Q A_for_RFP-15-100-SOL-00004_4.24.15.pdf

Questions and Answers for BARDA Chem and RadNuc Animal Model Development

RFP-15-100-SOL-00004 (4/24/15)

1. Q: Should the Small Business Subcontracting Plan be based on the dollar amount of the proposed task order or the Maximum Ordering Amount of $100,000,000?

A: The Small Business Subcontracting Plan should be based on the dollar amount of the sample task order.

2. Q: Do we submit at this stage a ‘sample’ small business subcontracting plan based on our responses to the sample task orders under attachment #1 and/or #2? Or is the submission of a small business subcontracting plan is not needed until the master agreement has been awarded and we compete for the RTORs?

A: A Small Business Subcontracting plan needs to be submitted as part of the proposal. (See section L.5.2. Business Proposal – Components, Section 7: Small Business Subcontracting Plan.) The plan will be will be subject to negotiations if the proposal is determined to be in the competitive range and the plan will be included in and made a part of any resultant contract. (See Section M.8)

3. Q: Does a CRO need to be a full service organization to apply and to qualify? That is, could a

CRO that only performs small animal studies or a CRO that only has NHP capability apply successfully and become part of the BARDA non-clinical network?

A: A CRO that has only small animal studies capability should provide a plan to expand capability to include large animals. A CRO that has only large animal capabilities should provide a plan to expand capability to include small animals.

Section M.2., item #7 states:

The Offeror must also provide a plan for conducting studies in both small and large animals.

Subcontracting is an available option to expand capabilities. The Offeror shall provide a list of all animals (small and large) that the Offeror can accommodate (noting any proposed subcontracted capability). Also (if applicable) the Offeror shall provide copies of any agreements or intention statements with potential subcontractors that could be used to expand capability. (Applies to both Chem and RadNuc)

4. Q: How does an organization that has no mini-pig capability or experience respond to the draft

RTOR?

A: Subcontracting is an available option to expand capabilities. Please see response to #3.

5. Q: The answer provided in the 4/21/15 Q&A to item #3 is confusing. What does the following sentence mean? “Contractors under the IDIQ will compete against each other for RTORs. RTOR submitted offers (or intentions to submit offers) should not be discussed between Contractors - to do so would be collusion.”

A: Prior to RFP/IDIQ award, all responses to the RFP/IDIQ come from “Offerors” and Offerors are encouraged to subcontract, collaborate and team as needed in order to expand their capabilities and make their proposal as strong as possible. After the awards are made for the RFP/IDIQ the awardees are now “Contractors” and Contractors are not allowed to discuss their responses (or intentions to respond) to task orders/RTORs with the other awarded Contractors under this RFP/IDIQ.

6. Q: Given that some response documentation to Section H can be lengthy, can we include the documentation for the following requirements in the Mandatory Requirements section, which has no page limit?

Questions and Answers for BARDA Chem and RadNuc Animal Model Development

RFP-15-100-SOL-00004 (4/24/15)

i. Information on Compliance with Animal Care Requirements

ii. Requirements for Adequate Assurance of Protection of Vertebrate Animal Subjects

iii. Care of Laboratory Animals

iv. Care of Live Vertebrate Animals

v. Conflict of Interest

A: No, other documentation cannot be included in the Mandatory Requirement Section because the Mandatory Requirements section should be a dedicated section that addresses only the mandatory criteria for eligibility. The Mandatory Requirements section will be reviewed for compliance prior to the technical review of the proposal (L.2.1 and M.2).

Please include the Section H response items at the end of the Appendices to Technical Proposal section after the items listed in L.4.2. Clearly designate within the Appendices where Section H documentation begins and ends. The responses to Section H will not have a page limitation. All other documentation in the Appendices to Technical Proposal as listed in L.4.2 will need to be within the 50 pages limit as stated in the RFP.