Attachment 1 - DRAFT Performance Work Statement.docx

PERFORMANCE WORK STATEMENT

Biomedical Research Application Evaluation and Support

Attachment 1

SECTION 1.0: GENERAL INFORMATION

1.1 Objective:

To support biomedical research application evaluation for the Congressionally Directed Medical Research Programs (CDMRP) within the Defense Health Agency Research and Development (DHA R&D), Medical Research and Development Command (MRDC). In addition, other federal organizations may be approved through the CDMRP Contracting Officer’s Representative (COR) and the DHA Contracting Activity (DHACA) Contracting Officer for use of the Multiple-Award base-level Indefinite Delivery Indefinite Quantity (MA-IDIQ) contracts on a case-by-case basis.

1.2 Background:

The CDMRP manages biomedical research in response to the expressed needs of Congress and its stakeholders. Congress adds funding for the CDMRP into the annual defense appropriations bill. The CDMRP is responsible for planning, coordinating, integrating, programming and budgeting program funding.

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.

Based on recommendations provided by the National Academy of Sciences Institute of Medicine (IOM), a two-tier review process for evaluating and selecting research applications has become a cornerstone within CDMRP. This novel two-tiered process involves reviewing every research application for scientific merit as well as programmatic relevance.

The first tier of the two-tier review process is peer review. Peer review is a criterion-based process where applications are evaluated based on their scientific and technical merit. Applications are evaluated by scientific discipline, specialty area, or award mechanism by scientific, technical and consumer peer reviewers.

The second tier of review is programmatic review. Applications are programmatically reviewed by members of the programs’ Programmatic Panel. Programmatic review is a comparison-based process in which the peer reviewed applications compete in a common pool. Programmatic review considers the scientific merit as well as the potential impact and outcomes of the applications to select those that have the highest potential to help achieve the vision and goals of the respective program.

Historically, CDMRP has utilized separate vendors for each tier of review. As stated in section 1.3 Scope, the CDMRP support herein encompasses scientific merit peer review. Programmatic review is a wholly separate requirement; this information is included only to provide a clearer understanding of the CDMRP Processes.

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 Scope:

The CDMRP Support encompasses non-personal services for 1) funding opportunity announcement set-up within CDMRP’s electronic Biomedical Research Application Portal (eBRAP) (awarded to a single vendor); 2) oversight of electronic receipt and processing of intramural and extramural pre- and full research applications in eBRAP (awarded to a single vendor); 3) application compliance review in eBRAP (awarded to a single vendor); and 4) scientific merit peer review including operation of a secure Contractor-owned, Contractor-operated web-based electronic system which supports all activities and capabilities specific to peer review (i.e. Scientific Administration and Management) (awarded to multiple vendors)

1.4 Award type:

Multiple-Award Indefinite Delivery Indefinite Quantity (MA-IDIQ)*

* Peer Review (multiple awardees). eBRAP (single awardee)

1.5 Contract type:

Cost Plus Fixed Fee/CPFF (w/Firm Fixed Price/FFP and Cost components)

1.6 Service type:

Non-commercial, performance-based.

1.7 Estimated Period of Performance (PoP):

Base Period: 28 January 2027 – 27 January 2032

SECTION 2.0: GOVERNMENT-FURNISHED PROPERTY AND GOVERNMENT 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 (GFP)

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. All GFP data/records will be uploaded and maintained in the Procurement Integrated Enterprise Environment (PIEE) GFP module at https://piee.eb.mil/xhtml/unauth/home/login.xhtml (additional information can be found at: https://dodprocurementtoolbox.com/site-pages/gfp).

2.3 Government Business Systems

The CDMRP utilizes a custom developed research administration platform consisting of two (2) systems, the eBRAP and the Electronic Grants System (EGS). A process map is provided in the Data Flow (Attachment 16).

2.3.1 The electronic Biomedical Research Application Portal (eBRAP) The eBRAP is a government-owned custom developed system required for use in the establishment of funding opportunity announcements (FOA), compliance, and receipt/submission and processing of research proposals, document collection, and information dissemination. All FOAs must be configured within the eBRAP system according to milestones and deadlines outlined in individual program task orders.

