00019-Q A.pdf

RFP 15-100-SOL-00019 Questions and Answers

Autograft-Sparing Products for Definitive Care of Burn Injuries

15-100-SOL-00019

QUESTIONS AND ANSWERS

The following are answers to questions received from potential Offerors:

Q1: Is the Mandatory Criteria a stand-alone section or is it intended to be a portion of the Technical

Proposal? Page 53 states that the Mandatory Criteria should be a separate section for submission, however, it is also included under instructions found in L.3.1.1. (2) for Technical Proposal Overview.

A1: Mandatory Criteria shall be a separate section as described in section L.2. of the solicitation.

Q2: Do the title page, table of contents, and government instructions on handling proposals count towards the 75 page limit for the technical proposal?

A2: No, the above mentioned documents do not count towards the 75 page limit for the technical proposal.

Q3: Should the mandatory criteria section describe and support the status of the product or is it just a statement that the product meets the criteria?

A3: All Offerors shall clearly state if the product meets the mandatory criteria as described in

Section M of the solicitation as well as a narrative that supports this position to be no longer than 5 pages.

Q4: Can you make editable versions (Word or Excel, as appropriate) of attached forms and questionnaires available?

A4: Yes, an updated word version is now posted to FBO for this solicitation.

Q5: Please verify the correct zip code is 20024.

A5: The correct zip code for this building is 20024 for all FedEx and UPS packages.

Q6: Is there an anticipated award ceiling?

A6: There is no set award ceiling for this requirement.

Q7: Is the 75 page limit for the business proposal just for the breakdown of proposed costs or does it also include all of the required forms (Points of Contact, Related Activities, Disclosure of Lobbying Activities, Past Performance Questionnaires, and Representations and Certifications)?

A7: There is no page limit for business proposals. The solicitation is amended to reflect this change.

Q8: BARDA templates are given for the Work Breakdown Structure (WBS), Gantt Chart, and Contract

Milestones/Deliverables. Is there an additional template that should be followed for the Integrated Master Project Plan, such as DOD's Integrated Master Plan (IMP), or is it sufficient to integrate the aforementioned documents to show interdependencies?

A8: There is no template that should be followed for this solicitation. Please ensure that certain criteria are listed in order to illustrate all accomplishments in the Integrated Master Project Plan.

Q9: Is the Integrated Master Schedule the same Gantt chart referenced in 5.1.1 (page 11)?

A9: Upon award of a potential contract, all Offerors shall provide a MS Project (or equivalent) file detailing the execution of the program. The information on the left side of the file is considered the Integrated Master Schedule which will automatically generate a Gantt chart.

Q10: In Attachment 13, Risk Mitigation Plan/Matrix Template, the referenced document is provided in the instructions on Page 88. However, it is unclear whether this completed template is to be included in the proposal (in addition to the Risk Register), or whether it is only a contract deliverable. Can you please clarify? If Appendix 13 is to be included in the proposal, do we only need to complete the leftmost (pink) columns for "Prior to Risk Mitigations Strategy" for the proposal?

A10: Attachment 13, Risk Mitigation Plan/Matrix shall be completed within 90 days if awarded a contract. This does not need to be submitted prior to award.

Q11: Can you confirm that section L.4.3.5 is asking that proposed major subcontractors also complete

Past Performance Questionnaires covering the previous 3 years? What constitutes a “major” subcontractor?

A11: For the purposes of this solicitation, a major subcontractor is defined as one performing overall work with a value of $500,000 and above.

Q12: Section 3.3.1.3 (page 9) states that for products in development, Contractors shall provide data from all GMP lots used in Phase II and Phase III clinical studies as appropriate. Please clarify the specific data that is being requested.

A12: When different GMP lots have been used in Clinical studies, all Offerors shall provide data which supports their stability and use in the indication being pursued, as shared with the FDA. The data must be consistent with the overall scope and mandatory criteria in the solicitation.

Q13: In Section 4 (Procurement, Storage, or Delivery of Product Objectives), the USG is seeking product (FDP) availability to treat up to 680 m (and 2000 m of surge capacity) skin surface area with deep-partial and/or full-thickness burn injuries. We have 2 questions pertaining to this requirement:

a. In cases where a single device treats a single patient, the inventory required is affected not only by the total area to be treated, but also by the number of patients involved. Can BARDA break down the 680 m total area (and 2000 m of surge capacity) by number of patients and distribution of wound sizes?

A13a. BARDA cannot specify a breakdown metric to the target amount of 680 m

. All

Offerors shall specify their own rationale/approach. Since a single device or product unit treats a specified amount of injured area, Offerors shall specify the calculation as to how the proposed procurement amount may either partially or fully meet the 680 m target under section 3.4.1; sections 4.3.1 and 4.3.2; and surge capacity (section 4.3.3).

b. Is there a minimum threshold of wound area to consider for purposes of mass casualty event planning (e.g. what is the expected minimum TBSA injury planned to be treated during a mass casualty event)?

A13b. BARDA cannot specify a target amount. All Offerors shall specify the treatment capacity for a unit product and be consistent with the assumptions used for procurement. Note that the expectation is for products to be commercially viable to treat the burns in mainstream or normal market conditions.

Q14: Inventory and Logistics:

a. Should multiple/distributed stockpile sites be planned? If so, should each site contain the full inventory to treat 680 m (and 2000 m of surge capacity) of skin surface area?

A14a. In the RFP the specified procurement limits for products to treat burn injuries are up to 680 m and 2000 m

. These indicate the maximum amount up to which the

USG may consider procurement under CLIN 0002 (Base) or under CLIN 0005 (Option), respectively.

The final quantity procured and the intent to exercise the option for CLIN 0005 being at the sole discretion of the USG.

The Offeror may choose to have one or more VMI facilities and can specify it in response to Section 4 of the SOO in the solicitation.

b. Are there any requirements for delivery of wound treatment products in advance of the start of definitive care (e.g., 24 hours prior to use)?

A14b. In accordance with the terms and conditions of this solicitation, there are no requirements for delivery of wound treatment products in advance of the start of definitive care.

c. Is it anticipated that patients will receive definitive care near the event site, or transported away from the site to treatment centers? Based on this, will stockpiled items be distributed primarily to (near) an event site, or to multiple sites around the country corresponding to the locations of anticipated treatment centers?

A14c. As specified in section 4 of the SOO in this solicitation, procurement, storage, or delivery of product is planned using a Vendor Managed Inventory (VMI). Hence, it would be up to the Offeror to specify the number of locations for delivery which is consistent with the principles for supporting commercial use to treat the burns in mainstream or normal market conditions.

The logistics governing the procurement are specified in sections 4.3.4. and 4.4. of the SOO in Section C of the solicitation.