The FAQ have recently been updated (October 06, 2021), and include new and revised entries (indicated below).
1. When are applications due?
Upcoming application due dates for PAR-21-315 Blueprint MedTech Translator (UG3/UH3 - Clinical Trial Optional) and PAR-21-282 Blueprint MedTech: Small Business Translator (U44 - Clinical Trial Optional) are October 20, 2021, and February 18, 2022. Additional dates are listed in the FOAs.
The upcoming and only application due date for PAR-21-314 Blueprint MedTech: Incubator Hubs (U54 Clinical Trial Not Allowed) is October 20, 2021.
2. I didn't submit a letter of intent by the deadline, can I still submit an application?
Yes. Letters of intent help us learn more about which applicants may be submitting, so we can build the most appropriate peer review panel. We also strongly encourage all potential applicants to contact us to ensure their project is in scope for our program and to answer any questions that they may have. That said, letters of intent are not required or binding.
3. Who do I talk to for questions about the BP MedTech funding opportunities?
Please email the BP MedTech core team (Blueprint-MedTech@nih.gov) and we’ll get back to you shortly. We are happy to set up a time to answer questions and provide programmatic technical assistance. For questions related to whether your device might address a disorder supported by this program, please contact the most appropriate point of contact at BP MedTech Participating Institutes/Centers and Contacts.
4. What are the general criteria for entry?
Applications to the BP MedTech program must include novel medical device technologies that will advance upon current neurotechnology. Applicants should:
- clearly define the current state of the art and highlight how their proposed technology will advance patient care.
- propose medical devices, expected to be regulated by the FDA, with first-of-its-kind technologies, unique and novel intended use, new safety questions, and/or new regulatory questions.
Responsive applications may also pivot and refine existing technologies toward new intended use and/or use in novel settings (e.g., innovating and translating a neuromodulation device approved for healthcare-setting only to home-use). Please contact us if you have any questions.
5. My device meets the entry criteria for Blueprint MedTech, but we do not have a human-grade prototype and are not ready to start a clinical trial. How do I apply?
Although we had intended to publish a U18 FOA (NOT-EB-21-018) to support the development of human-grade medical device prototypes, we no longer intend to do so. The Blueprint MedTech program will now support all prototype development activities through the incubator hubs (i.e., the hubs will solicit, evaluate, and manage efforts to develop prototypes). More information about how to apply will be provided by the incubator hubs, shortly after NIH announces recipients of the U54 FOA next summer.
6. What are non-responsive activities?
Applications that include the following activities will not be reviewed:
- Animal model development: all in vivo models must be established and characterized, and available to the applicant;
- Efforts to develop neurotechnology for fundamental study of the nervous system;
- Fundamental basic/applied research projects that employ existing market approved devices for their labeled uses;
- Projects focused on technologies for augmentation of healthy individuals;
- Delayed-onset clinical studies for either Translator FOA;
- Clinical evaluation of safety and effectiveness for the Incubator Hubs FOA;
- Device technologies where the Small Business Concerns do not have the needed intellectual property (IP) to enable further development/commercialization;
- Device technologies not regulated by the FDA.
7. Our technology is a drug not a device, does this fall outside the scope of the funding mechanisms?
Although the Blueprint MedTech program only supports medical devices, our sister program Blueprint Neurotherapeutics for Small Molecules supports therapies based upon small molecules. After you review the BPN-small molecules website, please feel free to contact Dr. Cywin to answer any other questions you may have.
8. Our technology is a biologic not a device, does this fall outside the scope of the funding mechanisms?
Although the Blueprint MedTech program only supports medical devices, our sister program Blueprint Neurotherapeutics for Biologics supports therapies based upon biologics. After you review the BPN-biologics website, please feel free to contact Dr. Broome to answer any other questions you may have.
9. [Revised 9/2/21] Our technology is a combination device, does this fall outside the scope of the funding mechanisms?
