAP-generated application/proposal log numbers, including application/proposal title, for PIs that have submitted multiple applications/proposals to the same program and/or have submitted applications/proposals to multiple programs including the USAMRDC and program-specific BAA (include two (2) years) within the same fiscal year. This report shall be provided on the same day that application compliance is complete.

4.2.8 Using eBRAP, generate notifications to PIs and business officials/authorized organizational representatives informing them of their pre-application/pre-proposal or applications/proposals non- compliance status and the reasons for its non-compliance.

4.2.8.1 Prepare a draft of the annual template notification letter, in accordance with Army Regulations, for non-compliant notification and deliver to the base COR within 20 business days following release of the first fiscal year FOA. Within five (5) business days after receipt of COR input, edit and forward letter to the COR.

4.2.8.2 Using eBRAP compliance set-up module, make configurations to inform the appropriate CDMRP Program Manager and Grants Officer that non- compliant letters are available for review.

4.2.8.3 Ensure non-compliant letters have been automatically posted in eBRAP following approval by the Grants Officer and inform the CDMRP Program Manager that the applicant has been notified.

4.3 Reporting Requirements

4.3.1 Provide ad hoc reports on peer review data, processes, procedures, and outcomes as requested.

4.3.2 Perform data analyses and ad hoc reporting to support the CDMRP’s management activities such as an internal CDMRP process to evaluate alleged errors in the review process (see section 4.5.6.7).

4.3.3 Other reporting requirements shall be added and negotiated by task order to include a Cost to Complete (CTC) estimate which will be due 60 business days after the final peer review unless otherwise stated in the task order PWS.

4.3.4 Provide a quarterly report to the base COR consisting of a summary of program deliverables, quality assurance, an assessment of processes and procedures in place, and process improvements identified, as applicable. Any recommendations affecting the performance work statement will be accomplished through the execution of a contract modification.

4.3.5 Provide a quarterly task order package for each task order to the task order COR consisting of a quarterly progress report, monthly invoices and monthly task detail lists.

4.4 Technical Requirements

4.4.1 Provide a secure contractor-owned, contractor-operated and hosted web-based electronic system that supports activities and capabilities specific to peer review, including but not limited to: document viewing, facilitation of various meeting formats including virtual meetings, individual reviewer and panel scoring and written evaluations, and conducting concurrent review in multiple meetings and/or panels. The Contractor shall be responsible for the maintenance, operation, and hosting of the system and Government provided data referenced in Section 6.1. Such a system will have accessibility for the CDMRP Program Managers and Government observers/representatives. At minimum, the system must incorporate the following capabilities:

· Exchange of data via Web Services with the Government’s backend business system, Electronic Grants System (EGS), via existing API or other systems as needed and abiding by an interconnection agreement

· Support conducting concurrent reviews in multiple meetings and/or panels

· Display meeting documents (e.g. agenda, forms, briefings, booklets, graphs, documents, program- relevant policies or guidance, etc.)

· Display application review documents (e.g. application, budget, abstracts, statement of work, etc.)

· Display application information (e.g. title, org, PI, budget, assigned reviewers)

· Block viewing of specific applications by reviewers who have a conflict of interest (COI)

· Capture COIs for each reviewer

· Capture pre-meeting comments/votes/scores

· Capture meeting comments/votes/scores

· Share panel comments with other attendees

· Capture meeting notes from multiple sources

· Real time viewing of reviewer comments and viewing, sorting, and ordering of interim and final scores

· Access for CDMRP Program Manager and other designated Government representatives to input notes and view progress, reports, notes, and documents

4.5 General Program Assistance

4.5.1. Attend and participate, as requested by the CDMRP Program Manager, in program Integrated Program Team (IPT) meetings and activities. Assist with setting program milestones. Provide input on the content for fiscal year PAs (one PA per award mechanism), program-specific BAA’s, and the USAMRDC BAA (one per fiscal year). Participate in other pertinent business as requested (note this is typically for CDMRP; other customers shall specifically request attendance at their standard meetings at the task order level).

4.5.2. Provide ad hoc scientific and technical peer review advice, plans, recommendations, and innovative approaches as requested.

