HT942524R0011 - RFI Health Sciences Award Management Support Services.docx

Request for Information (RFI) HT9425-22-R-0011

Health Sciences Award Management support services to the Congressionally Directed Medical Research Programs (CDMRP), the United States Army Medical Research and Materiel Command, and its subordinate commands.

Requirement: This future acquisition will provide Health Sciences Award Management support for the Congressionally Directed Medical Research Programs (CDMRP).

THIS IS NOT A REQUEST FOR PROPOSALS (RFP) OR A REQUEST FOR QUOTATIONS (RFQ); IT IS STRICTLY A REQUEST FOR INFORMATION (RFI). NEITHER UNSOLICITATED PROPOSALS NOR ANY OTHER KINDS OF OFFERS WILL BE CONSIDERED IN RESPONSE TO THIS RFI. NO CONTRACT WILL BE AWARDED PURSUANT TO THIS ANNOUNCEMENT.

1.0 DISCLAIMER: This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding accordingly. Responses to the RFI will not be returned. At this time, questions concerning the composition and requirements for a future RFP will not be entertained.

2.0 SUBJECT: The CDMRP is conducting market research to assess the availability of vendors to provide Health Sciences Award Management support

3.0 Following a restructuring in 2019, the U.S. Army Medical Research and Development Command (USAMRDC) became a major subordinate Command of the U.S. Army Futures Command. On 1 October 2022, USAMRDC consolidated assets and resources within the Defense Health Agency, as stipulated in the 2019 National Defense Authorization Act, Section 711. The USAMRDC manages Army biomedical research and development programs and selected Congressional Special Interest programs within the Department of Defense (DoD) Defense Health Program, including CDMRP.

4.0 RESPONSE INSTRUCTIONS: The United States Army Medical Research Acquisition Activity (USAMRAA) is conducting market research to locate sources capable of providing health science award management support services. USAMRAA wishes to obtain information from sources that possess the capability to provide the above-mentioned support services for current and future programs. Respondents should address the following in their submission:

· Name and address of company.

· Any small business designation as certified by the Small Business Administration and applicable certification.

· A thorough description of experience in managing support requirements of this nature.

· Past performance for the same and/or similar projects of the same size and complexity.

Capability statements shall be no more than five (5) pages and content shall be no smaller than Times New Roman font 12 pitch. Exhibits, graphics, charts, captions, etc.,

5.0 CONTACT INFORMATION: Any and all responses related to this RFI shall be directed to Luke Burke at luke.e.burke.civ@health.mil. All information regarding responses to section 4 or any other proprietary information relative to this RFI shall be submitted via email to luke.e.burke.civ@health.mil. No later than 4:00 PM (EST) on 22 December 2024.

DRAFT Performance Work Statement (PWS) Health Sciences Awards Management Support

1.1 Purpose

To award a contract for health sciences award management support services in support of the Congressionally Directed Medical Research Programs (CDMRP) located at Fort Detrick, Maryland.

1.2 Background

As directed by the Office of the Assistant Secretary of Defense for Health Affairs [OASD(HA)], the Defense Health Agency, Research, Development, and Acquisition (DHA RDA) Directorate manages and executes the Defense Health Program (DHP) Research, Development, Test, and Evaluation (RDT&E) appropriation. The US Army Medical Research and Development Command (USAMRDC) CDMRP provides execution management support for a number of medical research and development programs as directed by Congress. The CDMRP is responsible for planning, coordinating, integrating, programming, and budgeting these programs.

The CDMRP originated in 1992 via a Congressional appropriation to fund novel approaches in biomedical research to transform health care for Service Members, their families, Veterans, and the American public. The CDMRP fills research gaps by funding high impact, high risk and high gain projects. 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 lead to cures or improvements in patient care, breakthrough technologies, or resources for clinical benefit. Reference CDMRP’s website for more information https://www.cdmrp.health.mil.

The CDMRP award management team is composed of civilian Science Officers (SOs)/Grants Officer’s Representatives (GORs), as well as contractor support personnel. Award management contractor support personnel should have a range of scientific expertise, to provide support for CDMRP’s research funding programs and award management needs. CDMRP’s portfolio consists of a wide variety of award types, from basic science research awards to multi-institutional and multidisciplinary consortia, advanced therapeutic development, and clinical trial research awards. These awards are made primarily through grants and cooperative agreements but may also include research contracts and other transaction agreements. Individual expertise/backgrounds may be a consideration for program/award assignments; however, the contractor will be expected to provide flexible support across all award types. Workload will be based on a combination of the complexity of the awards and number of awards to be managed and will be determined by the Government at the time of delivery order award.

