U18 SPARC Funding Opportunity Announcement (FOA)
Frequently Asked Questions (FAQs) for RFA-RM-15-002
We appreciate your interest in the SPARC funding opportunity and hope that you and your team will choose to submit an application. In order to maximize your chances of success, we would like to provide some guidance that may be helpful as you put the finishing touches on your application:
- Please review these FAQs to be sure that your application is consistent with the information provided below.
- For clarification of these or other issues, we encourage you to submit your questions to [email protected] and/or the scientific contact listed in the RFA.
Programmatic Interests & Responsiveness
1. I understand that this FOA is the first initiative in the first phase of the SPARC program, which is developing tools and technologies to be used to understand mechanisms of action. When does the second phase of the SPARC program begin, which is to incorporate knowledge from mechanisms into the development of next generation neuromodulation technologies?
2. Is there an expectation that awarded U18 projects will be incorporated into later funding opportunities or expanded into larger projects once the initial two (2) years of funding are completed?
3. Will proposed projects that focus on developing new technology for neuromodulation therapies be acceptable?
4. Will projects proposing to develop a technology primarily as a therapeutic tool with exploration of the biology as a side effect be considered responsive?
5. Is it appropriate to study why or how an existing neuromodulation therapy with demonstrated modest effects is working (or not working), or rather why the targeted organ is functioning better?
6. Do applicants need to identify the mechanism(s) for which a proposed tool(s) will demonstrate targeted control, or must the proposal include use of the tool to study the mechanism(s)?
7. If the goal is to develop tools to understand the underlying biological mechanism(s), can applicants propose to develop any technology whether novel or existing?
8. To what extent is validation of the proposed tool required?
9. The FOA explains that general purpose platforms are non-responsive. Doesn’t the example – “reliable, wireless, high density recording/stimulating capable of recording all neural signals going to and coming from a targeted organ” – provided under “Scope of the Funding Opportunity” describe a platform technology that is not targeted to a specific biological question?
10. Where are the biological boundaries of the SPARC program? What nerves are included (e.g., motor)? Are brain, brainstem and/or spinal cord included?
11. What is the definition of “end organ”? Are projects that explore interfacing with autonomic ganglia acceptable? What about the brain?
12. Are projects targeting the olfactory system eligible?
13. Are projects that focus on acupuncture and exploring its mechanisms of action and/or impact on organs acceptable?
14. Is an in vitro model system an acceptable tool or technology for this FOA?
15. Are projects that focus on development of a novel animal model an acceptable tool for this FOA?
16. Are projects aimed to develop computational models an acceptable tool or technology for this FOA?
Pre-Submission
17. Are LOIs required?
18. Is a U18 (Research Demonstration Cooperative Agreement) similar to a R21 (Exploratory/Developmental Grant) in that preliminary data is not required?
19. Should applicants contact NIH prior to submission to establish a Cooperative Agreement between the home institution and the NIH and/or other potential awardees?
Review
20. Are confidentiality regulations in place during the review for the U18 mechanism (Research Demonstration Cooperative Agreement) similar to those for Small Business Innovation Research (SBIR) mechanisms?
21. How many reviewers will be assigned to review each application?
22. What will the scoring format be for review of the applications?
23. Are funding decisions based solely on the scores?
24. What is the significance of identifying milestones within the application?
25. Will an application be scored lower if study of the target organ function and/or underlying biology network is exploratory (e.g., the science involved in understanding the mechanism, regardless of the tool used, is not well known or defined)?
26. Is there a preference for projects that propose to use a mix of animal and human models versus those that propose to use solely animal or human models?
27. Does NIH Program staff expect applicants to incorporate a broad team of experts as part of the application?
Awards
28. How many awards will be issued under the current funding opportunity (RFA-RM-15-002)?
29. Is NIH Program staff planning to issue awards based on broad coverage of the peripheral nervous system (PNS) to avoid funding all awards on one (1) organ?
30. Will indirect costs be included in the award amount as the current funding opportunity (RFA-RM-15-002) states that “direct costs are limited to $200,000 (USD) per year” for each award?
31. The NIH traditionally funds academia rather than industry, so will consideration be given to industry applicants?
32. How will NIH Program staff know whether the proposed milestones are being met, and will achievement of the milestones be tied to funding?