The eBRAP serves as the portal for the worldwide research community with the CDMRP, MRDC and other Department of Defense (DoD) organizations. The eBRAP’s primary functionality is in the area of receipt of pre-applications, direct receipt of intramural DoD proposals, interfaces with Grants.gov (e.g., pulls down/retrieves applications from Grants.gov) for retrieval, processing of extramural/intramural applications and administrative review for compliance. It is also the system for receipt/submission of award management information and files (e.g., invoices, regulatory documents, technical reports, quad charts) over the lifetime of research awards; the eBRAP also interfaces with the government’s central 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.

Under this requirement, eBRAP shall be available to support tasks by organizations, other than CDMRP, with which CDMRP has executed a Memorandum of Agreement (MOA). Instructions for billing Contractor support will be provided in individual task orders. Data transfer dependencies with EGS exist (as described above) as the eBRAP system does not directly provide or transfer application information to peer review systems. Therefore, application data may need to be transferred to EGS in order to make available for peer review retrieval.

Contractor/government discussions are required, post-award, 1-2 months in advance of task order start date to define application data transfer needs.

2.3.2 The Electronic Grants System (EGS) (information purposes only) 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 proposals and award data as well as files including contracting, regulatory, administrative, and other relevant information. The 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. The 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.

NOTE: EGS or EGS management is NOT a requirement within this PWS, rather information herein is only provided for context regarding interface with the eBRAP.

SECTION 3.0: CONTRACTOR REQUIREMENTS

3.1 Contractor-owned, Contractor-operated (COCO) system

Each Contractor shall have a current and secure Contractor-owned, Contractor-operated (COCO) web-based electronic system, which includes hosting of such system. The COCO system is not required to be owned by the prime vendor and may be provided by a 3rd party as long as it meets the same functional system requirements and conforms to minimum government data protections specifications. The COCO system shall be capable of supporting high volumes (e.g., > 10,000 preapplications and >6,000 full applications across 30+ distinct research programs) of peer review activities and delivering data to the government’s EGS via secure web services and adherence to an interconnection agreement. The COCO 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. The COCO, or 3rd party owned system usage expense will be included as a separate CLIN (e.g., other direct cost/[ODC]) on each program task order.

3.2 electronic Biomedical Research Application Portal (eBRAP) One Contractor only shall manage the eBRAP consisting of configuration, communications and applicable processing/set-up, research application compliance and helpdesk support as well as eBRAP data file and deliverables. The eBRAP Task Order awardee will provide an Organizational Conflict of Interest (OCI) mitigation plan. The OCI plan will ensure that eBRAP management does not give the eBRAP awardee an unfair competitive advantage in competing for individual peer review program support (sections 4.3 and 4.4) task orders, or otherwise create an OCI.

3.3 Science Administration and Management (SAM)

Each Contractor shall provide SAM support which consists of full-time senior administrative staff who support all research programs as well as other administrative staff who support tasks including, but not limited to, quarterly report(s) and deliverables; quality management and oversight; resource materials; office expenses and supplies; Scientific Review Officer training and recruitment; training for all Government-required training for common access card (CAC) holders; coordination of NAC processing; recurring operational meetings with the COR and Government leads; GFE maintenance; standard operating procedures and other document templates; and security requirements. Additionally, SAM support shall include software licensing, transition-in of COCO system and any Government-approved COCO system enhancements (CPFF). A SAM task order will be awarded annually to each vendor.

3.4 Cybersecurity Maturity Model Certification (CMMC)

Cybersecurity Maturity Model Certification (CMMC) level 1 is required with level 1 “self-assessment” required prior to award of the IDIQ contract(s). It is anticipated that during the period of performance, level 2 “self-assessment” will be implemented in a “phased-in” approach sometime throughout contract performance. Individual Task Orders may require a level 2 (Self assessment). CMMC Program requirements apply to Contractors who will process, store, or transmit Federal Contract Information (FCI – information NOT intended for public release) or Controlled Unclassified Information (CUI – information that requires safeguarding and is subject to dissemination controls). More information can be obtained at: https://dowcio.war.gov/CMMC/.

3.5 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 (6) 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 to the COR five (5) 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 (10) business days prior to reporting for performance.