The CDMRP award management team (SOs/GORs and contractors) supports portfolio coordination and maintenance. The CDMRP routinely awards 1,000-1,500 grants and cooperative agreements, other transaction agreements, and research contracts. The CDMRP monitors the awards throughout their period of performance which may last up to five years. The CDMRP assesses all new awards and open awards for any undue foreign influence. At any time, the CDMRP manages about 5800 open awards. CDMRP SOs/GORs are assigned portfolios of 60-120 awards per SO/GOR. The contractor will be expected to manage 15-20% open awards and will be expected to assist the GOR in negotiation of new awards recommended for funding. The contractor will provide award administrative and undue foreign influence analyses support depending on the phase of the award life cycle (pre-award, open award, post award [period of performance expired, pending close out, closed award]). The CDMRP funded nearly 20,000 awards since its inception, and the contractor will provide support for program evaluation for 5-15% of the closed awards during the post-award phase.

1.3 Period of Performance

The anticipated period of performance of this contract is date of contract award for one year. There will also be four (4) one-year renewable options to be exercised at the discretion of the government (total potential of a five (5) year period of performance).

1.4 Hours of Operation

1.5 CDMRP operates on a Monday through Friday work schedule, except U.S. Federal Holidays. Overtime is not permitted. Core hours of operation are from 9:00 AM -3:00 PM eastern time (ET) with flexibility to adjust around that for daily schedules. Telework and alternate work schedules may be considered as approved in advance by the Government Contracting Officer’s Representative (COR). Contract Kick-Off Meeting The Contractor shall contact the COR within five business days after the start date to set up a post-award kick off meeting with the COR, CDMRP designated staff, Contracting Officer and Contract Specialist. The kick-off meeting shall be held within 30 business days after the start date.

1.6 Travel

Travel may be required to perform tasks in Section 4.0 below. All non-local travel must be pre-approved by the COR using the CDMRP Travel Request Form 30 calendar days prior to incurring any travel related expenses. Travel requiring approval from USAMRDC HQ must be submitted 90 days prior to travel. All travel costs shall be reimbursed in accordance with the Joint Travel Regulations. The Government will not pay for business class or first-class travel. Overnight stays will only be considered in the event that total travel time exceeds a 12 hours, inclusive of commute time and workday.. It is anticipated that each support contractor will travel to two meetings per year. For example, program-specific meetings and a relevant conference (e.g. Military Health System Research Symposium). No OCONUS travel is anticipated. For all approved official travel to national scientific conferences, an After Action Report (AAR) will be required no later than 5 business days upon return. The AAR shall include conference details, how the conference advances CDMRP’s mission, benefits, information learned, collaborations made, if any, etc. A template AAR will be provided.

The Government will provide a “Plugged” Not to Exceed (NTE) amount of $20,000.00 (other direct costs) for the base period and each option period for travel.

1.8. Key Personnel

Key personnel positions are identified below. 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 COR. Resumes shall be provided at least one week (or as mutually agreed upon) prior to making any personnel changes. The Government reserves the right to review any replacement or substitutions of Key personnel. Contractor personnel must submit necessary information to start the clearance review process prior to reporting for performance.

The Government designated the following major research portfolio areas to be supported with subject matter experts who will be considered key personnel:

-Cancer -Autoimmune/Genetic Disorders/Infectious Diseases -Psychological Health/Neurological Diseases -Musculoskeletal Diseases/Injuries/Restorative/Rehabilitative Medicine

SECTION 2.0: GOVERNMENT-FURNISHED PROPERTY AND SERVICES

2.1 General Information

The Government must provide the facilities, equipment and materials listed here.

2.2 Government-Furnished Property

The Government will make available a personal laptop computer as well as shared equipment described in section 2.3. Government Provided Spaces, to each individual requiring network access and email. For remote or telework staff, the Government will provide a laptop computer, but telephone, internet connectivity, and other equipment will not be provided and shall be the sole responsibility of the contractor’s employee or employer. All work shall be conducted on Government owned servers unless specifically requested and approved by the COR. Alternate strategies for application development on contractor equipment and environment may be proposed within the limits allowable based on need to access Government network resources and equipment.

All Government Furnished Property (GFP) data/records will be uploaded and maintained in the GFP module at https://piee.eb.mil Procurement Integrated Enterprise Environment (PIEE). (Additional information can be found at: https://dodprocurementtoolbox.com click “Government Furnished Property” at the top).

2.3 Government-Furnished Services

The Government will provide workspace located on Fort Detrick at the CDMRP site for up to 40% of the contractor employees. The Government will provide access cards, workstations with chairs, telephones, shared fax machine, copying and scanning machines, printers and supplies necessary for on-site personnel to perform the work on-site. Contractor may request additional onsite team members for approval by the COR.

The Government will provide ad hoc workspace as available for remote or telework staff who travel to Fort Detrick for ad hoc required meetings. The Government will provide custodial, utility, pest control, telephone, refuse collection, and postage (Government related materials only) services for Government provided space.

