FAQ Topics: LEAP in Health IT, 2019

2019 LEAP in Health IT Questions

Questions for Week Ending 05-24-2019
  1. Q: The website does not state that a human subjects research plan is required as part of the proposal. If we submit a proposal that includes some human subjects research (e.g., evaluation of usability), what human subjects forms are required?
    A: Currently the application package in grants.gov is not set-up to accept human subject research forms. If there is additional information you would like to provide in terms of other questions pertaining to your approach, please follow back up and send them to ONC-LEAP@hhs.gov.
  2. Q: We are applying for the ONC-LEAP Application and one of our subcontractors (subrecipients) wants to prepare their budget using approved rates under GSA Schedule Group 70 instead of reporting salary with % level of effort and fringe benefits. They are an approved supplier as listed under contract number: GS-35F-0034W, Special Item Number 132-51:  Information Technology (IT) Professional Services.Must all subrecipients provide a budget with listing all personnel with their salary and % level of effort or may they use estimate number of hours with approved hourly rates under GSA Schedule Group 70?
    A: As a subrecipient, a budget must list all personnel with their salary and % level of effort for the project.
  3. Q: We are interested in the NAP-AX-18-003 funding announcement. I came across it last week, but see there is a due date for May 28, 2019. However, on grants.gov it mentions an open application period and shows the closing date as September 30, 2023. Will there be another cycle after the May cycle?
    A: Additional funding cycles are subject to the availability of funds.
  4. Q: I would like to know the details of previous LEAP awards made by ONC in terms of organization, title of proposal, amount, and any other details that you make available to the public. My colleagues and I need this information in order to help decide the time and effort we should invest in preparing and submitting a LEAP proposal.
    A: Please see the HHS news release  announcing the LEAP in Health IT award winners from 2018.
  5. Q: 1. I did not attend the briefing session held in April. If the deliberations of that session are available in online video, transcript, or other format, I would appreciate if you can send its link or copy to me.2. I would like to know the details of previous LEAP awards made by ONC in terms of organization, title of proposal, amount, and any other details that you make available to the public.3. I did not submit a letter of intent earlier, and hope that it is okay to submit a proposal. Please confirm.4. If there are any more notices/information that has been circulated about this RFP this month, please let me know.
    A: The Informational Session  recording can be found on the LEAP in Health IT page. For information regarding last year’s awards please see the HHS news release  announcing the LEAP in Health IT award winners from 2018. LOIs are strongly encouraged but not required. All information regarding this notice of funding opportunity – special emphasis notice are posted on the LEAP in Health IT page.
Questions for Week Ending 05-17-2019
  1. Q: For the Notice of Funding Opportunity for Leading Edge Acceleration Projects (LEAP) in Health Information Technology, we have reviewed the guidance around page limitations for the project narrative and appendices, but had a clarification question. It states that biosketches will not count towards the project narrative, but wanted to confirm if the biosketches are considered a part of the appendix section, or are separate attachments. Specifically, since the appendix section has a 30 page material limit, want to clarify if this would apply, or only the individual 5 page limit per biosketch.
    A: Answered from 2018 FAQs on 8/15/2018: 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.”
  2. Q: Please confirm that there are no cost-sharing or match requirements for NAP-AX-18-003 Special Emphasis Applications to Address Standardization of Patient Information for Seamless Access, Exchange, and Use.
    A:  Answered from 2018 FAQs on 7/27/2018: There is no matching requirements under this funding opportunity, please see page 14 of the NOFO; we also recommend you review 45 CFR 75.306, which provides the HHS regulations for cost sharing/matching.
  3. Q: I am preparing the Project Team and the Biographical Sketches for our team and have a few questions:1) On a research team, what qualifies as “key personnel”? 2) Are team members beyond the highlighted roles (PI, HIT expert, user-centered design expert, data visualization member, Cognitive support member) such as project managers, developers, and administrators considered “key personnel”?
    A: Key Personnel would be personnel critical to the project, i.e., their removal or absence from the project would have a significant impact on the approved project, including a Principal Investigator/Project Director (PI/PD), a Project Director or Project Manager, a Finance Director, and a technical director.
Questions for Week Ending 05-10-2019
  1. Q: We interpret the language in the NOFO as $1,000,000 per award, which [sic] spans a two year period. We have heard others interpret as $1,000,000 per year per award, with awards capped at $2M over the two year period. Can you please validate which is the correct interpretation? Thank you.
    A: There will be 2 awards, at $1 million per award for a 2-year period-of-performance.
  2. Q: Im [sic] looking at the new FHIR Consent (Area 1) LEAP Grant and see that the second (FOA full) document is still for the old 2018 grant.https://www.grants.gov/web/grants/view-opportunity.html?oppId=306704 

