SPARC Other Transactions (OTs)
The Stimulating Peripheral Activity to Relieve Conditions, or SPARC, program employs an active and collaborative program management strategy using primarily Other Transactions (OTs), which are not contracts, grants, or cooperative agreements.
SPARC leverages OTs to manage projects in which time-critical developments and nimble integration of ideas and expertise from various disciplines are essential to achieve a programmatic goal. The cutting-edge research supported by the SPARC program requires multidisciplinary teams of scientists. SPARC’s use of OTs facilitates engagement of nontraditional partners (e.g., large corporations and unaffiliated individuals) as well as sharing of devices between industry partners, academics and clinicians to rapidly develop therapeutic advances.
The SPARC program relies on use of OT awards to adapt as new knowledge and technologies emerge. The SPARC Program Manager (PM), in collaboration with the SPARC Agreement Officer, adds or aggregates the necessary expertise and combines projects as needed. Components of SPARC may be expanded, modified or discontinued based on project feasibility and emerging methods, technologies, or approaches that are more useful. In addition, SPARC awardees collaborate and cooperate with the SPARC PM, NIH program staff and one another to incorporate relevant breakthroughs and discoveries, and engage pioneers. This strategy is designed to mitigate the inherent risk of such a program. The SPARC PM uses a rapid review process and a highly responsive post-award management process to take advantage of advances emerging from diverse scientific fields and parallel programs such as the NIH BRAIN Initiative.
The various guidelines and polices to which SPARC OT awardees must adhere as a member of the SPARC consortium are provided in the SPARC Material Sharing Policy. Additional information regarding the various laws, regulations, guidelines and polices to which SPARC will adhere when issuing SPARC OT awards are listed within the SPARC OT Award Policy Guide while key features of the SPARC program that differ from traditional methods and procedures associated with grants, cooperative agreements and contracts are discussed in the Q&A below.
General Information
1. What is the Common Fund?
The NIH Common Fund, managed by the Office of Strategic Coordination in the Office of the Director, supports cross-cutting trans-NIH programs that require participation by multiple Institutes and Centers. Common Fund programs are intended to be transformative, catalytic, synergistic, cross-cutting, and unique. More information can be found at: https://commonfund.nih.gov/index. 2. What is the SPARC program?
The Stimulating Peripheral Activity to Relieve Conditions or SPARC program’s overarching goal is to provide the scientific foundation necessary to pilot new and/or improved closed-loop neuromodulation devices and stimulation protocols to treat diseases and conditions through precise neural control of peripheral end-organ system function.
To achieve this goal, the SPARC program is comprised of four interrelated research components
to be managed in an interactive manner as a consortium. The program aims to support multidisciplinary teams of investigators to deliver detailed, predictive, functional and anatomical neural circuit maps of the innervation of multiple major internal organs in humans. These maps will provide a foundation for the development and testing of novel electrodes, stimulation protocols, and minimally invasive surgical procedures to improve existing, or develop new, neuromodulation therapies, and to test existing approved neuromodulation devices in new applications. Driven by end goals of improving existing, and developing new, neuromodulation therapies to relieve conditions, the program will be iterative and dynamic, with the technologies informing neural mapping efforts, and the mapping results defining new technology requirements.
3. What is the role of the SPARC Program Manager (PM)?
The SPARC PM will be a scientist familiar with the program area, the corresponding scientific communities, and the steps necessary to achieve the identified scientific goals. The SPARC PM will be responsible for the programmatic, scientific, and technical aspects of assigned applications and OT awards. This includes, but is not limited to, development of research programs to meet SPARC’s mission; oversight of the objective review process; and post-award administration, including review of progress reports, participation in site visits, and other activities complementary to those of the SPARC Agreement Officer. More information about the SPARC PM’s role post-award is available under Post-Award Management Information.The SPARC PM oversees the review applications for completeness and conformity to requirements, ensures that adequate numbers of reviewers with appropriate expertise are available for application review, assigns applications to individual reviewers as discussion leaders and for preparation of written critiques, moderates the review meetings, prepares and sends review outcomes for all applications reviewed, and serves as the scientific point of contact with applicants during the initial phase of the peer review process. 4. What is the role of the SPARC Agreement Officer (AO)?
