W81XWH-21-R-0074 AMENDMENT 0001.pdf

PDF 448 KB Posted Aug 13, 2021

Attached to: DEVELOPMENT OF NOVEL MONOCLONAL ANTIBODIES AND LONGITUDINAL STUDY OF IMMUNE RESPONSES USING SERUM AND PERIPHERAL BLOOD MONONUCLEAR CELLS (PBMC’s) OF INFECTIOUS DISEASE SURVIVORS
Solicitation number: W81XWH-21-R-0074
Issued by: Department of the Army Medical Command

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Written by GovTribe AI · Dec 28, 2023

This is a solicitation for the development of novel monoclonal antibodies and a longitudinal study of immune responses using serum and peripheral blood mononuclear cells from survivors of infectious diseases. The solicitation requires identifying cohorts of survivors of Crimean-Congo hemorrhagic fever virus and Old World hantaviruses in Georgia, Lassa virus in Sierra Leone, and Yersinia pestis in Madagascar to perform whole blood collection and follow-up collections every six months. Additional requirements include assisting with blood processing and analysis, shipping blood products to laboratories within fourteen days, and providing evidence of existing infrastructure and protocols to allow for immediate collections. The primary agency is the Department of the Army Medical Command.

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Other files

File	Type	Posted
W81XWH-21-R-0074 CONFORMED COPY THROUGH AMENDMENT 0001.pdf	PDF	Aug 13, 2021
Solicitation Attachment 3 - Non-Disclosure Agreement.pdf	PDF	Aug 13, 2021
Solicitation Attachment 2 - Past Performance Questionnaire.pdf	PDF	Aug 13, 2021
Solicitation Attachment 1 - OCI.pdf	PDF	Aug 13, 2021
Solicitation Attachment 2 - Past Performance Questionnaire.pdf	PDF	Jul 27, 2021
Solicitation Attachment 1 - NDA and OCI.pdf	PDF	Jul 27, 2021
W81XWH-21-R-0074.pdf	PDF	Jul 27, 2021

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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:

1. Provide Answ ers to Questions.

2. Add the Organizational Conflict of Interest and the Non-Disclosure Statements as attachments to this Solicitation separately in accordance w ith new policy regulations.

3. Correct the CLIN Description's to show the proper location for each Blood Collection Site, and, update the Performance Work Statement as a result of questions asked by Offerors to this Solicitation.

4. All Other Terms and Conditions of this Amendment Remain Unchanged.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 34

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

16C. DATE SIGNED

BY 13-Aug-2021

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 W81XWH21R0074

X 9B. DATED (SEE ITEM 11)

26-Jul-2021

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

13-Aug-2021

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:

W81XWH21R0074

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION A - SOLICITATION/CONTRACT FORM

The following have been added by full text:

SOLICITATION AMENDMENT #0001

THE FOLLOWING ARE ANSWERS TO QUESTIONS ASKED UNDER

SOLICITATION #W81XWH-21-R-0074:

QUESTION #1 – It is noted that in the CLIN section, the following sections mistakenly refer to the Republic of Georgia rather than Sierra Leone and Madagascar. The affected sections are in CLINS 002, 003, 1002, 1003, 2002, 2003, 3002, 3003, 4002, and 4003. We assume it is alright to make this change in our proposal. Is this correct?

ANSWER #1 – Yes. This is Correct. Each CLIN has been updated accordingly. The Solicitation has been updated to reflect this change.

QUESTION #2 – Section 1.4.4. “Assist USAMRIID and/or host country personnel in blood processing and analysis as needed.” Could the Government provide more specificity on the type of blood processing and analysis that may be needed?

ANSWER #2 – Isolation of serum from whole blood by centrifugations. Isolation of PBMCs from whole blood by centrifugation over ficol. Cell counting for plating into intracellular cytokine staining assays. Freezing of remaining lymphocytes for shipment to USARMIID. The PWS has been updated to reflect this change.

QUESTION #3 – Section 2.8.1.2. “Each trip will require Three (3) Contractor Personnel for blood sample collection, processing and shipping, as well as flow cytometry experiments in country.”

