QA's Post Pre-Proposal Conf 8 Apr 2009 v3.doc

Questions and Answers BARDA-09-100-SOL-0005

Pre-Proposal Conference 8 April 2009

1. The final scale required for the manufacturing process is dictated by the number treatment courses that will need to be provided over a defined period. Please provide guidance on the required treatment courses and the time span for delivery.

A. Clarification from previous answer published: This solicitation will not procure treatment courses for the SNS. The potential exists for successful candidates to receive a follow on competitive award for the procurement of treatment courses for Neutropenia for the SNS. Based on modeling, DHHS has a current requirement to treat up to 200,000 individuals for neutropenia resulting from acute exposure to ionizing radiation. To reiterate this solicitation will not procure treatment courses and the work required is defined within the solicitation.

2. Is there a “standard” award amount or cap established for this solicitation?

A. The Government is seeking candidates that present the greatest potential to develop a therapeutic to meet the stated requirement. All proposals with costs that are reasonable and realistic will be considered.

3. Are there limits to which a proposal may allocate funding, in terms of award percentages, to the different ARS product development activities, including manufacturing facilities? Are there specific areas within product development or manufacturing to which funding may not be applied?

A. Costs allocable to the contract, allowable by the contract and reasonable may be accrued by the Contractor and paid by the Government for performance of the effort. Costs not yet accrued are not allowable in cost reimbursement contracting. A proposal must provide the Offeror’s best estimate of actual costs to perform the effort. Funding may be applied to product development or manufacturing that is allowable and allocable to this contract in accordance with FAR 31.2.

4. Because of the limited potential commercial applications of products intended for the treatment of ARS, upon successful completion of the proposed project, and receipt of regulatory approval of a product license application (NDA or BLA), is there a process for approval and timeline for acquisition of the product(s) for the Strategic National Stockpile?

A. No, the Public Health Emergency Medical Countermeasures (PHEMC) Enterprise Implementation Plan for CBRN Threats (Apr. 2007) allows for advanced development followed by acquisition.

5. Experience has shown that the FDA Quality System regulations require medical device developers to follow a rather exacting procedure - neither simple nor low effort - known as Design Controls necessary for creating safe and effective devices. Application of Design Controls do not occur at the beginning or end of the development, but are continually applied throughout the process. Since many or most of the BAA respondents may not be medical device firms, does the DHHS envision the very significant level of effort required to support compliance with these regulations or will there be a special dispensation from the FDA for any devices developed under this contract?

A. This is not a device-oriented solicitation.

6. RFP Section F.3 (p. 10) states that the period of performance is “anticipated to be a maximum of 60 months.” FAR clauses 52.217-8 (Option to Extend the Services) and 52.217-9 (Option to Extend the Term of the Contract) are incorporated in RFP Section I.2 (p. 22) and provide for contract extension of up to 6 months, for a total of 66 months. Please confirm that BARDA may extend contractor’s performance period to 66 months pursuant to the FAR clauses in RFP Section I.2, notwithstanding the 60 month anticipated maximum period of performance stated in RFP Section F.3.

A. Correct. The terms and conditions allow the Government to extend the term up as many times as necessary up to a maximum of 6 months beyond the contracted period of performance. This may be required to complete some activity that has been started but cannot be completed by the end of the 60th month. Under rare circumstances would a new activity be allowed to start after the 60th month, however it is not prohibited. The caveat is that extension past the 66th month is unallowable even if an activity is not completed.

7. RFP Section L.8, Part 1(b) (p. 35) states “Non-clinical studies. The proposal shall contain existing relevant data or detail planned studies that evaluate non-clinical elements such as (1) safety, pharmacokinetics/ pharmacodynamics, bioavailability, solubility, formulation, dose, route and schedule of the therapeutic candidate/product in vitro and in animal models following Good Laboratory Practice guidelines (GLP: as defined in the U.S. Code of Federal Regulations – 21CFR §58).” Please confirm in light of this statement that BARDA would not view inclusion of non-GLP pilot studies as unacceptable.