Programmatic Interests & Responsiveness
1. I understand that this FOA is the first initiative in the first phase of the SPARC program, which is developing tools and technologies to be used to understand mechanisms of action. When does the second phase of the SPARC program begin, which is to incorporate knowledge from mechanisms into the development of next generation neuromodulation technologies?
There is no set date for launch of for the second phase, but please check the SPARC website for updates and information regarding future funding opportunities. Like other Common Fund programs, SPARC will comprise multiple funding opportunities and consortium activities. These will span understanding of underlying biology, development of new technology, public-private partnerships, and data coordination, sharing, and collaboration.
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2. Is there an expectation that awarded U18 projects will be incorporated into later funding opportunities or expanded into larger projects once the initial two (2) years of funding are completed?
The current funding opportunity (RFA-RM-15-002) is the first FOA for the SPARC program. Later funding opportunities including biology initiatives, further technology development initiatives, and data coordination efforts, will support a consortium of projects. U18 awardees will be incorporated into the SPARC program consortium as stated in the terms and conditions of the cooperative agreement (Section VI of the guidelines). U18 projects will not be expanded into larger projects, but awardees may apply to future SPARC announcements as appropriate.
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3. Will proposed projects that focus on developing new technology for neuromodulation therapies be acceptable?
No, technology development for next generation neurmodulation therapies will be considered non-responsive to this FOA. These types of technologies will be solicited in the second phase of SPARC.
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4. Will projects proposing to develop a technology primarily as a therapeutic tool with exploration of the biology as a side effect be considered responsive?
Investigators should focus the U18 application primarily on the development of technology to elucidate the neurobiology and neurophysiology underlying autonomic control of internal organs in health or disease. If the technology development entails re-tooling an existing therapeutic device to study mechanism, then that is acceptable. A project focused primarily on development of a therapeutic tool would not be responsive.
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5. Is it appropriate to study why or how an existing neuromodulation therapy with demonstrated modest effects is working (or not working), or rather why the targeted organ is functioning better?
The purpose for development of detailed, integrated functional and anatomical neural circuit maps in organs in the first phase of SPARC is to have a deeper understanding of the biology to enable optimal neuromodulation and control of end organ function. Investigators should start from this perspective, rather than starting with existing therapies and developing technologies to understand how that technology is working (or not).
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6. Do applicants need to identify the mechanism(s) for which a proposed tool(s) will demonstrate targeted control, or must the proposal include use of the tool to study the mechanism(s)?
The former; applicants should develop tools that are tailored to study a specific mechanism for targeted control. By the end of the two (2) year U18 award, there should be adequate data to support the full development of the tool, or use of the tool for a future biological study. Use of tools to study mechanisms is not responsive to this FOA.
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7. If the goal is to develop tools to understand the underlying biological mechanism(s), can applicants propose to develop any technology whether novel or existing?
Yes, but applicants must describe how the technology will be tailored to study the mechanism of focus. Please note that tools developed for understanding mechanisms (through this FOA) can be very different from the tools used for future neuromodulation therapies.
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8. To what extent is validation of the proposed tool required?
Proposed projects may fall anywhere along the technology development pipeline. Applicants should keep in mind that this is a two (2) year award. The funds can be used for establishing feasibility, technology development, or technology validation studies. Applicants should define where they fit in the technology pipeline, as well as the scientific needs for the development of the technology. Validation may or may not be needed earlier in the pipeline.
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9. The FOA explains that general purpose platforms are non-responsive. Doesn’t the example – “reliable, wireless, high density recording/stimulating capable of recording all neural signals going to and coming from a targeted organ” – provided under “Scope of the Funding Opportunity” describe a platform technology that is not targeted to a specific biological question?
The examples given under the “Scope of the Funding Opportunity” section are examples of technologies which applicants could tailor to specific mechanisms of study. General development of high density recording electrodes without a specific targeted use case will not be responsive to this FOA.
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10. Where are the biological boundaries of the SPARC program? What nerves are included (e.g., motor)? Are brain, brainstem and/or spinal cord included?