Flow cytometry experiments are not referenced in Section 3. Is the Contractor expected to provide personnel who have flow cytometry experience? Is the Contractor expected to provide flow cytometers and necessary supplies to conduct experiments? Will flow cytometry experiments be limited to assessment of the specified PBMC major subpopulations (i.e., percentage of B and T cells) or will additional subpopulations be assessed? If the latter, how many markers should be assessed?

ANSWER #3 – The contractor is expected to provide personnel that have a basic understanding of flow cytometry.

If flow cytometers are not available in country, USAMRIID will provide portable flow cytometers to complete.

Preferable, the host lab will have flow cytometry options, but it is not required. The experiments will be intracellular cytokine staining with established panels for sub populations of B and T cells. 8-12 color flow cytometry is typical. The PWS has been updated to reflect this change.

QUESTION #4 – Section 3.1.1. “The contractor shall provide all necessary services and supplies in the development…The contractor shall . . . .” There seems to be a missing phrase. What development activities are contemplated in the project?

ANSWER #4 – Section 3.1.1. is revised as follows,” The contractor shall provide all necessary services and supplies in the development of monoclonal antibody therapeutics, evaluation of the humoral and cellular immune responses in humans to Crimean Congo Hemorrhagic Fever Virus (CCHFV), Old World Hantaviruses, Lassa Virus (LASV), and Yersinia Pestis and examining specific memory immunity and its persistence over time.” The PWS has been updated to reflect this change.

QUESTION #5 – Section 3.1.1.1. “. . . PBMCs must be isolated and stored at -80ºC within 12 hours of collection.”

Also, 3.1.1.3. “The Contractor shall assist USAMRIID and/or host country personnel in blood processing and analysis as needed.” Minimum requirements for blood processing to obtain PMBC would include equipment and supplies for the separation process and counting/assessment of viability of PBMC. Quality Assurance for PBMC preparation should include assessment of pre- and post-freezing cell viability. Is the Contractor expected to provide equipment and supplies to support these activities, or is support for post-collection PBMC processing activities limited to provision of personnel?

ANSWER #5 – Yes the contractor is expected to provide all of the equipment and supplies to support these activities. It is NOT limited to personnel. The equipment and lab space required to complete processing, assessment, and storage of PBMC samples is essential. The PWS has been updated to reflect this change.

QUESTION #6 – The Past Performance Questionnaire (Attachment #2) says “To be completed by a Government POC.” Can Non-Government Contract Representatives from Non-Governmental Organizations (NGO’s) or from Prime Contractors (Non-Profits or Commercial Entities) submit Past Performance Questionnaires for Contracts on which the Offeror performs work similar to this solicitation’s requirements?

ANSWER #6 – A Government Point of Contact is preferred; however, individuals, as long as they are “customers” from Non-Governmental Organizations can fill out and submit the Past Performance Questionnaire. A Prime Contractor to which you were a Sub is not able to fill out the Questionnaire as that would be a Conflict of Interest.

SECTION B - SUPPLIES OR SERVICES AND PRICES

CLIN 0002

The CLIN extended description has changed from:

Lassa Mammarenavirus (LASV)Both B and T cell responses will be tracked over time to develop a picture of the protective immune response in humans. **Up to TWO (2) Blood Collections are planned for the Republic of Georgia; however, only ONE (1) Trip may be necessary. Therefore, a price estimate PER TRIP is being requested.

***This CLIN will be a Firm-Fixed-Price Not-To-Exceed (FFP NTE) CLIN as only ONE TRIP may be utilized during this period.

To:

however, only ONE (1) Trip may be necessary. Therefore, a price estimate PER TRIP is being requested. ***This CLIN will be a Firm-Fixed-Price Not-To-Exceed (FFP NTE) CLIN as only ONE TRIP may be utilized during this period.

CLIN 0003

Yersinia Pestis (Y.Pestis)Both B and T cell responses will be tracked over time to develop a picture of the protective immune response in humans. **Up to TWO (2) Blood Collections are planned for the Madagascar; however, only ONE (1) Trip may be necessary. Therefore, a price estimate PER TRIP is being requested. ***This CLIN will be a Firm-Fixed-Price Not-To-Exceed (FFP NTE) CLIN as only ONE TRIP may be utilized during this period.

