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 FROM 8/16/2018
Q: A SF424 question has arisen on a grant submission for the attached announcement:
The SF424 is asking for “Grant Program Function or Activity” We are not clear on what to list here.
A: Leading Edge Acceleration Projects (LEAP) in Health IT
Q: Funding Opportunity NAP-AX-18-003 (Leading Edge Acceleration Projects (LEAP) in Health Information Technology) requires bidders to utilize Appendix D as the budget narrative. Page 18 of the RFP states that the Budget Narrative must be double-spaced with 1” Margins; however, the appendix D provided isn’t formatted with 1” margins or double spaced.
We’re a bit concerned that formatting Appendix D may cause the document to lose the intended table formatting. Can you please confirm if the double spaced/1” margin is required for Appendix D, or should we leave it as is?
A: The budget narrative referred to on Page 18 of the NOFO is a high level narrative to be included as part of your project narrative. Appendix D as mentioned above can stay as is, as that is a part of the budget template/narrative to be submitted as an attachment as part of your application. This template allows the applicant to break down the costs being proposed as part of the application and provides the individual reviewing your application additional information to better gauge how the funds will be spent.
Q: Does the project abstract count as part of the maximum included in the 35 page narrative?
A: The Project Abstract referred to on Page 18 of the NOFO is a one-page abstract that is no more than 500 words and is not counted as part of the 35-page Project Narrative. The Project Abstract should contain the information specified on Page 18.
QUESTIONS FROM 8/15/2018
Q: Since your FAQ section has ended, can you answer a question via email? Should Key Personnel Biosketches be uploaded within the Project Narrative in Section 3: Project Team? Or should they be uploaded separately in the attachments section?
A: Per pages 20-21 of the NOFO, “All key personnel mentioned in this section must have biosketches (https://grants.nih.gov/grants/forms/biosketch-blankformat.docx) provided in a separate section of the application,” and “Biosketch for each should not exceed 5 pages in length. These will not count towards the page limit.”
Q: Can you please confirm whether or not the PHS/NIH salary limitation does not apply to this funding opportunity?
A: Please see FAQs from Week Ending 8/10/2018 below.
QUESTIONS FROM 8/13/2018
Q: In working on our LEAP application, NAP-AX-18-003 - PKG00243507, the issue of an indirect cost agreement was raised. Can you please send information regarding the process of securing an indirect cost agreement with HHS? Thank you.
A: Info on applying for an indirect cost rate agreement can be found below:
QUESTIONS FOR WEEK ENDING 8/10/2018
Q: For the LEAP NOFO, is there a percentage that the ONC would like non-profits to use for fringe benefits or is it based off of what the company benefit rate is? Is there a cap on what the fringe rate can be?
A: Grantees are required to utilize the rate outlined on their fringe rate agreement.
Q: At our institution, we utilize a system-to-system application portal (Cayuse) to submit our applications to Grants.gov. On page 25 of the guidelines, however, it states that ‘completed applications are uploaded into Grants.gov. Applications will not be accepted through any other website…’. On behalf of our PI, I wanted to confirm that we will be able to submit to Grants.gov via Cayuse, and that this will not cause any issue with submission.
A: Per the NOFO, all applications must be uploaded to Grants.gov. ONC cannot confirm the effectiveness of any other application portal to submit application to Grants.gov.
Q: It appears that the closing date for applications has been moved out and is now Sep 30, 2023. Is this correct? It had been Aug 17, 2018.
A: Applications for this funding opportunity are due on Friday, August 17, 2018 per NOFO page 15. Under this announcement, as new emerging issues and vexing problems/challenges are documented, program will call attention to these specific areas of interest for further investigation via a special emphasis notice (SEN). This funding opportunity will have an open application period, where ONC may issue future awards to other eligible applicants for future priority areas of interest to address emerging challenges in the field, via SEN; contingent on the availability of funds and ONC priorities. Any SENs will be issued at least 60 days prior to the due date of applications.
Q: Quick question... do the bio sketches for the LEAP grant application require that each participant have an eRA Commons login?
A: Please scroll down and read the last Q&A on this page.
Q: For the (LEAP) funding opportunity, can you please clarify the funding? Should our budget be restricted to $1 Million over the 5 year period? Or should we only restricting the first 2 years to a total of $1 Million so a budget of 5 years could be over the $1 Million mark?
A: Please scroll down and see Q&A under “QUESTIONS ABOUT FUNDING”.
Q: Is the DHHS Executive Level II salary cap ($189,600) applicable to Funding Opportunity # NAP-AX-18-003?
A: No, Funding Opportunity # NAP-AX-18-003 do not have a salary cap. However, recipients should be cognizant about salaries charged to the award and ensure it is reasonable, necessary, allocable, and in line with their organization’s Human Resources policy.
Q: For the ONC LEAP application is it permitted to have tables (e.g. in the approach section), and if so, must they be double spaced or can single spacing be used?
A: Tables are permissible, however the page limitations still apply. Tables should use double space.