2.4 Government-Mandated Training

All Government mandated training (noted in Section 3.0 below) is required for all individuals. All government mandated training shall be completed online or onsite, during duty hours, and in accordance with established timelines.

2.5. Government Owned Systems

The Electronic Grants System (EGS) is a Government- Owned, and Operated system. EGS encompasses business processes covering the life cycle management of research proposals and awards. With over 500 users across different agencies at USAMRDC and external organizations, EGS serves as a critical business system supported by Government Staff and contractor staff across multiple contracts.

The Electronic Biomedical Research Application Portal (eBRAP) is a government-owned, contractor-operated system, which allows for research application submission and processing, document collection, and information dissemination. It serves as the front-end portal for the worldwide research community with the CDMRP, USAMRDC and other DOD organizations. eBRAP’s primary functionalities are in the submission of pre-applications, direct submission of intramural DOD proposals, interface with Grants.gov for application retrieval, processing of extramural/intramural applications, and administrative review for compliance. The system also provides access for awardees to submit administrative and regulatory documents.

SECTION 3.0: CONTRACTOR REQUIREMENTS

3.1 Contractor Personnel Minimum Requirements

3.1.1 For contractors requiring Common Access Card (CAC). Before CAC issuance, the contractor personnel requires, at a minimum, a favorably adjudicated National Agency Check with Inquiries (NACI) or an equivalent or higher investigation in accordance with Army Directive 2014-05. The contractor personnel shall 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. At the discretion of the sponsoring activity, an initial CAC may be issued based on a favorable review of the FBI fingerprint check and a successfully scheduled NACI at the Office of Personnel Management.

3.1.2 All contractor personnel proposed on this contract shall be designated as “Automated Data Processing (ADP) Level III (non-sensitive positions) in accordance with Army Regulation 380-67, dated 24 January 2014 at: https://armypubs.army.mil/epubs/DR_pubs/DR_a/pdf/web/r380_67.pdf. See page 22 and 72. Each employee must also be a United States citizen. This is necessary so the contract employee may be granted access to the Fort Detrick domain. The CDMRP will initiate the process with the appropriate personnel at Fort Detrick for the successful offeror’s employees to obtain a NACI If contractor personnel are unable to receive a favorable NACI and/or be a United States citizen, that individual may not be employed under this contract.

3.1.3 AT Level I training. All contractor personnel, to include subcontractor personnel, requiring access to Army installations, facilities and controlled access areas shall complete AT Level I awareness training within 30 calendar days after contract start date or effective date of incorporation of this requirement into the contract, whichever is applicable. The contractor shall submit certificates of completion for each affected contractor and subcontractor personnel, to the COR or to the contracting officer, if a COR is not assigned, within 30 calendar days after completion of training by all contractor personnel. AT level I awareness training is available at the following website: https://jkodirect.jten.mil/.

3.1.4 Access and general protection/security policy and procedures. Contractor and all associated subcontractor personnel shall provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshal Office, Director of Emergency Services or Security Office. Contractor workforce must comply with all personal identity verification requirements (FAR clause 52.204-9, Personal Identity Verification of Contractor Personnel) as directed by DOD and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

3.1.5 Army Training Certification Tracking System (ATCTS) registration for contractor personnel who require access to Government information systems. All contractor personnel with access to a Government info system must be registered in the ATCTS (Army Training Certification Tracking System) at commencement of services, and must successfully complete the DOD Information Assurance Awareness prior to access to the IS and then annually thereafter.

3.1.6 Information Assurance (IA)/ Information Technology (IT) Training. All contractor personnel and associated subcontractor personnel must complete the DOD IA awareness training before issuance of network access and annually thereafter. All contractor personnel working IA/IT functions must comply with DOD and Army training requirements in DODD 8570.01, DOD 8570.01-M and AR 25-2 within six months of appointment to IA/IT functions.

3.1.7 Operations Security (OPSEC) Training. Per AR 530-1 Operations Security, the contractor personnel must complete Level I OPSEC Awareness training. New employees must be trained within 30 calendar days of their reporting for duty and annually thereafter.

3.1.8 Threat Awareness Reporting Program (TARP). Per AR 381-12 Threat Awareness and Reporting Program (TARP), contractor employees must receive annual TARP training by a Counter Intelligence (CI) agent or other trainer as specified in 2-4b of the AR.

3.1.9 Health Insurance Portability and Accountability Act (HIPAA) and Privacy Security Act Training. All contractor personnel and associated subcontractor personnel with access to a Government information system must complete the initial Health Insurance Portability and Accountability Act (HIPAA) and Privacy Act Security Training before being granted access to the network. The Contractor and subcontractor personnel shall then complete this training annually thereafter.