CLIN 0004

Other Direct Costs (ODCs) - The Contractor may be required to incur ODCs during contract performance in accordance with the Performance Work Statement (PWS).Other Directs Costs, if including travel, shall be in accordance with the Joint Travel Regulations (JTR) as derived from the U.S.C. Title 5 statutes, General Service Administration's (GSA) Federal Travel Regulation (FTR), and the Department of State's Standardized Regulations.

NOTE: The requirements in DFARS 252.211-7003, Item Identification and Valuation, are applicable for this line item. The contractor shall provide DoD unique identification or a DoD recognized unique identification equivalent..

CLIN 1002

***This CLIN will be a Firm-Fixed-Price Not-To-Exceed (FFP NTE) CLIN as only ONE TRIP may be utilized

CLIN 1003

CLIN 1004

CLIN 2002

***This CLIN will be a Firm-Fixed-Price Not-To-Exceed (FFP NTE) CLIN as only ONE TRIP may be utilized

CLIN 2003

CLIN 2004

CLIN 3002

***This CLIN will be a Firm-Fixed-Price Not-To-Exceed (FFP NTE) CLIN as only ONE TRIP may be utilized

CLIN 3003

CLIN 3004

Administration's (GSA) Federal Travel Regulation (FTR), and the Department of State's Standardized Regulations.

CLIN 4002

***This CLIN will be a Firm-Fixed-Price Not-To-Exceed (FFP NTE) CLIN as only ONE TRIP may be utilized

CLIN 4003

CLIN 4004

The following have been deleted:

PERFORMANCE WORK STATEMENT

QASP

SECTION C - DESCRIPTIONS AND SPECIFICATIONS

The following have been added by full text:

PERFORMANCE WORK STATEMENT

PERFORMANCE WORK STATEMENT (PWS)

FOR

DEVELOPMENT OF NOVEL MONOCLONAL ANTIBODIES AND LONGITUDINAL STUDY OF

IMMUNE RESPONSES USING SERUM AND PERIPHERAL BLOOD MONONUCLEAR CELLS

(PBMC’s) OF INFECTIOUS DISEASE SURVIVORS

FOR

UNITED STATES ARMY MEDICAL RESEARCH INSTITUTE OF INFECTIOUS DISEASES

(USAMRIID)

SECTION 1 PURPOSE

1.1. INTRODUCTION

1.1.1. Since 1969, the U.S. Army Medical Research Institute of Infectious Disease (USAMRIID) has served as the Department of Defense's (DoD) lead laboratory for medical biological defense research.

While its core mission is to protect the warfighter from biological threats, USAMRIID also investigates disease outbreaks and threats to public health. Research conducted at USAMRIID leads to medical solutions - therapeutics, vaccines, diagnostics, and information that benefit both military personnel and civilians. USAMRIID is a subordinate laboratory of the U.S. Army Medical Research and Materiel Command (USAMRMC) at Fort Detrick, located in Frederick, MD.

1.2. MISSION

1.2.1. The mission of USAMRIID is to provide leading edge medical capabilities to deter and defend against current and emerging biological threat agents. Specifically, the Viral Immunology Branch seeks to understand the relationship between human immunity and viral diseases, and use that knowledge to develop medical countermeasures to protect the Warfighter.

1.3. BACKGROUND

1.3.1. The purpose of this contract is for the collection and shipping of whole blood and blood products to support the following tasks: development of monoclonal antibody therapeutics, evaluation of the humoral and cellular immune responses in humans to Crimean Congo Hemorrhagic Fever Virus (CCHFV), Old World Hantaviruses, Lassa Mammarenavirus (LASV), and Yersinia Pestis and examining specific memory immunity and its persistence over time.

1.3.2. Contractor shall provide all personnel, materials, equipment, tools, transportation, supervision and other items necessary to identify and engage survivors of CCHFV and Old World Hantavirus outbreaks in Georgia, LASV in Sierra Leone, and Y. Pestis outbreaks in Madagascar. Subcontracting to local contractors with greater familiarity and expertise in the collection locales is encouraged.

1.4. SCOPE

1.4.1. The primary objective of this requirement is to identify and engage survivors of CCHFV and Old World Hantaviruses, LASV and Y. Pestis in Georgia, Sierra Leone and Madagascar respectively. Both B and T cell responses will be tracked over time to develop a picture of the protective immune response in humans. This study will involve collaboration with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID).

