A07_SOLICITATION_AMENDMENT_(W81XWH-16-R-0033-0001).docx

W81XWH-16-R-0033

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION C - DESCRIPTIONS AND SPECIFICATIONS

The following have been added by full text:

Bidder Questions and Responses: Request For Proposals (RFP) # W81XWH-16-R-0033

**Please Note, as a result of delay in releasing the responses to bidder’s questions, the deadline to submit proposals against this solicitation will be extended until 2:00PM (Eastern), on 29 July 2016. The amended solicitaion reflecting this changes is attached.

1. I recently learned of the LITES contract. My institution has been expanding our research capabilities and trauma program and I’m interested in applying to be a participating site. From the online materials, it seems like you’re seeking proposals for the entire network and coordinating center. Are you also taking applications for participating sites? Or are you aware of a lead group preparing an application who I should reach out to?

Gov’t Response: The government is primarily interested in receiving proposals from coordinating centers. The coordinating centers have responsibility for establishing their clinical participating networks and should negotiate with them accordingly. The government cannot and will not refer or endorse any potential offerors for this solicitation.

2. For TASK order 0001, are the individual sites of the network are able to use their own IRB for approval (observational cohort study) and subsequent studies (task orders) will entail the use of a central IRB?

Gov’t Response: The government prefers, but not required, a harmonized protocol format. The intent of a Single Institutional Review Board of Record (sIRB) for Multi-Site Research involving non-exempt human subjects’ research funded by DoD is to enhance and streamline the process of IRB review and reduce inefficiencies so that research can proceed as expeditiously as possible without compromising ethical principles and protections for human research participants. The sIRB would only apply to domestic sites. Foreign sites will not be expected to follow this recommendation. The Offeror is expected to include a plan for the use of a sIRB in the proposal if appropriate and feasible based on this solicitation or future task orders.

3. Is pt. sampling (blood/plasma/serum) required for TASK order 0001 as this will likely entail consent of all patients enrolled. We envision a subcohort of sicker patients that get sampling performed for novel aims?

Gov’t Response: No, patient sampling (blood/plasma/serum etc.) is not required for Task Order 0001. The data to be collected for a two year period should be prospective, multicenter and observational to include all trauma centers within the proposed LITES network. The inaugural project (Task Order 0001) will be an observational study with the primary aim to understand the epidemiology of traumatic injuries in the US; including regional variations in severity and types of injury, mode and methods of management, survival and recovery rates (outcomes) based on standards of care at the coordinating center and the participating network. The DoD anticipates that the offeror will require six months to initiate the study in Task Order 0001. Additionally, it is anticipated that at the conclusion of data collection for two years, the offeror may require an additional six months to analyze the data and prepare a Final Report. Task Order 0001 does not solicit/authorize experimental research on any specific patient population or cohort of patients based on their medical history.

4. Regarding the sites for the LITES network, is a letter of support documenting the abilities to participate and potential for central IRB participation for future task orders enough/appropriate for the DOD to demonstrate network capabilities (with the understanding that the DOD has the right to pick and chose)?

Gov’t Response: Yes, Letters of Intent/Support is reasonable documentation to support the proposed establishment of the coordinating center and participating network sites (proposed LITES network). Participating network sites are not prohibited from aligning themselves with multiple coordinating centers. Additionally, future participating network sites can be identified by the coordinating center as deemed appropriate based on the requirements of future Task Orders. The intent of this solicitation is to make a single award to a single coordinating center.

5. Is the budget to be a 5 year lump sum as on page 2 of the solicitation? Is there a break down to be put some where?

Gov’t Response: In accordance with Page(s) 88-89 of Solicitation, The Offeror shall submit a cost/price proposal with a breakout of all labor categories by completing the worksheet in Attachment 1, Labor Mix Pricing Sheet. This template shall be used in place of the Section B format for cost buildup submissions. All labor categories are included on the pricing spreadsheet and should correlate to the prevailing locale, which supports the Offeror’s approach to the LITES requirement. **All categories in the Labor Mix Pricing Sheet (Attachment 1) should have a proposed rate in the Offeror’s cost proposal.

6. Does the LITES-BASE PERIOD (item no 0001; pg 2 of solicitation) include the first 5 years and the same for travel?

Gov’t Response: Yes.

7. Does the OPTION PERIOD 1-5 include the potential 6-10 years of the network?

Gov’t Response: Yes.

8. For the initial clinical study task 0001 should this include moneys for the sites of the network in addition to infrastructure?

Gov’t Response: The intent of this solicitation is to budget for the coordinating center for years 1-5. The proposal (technical/cost) should include the coordinating center (years 1-5) and the proposed network sites for Task Order 0001. Letters of Intent/Support for the participating sites should be included in the technical proposal. Future participating sites maybe proposed based on additional Task Orders.

9. Should we budget for all of our established sites and LITES network during years 1 thru 5, or just the infrastructure?

Gov’t Response: Please reference response to Question 8.

