A07-W81XWH-16-R-0019-0001.docx

W81XWH-16-R-0019

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION C - DESCRIPTIONS AND SPECIFICATIONS

The following have been added by full text:

QUESTIONS AND ANSWERS

Questions and Responses to W81XWH-16-R-0019 Research and Laboratory Services Support to The Lugar Center, Republic of Georgia and Azerbaijan

1. Question:

Do contractors currently working at the Lugar Center have access to information that may provide an unfair competitive advantage when responding to this solicitation, and if so how will this be addressed during evaluation?

1. Government Response:

This requirement has changed significantly from the current requirement; therefore, no contractor was identified as being an incumbent contractor.

Insofar as avoiding, neutralizing, or mitigating any unfair competitive advantage or organizational conflict of interest, the Government previously identified an individual who is likely to be proposed to fill a key personnel position. The contractor and subcontractor for whom this individual is employed, as well as the individual, were all notified that the individual CANNOT assist any prospective offeror with proposal preparation.

The notice continues to state the Government may eliminate from competition any offeror who is found to have employed this individual in preparing their proposal.

2. Question:

Reference: A07-W81XWH-16-R-0019, Section L - Instructions, Conditions and Notices to Bidders, pg 106, point #4, “Question Submission Requirements” states: “…submit questions no later than Thursday 16 June 2016 at 12:00 PM Eastern Standard Time…”

Will the Government allow for another round of questions at a later date? As solutions and pricing are developed, questions often arise mid-way through the proposal cycle and an additional round of questions would make the proposals more succinct.

2. Government Response:

A second round of questions will not occur.

3. Question:

Reference: A07-W81XWH-16-R-0019, Section L - Instructions, Conditions and Notices to Bidders, pg. 106, point #5, “Proposal Due Date” states: “Monday 11 July 2016.”

This is a complex proposal in a difficult OCONUS location. Will the Government extend the due date by 2 weeks to Monday 25 July 2016?

3. Government Response:

The proposal has been extended until Thursday 14 July at 12:00pm ET in Amendment 1.

4. Question:

References:

1. “A07-Attachment__17_Sample_Task_Order_1_Performance_Work_Statement”, Page 1, Section 1.0, 1st sentence in last paragraph, “The initial Task Order may potentially include a base period of nine (6) months and four (4) 12-months option periods.”

2. “A07-Attachment__17_Sample_Task_Order_1_Performance_Work_Statement”, Page 20, Section 14.0, 2nd Header in table. “Base period Option 3 months through 9 months after date of award.”

3. “A07-Attachment__18_Sample_Task_Order_2_Performance_Work_Statement”, Page 1, Section 1.0, 1st sentence in last paragraph. “The initial Task Order may potentially include a base period of nine (6) months and four (4) 12-months option periods.”

4. “A07-Attachment__18_Sample_Task_Order_2_Performance_Work_Statement”, Page 12, Section 14.0, 2nd Header in table. “Base period Option 3 months through 9 months after date of award.”

The solicitation identifies the Base Period as a 6-Month Duration, however a few references to a 9-month duration remain. The estimated LOE tables for the Base Period of each Sample Task Order reflect 9-Months of hours. Can the government clarify which Base Period duration applies?

4. Government Response:

The Base period is six months. All attachments have been updated to reflect six months in Amendment 1.

5. Question:

References:

1. “A07-Attachment__17_Sample_Task_Order_1_Performance_Work_Statement.docx”, Page 13, Section 9.1, 1st paragraph, “It is anticipated travel will not exceed $100,000 per period.”

2. “A07-Attachment__17_Sample_Task_Order_1_Performance_Work_Statement.docx”, Page 12, Section 9.0, 1st paragraph, “It is estimated non-travel ODCs will not exceed $99,000 per year.”

3. ”A07-Attachment_9_Pricing_Table.xlsx”, Task Order 1 tab, cells B32:D37, “CLIN X003 shall utilize the plug amount of $210,000.00 plus, proposed DBA insurance costs, plus any indirect application, if needed.”

Attachment 17 provides a non-travel NTE amount of $99K and a travel NTE amount of $100K, which is a total of $199K not to exceed. The pricing template ODC plug number is $210K which exceeds the stated amounts in Attachment 17. Can the government provide clarification regarding the Sample task order NTE travel and non-travel ODC amounts?

5. Government Response:

Attachment 9 Pricing Table, has been corrected to reflect a pricing plug amount of $199,000.00 for travel and non travel ODCs in Amendment 1.

6. Question:

Reference: ”A07-Attachment_9_Pricing_Table.xlsx” Lists five (5) interpreter LCATs.

Please clarify that these interpreters are interpreting from the stated language into English.

6. Government Response:

See Labor Category and Description Attachment 10 sent with initial Solicitation.

7. Question:

Reference: A07-W81XWH-16-R-0019, 11.4. Key Personnel While the RFP discusses the replacement procedures for Key Personnel, there is no specific requirement for Key Personnel to exist at the IDIQ level. Is there a requirement for Key Personnel at the IDIQ level and, if so, what are those requirements?