1.4.2 Identify a cohort of survivors of CCHFV and Old World Hantaviruses (Georgia), LASV (Sierra Leone) and Y.

Pestis (Madagascar) and perform whole blood collection. Blood samples will be delivered to the in-country host laboratory expeditiously following each collection. Peripheral Blood Mononuclear Cells (PBMC’s) must be isolated and stored at -80ºC within Twelve (12) Hours of collection.

1.4.3. Every six (±2) months, perform follow-up collection of survivor’s sera and lymphocyte samples (whole blood), as in 1.4.1. Travel schedules will require coordination with USMARIID personnel.

1.4.4. Assist USAMRIID and/or host country personnel in blood processing and analysis as needed. This will include, but, is not limited to: Isolation of serum from whole blood by centrifugations, Isolation of PBMCs from whole blood by centrifugation over ficol, Cell counting for plating into intracellular cytokine staining assays, and, Freezing of remaining lymphocytes for shipment to USARMIID.

1.4.5. Ship blood products to laboratories at USAMRIID, or to collaborators, as needed. Shipments must occur within Fourteen (14) days of collections.

1.4.6 Contractor must provide evidence of pre-existing infrastructure within the countries identified to allow collections to occur immediately upon award of the contract.

1.4.7 Contractor must provide evidence of having an active human use protocol in countries to allow collections from survivors.

1.5. ORGANIZATIONAL CONFLICT OF INTEREST (OCI) & NON-DISCLOSURE

STATEMENT (NDS)

1.5.1. Organization Conflict of Interest and Non-Disclosure Statement, (Deliverable #1). This Contract will be used to procure U.S. Army Medical Research and Development Command (USAMRDC) OCI Category Two (2) – Program and/or Administrative Support, which falls within the scope of the PWS.

The contractor shall provide an OCI certification with their proposal. In additions, the contractor shall ensure that all contractor personnel are advised of nondisclosure policies as well as restrictions from communicating official business to media outlets. The contractor shall provide signed non-disclosure statements from each personnel assigned, prior to performing any services.

SECTION 2 GENERAL REQUIREMENT

2.1. PERFORMANCE

2.1.1. Place of Performance.

2.1.1.1. Place of Performance will be GEORGIA (In-Country), SIERRA LEONE (In-Country), MADAGASCAR (In-Country) and the United States Army Medical Research Institute of Infectious Diseases (USAMRIID). Travel between these locations may be required.

2.1.2. Period of Performance. This contract is for one (1) Twelve (12) Month Base Period, and Four (4), Twelve

(12) Month Option Periods. The periods of performance for this contract are as follows:

DESCRIPTION PERIOD OF PERFORMANCE

Base Year 15 September 2021 – 14 September 2022 Option Year 1 15 September 2022 – 14 September 2023 Option Year 2 15 September 2023 – 14 September 2024 Option Year 3 15 September 2024 – 14 September 2025 Option Year 4 15 September 2025 – 14 September 2026

2.1.2.1. See Section 3 of the PWS for additional information regarding the deliverables and how they tie in with the Period of Performance.

2.2. NON-PERSONAL SERVICES

2.2.1. This PWS identifies services that are strictly non-personal in nature, as defined by Federal Acquisition Regulation (FAR) Part 37, Service Contracting. To ensure there is no appearance of any personal services, the Government shall neither supervise contractor personnel nor control the method by which the contractor performs the required tasks. Under no circumstances shall the Government assign tasks or prepare work schedules for individual contractor personnel. It shall be the responsibility of the contractor to manage its personnel and to guard against any actions that give the perception of personal services. If the contractor believes that any actions constitute, or are perceived to constitute personal services, it shall be the Contractor’s responsibility to notify the Contractor Officer (KO) immediately.

2.2.2. Contract personnel performing services under this contract shall be controlled, directed and supervised by contract management personnel only. The contractor’s management shall ensure that personnel properly comply with the performance standards outlined in the Quality Assurance Surveillance Plan (QASP). Contractor personnel will perform independent of and without the supervision of any Government official. Actions of contractor personnel may not be interpreted or implemented in any manner that results in any contractor personnel creating or modifying Federal policy, obligating the appropriated funds of the U.S. Government, overseeing the work of Federal personnel, providing direct personal services to any Federal personnel or otherwise violating the prohibitions set forth in FAR 7.5 entitled, “Inherently Government Functions” as well as in FAR 37.1, entitled, “Service Contracting.”

