Opportunity Information: Apply for N62645 PA 20 01
This funding opportunity, titled "Conduct of Clinical Trials to Facilitate the Development and Approval of Novel Countermeasures (vaccines, devices, drugs) for Use by the Warfighter," is a Department of Defense cooperative agreement aimed at advancing medical products that can protect or treat U.S. military personnel. The sponsoring office is the Naval Medical Logistics Command, and the work is designed to directly support the research mission of the Naval Medical Research Unit No. 6 (NAMRU-6). In practical terms, the government is looking to partner with an awardee in a joint research and development effort where both sides are expected to be actively involved, rather than simply providing funding with minimal federal participation.
At the center of the program is the conduct of clinical trials, along with the epidemiologic studies needed to support those trials. The objective is to generate the kind of high-quality human data that regulators require so that novel countermeasures, including vaccines, medical devices, and drug products, can ultimately be approved or cleared by the U.S. Food and Drug Administration for military use. The emphasis on FDA approval or clearance signals that the trials and supporting studies are expected to be conducted under rigorous regulatory and ethical standards, with data quality, participant protections, and documentation practices suitable for submission in an FDA regulatory package. The overall purpose is operational: to ensure that products intended for the warfighter move efficiently from development into authorized, fieldable solutions.
The award mechanism is a cooperative agreement, which typically means the Department of Defense anticipates substantial collaboration during planning and execution. That collaboration can include scientific and technical coordination, alignment with NAMRU-6 priorities, shared decision-making on study design or endpoints, and close involvement in operational and logistical considerations that come with conducting clinical research tied to defense needs. The activity category is classified under science and technology and other research and development, reflecting that the funded work is not just service delivery, but structured R and D intended to produce generalizable evidence and regulatory-grade outcomes.
The opportunity is listed under CFDA number 12.340 and is described as having unrestricted eligibility, meaning it is broadly open to applicants of any entity type as long as they meet any additional eligibility notes contained in the full announcement. The government planned a single award (expected awards: 1), indicating a preference for one main partner to carry the program forward, potentially acting as a prime that coordinates multiple research sites, subcontractors, or collaborators if needed. The stated award ceiling is $41,822,342, which suggests a large, multi-activity clinical research portfolio could be supported under this agreement, such as multiple trials, phased trial activities, or a combination of trials and supportive epidemiologic work over the period of performance.
Key dates associated with the posting include a creation date of October 9, 2019, and an original closing date of November 8, 2019. The funding opportunity number is N62645 PA 20 01, which can be used to locate the official notice and any attachments or required forms. Overall, the solicitation is best understood as a DoD effort to build a capable clinical research partnership around NAMRU-6 priorities, with the explicit end goal of producing FDA-relevant clinical and epidemiologic evidence that accelerates the availability of new vaccines, devices, and drugs for the warfighter.Apply for N62645 PA 20 01
- The Department of Defense, NAVAL MEDICAL LOGISTICS COMMAND in the science and technology and other research and development sector is offering a public funding opportunity titled "Conduct of Clinical Trials to Facilitate the Development and Approval of Novel Countermeasures (vaccines, devices, drugs) for Use by the Warfighter" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.340.
- This funding opportunity was created on Oct 09, 2019.
- Applicants must submit their applications by Nov 08, 2019. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $41,822,342.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.
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Frequently Asked Questions (FAQs)
What is the title of this funding opportunity?
The opportunity is titled "Conduct of Clinical Trials to Facilitate the Development and Approval of Novel Countermeasures (vaccines, devices, drugs) for Use by the Warfighter."
What type of funding mechanism is being used?
This is a Department of Defense cooperative agreement. That typically means the government expects to be substantially involved in the planning and execution of the work, rather than acting only as a funding source.
Which Department of Defense office is sponsoring the award?
The sponsoring office is the Naval Medical Logistics Command.
What is NAMRU-6 and how does it relate to this award?
The work is designed to directly support the research mission of the Naval Medical Research Unit No. 6 (NAMRU-6). The partnership and research activities are expected to align with NAMRU-6 priorities.
What is the overall purpose of the program?
The purpose is to generate high-quality human data needed to support regulatory submissions so that novel medical countermeasures can ultimately be approved or cleared by the U.S. Food and Drug Administration (FDA) for use by U.S. military personnel (the warfighter).
What kinds of products or countermeasures are in scope?
The scope includes novel countermeasures such as vaccines, medical devices, and drug products intended to protect or treat U.S. military personnel.
What activities are expected to be performed under this cooperative agreement?
The central activities are the conduct of clinical trials and the epidemiologic studies needed to support those trials.
Why are epidemiologic studies mentioned along with clinical trials?
Epidemiologic studies are included because they may be needed to support the design, feasibility, interpretation, or operational execution of clinical trials, and to help generate the broader evidence package required for regulatory-grade outcomes.
What does "FDA approval or clearance" imply for the expected studies?
It implies the trials and supporting studies are expected to follow rigorous regulatory and ethical standards, with data quality, participant protections, and documentation practices suitable for inclusion in an FDA regulatory submission package.
Is this opportunity more about research and development or service delivery?
It is categorized under science and technology and other research and development, indicating the funded work is structured R and D intended to produce generalizable evidence and regulatory-grade outcomes, not simply service delivery.
How collaborative is the government expected to be during the project?
Because it is a cooperative agreement, substantial collaboration is anticipated. The description notes potential scientific and technical coordination, alignment with NAMRU-6 priorities, shared decision-making on study design or endpoints, and close involvement in operational and logistical considerations tied to defense needs.
Who is eligible to apply?
The opportunity is described as having unrestricted eligibility, meaning it is broadly open to applicants of any entity type, subject to any additional eligibility notes that may be included in the full announcement.
How many awards does the government expect to make?
The listing indicates a single award is planned (expected awards: 1).
What does a "single award" imply for applicants and project structure?
It suggests the government prefers one main partner to carry the program forward. That awardee could potentially act as a prime and coordinate multiple research sites, subcontractors, or collaborators if needed.
What is the maximum (ceiling) amount available under this award?
The stated award ceiling is $41,822,342.
What does the award ceiling suggest about the potential scope of work?
The ceiling suggests the agreement could support a large, multi-activity clinical research portfolio, potentially including multiple trials, phased trial activities, and/or a combination of clinical trials and supportive epidemiologic work over the period of performance.
What is the CFDA number for this opportunity?
The CFDA number listed is 12.340.
What is the funding opportunity number and why does it matter?
The funding opportunity number is N62645 PA 20 01. It can be used to locate the official notice and any associated attachments or required forms.
When was the opportunity created and when did it close?
The creation date is October 9, 2019, and the original closing date is November 8, 2019.
What is the primary end goal for the Department of Defense?
The end goal is operational: moving products intended for the warfighter efficiently from development into authorized, fieldable solutions by producing FDA-relevant clinical and epidemiologic evidence.
Does this opportunity focus on partnership or pass-through funding?
It is framed as a joint research and development effort where both the government and the awardee are expected to be actively involved, rather than a structure with minimal federal participation.
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