A. All supportive data for pivotal product characteristics must be generated under GLP.

8. Is having an approved IND for an indication other than ARS by May 7th a disqualifier to submit for this opportunity?

A. It is not a disqualifier.

9. If BARDA decides to ask the Contractor to submit a specific data package to meet EUA or CU-IND, would this be handled under this contract as a modification?

A. BARDA wants the Contractor to perform studies which move their product down the path toward licensure for the treatment of neutropenia arising from ARS. Taken as a whole, the data obtained may form the basis for an EUA package. A pre-EUA data package would be submitted by the CDC, not by the Contractor.

10. Would a cellular product that may not be delivered orally, may not be stable at RT for 48 hours and may not be delivered in less than 1 minute be considered disqualifying characteristics?

A. Such a product may be responsive to the solicitation and would not be disqualified based on the characteristics listed.

11. Can the requirement for box/carton mockup be removed since no product is being shipped?

A. Yes. They can be removed but plans for overall storage and shipping should be part of an Offeror’s TPP.

12. Does an anticipated award by “the end of the fiscal” year mean a fully executed contract? Is there a potential for a pre-award period, i.e. 90 days?

A. Yes, the Government’s intent is to award one or more contracts by the end of the fiscal year. With the constrained timeline and an intent to make award by the end of the fiscal year, there is no anticipated pre-award period.

13. Considering an annual basis of funding, how would a contractor plan/execute development activities, especially with sub-contractors that span over, or more than 1 year?

A. The Prime Contractor is responsible for sub-contractor activities to include contract/agreement formulation and obligation. How a Contractor establishes those activities is up to the Contractor. For funding issues and concerns, terms and conditions of the contract, specifically FAR 52.232-22 Limitation of Funds, obligates the Contractor to provide the Contracting Officer advanced notification of when obligated funds will be expended or are expected to be expended. This methodology allows a Contractor who is aware of inadequate funding to fully cover a specific activity to provide notification before starting the activity. This will allow the Government to 1) provide more funding; 2) have the Contractor to proceed up to the funding limit; or 3) cancel/postpone the activity until adequate funding is available.

14. What is the rationale for the contract structure where by there is a one-year base contract and four one-year option periods?

A. The rationale is driven by applicability of available funding (limitation of funds), severability of a service contract, fiscal law and contract law. In short, unless the contract will be fully funded in the year awarded with current year appropriations (bonafide need) or meet the provisions of “Multi-Year Contracting” (FAR 17.1 and 41 U.S.C. 254c), which is not most advantageous to the Government in this acquisition, the most appropriate method to meet required statutes and regulations is through the base and option year structure.

15. Will there be an RFP amendment to extend the proposal due date to reflect a 60 day response period?

A. The Government does not anticipate extending the response time. The response period from time of RFP publication (Mar 13) on FBO to submission is 57 days. The synopsis for the effort was published Jan 16th and the draft RFP was published Feb 20th. Although the final RFP had changes from the draft, the core requirement remained substantially the same and total notification time afforded to all potential Offerors for consideration of this action at time of proposal submission will be ~111 days.

16. What optional ORCA representations are required for submission?

A. ORCA representations and certifications must be completed. If a required optional rep or cert is not completed, the Offeror will be afforded an opportunity to submit the required information in accordance with “clarifications” to correct administrative errors or omissions as specified in FAR 15.306. NOTE: This statement would apply to “optional” requirements that may not otherwise be known by the Offeror to be expected and expressly does not apply to a complete omission of representations and certifications as required by Section L of the RFP which may result in an Offeror being determined non-responsive. In addition to those representation and certifications on ORCA, there are several not covered by ORCA but are required by the FAR depending on the status of the company applying. Specifically, FAR 52.230-1 Cost Accounting Standards Notifications and Certifications. Such Representations and Certifications are listed in Section K of the RFP.

17. The Price/Cost proposal page limitation of 150 pages is too restrictive for cost information and sub-contractor’s cost information.