The Government will control access to the facility and will perform the inspection and acceptance of the completed work.

2.3. CONTRACT MANAGEMENT

2.3.1. Government Management. The Contracting Officer’s Representative (COR) for this contract will be appointed by the Contracting Officer (KO). The COR will serve as the primary point of contact for all activities and issues that occur under this contract. In the event that the COR is not available, a secondary Point of Contact (POC) identified by the COR will assume the COR’s responsibilities.

2.3.2. Contractor Management. The contractor shall designate a single Program Manager (PM) to be the contractor’s authorized point of contact (POC) with the COR. The PM will be responsible for formulating and enforcing performance standards, assigning contractor schedules, reviewing performance quality, communicating policies, purposes, and goals to subordinates. This will include coordination with the KO, Contract Specialist and the COR to resolve any issues that may arise, trends relating to the contract, or proposed changes or modifications to the contract. The PM shall demonstrate capability in the overall management of complex tasks, and strong team building skills. The name of the PM and an alternate (who shall act for the Contractor when the manager is absent) shall be designated in writing to the KO. The Manager or alternate shall have full authority to act for the Contractor on all contract matters relating to daily operation of this contract. The Manager or alternate shall be available (in-person or virtually) as required.

2.3.2.1. The contractor shall establish clear organizational lines of authority and responsibility to ensure effective management of the resources assigned to the requirement. The contractor shall ensure that all contractor personnel are advised of their chain of command and who they should contact if they have questions.

2.3.2.2. Contract Management Plan (CMP) (Deliverable #2). The Contractor shall develop and provide a Contract Management Plan (CMP) with their proposal. The CMP shall include a detailed staffing plan which includes a listing of personnel utilizing a job description to describe the position that will be required to meet the objectives of the Performance Work Statement (PWS).

2.3.3. Quality Control Plan (QCP) (Deliverable #3). The Contractor shall provide a DRAFT QCP with their proposal and a FINAL QCP no later than Fifteen (15) days after contract award. The Contractor shall prepare and adhere to a QCP describing how the Contractor intends to manage the contracts to achieve the established standards as set forth in the PWS Summary Matrix and the Contractor’s QCP.

2.3.4. Subcontract Management. The Contractor shall be responsible for the management and performance of Subcontractors during this contract. Contractors may add Subcontractors to their team after notification and approval from the Procuring Contracting Officer (PCO) and COR. Cross Teaming shall be permitted.

2.3.5. Requirement to Fill Vacant Positions. The contractor shall fill vacant positions within Forty-Five (45) business days. If contractor positions are vacant for more Forty-Five (45) days, the Contracting Officer (KO) shall immediately be notified in writing.

2.3.6. Key Personnel. There are no Key Personnel for this project. The Contractor is expected to assign personnel for this requirement with a strong background in this work.

2.4. REPORTS

2.4.1. Reports and documents delivered by the contractor in the performance of this contract shall be considered Technical Data as defined in the applicable FAR clause 52.227-14, Rights in Data. All documentation shall reflect the latest version of the work product or activity, unless specifically directed otherwise by the Government. All documentation shall be prepared in accordance with (IAW) standard industry practices, ensuring electronically produced documents which reflect logical flow of material, tables of contents indexes and page numbering. Where applicable, the contractor’s attention is called to the availability of commercial, industry, federal, and military guides, instructions, and standards for many of the topics addressed in this PWS and under this contract.

2.4.2. Post Award Conference – Including Quality Control Reporting (Deliverable #4). The Contractor shall attend a post award conference (kick-off meeting) in coordination with the Government within Five (5) business days after contract award. The Contractor shall meet with the Government to present an overview of their approach and establish schedules, procedures, and points of contact necessary to conduct the tasks outlined herein. The meeting may be held via teleconference or in-person at a Government facility, as determined by the Government. The meeting should be coordinated and led by the Contractor Program Manager with additional Contractor employees in attendance as needed. The Contractor shall ensure that meeting materials are provided to Government participants Two (2) business days prior to the meeting.

