W81XWH19R00980004.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83) Prescribed by GSA

FAR (48 CFR) 53.243

The purpose of this amendment is to clarify the 6 research areas in section 3.1.2 of the PWS and to update the period of performance.

1. CONTRACT ID CODE PAGE OF PAGES

S 1 18

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

16C. DATE SIGNED

BY 23-Oct-2019

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code) X W81XWH19R0098

X 9B. DATED (SEE ITEM 11)

19-Sep-2019

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer is extended, X is not extended.

Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:

(a) By completing Items 8 and 15, and returning copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN

REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE

CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

22-Oct-2019

CODE

USA MED RESEARCH ACQ ACTIVITY

820 CHANDLER ST

FORT DETRICK MD 21702-5014

W81XWH 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

W81XWH19R0098

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

DELIVERIES AND PERFORMANCE

The following Delivery Schedule item for CLIN 0001 has been changed from:

DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

POP 22-DEC-2019 TO

21-DEC-2020

N/A FORT DETRICK - CDMRP

FORT DETRICK - CDMRP

1120 FORT DETRICK

FREDERICK MD 21702

FOB: Destination

W91ZSQ

To:

DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

POP 01-APR-2020 TO

31-MAR-2021

N/A FORT DETRICK - CDMRP

FORT DETRICK - CDMRP

1120 FORT DETRICK

FREDERICK MD 21702

The following Delivery Schedule item for CLIN 0002 has been changed from:

CAGE

POP 22-DEC-2019 TO

21-DEC-2020

N/A FORT DETRICK - CDMRP

FORT DETRICK - CDMRP

1120 FORT DETRICK

FREDERICK MD 21702

CAGE

POP 01-APR-2020 TO

31-MAR-2021

N/A FORT DETRICK - CDMRP

FORT DETRICK - CDMRP

1120 FORT DETRICK

FREDERICK MD 21702

The following Delivery Schedule item for CLIN 0003 has been changed from:

CAGE

POP 22-DEC-2019 TO

21-SEP-2020

N/A FORT DETRICK - CDMRP

FORT DETRICK - CDMRP

1120 FORT DETRICK

FREDERICK MD 21702

CAGE

POP 01-APR-2020 TO

31-MAR-2021

N/A FORT DETRICK - CDMRP

FORT DETRICK - CDMRP

1120 FORT DETRICK

FREDERICK MD 21702

The following Delivery Schedule item for CLIN 1001 has been changed from:

CAGE

POP 22-DEC-2020 TO

21-DEC-2021

N/A FORT DETRICK - CDMRP

FORT DETRICK - CDMRP

1120 FORT DETRICK

FREDERICK MD 21702

CAGE

POP 01-APR-2021 TO

31-MAR-2022

N/A FORT DETRICK - CDMRP

FORT DETRICK - CDMRP

1120 FORT DETRICK

FREDERICK MD 21702

The following Delivery Schedule item for CLIN 1002 has been changed from:

CAGE

POP 22-DEC-2020 TO

21-DEC-2021

N/A FORT DETRICK - CDMRP

FORT DETRICK - CDMRP

1120 FORT DETRICK

FREDERICK MD 21702

CAGE

POP 01-APR-2021 TO

31-MAR-2022

N/A FORT DETRICK - CDMRP

FORT DETRICK - CDMRP

1120 FORT DETRICK

FREDERICK MD 21702

The following Delivery Schedule item for CLIN 1003 has been changed from:

CAGE

POP 22-DEC-2020 TO

21-DEC-2021

N/A FORT DETRICK - CDMRP

FORT DETRICK - CDMRP

1120 FORT DETRICK

FREDERICK MD 21702

CAGE

POP 01-APR-2021 TO

31-MAR-2022

N/A FORT DETRICK - CDMRP

FORT DETRICK - CDMRP

1120 FORT DETRICK

FREDERICK MD 21702

The following Delivery Schedule item for CLIN 2001 has been changed from:

CAGE

POP 22-DEC-2021 TO

21-DEC-2022

N/A FORT DETRICK - CDMRP

FORT DETRICK - CDMRP

1120 FORT DETRICK

FREDERICK MD 21702

CAGE

POP 01-APR-2022 TO

31-MAR-2023

N/A FORT DETRICK - CDMRP

FORT DETRICK - CDMRP

1120 FORT DETRICK

FREDERICK MD 21702

The following Delivery Schedule item for CLIN 2002 has been changed from:

CAGE

POP 22-DEC-2021 TO

21-DEC-2022

N/A FORT DETRICK - CDMRP

FORT DETRICK - CDMRP

1120 FORT DETRICK

FREDERICK MD 21702

CAGE

POP 01-APR-2022 TO

31-MAR-2023

N/A FORT DETRICK - CDMRP

FORT DETRICK - CDMRP

1120 FORT DETRICK

FREDERICK MD 21702

The following Delivery Schedule item for CLIN 2003 has been changed from:

CAGE

POP 22-DEC-2021 TO

21-DEC-2022

N/A FORT DETRICK - CDMRP

FORT DETRICK - CDMRP

1120 FORT DETRICK

FREDERICK MD 21702

POP 01-APR-2022 TO

31-MAR-2023

N/A FORT DETRICK - CDMRP

FORT DETRICK - CDMRP

1120 FORT DETRICK

FREDERICK MD 21702

The following Delivery Schedule item for CLIN 3001 has been changed from:

CAGE

POP 22-DEC-2022 TO

21-DEC-2023

N/A FORT DETRICK - CDMRP

FORT DETRICK - CDMRP

1120 FORT DETRICK

FREDERICK MD 21702

CAGE

POP 01-APR-2023 TO

31-MAR-2024

N/A FORT DETRICK - CDMRP

FORT DETRICK - CDMRP

1120 FORT DETRICK

FREDERICK MD 21702

The following Delivery Schedule item for CLIN 3002 has been changed from:

CAGE

POP 22-DEC-2022 TO

21-DEC-2023

N/A FORT DETRICK - CDMRP

FORT DETRICK - CDMRP

1120 FORT DETRICK

FREDERICK MD 21702

CAGE

POP 01-APR-2023 TO

31-MAR-2024

N/A FORT DETRICK - CDMRP

FORT DETRICK - CDMRP

1120 FORT DETRICK

FREDERICK MD 21702

The following Delivery Schedule item for CLIN 3003 has been changed from:

CAGE

POP 22-DEC-2022 TO

21-DEC-2023

N/A FORT DETRICK - CDMRP

FORT DETRICK - CDMRP

1120 FORT DETRICK

FREDERICK MD 21702

CAGE

POP 01-APR-2023 TO

31-MAR-2024

N/A FORT DETRICK - CDMRP

FORT DETRICK - CDMRP

1120 FORT DETRICK

FREDERICK MD 21702

The following Delivery Schedule item for CLIN 4001 has been changed from:

CAGE

POP 22-DEC-2023 TO

21-DEC-2024

N/A FORT DETRICK - CDMRP

FORT DETRICK - CDMRP

1120 FORT DETRICK

FREDERICK MD 21702

CAGE

POP 01-APR-2024 TO

31-MAR-2025

N/A FORT DETRICK - CDMRP

FORT DETRICK - CDMRP

1120 FORT DETRICK

FREDERICK MD 21702

The following Delivery Schedule item for CLIN 4002 has been changed from:

POP 22-DEC-2023 TO

22-DEC-2024

N/A FORT DETRICK - CDMRP

FORT DETRICK - CDMRP

1120 FORT DETRICK

FREDERICK MD 21702

CAGE

POP 01-APR-2024 TO

31-MAR-2025

N/A FORT DETRICK - CDMRP

FORT DETRICK - CDMRP

1120 FORT DETRICK

FREDERICK MD 21702

The following Delivery Schedule item for CLIN 4003 has been changed from:

CAGE

POP 22-DEC-2023 TO

21-DEC-2024

N/A FORT DETRICK - CDMRP

FORT DETRICK - CDMRP

1120 FORT DETRICK

FREDERICK MD 21702

CAGE

POP 01-APR-2024 TO

31-MAR-2025

N/A FORT DETRICK - CDMRP

FORT DETRICK - CDMRP

1120 FORT DETRICK

FREDERICK MD 21702

The following have been modified:

PERFORMANCE WORK STATEMENT

PERFORMANCE WORK STATEMENT

Senior Scientific Support Services

SECTION 1.0: GENERAL INFORMATION

1.1 Purpose

To award a contract for senior scientific support services in support of the US Army Medical Research and Development Command (USAMRDC) and its subordinate organizations.