The stated purpose of the current funding opportunity (RFA-RM-15-002) is develop technologies “to elucidate the neurobiology and neurophysiology underlying autonomic control of internal organs in health or disease” so applicants must stipulate the associated mechanisms being targeted for the indicated internal end organ. These mechanisms may include those nerves and pathways that affect end organ function.
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11. What is the definition of “end organ”? Are projects that explore interfacing with autonomic ganglia acceptable? What about the brain?
For the proposed technology, applicants will need to discuss the connection between what they propose to study and its relationship to autonomic control of the targeted internal end organ. SPARC is interested in conditions affecting internal organs, so the brain is not considered a targeted end organ in the SPARC program. Neural control pathways of interest to the first phase of SPARC may involve central nervous system (CNS) pathways, in addition to pathways of the sympathetic, parasympathetic, and/or sensory nervous systems. Technology development for the study of all relevant pathways; including peripheral ganglia, are acceptable areas for use of the proposed U18 technology. Technology development for the study of relevant CNS pathways must be justified for this context.
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12. Are projects targeting the olfactory system eligible?
It depends. The olfactory system is biologically associated with the central nervous system (CNS), however if certain olfactory pathways are linked to autonomic control of an internal organ, then that link may be justified for an area of study, especially if this mechanism will inform future neuromodulation therapies in the second phase of SPARC.
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13. Are projects that focus on acupuncture and exploring its mechanisms of action and/or impact on organs acceptable?
Applications developing technology tailored to explore the neurobiology and neurophysiology underlying autonomic control of the internal organs being affected by acupuncture is acceptable to this FOA.
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14. Is an in vitro model system an acceptable tool or technology for this FOA?
Yes, however, development of the in vitro model system should be progressed enough such that the applicant can justify broad use of this system for the SPARC program overall, including delivery of neural circuit maps of several organs, within the next four (4) years. Applicants must justify the in vitro model system as being a relevant tool to elucidating the neurobiology and neurophysiology underlying autonomic control of internal organs in health or disease.
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15. Are projects that focus on development of a novel animal model an acceptable tool for this FOA?
Applicants would need to justify how the new animal model will be used as a tool to elucidate the neurobiology and neurophysiology underlying autonomic control of internal organs and ultimately inform the development of neural circuit maps and future neuromodulation therapy for humans. Applicants should also justify broad use of this new animal model for the SPARC program overall, within the next four (4) years.
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16. Are projects aimed to develop computational models an acceptable tool or technology for this FOA?
Yes, the development of computational models and theoretical frameworks are strongly encouraged for the study of mechanisms of autonomic control of internal organ function.
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Pre-Submission
No, LOIs are not required but may prove helpful for the applicants, NIH Program staff and the Scientific Review Officer as they afford the opportunity for additional and/or individual replies to specific questions and/or concerns. Those submitting LOIs will be asked to send draft specific aims of the project for program staff to evaluate and use to guide the applicants.
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18. Is a U18 (Research Demonstration Cooperative Agreement) similar to a R21 (Exploratory/Developmental Grant) in that preliminary data is not required?
Yes, the U18 is similar to the R21 in that preliminary data is not expected. A U18 differs from the R21 in that the Cooperative Agreement allows for greater NIH oversight and collaboration with awardees.
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19. Should applicants contact NIH prior to submission to establish a Cooperative Agreement between the home institution and the NIH and/or other potential awardees?
No, the “Cooperative Agreement Terms and Conditions of Award” are listed in Section VI of the current funding opportunity (RFA-RM-15-002) guidelines, and stipulate what each awardee will agree to do and/or uphold upon award issuance. Language identical to that listed under “Cooperative Agreement Terms and Conditions of Award” will be included in each awardee’s Notice of Award (NOA). In the application, applicants should indicate how travel to/from required NIH-sponsored meetings and/or workshops will be incorporated into the proposed budget (see Section IV, Budget).
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Review
20. Are confidentiality regulations in place during the review for the U18 mechanism (Research Demonstration Cooperative Agreement) similar to those for Small Business Innovation Research (SBIR) mechanisms?
Reviewers are sworn to uphold confidentiality and agree they cannot discuss or pursue research endeavors based on any information disclosed in the applications. This is part of the standard NIH Reviewer Orientation. Applicants are welcome to mark applications pages as “Confidential” to remind reviewers.