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

Position Title:

· Scientific Director

· Scientific Review Manager

· Consumer Reviewer Administrative Manager

· Program Support Coordinator

3.6 Government-Mandated Training (Deliverable 7)

All Government-mandated training is required for all Contractor personnel and associated subcontractor personnel requiring access to a government information system. Service Training Certification Tracking System registration for all IT Contractor personnel is required. All Government-mandated training shall be completed online during duty hours and in accordance with timelines established by the Government. 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 DHA and/or MRDC. Each affected Contractor and subcontractor personnel shall submit “certificates of completion” to the CDMRP Training Coordinator upon completion. The Government estimates it will take ten (10) hours to complete all Government-mandated training.

Initial and Annual Training Requirements for CAC holders NOT requiring network access:

Department of Defense (DoD) Cyber Awareness Challenge

Available

Initial and Annual Training Requirements for CAC holders REQUIRING network access:

Department of Defense (DoD) Cyber Awareness Challenge

Available

Available

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

Available

Available

CAC Enabled Only

Non-CAC Option Available

Non-CAC Option Available

SECTION 4.0: PERFORMANCE OBJECTIVES

The Contractor shall provide biomedical research application evaluation and support by performing the tasks within this PWS. In addition, the Contractor shall have a current and secure Contractor- owned, Contractor-operated web-based electronic system, which includes hosting of such system. The COCO 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: Application submission is a two-step process requiring both a pre-application and a full application. Pre-applications and applications are submitted in response to a Program Announcement (PA) developed and released by the Government program office. Pre-applications/pre-proposals and applications/proposals may also be submitted in response to a program-specific Broad Agency Announcement (BAA).

The Deliverables required for each program task order are detailed in the Task Order Performance Work Statement, which may vary per program. Task Order Deliverables/Receivables Tracking Sheet (D/RTS) (Deliverable 1 Program Task Order), to include all required deliverables from the Contractor and respective receivables expected from the Government, shall be prepared by the Contractor. The Contractor shall provide the D/RTS no later than (NLT) ten (10) business days after the last FOA for the cycle is released.

Each successful offeror will be awarded its own SAM task order. A single vendor will be awarded the eBRAP Support (section 4.1) task order to include eBRAP set-up, compliance and helpdesk support (Attachment 14). Individual peer review program support (sections 4.3 and 4.4) task orders will be competed annually amongst all IDIQ contract holders under the base contract. Contract holders will be offered a fair opportunity to compete for and be awarded multiple task orders. The minimum guaranteed amount is $2,500.00.

4.1 eBRAP/Helpdesk Support for Research Programs The eBRAP support activities include a variety of tasks aimed at ensuring smooth program operations, application compliance, and user assistance for all FOAs as well as pre- and full applications submitted under a PA or program-specific BAA. These activities leverage eBRAP's automated functionalities across all FOAs. Additionally, the eBRAP helpdesk offers customer service to address inquiries related to FOAs and application submissions, ensuring timely and accurate support.

4.1.1 General eBRAP Support

4.1.1.1 Perform pre-planning activities for individual research programs, as needed, to ensure continuity of effort and a smooth transition from one fiscal year program to the following fiscal year program. Such activities include, but are not limited to, reviewing draft FOAs, discussing milestone planning, and supporting FOA setup in eBRAP (once the appropriation bill has been passed).

4.1.1.2 Maintain the manual of operations addressing any changes in Standard Operation Procedures (SOP) and eBRAP functionality.

4.1.1.3 Attend CDMRP business systems management Integrated Program Team meetings and communicate any eBRAP related functionality/issues reported by users.

4.1.1.4 Provide general coordination activities across helpdesk and program support.

4.1.1.5 Monitor Grants.gov for system outages, changes in procedures and forms.

4.1.1.6 Perform applicant entity coding and validation (e.g., Unique Entity ID (UEI), DoD Activity Address Directory (DoDAAC), etc.) as necessary and coordinate with CDMRP data management for updates as necessary.