We encourage you to contact FDA Office of Combination Products to discuss the jurisdiction of your product to ensure that the product review will be led by CDRH. If the primary technical and regulatory challenges are related to medical devices and the product review is CDRH-led, then please contact us to discuss. Otherwise, we'd encourage you to reach out to our sister programs on small molecules and biologics for products where the device is incidental to the novelty of the small molecule or biologic. We encourage you to contact FDA Office of Combination Products to discuss the jurisdiction of your product to ensure that the product review will be led by CDRH.
10. [Revised 9/2/21] Are there budget limits for BP MedTech awards?
Application budgets are not limited but must reflect the actual needs of the proposed project. Budget requests must be well justified and reflect the work that will be conducted by the applicant organization(s). For U44, NIH has received a waiver from SBA, as authorized by statute, to exceed these total award amount hard caps for specific topics. The current list of approved topics can be found at https://sbir.nih.gov/funding#omni-sbir. Navigate to the current "SBA approved topics list for budget waivers."
Resources provided by BP MedTech contractors will be paid directly by the NIH. Budgets for the UG3/UH3 and U44 cooperative agreements are not anticipated to exceed $500K direct costs per year for the UG3 phase/U44 phase I and up to $1,500,000 total cost per year for U44 Phase II, assuming all work is conducted by the applicant organization(s). If applicants anticipate that BP MedTech resources will be provided by NIH (as identified on the Resource Checklist), the budget for those resources should not be included in the application. Please contact us if you have any questions
11. What resources are available through the BP MedTech program?
BP MedTech provides several resources and services to support device development and optimization through incubator hubs and Clinical Research Organization (CROs). These include services for design prototyping and bench testing, business development, biocompatibility and animal studies, regulatory, compliance, and quality and clinical support. Assistance and advice from consultants and industry experts will also be provided. For more information on the resources provided, please visit BP MedTech Resources and Support Services. UG3/UH3 and U44 applications must include a Resource Checklist attachment. U54 applications are expected to provide an overview of the translational resources they anticipate providing to the Blueprint MedTech consortium.
12. Is our project a good fit for the BP MedTech program?
The best way to determine if your project is a good fit for the MedTech program is to review the participating BP MedTech Institutes and Centers (IC)s’ interest statements related to the proposed device's target system. All BP MedTech projects must fall under one of the IC's missions.
Applicants are also encouraged to contact the IC's BP MedTech representative to gauge their level of interest, whether the proposed technology aligns with their mission and if the IC would be supportive if the project were to potentially be funded. IC Interest statements and MedTech contacts can be found at BP MedTech Participating Institutes/Centers and Contacts. If you are unsure which ICs to contact, let us know what indication(s) you're considering along with a draft of your Specific Aims, and we will direct you to the best point of contact.
13. What are the entry criteria for innovator subprojects?
Innovator “are expected to provide comprehensive supporting data based on bench, in vitro, and/or in vivo models representative of the intended patient population and indication.” Innovators should only have one remaining research question: “Will it be at least as safe and efficacious in humans using a human-grade prototype as it is in the lab?” If additional R01-equivalent research questions need to be addressed prior to demonstrating that there exists a credible ”deviceable target,” then innovators are not ready for entry to Blueprint MedTech.
In other words, innovators that need further R01-equivalent research are better served by R01-equivalent grants. The incubator hubs serve only to support the “D” in R&D. Please contact us if you need help finding the most appropriate basic research funding announcements, by sending us a draft of your Specific Aims.
14. We have an established proof of concept and published papers using a similar technology for a different indication, but we do not have proof of feasibility to demonstrate its applicability to a new indication. Would we still be eligible for this program?
The entry criteria for BP MedTech requires applicants to “include data showing that the diagnostic or therapeutic intervention has already been demonstrated to address the targeted indication in silico or in vivo with enough confidence that the remaining challenges are primarily related to building a commercializable prototype and demonstrating its safety and effectiveness.” If such data are not available, we encourage you to conclude the basic research before submitting an application to BP MedTech. Please contact us to discuss if you need help finding the most appropriate NIH funding opportunity.
