A07_SOLICITATION_AMENDMENT_(W81XWH-16-R-0033-0002).docx

W81XWH-16-R-0033

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION C - DESCRIPTIONS AND SPECIFICATIONS

The following have been modified:

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 solicitation reflecting this change 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.

52. Where will the Military Health System Research Symposium/other national medical conference be held?

Gov’t Response: The 2016 Military Health System Research Symposium will be held in Orlando FL. The venue may change annually. MHSRS information can be found on their website at: https://mhsrs.amedd.army.mil/SitePages/MHSRS_2016.aspx

Regarding other national conferences please reference their websites.

53. Because this is a cost reimbursement type contract, please confirm that the Prime Contractor will present unloaded rates in Task Order 0001.

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

54. Please confirm that the Attachment 1-Labor Mix Pricing Sheet, is required only for the prime contractor, and not for subcontractors or consultants.

Gov’t Response: Please reference response to Question 5.

55. Since this is a cost reimbursement type contract, please confirm that the labor rates proposed in Attachment 1 are representative rates, and not maximum rates since we will invoice based on actual costs incurred.

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

56. Please provide some assumptions about the number of subjects expected to be enrolled in the study described in Task Order 0001. If these assumptions are not possible at this point, should we make our own assumptions based on the number of sites?

Gov’t Response: The number of subjects to be enrolled is not prescribed by the government. It is expected for bidders to propose the number of subjects that will be required based on a power analysis.

57. Since we are not planning to assign substantial scientific control to each of the enrollment sites, we anticipate structuring the upcoming task orders computed based on enrollment at multiple sites, with each site receiving the same dollar amount per subject. Is this an acceptable approach?

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

58. Due to the complex nature of this proposal, and the limited amount of time provided between the solicitation release date and the response date, we respectfully request an extension to July 29th, 2016 at 2:00 PM.

Gov’t Response: Yes.

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