2.4.3. Monthly Status Reports (Deliverable #5). The contractor shall provide monthly reports detailing all work completed within Seven (7) calendar days after each end of month. The report shall include, but not limited to a detailed list of all data deliveries completed during the previous month, all documentation scheduled for delivery during the next Two (2) months, those items which required Government approval during the previous month, and whether approval has been given or is still pending, a list of documentation which was due and not delivered, and the status of delinquent data deliveries to include impact statements for each delinquency. It shall be submitted with a transmittal letter that highlight major events in the reporting period. The report shall also include details outlining the expenditures and billings to date, projected expenditures and billings, progress, status, inventories, and any problems/issues encountered as applicable. The format for the report shall be agreed upon by the Government and Contractor.

2.4.4. Quarterly Reports (Deliverable #6). The Contractor shall submit a quarterly report summarizing the work performed and completed throughout the quarter. The Contractor shall provide a copy of the quarterly report to the Contract Specialist, Contracting Officer, and COR no later than fifteen (15) calendar days from the end date of each quarter. Quarters run on a calendar basis (March, June, September, and December).

2.4.5. Final Report (Deliverable #7). The Contractor shall provide a Final Report to the KO and COR. The Contractor shall prepare the Final Report that shall include, but not be limited to. The results of the work performed and completed throughout the life of the contract and list of deliverables provided by the Contractor as part of the requirement.

2.5. PERSONNEL TRAINING REQUIREMENTS

2.5.1. Completion of All Training Requirements (Deliverable #8). The contractor shall track and complete all initial and refresher trainings to maintain training compliance and readiness status. The contractor shall submit certificates of completion for each contractor and subcontractor personnel working under this contract to the COR within five

(5) calendar days after completion of training.

2.5.1.1. Anti-Terrorism (AT) Level 1. All contractor employees, including subcontractor employees, requiring access to Army installations, facilities, or 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 applies. The contractor shall submit certificates of completion for each affected contractor employee and subcontractor employee to the COR (or to the contracting officer, if a COR is not assigned) with 5 calendar days after completion of training by all employees and subcontractor personnel. AT Level I awareness training is available at https://atlevel1.dtic.mil.

2.5.1.2. Health Insurance Portability and Accountability Act (HIPAA) and Privacy Act Security Training.

Contractor shall complete this required non-residential course annually, available on-line at https://jkodirect.jten.mil.

It takes approximately two-hours to complete.

2.5.1.3. Sexual Harassment/Assault Reponses and Prevention (SHARP) Contractor Training. This paragraph is added to incorporate reporting and training requirements and to reference the Office of the Surgeon General (OTSG)/Medical Command (MEDCOM) Policy Memo 16-033, dated 29 March 2016 as an attachment to the contract, Sexual Harassment Assault Response Prevention (SHARP) AKO ALMS instructions. This training is in accordance with USAMRAA Policy 17-01, SHARP FINAL DATED 19OCT2016 with attachments, and is applicable to all on-site contractors and contractor personnel supporting all Services type Contracts over the Simplified Acquisition Threshold (SAT), that are awarded by USAMRAA, and who are performing those services on-site in a Government facility or work space, leased or owned. Training may be obtained online for contractor personnel with an Army Knowledge On-line (AKO) account or it can be taken in person. If the personnel has an AKO account, they can access training online at Army AKO https://www.us.army.mil/.

2.5.1.3.1. In addition, All contractor personnel shall comply with OTSG/MEDCOM Policy Memo 16-033, Sexual Harassment/Assault Response and Prevention (SHARP) Program which states that All allegations of sexual harassment and sexual assault shall be immediately addressed, no matter where they occur or who are involved. This includes all personnel working in Government facilities in support of contracts awarded by United States Army Medical Research Acquisition Activity (USAMRAA). Department of Defense and Department of the Army (DoDDA) civilian complaints of sexual harassment or sexual assault will be investigated and processed in accordance with the Equal Employment Opportunity (EEO) Program and AR 690-600. Contract personnel with knowledge of an incident of sexual harassment or assault will immediately report the incident to their employer and their employer will immediately report the incident to the Government’s Contracting Officer Representative (COR) or Contracting Officer.

