1. PWS.docx

PERFORMANCE WORK STATEMENT

Biomedical Research Application Evaluation and Support

SECTION 1.0: GENERAL INFORMATION

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 of the base-level Indefinite Delivery Indefinite Quantity (IDIQ) to use this mechanism on a case-by-case basis.

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. The CDMRP uses the two-tier review process to develop funding recommendations that balance the most meritorious science across many disciplines and offer the highest promise to fulfill programmatic goals. Historically, CDMRP has utilized separate vendors for each tier of review.

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.

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

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 Quality Assurance Surveillance Plan (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

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

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.

Government Business Systems The CDMRP utilizes a custom developed research administration platform consisting of two systems, the Electronic Biomedical Research Application Portal (eBRAP) and the Electronic Grants System (EGS). A process map is provided in the Data Flow (Attachment 1).

The electronic Biomedical Research Application Portal (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, MRDC and other DoD organizations. eBRAP’s primary functionality is 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.

The eBRAP is available to support tasks under this PWS by organizations other than CDMRP with which CDMRP has executed a Memorandum of Agreement (MOA). Instructions for billing contractor support will be provided in affected task orders. Certain dependencies exist with the Electronic Grants System as described above which also require discussions well in advance of any task orders issued under this contract.

The Electronic Grants System (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 proposals 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

Reimbursement of costs for the contractor-owned, contractor-operated (COCO) peer review system can be accounted for through only one of the Science Administration and Management (SAM) options.

Science Administration and Management (SAM-1) will support senior administrative staff and optional COCO system operations and maintenance if required by the vendor. SAM-1 will be awarded annually to each vendor.

Additional Science Administration and Management support (SAM-2) will support individual program management staff and COCO system operations as part of the individual program task orders if not included under SAM-1 (e.g. if included as fee-for-service use on a program/application level basis). SAM-2 will be competed and awarded with each program level task order.

COCO system support may be proposed at a base level (SAM-1) - or- as a fee-per-use program expense (SAM-2).

Contractor Personnel Minimum Requirements 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.

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.

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.

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.

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).

Training Requirements 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 DHA and/or MRDC. 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

CAC Enabled Only

Non-CAC Option Available

Non-CAC Option 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.

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 DoD 8570.02 located at: https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/520002p.pdf?ver=2018-05-11- 100552-223, DoD 8570.01-M located at: https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodm/857001m.pdf?ver=2019-07-08-101252-253, 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 Contractor shall provide biomedical research application evaluation and support by performing the tasks within this PWS. 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: Application submission is a two-step process requiring both a pre-application and a full application. Pre-applications and applications are submitted to a Program Announcement (PA) developed and released by the government program office; pre- applications/pre-proposals and applications/proposals may also be submitted to a program-specific 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.

A single vendor will be awarded an eBRAP Support (section 4.1) task order to include eBRAP set-up, compliance and helpdesk support (Attachment 2). Each vendor will be awarded its own SAM-1 task order. The minimum guaranteed amount is $2,500.00. Individual program support (sections 4.3 and 4.4) task orders will be competed annually amongst all IDIQ holders under the base contract. Additional program-specific SAM-2 support will be awarded as a Contract Line Item Number (CLIN) on the individual program task order (Attachment 2). Vendors may compete for and be awarded multiple task orders.

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 Funding Opportunity Announcement (FOA)s, as well as pre- and full applications submitted under a Program Announcement (PA) or program-specific Broad Agency Announcement (BAA). These activities leverage eBRAP's automated functionalities across all FOAs. Additionally, the public helpdesk offers customer service to address inquiries related to FOAs and application submissions, ensuring timely and accurate support.

General eBRAP Support

Perform pre-planning activities for individual 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 support FOA setup in eBRAP (once the appropriation is passed).

Maintain Manual of Operations addressing any changes in Standard Operation Procedures (SOP)s and eBRAP functionality.

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

Provide general coordination activities across helpdesk and program support.

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

Perform applicant entity coding and validation (i.e. UEI, DODAC, etc.) as necessary and coordinate with CDMRP data management for updates as necessary.

eBRAP Configuration, Communications and Application Processing

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).