7. Government Response:

Key Personnel will be identified at the task order level.

8. Question:

Reference: A07-Attachment___17_Sample_Task_Order_1_Performance_Work_Statement, 6.6.3. Organic Transportation Services (Optional Task): “The Contractor shall provide a driver for these tasks….”

There are no allowances in the Task Order CLIN structure for optional tasks. Does the Government want optional tasks priced out and, if so, where?

8. Government Response:

The Government will be removing 6.6.3 from the Sample Task Order 1 Performance Work Statement in Amendment 1. Optional tasks listed on the base IDIQ not identified in the samples task orders shall not be priced out, however labor category pricing is to be provided. The optional task for transition out on the task orders is provided in the pricing table CLIN structure and is to be priced out.

9. Question:

Reference: A07-Attachment___17_Sample_Task_Order_1_Performance_Work_Statement, 9. CONTRACTOR PAYMENT PROCESSING states, “The Contractor shall provide payment to study site research assistants (such as physicians, nurses, phlebotomists, lab techs, etc.) as needed to facilitate conduct of approved efforts in host nation facilities (non-USAMRD-G).” But the table below the verbiage states, “Studysite Assistants Stipend” as “N/A.”

How many Studysite Assistants Stipends will the Contractor be required to pay?

9. Government Response:

Payment of study site research assistants as stipulated will be on an as needed basis based upon study protocol and funding level. Previously, protocols have typically needed 2-4 people per clinical site. Currently USAMRD-G is supporting ~12 sites. Estimates based on current study support indicate 30-35 site assistants being required in a year with a total estimated value not to exceed $8,000.00. These assistants will be compensated in accordance with the approved clinical protocol. The estimated $8,000.00 in stipends has already been incorporated into the Government’s estimate of $99,000.00 for non-travel ODCs.

10. Question:

Reference: A07-W81XWH-16-R-0019, Section 6.5.4. VOLUME III – Past Performance.

The RFP references a Past Performance Questionnaire that should have accompanied the RFP package. However, the template was not included in the package. Please forward the Questionnaire.

10. Government Response:

This has been added as Attachment # 19 Past Performance Evaluation Questionnaire Form in Amendment 1.

11. Question:

The sample task labor category tables indicate 2080 hours per FTE but the PWS indicates both US federal and Georgian holidays will be observed. Is the estimated hours per FTE accurate, suggesting more than 8 hours of work per day?

11. Government Response:

Employees are not expected to work more than an 8 hour work day. The Government has revised the estimated hours in the sample task orders’ suggested support section in Amendment 1. US Holidays will only be observed in the Republic of Georgia.

Estimated FTE in Georgia will be 1888 not including Personal Time Off.

Estimated FTE in Azerbaijan will be 1920 not including Personal Time Off.

12. Question:

Is there a list of current and/or future laboratory equipment and layouts which can be used to inform the Logistics Support Plan?

12. Government Response:

The Government is providing a list of current equipment under Attachment 20 Medical Equipment and Maintence Schedule in Amendment 1. This is not a list of GFE. The only GFE will be personal computing devices.

13. Question:

Given the complex nature of the support requested, will the government give a two month extension to the proposal deliver date?

13. Government Response:

The proposal has been extended until Thursday 14 July at 12:00pm ET in Amendment 1.

14. Question:

Will the contractor staff operate at BSL-3?

14. Government Response:

Contractor staff will not operate at BSL-3.

15. Question:

What organisms or agents will the contractor staff work with?

15. Government Response:

The contractor will work with many infectious agents at BSL-2 and below.

16a. Question:

Will the contractor staff work with Especially Dangerous Pathogens or US DoD designated Biological Select Agents and Toxins (BSATs)?

If so, and given that DoD 5210.88 and 5210.89 are designated as applicable to this effort, has the government developed a process to allow contractor personnel, including Georgian Nationals, authority to do the work?

16a. Government Response:

Contractor personnel will not work with known or presumptive BSAT.

16b. Question:

Will the government share that process at this time?

16b. Government Response:

Contractor personnel will not work with known or presumptive BSAT.

17. Question:

Will the government provide potential bidders reasonable access to the facility and its operation to gather information for the Transition Plan and other deliverables requested with the proposal?

17. Government Response:

A site vist will not be held. A DRAFT Transition In Plan for Sample Task 1 will be required with proposal and the final acceptance has been updated in the deliverables table in Amendment 1.

18. Question:

For in-country contractor personnel requiring a Common Access Card (CAC) what is the government process for obtaining the CAC in country?

18. Government Response:

The individual requiring a CAC would be required to take all authorizing documentation to a Rapids station anywhere globally to be issued a CAC.

18a. Question:

Does that process apply to Georgian nationals or other non-US citizens?

18a. Government Response:

This process applies to all personnel.

18b. Question:

What positions/labor categories on Sample Task Order 1 would require a CAC (if it were a real Task Order)?

18b. Government Response:

The IT Support services described in para 6.7 will require CAC issuance.

18c. Question:

We assume the position on Sample Task Order 2 would require a CAC (if it were real), due to the nature of the work. Is this correct?