4.1.1.7 Provide a consolidated master D/RTS export (Excel) to include all research programs as they are finalized in an updated version each month. (Deliverable 14 eBRAP Task Order)

4.1.2 eBRAP Configuration, Communications and Application Processing

4.1.2.1 eBRAP setup and Compliance Specification templates will be provided by the Government at the beginning of the program cycle. Coordinate with the CDMRP Program Manager to complete and provide the eBRAP set-up and Compliance Specification Sheet for each FOA within three (3) business days of draft version sent to Grants Review Board (GRB) FOA receipt (Deliverable 1a eBRAP Task Order). Maintain a master checklist of all FOA deliverables (setup and compliance sheets) per program and provide within ten (10) business days after the final FOA release (Deliverable 1b eBRAP Task Order).

4.1.2.2 Post notification documents and update statuses to applicant records including Invite/Not Invite status and letters, summary statements, funding notification letters, information papers, and other documents as applicable and as requested within one (1) business day of receipt. Ensure automated and/or manual email notifications are sent to applicants/awardees based on status updates.

4.1.2.3 Make modifications to FOA setup due to extenuating circumstances (e.g., deadline extensions, corrections to FOAs, system errors).

4.1.2.4 Send email blasts via eBRAP to users/news subscribers as requested for information dissemination purposes (e.g., funding opportunity announcements, special news, updates to FOAs, deadline extensions, other announcements) within two (2) business days of request.

4.1.2.5 Manage email subscription lists in eBRAP.

4.1.2.6 After initial coordination of the draft review and testing with the Government, set up final FOA posting in eBRAP within three (3) business days of final FOA receipt (version sent to Grants.gov for posting).

4.1.2.7 Set up a test for each FOA using each FOA’s requirement, including all options for pre- and full application/proposal submission.

4.1.2.8 Post final FOAs in eBRAP within one (1) business day of final FOA receipt if draft FOA was provided. Otherwise, post final FOAs in eBRAP within two (2) business days of final FOA receipt if Grants Review Board-version of FOAs was not provided.

4.1.2.9 Provide manual intervention of application processing issues, including but not limited to, security features in PDF documents; validation between full application and pre-application mismatch; presence of unsolicited application components; and appeals or other issues that may be funding opportunity specific.

4.1.3 eBRAP Research Application Compliance Support

4.1.3.1 The Contractor shall assist in developing Compliance Standard Operating Procedure in consultation with the Government for each FOA. 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.

4.1.3.2 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.

4.1.3.3 Conduct a compliance review by identifying compliance issues and administrative modifications for every pre-application/pre-proposal submitted, in accordance with each respective FOA and the associated Compliance Specification Sheet within ten (10) business days prior to FOA release. Using eBRAP, provide a list of the compliance issues and administrative modifications in eBRAP, and 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 Contractor must be able to implement a scale-up strategy to accommodate the workload requirements. (Deliverable 2 eBRAP Task Order)

4.1.3.4 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. (Deliverable 3 eBRAP Task Order)

4.1.3.5 Provide a report (e.g., Multiple Submission 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 MRDC 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. (Deliverable 4 Program Task Order)

4.1.3.6 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.

4.1.3.7 Prepare a draft of the annual template notification letters, in accordance with DHA Regulations, for non-compliant notification and deliver to the Government POC within 20 business days following release of the first fiscal year FOA. (Deliverable 4 eBRAP Task Order)

4.1.3.8 Using eBRAP compliance set-up module, make configurations to inform the appropriate Government POCs that noncompliant letters are available for review.

4.1.3.9 After completion of compliance review, ensure non-compliant letters have been posted in eBRAP and inform the Government POCs that the applicant has been notified.

4.1.4 eBRAP Data and File Deliverables

4.1.4.1 Provide all data and files associated with pre-applications, full original and peer review applications/proposals. For CDMRP, all data will be delivered from eBRAP to EGS via secure web services meeting Government-established technical specifications. Files shall be transferred to a Government-shared network repository as needed to meet defined timelines for each program, which will be established and agreed to annually within a D/RTS. (Deliverable 5-12 eBRAP Task Order)

Data and files include:

· 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 Review Application Files I)

· Compliant version of full application data

· Compliant version of any requested modified full application files (Peer Review Application Files II)

4.1.4.2 Prepare deliverables including data and files as per delivery schedule (refer to section 4.4.3.1). Ensure quality control processes are in place.