15. Will BP MedTech support the development of products intended soley for use in a research environment?
No, the program will only support the development of commercial products for diagnosis and treatment of nervous system disorders.
16. What happened to the Funding Opportunity Announcement for the Blueprint MedTech Prototype Developer (U18)?
We previously released a Notice of Intent to Publish a Funding Opportunity to support the development of human-grade medical device prototypes using resources from incubator hubs in preparation for first-in-human studies. These opportunities will now be solicited, reviewed, and managed by BP MedTech-funded incubator hubs. More information about these opportunities will be provided via the incubator hubs later next year.
17. Is there anything else I should know?
We encourage all applicants to carefully review the FOA, including Section V that provides instructions to peer reviewers on how they should score your application.
Incubator Hubs (U54; PAR-21-314)
1. How can I learn more about the U54?
2. Will there be a second receipt date for incubator hubs?
No, please be sure your application is submitted no later than October 20, 2021 to be considered for Blueprint MedTech.
3. The FOA says I can only enter three pages for the Innovator and Resource Cores, but ASSIST lets me use up to six pages. What's the page limit?
Three. We're unable to reprogram ASSIST to support non-standard page limits, but rest assured that applications with four, five, or six pages in these components of your application will indeed be withdrawn without review.
4. The multi-component application process is confusing, can someone assist me with ASSIST?
Please start by contacting the eRA Commons Service Desk. They may refer you to contact us, and we'll be happy to help. We encourage you to start entering your application information into ASSIST early, rather than waiting until the deadline approaches.
5. How many centers will be awarded?
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
6. [Revised 9/2/21] How large should our center be? What budget should we target?
“Application budgets are not limited but need to reflect the anticipated needs of the proposed project.” Since the cost of innovator and resource subawards are not known at time of application, you should provide detailed estimates for a modest level of activity and extrapolate to full scale operation (up to 15 innovator subprojects per year). This is also described on slides 22 through 25 of the U54 webinar(pdf, 1078 KB). Please contact us if you need additional help.
7. [Revised 9/2/21] Should we focus on our geographic region, or nationally? Is there preference for underserved regions?
Nationally, applicants are expected to support a broad range of "under-represented technologies, patient populations, geographical regions, and proposers from diverse backgrounds" [...] and "to reach potential proposers outside the applicants' organization(s)."
We encourage you to notice what is not stated in the FOA. There is no stated preference as with IDEeA, REACH hubs, CTSAs, EPSCoR, INCLUDES, or any other programs designed to support specific geographical regions or communities. The goal is for each incubator hub to be able to serve all potential innovators across the U.S. and, secondarily, internationally.
8. [Revised 9/2/21] Should we focus on a core area of strength, or be able to support a broad range of innovators?
"It is expected that justification will be provided that applicants are able to support a very broad range of innovator subprojects outside [their] comfort zone" ... "spanning a breadth of unmet needs across the interests of the” BP MedTech Participating Institutes/Centers and Contacts.
If your expertise lies in only a subset of this spectrum, we encourage you to find partners across all of the interests of the BP ICs.
9. What attachments are allowed?
Two attachments are required. If “Draft Solicitation.pdf” and “Needs Assessment.pdf” are not included, then applications will be withdrawn without review. In addition, we encourage (but do not require) applicants to include drafts of the agreements that they expect to use when engaging with consultants, innovators, and resource providers. Please use the file names listed in the FOA (i.e., "Draft Solicitation.pdf") because these names will be used as bookmarks that NIH peer reviewers see when reviewing U54 applications.
10. What needs to be in the letter of support from institutional officials?
This primarily applies to larger organizations (such as universities) and is an opportunity for the institutions' officials to commit to supporting the needs of the PI(s) in running an incubator hub out of their organization. Smaller applicant organizations (e.g., where one of the PI(s) is also the institutional official) still need to include the letter of support.