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21. How many reviewers will be assigned to review each application?
Typically, each application will be assigned to three (3) reviewers, sometimes four (4).
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22. What will the scoring format be for review of the applications?
The standard NIH Scoring System and Procedure will be used. Please keep in mind that the review score is only one factor NIH Program staff will use in making funding decisions.
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23. Are funding decision based solely on the scores?
No, funding decisions will be based on scientific and technical merit of the proposed project as determined by scientific peer review, availability of funds, and relevance of the proposed project to program priorities.
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24. What is the significance of identifying milestones within the application?
This FOA requires applicants to propose milestones and timeline for the deliverables of the proposed project. Program staff will negotiate milestones with the investigators prior to award, based on the comments from the review panel. If the review panel identifies “fixable flaws” in the research plan that can be addressed through programmatic negotiations (and not require further peer review), then these flaws should not significantly affect the review score. These identified fixable flaws may result in changes in the negotiated milestones and timeline. Adherence to meeting milestones will be considered in continued funding of the award.
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25. Will an application be scored lower if study of the target organ function and/or underlying biology network is exploratory (e.g., the science involved in understanding the mechanism, regardless of the tool used, is not well known or defined)?
The purpose of the current funding announcement (RFA-RM-15-002) is to support the development of technologies to enable better understanding of the neurobiology and neurophysiology underlying autonomic control of internal organs. If the biological aspects are not known, then it is expected that the technology will be developed in a “push- pull” format with the biology (i.e. develop the technology, test it on the biology, refine the technology, further test on the biology and so on).
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26. Is there a preference for projects that propose to use a mix of animal and human models versus those that propose to use solely animal or human models?
No, there is no expectation regarding use of animal and/or human models. A clear explanation of why a particular model is being used should be included in the Research Plan. As noted in Section IV, “Applicants interested in developing technologies specific to animal models must justify the model as one that will potentially have broad use for the SPARC program overall, within the next four (4) years.”
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27. Does NIH Program staff expect applicants to incorporate a broad team of experts as part of the application?
No. Applicants are encouraged to “utilize a multidisciplinary approach, consulting with experts in anatomical and functional mapping of innervation for each organ system in animal models, surgeons who routinely access the nerves for each organ system, technologists with expertise in multiple academic technologies, and translational engineers.” It is up to the applicant to determine who should be involved in their project (e.g., may need a co-investigator or simply a consultant) based on what is proposed in the application and the phase of development for the proposed tool(s).
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Awards
28. How many awards will be issued under the current funding opportunity (RFA-RM-15-002)?
NIH intends to fund an estimate of five (5) to seven (7) awards, corresponding to a total of $2.1 million (USD) for fiscal year 2015, and $2.1 million (USD) for fiscal year 2016.
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29. Is NIH Program staff planning to issue awards based on broad coverage of the peripheral nervous system (PNS) to avoid funding all awards on one (1) organ?
It is anticipated that the scientific community will submit meritorious projects that are feasible within the specified two (2) years and will advance the goals of the SPARC program.
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30. Will indirect costs be included in the award amount as the current funding opportunity (RFA-RM-15-002) states that “direct costs are limited to $200,000 (USD) per year” for each award?
Yes. The funding announcement only lists direct cost budget limits. As with other NIH applications, the indirect costs are calculated based on the direct costs proposed and added to the overall budget request and award.
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31. The NIH traditionally funds academia rather than industry, so will consideration be given to industry applicants?
The SPARC program welcomes industry applicants and this is reflected in the “Eligibility Information” of the current funding opportunity (RFA-RM-15-002). Awardees from industry would adhere to the “Cooperative Agreement Terms and Conditions of Award”, as stated in the FOA.
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32. How will NIH Program staff know whether the proposed milestones are being met, and will achievement of the milestones be tied to funding?
The NIH requires awardees to submit annual progress reports. Cooperative Agreements allow for NIH Program staff to periodically meet with awardees (e.g., monthly phone calls to gauge progress, and the four (4) stated workshops throughout the award duration). Failure to report progress or not achieving milestones may result in a funding reduction/cut at the end of year one (1).
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