10. Should funding of infrastructure and services relevant to the network be described somewhere per year and summed up over 5 years and add on top of that the cost for TASK 0001?

Gov’t Response: Yes, cost associated with infrastructure and services relevant to the network shall be described per year and summarized over five years, as it pertains to Task Order 0001. However, in accordance with Page 89 (Paragraph 5.2), all costs (labor, subcontracts, materials, etc) necessary to establish and maintain ongoing capability for the proposed LITES network shall be separated (in the task order 0001 proposal cost) from costs strictly associated with the performance of the initial study outlined in the Task Order 0001 PWS. The Government anticipates funding the network/infrastructure and study on a separate CLIN’s, on Task Order 0001 at time of award.

11. If the base is not funded as stated in the solicitation but each task order is, we are confused on how to budget as we don’t know the subsequent tasks. Is there somewhere where further instructions can be obtained regarding what is expected regarding budgeting for the LITES network?

Gov’t Response: Please reference Page(s) 88-92 of Solicitation, pertaining to Cost/Price Volume.

12. Should the budget just include task order 0001 costs?

Gov’t Response: Please reference response to Question 11.

13. Is there rules prohibiting affiliating with more than one application?

Gov’t Response: No.

14. Please confirm the number of trauma sites needed and clarify if these should primarily be domestic or also include international sites.

Gov’t Response: The number sites need to be scalable depending on the subsequent task efforts. Sites should be predominately domestic when possible however, international sites can be considered when products are not licensed in the U.S.

15. Please clarify if this is a sole source IDIQ, or if there will be multiple awards.

Gov’t Response: Please reference Page 93 of Solicitation, pertaining to Basis for Award.

16. Are government grants acceptable as examples of past performance?

Gov’t Response: Yes.

17. Please clarify if the network plans to implement IND studies. The RFP states there will not be IND studies, but yet there are multiple references to providing support of FDA-regulated trials.

Gov’t Response: The goal of the network is not to conduct regulated trials but to gain knowledge on FDA approved products to guide clinical practice guidelines (CPGs).

18. Please clarify the Task Order (TO) specific information that is to be included in the base agreement submission Technical Approach. Language in section 4.3 on page 84 and section 3.1 (evaluation factors) on page 94 is confusing.

Gov’t Response: For the task order, Offerors are instructed to address the requirements of the Task Order 0001 PWS (Attachment 2) and demonstrate an understanding of those requirements.

The Offeror’s technical approach shall demonstrate the manpower and resources necessary to complete the tasks outlined in the Task Order PWS.

The Offeror shall address the topic areas needed to request Institutional Review Board (IRB) approval at the site where the proposed central IRB will be located. At a minimum, this should include background, specific aims, research methods, analysis plan, and subject confidentiality protections.

The Offeror’s technical approach shall demonstrate the ability to provide deliverables if required by the tasks in the Task Order PWS.

19. On page 93, Section 2.0, it says that offerors are required to submit separate responses for the IDIQ and the Task Order 0001.

Gov’t Response: The cited statement will be removed. The solicitation will be amended to include the following:

The Offerors shall submit responses for requirements pertaining to the base IDIQ and the Task Order 0001, as outlined in the solicitation.

1. What are the specific instructions and page limit for the TO response?

Gov’t Response: Please reference Page 78 of Solicitation, pertaining to Proposal Organization for page limitations of each section.

b. Should we submit a 25-page Technical Approach for the TO and another 25-page Technical Approach for the Base (page 93) or a single document addressing both limited to 25 pages (page 84 Section 4.3).?

Gov’t Response: Please reference response to Question 19(a). In accordance with Page 79 (Paragraph 2.5) Page limitations shall be treated as maximums. If exceeded, the excess pages will not be read or considered in the evaluation of the proposal. Page limitations exclude Curriculum Vitae and bibliographic data for key personnel.

c. Should we submit a 25-page Experience document for the TO and another 25-page Experience document for the Base or a single document addressing both limited to 25 pages (page 93)?

Gov’t Response: Please reference response to Question 19(b).

20. Should Task Order 1 include data collection for pediatric (age less than 18) and geriatric (age 65 or greater) patients?

Gov’t Response: No

21. On page 77, Section 1.0 General Instructions, it states “the offeror shall include evidence (e.g., statement of intent to enter into a teaming agreement) of subcontractor relationships.” We will have letters of support. Should these letters be included in the response or just referenced?

Gov’t Response: Yes. The solicitation will be amended to add letters of support from intended subcontractors to page limitation exclusions on Page 79 (Paragraph 2.5).

22. May we include drafts of management policies and procedures?

Gov’t Response: Yes. However, these documents will not be excluded from the applicable per section page limitations outlined on Page 78 of Solicitation, pertaining to Proposal Organization.

23. The Past Performance section addresses Government contracts. Is that contracts in the strictest sense or does it also include grants, cooperative agreements, and other assistance awards?

Gov’t Response: Please reference response to Question 16.