11. Should we plan for human use?
Yes. Innovators may need to perform user preference surveys. Although this kind of research is typically considered non-significant risk and is often exempt, it is still nonetheless human subjects research. Since the scope of this human subjects research is not known at the time you submit the application, please select "delayed onset." Prior to starting any human subjects research, all U54 awardees will need to provide NIH with detailed plans and must wait for permission to start. Please contact us if you have any questions.
As a reminder, Clinical Trials are not allowed. Safety and efficacy human studies will only be supported through the Blueprint MedTech Translator FOAs.
12. [Revised 9/2/21] Should we plan for animal use?
Yes. Innovators may need access to non-GLP animal testing, such as validating that a prototype functions safely in a large animal model. Since the scope of this animal research is not known at the time you submit your grant application, you should select "delayed onset." Prior to starting any animal research, all U54 awardees will need to provide NIH with detailed plans and must wait for permission to start.
Note that GLP animal studies will be made available to innovators by the BP MedTech consortium, and the incubator hubs are not responsible for supporting them.
13. Is it better for the incubator hubs to be led by an academic, non-profit, or for-profit organization?
We anticipate some degree of blending between non- and for-profit activities. That said, it is up to applicants to justify to NIH peer reviewers that the “org chart” of participating organizations makes sense.
14. We all know DEI is important, but how will it be scored in this FOA?
Your priority score will be impacted by the clarity of your DEI plans for the center, as well as diversity in the Steering Committee and how well the center will perform outreach to a diverse pool of innovators. We encourage applicants to avoid considering diversity to be an afterthought.
15. Does this mean innovators with diverse backgrounds should get preference?
The Outreach Core is expected to find, foster, and educate diverse proposers to ensure that they have every opportunity to submit competitive proposals. That said, we expect the Evaluation Core to treat all innovators equally. If any innovator meets the entry criteria (see below) but is unprepared for a full-scale development effort, the incubator may provide mentoring support through a seedling project (see next question).
16. What is a seedling?
It is an innovator subproject that is the equivalent of a planning grant. Seedling proposers must meet the entry criteria for innovator subprojects as described in the FOA (see next question), but may not have developed a compelling market analysis, regulatory plan, or reimbursement plan. The goal of seedling subprojects is to prepare them to submit a compelling and detailed innovator subproject proposal with a small amount of funding and mentorship.
17. When should we plan to start soliciting, evaluating, and funding innovator subprojects?
NIH anticipates issuing U54 awards during the summer of 2022. Awardees will be expected to issue a solicitation very soon after this (e.g., weeks, not months). Centers should begin evaluating initial proposals soon thereafter. We are eager to launch innovator seedlings and subprojects as fast as possible!
18. Are foreign organizations eligible to be incubator hubs?
No. U.S.-based organizations may include foreign organizations as subawardees, and may include foreign individuals as collaborators. Please read the NIH FAQ on Foreign Components and the Grants Policy definition, and include any anticipated foreign components in your U54 application. Please contact us if you have any additional questions.
19. Which resources are we expected to provide?
20. [Revised 9/15/21] What should we put in the Resource Sharing Plan section of the U54 application?
This FOA does not require you to share Blueprint MedTech resources (e.g., consultants, prototyping capabilities, non-GLP animal testing) with parties outside the Blueprint MedTech consortium.
The Application Guide states:
“Data Sharing Plan: Investigators seeking $500,000 or more in direct costs (exclusive of consortium F&A) in any budget period are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible”
and the FOA modifies this by stating:
“Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.”
21. We are interested in participating in BP MedTech as a resource provider. How do we join?
NIH is not directly soliciting resource providers through this funding announcement. “Applicants [to this funding announcement] should provide letters of support from potential resource providers that the applicant has a prior relationship with. These letters should describe the resource provider's unique capabilities and typical costs associated with providing a resource capability to the center.”