3.1.10 Science Officer Training Program (SOTP). All contractor employees shall be responsible for completing the SOTP within eight (8) weeks from their start date. Contractors shall successfully complete each of the training modules. Contractors are expected to score a minimum of 90% in each of their exams with two attempts to pass.

Training Course Title

SOTP basic – Science Officer Training Program course

CLM 003 Overview of Acquisition Ethics

ACQ101 Fundamentals of System Acquisition Management

Combat Trafficking in Persons (CTIP)

Anti-terrorism

Ethics

TARP (Threat Awareness and Reporting Program

CITI (Collaborative Institutional Training Initiative)

Active Shooter (optional)

*CDMRP or DHA may require additional training other than those listed above.

SECTION 4.0: PERFORMANCE OBJECTIVES

Key Task 1: Award Support (CLIN 0001)

Contractor will provide support for research funding programs as outlined below for annual appropriations:

4.1 Pre-Award Phase

4.1.1 Provide Award Technician (AT) support for research program(s) to support CDMRP managed research grants and cooperative agreements.

4.1.3 Support for prescreening all awards recommended for funding or selected as alternates for review and analysis of scientific overlap using current and pending support information in application package, peer review administrative notes, programmatic notes, and Query, View, Report (QVR) for the National Institutes of Health (NIH) funded awards. A report to the GOR and Program Manager will be prepared within 10 business days of award assignment.

4.1.3 Support for reviewing the GOR negotiation notes and GOR identified laboratory animals, cadavers, commercially available cell lines, human anatomical samples, or human subjects to be used in awards recommended for funding. Create a Gantt chart based on the award’s Statement of Work (SOW) and the GOR negotiation notes. Coordinate the documents needed with the Office of Human and Animal Research Oversight (OHARO). Report any deficiencies to the SO/GOR for action.

4.1.4 Extract Inclusion of Women and Minorities in Clinical Research policy-required documentation for all applicable awards in a PDF file format from the proposal and record whether an Inclusion Enrollment Report (IER) will be required. If an IER is required, track the number of women and/or minorities recruited throughout the award performance period.

4.2 Open Award Phase

4.2.1 Assist with coding awards using program, organizational, or other codes as required by CDMRP. All codes will be entered to EGS or compiled in program specific data sheets in accordance with the organizational or program deadlines.

4.2.2 Support for any consortium, academy, clinical trials, and/or multi-investigator awards with requirements for SO/GOR initiated kick off meetings, milestone meetings, including taking notes, tracking invitations for meetings and acceptances, scheduling meetings, assisting in creating documents for meetings, and analyzing outcomes or award performance. Create an after-action report from meetings and submit to the SO/GOR within two (2) business days.

4.2.3 Track progress of complex awards with respect to the SOW and Gantt charts, for awards that are classified as consortia, academies, and clinical trials, and report on any delays or issues with awards to the GOR/COR/SOTR monthly.

4.2.4 During award period of performance, conduct pre-screen of all technical progress reports within 10 business days of receipt for noncompliance with Research Performance Progress Report (RPPR) formatting and/or data omission that would be grounds for immediate report disapproval. Prepare quarterly summary report of RPPR compliance review activities.

4.2.5 During award period of performance, review progress reports annually for any new funding by the Principal Investigator (PI) and key personnel for scientific overlap and report to SO/GOR.

4.2.6 For clinical trials, monitor registration with www.clinicaltrials.gov. Record issued national clinical trial number (NCT#) in the EGS awards files. Review the CT.gov entries to ensure compliance with award sponsorship documentations as defined in the award terms and conditions and required data entries.

4.2.7 For studies using non-human primates (NHPs), track projected initiation dates for the associated tasks. Monitor communications regarding successful acquisition/challenges experienced by the funded investigators.

4.3 Post Award Phase

4.3.1 For awards approaching or past the end of the period of performance, coordinate with the SO/GOR to identify awards with no cost extensions (NCE). Identify any changes in SOW, budget, or personnel during the NCE. Track the number of NCEs per award and generate a report from EGS on the number of awards with NCEs per quarter.

4.3.2 For the final report, conduct a pre-screen of technical progress reports within 10 business days of receipt for noncompliance with RPPR formatting and/or data omission that would be grounds for immediate report disapproval. Prepare quarterly summary report of RPPR compliance review activities.

4.3.5 Coordinate with the SO/GOR and Program Manager to identify awards for post-award follow up activities.

4.3.6 Coordinate with the Program Evaluation IPT to prioritize awards for post-award follow-up and assist with review of post-award updates. Assist with entering approved updates into EGS.

4.3.7 Assist the Chief of Program Evaluation with planned triage process to facilitate updates provided by the program evaluation team with input from Program Managers and/or GOR/SOs.

