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U.S. Department of Health and Human Services

Preparing White Papers

White papers or full proposals are required in Stage 1 of the application process in response to the Broad Agency Announcements (BAAs) for Advanced Research and Development of Medical Countermeasures for Pandemic Influenza and Chemical, Biological, Radiological and Nuclear Threats. The specific requirements and instructions for preparing and submitting white papers are included in each BAA.

Frequently Asked Questions

Communicating with ASPR/BARDA | Deadlines | Definitions | General | Technical | Templates

Communicating with ASPR/BARDA:

Question 1: Are communications with ASPR/BARDA allowed after white paper submittal?
The only exchange with offerors allowable after submitting a white paper is with an AMCG Contracting Officer.

Question 2: Why haven’t we had any response in regards to our white paper submission although the allotted time for review has passed?
You should receive feedback from an AMCG Contracting Officer on your white paper within the 90 day window following the submission deadline. If this does not occur, please contact the Contracting Officer listed as the point of contact for the BAA on FedBizOpps.gov.

Question 3: I know my project’s maturity level is not yet at the stage indicated in the BAA and that I may seek opportunities with another government agency. What other ways can I present my research to BARDA personnel?
Interested product developers may participate in BARDA’s Technology Watch program. You may also contact via email any of the Technical Points of Contact listed in the BAAs.

Deadlines:

Question 1: Can submission deadlines occur on weekends or government holidays?
No. Submission deadlines are typically during the standard work week, Monday through Friday. However, if the deadline for submission falls on a Saturday, Sunday, or government holiday, the white paper will be due on the next business day.

Question 2: If I submit a white paper a few days after the cutoff date does that mean that my white paper will “sit and wait” for three months to be reviewed?
The deadline dates provide time frames for white paper review and the decision letter response. Upon white paper submission, decision letters can be expected to be provided within 90 days after the next cutoff date. Depending upon availability of reviewers and BARDA/AMCG workload, it is possible that if your submission is beyond the cutoff date, review of your white paper may be scheduled with the white papers submitted before the next white paper deadline.

Question 3: Does the deadline apply to both white papers and full proposals? That is, if an investigator were to submit a white paper by the cutoff date, would the investigator still have the opportunity to be invited for a full proposal?
The Broad Agency Announcement (BAA) encourages companies to first submit a white paper. However it also allows for companies to skip the white paper process and submit a full proposal. For the 2018 Broad Agency Announcement  for Advanced Research and Development of Medical Countermeasures for Pandemic Influenza and Chemical, Biological, Radiological and Nuclear Threats, your first submission (white paper or possibly full proposal) must be received by the next interim deadline or closing date of the BAA (please note: future iterations of the BAA may vary). If you choose to submit a white paper, the review process is completed an then a letter is sent that either informs you that the submission is not invited for a full proposal or that invites a full proposal and provides specifics on that path forward. This letter is provided within 90 days of the interim deadline.

A white paper is encouraged as a first submission because it provides a brief summary  of the concept to BARDA. They can review and determine if the concept is within their mission space before a company invests the expense of creating a full proposal. It is understood that preparing a full proposal is very expensive and pre‐award costs are not reimbursed. White papers are a lower barrier to submission for offerors and provide BARDA staff with an opportunity to rapidly provide feedback on the relevance and technical merit of a potential project.

Question 4: Is it correct that the BARDA BAAs are now open for a 2 year period rather than the one-year for previous BAAs?
The BAAs are now open for 2 years subject to any amendments. Please monitor FedBizOpps for any updates.

Definitions:

Question 1: Could you provide a clear‐cut definition of what the regulatory plan is and what information is being sought? What is a regulatory plan?
Please review the BARDA Industry Day presentations for insight into the regulatory approval requirements and developing a regulatory strategy.

General:

Question 1: I understand that funding for the last round of responses is sometimes dependent on the availability of funds. Can you verify that funding is available for the last round?
Actions under the Broad Agency Announcement (BAA) are always subject to the availability of funds.

Question 2: Can information be provided describing the potential value of anticipated awards?
The award dollar value is dependent on several factors, such as funding availability, innovation presented, viability of concept and/or approach, and alignment with BARDA priorities. These are some of the various factors utilized internally to determine BARDA’s ability and degree of interest for award potential. To learn more about BARDA’s goals and priorities, see the BARDA Strategic Plan.

Question 3: We think our two projects are related, and in fact both therapeutics and diagnostic devices can be implemented in the same package.  Do we need to create two separate submissions?
As outlined in the BAAs, AMCG/BARDA requires separate submissions for individual AOIs. While the submissions may be similar, they must be received as a direct submission to one AOI. Please feel free to submit to multiple AOI’s with separate submissions.