24. General: Contract Structure and CLINS XXX1- CLINS XXX1 Are stated as CPFF and in contract structure it states “No task order will be awarded with labor rates higher than those approved in the base contract.” According to FAR 16.3 “CPFF is a cost reimbursement contract that provides for payment to the contractor of a negotiated fee that is fixed at the inception of the contract.” The statement regarding fixed labor rates would indicated a Time and Materials contract where rates are set with a not to exceed level. Please clarify the intention as to the type of contract that will be awarded, with the conflicting terminology being removed.

Gov’t Response: Please reference response to Question 11. The Government does not recognize cited conflict.

25. General: Can the government provide an indication of timing of Task Order Release, by an indication of quantity per year and approximate size?

Gov’t Response: No.

26. General: Will onsite facilities be provided for contract staff, or is contractor expected to procure off-site facilities for personnel at any given location?

Gov’t Response: The awardee will be responsible for any necessary facilities. No facilities will be provided by the government.

27. General: Throughout the solicitation for both the IDIQ and the task order there are numerous references for multiple locations without specifics locations specified for bidding purposes. The Price Proposal is to be submitted inserting a locale. How are proposals to be evaluated consistently with different bidders using different locales?

Gov’t Response: In accordance with Page 87 of Solicitation (Paragraph 5.1), all labor categories are included on the pricing spreadsheet and should correlate to the prevailing locale, which supports the Offeror’s approach to the LITES requirement. The Government’s source selection plan is considered procurement sensitive information and not authorized for public release in accordance with FAR 3.104.

28. General: What is the government’s intent if this is a contract with not to exceed labor rates to compensate the contractor for the various locales within CONUS locations and then OCONUS locations?

Gov’t Response: Please reference response to Question 24.

29. General: Are VA Medical Centers to be considered in the LITES Network?

Gov’t Response: The awardee is responsible for identifying individual sites that will meet the enrollment requirements of subsequent task areas and this does not exclude the VA sites from consideration.

30. General: During the period of performance, some internal tools may be created to perform certain data modeling or analysis to produce the required products for deliverables. Should the customer find these tools valuable, what is the path for acquisition for the government for the proprietary products created as internal tools during the period of performance?

Gov’t Response: The Government will receive access to technical data in accordance with the governing data rights provisions and clauses included in the solicitation and subsequent contract.

31. PWS 5.1.2 Page 10: Please provide an indication of which MTFs may be considered as a location, as well as any OCONUS (worldwide) locations to be considered.

Gov’t Response: Please reference response to Question 29.

32. PWS 5.1.4 Page 11: Is contractor responsible for procuring storage space, if so is this, as well as any additional costs associated with “purchasing suitable shipping materials” considered an ODC?

Gov’t Response: Each Offeror’s response to requirements contained within PWS, will vary based on technical approach.

33. PWS 5.2.1 page 12: “Provide support to arrange/coordinate travel for non-government members and/or collaborators for the conduct and/or oversight of site assessment and selection visits, civilian and/or military, as defined at the task order level.” Will this support be requested/performed under one of the billable labor categories (for example: Administrative Assistants) at the task order levels?

Gov’t Response: Please reference response to Question 32.

34. PWS 5.2.11 page 13: Are all costs associated with distribution of training materials, provision of A/V equipment reimbursable as ODC?

Gov’t Response: Please reference response to Question 32.

35. PWS 5.2.7 Page 13: Which "electronic systems" are used for clinical data management, are they internal systems that exist, that need to be built, or are they government systems that contractor will need to access.

Gov’t Response: Each Offeror will need to provide their own data management system.

36. Supplemental question: Is LITES a persistent data source, or is it a dynamic pool with multiple data sources?

Gov’t Response: Each Offeror’s response to requirements will vary based on technical approach.

37. PWS. 5.2.10 Page 13: Is the purchase of COTS (Commercial Off the Shelf) Statistical Analysis Software (SAS) a reimbursable cost with software license transferred to the government?

Gov’t Response: The cited PWS reference is merely a base-level IDIQ task. The specifics of SAS as pertaining to procurement or performance will vary based on each Offeror’s technical approach.

38. PWS 5.8 page 16 of 99, and Page 26: 5.8 Key Personnel for the Base Award are identified as Senior Research Scientist ("Principal Investigator"), Program Administrator, and Central IRB Coordinator. However, KEY PERSONNEL on page 26 states Key Personnel are TO BE DETERMINED at the TASK ORDER LEVEL. Please explain.

Gov’t Response: The names of the identified Key Personnel will be added in the clause provided on Page 26, at time of task order award.

39. Supplemental Question: Are the Senior Research Scientist ("Principal Investigator"), Program Administrator, and Central IRB Coordinator considered Key Personnel on Task Order 001.

Gov’t Response: Please reference Page 16 of Solicitation (Paragraph 5.8), pertaining to Key Personnel.

40. Section D Deliverable/Delivery Schedule Page 27. Please revise this table to eliminate redundant rows and mis-numbering.

Gov’t Response: Government does not recognize cited errors.