To support the tasks identified below requires an experienced and cohesive team of senior level scientists who can demonstrate a comprehensive understanding of the requirements to produce acceptable deliverables within the required timelines while meeting cost, schedule, and performance requirements.

1.2 Background

The USAMRDC is a major subordinate Command of the United States Army Futures Command (AFC).The Commanding General (CG), USAMRDC, directs the management of a number of medical research, development and acquisition programs. Research includes breast, prostate, ovarian, kidney, and lung cancer, defense health, neurofibromatosis, tuberous sclerosis complex, autism, psychological health/traumatic brain injury, spinal cord injury research, bone marrow failure, multiple sclerosis, Alzheimer’s, Parkinson’s, medical simulation and information sciences, military infectious diseases, military operational medicine, combat casualty care, radiation health effects, and clinical and rehabilitative medicine. The USAMRDC is responsible for planning, coordinating, integrating, programming, budgeting and executing these programs. Reference Congressionally Directed Medical Research Programs (CDMRP) https://cdmrp.army.mil/ and USAMRDC https://www.detrick.army.mil/ websites.

1.3 Period of Performance

The anticipated period of performance of this contract is date of contract award for 12 months. 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). The Contract Specialist will notify the Contractor of the intent to exercise an option year 30 calendar days before the option is to be exercised.

1.4 Hours of Operation

USAMRDC operates on a Monday through Friday work schedule. Overtime is only permitted when pre-approved by the Contracting Officer. Overtime typically occurs during business travel. Core hours of operation are from 9:00 AM -3:00 PM with flexibility to adjust around that for daily schedules. Telework and alternate work schedules may be considered as approved in advanced by the Government COR.

1.5 Contract Kick-Off Meeting

The Contracting Officer will coordinate with the Contractor and the COR to set up a post-award conference with the COR and other designated staff, within 30 business days after the start date of the contract.

1.6 Contract Description

The government intends on awarding a commercial firm-fixed price requirements contract.

1.7 Travel

Travel may be required to perform tasks in Section 4.0 below. Travel costs shall be estimated as an Other Direct Cost. All travel costs shall be reimbursed in accordance with the Joint Travel Regulations.

1.8. Key Personnel

The names of key personnel will be identified (in the contract) at time of award. 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.

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 shall provide office space at the government site. The government shall also make available a personal computer, telephone, fax machine, copying and scanning machine, printer, and supplies necessary to perform the work on-site. If the employee is a teleworker, the government shall provide laptop and monitors.

Telephone, internet connectivity, and other equipment will not be provided and be the sole responsibility of the contractor’s employee.

2.3 Government-Furnished Services

The government shall 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 who are physically located at Fort Detrick, including contractors. All government mandated training shall be government furnished and shall be completed, during duty hours at contractor’s duty location, and in accordance with established timelines.

SECTION 3.0: CONTRACTOR REQUIREMENTS

3.1 Contractor Personnel Minimum Requirements

3.1.1 The contractor must have a signed letter of commitment from the proposed key personel employees in response to this solicitation and must be available to begin work at the CDMRP at Fort Detrick, MD.

3.1.2 It is anticipated that Ph.D. and Masters-level scientists at multiple levels (labor categories) of subject matter expertise based on scientific grants management and post-graduate biomedical research experience will be proposed by the contractor to support this effort. The six major research portfolio areas to be supported with subject matter expertise are:

1. Autoimmune and Genetic Disorders;

2. Cancer;

3. Cardiovascular and Respiratory Health;

4. Infectious Diseases;

5. Neurological and Psychological Health; and

6. Tissue, Organ, and Orthopedic Injuries and Restorative/Rehabilitative Medicine.

Previous experience managing awards for DoD medical program areas using DoD electronic grants systems will be a major consideration.