QUESTIONS FOR WEEK ENDING 8/3/2018
Q: With respect the Budget Narrative, is it sufficient to supply ALL budget narrative/justification information in the format of Appendix D, which is a table of succinct information without double-spacing OR do you require an additional 2-3 page (or longer) written Budget Justification document, with double-spaced text and 1” margins, describing, in prose, personnel qualifications, as indicated in a bulleted comment within section, “3. Project Team”?
A: The Budget, Level of Effort, and Justification (instructions can be found on page 29 of the NOFO) of your Project Narrative (NTE 35 pages total) is separate from the Budget Justification documents; instructions for Budget Justification documents can be found on pages 22-23 of the NOFO.
Q: In Appendix C, the instructions for form SF-424A, both of these statements are made (bold added):
- Line 6f: Contractual: “Do not include payments to individuals or consultants on this line”
- Line 6h: Other: “Note: Costs for contractual arrangements (vendors, consultants) should be budgeted in the “Contractual” cost category.”
Could you clarify whether consultant costs should be placed under the “Contractual” or “Other” cost category?
A: Consultant costs should be placed under the “Other” category.
Q: We learned about this opportunity too late to submit an LOI. We are declaring our interest at this point in case it is helpful.
A: Letters of Intent are not required in order to apply.
Q: My main submission question is about citations/references to literature in the Approach section. This section is limited to 10-14 double-spaced pages, which severely limits the ability to include citations. Are citations considered part of the page limit or separate?
A: Citations can be single spaced, TNR or Cambria, Size 11 font, and should be submitted as a separate attachment.
Q: The NOFO says that additional funding may be available for years 3-5 but does not specify the level. Are we able to budget whatever we need, or should we assume the same maximum level of approx. $1.5M for the 3 out-years, based on the $1M for first 2 years?
Typically in a successful project, out years may need more funds for scale up and dissemination.
A: We are unable to specify a budget level for years 3-5 at this time. Please note that the potential for years 3-5 are subject to the availability of funding.
QUESTIONS FOR WEEK ENDING 7/27/2018
Q: The LEAP funding announcement references an ONC Match requirement – it is unclear to me since this is labeled as “sample language” if this is actually on ONC requirement, or just an example of cost-matching if we intended to do so.
ONC’s Match Requirement – (Sample Language)
Under this project, the applicant’s match requirement is $1 for every $3 Federal dollars In other words, for every three (3) dollars received in Federal funding, the applicant must contribute at least one (1) dollar in non-Federal resources toward the project’s total cost. This “three-to-one” ratio is reflected in the following formula which you can use to calculate your minimum required match: Federal Funds Request/3 = Minimum Match Requirement
For example, if you request $100,000 in Federal funds, then your minimum match requirement is $100,000/3 or $33,333. In this example the project’s total cost would be $133,333. If the required non-Federal share is not met by a funded project, ONC will disallow any unmatched Federal dollars.
Can you please confirm if cost-matching is required? And if so, what the percentage is?
A: The sample language is an example for awards that do require match. However, under this NOFO, there is no matching requirements, please see page 14 of the NOFO; we also recommend you review 45 CFR 75.306 which provides the HHS regs for cost sharing/matching.
Q: The Funding Opportunity Award Information states that “There are no cost sharing requirements associated with this award.” Can you confirm that Matching Funds (as discussed in the Instructions for Application Item 18) are considered as one and the same as Cost Sharing, and that neither cost sharing or matching funds are required for this award?
Q: For Years 3 to 5 in our budget period, which are the years NOT covered by the initial award period, may we specify potential subcontractors and set aside monies in Years 3 to 5 to cover potential subcontracts, WITHOUT NAMING the subcontractors and therefore without establishing those subcontract relationships now?
A: You do not need to name your subcontractors/establish your subcontractor relationships for years 3-5 as part of your budget proposal.
Q: For Years 3 to 5 in our budget period, which are the years NOT covered by the initial award period, may we specify potential subcontractors and set aside monies in Years 3 to 5 to cover NAMED subcontractors who provide a letter of support BUT NOT an approved budget from their institution?
A: You may do so, with the notation that the budget has not yet been approved by their institution. Also note that the potential for years 3-5 is subject to the availability of funds.
Q: For the budget justification, we intend to list our organization’s billable hourly rate for each key person. Are we required to break down fringe benefits?
A: Yes, fringe benefits must be broken down and included in your budget.
Q: You mention future possible grants in the next 3 years - are the approximate deadlines known?
A: No. It is also important to note that the potential for future funding is subject to the availability of funds.
Q: We submitted a question about our Canadian collaborators and you replied (on the web page) that these must be approved in advance. So this is a request for approval; they are: [Redacted]
A: ONC does not provide prior approval of subcontractors/sub recipients during the application submission process. If your international collaborators are intended to serve as subcontractors/sub recipients, they would need to be included as part of your budget for ONC to review and ensure that costs are allocable, allowable, reasonable, and necessary. Recipients would not be able to start work with them until there is an approved budget and a notice of grant award informing them of approval. If the international collaborators would not be receiving direct funding and just providing input/guidance then it should be included in part of your application proposal, and approval would be determined after an award is made.
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.