Public Health Emergency - Leading a Nation Prepared
BARDA works with its partners throughout the acquisition process to develop and make available products that can be used to protect Americans from a wide range of 21st century health security threats.
BARDA is soliciting proposals for the advanced research and development of medical countermeasures (MCMs) such as vaccines, therapeutics, diagnostics, and devices to address chemical, biological, radiological, and nuclear (CBRN) threats; pandemic influenza; and emerging infectious diseases under the BARDA Broad Agency Announcement.
Offerors are expected to move through the acquisition process in the following stages:
If you or your company are developing a MCM or platform technology to combat CBRN threats, pandemic influenza, or other emerging infectious diseases, you can get insights and strategic advice from BARDA at a TechWatch meeting.
BARDA TechWatch meetings provide an opportunity to present your proposed solutions that may meet BARDA’s current priorities. The meetings serve as the beginning of an important dialogue. Offerors are strongly encouraged to participate in the TechWatch program prior to any White Paper or Full Proposal submissions under the BARDA BAA.
During the meeting, you will have an opportunity for a question-and-answer session with technical experts from BARDA as well as acquisition experts from the HHS/ASPR Office of Acquisitions Management, Contracts, and Grants (AMCG). Depending on the technology you are presenting, representatives from National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), Veterans Affairs (VA), or Department of Defense (DOD) may attend as well. If information provided during the TechWatch does not meet BARDA’s mission requirements or current priorities, then one of our partner agencies may be a viable alternative.
Participating in the TechWatch program is not a prerequisite for submitting a proposal under the BARDA BAA, but the meeting enables you to gather important insights about your product. Incorporating the feedback that you receive at a TechWatch meeting into your White Paper may increase your chance of success later in the acquisition process.
Before you attend, find out how to prepare for a successful TechWatch meeting and then register for a meeting via MedicalCountermeasures.gov.
Under the BAA, BARDA solicits proposals for the advanced research and development of medical countermeasures (MCMs) such as vaccines, therapeutics, diagnostics, and devices to address chemical, biological, radiological, and nuclear (CBRN) threats; pandemic influenza; and emerging infectious diseases. The BAA does not support the acquisition of products or the construction of facilities.
BARDA anticipates that the research and development activities supported under this BAA will serve to advance candidate MCMs toward licensure or approval by the FDA.
Want to learn more? Read the full BARDA BAA and check out the BARDA BAA Frequently Asked Questions.
Your submission under the BARDA BAA consists of a White Paper and a Quad Chart. The White Paper expands on the information provided in the Quad Chart.
Your Quad Chart and White Paper should provide enough relevant data and details about the proposed project to enable BARDA to evaluate the concepts that you are presenting and their technical merits. The Quad Chart and White Paper should also clearly articulate the ways that your project may contribute to BARDA’s mission.
If you would like to meet with BARDA to discuss some of the concepts that will be presented in your White Paper, please request a TechWatch meeting prior to the submission of your White Paper. After a White Paper or Full Proposal has been submitted, all communications related to that submission must go through a Contracting Officer in AMCG.
The initial submission is limited to a cover page, one-page Quad Chart, White Paper (not to exceed 10 pages), and an addendum (not to exceed two pages). The entire submission packet must be 14 pages or less.
To learn more about preparing the Quad Chart and White paper, submission deadlines, the evaluation process, and more, please see the BARDA BAA Frequently Asked Questions, the BARDA BAA Toolkit, and the BARDA BAA.
The White Paper and Quad Chart will be reviewed by a panel with primary focus on the submission’s technical merit and relevance to BARDA’s programmatic priorities.
If your Quad Chart and White paper receive an unfavorable rating, you can use the feedback that you have received as the basis for improvement of your White Paper for a future BAA resubmission for reevaluation.
If you want to continue to pursue your project after receiving an unsuccessful rating, you may still submit a Full Proposal; however, this is not recommended. Instead, BARDA strongly recommends that you resubmit a revised White Paper that incorporates the feedback you received.
To learn more, see the full BARDA BAA and check out the BARDA BAA Frequently Asked Questions.
If you receive an invitation to submit a Full Proposal, it will contain feedback that you should take into account as you prepare your submission. To further assist you as you begin this process, you may be invited to participate in a teleconference soon after issuance of the invitation letter.
The Full Proposal must be prepared in two separate volumes: technical (Volume I) and cost (Volume II) proposals. Tools for preparing various elements of the technical and cost proposals are available in the BARDA BAA Toolkit. For full instructions on preparing the proposals, submission deadlines, information on government response times, and more, please see the BARDA BAA.
Full Proposals will be evaluated by a peer or scientific review process and based on the following criteria (listed in descending order of importance):
The following are additional evaluation criteria in the review process:
The final evaluation will be based on an assessment of the overall best value to the government based on these criteria. Awards, if any, will be made based on proposal evaluation and funds availability.
If your Full Proposal is considered acceptable, feedback will be provided and the you may be invited to enter into negotiations with the government. Offerors whose proposals are selected for negotiations may be contacted to provide additional clarifications and technical information if necessary.
If your Full Proposal is designated unacceptable, you will be notified and receive technical feedback.
If your proposal has been rated acceptable, you may be invited to enter into contract negotiations. At the conclusion of negotiations, the Contracting Officer will request a final proposal.
Depending on the differences between parties, more than one round of proposal revisions may be required during the course of negotiations. When both parties come to a mutual agreement, the process of contract writing starts. Then a completed contract is signed by both parties.
Proposals selected for award are considered to be the result of full and open competition and in full compliance with 41 U.S.C. § 3301.
If both parties reach a final agreement in the negotiation phase, a contract is then awarded.
After an award is signed, you may begin work on the plan contained within the contract to meet all milestones and deliverables. Shortly after Award, a “Kick-Off Meeting” will be held between the parties to discuss expectations of the new relationship going forward.
Awards resulting from the BARDA BAA may also benefit from BARDA’s Core Services. These core services include an animal study network; flexible manufacturing facilities; and technical expertise in development, manufacturing, regulatory affairs, quality systems, and clinical studies.
If an agreement cannot be reached between both parties for a contract award, then no award will be made.
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