4.1.4.3 Establish and ensure data integrity, proper configuration for all program and record set-up, including but not limited to, Organization, Program, and Mechanism codes.

4.1.4.4 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.

4.1.5 eBRAP Helpdesk

4.1.5.1 Maintain and operate a customer service/helpdesk center to address inquiries about support of FOAs for pre-application and application submissions, document collection for funded applications (e.g. regulatory documents, technical reports, invoices, quad charts), and general information. User support shall be provided via email and telephonically, as appropriate. An estimated 2,000-4,000 telephone calls and emails are received each month based on number of open FOAs.

4.1.5.2 Provide complete and accurate responses to questions/queries within specified timelines (i.e. responses within 8 – 24 hours) and 75 – 95% user feedback rating of 4 and 5.

4.1.5.3 Helpdesk must be available during normal working hours (8:00 a.m. to 5:00 p.m. EST), with potential increase in support needed during surge periods.

4.1.5.4 Escalate issues as necessary to the appropriate government program office points of contact if inquiries are technical in nature and require appropriate program office response.

4.1.5.5 Helpdesk tickets and responses must be appropriately tracked using software provided by the Government (currently Helpspot). The Government POC shall have access (in real time) to review for consistency, accuracy, and quality.

4.1.5.6 Reports with metrics (e.g., number of requests by program or other categories requested, responses, time to resolution) shall be provided monthly. (Deliverable 13 eBRAP Task Order)

4.1.5.7 Helpdesk management staff shall participate in regular meetings with CDMRP Business Systems IPT to review and discuss ticket responses and address any issues.

4.2 Contractor-Owned, Contractor-Operated (COCO) System

Each vendor shall have an already developed and functional secure Contractor-owned, Contractor-operated and hosted web-based electronic system, or 3rd party 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, Government-provided data referenced in Section 6., as well as System Enhancement Ticket(s) Report (Deliverable 10 SAM Task Order). Such a system will have accessibility for the CDMRP Program Managers and Government observers/representatives. The Contractor shall be expected to abide by a system interconnection agreement (Attachment 15 – System Interconnection Agreement Between Government & Contractor) which will be provided by the Government within 30 calendar days of award, for exchange of data/files between the COCO system and EGS (or other Gov. application/resource as needed). The System Interconnection Agreement will specify details to include security considerations, documentation, technical controls and standards, configuration control, communication plans, and roles and responsibilities. The Contractor shall agree to a data use policy (refer to section 3.4 of Attachment 15 - System Interconnection Agreement Between Government & Contractor), which will define and limit how application/proposal data/files may be used and how long application/proposal data will be retained in the COCO system. At minimum, the COCO system must incorporate the following capabilities by the time of award:

· Exchange of data via Web Services with the Government’s backend business system, EGS, via existing Application Programming Interface (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.

4.3 SAM General Program Support (Deliverable 3-7 SAM Task Order)

General support for SAM tasks may include Government-required training for CAC holders, quarterly report and related deliverables, recurring operational meetings, quality management and oversight, office expenses and supplies, and reviewer training, resource, and handbook materials among other tasks. Program-specific support shall be provided under the individual program task orders, including but not limited to, scientific review management, project management, and consumer reviewer administration. Reports on findings of scientific misconduct or research integrity during the peer review process will be sent to the base COR as needed. A program peer review meetings schedule will be updated as needed and provided to the base COR on a monthly basis.

4.4 Program-Specific Support

4.4.1 Integrated Program Team (IPT) Support

Attend and participate, as requested by the CDMRP Program Manager, in program 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 BAAs, and the MRDC 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).

4.4.1.1 Complete and provide an eBRAP set-up checklist and compliance specification sheet NLT ten (10) business days prior to FOA release. A template for the checklist and compliance specification sheet, with agreed upon elements, will be provided by the Government. Within 10 business days after FOA release, coordinate verification of the eBRAP setup in accordance with each respective PA or program-specific BAA via the task order COR and Government technical lead. (Deliverable 1a & 1b eBRAP Task Order)

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

4.4.3 Prepare and Plan for Peer Review of Applications/Proposals

4.4.3.1 For each task order, within ten (10) business days after FOA release, prepare a Deliverables/Receivables Tracking Sheet (D/RTS) outlining every deliverable/receivable and due date. (Deliverable 1 Program Task Order)

4.4.3.2 Provide Review Specification Sheets (RSS) according to each FOA for review ten (10) business days prior to pre-application receipt. The specifications shall include, but are not limited to, peer review panel (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. (Deliverable 5 Program Task Order)

4.4.3.3 Establish process(es) to ensure reviewer’s understanding and agreement to adhere to the Contractor’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.