3.1.3 All contractor personnel proposed on this contract shall be designated as ADP III at a minimum as defined by Department of Defense Regulation 5200.2R (for reference, review http://www.dtic.mil/whs/directives/corres/pdf/52002r_0187/p52002r.pdf). 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 National Agency Clearance and Inquiries (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.

3.1.4 All contractor employees, including sub-contractor employees, requiring access to Army installations, facilities or controlled access areas shall complete AT Level I training within (30) calendar days after contract start date. Training will be completed annually after initial training is completed. The contractor shall submit certificates of completion for each affected contractor employee and sub-contractor employee to the COR and CDMRP Training

Officer within five (5) calendar days after completion of training by all employees and sub-contracting personnel.

AT Level I awareness training is available at https://jkodirect.jten.mil/Atlas2/page/login/Login.jsf

3.1.5 The contractor and all associated sub-contractor employees 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 to be accomplished by the Command Security Office. The contractor workforce must comply with all personnel identity verification requirements as directed by DoD, HQDA, and local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

3.1.6 All contractor employees with access to a government information system must be registered in the Army Training Certification Tracking System (ATCTS) at commencement of services and must successfully complete the Cyber Awareness Challenge training prior to access to the information system and then annually thereafter.

CDMRP will register contractor employees and will be responsible for tracking and uploading all training certificates into ATCTS.

3.1.7 All contractor employees must complete Level I Operations Security (OPSEC) training within 30 calendar days of their reporting for duty. All contractor employees must complete annual OPSEC awareness training thereafter.

3.1.8 All contractor employees shall have initial and annual HIPAA/PII training. The requirement for reviewing, signing, and providing a copy of the USAMRDC Acceptable Use Policy must be provided to the CDMRP Security Officer prior to being granted access to any .mil network resources.

3.1.9 Additional general and recurring training required:

Training Course Title

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 may require additional training other than those listed above. All government training shall be government furnished and shall be completed during duty hours, and in accordance with established timelines.

SECTION 4.0: PERFORMANCE OBJECTIVES

The CDMRP requests contractor support personnel with a range of scientific experience to support the research programs and award management needs within the organization. CDMRP’s portfolio consists of a wide range 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. 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 at the time of delivery order award.

The CDMRP anticipates the level of effort shall be forty (40) Science Officers. Six (6) senior-level Science Officers will be considered Key Personnel

All contractor employees shall be responsible for performing the following tasks:

4.1 Provide full-cycle award management support as a member of an Integrated Program Team (IPT) and as requested by the Program Manager. Such support may include: identifying notable accomplishments from the funded awards and preparing/reviewing materials for research highlights; communicating award management issues as well as award successes to the IPT; supporting tasker responses and data calls; supporting award outcome and product analyses; and reviewing program announcements and other program materials for consistency with CDMRP award management processes and best-practices.

4.2 Upon assignment of a new award that has been recommended for funding, identify missing documentation required to complete award negotiations. Documents can include but are not limited to: animal and human use regulatory documents; previous, current, and pending support (PCPS); statement of work (SOW); budget justification; Lay and Technical Abstracts. Verify that the Principal Investigator (PI) is eligible for the award according to the Program Announcement/Funding Opportunity.

4.3 Identify instances of existing or potential funding duplications with other federal agencies and/or private organizations using financial support documents provided by the PI/institution and publically available research award databases. Review the level of effort (LOE) for concurrent awards and identify instances of over-commitment. Document instances of funding overlap or over-commitment in the award file and coordinate discussion with the United States Army Medical Research Acquisition Activity (RAA), the PI, and the other funding entity(ies) to determine possible solutions that remove the redundant support. Identify any potential intragovernmental funding components in the project.

4.4. Determine whether the PI needs to address any major concerns identified in the summary statement during peer review or issues raised by the Programmatic Panel during programmatic review. Facilitate communications among the PI, RAA, ORP, and the program funding office regarding issues that may arise during pre-award negotiations.

4.5 For awards newly recommended for funding, determine if the project will be using laboratory animals, cadavers, commercially available cell lines, human anatomical samples, or human subjects. Coordinate with the Office of Research Protections (ORP) to provide regulatory guidelines and requirements to the appropriate PIs whose research requires approval of human and/or animal use, as well as approvals by US Food and Drug Administration (FDA) or other regulatory agency.