The SPARC AO comprehensively understands how to develop agreements with external organizations. The SPARC AO advises the SPARC PM about the capability of individuals or organizations selected for award and works with the SPARC PM to establish, modify and terminate OT awards. These activities include, but are not limited to, evaluating OT applications for administrative content and compliance with statutes and guidelines; negotiating OT awards; providing consultation and technical assistance to applicants and recipients, including interpretation of OT administration policies and provisions; and administering and closing out OT awards.The SPARC AO is the focal point for receiving and acting on administrative requests (e.g., for changes in the terms and conditions of award, see Sections 1.2.3-1.3 of the NIH Other Transaction Award Policy Guide for the SPARC Program). The SPARC AO is also the only NIH official authorized to obligate NIH to the expenditure of Federal funds or to change the funding, duration, or other terms and conditions of award. 5. What is an Other Transaction (OT) award?
The term OT award refers to a transaction other than a contract, grant or cooperative agreement under section 402(b)(7) or 402(b)(12) of the Public Health Service Act.
6. What are “benchmarks”?
Benchmarks are metric-driven, quantifiable and verifiable, minimum-success criteria for each year of the project. The adequacy of the proposed project benchmarks and the feasibility of achieving them will be considered by reviewers in determining the scientific and technical merit of the application. In addition, benchmarks will be used to determine whether support for a study will continue after the end of each year, or if funding will be substantially reduced (i.e., expand/continue/reduce funding or project scope).
7. Where are Other Transaction (OT) Funding Opportunity Announcements (FOAs) posted?
SPARC OT FOAs will appear in Grants.gov, the NIH Guide and/or other sources to make sure the information is widely available to the entire pool of potential applicants. For example, announcements will be advertised on the SPARC Funding Opportunities website. 8. From which disciplines does SPARC wish to draw submissions?
SPARC plans to support experts from several disciplines, including but not limited to anatomy, physiology, surgery, neuroscience, engineering, biotechnology, neuromodulation and device design.
9. Is there a special application process or format for Other Transaction (OT) Funding Opportunity Announcements (FOAs)?
Applications that will be received through Grants.gov will use an electronic Standard Form 424. The SF424 is implemented as both a fillable electronic and as a web-based form, giving potential applicants the ability to make maximal use of available resources. For applications being received through a designated SPARC mailbox or other resource, submission requirements and isntructions will be specified in the SPARC OT FOA. 10. Who is eligible to apply for an Other Transaction (OT) Funding Opportunity Announcements (FOAs)?
In principle, OT awards may be issued to organizations that are domestic, foreign, public, private, non-profit or for-profit. Eligible organizations include but are not limited to governments, including Federal institutions, institutions of higher education, other non-profit organizations, hospitals, large for-profit corporations, private sector companies, and, in rare occasions, individuals.
Eligibility for individuals unaffiliated with an institution will be specified in each SPARC OT FOA. If indicated, OT awards may be issued to unaffiliated individuals. These awards will be made to promising applicants who have the ability to be productive, independent investigators in fields related to the SPARC mission. The eligibility of these individuals to complete the project will be evaluated during the objective review process and by the SPARC PM and SPARC AO.
11. Are applicants required to have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number?
All OT awardee organizations and unaffiliated individuals must have a DUNS number as the Universal Identifier when applying for SPARC OT awards. The DUNS number is a nine-digit number assigned by Dun and Bradstreet Information Services. An Authorized Organizational Representative (AOR) should be consulted to determine the appropriate number. If the organization does not have a DUNS number, an AOR should complete the US D&B D-U-N-S Number Request Form or contact Dun and Bradstreet by telephone directly at 1-866-705-5711 (toll-free) to obtain one. A DUNS number will be provided immediately by telephone at no charge. Individual PD/PI(s) do not need to register for a DUNS number unless they are unaffiliated with an institution.If a SPARC OT award is issued, the recipient must notify potential subrecipient organizations or unaffiliated individuals that they may not receive a subaward under the OT award unless they have provided their DUNS number to the recipient. 12. Is System for Award Management (SAM) registration required?