4.5.3 Prepare and Plan for Peer Review of Applications/Proposals

4.5.3.1 For each task order, within 10 business days after FOA release, prepare a Deliverables/Receivables Tracking Sheet (D/RTS) outlining every deliverable/receivable and due date. A sample D/RTS is attached to the solicitation in section X.

4.5.3.2. Provide review specification sheets (RSS) according to each FOA for review 10 days prior to pre-application receipt. The specifications shall include, but are not limited to, peer review panels (PRP) details, applicant components assigned to the reviewers, needed reviewer expertise, composition of the summary statements, and peer reviewed application files to be delivered to the Government.

4.5.3.3 Establish process(es) to ensure reviewer’s understanding and agreement to adhere to the offeror’s policies on Conflicts of Interest (COI) and to maintain the integrity of confidential and proprietary information. Such agreement includes disclosure of any reviewer COIs, whether real or apparent. Reviewer participation in foreign talent programs or other sponsorships should be included in such disclosures. Establish management approaches on enforcing policies, including reviewer confidentiality breaches.

a. COI is defined as a situation in which an individual, or the individual’s spouse or dependent children, has a significant financial interest, or financial relationship that could directly and significantly affect the design, conduct, reporting, or funding of research.

4.5.3.4 Generative Artificial Intelligence (AI) Technologies is prohibited for reviewers to employ for purposes of evaluating applications during the CDMRP Peer Review Process. Generative AI refers to deep-learning models that can generate high-quality text, images, video, audio, and other content based on the training dataset(s). Reviewers are required to independently formulate their critiques and scores for each application based on their personal knowledge and expertise. Further, reviewers are prohibited from transmitting proposal text, data, images, video or audio to any third-party system, database or application (including generative AI tools) without prior approval from the Government. The Contractor shall incorporate appropriate restrictions and covenants into the agreement(s) signed by each reviewer to ensure compliance with this requirement.

4.5.3.5 The offeror is expected to employ state-of-the-art strategies and/or technologies and best practices for preventing unauthorized disclosure of confidential and proprietary information.

4.5.5 Conduct Peer Review of Applications/Proposals

It is anticipated that there shall be four (4) possible modalities for conducting scientific peer review: 1) onsite, in person peer review panels (PRPs); 2) virtual PRPs; 3) online-only PRPs (not convened in a meeting for panel discussions); and 4) online individual peer reviews (conducted individually and not discussed). The peer review modality shall be decided upon at the issuance of the task order for each requirement. Each peer review modality shall be executed using the web-based contractor-owned, contractor-operated electronic system. It is expected that the contractor will utilize best practices and state-of-the-art technology to execute each peer review modality as applicable. Additional 3rd party applications e.g. virtual interfaces may be used to augment meetings whether onsite or virtually and must meet security standards to ensure protection of procurement sensitive and government data.

Due to the nature of the federal appropriations cycle, CDMRP may require concurrent program activities and a high workload volume during various times of the year. It is anticipated that contract support will be adequately ramped up during these peak times to provide adequate support without compromising quality.

4.5.5.1 Conduct in person PRP meetings. PRP meetings shall be held after receipt of applications/proposals from the CDMRP and in accordance with timelines in the D/RTS. Variance from this timeframe shall be agreed to by the CDMRP Program Manager and Contractor. It is anticipated that there shall be two (2) to three (3) scientist/technical reviewers and one (1) consumer reviewer per application (any deviation must be discussed with the appropriate task order POC prior to final assignments). The Contractor shall make all logistical arrangements necessary for the in person PRP meetings. Deliverable timeline shall be included in the D/RTS and shall be negotiated before the review commences.

4.5.5.2 Conduct virtual PRP meetings. It is anticipated that there shall be two (2) to three (3) scientist/technical reviewers and one (1) consumer reviewer per application (any deviation must be discussed with the appropriate task order POC prior to final assignments). The Contractor shall make all logistical arrangements necessary for the video/telephonic review and meetings. Deliverable timeline shall be included in the D/RTS and shall be negotiated before the review commences.

4.5.5.3 Conduct online-only PRP. It is anticipated that there shall be two (2) to three (3) scientist/technical reviewers and one (1) consumer reviewer per application as applicable (any deviation must be discussed with the appropriate CDMRP Program Manager prior to final assignments). Online- only PRPs will not be convened in a meeting for panel discussions. Following initial scoring, an online panel discussion among peer reviewers and the Chairperson shall be moderated by the PRP’s Scientific Review Officer, as needed. The online discussion may be conducted to clarify score disparities and to provide a second iteration as needed before finalizing scores. The Contractor shall make all logistical arrangements necessary for the online review and discussions. Deliverable timelines shall be included in the D/RTS and shall be negotiated before the review commences.