18c. Government Response:

The work in Sample Task 2 would require a CAC.

18d. Question:

Is there an incumbent contractor performing the equivalent of the work in Sample Task Order 2 currently?

18d. Government Response:

This requirement has changed significantly from the current requirement; therefore, no contractor was identified as being an incumbent contractor. However, there is an individual performing similar work to that outlined in Sample Task Order 2.

18d(i). Question:

If yes, does this individual have a CAC?

18d(i). Government Response:

Yes.

18d(ii). Question:

Does this individual currently have access to Government systems such as GFEBS as described in the Task Order?

18d(ii). Government Response:

Yes.

19. Question:

For those contractor personnel not requiring a CAC, what are the vetting and identification process required in order to work at the facility in Georgia?

19. Government Response:

As a tenant in a host nation facility, there is a documented Visitor Access Process for access to the Lugar to include employment verification. Policies, procedures and modifications on those processes are within the rights and purview of the host nation. All personnel also must submit to metal detector and x-ray screening as a part of daily physical security measures.

20. Question:

Does the government provide in-country access for required DoD training such as AT Awareness, iWatch, etc. that are mandated as part of the contract?

20. Government Response:

Yes.

21. Question:

The RFP defines two types of potential OCI categories: Global and Isolated, and says the category will be established with each Task Order. Sample Task Orders 1 and 2 are listed as OCI category Local. Is this the same as Isolated?

21. Government Response:

Yes. The government revised the language included in the sample task orders in Amendment 1.

22. Question:

Paragraph 6.8.3 of the base award states the contractor is responsible for providing vaccinations if a licensed vaccine is available. Does that mean licensed in the US, in Georgia or in any jurisdiction?

22. Government Response:

Personnel must be vaccinated with those vaccines licensed in the US.

23. Question:

The current Implementing Agreement lists the Defense Threat Reduction Agency as the US Executive Agent. Will the contract staff be required to interact with DTRA directly, or only through USAMRD-G channels?

23. Government Response:

DTRA is an “Implementing Agent” as cited in Article I paragraph 2b of the JTA. Article 3 paragraph 2d references the US Army as “Executive Agent.” No contractor staff will interact directly with DTRA.

24. Question:

What is the current inventory of GFE the Government expects to furnish to the Contractor and in what location(s) is it?

24. Government Response:

The only GFE will be personal computing devices. GFE has not been specifically identified as these are sample task orders.

24a. Question:

In particular, will the government provide the descriptions of items requiring the services of the Biomedical Equipment Technician, the Facilities Technician and Facilities Manager labor categories, so that the requirements and pricing for these categories can be developed?

24a. Government Response:

A list of equipment requiring Biomedical maintenance support is incoporated as Attachment 20 in Amendment 1. This equipment will not be issued as GFE.

24b. Question:

How many equipment items require annual certification and or validation, and what are those items of equipment?

24b. Government Response:

No GFE items will require annual certification or validation. A maintenance schedulefor the laboratory equipment is provided in Attachment 20 in Amendment1.

25. Question:

The government provided a list of Georgian and US holidays, and a separate Azerbaijani list of holidays. Are we to assume the US holidays will also be observed during any work in Azerbaijan?

25. Government Response:

The US Holidays will not be observed during work in Azerbaijan as there no U.S. presence associated with the work outlined in this IDIQ.

26. Question:

Will the Contractor be responsible for international transport and shipping of biological samples and specimens, including shipping to/from the United States?

26. Government Response:

In accordance with A07-W81XWH-16-R-0019, 6.6.3 Shipment of Biologics, Supplies and Equipment, the contractor shall provide shipment of biologics, supplies and equipment locally or worldwide.

27. Question:

Upon award, does the Government intend to issue real Task Orders that are essentially the same as the sample task orders?

27. Government Response:

The sample task orders are representative of actual task orders the Government anticipates issuing under this IDIQ.

27a. Question:

If yes, how many current contractor personnel are working under contracts that approximate the work requested under Sample Task Order 1?

27a. Government Response:

This requirement has changed significantly from the current requirement; therefore, no contractor was identified as being an incumbent contractor. Suggested support these sample tasks is outlined under Section 14 in the sample task orders 1 and 2 PWS.

27b. Question:

Does the Government anticipate there will be current contractor staff that it expects the Contractor to hire?

27b. Government Response:

This requirement has changed significantly from the current requirement; therefore, no contractor was identified as being an incumbent contractor. Suggested support these sample tasks is outlined under Section 14 in the sample task orders 1 and 2 PWS. The Government does not select the personnel the contractor will supply to execute work in accordance with any issued task order.

27c. Question:

Even if there is no expectation that that the Contractor hire currently-employed staff, does the Government anticipate that there will be local Georgian contract staff desiring to transition to the new Contractor because their current work is ending at approximately the end of September?

27c. Government Response:

This is unknown and the Government cannot predict.

28. Question:

Please confirm that the only prices required at the time of proposal submission are the prices of the two Sample Task Orders and the fully loaded rates for the specified labor categories from Attachment 9?