Unfortunately, NIH cannot serve as a ‘matchmaker’ with potential U54 applicants. If you can’t find partners before the October 20, 2021 receipt date, you may reach out to the awarded incubator hubs once NIH announces the recipients next summer.
As shown on the BP MedTech Resources page, not all of the resources provided by BP MedTech will be managed by the incubator hubs. Additional resources will be solicited at a later date through other means. To learn about a prior “sources sought” request for information, please see N01DA-22-1233. If you would like to be notified of future solicitations for the resources that are not supported through the incubator hubs, please contact us.
22. I am interested in participating in BP MedTech as an individual consultant. How do I join?
NIH is not directly soliciting individual consultants through this funding announcement. Unfortunately, NIH cannot serve as a ‘matchmaker’ with potential U54 applicants. If you can’t find potential applicants before the October 20, 2021 receipt date, you may reach out to the awarded incubator hubs once NIH announces the recipients next summer.
23. [New 9/2/21] Can I or my institution contribute to more than one U54 application?
Yes, but NIH will not fund the same individual or organization to perform the same work more than once. Please note the Grants Policy statement on “overlap” that states that we do not allow:
budgetary overlap, scientific overlap, or commitment of effort greater than 12 person-months for the PD/PI(s) or any Senior/Key Personnel
24. [New 9/2/21] Instead of consultants, can we provide all mentoring, evaluation, and guidance using center staff?
Yes, but these individuals should not expect to be solely funded by this program. Since we want to support a very diverse range of technologies and indications, it is unlikely that any one individual mentor or evaluator would have enough expertise to support the entire range of interests of the BP MedTech Participating Institutes/Centers. The ability to bring on part-time experts for specific innovator projects might produce higher quality outcomes and cost less than being limited to a smaller set of “jack of all trades, master of none.” That said, the same NIH peer review principles stand: you must justify your rationale, and the peer reviewers will gauge the merit of your justification.
25. [New 9/2/21] Does the Steering Committee need to be selected by October 20, 2021? Who should be in it?
“Each member of the Steering Committee must include a Biographical Sketch” in the Administrative Core component of the application. “The Steering Committee should include as many diverse perspectives as practicable. [...] Justify the initial roster of Steering Committee members. Include a very short summary on each individual and their relevance to the center. Justify the size of the Committee. Outline any plans for rotation of the membership.”
26. [New 9/2/21] Do we need to have every potential resource provider lined up prior to October 20, 2021? Do we also have to solicit, evaluate, and manage resource providers?
In the Resource Core component of your application, “Applicants should provide letters of support from potential resource providers that the applicant has a prior relationship with. These letters should describe the resource provider's unique capabilities and typical costs associated with providing a resource capability to the center.” Bear in mind that as stated in the Evaluation Core, “Even if the center has a long track record with a vendor, the costs and timeline must be competitive.”
Which is all to say that you will need to solicit and compete out all resources needed by an innovator in order to build a competitive proposal package. Pre-existing relationships with resource providers will simply accelerate the process, rather than side-step it.
27. [New 9/2/21] We have X expertise/resource that’s not called for by the incubator hub FOA. Can we include it in our proposal?
Yes, you may include it. Please be aware that if selected for funding, NIH is unlikely to fund the hub to perform “X” through this FOA if we did not ask for it. While many existing incubators/accelerators already support capabilities like regulatory consulting, biocompatibility testing, and clinical trials, NIH expects to support these activities through a separate contract solicitation. Please contact usif you’d like to be notified when these services are solicited.
28. [New 9/2/21] Do all participating institutions in an U54 application need to be located in the same city/region?
No. COVID-19 has taught us one thing: how to collaborate effectively. The FOA states no preference for or against “virtual hubs” or co-located hubs. Applicants proposing a “virtual hub” should provide ample justification that they have a fine-tuned approach to building and running a complex operation that is not co-located.
29. [New 9/2/21] What do we need to include in the ramp-up plan?