4.5.5.4 Conduct online individual application/proposal peer reviews. It is anticipated that there shall be two (2) to five (5) scientist/technical reviewers and one (1) consumer reviewer per application as applicable. Their reviews shall be conducted individually and not discussed among each other as a PRP. Final reviewer assignment shall be discussed with the CDMRP Program Manager prior to assignment.

4.5.5.5 Typically, a PRP consists of a Scientific Review Officer (SRO) or equivalent administrator, a chairperson with appropriate experience with peer review and scientific discipline related to the PRP topic, scientist/clinician reviewers, and consumer reviewers. Other specialist reviewers and PRP configurations may be considered at the request of the task order POC or at the recommendation of the Contractor.

4.5.5.6 The specific roles and responsibilities of the Scientific Review Manager, SRO, Consumer Reviewer Administrator, Chairperson, and any other Contractor staff in coordinating the PRPs shall be described in detail by the Offeror/Contractor. The ability to customize support for CDMRP programs with multiple review cycles or large application receipt shall be described.

4.5.5.7 The Offeror is expected to employ state-of-the-art strategies and/or technologies and best practices for identifying and recruiting appropriate subject matter experts to serve as PRP chairpersons and scientist/clinician reviewers. As an option, the Government will make available access to a web-based tool to assist in locating experts, based on their field of study and qualifications, and to assign reviewers for specific grant applications.

4.5.5.8 Deliver a preliminary report of recruited reviewers, chairpersons, and assigned SROs (by program and PRP) within 10 business days of application/proposal receipt and deliver a final report 15 business days prior to the peer review meeting.

4.5.5.9 Deliver a report detailing the peer reviewers’ organizational conflicts of interest with the PRP’s applications, 15 days prior to the peer review meeting.

4.5.5.10 Recruit a Chairperson for each PRP. Chairpersons shall have appropriate experience with peer review, qualifications commensurate with leading the panel discussions, and expertise in the specific discipline related to the PRP topic. A process for CDMRP Program Manager input on Chairperson selections shall be described. As requested, provide the Chairperson candidates’ names and bio sketches to the CDMRP Program Manager for review and comment.

4.5.5.11 Recruit PRP scientist/clinician and specialist reviewers. Conduct recruitment initiatives of scientist/clinician reviewers for each research program. Scientist/clinician reviewers shall possess appropriate education, training and experience relevant to task order requirements, applications assigned for review, and to the intent of the award mechanism. The majority of scientist/clinician reviewers shall have recent experience as a PI, Co-PI or manager of an extramurally funded research program or effort. Offerors must define a fair and reasonable pay scale. Some program-specific task orders will require reviewers with experience in military medical research, the military health system, military treatment facilities and/or deployment related medical care. The Contractor may recruit individuals serving as active-duty military or civilian federal employees with the requisite expertise to serve as peer reviewers for compensation. This may be done as long as the individual recruited is paid in their capacity as a Contract employee or sub-contractor, and not in their official Government capacity. When active duty military or civilian federal employees are identified as PRP members, the Contractor shall notify the individual of the following: 1) they are responsible to adhere to all Federal ethics laws and should coordinate with an appropriate Government Ethics Counselor about "outside employment"; and 2) they are required to be in a leave or other unofficial status in order to receive compensation for participating on the PRP.

4.5.5.12 Up-to-date bio sketches, including past, current, and pending support, of recruited reviewers shall be made available to the Government as requested.

4.5.5.13 Develop and maintain a Consumer Nomination process. Provide consumer nomination materials to the base COR for review annually. Coordinate with the CDMRP website COR on utilizing the CDMRP website Consumer Nomination Application for recruitment and to enhance advertising for consumer involvement.

a. Recruit consumer reviewers. Develop and/or update a Consumer Outreach Plan for each program as requested in the program-specific task order and after consultation with the CDMRP Program Manager. Provide the plan no later than 20 business days following Vision Setting or Strategic Planning Meeting for each respective program as applicable. Maintain contacts with a broad representation of active consumer advocacy/support organizations. Prepare and distribute information to recruit consumer reviewers. Solicit nominations from consumer/advocacy support groups for upcoming peer reviews, evaluate nominations, and select consumer reviewers according to CDMRP guidance.

b. Devise and implement strategies for recruiting consumer reviewer’s representative of the community affected by the disease/condition, including representation of disproportionally minority populations/groups, military veterans, and affected populations.