4.3.8 As requested by the Program Manager, Program Evaluation IPT, or the Chief of Program Evaluation support external outreach for follow-up on outcomes and outputs during the post award phase. Collect data and submit reports quarterly. Reports should follow the guidance of the Program Manager, Program Evaluation IPT, or the Chief of Program Evaluation.

4.3.9 Review historically captured products and outcomes for data quality and integrity in consultation with the Program Manager, Program Evaluation IPT, or the Chief of Program Evaluation and update the EGS record as needed.

Key Task 2: Award Management (CLIN 0002)

4.4 Pre-Award Phase.

Contractor will provide support for research funding programs as outlined below for annual appropriations:

4.4.1 Serve as the Award Manager (AM) for assigned research program(s). Serve as Technical Liaison/AM to monitor 15-20% of all CDMRP managed research grants and cooperative agreements by providing subject matter expertise on extramural agreements (optional: and intramural agreements).

4.4.2 Complete and send notes to the U.S. Army Medical Research Acquisition Activity (USAMRAA) for awards balancing the application of scientific principles and exigencies of cost and other priorities within the timeline of eight (8) weeks from official assignment of applications (applications are assigned to AM and application package is available for negotiation in EGS). Complete 50% of award negotiations within four (4) weeks of application assignments, 75% of award negotiations within six (6) weeks of application assignments, and 100% of award negotiations within eight (8) weeks of application assignments. If USAMRAA’s acquisition cutoff date is less than eight (8) weeks within application assignments, complete all negotiation notes to USAMRAA within a truncated timeline. Inform the Program Manager, and GOR of any suspected or confirmed overlap, duplication of effort, or award withdrawals within two (2) business days of identification or notification. Follow the current organizational guidance on overlap assessment and reporting. Prepare a quarterly report summarizing progress on completion of notes to USAMRAA within specified timelines.

4.4.3 Complete and send negotiation notes to OHARO, as applicable per award. Assess and provide detailed information on the types of animals and estimated start date and information on human subject use to include cell lines used, human subjects participants, and/or cadaver use. All notes shall be sent to OHARO within 12 weeks of award assignment barring any contingencies such as overlap issues. Inform the GOR and Program Manager of any animal or human subject use issues that may delay award. Prepare a quarterly report summarizing progress on completion of notes to OHARO within specified timelines.

4.4.4 Record and track all award change request actions that could contribute to an award modification in the EGS Award Actions Module. Provide recommendations to GOR/COR/ Sponsors Office Technical Representative (SOTR). Update status of all completed actions within five (5) business days of resolution.

4.4.5 Document all requested changes in the SOW that will not require an award modification and capture the justification within an email or comment box in EGS.

4.4.6 Respond to all communications from DHA and USAMRDC partners such as USAMRAA and OHARO on award activities such as negotiations, modifications, progress, and issues within 5-7 business days; for all issues notify the GOR, Program Manager and/or Deputy Directors for Awards Management (DDsAM) within one (1) business day.

4.4.7 Coordinate with GOR, Program Managers, and relevant external entities to include other Federal and non-Federal funding agencies to adjudicate, document, and resolve funding and scientific overlap within the negotiation period, to facilitate reallocation of funds, when needed, to maximize the amount of funds invested in research.

4.5 Open Award Phase

4.5.1 Maintain up-to-date and complete electronic award files in the EGS. Acceptable award management files will be determined within a range published by the DDsAM.

4.5.2 Document all requested changes in the SOW that will not require an award modification and capture the justification within an email or comment box in EGS.

4.5.3 Monitor and track the Award Health status of all assigned awards using the EGS Award Health Module. As needed, record details to describe why changes in status have occurred and any major threats requiring attention and resolution/mitigation.

4.5.4 Utilize technical expertise to monitor the scientific and clinical work for all awards and to ensure they are adhering to the SOW. Recommend action to the GOR within two (2) business days of identifying any issues or concerns.

4.5.5 Actively participate in team efforts to produce, develop, and present case series presentations and research highlights for educational opportunities during meetings, as requested.

4.5.6 Actively participate in program(s) evaluation projects to assess the outputs and outcomes of awards within the managed portfolio. Report analyses to GOR and Program Manager(s) within the designated timelines of the program(s).

4.5.7 Facilitate communications between award recipient PIs and the OHRO and Animal Care and Use Review Office (ACURO). Facilitate initial and continuing reviews by the OHRO and ACURO. Notify DDsAM within 24 hours (preferably the same business day) of becoming aware of problems with any protocol (e.g., Unanticipated Problem Involving Risk to Subjects or Others [UPIRSTO], Serious Adverse Events, For Cause Holds and Audits). Coordinate with the GOR on the production of an Executive Summary (EXSUM) with OHARO or ACURO for delivery within 48 hours of reporting the incident to CDMRP leadership.

4.5.8 Respond to all communications from USAMRDC partners such as USAMRAA and OHARO on award activities such as negotiations, modifications, progress, and issues within seven (7) business days; for all award issues notify the Program Manager and/or DDsAM within one (1) business day.