28. Government Response:

Offerors must also provide a supplemental pricing sheet with unburdened labor rates for each labor category and the application of all direct and indirect rates (i.e., fringe, overhead, and G&A) as stated in 6.5.2 of Section L in the solicitation.

28a. Question:

If there is any other item requiring pricing at the time of submission, please clarify?

28a. Government Response:

None other.

28b. Question:

Would the Government clarify the difference between hourly firm-fixed prices (with ODCs as a cost reimbursement item) and Time and Material hourly rates in terms of whether this contract will be operated as true fixed price contract where the contractor bills 1/12 of the annual fixed value per month and the Government does not expect monthly billings to fluctuate based on hours worked. Please provide any clarifications necessary so that Contractors will have a full understanding of the Government’s requirements related to invoicing when levels of effort fluctuate?

28b. Government Response:

Task orders shall be issued as Firm fixed-price efforts.

29a. Question:

Section L.6.5.1 – Volume I – Business Proposal:

In section a. the Government requires a cover letter … is it being evaluated or is it required to contain any specific information? Can the proposal cover page suffice for this letter?

29a. Government Response: The cover letter will not be evaluated. The Cover letter is separate from the cover page.

29b. Question:

In section d. Contract Administration Data … what data is required?

29b. Government Response:

Section G has been revised to include the requested data.

30a. Question:

Attachment 9 – Task Order 1 Tab:

The Base Period contains a 2 month Transition-In Period and 4 months of Services, but requires ODCs for 6 months. Does the Government expect the Contractor will be providing Services for the entire 6 month period? (We note Sample Task Order 2 contains equivalent Service and ODC periods)

30a. Government Response:

The Base period is six months. All attachments are updated to reflect six months Amendment 1.

30b. Question:

The Option Period 4 requests Services for 10 months but ODCs for 12 months. Does the Government expect the Contractor will be providing Services for the entire 12 month period? (We assume the same answer will apply regarding Sample Task Order 2)

30b. Government Response:

This is due to the 2 month transition out period where ODCs may still occur in the 12 month period (services cover 10 month performance, 2 month transition out performance).

31. Question:

Sample Task Order 1 – Section 6.5.3: The instructions reference that the Contractor shall ensure … “execution of any agreed upon incentive or benefits programs …” Are there any “agreed” upon incentive plans currently in place for contractor employees at this facility that the Government has “agreed” to with the Contractor or does this just refer to employee fringe benefits that may vary from company to company?

31. Government Response:

This refers to your employee benefits plan offered to your employees upon execution of the award.

32a. Question:

Sample Task Order 1 – Section 6.7.5: Regarding SLAs, would the Government clarify expectations regarding these agreements:

We assume that SLAs are agreements that must be executed by the Government and not contractor personnel?

32a. Government Response:

SLA’s would be executed by the Government, but managed by the contractor.

32b. Question:

Assuming contractor personnel are not authorized to sign contracts with service vendors, how will the contractor ensure that SLAs remain current?

32b. Government Response:

The Government would expect the contractor to ensure support is provided to manage activities in accordance with Government approved SLA’s. If the SLA’s are modified by the Government, the contractor would be expected to change the level of management commensurate with the revised SLA’s.

32c. Question:

Likewise, the instructions indicate the Contractor must monitor monetary transfers related to the SLAs. We assume the Government will make payments against contracts it executes? If yes, how will contractor employees monitor payments by the Government?

32c. Government Response:

This has been removed from the sample task order and the Base IDIQ in Amendment 1.

33. Question:

Sample Task Order 1 – Section 6.7 IT Services: Are there any special background requirements or access processes (not listed in the Sample Task Order) required by local personnel performing the functions listed in Section 6.7 (e.g., confirm that there are no requirements for US citizenship, or any level of classified clearance for access to IT systems to perform any of the work in 6.7, etc.)

33. Government Response:

Although the current network is configured as a .org and does not require a CAC to support, the intent is to certify the network in accordance with .mil standards. The contractor will comply with the documents in the compliance section of the Base IDIQ PWS. This section has been updated to break out compliance and reference documentation.

34. Question:

A number of specific items are requested as part of the Volume II -Technical Submission that by virtue of format and length will make inclusion within the stated 40-page limit difficult without sacrificing the quality of the Technical Approach. These items are as follows:

1. Operation Support Plan including:

0. Human Resources Support Plan

0. Logistics Support Plan

0. IT Support Plan

0. Occupational Health and Safety Plan

0. Contingency Plan

0. Transition Plan

1. Management Plan including:

1. Organizational chart

1. Experience Tables We request that you include these items in the list of items exempted from the page limit.

34. Government Response:

The cumulative page limit for tabs B, C and D of Volume II has been increased to 70 pages.

35. Question:

Page 112, Section B requests three references or relevant contracts be provided and one reference per subcontractor. Are references outside the page limitation?

35. Government Response:

References are not exempt from the Past Performance page limitation.