A. Experience shows that adequate pricing information for similar efforts is normally accomplished in 50-60 pages. If true, a 150 page limitation is more than adequate to submit the required data. The indication that 150 pages is not enough raises questions if the Offeror is submitting the appropriate data. To be clear, Cost and Pricing Data in accordance with FAR 15.4 is required from the Prime Contractor. Sub-Contractor Cost and Pricing Data is the responsibility of the Prime Contractor and is not required by the Government unless specifically requested to clarify an ambiguity. Sub-Contractors and Consultants are normally classified as “Other Direct Costs” (ODCs) on a Prime Contractor’s offer. Further, the Government negotiates and pays direct and indirect cost rates with the Prime. The Government does not pay indirect cost rates/pools of sub-contractors in most circumstances. See FAR 31.2 Cost Principles for more information.

18. Regarding EVMS: What has prompted the change between the draft RFP that did not require EVMS and the final RFP that has a requirement for an EVMS Implementation plan? Is the EVMS implementation plan negotiable? Is a fully validated ANSI compliant EVM system required? Is the timeframe for EVMS implementation negotiable?

A. By regulation and HHS policy, EVMS is not required for research contracts and was therefore excluded from the draft RFP. However, by regulation and policy, an EVM system is required for development contracts exceeding a specific dollar threshold. Ambiguity exists; especially this type of effort, between when “research” stops and “development” begins. After further definition of where the Government anticipates the final objective of this acquisition, the performance will have transitioned from research to development or be on the verge of development. Therefore, the Government is seeking success over the long term and requesting Offerors to submit their plan for implementation of an EVMS that is consistent with, not compliant with ANSI standards. Time and degree of implementation is at the discretion of the contractor. Successful candidates should understand that an EVM-like system will be required in late stages or follow on efforts and phasing in a plan positions both parties for continued success.

18. How should Contractor’s accrue/account for costs, especially if a specific even slides to the right from one contract period into another?

A. Under the rules of cost reimbursement contracting, a Contractor is only allowed to be paid actual accrued costs that are allocable to the contract, allowable by the contract and reasonable. Under such a scenario, costs for work planned but not performed in one contract period would be unallowable for payment and should not be invoiced for. The funds not disbursed but planned for that effort would remain on the contract and would be disbursed after performance is completed and properly invoiced. This would meet the allocable, allowable and reasonable requirements.

19. Is it appropriate to add in termination, cancellation or contingency fees that may need to be paid to sub-contractors for reserved capacity in the event a planned trial shifts to the right?

A. No, under the rules of cost reimbursement contracting, penalty fees, contingency fees or reserve fees of any sort are unallowable costs. Rationale is that only actual costs are paid when accrued and this is based on the Contractor’s best estimate to perform the work. Because penalty, contingency and reserve fees would only be required in the event of a certain contingency—which is an unplanned event—by definition they are unallowable and would be removed from an Offeror’s proposal. This does not mean that a legitimately incurred penalty fee during performance that is allocable, allowable and reasonable would not be an authorized cost and paid by the Government.

20. Does the Government understand that writing a base plus option year contract may significantly drive up costs?

A. The Government is operating within the laws and regulations for Federal Acquisitions. Federal R&D contracting is typically executed in this manner across all sectors and agencies. This method should not present a significant problem. The Government’s intent is to have this contract go to term—up to five years, and regardless of the contract structure, the Government is committed to the term. This said, fiscal appropriations are beyond our control and there is always a risk that funding will be withdrawn. However, this stands equally true for a 5-year CPFF incrementally funded contract and a 5-year CPFF base plus options incrementally funded contract. Further, proposed costs will be evaluated for cost realism and cost reasonableness in accordance with Section M of the RFP. Arbitrary inflation of costs may reflect an Offeror does not have a clear understanding of the requirement or may be determined to be unrealistic and/or unreasonable. Any of these determinations may be unfavorable for potential offerors.

21. Can clinical or pivotal studies be performed outside of the US?

A. Yes. Offeror’s need to consider that all studies need to be performed to acceptable standards per FDA requirements.

22. Other studies may be required by the FDA. Will these studies be covered?

A. Yes.