4.5.9 Evaluate all monthly, quarterly, semi-annual, and annual progress reports as assigned within a completion rate of 95% or better before the established suspense dates (90 days for annual and final reports, 45 days for semi-annual reports, 30 days for quarterly reports and 7 days for monthly reports). Provide feedback on all reports to acknowledge the work done or to clarify why the report may be disapproved. Identify anticipated outcomes and outputs at the start of the award. Identify the produced significant research accomplishments, outputs and outcomes and enter into the award file, alert the GOR. Prepare a quarterly report summarizing technical progress report review activities within specified timelines. Report any potential overlap issues in accordance with organizational guidance.

4.5.10 Report to the GOR and document any changes to the SOW and/or budget that will require an award modification.

4.6 Post Award Phase

4.6.1 Evaluate final progress reports as assigned within a completion rate of 95% or better before the established suspense dates (90 days for final reports). Provide feedback on all reports to acknowledge the work done or to clarify why the report may be disapproved. Identify final outcomes and outputs at the start of the award. Report findings to GOR within five (5) business days of review. Prepare a quarterly report summarizing final technical progress report review activities within specified timelines.

4.6.2 Acknowledge communications from the CDMRP award close out team to include review of identified provisional patents or and/or patents. Evaluate if the identified provisional patent and/or patent is related to the award, and report to the GOR.

4.7 Key Task 3: Award Management Research Security Support (CLIN 003)

Contractor will provide support for research funding programs as outlined below for annual appropriations:

4.7 Pre-Award Phase

4.7.1 Serve as the Award Analyst to review award portfolios for undue foreign influence from foreign countries of concern (FCOC) as defined by the CHIPS and Science Act of 2022, Fiscal Year (FY) 2019, 2021, 2023, 2024 National Defense Authorization Acts, and the National Security Presidential Memorandum-33 and current organizational policies updated the Office of the Undersecretary of Defense, Research and Engineering.

4.7.2. Support prescreening all awards recommended for funding or selected as alternates to identify any foreign affiliations with foreign country of concern (FCOC) in updated biosketches or current and pending support documents of key personnel and in accordance with organizational guidance. Generate a report based on the organizational workbook for reporting to the GOR and CDMRP’s Research Integrity and Security Group (RISG). Complete all prescreening within 10 business days of assignment and send to the RISG inbox following organizational procedures for email formats.

4.7.3. If requested by the RISG, prepare an in-depth report using organizational analytical tools of those identified pre-screened awards with potential FCOC influence. Prepare the report within 5 days of request with a quad chart in the format acceptable by the organizational template. Inform the DDsAM for RISG and the Chair of the RISG through the secure MS Teams channel.

4.7.4. Monitor RISG inbox, track all workbook submissions and questions, and report to the RISG weekly following the organizational timelines and policy.

4.8 Open Award Phase

4.8.1 Utilize RPPR documents and updated biosketches, current and pending support documents to identify affiliations/associations with FCOC of the principal investigator, subawardee(s), contracting research organizations, collaborator(s), partnering PI(s), in-kind support, or other key personnel. Generate a report based on the organizational workbook for reporting to the GOR and CDMRP’s Research Integrity and Security Group (RISG). Complete within 5 business days of assignment and send to the RISG inbox following organizational procedures for email format (as identified by organization).

4.8.2. If requested by the RISG, prepare an in-depth report using organizational analytical tools of those identified pre-screened awards with potential FCOC influence. Prepare the report within 5 days of request with a quad chart in the format acceptable by the organizational template. Inform the DDsAM for RISG and the Chair of the RISG through the secure MS Teams channel.

4.8.3. Monitor RISG inbox, track all workbook submissions and questions, and report to the RISG weekly following the organizational timelines and policy.

4.9 Key Task 4: General Award Management Support (CLIN 0004)

4.9.1 Provide information to the GOR as requested for internal or external audits of award portfolio(s) before the suspense date.

4.9.2 Actively participate in all Awards Management meetings (except when on leave, temporary duty (TDY), or attending other high priority work meetings). Serve as AM meeting notetaker on a rotating basis.

4.9.3 Actively monitor and participate in communications on the Award Management Community Teams channel, the SOTP channel, or other relevant Teams channels to provide support and share information.

4.9.4 Provide timely responses within the suspense time to taskers or other program-related requests for information and data, as assigned.

4.9.5 Monitor and track study result submissions to clinicaltrials.gov for research meeting the definition of an Applicable Clinical Trial as defined in Section 801 of the Food and Drug Administration Amendments Act and 42 CFR 11.

