00021-QA-_Debridement_(2).pdf

Non-Surgical Debridement for Definitive Care of Burn Injuries

15-100-SOL-00021

QUESTIONS AND ANSWERS

The following are answers to questions received from potential Offerors:

Q1: Would it be beneficial and appropriate to include data and studies evaluating treatment of burn wounds from radiation or chemical agents…in this proposal?

A1: Please refer to page 6 sections 1 and understand the scope under section 2. Under this RFP, BARDA plans to support late stage development and acquire medical countermeasures to address the recovery and healing of burn victims.

Q2: Is BARDA looking to vendors for the development of a nonclinical model specific for the treatment of wounds affected by radiation/chemical agent as part of this proposal?

A2: Please refer to the response to the question 1 above.

Q3. Is BARDA seeking specific packaging of the burn care products specified in this proposal for field use?

A3: Please refer to the title, page 6 for sections 1 and understand the scope under section 2. BARDA is not seeking specific packaging of products for field care.

The expectation is the products procured under this RFP are also products to treat the burns in mainstream or normal market conditions in burn care facilities. As such they would be expected to have packaging for commercial use and managed under Vendor Managed Inventory (VMI).

Q4. The RFP indicates that the desired manufacturing capacity is for the production of 680 m2 of skin surface, with a surge capacity of up to 2000 m2. Over what time period would BARDA require to have these amounts produced?

A4: Please refer to section 4.3.1, which covers the initial procurement of product to treat up to 680 m2 of burn injuries, based on availability, the amount being at the sole discretion of the USG.

Please refer to section 4.3.2, which requires a production plan and timeline under normal market conditions for product availability up to 680 m2. If the current production capability is unable to meet the stated availability, then information (production plan and timeline) can be provided that would allow the Offeror to meet this overall requirement in a defined period of time.

The USG is seeking product availability to treat up to 680 m2 which meets either criteria 4.1 or

4.2. The ‘timeframe’ would depend on the when the product becomes eligible under the criteria and the production capacity. Please note that procurement of products must be initiated within the 5 year period of performance.

The initial procurement (under VMI) negotiated during a potential contract award would be for a defined amount of product over a timeframe (driven by the production capacity). Product expiring during this time-frame has must be replenished to maintain the inventory amount negotiated.

Q5. Is supply and sale of the product only in the event of a national emergency? Will you be buying and using as part of standard operations?

A5: This RFP covers an initial procurement under CLIN 0002 as described in response to Q4.

RFP 15-100-SOL-00021

Questions and Answers

Q6. Will it be a pre-purchase or will you only by as needed?

A6: A potential contract award would include procurement for a defined amount of product over a timeframe after meeting criteria under section 4.1 or 4.2. The amount of product procured would be at the sole discretion of the USG. Please note that procurement of products must be initiated within the 5 year period of performance.

The product procurement would be under a Vendor Managed Inventory (VMI) and the logistics are mentioned in Sections 4.3.4 and 4.4. If considered for award, the actual amount (unit increments to meet up to 680 m2) and specifics of VMI would be discussed during contract negotiations.

The additional procurement (Surge Capacity) for 2000 m2 is an Option (CLIN 0005) which may or may not be exercised at the sole discretion of the USG. All Offerors are required to provide information in a tabular format with cost and schedule for procurement in 100 m2 increments as mentioned in section 8.1 and see applicable conditions in section 4.3.

RFP 15-100-SOL-00021

Questions and Answers