41. Section I Clause 52.219-28 (d) page 57. Please confirm that the small business size standard is 1000 not 500 as indicated

Gov’t Response: The small business size standard as cited in clause 52.219-28 for re-representation is accurate, as written in solicitation.

42. Section L 2.9 Page 80 and L.3.1 and L. 4.2: Please confirm that Index and Table of Context synonymous and that an Index (detailed) and a TOC are not both required.

Gov’t Response: TOC’s cited in question pertain to separate volumes. TOC’s shall be provided as indicated in solicitation.

43. Section L 2.1 page 79: Please confirm that 5 (five) hard copies of the complete proposal shall be provided to the Government Point of Contact (POC), is to say that all 3 volumes will be in one binder; thus totaling 5 binders? Or, each volume is in its own binder, thus totaling 15 binders?

Gov’t Response: Please reference Page(s) 78, 79 of Solicitation (Paragraph 2.0, 2.3), pertaining to Organization or Proposals, Number of Copies, Page Limits, and Volume Content.

44. Section L 2.2 page 79: Please confirm each volume shall be submitted in two electronic copies (including the “Original” copy described above) on a separate CD-ROM or DVD-ROM". Is this to say each volume shall be on its own CD, and provided in 1 original and 1 copy, totaling 6 CDs? Or all 3 volumes on 1 CD/DVD original and 1 CD/DVD Copy totaling 2 CD/DVDs?

Gov’t Response: Please reference response to Question 43.

45. Section L 4.5 page 85 and M 3.3 page 95: Are Resumes required for the Key Personnel named in section 5.8? Or is the Contractor to name any (additional) labor categories for TO001 it would deem "Key" as no key personnel are named in the TO SOW.

Gov’t Response: In accordance with Page 85 of Solicitation (Paragraph 4.5), The Offeror shall provide representative resumes for all labor identified as key personnel in the proposed technical approach.

46. Section L 4.7.1, and 4.7.4 pages 86 and 87: Please clarify the sub-contracting goals for HBCU/MI and if HBCU/Mi are to be included in the small business participation plan.

Gov’t Response: Please reference Page 86 of Solicitation (Paragraph 4.7), pertaining to Small Business Participation/Subcontracting Plan for procurement goals.

47. Section L 5.1 pg. 88 M.3.6.3: For the price proposal, and in an effort to balance bidding evaluations and cost realism, please provide a prevailing locale to be used to complete the pricing attachment.

Gov’t Response: Please reference response to Question 27.

48. Section L. 4.6 Page 85: Please confirm questionnaires to be returned to the company and provided as part of the Technical Proposal?

Gov’t Response: Yes.

49. Section L.5.0 page 88: Are offers expected to provide a narrative (Word) to accompany the price proposal (Attachment 1, Labor Mix Pricing Sheet)?

Gov’t Response: Please reference response to Question 11.

50. Amendment 1: Per the PWS, the Key Personnel is listed as "Central IRB Coordinator" however, the Labor Categories indicate a "Central IRB Manager" Please clarify.

Gov’t Response: Attachment 1 will be amended to change “Central IRB Manager” to “Central IRB Coordinator.”

51. Attachment 1: Please specify, for which positions will Medical Malpractice be required?

Gov’t Response: Please reference response to Question 27.

SECTION L - INSTRUCTIONS, CONDITIONS AND NOTICES TO BIDDERS

The following have been modified:

INSTRUCTIONS TO OFFERORS

1.0 GENERAL INSTRUCTIONS

This section provides general guidance for preparation of proposals as well as specific instructions on the format and content of the proposal. The Offeror’s proposal must include all data and information requested and must be submitted in accordance with these instructions. The proposal shall be compliant with requirements as stated in the Government’s Performance Work Statements (PWS’s). This acquisition is a full and open (UNRESTRICTED) procurement under NAICS 541712 (size standard 1000 employees). The Offeror shall include evidence (e.g., statement of intent to enter into a teaming agreement) of subcontractor relationships. Non-conformance with these instructions may result in an unfavorable proposal evaluation. Any Offeror who submits an incomplete package may be rejected and eliminated from further competition.

1.0.1 The proposal shall be clear, concise, and shall include sufficient detail for effective evaluation and for substantiating the validity of stated claims. The proposal should not simply rephrase or restate the Government’s requirements, but rather shall provide convincing rationale to address how the Offeror intends to meet these requirements. The Offeror shall assume that the Government has no prior knowledge of the Offeror’s facilities and experience. The Government will base its evaluation on the information presented in the Offeror’s proposal

1.0.2 Elaborate brochures or documentation, binding, detailed art work, or other embellishments are unnecessary and not desired.

1.0.3 The proposal acceptance period (120 days, minimum) after the solicitation closing date (block 9 on Standard Form 33) shall be specified in block 12 of the Standard Form 33.