SECTION 5.0: QUALITY ASSURANCE SURVEILLANCE PLAN (QASP):

5.1 The Government intends to utilize a Quality Assurance Surveillance Plan (QASP) to monitor the quality of the Contractor’s performance. The QASP will help to ensure that service levels reach and maintain the required levels throughout contract performance. Further, the QASP provides the COR with a proactive way to avoid unacceptable or deficient performance, and provides verifiable input for the required Past Performance Information Assessments. The QASP is a living document and may be updated by the Government as necessary. The COR will inspect the services performed by the Contractor by reviewing work products on a random sampling basis, evaluation of the monthly reports and by obtaining regular customer feedback.

5.2 The contractor shall contact the COR to set up quarterly evaluation meetings to discuss the status of the contract, deliverables, contract performance and results of the QASP evaluation. Prior to the meeting, the COR will coordinate schedules on behalf of the Government staff, and the contractor will provide a draft agenda to the COR (5) business days before the scheduled meeting.

SECTION 6.0: SECURITY REQUIREMENTS

6.1 Information Security

Establish appropriate administrative, technical, and physical safeguards to protect any and all Government data. Ensure the confidentiality, integrity, and availability of Government data in compliance with all applicable laws and regulations, including data breach reporting and response requirements, in accordance with DFAR Subpart 224.1 (Protection of Individual Privacy), which incorporates by reference DODD 5400.11. The contractor shall also comply with federal laws relating to freedom of information and records management.

6.1.1 Health Insurance Portability and Accountability Act (HIPAA) Comply with all requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) (Pub. L. 104-191), as implemented by the HIPAA Privacy and Security Rules codified at 45 C.F.R. Parts 160 and 164, and as further implemented within the Military Health System (MHS) by DOD 6025.18-R, “DOD Health Information Privacy Regulation,” January 24, 2003, and DOD 8580.02-R, “DOD Health Information Security Regulation, July 12, 2007. Comply with all applicable HIPAA-related rules and regulations as they are published and as further defined by later-occurring Government requirements and DOD guidance, including current and forthcoming DOD guidance implementing applicable HIPAA amendments under the American Recovery and Reinvestment Act of 2009 (ARRA). Any rules and regulations that are published, and/or requirements that are defined after the award date of this contract, and that require expenditure of additional Contractor resources for compliance, may be considered “changes” and will be subject to the “changes” clause under the contract.

6.1.2 Breach Response

DOD 5400.11-R, “DOD Privacy Program,” defines a breach as the “actual or possible loss of control, unauthorized disclosure, or unauthorized access of personal information where persons other than authorized users gain access or potential access to such information for other than authorized purposes where one or more individuals will be adversely affected.” Within one hour of discovery, the breach must be reported to the US Computer Emergency Readiness Team (US CERT) at https://forms.us-cert.gov/report/ and to the COR and CDMRP IA.

Adhere to the reporting and response requirements set forth in the Office of the Secretary of Defense (OSD) Memorandum 1504-07, “Safeguarding Against and Responding to the Breach of Personally Identifiable Information,”; DOD 5400.11-R, and applicable TMA Privacy Office guidance, including current and forthcoming DOD guidance on breach notification requirements, available at: https://www.health.mil/Military-Health-Topics/Privacy-and-Civil-Liberties/Breaches-of-PII-and-PHI.

6.1.3 Records Management

When creating and maintaining official Government records, comply with all federal requirements established by 44 United States Code (USC), 41 USC, 36 Code of Federal Regulations (CFR), Department of Defense (DOD) Administrative Instruction No. 15 (DOD AI-15), “Records Management, Administrative Procedures and Records Disposition Schedules,” and Chapter 2 of the TRICARE Operations Manual.

6.1.4 Freedom of Information Act (FOIA) Office

TRICARE Freedom of Information Act Service Center procedures require a written request under FOIA to be addressed to the Freedom of Information Officer, U.S. Army Medical Research Acquisition Activity (USAMRAA). The request shall describe the desired record as completely as possible to facilitate its retrieval from files and to reduce search fees which may be borne by the requestor. No more than ten working days shall elapse after a request has been received by the Freedom of Information Officer before notification is sent that the request has been granted or denied. The administrative time limit for responding to FOIA requests does not begin until the request is received by USAMRAA.

In response to requests received by contractors for the release of information, unclassified information, documents and forms which were previously provided to the public as part of routine services shall continue to be made available in accordance with previously established criteria. All other requests from the public for release of USAMRDC records and, specifically, all requests that reference the Freedom of Information Act shall be immediately forwarded to USAMRAA, ATTENTION: Freedom of Information Officer, for appropriate action. The contractor shall process requests by individuals for access to records about themselves under the Privacy Act procedures when those procedures are more advantageous to the requestor.

SECTION 7.0: DELIVERABLES

7.1 Delivery Address

All deliverables shall be submitted to the COR designated in the COR appointment letter. Additional distribution is included in the Deliverables Table (7.4).