The following have been modified:

PWS

PERFORMANCE WORK STATEMENT

Research and Laboratory Services Support to The Lugar Center, Republic of Georgia and Azerbaijan

1. SCOPE OF WORK

Walter Reed Army Institute of Research (WRAIR), in support of its biomedical research mission, has a requirement to support the Department of Defense (DoD) and the United States’ international mission to build partnerships in global health and meet DoD overseas medical research laboratory mission requirements. This single award Indefinite Delivery Indefinite Quantity (IDIQ) contract vehicle shall support WRAIR’s mission to the Lugar Center, Tbilisi; the Republic of Georgia; and the Caucasus (Azerbaijan). Specifically, this award shall provide services to support clinical research and product development, program management and operational support, information technology support, safety support, logistics support, and administrative support to the WRAIR mission at the Lugar Center, and Azerbaijan.

In order to facilitate the establishment of the United States Army Research Directorate – Georgia (USAMRD-G) at the Lugar Center, WRAIR’s research efforts must be world class quality and adaptive to changes in the Nation’s requirements for support of their military services. This performance work statement (PWS) provides for scientific support, clinical research support, and operational (management and ancillary) support. Task orders under this vehicle may entail surveillance and sample collection; basic and exploratory science; translational research; product research and development; and/or operational support to USAMRD-G in terms of logistics support, facilities service, safety, recruitment, retention, and training, as well as operational IT support primarily in a .org environment.

These tasks may require, but not limited to, the expertise of the below functions:

Scientific Support:

· Clinical Research Principal Investigation Support Services

· Microbiological Support Services

· Virological Support Services

Clinical Research Support:

· Bioinformatics Support Services

· Quality Assurance/Quality Control Support Services

· Geography Information System (GIS) Technical Support services

· Research and Laboratory Technical Support Services

· Insectary Support Services

· Animal Use Research

· Human Resources

Operational Support:

· Program and Operational Management

· Human Subjects Research Protection

· Translation Services

· Logistics, Biomedical Equipment and Supply Support Services

· Transportation Support Services

· Facilities Management Support

· Information Technology Support Services

· Safety Support Services

· Training

· Administrative and Clerical Support Services

· Contingency

Performance requirements under this contract shall flow through the issuance of task orders individually negotiated and issued pursuant to the contract by the Contracting Officer (KO). The PWS for each required outcome will be detailed in each task order. More than one task order can be issued at any one time with overlapping periods of performance.

Individual task orders will identify equipment, supplies, and materials that may be required to be purchased in support of the individual task order. Subcontractor support may be required to complete specific scopes of work in support of an individual task order (i.e. clinical research organizations, data management services, etc.).

Individual task orders will also identify any necessary travel support for non-military and non-government employees to participate in off-site strategic planning meetings, seminars, training, and symposia in support of a task order.

1. BACKGROUND

WRAIR’s mission is to conduct biomedical research that is responsive to Department of Defense and U.S. Army requirements and delivers lifesaving products including knowledge, technology, and medical materiel that sustain the combat effectiveness of the warfighter. WRAIR's focus on research for the soldiers affects all aspects of its operations as military medical research priorities differ from those of the civilian sector. WRAIR scientists have a unique understanding of military operations and environments, including the stresses and exposures troops encounter and the performance requirements of a deployed military force. Despite WRAIR's focus on the military, its research has been used to solve non-military medical problems around the world. Its history is filled with the lifesaving or life-enhancing discoveries of distinguished scientists. (WRAIR Organizational Chart can be found in Section J.)

In 2009, the Cooperative Biological Engagement Program (CBEP) engaged the United States Army Medical Research and Material Command (USAMRMC), following a request from the Government of Georgia to establish a long-term U.S. presence at the Richard G. Lugar Center for Public Health Research (Lugar Center), which will serve as the cornerstone of the Georgian National Disease Surveillance Program. In January 2011, WRAIR, through its command channels, was tasked by the Deputy Secretary of Defense as the Executive Agent, to establish a medical research unit at the Lugar Center in Tbilisi, Georgia. The new U.S. Army Medical Research Directorate-Georgia (USAMRD-G) under the command and control of WRAIR, and in partnership with the Georgian Ministry of Defense, Ministry of Labor, Health, and Social Affairs; and Ministry of Agriculture, will build partnerships in global health and meet DoD overseas medical research laboratory mission requirements.

1. OBJECTIVES

The USAMRD-G mission statement is to promote global health security, identify infectious disease threats to global health security, and develop interventions to mitigate those threats. USAMRD-G shall collaborate and assist the Government of Georgia in its efforts to combat endemic disease threats of military importance as well as to participate in cooperative surveillance and research projects addressing military and public health issues in the region. Its mission shall also provide for extensive capacity building to train Georgian scientists, physicians, students, and technicians in a wide range of bioresearch-related topics. The incorporation of the United States led medical research and development program, along with the experience of the DoD Global Emerging Infectious Surveillance (GEIS) program, will provide an opportunity to integrate the Georgian laboratory platform into an international site for infectious disease surveillance and research.

USAMRD-G will provide subject matter expertise in a broad range of pathogen research methods and technologies, medical product development, grants writing training, and research marketing. Execution of these programs in Georgia will offer a solid foundation from which the Georgian government can build and sustain critical internal research laboratory capabilities for future operations.