1.0.4 Questions regarding this Request for Proposal (RFP) are due no later than 2:00 PM Eastern Time (ET) on 22 June 2016 and shall be submitted by email to the Contract Specialist, Wayne A. Medina at wayne.a.medina2.civ@mail.mil. The Government will not address questions received after this time and date. Offerors shall submit one set of questions only; multiple emails shall not be accepted. Telephonic questions will not be accepted. An amendment to the solicitation will respond to all questions submitted within the solicitation question period. Distribution shall be through www.fbo.gov.

PROPOSAL DUE DATE: No Later Than: 29 July 2016 at 2:00PM Eastern Time.

1.0.5 If an Offeror believes that the requirements in these instructions contain an error, omission, or are otherwise unsound; the Offeror shall immediately notify the Contract Specialist listed above in writing with supporting rationale. The Government reserves the right to award this effort based on the initial proposal, as received, without discussion.

1.0.6 Any request for “Change Pages” by the Government shall be submitted by the Offeror using highlighted text to identify changes made from the original proposal with a revision date affixed to the subject page.

1.0.7 In accordance with Federal Acquisition Regulation (FAR) Subpart 4.8 (Government Contract Files), the Government will retain one copy of all unsuccessful proposals.

1.0.8 The Government may conduct a pre-award survey during the Government evaluation period (prior to contract award). The pre-award survey may examine the Offeror’s record of integrity and business ethics, data management system, financial capability, and accounting systems.

2.0 ORGANIZATION OF PROPOSALS, NUMBER OF COPIES, PAGE LIMITS

The Offeror shall prepare the proposal as set forth in the Proposal Organization table below (Table 1). The titles and contents of the volumes shall be as defined in this table, all of which shall be within the required page limits as specified in Table 1. There should be three (3) separate and distinct volumes: Volume I is the Documentation Volume; Volume II is the Technical Volume; and Volume III is the Cost/Price Volume. These are (3) separate volumes. Do not include cost information in the Technical Volume. The Offeror shall clearly mark one (1) electronic copy of each volume as “Original” and one (1) additional electronic copy shall be clearly marked as “Copy”.

Table 1: Proposal Organization

III

2.1 SUBMISSION COPIES

Each volume shall be submitted in two electronic copies (including the “Original” copy described above) on a separate CD-ROM or DVD-ROM in PDF format, with the exception that the Cost Volume be submitted as a “Read Only” Microsoft Excel file, showing all formulas and links, including applicable subcontractor costs. In addition, 5 (five) hard copies of the complete proposal shall be provided to the Government Point of Contact (POC).

2.2 ELECTRONIC SUBMISSION

Each electronic submission shall be submitted on separate CD/DVD-ROMs in PDF format, with the exception that the Cost Volume shall be submitted as a “Read Only” Microsoft Excel file. The electronic submission shall be compatible with Microsoft Windows XP, Microsoft Excel 2007, Microsoft Word 2007, Microsoft Project 2007, and Adobe Acrobat Reader 8.0. The files shall be virus and malware free. All passwords shall be removed.

2.3 VOLUME CONTENT

Each volume shall be written on a stand-alone basis. Information required for proposal evaluation which is not found in its designated volume or section will be assumed to have been omitted from the proposal. Each volume shall contain a cover page with identifying RFP number, Offeror name and mailing address, CAGE Code, Business Manager’s name, and contact information. Also to be included in each volume is an index and a glossary of abbreviations or acronyms used. Cover pages and index/glossary will not be counted against page limitations.

The information in each volume should be specific and complete. Legibility, clarity, and coherence are very important. Your responses will be evaluated against the factors defined in Section M, Evaluation Factors for Award (exception for Volume I, OCI, which is a stand-alone review and is not considered to be part of an Offeror’s technical proposal). Using the instructions provided below, provide as specifically as possible, the actual methodology you would use for accomplishing/ satisfying the requirement. All of the information specified in the solicitation is mandatory. By your proposal submission, you are representing that your firm will be responsible for meeting the requirements specified in the solicitation. Do not merely reiterate the objectives or reformulate the requirements specified in the solicitation.

2.4 COST INFORMATION

All cost information shall be addressed ONLY in the Cost Volume. Do not address cost in the Technical, Past Performance of OCI Volumes. Cost trade-off information, work hour estimates, and material kinds and quantities may be used in other sections only as appropriate for presenting rationale for alternatives or design and trade-off decisions.

2.5 PAGE LIMITATION

Page limitations shall be treated as maximums. If exceeded, the excess pages will not be read or considered in the evaluation of the proposal. Page limitations exclude Curriculum Vitae, Letters of support from Subcontractor(s)/Consultant(s), and bibliographic data for key personnel.

2.6 PAGE SIZE AND FORMAT

A page is defined as each face of a sheet of paper containing information. When both sides of a sheet display printed material, it shall be counted as two (2) pages. Page size shall be 8.5 x 11 inches, not including foldouts. Pages shall be single spaced. Except for the reproduced sections of the solicitation document, the text size shall be no less than 12 point. Tracking, kerning, and leading values shall not be changed from the default values of the word processing or page layout software. Use at least 1 inch margins on the top and bottom and ¾-inch side margins. Pages shall be numbered sequentially by volume. These page format restrictions shall apply to electronic proposals.