“Provide a high-level plan to ramp up each Core within the first year, including a specific timeline describing when each capability is anticipated to be available and when the first innovator subprojects will be presented to NIH for consideration.” In other words, you should provide justification that you’ll be “firing on all cylinders” quickly.
30. [Revised 9/15/21] I’m still confused how the funding works? Who pays the innovators? Who pays the resource providers?
Please see slides 22 through 25 of the U54 webinar(pdf, 1078 KB). NIH will initially fund the U54 recipients to solicit and evaluate proposals. “If the Evaluation Core recommends an innovator subproject to the Administrative Core, then the PI(s)/ PD(s) would work with the Steering Committee to develop a “proposal package” for NIH that includes its detailed analysis, plan of action, milestones, cost for the subproject, cost for specific resource subawards, and cost for the center to manage the effort.” If NIH has funding available to support a proposal package, additional funding will be provided to the U54 recipient so they can issue subawards to the innovator and the resources they’ll need. As well, additional funding will be provided to the center to support the additional administrative load of the new innovator subproject.
The anticipated costs for up to 15 proposal packages should be included in incubator hub applications to NIH. The goal is for NIH to provide innovators with everything they will need to prepare for entry into the Translator FOAs (UG3/UH3, U44). Please contact us if this is still not clear.
31. [Revised 9/15/21] What’s the driving function for innovator subprojects? Does the innovator, hub, or NIH set a direction? What do I put into the “Needs Assessment.pdf”?
It’s a little bit of everything. The incubator hub’s market research/needs assessment team should be continually looking for opportunities to address the unmet needs of the BP ICs (i.e., under-addressed therapeutics and/or diagnostics for disorders supported by those ICs). This should be based upon a clear analysis of what therapies and/or diagnostics are on the market, what their weaknesses are, and whether there are innovative technologies out there that might address those unmet needs if they were to receive Blueprint MedTech funding.
In other words, to identify areas that the BP ICs would be excited about supporting. Ultimately, all proposal package funding comes from the BP ICs and all of their BP MedTech funding is discretionary. As no one innovator is likely to solve an entire class of problems, the needs assessment team will help to develop targeted solicitations to foster development of that class of technologies.
All that said, the FOA’s description of the contents of the “Needs Assesssment.pdf” was intentionally vague. It is up to applicants to justify what unmet medical device needs they envision that the incubator hub can address.
Please note NOT-EB-21-026, which states that the “Needs Assessment.pdf” can not exceed three pages.
32. [New 9/2/21] Can you give some advice on PI(s), MPIs, Senior/Key individuals and on conflicts of interest?
You may submit as a Multiple Principal Investigator application. You’ll need to provide justification on the leadership structure and include the Multiple PD/PI Leadership Plan attachment. The sum commitment of all MPIs must be at least 2.0 calendar months per year. For example, if you have two MPIs, and each one contributes 1.0 cm/yr, then that meets the minimum. You should expect that NIH will designate each Core leader as a Senior/Key individual, but this does not inherently mean they must also be MPIs. As with all NIH applications, you need to justify justify justify your choices.
“Applicants must describe the conflict-of-interest policy for center personnel and members of the consultant network.” While there is not enough space to address all “corner cases,” your policy should cover all foreseeable conflicts, such as how to handle an MPI or Steering Committee member who would like to submit an innovator or resource proposal to the hub.
33. [New 9/15/21] Can an innovation subproject be of interest to only one of the participating Blueprint Institutes and Centers?
Yes. While we expect the incubator hubs to support innovator subprojects across all of the interest areas of the BP MedTech Participating Institutes/Centers
34. [New 9/15/21] Can members of the Steering Committee be paid?
Yes. Please include this in the “Budget (Admin Core).”
35. [New 9/15/21] Can innovators be from academia? Can innovators be from non-profit organizations? Can innovators be from for-profit organizations?
