Amendment 2 Responses to Questions.docx

Amendment 2

Responses to Questions:

1. Allotment of funds given upfront?

0. FDA does not allow advance payments. Payment is made for work accomplished and received by FDA via the FDA invoicing system, monthly or quarterly based on deliverables. No allotment of funds can be given upfront, which means there’s a higher administrative burden on keeping track of invoices and submitting for reimbursement. The fee-for-service mechanism can be tedious to the investigator, including initiating projects. To buffer these concerns and to assist investigators FDA developed the RFP with the initial deliverable to be the experimental design. This deliverable will allow the FDA and investigator to evaluate the projected experimental procedure, model systems, and other significant parameters to meet the project goals and collaboratively address any concerns to the investigator. Additionally, this deliverable will serve as the first point of service resulting in payment which should then further assist the investigators with the next stages of their project, including purchases for their experiments.

1. We were also curious if a contract is agreed to upfront, if the research data takes us in a slightly different direction, we were wondering if there any mechanisms with such an arrangement to be able to re-allot some subset of funding to perform new studies as needed. We can of course write things a bit more general to begin with in order to be more (rather than less) inclusive perhaps.

1. So long as this is kept within the scope and does not incur additional cost to the government, as this is a firm fixed price contract. Per end user, for the this question, “the answer would be yes, but likely what would happen is – the investigator will share data and we would all discuss the results (FDA and the investigative party) and the investigator will share how they would like to approach answering this new question. The RFP is more broadly written for this solicitation with that consideration in mind.

0. FDA we will be supportive so long as things data and potential new experiments were shared and mutual agreements made.

0. The goal even though it’s a fee-for service solicitation remains scientific, FDA recognize that as experiments are conducted and results are gathered changes in hypothesis will occur and new directions pursued.