7.2 Method of Delivery

Electronic copies shall be delivered using Microsoft Office suite of tools (for example, MS Word, MS Excel, MS PowerPoint) or in Adobe PDF format, unless otherwise specified by the COR. Electronic submission shall be made via email, unless otherwise agreed to by the COR.

7.3 Deliverables

7.3.1 Confidentiality Agreement (Deliverable 1)

The Contractor shall sign the CDMRP Confidentiality Agreement within (5) business days after contract award and ensure that all staff including all contractor and subcontractor personnel assigned to or performing under the contract execute, sign, and adhere to the terms of the Confidentiality Agreement. Assignment of key personnel who have not executed this agreement or failure to adhere to this agreement may constitute default on the part of the Contractor.

7.3.2 Monthly Task Status Report (Deliverable 2)

The Contractor shall submit a Monthly Report summarizing efforts.

7.3.3 Outgoing Transition Plan (Deliverable 3)

7.3.3.1 The Contractor shall provide an Outgoing Transition Plan for the 60-day period prior to contract end when work is being transitioned to a follow-on contract/order or Government entity. A draft Outgoing Transition Plan shall be submitted 90 calendar days prior to the end of the contract. The final plan shall be submitted 70 calendar days prior to the end of the contract. This transition may be to a Government entity, another Contractor, or to the existing Contractor under a new contract/order.

7.3.3.2 In accordance with the Government-approved plan, the Contractor shall assist the Government in planning and implementing a complete transition from this Contract and/or orders issued under this Contract to a successful provider. This shall include formal coordination with Government staff and successor staff and management. The transition plan may include tasks such as:

· Ensuring continuity of services

· Coordination with Government representatives

· Transition of historic data to new Contractor system including a list of current incumbent contractor personnel

· Transfer of any Contractor purchased Government owned assets (if applicable)

· Transfer of GFP and Government Furnished Information (GFI) inventory management assistance

· Coordination with the Government to account for Government keys, ID/access cards, and any security codes (if applicable)

7.3.4 Service Contract Reporting (formerly Contractor Manpower Reporting) (Deliverable 4) The Contractor shall complete Service Contract Reporting (Deliverable 4) by 31 Oct annually at SAM.gov website in accordance with DFARS 252.204-7023 Reporting Requirements for Contracted Services. Confirmation of completion shall be emailed to the COR, Contract Specialist, and Contracting Officer.

7.3.5 The Contractor shall provide a Quality Control Plan (QCP) that clearly identifies processes, procedures, and metrics which will likely result in successful outcomes within cost and schedule.

7.4 Deliverables Table

A summary of deliverables follows. Copies are to be provided to the Government officials indicated in electronic file.

DACA: Days after contract award NLT: No later than

CPARS POC- 10 calendar days after award Annually

SECTION 8.0 CONTRACTOR PERFORMANCE ASSESSMENT REPORTING SYSTEM (CPARS)

8.1 A CPARS assesses a contractor's performance and provides a record, both positive and negative, on a given contractor during a specific period of time. Each assessment is based on objective facts and supported by program and contract management data, such as cost performance reports, customer comments, quality reviews, technical interchange meetings, financial solvency assessments, construction/production management reviews, contractor operations reviews, functional performance evaluations, and earned contract incentives. Performance evaluations are transmitted into the Past Performance Information Retrieval System (PPIRS) which is used by Government agencies to assess contractor past performance for future acquisitions. The contractor shall appoint a Contractor Representative (CR) and provide this information to the Contracting Officer within 10 calendar days of award (Deliverable 7). The contractor POC shall have the authority to comment on the CPAR assessment on behalf of their company and within the timeframes established.

A CPARS assessment must be completed within 120 calendar days after the evaluation (Deliverable 7). Evaluations are sent to PPIRS within 14 calendar days after the Government Assessing Official (AO) has submitted the rating. If the CR has not concurred/non- concurred with the rating; PPIRS will show the Government evaluation as “Contractor Comment Pending Review”. The CR has a total of 60 calendar days to concur/non- concur with the assessment. After 60 days, the CR can either concur/non-cur. The CR has the authority to access the Government evaluation; review/comment/concur or non-concur with the assessment within 60 calendar days after notification of the Government’s assessment. The CR has the right to request a meeting (in writing) with the Government within 7 calendar days of notification of an assessment. Once the Government and the CR complete the evaluation; an automatic update will be sent to PPIRS and visible for Source Selection. If the CR fails to respond within 60 days, the assessment will be finalized. Training for CPARS can be found on the CPARS website: https://www.cpars.gov/index.htm.

To access CPARS, the contractor must have a Public Key Infrastructure (PKI). It is suggested an ECA certificate of Medium Assurance should be purchased. This should be a Department of Defense identity certificate, not an e-mail certificate.