All OT awardee organizations and unaffiliated individuals must register in the SAM (formerly the Central Contractor Registry (CCR)) and maintain the registration with current information for the entire duration that the application is under consideration for funding by NIH. SAM is the primary registrant database for the Federal government and is the repository into which an entity must provide information required for the conduct of business as a recipient. 13. Is eRA Commons registration required?
In order to participate in the SPARC program, an OT awardee organization, PD/PI(s) and unaffiliated individuals must complete a one-time registration in the Commons. Organizations registering in the eRA Commons for the first time should allow 2-4 weeks to complete the registration process.Organizations may verify their current registration status by accessing the “List of Recipient Organizations Registered in eRA Commons”.PD/PI(s) should only have one eRA Commons user account. If the PD/PI has been registered in eRA Commons by an organization other than the organization submitting an application, the submitting organization must take steps to affiliate the PD/PI(s) with its organization so that the PD/PI(s) can view and access data records for those applications.Individual applicants not affiliated with an organization or who want to submit an application independently must complete all the required registrations as though they are an organization (http://grants.nih.gov/grants/ElectronicReceipt/UnaffiliatedUserRegistra…). In eRA Commons, they will be registered as “independent scholars” and will also act as the Signing Official, with the same authority in eRA Commons that the Authorized Organizational Representative(s) has in Grants.gov. 14. What is “objective review”?
As required by 402(b)(7) and 402(b)(12) of the Public Health Service (PHS) Act, objective review is an assessment of scientific or technical merit of applications by individuals with knowledge and expertise equivalent (peer) to that of the individuals whose applications of support they are reviewing, i.e., reviewers who are the professional equals of the principal investigator (PI) or program/project director (PD) for the proposed project and who often are engaged or were previously engaged in comparable activities.
Objective review is essential to ensuring selection of applications that best meet the needs of the program, consistent with established criteria, and providing assurance to the public that the evaluation and selection process was impartial and fair. To achieve this result, NIH conducts reviews under the highest ethical standards. Any circumstance that might introduce any conflict of interest, or appearance thereof, prejudices, biases, or predispositions into the process must be avoided.
The review process and criteria will be specified in each SPARC OT Funding Opportunity Announcement (FOA). Only the review criteria described in the FOA will be considered in the review process. All applications submitted in response to the FOA will be evaluated by an appropriate review group.
15. What is the review procedure for a SPARC “Limited Competition” Other Transaction (OT) application?
The SPARC program plans to use a two-stage (OT1 followed by an OT2/OT3) application and review process in order to expedite and refine the selection of applications for SPARC awards, emphasizing programmatic priorities. The SPARC PM will invite meritorious OT1 applicants to develop and submit an OT2/OT3 application for an OT2/OT3 award. This invitation is predicated on the outcome of the OT1 review. Successful OT2/OT3 applicants will be those whose projects demonstrate the greatest potential to meet SPARC program goals. This decision is informed by the OT2/OT3 review results and input from the SPARC Agreement Officer regarding applicant’s business capabilities.
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SPARC OT1 FOA Application and Review Information
16. What is an “OT1” mechanism?
For SPARC, OT1 is a non-fundable pre-application or “white paper” that describes an applicant’s planned approach and capabilities, and provides minimal budget information. Similar to a traditional X02 grant mechanism, the OT1 mechanism will be used to invite eligible individuals or organizations to submit a pre-application. Applicants who submit OT1 applications that are judged to be scientifically meritorious will be asked to submit a subsequent OT2 or OT3 proposal (i.e., they will receive an “Invitation to Submit”). 17. What is a “rolling” receipt date?
The SPARC program will not use standard receipt dates for application submission. The receipt date(s) will be specified in each SPARC OT FOA. For FOAs that specify a rolling receipt date, applications are due by the date(s) specified. For example, a SPARC OT FOA may state that applications are due by the 15th of each month.
