The 21st Century Cures Act (Cures) directs ONC to improve the interoperability of health information, facilitate information exchange, address barriers to interoperability, and reduce clinician burden relative to EHRs.
This funding opportunity will address well-documented and fast emerging challenges that inhibit the development, use, and/or advancement of well-designed, interoperable health IT. It is expected to further a new generation of health IT development and inform the innovative implementation and refinement of standards, methods, and techniques for overcoming major barriers and challenges as they are identified.
It is critical that the field of health care innovate and leverage the latest technological advancements and breakthroughs far quicker than it currently does to optimize real-time solutions, especially in areas that are ripe for acceleration.
This funding opportunity is specifically interested in innovative solutions and breakthrough advances in the following areas of interest:
- Area 1: Expanding the scope, scale, and utility of population-level data-focused application programming interfaces (APIs)
- Most importantly, reducing provider burdens associated with reporting through this technology;
- Investigating and assessing trade-offs associated with various big data formats; and
- Challenges to the scope and scale of FHIR-based APIs for these purposes.
- Area 2: Advancing clinical knowledge at the point of care
- Emerging innovations in clinical medicine;
- Data-driven medicine infrastructure;
- Integrating knowledge at point of care; and
- Legal and policy implications for innovative approaches
ONC anticipates issuing one (1) award per area of interest (for a total of two (2) recipients), up to $1M per recipient (for a total of up to $2M in funding in fiscal year 2018). These awards will have a 2-year project and budget period at initial award. However, applicants are encouraged to submit their responses based on a 5-year project and budget period. Additional funding for years three to five (3-5) may be provided; contingent on availability of funds and meaningful progress.
This funding opportunity will have a 3-year open application period. ONC may issue future awards under this NOFO to other eligible applicants for future priority areas of interest. This will be contingent on the availability of funds and ONC priorities.
Informational Session will be held on Thursday, July 12, 2018 from 2:00 p.m. – 3:00 p.m. ET. Register to participate in the webinar.
For more information, email: ONC-LEAP@hhs.gov
Please note that this is a competitive award and we are only able to answer general questions. We will make information equally and publically available in the form of a written FAQ which is updated on a weekly basis. ONC is not able to answer direct questions specific to individual organization’s proposals.
QUESTIONS FOR WEEK ENDING 7/20/2018
Q: Is there a program officer I may make an appointment with?
Q: I just missed your 7/12 LEAP webinar and am wondering if there is a webinar recording that is available I can review to see if this is an area my organization can pursue.
A: A recording and the slides decks from the 7/12 Informational Session will be made available on this webpage. To see if this is an area your organization can pursue you can also read Section A of the NOFO.
Q: On Page 10 of the NOFO, please clarify whether the Draft Project Plan is:
a. Required to be appended to our application,
b. Is a deliverable due within 1 month after award, or
c. Both. If both, what is the difference between the Draft Project Plan we need to append to the proposal and the Draft Project Plan that will be due within 1 month of award.
A: The Draft Project Plan is a listed deliverable under the cooperative agreement award. Please refer to Section D of the NOFO for what is required in your application.
Q: According to the NOFO: “This form contains the name and address of lobbying registrants. Please note that a duly authorized representative of the applicant organization must sign the disclosure form. Failure to complete and sign the form may result in civil penalties ranging from $10,000 to $100,000” The form requires a name of the lobbying company and since our company does not participate in lobbying, what would we put in those fields/should we still submit this form?
A: If your organization does not conduct any lobbying activities or have a lobbyist, you are still required to submit the form as part of your application. Please fill out the form, enter N/A, and sign the form as applicable.
Q: Is the letter of intent for NOFO No. NAP-AX-18-003 due 7/17 (tomorrow) or 7/19 (thurs)- I see it listed differently in two places in the full NOFO (see below)?
A: LOIs are due by 7/19. Please note that LOIs are non-binding and not required.
Q: Will the notices of intent to apply for the LEAP HIT Grant (NOFO No. NAP-AX-18-003) be made public?