4.5.5.14 Provide updates to the CDMRP Program Manager during the recruitment period on recruitment accomplishments, barriers to recruitment, etc., on a monthly basis or as needed.

4.5.5.15 Assign and provide application review materials to the recruited reviewers, allowing an appropriate amount of time to conduct a thorough review while meeting task order COR-approved timelines as agreed upon in the deliverables/receivables tracking sheet (D/RTS).

4.5.5.16 The minimum number of applications per PRP shall be coordinated with the appropriate CDMRP Program Manager. In general, each scientist/clinician PRP member shall be responsible for reviewing eight (8) to ten (10) applications; any exceptions must have prior approval of the CDMRP Program Manager. Each consumer reviewer shall be responsible for reviewing no more than 20 applications, with their reviews focused primarily on specific application components; any exceptions must have prior approval of the CDMRP Program Manager. However, specific requirements for reviewer assignments shall be detailed in each program specific task order.

4.5.5.17 Ensure each PRP maintains a quorum. A quorum shall consist of at least 80% of all PRP members (including COIs but exclusive of SROs and other administrative staff) for each PRP in order for discussions to proceed without prior approval. For example, if the PRP consists of 10 members, no more than two (2) members may be out for any reason, including COIs, travel reasons, or other brief absences from the PRP without approval of the CDMRP Program Manager. Ad hoc reviewers are considered PRP members only for the applications for which they are participating. A mitigation strategy for unanticipated quorum issues, particularly in a virtual setting, shall be described.

4.5.5.18 Furnish information summary sheet(s) of PRP member degrees, expertise, Department/Institution, PRP assignment, and USAMRDC peer review history.

4.5.5.19 If requested in the program-specific task orders or on an ad hoc basis, provide a report of PRP member demographics, including but not limited to gender, ethnic diversity, academic rank, military rank, active-duty status, military dependent, Veteran status, education/degrees, affiliation with Department of Defense and/or Department of Veterans Affairs, and institutional association in aggregate and by PRP.

4.5.5.20 Provide a peer review debriefing report following each peer review or as specified in the program-specific task order. The report shall consist of a summary of feedback from reviewers about the process and their experience collected from reviewers during peer review debriefings.

4.5.6. Evaluate Scientific Research Applications

4.5.6.1. Perform a technical review of all applications providing evaluative critiques and utilizing the scoring process (e.g., overall and individual criteria scores) established for each funding opportunity according to the individual task order. Standard deviations shall be required on each application’s overall score. The Offeror must describe quality control processes and/or strategies that will be employed to ensure that reviewer critiques are free of factual errors and inflammatory or inappropriate statements. The Offeror must also describe best practices that will be utilized to ensure that reviewer critiques are consistent with the criteria scores and overall score, and that critiques are consistent within each distinct evaluation criterion (i.e. avoid criteria bleeding). Scoring guidance and visual assistance resources shall be provided prior to and during the peer review meetings.

4.5.6.2 Coordinate with the CDMRP Program Manager on the final expedited (triage) range parameters, as applicable. Provide an expedited (triage) review report for applications scoring outside the pre- determined range of parameters within two (2) business days prior to the peer review meeting.

4.5.6.3 Provide finalized scoring reports in both Microsoft Excel and PDF within one (1) business day of the peer review meeting completion.

4.5.6.4 Provide reports comparing pre-meeting and final (post-meeting) scores per application, assigned reviewer, criteria, and PRP within one (1) business day of the peer review meeting, as requested ad hoc by program-specific task order.

4.5.6.5 Provide score distribution reports by panel and by award mechanism within two (2) business days after delivery of final score report, as requested ad hoc by program specific task order.

4.5.6.6 Provide a report with the names, degrees, and organizations of all reviewers per program per fiscal year for web posting within 30 business days after the last peer review meeting for a program- specific task order.