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 1 business day of receipt. Ensure automated and/or manual email notifications are sent to applicants/awardees based on status updates.

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

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).

Manage email subscription lists in eBRAP.

After initial coordination with the Government, set up draft FOA posting in eBRAP within three (3) business days of draft (version sent to grants review board, or GRB) FOA receipt.

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

Post final FOAs in eBRAP within 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 GRB- version of FOAs was not provided.

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, appeals or other issues that may be funding opportunity specific.

Research Application Compliance Support

The offeror 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.

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.

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.

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.

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 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.

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.

Prepare a draft of the annual template notification letters, in accordance with DHA 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.

Using eBRAP compliance set-up module, make configurations to inform the appropriate government POCs that non- compliant letters are available for review.

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.

eBRAP Data and File Deliverables

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.

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)

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

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

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.

Public Helpdesk

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.

Provide complete and accurate responses to questions/queries within specified timelines indicated in the QASP.

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.

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

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.

Reports with metrics (i.e. number of requests by program or other categories requested, responses, time to resolution) shall be provided monthly.

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

Contractor-Owned, Contractor-Operated System

Each vendor will provide a 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 and Government provided data referenced in Section 6.1. Such a system will have accessibility for the CDMRP Program Managers and Government observers/representatives. 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. 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. At minimum, the system must incorporate the following capabilities by the time of award:

· 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.

General Program Support

In addition to Science Administration and Management (SAM) support for senior administrative staff, and COCO system operations/maintenance as applicable, awarded annually to each vendor (SAM-1), program level CLINs (SAM-2) to support individual program management staff, and additional COCO system operations as applicable, will be awarded with each program level task order (Attachment 2).

General support for SAM-1 tasks are applicable to all CDMRP programs and may include participation in integrated team meetings, providing input on the content of funding opportunity announcements, development of training materials/templates, and assistance with setting program milestones. Program-specific support (SAM-2) shall be provided as CLIN support under the individual program task orders, including but not limited to, scientific review management, project management, and consumer reviewer administration.

Program-Specific Support

Integrated Program Team (IPT) Support 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 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).

Complete and provide an eBRAP set-up and compliance specification sheet/checklist in accordance with each respective PA or program-specific BAA within ten (10) business days after FOA release.

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

Prepare and Plan for Peer Review of Applications/Proposals

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.

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.

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.

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.

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

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; 2) online-only PRPs (not convened in a meeting for panel discussions); 3) onsite, in person peer review panels (PRPs); and 4) online individual peer reviews (conducted individually and not discussed). 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 federal appropriations cycle, the offeror 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:

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.

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.

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.

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:

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. Each peer review panel may contain a range (e.g., 5-15 reviewers per panel).

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 Offeror/Contractor. The ability to customize support for CDMRP programs with multiple review cycles or large application receipt shall be described.

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.

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.

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

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 sex, 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.

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.

Reviewer Recruitment:

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.

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.

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

Recruit a Chairperson for each PRP. The accommodation of more than 100 PRP 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.

Recruit PRP scientist/clinician and specialist reviewers. 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. 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 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.

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

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 high-risk groups, military veterans, and affected populations.

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.

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).

Conduct COI review of proposals (in sections other than “References Cited”) of programmatic review panel members (who serve on the second tier of review) and provide a report by research program and FOA of pre-applications/pre-proposals and applications/proposals. For CDMRP, a list of these members is available on the CDMRP website program. Report to be delivered no later than one (5) business days after compliance review is completed.

Evaluate Scientific Research Applications

Perform a technical review of all applications providing evaluative critiques and utilizing the scoring process (e.g., overall and individual criteria scores; scales determined by the government) 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.

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.

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

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.

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.

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.

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. An estimated 10-20 application re-reviews may occur each year. 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.

Data and File Deliverables

Provide all data and files from the results of peer reviews. For CDMRP, all data will be delivered to EGS 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 or network repositories 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

· Peer Review Summary Statements

· Full application budget report

· Application Score Data

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.

Deliver Summary Statements

Provide a summary…