2.7 TABLES, CHARTS, GRAPHS, AND FIGURES

Legible tables, charts, graphs, and figures shall be used wherever practical to depict organizations, systems and layout, implementation schedules, plans, etc. These displays shall be uncomplicated, legible, and shall not exceed 11 x 17 inches in size. Foldout pages shall fold entirely within the volume, and count as a single page. Foldout pages may only be used for large tables, charts, graphs, diagrams and schematics, not for pages of text. For tables, charts, graphs and figures, the text shall be no smaller than 10 point. These limitations shall apply to electronic proposals.

2.8 CROSS-REFERENCING

To the greatest extent possible, each section of the proposal shall be written on a standalone basis, so that its content may be evaluated with a minimum of cross-referencing to other sections of the proposal. Information required for proposal evaluation, which is not found in its designated section, will be assumed to have been omitted from the proposal.

2.9 INDEXING

Each volume shall contain a more detailed table of contents to delineate the subparagraphs within that volume. Tab indexing shall be used to identify sections. Indices do not count against the page limitations for their respective volumes.

2.10 GLOSSARY OF ABBREVIATIONS AND ACRONYMS

Each volume shall contain a glossary of all abbreviations and acronyms used, and with an explanation for each. Glossaries do not count against the page limitations.

2.11 DISTRIBUTION

The “original” electronic copy and one (1) additional copy, as well as, the five (5) hard copies shall be addressed to the Contract Specialist and either mailed or hand carried to: Mr. Wayne A. Medina, Contract Specialist, Phone: (301) 619-9204, U.S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick, MD 21702.

3.0 VOLUME I/SECTION I – DOCUMENTATION VOLUME/TOC

3.1 Table Of Contents (TOC)

The Offeror shall include TOC of the volume.

3.2 VOLUME I/SECTION II –DOCUMENTATION VOLUME/EXECUTED REQUEST FOR PROPOSAL (RFP) & RECORD OF ENVIRONMENTAL COMPLIANCE (REC) DOCUMENTS

The Offeror shall submit a fully executed copy of the RFP. This submission shall be signed/dated and all clauses requiring a “fill-in” shall be completed.

The Offeror shall submit an executed Record of Environmental Consideration (REC) (Attachment 4) for efforts proposed against Task Order 0001. The REC shall be executed by the institution’s official responsible for environmental compliance. The Council on Environmental Quality (CEQ) regulations (40 CFR, 1500-1508) that implement the National Environmental Policy Act (Public Law 91-190, as amended) requires all federal agencies to examine possible environmental consequences of their proposed and ongoing actions. This form must be submitted for each site conducting research under the submitted research proposal for Task Order 0001. This includes all subcontractors.

3.3 VOLUME I/SECTION III –DOCUMENTATION VOLUME/ORGANIZATIONAL CONFLICT OF INTEREST (OCI)

The Federal Acquisition Regulation (FAR) Part 9.5 provides guidance for Contracting Activities with regards to Organizational conflict of Interest. OCI is characterized by a) biased judgment on the part of the contractor or b) unfair competitive advantage in a procurement. The FAR encourages mitigation of a conflict if at all possible. The Contracting Officer has significant discretion as to the acceptability of any mitigation plan offered.

The United States Army Medical Research Materiel Command (MRMC) has categorized its services requirements into three broad categories, as defined below, for purposes of identifying, avoiding or militating against OCI in accordance with FAR Subpart 9.5. These categories are defined as follows:

Category 1: Program and/or Administrative 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 or otherwise affect their impartiality..

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.

Category 2: Program and/or Administrative Support: Services which assist in planning and managing an organization’s activities and programs.

Services would be characterized as having access to only Directorate or Subordinate Command level procurement sensitive information or work that would have little influence on follow-on requirements or requirements of other directorates/Subordinate Commands .

Mitigation Strategies: Within the requirements office – avoidance or firewalls; in other Directorates/Subordinate Commands – acceptable mitigation plan or certification that no OCI (real or apparent) exists.

Category 3: Product Support. Services or end items required to meet the mission requirements of the organization’s activities and programs.

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 certification that no OCI exists.

Contractor’s 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 information 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 MRMC presumes that award of a contract or order in the subject category will give rise to real or apparent OCIs with respect to requirements in the other two categories; (2) to assist current Contractors and prospective Offerors in developing their own business strategies regarding participation in MRMC 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 MRMC requirements consistent with the restrictions required under FAR Subpart 9.5 and sound business practices.

For purposes of identifying, avoiding and / or militating against OCIs, MRMC will examine all its services requirements and acquisitions regardless of the type of contract vehicle used.