2.6. DUTY HOURS

2.6.1. Contractor personnel shall perform services during regular duty hours; Monday through Friday. For purposes of when the Contractor has to schedule training and maintenance, the core hours of operation for USAMRIID are 7:30 – 4:30pm pm; however, times may be changed with little to no notice.

2.6.2. The contractor shall not perform services on days designated as a Federal Holiday by Federal Status, Executive Order, Presidential Proclamation, or from the Installation Commander.

2.6.3. Federal holidays are an exception to the regular duty hours. Any of the holidays listed below falling on a Saturday will be observed on the preceding Friday; holidays falling on a Sunday will be observed on the following Monday. The following is a list of legal federal holidays that services shall not be performed:

2.6.3.1. New Year’s Day, 1 January

2.6.3.2. Martin Luther King’s Birthday, 3rd Monday in January

2.6.3.3. President’s Day, 3rd Monday in February

2.6.3.4. Memorial Day, last Monday in May

2.6.3.5. Juneteenth, 19 June

2.6.3.6. Independence Day, 4 July

2.6.3.7. Labor Day, 1st Monday in September

2.6.3.8. Columbus Day, 2nd Monday in October

2.6.3.9. Veteran’s Day, 11 November

2.6.3.10. Thanksgiving Day, 4th Thursday in November

2.6.3.11. Christmas Day, 25 December

2.6.4. Contractor Personnel shall not perform services or report to work on days the Government or installation is closed due to local determinations relating to safety conditions, inclement weather conditions, national emergencies, or energy conservation. During these periods of closure, the contractor personnel who are not designated as essential personnel shall not report for work nor shall they be compensated for those days.

2.7. TRAVEL / TEMPORARY DUTY (TDY).

https://www.us.army.mil/

2.7.1. The COR is the CONUS travel order approval authority as designated in writing by the KO. Travel to other Government facilities or other Contractor facilities may be required and will be specified in the PWS. All CONUS travel requirements (including plans, agenda, itinerary, or dates) shall be pre-approved by the COR and is on a strictly cost reimbursable basis. The Contractor shall be authorized travel expenses consistent with the substantive provisions of the JTR and the limitation of funds specified in this contract. Costs for travel shall be billed in accordance with the regulatory implementation of Public Law 99-234 and FAR 31.205-46 Travel Costs, subject to local policy and procedures.

2.7.1.1. Travel Arrangements. Arrangements for and costs of all travel, transportation, meals, lodging, and incidentals are the responsibility of the Contractor. The Contractor shall remain current on applicable regulations, policies, and procedures that may impact processes for travel and modify their processes accordingly. No later than 30 calendar days prior to scheduled CONUS travel date, the Contractor will prepare the estimate in an official memorandum format. The estimate shall include airline ticket costs, car rental, per diem, registration fees and any other allowable costs associated with the travel request. All travel and transportation shall utilize commercial sources and carriers provided the method used for the appropriate geographical area that results in reasonable charges to the government. The Government will not pay for economy plus, business class or first-class travel. The COR will provide the Contractor a signed approval of Government Contractor Official Travel Letter of Identification before the Contractor is authorized to travel CONUS.

2.7.1.2. Travel Claim Procedures, Approval, and Reimbursement. Travel to be performed issued under this contract shall be reimbursed after the KO has determined fair and reasonable cost reimbursement IAW the JTR and FAR Part 31.205-46. The Contractor shall submit an estimate for travel to the COR no later than Thirty (30) calendar days prior to the first day of travel; in order for the Contractor to obtain economical travel arrangement and cost.

A. References:

i. Federal Travel Regulations, prescribed by the General Services Administration, for travel in the contiguous United States

ii. Joint Travel Regulation, Volume2, DoD Civilian Personnel, Appendix A

iii. Standardized Regulations (Government Civilians, Foreign Areas), Section 925 “Maximum Travel Per Diem Allowances for Foreign Areas.”

2.7.1.2.1. The COR will verify the travel receipts are valid and match the travel requirements identified in the PWS.

The Contractor shall provide a trip report to include costs associated with the travel to the COR within Ten (10) calendar days after the completion of travel trip. All travel costs shall be billed within 30 days after travel is complete unless an approval for later billing is approved by COR or KO. All travel cost reimbursement requests must detail all authorized expenses associated with the travel and all receipts including ticket stubs (booked airline, hotel receipts, etc.) shall be provided to substantiate claims for costs of all expense items in excess of $75.00.