USAMRD-G will occupy space within the Lugar Center, which was constructed using funding from the Defense Threat Reduction Agency (DTRA) as part of the Cooperative Biological Engagement Program. Major construction of this facility was completed in 2010. Additional work for commissioning and credentialing of the facility, funded by DTRA, for biomedical research is currently underway.

USAMRD-G shall work to achieve their mission by, first and foremost, understanding the infectious diseases threatening the fighting force both domestically and abroad. USAMRD-G stands ready to assist colleagues and collaborators supporting the USAMRMC mission across multiple work areas.

USAMRD-G’s bioresearch program includes working on strain characterization of pathogens in this region, antimicrobial resistance, bacteriophage, leishmaniasis, and exploring other emerging and re-emerging diseases posing a potential risk to the force in the Caucasus region (i.e. Crimean-Congo hemorrhagic fever (CCHF), anthrax, brucellosis, tularemia, etc.). Infectious disease syndromes caused by existing, emerging, or re-emerging viral pathogens, not otherwise identified, is also of interest to USAMRD-G. For example, USAMRD-G has interest in identifying the cause of the 50% of influenza-like illnesses which are NOT influenza but that result in a medically significant illness. Other syndromes of interest are acute febrile illness/fevers of unknown origin, acute respiratory infection, sexually transmitted infections and military prevalence, global traveler’s diarrhea, and central nervous system infection surveillance.

Once specific threats have been determined, USAMRD-G works on those identified threats along a scientific continuum including: 1) Epidemiologic disease surveillance and sample collection, 2) Basic and exploratory science, 3) Translational research, 4) Product research and development. The intent is to license (as applicable) and field medical countermeasures and medical solutions designed to eliminate or mitigate these threats in the most safe, expeditious, cost effective, and high quality manner possible.

Within each “lane” of the continuum, USAMRD-G performs and requires support, across a number of activities. For example, in the product research & development lane, USAMRD-G may complete a full spectrum of activities related to developing vaccines to include developing an approach for a protective vaccine, completing bench-top research to turn the approach into a tangible vaccine construct, and eventually completing testing in human clinical trials. The work may be conducted, whole or in part, at USAMRD-G, within the Caucasus region, at the WRAIR or United States Army Medical Research Institute of Infectious Diseases (USAMRIID), or at a partner’s institution.

USAMRD-G’s mission is in its early phases. It is expected, over time, that the lab will become a robust science asset in the Caucus region

1. GENERAL INFORMATION

3. Primary Customer This contract vehicle is restricted to the use of WRAIR, USAMRIID, and USAMRD-G components.

3. Non-Personal Services This PWS identifies services that are strictly non-personal in nature, as defined by FAR 37, and to ensure there is not an appearance of such, every task order shall have an identified task manager.

1. Inherently Government Functions This PWS has been reviewed and contains no services that are inherently governmental functions.

1. Functions Closely Associated with Inherently Governmental Functions.

This shall be assessed on each task order.

3. Organizational Conflict of Interest (OCI) Walter Reed Army Institute of Research (WRAIR) has categorized its requirements into two broad categories, as defined below, for purposes of identifying, avoiding or mitigating against OCIs in accordance with FAR Subpart 9.5. These categories apply to all enterprise laboratories (Armed Forces Research Institute of Medical Sciences (AFRIMS), United States Medical Research Unit – Kenya (USAMRU-K), and United States Medical Research Unit – Georgia (USAMRD-G). These categories are defined as follows:

Global Support: Where services which, by their very nature, give the Contractor access to non-public procurement sensitive data about the contract requirements, other contractors’ proprietary information, or put the Contractor in a position to influence the award decision on a contract in which they are participating. These services are identified as those having a direct impact to the operations of the greater WRAIR enterprise.

Services would be characterized as having access to command wide procurement sensitive information, or work that could likely have an influence over follow-on awards or contracts within subordinate Directorates/Commands.

Mitigation strategies may include: avoidance (non-participation), firewalls between existing personnel and new requirement.

Isolated Support: Services which have focused impact on a specific Branch/ Department/ Program of WRAIR rather than the WRAIR enterprise.

Services can be characterized as having little or no access to procurement sensitive information other than the immediate requirement and little chances of follow-on work that can be influenced by the immediate requirement.

Mitigation Strategies: Contractor can provide a mitigation plan or acceptable self-certification that no OCI exists.

Contractor participation in more than one of these areas may give rise to an unfair competitive advantage resulting from access to advance acquisition planning, source selection sensitive or proprietary information. Furthermore, Contractor participation in more than one area may give rise to a real or apparent loss of Contractor impartiality and objectivity where its advisory or planning assistance in one area potentially affects its present or future participation in another area.

The purpose of this categorization is to accomplish the following three objectives: (1) To inform prospective Offerors that WRAIR presumes that award of a contract or order in the subject category will give rise to real or apparent OCI’s with respect to requirements in the other category and or may give rise to an OCI in the same category; (2) To assist current Contractors and prospective Offerors in developing their own business strategies regarding participation in WRAIR requirements and in identifying and, where possible, avoiding or mitigating against OCIs; and (3) To ensure that all current Contractors and prospective Offerors are afforded the maximum practicable opportunity to compete for all WRAIR requirements consistent with the restrictions required under FAR Subpart 9.5 and sound business practices.