The work called for under this contract / order has been determined by MRMC to fall within the following OCI category: Category 3: Product Support

3.3.1 OCI Administration and Submission

USAMRMC will administer this clause for purposes of award eligibility as follows:

3.3.1.1 The offeror shall provide a listing of all contracts performed for the USAMRMC and any subordinate Commands in the last three (3) years. A single-category Offeror/Contractor wishing to submit an offer in a different category, or any Offeror/Contractor which now provides or previously has provided support in more than one category, must include the following as part of its offer:

3.3.1.2 Perform a comparative analysis of the potential new work against all current and previous work performed in support of USAMRMC in any category. The comparative analysis must be included in the proposal for the new work, and must include a statement certifying whether the Contractor believes that its performance of the proposed new work would create a real or apparent OCI. If the Contractor believes that no real or perceived OCI will result from an award of the proposed work, no additional action by the Contractor is required, unless the Contracting Officer specifically requests an OCI mitigation Plan.

3.3.1.3 If the Offeror/Contractor believes that a real or apparent OCI may exist as a result of an award, the Contractor shall also submit an OCI Mitigation Plan with its proposal.

3.3.2 Page Limitation

Inclusion of the comparative analysis and OCI Mitigation Plan will not be counted against any offer page limitations otherwise stated in the solicitation.

3.3.3 OCI Review

Review of a potential OCI is a stand-alone review and is not considered to be part of an Offeror’s technical proposal.

The Contracting Officer (and when applicable the appropriate program office, acquisition manager, and legal counsel) will review the comparative analysis and, if provided, the Mitigation Plan, in accordance with the requirements of FAR Subpart 9.5 (Organizational Conflict of Interest) to determine whether award to that Offeror would be consistent with those requirements. If it is unilaterally determined by the Contracting Officer that no OCI would arise or that the OCI Mitigation Plan adequately protects the interests of the government in the event of award to that Offeror, the Offeror will be determined, for purposes of this clause, to be eligible for award. If the Contracting Officer reasonably determines that a Contractor has not provided either a comparative analysis or Mitigation Plan, or both, or that the analyses or plan provided is inadequate, sanctions including elimination from the award process, or termination of the related contract effort already awarded, as well as other appropriate sanctions will be considered.

If the Offeror/Contractor knows of no OCI in accepting performance under this contract, it shall certify its OCI status and submit the certification at the end of this clause with its proposal. The Contractor shall also obtain a similar certification of OCI status from all subcontractors, teaming partners or consultants proposed for performance in accordance with this solicitation. The Contractor shall appropriately modify and include this clause, including this paragraph, in all consulting agreements and subcontracts of any tier to preserve the rights of the Government.

For breach of any of the above restrictions or for nondisclosure or misrepresentation of any relevant facts required to be disclosed concerning this solicitation and the potential resulting contract, the Government may terminate the contract, disqualify the Contractor from subsequent related contractual efforts, and pursue any remedies as may be permitted by law or the contract.

Prior to a contract modification involving a change to the Statement of Work, or an increase in the level of effort or extension of the term of the contract, the Contractor shall submit any applicable organizational conflict of interest disclosure or an update of the previously submitted disclosure or representation.

3.3.4 Considerations

The Offeror/Contractor should review the considerations below in determining whether or not a conflict of interest exists.

3.3.4.1 Does the Offeror or any intended subcontractors, teaming partners, proposed employees, or affiliates have Unequal Access to Information? Would award to the Offeror result in the Offeror having the opportunity to access nonpublic information that may give the Offeror a competitive advantage in a later competition for a government contract?

Specifically, will the Offeror/Contractor have access to any of the following information:

· Budget(s), or Budget Information?

· Acquisition Sensitive Information related to the procurement process to include, but not limited to Acquisition Plans, Requirements, Statements of Work, or Evaluation Criteria?

· Does the Offeror or any intended subcontractors, teaming partners, proposed employees, or affiliates have “impaired objectivity” because the Offeror’s ability to render impartial judgments may be compromised because of its conflicting role(s) on this effort and other government contracts?

· Do “biased ground rules” exist? Most commonly, this would include a situation where the Offeror has, as a government Contractor, written specifications or a statement of work for this effort, which could skew competition in favor of itself.

· Is the Offeror aware of any other information relating to this proposed contract/order, which could reasonably be construed as creating an OCI?

3.3.5 Offeror Certification

The Offeror/Contractor hereby certifies to the best of its knowledge its OCI status below:

(Offeror: Choose one of the following two statements. Indicate which one applies by placing an X in the box to the left of the statement.)

□ No real or perceived OCI, as defined in FAR 2.1 and discussed in FAR 9.5, will result from an award of the proposed performance (there are no ‘Yes’ responses to the questions above).

□ A real or apparent OCI may exist as a result of an award and therefore an appropriate OCI Mitigation Plan is attached (Offeror shall include an appropriate OCI Mitigation Plan, as required by this clause, with its quote to the Contracting Officer).

Upon award the Contractor agrees that it will provide timely OCI training to all employees and subcontractor employees working on this effort, which will include emphasis on how work performed by Contractor employees (either prime Contractor, subcontractor, or other teaming partners) under one USAMRMC OCI category can exclude the Contractor as well as its teaming partners from performing related tasks under a different OCI category of work.