4.6 In the Electronic Grant System (EGS), complete the negotiation page including the Surety and Environment (SE) checklist, Office of Research Protections (ORP) checklists, and the Negotiation Notes to RAA sections by the established organizational timelines.

4.7 Communicate to RAA the frequency of reporting that should be required based on the Program Announcement/Funding Opportunity and/or the complexity of the specific research project. Request that the appropriate clause is inserted in the assistance agreement or contract. Provide feedback to the contract specialist as to whether reviewer concerns have been addressed and revised budgets are appropriate.

4.8 Identify which research awards (i.e., clinical trials) require specific project milestones, such as subject accrual to clinical trials. Assist RAA in establishing specific milestones that should be tied to funding, such as for human research protocol approval. Monitor progress of the award and coordinate with RAA to make the appropriate award modification when an established milestone has been achieved.

4.9 Review the Scientific Classification System, Common Scientific Outline, and Physiology portfolio codes and ensure the appropriate codes are assigned to the award. If the project includes a clinical trial, identify what type of clinical trial is being done. Identify anticipated products, as required. Capture other portfolio codes such as disparity research or program-specific codes as appropriate.

4.10 Determine whether a kick-off meeting is appropriate on a by-award basis. Coordinate with PIs to hold kick-off meetings as appropriate and in coordination with RAA and ORP.

4.11 Review all post-award documents from the PI after they are submitted to the eBRAP system and are automatically transferred into EGS. If the regulatory or other documents are not correct, notify the PI and request a corrected document. Key correspondences related to the award must be saved to the EGS award file.

4.12 Review annual and final technical progress reports within 90 calendar days and 120 calendar days respectively of receipt by CDMRP. Verify that the SOW is being followed and all regulatory approvals are in place.

Document research progress in terms of tasks outlined in the SOW. Notify the contract specialist if the PI has significantly deviated from the approved SOW. Notify ORP and PM if work has been reported that does not have regulatory approval. Capture key research accomplishments and findings that have resulted from completion of tasks in the SOW. Review the publications reported by the PI or identified through program research for acknowledgement of MRDC funding and alignment with award SOW. Provide comments that will be returned to the PI, especially if a revised report is required. Evaluate key personnel to ensure no new or undisclosed awards are a cause for scientific overlap or level of effort over commitment concerns.

As required review quarterly reports within 30 days of receipt by CDMRP, and/or review monthly reports within 15 days of receipt by CDMRP. Document research progress in terms of tasks outlined in the SOW. Record and note issues and successes of the project. For all projects, be alert to potential issues and communicate concerns to the PM or other appropriate individuals in a timely manner.

4.13 During review of award/contract deliverables or upon receipt of other information relevant to the awards/contracts, continually identify reportable outcomes, key research accomplishments, potential patentable products and inventions, and publications. Maintain an up-to-date record of these in EGS, and communicate significant outcomes to the Program Manager and others as relevant. Where applicable, annotate the award file with the Technology Readiness Level (TRL) or Knowledge Readiness Level (KRL) of the project.

4.14 For awards that require quad/award charts, verify that the study approach aims and approaches, timeline chart, goals and milestones, and representative data are correct and current. Coordinate with the PI for revisions if needed.

4.15 Monitor awards supporting clinical trials or clinical studies for issues with human subject recruitment, enrollment, accrual and retention, serious adverse events (SAEs), Unanticipated Problems Involving Risks to Subjects and Others (UPIRTSO) and Clinical Holds, significant personnel changes, intervention availability and intellectual property concerns. Update the clinical trials section of EGS and communicate issues through the proper CDMRP chain of command including the PM, Deputy Director of Grants Management (DDGM), Deputy Director, Director, and others as appropriate. Notify the assigned HRPO Human Subject Protection Scientist (HSPS) of any changes or events associated with an open protocol.