Yes. There is no fundamental restriction on innovators. They may be employed by a for-profit or non-profit organization. They may even be self-employed. Innovators may be based domestically or outside the U.S. Anyone can be an innovator, though we do expect that most innovators will be from outside the applicants’ organization(s).
36. [New 9/15/21] Do we need to discuss sustainability?
The FOA does not ask for a sustainability plan.
37. [New 9/15/21] Do we need to cost-share any expenses?
"This FOA does not require cost sharing as defined in the NIH Grants Policy Statement."
38. [New 10/06/21] I'm still confused about how the budget scales up and down?
That’s not a question. The funding model is really quite unusual in that applicants to the U54 FOA do not know how much it will cost to support innovators and their linked resources. The FOA recommends providing a detailed calculations for a modest base level of activity (e.g., 2-3 innovator projects and linked resources) and using that to extrapolate up to 15 full-scale innovator subprojects (and their resources). Therefore, the anticipated costs for up to 15 proposal packages should be included in incubator hub applications to NIH. These calculations go in the budget of each Core.
In addition, one unique feature of this center is the ability to scale up to support new subprojects and subawards, and to scale down when these efforts end or are terminated. Describe the administrative approach to managing personnel, budgets, and other center resources necessary to meet this need. This description goes in the PHS 398 Research Plan (Admin Core).
Please contact us if this is still not clear.
39. [New 10/06/21] How do I add the Overall component in ASSIST?
You don’t need to, it is automatically populated once you add the first component (such as the Admin Core).
Translation Projects (UG3/UH3; PAR-21-315 and U44; PAR-21-282)
1. What are UG3/UH3 and U44 awards, and how do they compare to an R01 grant?
The UG3/UH3 is a phased cooperative agreement mechanism. The U44 is a phased Small Business Innovation Research (SBIR) cooperative agreement mechanism. BP MedTech uses the UG3/UH3 and U44 awards to pay for work that will be conducted by the Principal Investigator (PI) for translation-stage projects. The UG3 phase and U44 Phase I support the PI's activities for non-clinical testing to support an Investigational Device Exemption (IDE) submission for the clinical study or an Institutional Review Board (IRB) Non-Significant Risk (NSR) designation. The UH3 phase and U44 Phase II support subsequent clinical study work leading to a larger clinical study that will lead to either a marketing application or use of the clinical experience to inform device design decisions. BP MedTech applicants can request up to four years of UG3 or U44 Phase I support. The combined duration of the UG3 and UH3 awards (or, in the case of U44, Phase I and II awards) cannot exceed five years.
NIH is more involved in the management and oversight of research funded by cooperative agreements than by typical grants. The cooperative agreement mechanism enables NIH program staff participation in negotiating project and milestone plans before award, monitoring the research progress, and making go/no-go decisions.
2. If I plan to use BP MedTech resources, do I need to budget for them, and how?
BP MedTech provides additional resources and services at no cost to UG3/UH3 and U44 awardees. While these resources should not be budgeted, applicants to the Translator FOAs (PAR-21-315 and PAR-21-282) must include a resources checklist indicating which resources will be used and justification for any resources not being utilized. We highly encourage applicants to indicate that these resources will be provided by BP MedTech by inserting a statement along the lines of "If selected for funding, we expect that the following resources will be made available to this project by the Blueprint MedTech program. Since the program will provide these resources at no cost, this application does not request any labor or budget associated with these resources."
3. Can I request funding to do all of the work myself and/or with CROs that I select and pay directly?
Yes. However, we strongly encourage applicants to take advantage of the availability of BP MedTech consultants to add to your own expertise.
4. What are the criteria for translation stage projects (UG3/UH3 and U44 Phase I/II)?
- Comprehensive supporting data based on bench, in vitro, and/or in vivo models representative of the intended patient population and indication.
- Identified one or more clinically meaningful device outcome measures based on input from key stakeholders (e.g., clinicians, patients, and caregivers) as well as supporting literature.
- A compelling case for a successful IDE submission for an SR study or IRB approval for an NSR study. Required regulatory approvals for clinical studies must be in place prior to the start of the UH3 /U44 Phase I.