For purposes of identifying and/or mitigating against OCIs, WRAIR will examine all its services requirements and acquisitions regardless of the cognizant contracting activity (e.g., USAMRAA, GSA, other agency Multiple Award Schedules, etc.) or the type of contract vehicle used (e.g., FSS order, Fair Opportunity competitive order under Multiple Award IDIQ Contracts, competitively negotiated awards under FAR Part 15, etc.).

Each WRAIR task order proposal request will therefore be designated as falling within one of the above defined categories. The applicable OCI category will be set forth in each task order. Contractors may submit a proposal for task orders in either of the OCI categories. This requirement is categorized as Isolated Support.

(OCI Certification - Section J)

3. Contracting Officer’s Representative (COR) The COR will be identified by a separate letter. The COR monitors all technical aspects of the contract and assists in contract administration. The COR is authorized to perform the following functions:

· Assure that the Contractor performs the technical requirements of the contract

· Perform inspections necessary in accordance with PWS

· Maintain written and oral communications with the Contractor concerning technical aspects of the contract

· Issue written interpretations of technical requirements, including Government drawings, designs, specifications

· Monitor Contractor's performance and notify both the Contracting Officer and Contractor of any deficiencies

· Coordinate availability of Government Furnished Property and Equipment (GFE), and

· Provide site entry of Contractor personnel

A letter of designation issued to the COR, a copy of which is sent to the Contractor, states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting order.

1. MANAGEMENT AND COORDINATION SUPPORT REQUIRMENTS

4. Performance Requirements The Contractor shall furnish the necessary personnel, equipment, supplies and support, to complete the performance of the work outlined below at a standard enabling the WRAIR other USAMRMC subordinate commands, to achieve the cost, schedule, and performance goals of its research and development activities (inclusive of preparations for post Milestone-C requirements of the acquisition process), and to the level of quality necessary to comply with programmatic requirements, DoD and Army regulations, ISO (International Organization for Standardization) standards, and FDA (Federal Drug Administration) and EPA (Environmental Protection Agency) regulations (to include both human subject protection and animal care and use regulations); including submissions to federal regulatory agencies. Federal regulations governing Current Good Clinical Practices (cGCP) are found in, Code of Federal Regulations (CFR), 21 CFR 11, 50, 54, 56, 312, and 314 and important guidelines are in the FDA Information Sheets. Additional regulations for human subjects’ protection are found in 45 CFR 46. Those governing cGLP are found in 21 CFR 11 and 58. The International Convention on Harmonization Guidelines for Good Clinical Practice is the standard governing the conduct of research trials. References for military regulations and policies governing regulated research may be found at https://mrmc.amedd.army.mil/index.cfm?pageid=research_protections.overview. Specific task requirements will be further defined on a task order basis.

4. Management Plan The Contractor shall provide a draft Management Plan that includes detailed staffing plans and the Offeror’s approach to controlling, coordinating, and directing performance, as well as organizing and managing resources in order to achieve technical/scientific requirements. The Management Plan shall detail the Offeror’s approach to selecting, directing, and managing subcontractors. The Management Plan shall describe how the Offeror will communicate with subcontractors and ensure that performance is at the level required to ensure timely and effective contract execution. The Management plan shall detail how the Offeror will comply with requirements to obtain pre-approval of subcontractors and clearly identify the primary role of the subcontractor(s). The Management Plan shall explain the Offeror’s approach to recruiting, selecting, hiring, and managing employees having an exclusive OCONUS duty location. The Management Plan shall initially be submitted with the Offeror’s proposal and will be updated within 15 days after contract award.

4. Operational Support Plan The contractor shall submit a draft Operational Support Plan to address, at a minimum but not limited to, the daily functions such as:

· Human Resources Support (inclusive of training plan)

· Logistics Support

· IT Support

· Occupational Health and Safety

· Contingency

The Contractor shall develop separate sub-plans for each of the items listed above, which shall be incorporated into the operation support plan. The Operation Support Plan combined with the Management Plan will be used to develop the standard operating procedure (SOP) for use in contract performance.

Additional plans, which may be required, shall be addressed in individual task orders and consolidated in the SOP.

4. Transition Support

When applicable, the Contractor shall provide transition support services for transitioning work from a Government entity or from an active contract to a follow-on contract/order or to a Government entity. A draft Transition Plan shall be submitted with the proposal for a 60-day transition period and will be updated within 15 DACA. Transition Plans may be required at the task order level. When required, Contractor shall ensure a transition approach for both a phase-in and phase-out transition of the task order. The Contractor shall include formal coordination with Government and successor staff. The Contractor shall conduct planning, coordination, and implementation of a successful transition in accordance with the approved Transition Plan for each awarded task order and for the IDIQ award, as appropriate.