4.16 Provide recommendations to the Grants Officer’s Representative (GOR) and RAA regarding changes to the assistance agreement during the performance period to include changes in PI, transfer to a new institution, no-cost extensions, budget revisions and changes to the SOW. Review the relevant funding opportunity to verify that the change is allowed and coordinate with the GOR and Program Manager to determine program options. Document all modification requests and approval/disapproval recommendations in the Award Action tool of EGS.

4.17 Review and provide a recommendation to the GOR and RAA if review of invoices is required.

4.18 Maintain a thorough and up to date EGS file to include key communications and relevant award documents, ensuring completeness in the event of an audit or a program need to respond to taskers.

4.19 Organize site visits or local meetings for project planning or progress evaluation. Ensure attendance of the appropriate individuals from CDMRP leadership, ORP, RAA and other USAMRDC personnel as appropriate. If necessary (as specified in the program announcement), act as the primary point of contact to organize an External Advisory Board or Government Steering Committee for consortia or other multi-team awards.

4.20 Provide briefings regarding the research portfolio or individual awards to CDMRP, USAMRDC and DoD leadership as needed. Briefings may include quad/award charts that summarize the status of the research project(s) and award summaries in support program meetings. Project risks, mitigation strategies, or potential for future support may also be presented.

4.21 At award closeout, review any intellectual property generated by the award, note in the EGS award file.

Assist the closeout branch at RAA with patent and invention reports. Review the reports and capture products that may have been outcomes of the project. Note the final TRL/KRL of the products of the award. Provide support to the IPT in following up and assessing subsequent publications or products that were outcomes of the award.

4.22 Regularly attend Grants Management meetings to remain current on the latest policy, processes, and procedures. On a voluntary basis chair Grants Management meetings in support of the Deputy Director of Grants Management.

4.23 Participate in working groups, such as Program Evaluation Steering Committee, SBIR/STTR Working Group, Science Officer Training Program, and Clinical Awards Working Group, and ad hoc working groups as they arise. Participate in the Internal Review Process, assisting in the evaluation of perceived factual or procedural errors that occurred in the process of proposal review.

4.24 Attend peer review, programmatic review, other program-related meetings and scientific conferences as requested by PM and approved by CDMRP leadership.

4.25 Provide scientific writing support and review of program materials, as requested, including highlights, program book content, CDMRP annual report content, press releases, and other print and electronic products.

SECTION 5.0: SECURITY REQUIREMENTS

5.1 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 DoD 5400.11, “DoD Privacy Program,” May 8, 2007, and DoD 5400.11-R, “DoD Privacy Program,” May 14, 2007. The contractor shall also comply with federal laws relating to freedom of information and records management.

5.1.1 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.

5.1.2 Breach Response

DoD 5400.11-R, “DoD Privacy Program,” May 14, 2007, 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 TMA Privacy Office at PrivacyOfficerMail@tma.osd.mil as well as the USAMRMC Information Assurance and CDMRP Information Assurance and Security Office..

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,” June 5, 2009; DoD 5400.11-R, and applicable TMA Privacy Office guidance, including current and forthcoming DoD guidance on ARRA breach notification requirements, available at:

http://www.tricare.mil/tmaprivacy/breach.cfm.

5.1.3 Privacy Act and HIPAA Training

Ensure that all staff including subcontractors and consultants comply with the training requirements of the Privacy Act of 1974 (5 U.S.C. 552a) and Health Insurance Portability and Accountability Act of 1996 (HIPAA) (Pub. L.

104-191). The training requirements are mandated by OSD Memorandum 15041-07, “Safeguarding Against and Responding to the Breach of Personally Identifiable Information;” DoD 6025.18-R, “DoD Health Information Privacy Regulation,” January 24, 2003; and the TMA Workforce Training Policy Memorandum, dated May 28, 2008, on the subject, “Workforce Training Policy Pursuant to the Department of Defense Privacy Act Regulations and the Department of Defense Health Insurance Portability and Accountability Act Privacy and Security Regulations.”

Ensure that the annual Privacy Act and HIPAA training is completed by all staff assigned to or performing on this task order contract, including subcontractors and consultants. All required Privacy Act and HIPAA training will be conducted online through Military Health System Learn (MHS Learn) at https://mhslearn.csd.disa.mil to meet the above requirements. Ensure all employees and subcontractors supply a certificate of Privacy Act and HIPAA training completion to the Contracting Officer Representative (COR) within 30 days of being assigned to task order contract and on an annual basis based on the trainee’s birth month thereafter.

