Responses to Vendors.pdf

Responses to Vendors’ Questions

i. First, the RFP says a large animal model must be used. Do rats qualify? Or is FDA hoping for something larger such as a rabbit, pig, non-human primate/monkey, etc.?

Response COR: Rabbits would be acceptable to meet testing metal implants relative to human immune response. If the investigator readily has non-human primate models, porcine, equine, or other larger mammalian models accessible and are able to conduct the work described within the described timeline these models are also acceptable. While these scenarios are preferred, we would also consider proposals that integrate finished metallic devices into smaller animal models, if the device were sufficiently sized to be localized.

ii. Two, Funding amount or total budget not mentioned. It would be helpful to know what the total award amount is so that the bidder can figure out what’s possible not only within a 1-year timeframe, but also with the funds potentially available.

Response: The FDA cannot disclose the budget allotted to the requirement. The bidder must determine the budget needed for them to address the scope provided in the solicitation.

iii) There is also a section mentioning monthly invoices. Does this mean that contractor’s need to pay for things upfront and then get re-imbursed later in a monthly fashion?

Response COR: Correct, the FDA pays for work completed (e.g. experimental design, materials, animals, analytical services etc.), which is itemized in an invoice for the payment period.

vi. Though all of the attachments for this call have been downloaded, and the Vendor hasn’t interacted with the FDA before, the Vendor is curious what specific documents are needed now, other than a proposed project/research writeup?

Response COR/CO: Vendors should develop and submit the proposal as instructed. Nothing additional is required of the Vendor that has not been mentioned in the solicitation.