2.8. OTHER DIRECT COSTS (ODC’S)

2.8.1. Other Direct Costs (ODC’s). ODCs shall be billed on a Firm-Fixed-Price Not-To-Exceed (FFP NTE) basis, and, shall be in accordance with the Federal Acquisition Regulation (FAR) 31.205-46, Travel Costs. The Contractor is expected to familiarize themselves with this regulation as this is the basis for the reimbursement of travel costs.

2.8.1.1. The Contractor shall plan for up to Six (6) International trips a year (A possibility of Two (2) trips per location, per year), with each trip lasting approximately Fourteen (14) days at a time. Contractor Employees shall arrange travel from their Contractor Location directly to any of the following Three (3) locations: The Republic of Georgia, Sierra Leone or Madagascar.

2.8.1.2. Each trip will require Three (3) Contractor Personnel for blood sample collection, processing and shipping, as well as flow cytometry experiments in country. The contractor is expected to provide personnel that have a basic understanding of flow cytometry. If flow cytometers are not available in country, USAMRIID will provide portable flow cytometers to complete. Preferable, the host lab will have flow cytometry options, but it is not required. The experiments will be intracellular cytokine staining with established panels for sub populations of B and T cells. 8-12 color flow cytometry is typical.

2.8.1.3. Each trip will require supplies for collections, processing, storage and shipment of samples to USARMIID.

All costs associated with the shipment of product to USAMRIID should also be included in cost estimates.

SECTION 3 PERFORMANCE REQUIREMENTS

3.1. TECHNICAL REQUIREMENTS

3.1.1. The contractor shall provide all necessary services and supplies in the development of monoclonal antibody therapeutics, evaluation of the humoral and cellular immune responses in humans to Crimean Congo Hemorrhagic Fever Virus (CCHFV), Old World Hantaviruses, Lassa Virus (LASV), and Yersinia Pestis and examining specific memory immunity and its persistence over time.

3.1.1.1. The Contractor shall identify a cohort of survivors of CCHFV and Old World Hantaviruses (Georgia), LASV (Sierra Leone) and Y. Pestis (Madagascar) and perform whole blood collection. Blood samples will be delivered to the in-country host laboratory expeditiously following each collection. PBMCs must be isolated and stored at -80ºC within Twelve (12) hours of collection.

3.1.1.2. The Contractor shall perform follow-up collection of survivor’s sera and lymphocyte samples (whole blood), as in 3.1.1. Travel schedules will require coordination with USMARIID personnel.

3.1.1.3. The Contractor shall assist USAMRIID and/or host country personnel in blood processing and analysis as needed. Requirements for blood processing to obtain PMBC would include, but, are not limited to: equipment and supplies for the separation process and counting/assessment of viability of PBMC. Quality Assurance for PBMC preparation should include, but, is not limited to: the assessment of pre- and post-freezing cell viability. The Contractor should provide all of the equipment and supplies to support these activities. The equipment and lab space required to complete the processing, assessment, and storage of PBMC Samples is essential.

3.1.1.4. The Contractor shall ship blood products to laboratories at USAMRIID, or to collaborators, as needed.

Shipments must occur within 14 days of collections.

3.1.2. The Contractor must provide evidence of pre-existing infrastructure within the countries identified to allow collections to occur immediately upon award of the contract.

3.1.3. The Contractor must provide evidence of having an active human use protocol in countries to allow collections from survivors.

3.2. PERFORMANCE REQUIREMENT SUMMARY MATRIX

PERFORMANCE

REQUIREMENT

PWS

PARAGRAPH

REFERENCE

PERFORMANCE STANDARD

ACCEPTABLE

QUALITY

LEVEL (AQL)

SURVEILLANCE

METHOD

3.3. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP).

3.3.1. Every DoD contract awarded for services in excess of $2,500.00 shall contain a Quality Assurance Surveillance Plan (QASP) as discussed in the FAR 46, Government Contract Quality Assurance.

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File details come from the government source that posted it. Updated Aug 13, 2021.