FOA LEAP HealthIT (002).pdf

Jul 09, 2018 02:22:28 PM EDT 551.1 KB

  1. – this is linking to the old PDF (from 2018) Can you please send me the correct FOA pdf for 2019 grant (Notice Number: NAP-AX-18-003)
    A: Please refer to the related documents tab in order to access the special emphasis notice for further instruction on applying for this opportunity located here. The NOFO and SEN are also available on the LEAP in Health IT website on healthit.gov.
  2. Q: We are thinking of applying for the Leap grant, but have some concern about the timeframe. Is there going to be an extension?We are looking at the patient engagement for care (Area 2) in consent management. We believe we could work towards moving our community to a standard for consent gathering for behavioral health, social determinants and research. If we (providers, payers and the HIE), would use the same standard (we could create a FHIR app for them) then the HIE would hold the consent for the community. Patients could go to the consent manager and update as needed and as patients travel through healthcare providers or payers, the consent can follow them. However, the 28th of May is a bit tight to get this all coordinated and documented.
    A: Unfortunately application deadlines will not be extended. The grants.gov site will no longer accept applications that are submitted after May 28, 2019, 11:59 p.m. ET.
  3. Q: Please note that the program documents as provided on Grants.gov feature multiple unusable links. https://www.grantsolutions.gov/gs/preaward/previewPublicAnnouncement.do?id=62586  As far as LEAP goes, I’ve seen conflicting information regarding a 5/28 deadline and also an open solicitation. However I’m not sure the site features the current announcement. Can you help us with a better resource/ status update info?
    A: Please refer to the related documents tab in order to access the special emphasis notice for further instruction on applying for this opportunity located here. You can also access the notice of funding opportunity for application instructions. The application deadline for this round of awards is in fact 05/28/2019. You can find this clarification on the announcement page under the synopsis tab. In order to access the actual application forms, you must be a registered user in grants.gov and select the apply button. If you continue to have trouble accessing forms or documents please contact the help desk at 1-800-518-4726 or email support@grants.gov.
Questions for Week Ending 05-03-2019
  1. Q: Can you tell me what the earliest start date of the project period would be, if awarded? (webpage) Thank you
    A: Per Slide 22 of the Informational Session  held on April 2, 2019, the Anticipated Award and Anticipated Project Start Date is September 19, 2019.
  2. Q: We applied for the ONC-LEAP grant #NAP-AX-18-003 back in August 2018. We are applying again, with the new areas of interest, due May 28, 2019. I have some questions:
    • I could not find the current page with FAQs – do you have a link for this?Do we use our former workspace and re-open or do we need to set up a new workspace?Whether we use the previous workspace or open a new one, can we use all the previous documents, i.e.
      • Form SF-424, Application for Federal AssistanceForm SF-424A, Budget Information for Non-Construction ProgramsForm SF-424B, Assurances for Non-Construction ProgramsForm SF-LLL, Disclosure of Lobbying ActivitiesProof of Non-Profit Status (if applicable)

      Or do we need to complete these forms again?

    A: The current FAQ page can be found here. It is also referenced in the automatic email response from the ONC-LEAP@hhs.gov inbox. As this has new areas of interest, and you are applying with the new areas of interest, this should be treated as a new submission. You may use the same documents from last year, provided that all of the information is the same, but they must be attached to your new application.