Q: Regarding eligibility – you note on your FAQ that federal agencies are not eligible to apply or lead a project under this opportunity. What is your guidance on federally funded research and development centers (FFRDC)?
A: FFRDC’s will be considered as eligible applicants.
Q: Regarding the second topic (Advancing Clinical Knowledge at the Point of Care) which lists four objectives (Emerging Innovations, data-driven medicine infrastructure, integrating knowledge at point of care, and legal and policy implications for innovative approaches). Should we address all four in any application, or select one or more?
A: Yes, all four areas must be addressed in an application. For each area of interest, the associated objectives must be addressed.
Q: Are there restrictions on collaborators (e.g. we have Canadian collaborators who are international experts in health IT usability and safety; could they participate as a subcontract?).
A: HHS Policy allows for organizations outside of the US to operate as subcontractors/subrecipients however, these relationships require prior approval.
Q: There does not seem to be clarification of direct v. indirect costs - is the $1 million maximum a cap on the total of direct + indirect, or just direct costs? Are there any other restrictions?
A: The $1 million must include indirect costs as well. Please note that any organization planning to account for indirect costs within their budget must have an approved indirect cost rate agreement, and must maintain it throughout the period of performance in order to charge those costs to the award. Other restrictions will be determined on a case-by-case basis and is dependent on additional details regarding the circumstance.
Q: For the five-year plan should we budget with a maximum in mind?
Q: I was participating in a webinar on Thursday, July 12, 2018 1:00 pm, called ONC: LEAP Information Session. During the webinar, it was said that there will be video recording publicly available at healthit.gov. Could you please give me a direct link to the recording? Unfortunately, I could not find it at healthit.gov.
A: The presentation deck, as well as a recording of the Informational Session will both be made available on this webpage.
Q: We are an early stage startup building patient safety tools for clinicians at the point-of-care.
Specifically this addresses the problems identified in LEAP "Area 2. Advancing clinical knowledge at the point of care"
We cannot apply as a for profit company.
- What is the process to apply as a member of a consortia?
- We wouldn't apply as a sub-recipient.
- Would like to learn the definition of consortia so we can create one for this application.
A: If your organization does not fit into the category of eligible applicants as listed in the NOFO, you will not be able to apply. An eligible applicant may apply and include a for-profit entity as a collaborator, however the for-profit cannot be the prime award recipient.
QUESTIONS FOR WEEK ENDING 7/13/2018 (INCLUDES QUESTIONS FROM 7/12 INFORMATIONAL SESSION)
Questions About the Informational Session and Presentation Deck
Q: Is the [Informational Session] presentation deck available for download?
A: Yes, the presentation deck, as well as a recording of the Informational Session will both be made available on this webpage.
Q: When will the recording be made available?
A: The recording of this Informational Session will be made available within one (1) week.
Q: Can I get this info material through email?
A: All materials (presentation slide deck and recording of the Informational Session) will be made publically available on this webpage.
Q: Just need the email listed
A: Our email is ONC-LEAP@hhs.gov.
Questions About Letters of Intent
Q: What must the letter of intent include? Does it need to include details of a proposal?
A: Letters of intent should include the following information:
• Name of applicant organization
• Organization type
• City and state
• NOFO No. NAP-AX-18-003
• Subject Line: Leading Edge Acceleration Projects (LEAP) in Health IT
No details of the proposal are necessary in the letter of intent.
Q: We already submitted our LOI. However, we did not specifically call out that our organization is a privately-held for-profit organization. However, we did specify that our organization is an LLC. Should we resubmit our LOI?
A: No, you do no need to resubmit an LOI.
Q: If you do not submit a notice of intent, can you still submit the grant and be considered?
A: Yes. While a letter of intent is not required in order to submit an application, it is strongly encouraged.
Questions About Funding
Q: Is the $1M amount for each year or for the first two years?
A: There will be a $1M award for the two year period-of-performance, per recipient, subject to availability of funds.
