TOPIC RELEASE 1 Q and A _Ph II.pdf
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- Solicitation number
- HDTRA1-20-S-0001
- Issued by
-
Defense Threat Reduction Agency
About this file
This document contains questions and answers regarding the Defense Threat Reduction Agency's Chemical/Biological Technologies Broad Agency Announcement solicitation number HDTRA1-20-S-0001. Key details include that the Broad Agency Announcement will remain open for one year to release topics as they become available in the areas of chemical and biological defense technologies ranging from Technology Readiness Levels 3 to 6. Questions and answers provide guidance that subcontractor cost proposals can be accepted separately if proprietary information is a concern, biosketches for key personnel may be included as attachments, and clarification is provided on addressing regulatory strategy in proposals.
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Question Answer
Q1: For Topic CBS-03, a comment raised concern about regulatory strategy and suggested that "resolving the regulatory strategy should be a high priority in the project." Additional detail on the proposed regulatory strategy in the grant proposal will be provided and include a timeline, budget and milestone for formal meeting(s) with FDA to confirm the regulatory approval strategy is consistent with FDA’s expectations for the proposed product. Would this approach adequately address the reviewers’ comments? If not please suggest a preferred approach for resolving the regulatory strategy.
A1. The proposer's approach is appropriate as far as it goes. The intent in addressing regulatory strategy in the proposal is to have clarity that the proposed effort will be able to deliver a licensable product. The proposer's detailing of the steps as described, along with stating what the status will be at the end of the project and what will need to follow afterward, should be sufficient. If there are any uncertainties in the regulatory plan, risk mitigation should be discussed.
Q2: For Topic CBS-03, in the BAA, there's a requirement for a substantial amount of detail and justification about the proposed costs, including BOE and Cost Narrative. We are required to provide this info for all subcontractors as well. This is not always feasible as some of our subcontractors, while able to provide standard price quotes for most part, do not necessarily provide/disclose all the info requested by the BAA. How do we resolve this?
A2. We can accept subcontractor full cost proposals by separate email if there is a concern regarding proprietary information. The offeror should provide as much subcontractor information as possible in their proposal and inform subcontractors to be prepared to submit the cost details to the contracting office if requested.
Q3: For Topic CBS-03, we have NIH-style biosketches for our key personnel. Is there any way to include these in the proposal or should these just be briefly summarized under "Credentials"?"
A3. The "Senior/Key Person Profile" section of the proposal, under RESEARCH & RELATED Supplemental Form, permits attachments. Please attach biosketches there, if desired.
HDTRA1-20-S-0001 Phase 2 Q&A
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