Question 4: Where can I find a copy of the PHEMCE Strategy and Implementation Plan and the BARDA Strategic Plan?
To learn more about BARDA’s goals and objectives, see the BARDA Strategic Plan. To learn more about the PHEMCE, see the PHEMCE Strategy and Implementation Plan.

Question 5: How accurate do the cost estimates need to be in white paper submissions?
For white papers, BARDA requests that offerors submit their best estimate of the total costs of the work based on realistic timelines and program activities necessary to accomplish the objectives of the scope of work proposed. BARDA realizes that cost estimates may change after a full proposal is requested and submitted.

Question 6: Can BARDA fund a proposal that includes support from other federal research organizations (NIH, CDC, DoD, etc) involved in the research?
The BAAs are open to all responsible sources. Offerors may include single entities or teams from the private sector, Government laboratories, Federally Funded Research and Development Centers (FFRDCs) and academic institutions. However there must be no overlap in funding.

Question 7: I am a small business entity. Is there any preferential treatment in your selection process for my business size?
The BAA is considered a full and open procurement, in which the emphasis is on the merits of your project, the maturity level of your research and how your project fits into the BARDA portfolio. Small businesses are encouraged to submit proposals and join other entities as team members in submitting proposals.

Question 8: Can I bypass the white paper stage and submit a full proposal as my initial submission?
White Papers are not mandatory; however AMCG/BARDA  highly recommends that you submit a white paper because you will receive feedback prior to expending time and resources preparing a full proposal. Please see Question 3 under Deadlines for additional information.

Question 9: My firm is not based in the United States. Can I participate in this procurement?
Yes, both domestic and international firms are able to participate.

Technical:

Question 1: Do we need to focus on a specific drug/treatment to treat a specific condition or could we submit an application in order to further advance our platform technology assuming we could fit any known drug to our novel administration method?
Since BARDA typically supports late stage product development, platform development in this program is given preference to tools being applied to specific products. Some platform‐only development is possible through the SST BAA, but reviewers will need evidence of strong potential for future FDA approval.

Question 2: In the context of the ASPR BAAs, are novel or emerging pathogens restricted to pathogens with bioterrorism potential or could the term apply to any novel or emerging pathogen? What pathogens are BARDA most interested in pursuing?
A list of medical countermeasures that members of the PHEMCE are interested in are articulated in the PHEMCE Implementation Plan.

Question 3: Will a proposal that addresses multiple targets in a specific Area Of Interest (AOI) be responsive?
If it’s towards the same overall objective, yes. If they are completely separate pieces of work, then separate white papers might be more appropriate.

Question 4: What is meant by platform?
A platform can be defined in one of two ways.  Both definitions are applicable under the BAA:

  1. A medical countermeasure that can be used for multiple threat agents.
  2. Devices or capabilities that can be applied to multiple medical countermeasures; for example, detection assays and reagents that can be used on different diagnostic devices.

Question 5: What is meant by “emerging infectious disease” on the PHEMCE list?
BARDA’s highest threat agent priorities are pandemic influenza and CBRN threats as identified in the 2012 PHEMCE Strategy, as referenced in the CBRN BAA. The SST BAA is more focused on developing platform technologies. Applications to other pathogens can be considered if the application is justified and the technology represents a significant cross‐cutting innovation. However, funding for an advanced development project would be limited unless it is focused on the above threat agents.

Question 6: Is there a preferred level of risk?
BARDA as a whole needs to invest in products that can be used. In general, the lower the risk the better. The evaluation of any white paper submission will consider the potential to get a useful product that is FDA approved and can be manufactured and used routinely or in an emergency.

Question 7: Is there value in having commercial partners with potential products as part of the proposed effort?
Commercial partners can provide financial and organizational stability to smaller organizations while they pursue medical countermeasure development activities.

Question 8: What are some of the secrets to success for a diagnostics white paper?

  • Propose development of a product, not just a technology.
  • Provide data to establish current TRL of the product ‐ (produced by your organization). Include both Hardware and Biologics / Assay TRL 4 or greater
  • Specific data for threats proposed to address
  • Describe entire path from current state to FDA submission
  • Address team members and their capabilities. Include a well thought‐out regulatory plan. Address technical improvements and challenges
  • Describe your plans for manufacturing and commercialization.  Please note that volume manufacturing is not covered with AR&D funds.
  • Describe the team that will be required to develop the product
  • Include technical, regulatory, assay and hardware manufacturing; and clinical partners

Question 9: How much data should be included in the white paper given its page limitations?
Offerors should submit as much relevant data in their white paper as possible utilizing tables, figures, and graphics to convey the information in the most efficient manner possible to ensure BARDA reviewers are receiving sufficient technical data to complete its review.

Templates:

Question 1: Is there a template for WP submissions?
AMCG/BARDA does not provide a template for white paper submissions. Please review Part IV, Sections 2 and 3 of each BAA for instructions on how to submit a white paper.

  • This page last reviewed: November 17, 2017