________________________________(Signature) __________________ (Date)

________________________________ (Printed Name)

________________________________(Title)

4.0 VOLUME II/SECTION I –TECHNICAL VOLUME/COVER LETTER-EXSUM/TOC

The Technical Section shall not contain any reference to cost or price; however, information concerning labor hours and categories, Consultant services, travel requirements, materials and equipment needed, and, if applicable, subcontractor(s) shall be contained in the Technical Volume in sufficient detail so that the Government may adequately evaluate the Offeror’s understanding of the requirements.

4.1 COVER LETTER –EXSUM

In the Cover Letter-EXSUM, the Offeror shall provide a concise narrative summary of the Technical proposal, to include addressing the significant risks, identifying any schedule incentives and highlighting any key or unique features, excluding cost/price. The salient features should tie in with Section M, Evaluation Factors. Any summary material presented here shall not be considered as meeting the requirements for any portions of other volumes of the proposal.

4.2 Table Of Contents (TOC)

The Offeror shall include a TOC of the volume.

4.3 VOLUME II/SECTION II – TECHNICAL APPROACH (FACTOR 1)

The Offeror shall provide a technical approach which demonstrates a clear understanding of all the tasks to be performed, the methodology and flexibility that will be utilized, and how the approach will accomplish all tasks, subtasks, and administrative tasks as are necessary to ensure program success. The Offeror’s technical approach shall demonstrate a mix of prime and subcontractor capabilities to address the breadth of requirements in the PWS. In addition, the Offeror shall address the following in the technical approach:

a. A clear working knowledge of the entire trauma system, to include the point of injury, en-route care, emergency room/trauma bay, operating rooms, and inpatient settings

b. A strong working knowledge of the important elements of multi-center clinical research studies to ensure accuracy and reliability of data collection among each clinical site.

c. Addresses the entire clinical research process, to include the use of a central IRB, well-designed data collection and data submission process, and a collaborative approach to research analysis and data interpretation.

The technical approach shall demonstrate its methodology for yielding success and managing or reducing risk (cost, technical or schedule) to the Government.

The Offeror’s technical approach shall also address the requirements of the Task Order 0001 PWS (Attachment 2) and demonstrate an understanding of those requirements. The Offeror’s technical approach shall demonstrate the manpower and resources necessary to complete the tasks outlined in the Task Order PWS. The Offeror shall address the topic areas needed to request Institutional Review Board (IRB) approval at the site where the proposed central IRB will be located. At a minimum, this should include background, specific aims, research methods, analysis plan, and subject confidentiality protections. The Offeror’s technical approach shall demonstrate the ability to provide deliverables if required by the tasks in the Task Order PWS. ** Upon award of the base IDIQ contract, the Government will immediately award this task order based on the proposed approach.

4.4 VOLUME II/SECTION III – MANAGEMENT APPROACH (FACTOR 2)

The Offeror’s management approach shall relate management activities to all contract requirements. The Offeror’s management approach shall demonstrate its capability to manage in a manner that will ensure the successful operation of all work associated with the requirements of the PWS, to include but not limited to: multiple task orders; ability to manage all aspects of the work and provide reports and status to multiple agencies; data management and protection of data; protection of personal identification information; maintenance of facility security clearances; and all other aspects of the PWS.

The Offeror’s management approach shall present management strategies in detail and fully describes its management structure, critical management and support personnel, and lines of authority.

The Offeror’s management approach shall explain how its chain of command practices will contribute in a positive manner to ensuring completion of all tasks (particularly emphasizing communications, accounting, crosschecks on schedule early enough to take necessary corrective actions, and flexibility in allocating resources based on Government established priorities).

The Offeror’s management approach shall reflect how it will meet and comply with the requirements to control, coordinate, and direct performance, as well as organize and manage resources that will achieve the technical/scientific requirements established in the PWS. The management approach shall demonstrate the Offeror’s approach to selecting, directing, and managing subcontractors including the approach to overseeing execution of tasks. The Offeror’s management approach shall include a management and communication plan of how team of enrolling sites (subcontractors) will expand, contract, and adapt to requirements of future task orders. The management and communications plan shall address the communications strategy among enrolling sites and the Government. The Offeror’s management approach shall describe its plan for ensuring that performance is at the level required to ensure timely and effective contract execution.

The Offeror’s management approach shall include a Quality Control Plan (QCP), which reflects how the Contractor will meet and comply with the quality standards established in the PWS. The QCP shall demonstrate how the Offeror will achieve and maintain quality, timeliness, responsiveness, and customer satisfaction. The QCP shall include but not be limited to a clinical monitoring plan for LITES studies and processes for handling study materials (devices etc.). Note clinical study monitoring shall be in compliance with Good Clinical Practice Guidelines.

4.5 VOLUME II/SECTION IV – EXPERIENCE (FACTOR 3)

The Offeror’s experience shall demonstrate relevant research management experience identical to, similar to, or related to managing and performing all services contained within the Base PWS and in performing proposed processes and procedures.