Q A_for_RFP-15-100-SOL-00004_4.16.15.pdf

Questions and Answers for BARDA Chem and RadNuc Animal Model Development

RFP-15-100-SOL-00004

1. Q: Are salaries capped at the current Exec Level II ($183,300)?

A: Yes. Section I includes the full text clause of 352.231-70 Salary rate limitation (January 2010).

2. Q: Can a US company incorporated in the states with approximately 275 employees that is owned 100% by a foreign based company be considered a “Small Business” for purposes of this

RFP?

A: If a majority of a company is owned by a foreign business entity then that company cannot be considered a small business. Please refer to the following Code of Federal Regulation §121.105.

3. Q: What is a “GLP study”?

A: A GLP study is one conducted in compliance with 21 CFR Part 58.

4. Q: We have a GLP-like study currently being performed (set to end in February), but have not completed any fully compliant GLP studies. Are we eligible to propose?

A: No. Mandatory Criteria #5 states “The Offeror shall have completed at least one existing GLP Study”. (M.2. Mandatory Criteria for Eligibility)

5. Q: It shall not exceed 50 pages – is that inclusive of the 15 (30) pages for the sample ROTR or are these in addition?

A: The 50 page limit does not include the sample ROTR.

6. Q: The budget shall reflect all cost information per objective as delineated in the SOO (page 9): Does this mean we budget to keep our facility at the ready to bid on (ROTR) and potentially receive TO’s.

In preparation of this budget shall we include estimated effort for personnel (key personnel/program admin core staff/lab staff)? Equipment maintenance costs and regular calibration costs as required by GLP? Veterinary resources?

A: All item described in the question are part of the facility overhead charge. These costs are than spread to all lab users (clients). It is the responsibility of the offeror's lab to manage these costs.

7. Q: The budgets for the potential TO’s will be in addition to the budget provided under our business proposal as included in this response?

A: The sample ROTR and its associated budget is being used by BARDA to 1. evaluate the offeror's technical capability and 2. provide an indicator of the Offeror’s cost structure. All of the successful RFP Offerors will have an opportunity to bid on future ROTRs but they must use the cost structure proposed in the RFP.

8. Q: As for the labor categories and labor rates – most of our employees are salaried and not paid hourly and when budgeting we usually base this on percentage contributed to project – can we alter the table to reflect this as such or should we attempt to list hourly rates?

A: It is the Offeror’s responsibility to define the hourly rates.

9. Q: In regards to the OH column does this include the applicable F&A rate or is this added later.

A: F&A should be broken out if an institution uses this category for determine total labor rates.

10. Q: On Page 39 of the RFP, paragraph H.19 indicates that "No information related to data obtained under this contract shall be released or publicized without the prior written consent of the COR". This clause directly conflicts with HHSAR Clause 352.227-70 which allows for publication of the results of the research performed under this contract. Can you please confirm that there would be no restrictions placed on publication of the results of the research performed under this contract if our proposal were selected for funding?

A: Clause H.19 of the RFP does not conflict with HHSAR 352.227-70. RFP clause H.19 functions as the type of restriction which is explicitly permitted under HHSAR 352.227-70.

The studies under the referenced RFP will have the awardees function as a Contract Research Organization (CRO). It is anticipated that some of the task orders will be for proof of concept studies in support of the BARDA portfolio to create data for FDA submission. In studies where product specific data is included, the CRO will not be the Sponsor and therefore will need permission from BARDA and the Sponsor prior to any publication or information dissemination.

11. Q: In section L.5.2. Business Proposal – Components where is the referenced “Government notice…” located so we may include it in our Business Proposal?

A: Please refer to HHSAR 352.215-1 Instructions to Offerors--competitive acquisition and FAR 52.215-1(e) Restriction on disclosure and use of data.

12. Q: RFP Page 64, L.2.1, subsection 4. BUSINESS PROPOSAL: Please identify the section or page of the Statement of Objectives (SOO) that contains “…the information requested in the SOO (emphasis added) associating cost with identified task and all labor categories and labor rates for work under a prospective contract…” A: L.2.1. Business Proposal does not reference a specific page in the SOO. It refers to associating costs with the identified tasks and labor categories described in the SOO. Section L.5.2 clearly breaks out the components of the Business Proposal.

13. Q: L.2.1, TECHNICAL PROPOSAL: (a) Do the cover page and table of contents count against the page limitation? (b) Are the page limitations for responses to the technical evaluation criteria and the information requested in the SOO in the form of an Statement of Work (SOW) (maximum 50 pages total) and the page limitations for Appendices provided with the technical proposal (maximum 50 pages total) mutually exclusive, i.e., is the maximum page count for the entire Technical volume 50 pages or 100 pages?