18. How does a “rolling” receipt date differ from a standard receipt date?
For SPARC OT FOAs that specify a rolling receipt date, applications that miss a particular receipt date are held until the next available receipt date listed in the FOA. This differs from a standard receipt date in that all applications will be accepted unless received after the last receipt date specified in the FOA.
19. What are the review criteria for an “OT1” application?
The review criteria that will be considered for SPARC OT1 FOAs include the following: • Relevance and Justification; • Benchmarks and Deliverables; • Expertise. Only these review criteria as described in the OT1 FOA will be considered in the review process. All applications submitted in response to the FOA will be evaluated by an appropriate review group.
20. Will reviewer critiques be provided post-review?
No, the SPARC PM will provide each applicant with the overall review outcome. This may include information regarding major project changes that applicants may discuss during post-review communication(s) with the SPARC PM. These changes may include SPARC PM recommendations to integrate ideas from separate applications, expand specific components proposed in an application, and/or eliminate specific components proposed in an application. This may also include an “Invitation to Submit” an OT2/OT3 application.
21. What is the “Invitation to Submit”?
The SPARC PM will invite meritorious OT1 applicants to develop and submit OT2/OT3 applications via an Invitation to Submit. This document will include information regarding associated OT2/OT3 application receipt dates and may specify recommended project changes the SPARC PM discussed with the applicant following the OT1 reviews.
22. Will impact scores be released post-review?
No, impact scores will not be released.
23. Will reviewer rosters be released post-review?
No, reviewer rosters will not be released.
24. Will Other Transaction (OT) awards be issued to meritorious “OT1” applicants?
No, SPARC OT awards will only be issued to meritorious OT2 or OT3 applicants.
25. May the review results be appealed?
No, there is no appeal process. Applicants may resubmit an OT1 application that has been modified to address and incorporate prior review recommendations.
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SPARC OT2 and OT3 FOA Application and Review Information
26. What is an “OT2” mechanism?
For SPARC, OT2 is a fundable, single component award that describes in detail an applicant’s planned approach, capabilities and projected budget. The OT2 mechanism will be used to support small-to-large, discrete, specified, circumscribed research projects. The specific features of an OT2 application will be informed by the Invitation to Submit as well as the specific funding opportunity announcements for OT2 projects.
27. What is an “OT3” mechanism?
For SPARC, OT3 is a fundable, multiple component award that describes in detail an applicant’s planned approach, capabilities and projected budget. The OT3 mechanism will be used to support integrated, multi-project research projects. The specific features of an OT3 application will be informed by the Invitation to Submit as well as the specific funding opportunity announcements for OT3 projects.
28. When is the “OT2” or “OT3” application due?
The receipt date(s) will be specified in each Invitation to Submit an OT2/OT3 application. The date provided in the Invitation to Submit will supersede any date provided in the SPARC OT2/OT3 funding opportunity announcement.
29. Which Other Transaction (OT) Funding Opportunity Announcements (FOAs) are “Limited Competition” and does this impact OT2/OT3 FOA eligibility?
Yes, when “Limited Competition” is included in the SPARC OT FOA title, the competition for SPARC OT2 and OT3 FOAs will be limited to those investigators who have submitted a SPARC OT1 application and subsequently been invited to submit an OT2 or OT3 application.
However, SPARC OT FOAs may have specific eligibility requirements. Interested investigators should review all applicable FOAs to determine their eligibility. Contact the listed NIH Scientific/Research Contact if there are questions.
30. What are the review criteria for “OT2” and “OT3” applications?
The review criteria that will be considered for SPARC OT2 and OT3 FOAs include the following: • Scientific and Technical Merit; • Personnel Qualifications; • Institutional Commitment. Only these review criteria as described in the OT2/OT3 FOA will be considered in the review process. All applications submitted in response to the FOA will be evaluated by an appropriate review group.
31. Will reviewer critiques be provided post-review?
No, the SPARC PM will provide each applicant with the overall review outcome. This may include information regarding major project changes that applicants may discuss during post-review communication(s) with the SPARC PM. These changes may include SPARC PM recommendations to integrate ideas from separate applications, expand specific components proposed in an application, and/or eliminate specific components proposed in an application.