- Applicants are encouraged, but not required, to consult with FDA via a Pre-Submission meeting, study risk designation request, and/or 513(g) submission prior to applying. Applicants who do not have sufficiently relevant feedback from the FDA regarding all planned activities prior to application for funding will be expected to do so as the first milestone of the UG3 phase of the award. Funding may be restricted to a maximum of $100,000 in direct costs until FDA feedback that is consistent with the likely success of the regulatory path to market and overall device development plan outlined in the grant application is received.
5. What is the purpose of the UG3 and U44 Phase I?
The purpose of these phases is to identify and conduct all non-clinical testing necessary to obtain approval to conduct the subsequent clinical study. For example, these phases could serve to complete testing to support an investigational device exemption (IDE) submission to the FDA or to obtain Institutional Review Board (IRB) approval for a non-significant risk (NSR) clinical study.
6. What kind of work can be done during the UG3 phase or U44 Phase I?
Examples of studies that may be proposed during the UG3 phase include, but are not limited to
- Non-Good Laboratory Practice (GLP) animal studies to develop surgical techniques relevant to the device, optimize relevant therapeutic or diagnostic parameters, and refine device design as necessary for subsequent GLP testing or additional clinical studies for regulatory approval.
- Bench-top and animal testing to demonstrate compliance with FDA Recognized Standards.
- GLP compliant large animal model safety testing and/or testing of an implanted device.
- Activities to become current Good Manufacturing Practice compliant.
- Activities to bring the development process under Design and Quality Systems Control.
- Studies addressing usability or acceptability
- Device, software, firmware, and cybersecurity, design verification, and validation activities.
- Development of packaging, connectors, and other accessories necessary for the translation of the technology.
- Regulatory activities, including pre-submission meetings with FDA, IDE submission, or other FDA regulatory submissions (e.g., Humanitarian Device Exemption (HDE), Request for Risk Designation, 513(g) submission).
7. My project already meets the program requirements to initiate a clinical study. Can I skip the UG3 phase or U44 Phase I?
No. All translation projects must include UG3 phase or U44 Phase I activities and enter through these initial phases. Projects for which only a clinical phase is proposed are outside of the scopes of these funding opportunities.
8. What if my budget is above $500K direct costs for the UG3/UH3 (PAR-21-315)?
Applicants for UG3/UH3 requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact us at least six weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or more in Direct Costs as described in the SF424 (R&R) Application Guide.
9. I have an academic lab and IP licensed to my start-up. Is there a preference for academic vs. start-up funding?
Although there is no preference between academic or start-up applicant organizations, there is an expectation that eventually, the product will be made available for broad clinical use.
10. How do the MedTech Translator funding opportunities (UG3/UH3 and U44) differ from the regular NINDS funding opportunities?
The BP MedTech Translator opportunities differ from NINDS opportunities in that awardees will have access to several translational resources. The BP MedTech opportunities also support the missions of all fourteen Blueprint Institutes and Centers (IC)s. The FOAs have some similarities to existing programs (e.g., BRAIN, HEAL, TND) but cover the interest areas of all the Blueprint ICs.
Additionally, the scope of the technologies supported is more narrowly focused on novel medical device technologies that will advance upon current neurotechnology. The devices are expected to be first-of-its-kind technologies with unique and novel intended uses or address new safety or regulatory questions. Please contact us if you have any questions.
11. Are foreign organizations eligible for translator funding opportunities (UG3/UH3 and U44)?
The Translator funding opportunity PAR-21-315: Blueprint MedTech: Translator (UG3/UH3) is open to foreign applications. The key phrase to look for in NIH FOAs is in the "Eligible Organizations" section, where it says "Non-domestic (non-U.S.) Entity (Foreign Organization)."
PAR-21-282: Blueprint MedTech: Small Business Translator (U44) is only open to U.S.-based small business concerns.