A: The cover page and table of contents DO NOT count against the page limitation. The technical proposal may not exceed 50 pages. The appendix of the technical proposal may not exceed 50 pages. (L.4.1)

14. Q: L.2.1, BUSINESS PROPOSAL: (a) Do the cover page and table of contents count against the page limitation? (b) Are the page limitations for the information requested in the SOO associating cost with identified task and all labor categories and labor rates for work under a prospective contract (maximum 50 pages total) and the page limitations for the business portion of the Offeror’s response to the appropriate Sample Request for Task Order Response (maximum 15 pages total) mutually exclusive, i.e., is the maximum page count for the entire Business volume 50 pages or 65 pages?

A: The cover page and table of contents DO NOT count against the page limitation. The maximum page count for the entire Business volume 50 pages. (L.5.1)

15. Q: Is a laboratory ineligible to apply under mandatory criteria #5 if the most recent GLP Study was completed over 3 years ago?

A: Mandatory criteria #5 requires completion of “at least one existing GLP Study”. Compliance is demonstrated by providing a list of all studies completed within the last 3 years. However if it has been longer than 3 years since the last GLP Study was completed then it is acceptable to provide a list of activities dating back further than 3 years.

16. Q: Can you please clarify the requirement for this RFP, particularly if the requested budget should reflect a hypothetical study for the sample task orders, the way it would be addressed by my lab (i.e. GI-ARS in the minipig)?

A: Please refer to Section L.4.1 Technical Proposal Instructions and L.5.1. Business Proposal Instructions. The components of each volume (Technical and Business) are also described in detail within each of those sections.

17. Q: Is there a requirement for font size?

A: Submissions should be single-spaced, paginated (consecutively starting with page 1), and readable in all required copies. (L.2. Delivery and Packaging of Proposal)

18. Q: Can the budget be prepared following the sample task order for minipig GI-ARS (attachment 2, pg 93), but using a typical mouse H-ARS model instead (since mouse H-ARS studies is my area of expertise and what I will be proposing)?

A: The budget should be based on the Sample Task Order as indicated in the RFP. Alternative animal models should not be submitted in response to the Sample Task Order and to do so would be considered non responsive.

19. Q: Is the budget for the sample task order to be a fixed cost budget, or a cost reimbursement model?

A: For the Sample Task Order the budget should be cost reimbursement.

20. Q: Will a time line meet the requirement for a Gantt chart?

A: Please see section L.4.1.1.(4)d.

21. Q: L.5.2.(6), Past Performance: at RFP page 69, this section states that the Offeror shall provide a list of the last five (5) contracts completed during the past three years and all (emphasis added) contracts currently in process. On page 70 of this section regarding Past Performance, the RFP references “…performance under existing and prior contracts for similar products or services” (emphasis added). Please confirm that the Government is seeking a list of all contracts currently in process that are for similar products or services identified in the RFP SOO, and not a list of all contracts currently in process.

A: Yes the Government is seeking a list of all contracts currently in process that are for similar products or services identified in the RFP SOO.

22. Q: RFP Pages 67-68, L.4.2, Appendices to Technical Proposal: Sub-paragraph 3) “Animal Welfare Assurance.” does not specifically request that the Offeror submit its Animal Welfare Assurance as part of its proposal. However, that same Sub-paragraph states that “Offerors must submit their plan on how they will comply with all requirements concerning the use of animals….” Please clarify if “their plan” means the Animal Welfare Assurance or if it means the Offeror’s approach to meeting all requirements concerning use of animals.

A: “Their plan” means the Offeror’s approach to meeting all requirements concerning use of animals.

23. Q: Reference requirement for “small and large animal models”: If we use subcontractors, are we required to submit a budget along with the statement of expertise relative to small or large animals. Ex: IF we submit for a single large (or small) animal model; and use subs for mouse (large animal) models, is it responsive to just submit a statement of capability and expertise for the subs OR do we need that PLUS a budget for what a mini-pig GI model?

A: Each Offeror is required to have the capability to respond to future task orders that involve small and large animal models (Mandatory Criteria #6 and #7). The budget should be based upon the animal model identified in the sample task order.

24. Q: Attachment 15, the Security Plan Template references a proposed listing of sensitive information, Appendix A, but there is no Appendix A in the document. Will the document be amended to include this?

A: Attachment 15 Security Plan Template has been updated to remove references to Appendix A and Appendix B. The updated Attachment #15 has been uploaded to FBO along with this Q&A response.

25. Q: Can my company get an extension for proposal submission?

A: All proposals must be submitted by 12PM Eastern Time on May 4, 2015. Proposals received after that time will be considered non responsive.