32. Will impact scores be released post-review?
No, impact scores will not be released.
33. Will reviewer rosters be released post-review?
No, reviewer rosters will not be released.
34. May the review results and final awardee selections be appealed?
No, there is no appeal process. The SPARC PM may request applicants resubmit an OT2/OT3 application that has been modified to address and incorporate prior review recommendations.
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Award Management Information
35. What happens following selection of meritorious applicants for an Other Transaction (OT) award?
Once a SPARC OT2/OT3 application has been selected, the SPARC Agreement Officer (AO) will contact the applicant to update Other Support information or any other information necessary for the OT award. The SPARC PM and SPARC AO will negotiate agreements with the applicants to support selected projects. The negotiated benchmarks will be the basis for continuation or termination of the OT award.
36. Will a Notice of Award (NoA) be issued following selection of meritorious applicants for an Other Transaction (OT) award?
SPARC OT awards will be made via a Notice of Award (NoA) once a negotiation with the prospective awardee has been completed. The NoA will specify the terms and conditions for those awards including frequency of formal reporting, benchmarks and applicable policies.
37. What are the Terms & Conditions (T&C) of the Other Transaction (OT) award?
38. How long is the project period under an Other Transaction (OT) award?
The project period for an OT award will be specified in each OT funding opportunity announcement. Once an OT award has been issued, budget periods will be renewed annually following successful and timely completion of negotiated benchmarks.
39. Will a Project Officer be assigned to oversee my Other Transaction (OT) award?
Yes, the SPARC PM or a designated SPARC Project Manager will serve as the Project Officer for all SPARC OT awards.
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Post-Award Management Information
40. What is the SPARC consortium?
The term “consortium” refers to all awardees and research projects supported by the SPARC program and managed by the SPARC PM. Awardees within this highly collaborative, interdisciplinary consortium will share information, models, expertise, data and technologies in order to maximize progress. The SPARC PM will facilitate SPARC consortium interactions with external consultants, experts and industry partners.
41. Who participates in the SPARC consortium?
The SPARC consortium will consist of SPARC funded PDs/PI(s) supported by the SPARC program, as well as the SPARC PM, the SPARC Agreements Officer, and appropriate supplemental personnel.
42. What is the SPARC Steering Committee?
The SPARC Steering Committee is the governing body for the SPARC consortium. The committee will develop data integration and data sharing approaches and publication policies governing the SPARC consortium as well as develop common standards, formats, and means of communicating data. The committee will then submit these plans to the SPARC PM for review and approval.
43. Who participates in the SPARC Steering Committee?
The SPARC awardees and designated NIH program staff will participate as members of the SPARC Steering Committee. The SPARC PM will be a non-voting member, but will review and approve action plans developed by the Steering Committee.
44. What are post-award changes?
The SPARC PM and SPARC Agreement Officer (AO), with appropriate supplemental personnel, will monitor and administer each SPARC OT award on an ongoing basis. Awardees should make every effort to achieve the benchmarks. If a recipient fails to materially comply with the terms and conditions of award, s/he should communicate this in a timely manner to the SPARC PM and SPARC AO who will provide course correction strategies (e.g. adjust benchmarks). This also applies to necessary changes that arise based on programmatic need and the availability of funds for a project. Opportunities for supplemental funding may become available in response to evolving programmatic needs and emerging scientific advances. Additional activities that may qualify for funding adjustments include, but are not limited to, SPARC awardees entering into a collaboration, developments that overcome an unforeseen scientific roadblock, and sharing resources.Additional information on post-award changes is available in the NIH Other Transaction Award Policy Guide for the SPARC Program. 45. How are post-award changes decided and approved?
The SPARC PM will determine post-award unilateral changes, suspensions and terminations taking into account input from the Project Manager, Project Scientist, Working Group, Steering Committee and external evaluators’ advice. The SPARC PM will convey to the DPCPSI Director the decision to unilaterally change, suspend and/or terminate a project. Unilateral terminations are subject to approval by the DPCPSI Director. 46. May post-award changes be appealed and/or disputed?
No. There is no appeal or dispute process.