3. Incoming Transition Task In accordance with the individual task orders under this contract, the Government may direct the Contractor to separately price items for a draft plan for incoming transition. When ordered, the Contractor shall coordinate with the Government in planning and implementing a complete transition to the Contractor's support model. The Contractor shall collaborate with the Government to develop and deliver a Transition Plan. The Incoming Transition Plan shall include, but is not limited to:

· Coordination with Government representatives

· Transition of historic data (Protocols, SOPs, Current Status, etc.) to contractor

· Government required training and certification process

· Orientation phase and program to introduce Government personnel, programs, and users to the Contractor's team, tools, methodologies, and business processes

· Transfer of Government Furnished Equipment (GFE) and Government Furnished Information (GFI) assets to contractor

3. Outgoing Transition Task In accordance with the individual task orders under this contract, the Government may direct the Contractor to separately price item for a draft plan for transitioning work and/or leased facilities from an active contract or task order to a follow-on contract. (Note that the transition may be to a Government entity, another Contractor or to the incumbent contractor under a new contract vehicle). In accordance with the Government approved plan, the Contractor shall assist the Government in planning and implementing a complete transition from this contract to the follow-on provider. This Outgoing Transition Plan shall be on a task order level and delivered prior to the end of the task order base period and updated prior to the end of each task option period as directed by the Government in each task order. The Outgoing Transition Plan shall include, but is not limited to:

· Formal coordination with Government representatives and the follow-on provider’s staff and management

· Review, evaluation and transition of current support services

· Transition of historic data (Protocols, SOPs, Current Status, etc.) to new contractor or Government

· Transfer of Contractor purchased Government owned assets to Government

4. Contingency Operations Plan The Contractor shall prepare and submit a Contingency Operations Plan that shall be the plan in effect for all awarded task orders. The draft Contingency Operations Plan shall be submitted with the proposal as part of the Operational Support Plan and a final due ten (10) calendar days after the award of the task order. The plan shall be updated as needed, but no less than on a quarterly basis. The Contingency Operations Plan shall document Contractor plans and procedures to maintain WRAIR/USAMRD-G support during inclement weather, natural disasters, emergencies and on work outside of normal duty hours. The Contingency Operations Plan shall include the following:

· A description of the Contractor’s emergency management procedures and policy and data backup/restoration plans

· A description of how the Contractor shall account for their employees during an emergency

· Planned temporary work locations or alternate facilities

· How the Contractor shall communicate with WRAIR during emergencies

· A list of primary and alternate Contractor points of contact, each with primary and alternate:

· Telephone numbers

· E-mail addresses

· Procedures for protecting Government furnished equipment (if any)

· Procedures for safeguarding sensitive Government information (if applicable)

4. Operations During Emergency Situations Individual contingency operation plans shall be: Activated immediately after determining that an emergency has occurred, operational within twelve (12) hours of activation, and sustainable until the emergency situation is resolved and normal conditions are restored or the contract is terminated, whichever comes first. In case of a life threatening emergency, the COR shall immediately make contact with his contractor task managers to ascertain the status of any contractor personnel who were located in Government controlled space affected by the emergency. When any disruption of normal, daily operations occur, contractor task managers and the Contracting Officer Representative (COR) shall promptly open an effective means of communication and verify:

· Key points of contact (Government and Contractor)

· Temporary work locations, if applicable (alternate office spaces, telework, virtual offices, etc.)

· Means of communication available under the circumstances (e.g. email, webmail, telephone, FAX, courier, etc.)

· Essential work products expected to continue production by priority

The Government and Contractor task managers shall make use of the resources and tools available to continue WRAIR contracted functions to the maximum extent possible under emergency circumstances. Contractors shall obtain approval from the COR and Contracting Officer prior to incurring costs over and above those allowed for under the terms of this contract. Regardless of contract type, and of work location, contractors performing work in support of authorized tasks within the scope of their contract shall charge those hours accurately in accordance with the terms of this contract.

4. Use of Foreign Nationals Total performance of this award shall be conducted outside of the contiguous U.S. and its territories. It is expected that the Contractor shall recruit from within the host country as appropriate to obtain the required skill sets. The Contractor shall have and maintain a business license to perform in accordance with the host country laws and regulations. Contractor employees under this contract shall be compensated in host country currency and in accordance with host country laws.

All contractor personnel shall be capable of communicating, orally and in writing, in English. The level of English requirement is established per each labor category and in accordance with Common European Framework of Reference for Languages: Learning, Teaching, Assessment (http://www.coe.int/t/dg4/linguistic/Source/Framework_EN.pdf).

1. TECHNICAL SUPPORT REQUIREMENTS

The following functional areas identify the range of services that are anticipated in this award. The task orders shall specify the requirements:

5. Operational Support The Contractor shall manage the day to day operations and oversee requirements of USAMRD-G in clinical research, information technology services, logistics support, safety services, translation services, local transportation services, training, administration, and quality control. The contractor shall provide an on-site program manager to perform and/or oversee these functions. Additionally the contractor shall perform the required human resource support services to recruit, retain, and train contractor personnel, as well as programmatic support services to advise, manage, and direct a contractor force.

The contractor shall provide administrative, communications, facilities support, work transportation conducive to meet mission requirements, IT services primarily in…