4.5.6.7 If the Government determines that the peer review resulted in factual errors in the summary statement or procedural errors in the process at the fault of the contractor, an application re-review shall be conducted at the expense of the Contractor. The Government shall provide the Contractor with a Notification of Error in the form of an email from the CDMRP Program Manager and include the task order COR. Each application shall be re-reviewed by a PRP of scientist/technical and consumer reviewers, with appropriate administrative support, within 30 business days (unless a different timeline is approved by the CDMRP Program Manager) of the application re-review decision. The decision regarding the modality of the re-review shall be determined by the CDMRP Program Manager. A D/RTS specific to each re-review shall be developed. Format of the re-review deliverables shall be consistent with established deliverable formats.

4.6. Deliver Summary Statements

4.6.1 Provide a summary statement for each peer reviewed research application to document the peer review findings. The draft summary statement template(s) shall be provided to the CDMRP Program Manager for approval. Provide identifying information for the application, all scoring data and statistics, a nonevaluative summary of the application, individual reviewer written critique (summarizing strengths and weaknesses as established by the PRP), discussion notes and additional files as requested (e.g., abstracts, statements) for each application summary. A quality assurance process to at a minimum remove inflammatory language and ensure alignment with the published review criteria shall be applied prior to delivery of summary statements.

4.6.2 Furnish the draft summary statements as requested per task order and as they become available in the appropriate part in the summary statement preparation process. The CDMRP Program Manager reserves the right to request rewrites based on this review. Percentage of draft summary statements requested will depend on the program, funding opportunity, scoring distribution, and number of applications.

4.6.3 Deliver summary statements in batches (as identified by the respective CDMRP Program Manager) per each D/RTS. Deliver the first batch of summary statements no later than 15 business days and deliver the second batch of summary statements no later than five (5) business days prior to the appropriate programmatic review meeting. If required per the D/RTS, deliver the final Principal Investigator version of summary statements no later than 2 weeks after the programmatic review meeting. In the event of a re- review due to a factual error in the summary statement or procedural error in the process at the fault of the contractor, a new summary statement will be delivered NLT five (5) business days after the re-review peer review meeting.

4.6.4 Data and File Deliverables

Provide all data and files associated with pre-applications, full original and peer reviewed applications/proposals and results of peer reviews via secure web services meeting government established technical specifications. Data and files shall be transferred to CDMRP electronic business management systems, primarily the EGS or other systems as needed to meet defined timelines for each program which will be established and agreed to annually within a D/RTS. The contractor shall employ quality control procedures to ensure that all data and files delivered into the Government systems meets the highest level of data integrity, consistency and accuracy.

Data and files include:

· Administrative notes transferred to EGS

· Original pre-application data and files

· Original full application data and files

· Full application budget report

· Compliant version of pre-application data

· Compliant version of pre-application files

· Compliant version of full application files (Peer Reviewed Application Files I)

· Compliant version of full application data

· Compliant version of full application files (Peer Reviewed Application Files II)

· Application Score Data

4.6.4.1 The Contractor will be expected to abide by a system interconnection agreement for exchange of data/files between the contractor owned system and EGS (or other Gov. application/resource as needed). Agreement will specify details to include security considerations, documentation, technical controls and standards, configuration control, communication plans, and roles and responsibilities.

4.6.4.2 The Contractor must agree to a data use policy which will define and limit how application/proposal data/files may be used and how long application/proposal data will be retained in the contractor-owned and contractor-operated system.

4.6.4.3 The Contractor shall establish quality control processes to ensure that data/files delivered to the government meet standards of accuracy, integrity and consistency. Issues found with data after delivery must be corrected and redelivered.

4.7 Training

4.7.1 Furnish a coordinated training and orientation plan for all reviewer participants at the beginning of each fiscal year. The training and orientation plan shall incorporate separate sub-plans for training and orienting new scientist and technical reviewers and consumer reviewers within a master timeline for accomplishing the proposed training. Each sub-plan shall identify learning objectives outlined in measurable, behavioral terms, including process or intermediate demonstrations of terminal objective achievement and outcome performance evaluation tools/audits that correspond to the learning objectives. The training plan shall include the Contractor’s policies for COIs and protection of confidential and proprietary information. Each plan shall furnish proposed timelines for each audience, including educational materials, using portable, alternative and web-based media to the extent possible, and incorporating targeted levels of learning appropriate to each audience. Provide periodic updates to training materials to ensure materials are kept up to date. The training and orientation programs shall be approved by the base COR.