Q: Could the ONC provide some examples of match dollars that would be allowable, versus match dollars that may not qualify? How would volunteer hours be counted?
Q: What is the payment schedule for the award (i.e., at grant award date, certain milestones, at completion?)?
A: Recipients will be able to draw down funds as they incur costs for allowable charges to their award. Draw down of funds can only occur after their budget has been reviewed and approved by their grants management specialist and they have a notice of award that states it is approved.
Questions About Eligibility/Applicants
Q: Is there any limit on the number of participating organizations on a team?
Q: Are federal and state government agencies permitted to lead, or serve as collaborators? e.g. CMS, State Public Health
A: No. Federal agencies are not eligible to apply for or lead a project under this funding opportunity; however, applicants are allowed to collaborate with other federal agencies, so long as the federal agency does not receive federal funds as a result of it.
Q: Our project involves collaboration between a number of agencies (CTO, CDC, CMS, and state and local health depts). I understand that govt. agencies cannot endorse our project. But, should we include letters from them indicating their involvement?
A: Federal agencies are permitted to submit letters of support indicating their involvement provided that they are not included as a paid collaborator.
Q: I am developing one EHR which can bring all hospitals, pharmacies and labs into one system. will that be eligible to this program?
A: Please read through the Purpose and Approach sections of the NOFO to determine whether or not your work fits into the objectives under this funding opportunity.
Questions About Application/Applying
Q: Will this application information be available after the call? Perhaps it's online already.
A: The application information can be found in Section D of the NOFO.
Q: Can the same organization win both awards?
A: Yes. However, please note that in order to be considered for an award in both areas, you must submit an application for each.
Q: Can we submit our proposal for a specific area of interest or do we need to include all areas of interest?
A: Each proposal submission should be for one area of interest. If you wish to be considered for both areas of interest, you must submit an application for each separately.
Q: Can you provide more direction regarding the citations? Specifically, are the citations included in the 35 page limit of the project narrative or can they be added as a separate attachment? Also, for the up to 100 citations, are they required to be formatted the same (double-spaced, TNR or Cambria, size 11)?
A: Citations can be single spaced, TNR or Cambria, Size 11 font, and should be submitted as a separate attachment.
QUESTIONS ABOUT INTEREST AREA 2
Q: To accomplish Objective 4 of Interest Area 2, must the Project Team include a member with legal education and/or credentials?
A: Multidisciplinary research teams are strongly encouraged, as appropriate to conduct the project and associated activities.
Q: Re Objective 1 of Interest Area 2, exhaustive treatment would seem to contradict or at least impede the urgency implied by the Executive Summary excerpt "It is critical that the field of health care innovate and leverage the latest technological advancement"
A: Please refer to Area 2 summary in the NOFO. The goal of this area of interest is to advance clinical knowledge into the health care setting via innovative health IT tools and approaches. The four objectives required under Area 2 serve as guideposts for ensuring key elements are investigated thoroughly to ensure success while maximizing potential for scalability.
Q: Please explain/amplify the previous question re Objective 1 of IA 2.
A: See response above.
Q: For software developed who owns the code? Does the submitting organization maintain ownership?
A: HHS maintains the right to have irrevocable rights to access the information pertaining to an awardees efforts to building solutions or platforms using government funds to use as applicable. We are not seeking an organization's “code”.
Q: If a project involves EMR data extraction, does "scalable" and "interoperable" mean that the proposed technology solution must be able to interface with all EHR systems (at the outset)?
A: If a proposed solution requires interfacing with EHR systems, then to be successful it will ultimately need to be able to interface with EHR systems. Therefore, at the outset, an existing technology to be used in that solution that can interface with an EHR system would be assessed more favorably than one that couldn’t.
Q: Please explain the "eRA COMMONS USER NAME" field on the Biographical Sketch form.
A: Please use the bio-sketch form as a template; applicants can disregard the ‘eRA commons User Name’ Field within this template.