5.1.4 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.

5.1.5 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, 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 6.0: CONTRACTOR MANPOWER REPORTING (CMR)

The contractor shall report ALL contractor labor hours (including subcontractor labor) required for performance of services provided under this contract for the Congressionally Directed Medical Research Program via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address: www.ecmra.mil . Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year.

The four Service components user accounts and system data were merged and transferred to the new consolidated Enterprise Contractor Manpower Reporting Application (ECMRA) effective 1 October 2017 at www.ecmra.mil .

Contractors may direct questions to the new ECMRA Support Desk at dod.ecmra.support.desk@mail.mil or obtain detailed instructions from the CMR Contractor Manpower Reporting User Guide available on the new ECMRA website www.ecmra.mil.

The Order Data tab on the CMRA Contractor Data Entry website asks for the “Requiring Activity Unit Identification Code” (UIC). This is the UIC of the USAMRDC or other USAMRAA Supported activity or organization (such as DHS), the Requiring Activity that would be performing the mission if not for the contractor.

This is not necessarily the Contracting Office, Contracting Administrative Office, or Funding Source. The UIC is not the same as the Department of Defense Activity Address Code (DODAAC).

The UIC of the Requiring Activity for this contract is W03JAA.

SECTION 7.0: CONTRACTOR PERFORMANCE ASSESSMENT REPORTING SYSTEM (CPARS)

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 (KO) within 10 calendar days of award.

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. 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.

SECTION 8.0: QUALITY ASSURANCE SURVEILLANCE PLAN (QASP):

8.1 The COR shall inspect the services performed by the contractor by reviewing work products on a random sampling basis and by obtaining regular customer feedback.

8.2 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 meeting, the CDMRP contract manager will coordinate schedules for government staff (Contract Officer, Contract Specialist, COR and CDMRP personnel) to receive input for the evaluation of the performance of the contractor.

Quality Assurance Surveillance Plan Scientific Services in Support of Research Management Division

The following Performance Based Service Acquisition items are identified within the contract performance work statement to be monitored under this Quality Assurance Surveillance Plan.

Surveillance Activity Checklist (To be performed quarterly)

Contract Number:

Date:

Contract Requirement

Contract Paragraph Number

Method of

Surveillance

Surveillance Frequency

Date

Accomplished

Compliance?

Have all contract employees completed AT Level I training within 30 days of receiving security access upon employment and on an annual basis?

3.1.4

COR will inspect 100% of training certificates

Surveillance to coincide 30 days after contract award (or 30 days after a new employee starts after contract award) and annually thereafter

Have the contractor employees followed installation or facility access procedures?

3.1.4

COR will coordinate with

CDMRP Security Officer

Surveillance to coincide with quarterly meetings

Have the contractor employees completed initial Level I OPSEC training within 30 days of receiving security access upon employment?

3.1.7

100% of the training certificates

Surveillance to occur upon submission of training certificates

Have all contractor employees completed annual Level I OPSEC training?

3.1.7

100% of annual training

Surveillance to occur on an annual basis and in coordination with CDMRP training officer

Have contract employees completed the Notes to RAA section in the EGS according to organizational timelines?

4.6 Random Quarterly

Is the ORP checklist completed and submitted for all applicable grant applications?

4.6 Random Quarterly

Have the contract employees reviewed technical progress reports within the specific required timelines: 90 days for annual, 120 days for final, 30 for quarterly, and 15 for monthly reports?

4.12 Random Quarterly

Have contract employees identified and documented in EGS:

progress in line with the Statement of Work,

4.13 Random Quarterly

including award issues/problems;

reportable outcomes; key research accomplishments;

potential products & inventions; and publications?

Have contract employees updated EGS with clinical trial information including progress and milestones?

4.15 Random Quarterly

Have contract employees maintained a thorough and up-to-date EGS file?

4.18 Random Quarterly

Have the contract employees provided support for program materials as requested?

4.25 Random Quarterly

(End of Summary of Changes)