4.4.3.4 Generative Artificial Intelligence (AI) Technologies are 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.

4.4.3.5 The Contractor is expected to prevent unauthorized disclosure of confidential and proprietary information.

4.4.4. Preparation for Peer Review of Applications/Proposals:

It is anticipated that there shall be four (4) possible modalities for conducting scientific peer review: 1) virtual PRPs – uses a digital platform for the peer review deliberation in addition to the online review system and includes secure, live, online discussions; 2) online-only PRPs (not convened in a meeting for panel discussions) – uses an online system for proposal review and does not include a live, online discussion component; 3) onsite, in person peer review panels (PRPs) – involves face-to-face discussions for the peer review deliberation in addition to the online review system; and 4) online individual peer reviews (conducted individually and not discussed) – uses an online system for proposal review on an individual application/proposal basis and does not include a live, online discussion component. While the peer review modality shall be decided upon at the issuance of the task order for each requirement, the CDMRP anticipates the majority of panels will be convened virtually. The volume of meetings per modality is dependent on multiple factors, including the number and size of annual Congressional appropriations. The accommodation of more than 100 panels may be required. 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 virtually or onsite and must meet security standards to ensure protection of procurement sensitive and Government data.

Due to the nature of the federal appropriations cycle, the Contractor may be required to conduct 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 and timelines to meet Government requirements.

Peer Review Modalities:

4.4.4.1 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 CDMRP Program Manager 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.

4.4.4.2 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.

4.4.4.3 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.

4.4.4.4 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.

Review Panel Composition:

4.4.4.5 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 CDMRP Program Manager or at the recommendation of the Contractor. Each peer review panel may contain a range (e.g., 5-15 reviewers per panel).

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

4.4.4.7 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.

4.4.4.8 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.

4.4.4.9 Furnish reports containing information about recruited PRP members, including degrees, expertise, Department/Institution, PRP assignment, and CDMRP peer review history.

4.4.4.10 If requested in the program-specific task order or on an ad hoc basis, provide a report of PRP member demographics, including but not limited to 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. (Deliverable 10 Program Task Order)

4.4.4.11 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. (Deliverable 11 Program Task Order)

Reviewer Recruitment:

4.4.4.12 The Contractor 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.

4.4.4.13 Deliver a Preliminary Report of Recruited Reviewers, chairpersons, and assigned SROs (by program and PRP) within ten (10) business days after application/proposal receipt and deliver a Final Report of Recruited Reviewers 15 business days prior to the peer review meeting. (Deliverables 6 & 7 Program Task Order)

4.4.4.14 Deliver a report detailing the peer reviewers’ organizational conflicts of interest with the PRP’s applications, fifteen (15) business days prior to the peer review meeting. (Deliverable 8 Program Task Order)

4.4.4.15 Recruit a Chairperson for each PRP. The accommodation of more than 100 PRPs may be required. 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.

4.4.4.16 Recruit PRP scientist/clinician and specialist reviewers. 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 Government will provide a list of countries of concern where recruitment is prohibited. Conduct recruitment initiatives of scientist/clinician reviewers for each research program. 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. Contractors 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 or uncompensated in a temporary duty status if approved by their Commander/supervisor. Compensation 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.

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

4.4.4.18 Develop and maintain a Consumer Nomination process. Provide consumer reviewer orientation briefing templates (Deliverable 1 SAM Task Order) to the base COR for review annually. Coordinate with the CDMRP website POC 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 (Deliverable 9 Program Task Order) 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 reviewers representative of the community affected by the disease/condition, including representation of high-risk groups, military veterans, and affected populations.

4.4.4.19 Provide updates to the CDMRP Program Manager during the recruitment period on recruitment accomplishments, barriers to recruitment, etc.,…