4.7.2 Schedule, coordinate and provide an appropriate number of program-specific webinar orientations for 1) Scientific Review Officers; and 2) all reviewers (for all types of review processes). Orientations shall be developed in consultation with the CDMRP Program Manager. Provide orientation materials to the CDMRP Program Manager no later than 10 business days before the scheduled orientation. Additional teleconferences after distribution of review materials may be held as appropriate.

4.7.3 Design and implement consumer orientation sessions and provide support to consumer reviewers pre-meeting, on-site/in real-time and post meeting (as appropriate). Attend and participate in a dry run meeting as requested.

4.7.4 Participate in Working Groups

4.7.4.1 Participate in CDMRP program evaluation activities and working groups as requested. Some large efforts required for these sub-committee activities shall be negotiated as a separate task order. Provide science management advice on program evaluation projects as requested.

4.7.5 Attend Conferences/Meetings

4.7.5.1 Provide a list of the conferences and meetings the contractor staff desires to attend, not including CDMRP peer review meetings. This request shall include a justification for attendance at each conference/meeting per attendee. The list shall be delivered 60-90 calendar days prior to the conference/meeting date for base COR approval. Any changes to the list shall be approved by the COR (e.g., additions at a later date).

4.7.5.2 Conference and meeting attendance shall be for reviewer recruitment purposes only. Provide a summary of the recruitment results, to include number of contacts made and number of reviewers added to the recruitment list, within 20 business days of the conference or meeting conclusion.

4.8 Logistical Requirements for Onsite, In-Person Meetings

4.8.1 Secure hotel arrangements and reservations that satisfy the requirements of the onsite PRP’s. Inform the respective CDMRP Program Manager of planned and finalized venue when making the meeting arrangements within three business days of final venue selection.

4.8.1.1 Reserve appropriate number of meeting rooms in support of the meeting and supply any necessary audio/visual/IT support and equipment needed to conduct the meeting.

4.8.2 Arrange travel reservations for all non-DOD/government peer review participants.

4.8.3 Coordinate meals for all peer review attendees, including government representatives. Peer review meeting attendees shall pay for all meals provided in accordance with the Joint Travel Regulations.

4.8.4 Provide all logistical, administrative, and information technology support during all peer review meetings. Provide contingency/backup plans for unexpected disruption.

4.8.5 Coordinate with appropriate USAMRDC personnel to ensure meeting locations meet the current Force Protection Requirements. These requirements include, but are not limited to:

4.8.5.1 Each meeting room/auditorium/etc. must have doors lockable from inside the room;

4.8.5.2 Each meeting room must have more than one exit;

4.8.5.3 Location hosts must agree to not advertise the meeting’s association with the U.S. Government in any manner, e.g., names on bulletin boards, signs posted in lobbies or conference room doors, internet sites, etc.;

4.8.5.4 Facility must have organic or dedicated parking areas;

4.8.5.5 If the event will start or end during the hours of darkness or low-level daylight, the parking areas and avenues to and from the facility must be well-lit;

4.8.5.6 Each meeting room must have a working land-line telephone; and

4.8.5.7 Each meeting room must have a serviceable fire extinguisher.

4.8.6 The following are preferred/ desired attributes for meeting venues:

4.8.6.1 Dedicated security force;

4.8.6.2 Access-controlled parking areas;

4.8.6.3 Access control (human, electronic, or key) at entrances to facility;

4.8.6.4 Geographical separation from highly trafficked pedestrian areas;

4.8.6.5 Located in near vicinity of at least a Level III Trauma Center; and

4.8.6.6 Closed-circuit Television (recorded) security system.

4.9.2 Program Support

4.9.2.1 Utilize established SOPs and timelines to configure eBRAP for each FOA for draft review and testing, modify as necessary, and complete final posting upon approval by Government POCs. Maintain master eBRAP FOA set up document of all configuration parameters (e.g., FOA options, compliance requirements, and research classifications).

4.9.2.2 Post notification documents and update statuses to applicant records including Invite/Not Invite status and letters,…