Questions for Week Ending 04-26-2019
  1. Q: We are for-profit applying for the LEAP Grant. We considering the two options to apply for this Grant.
    1. Option 1: We could apply as part of a consortium that we are part of with one or two other members. However, the consortium is not an [sic] legal entity and doesn’t have a DUNs number. In this case is it still possible for us to apply with our DUNs number.
    2. Option 2: We could co-apply for this Grant with our Non-profit provider partner as a sub-recipient. Our Non-profit partner has a DUNs number.

    We would like to get your guidance if Option 1 is viable route for us to apply for this Grant or that we have to pursue Option 2. Also, note in either case all the parties (the consortium member and non-profit entity) will be part of the Grant with us.
    A: Please refer to page 13 of the NOFO where it says “for profit organizations may participate in projects as members of a consortia or as a sub-recipient only. Page 25 discusses application instructions. The first scenario, is not an option, as the for-profit is applying as a prime recipient, in addition to the fact that anyone receiving funds from this award must be a registered entity and eligible to receive federal funds. A DUNS number is required. You can’t register in SAM without a DUNS number. The second scenario would allow you to participate as a sub-recipient if your nonprofit partner applied as the prime recipient.

  2. Q: I have a few questions about the LEAP grant, can you let me know when you have a few minutes so I can review my questions with you?
    A: This is a competitive award so we unable to answer questions directly regarding the special emphasis notice for the LEAP award and are only able to answer general questions in the form of an FAQ that will be updated weekly on the Leading Edge Acceleration Projects page at healthit.gov.
    ONC IS NOT ABLE TO ANSWER DIRECT QUESTIONS SPECIFIC TO INDIVIDUAL ORGANIZATION’S PROPOSALS (please see page 26 of the NOFO). We also recommend that you check the FAQ page as your question(s) may have already been previously answered.
Questions for Week Ending 04-19-2019
  1. Q: Is it possible to submit an LOI for the May 28th Area 2 funding beyond the LOI due date? We just reveiwed this funding opportunity. Thanks
    A: Per page 6 of the Special Emphasis Notice, “Although not required, applicants are strongly encouraged to submit a non-binding e-mail letter of intent to apply for this funding opportunity.” This information can also be found on slide 23 from the Informational Session Webinar .
  2. Q: We, at [REDACTED] have been trying to initiate an application for Notice Number: NAP-AX-18-003, however the apply button doesn’t seem to be activated. Can you please let us know the earliest time we can start building our application on grants.gov?
    A: There could be a potential issue with the roles on your account. Please reach out to the help desk for assistance. You can reach them at support@grants.gov or you can call 1-800-518-4726.
  3. Q: I saw this opportunity advertised in www.grants.gov with the date of May 28, 2019 as a deadline for applications. However, in the funding notice attached, the application date is August 17 2018. Could I [sic] please clarify when is the deadline for this?
    A: Please refer to the Special Emphasis Notice for application information and deadlines.
  4. Q: Are you no longer accepting applications for the area of “Advancing clinical knowledge at the point of care”?
    A: Please refer to the Special Emphasis Notice for application information and deadlines.
  5. Q: Today, we are interested in learning if grant opportunity notice number #NAP-AX-18-003 is applicable to our need. We’re working with a federally qualified health center (FQHC) in [REDACTED] to find funds for the purposes of upgrading/replacing their electronic health records system. The ballpark dollar amount that we hope to secure is [REDACTED]. Please advise.
    A: Please reference the Background and New Area of Funding sections on the Leading Edge Acceleration Projects (LEAP) in Health IT webpage, as well as Page 2 of the Special Emphasis Notice. These sections state the purpose of this program and what types of projects are eligible for funding.
Questions for Week Ending 04-12-2019
  1. Q: Can you please provide a link to the slide deck from the webinar presented on April 2, 2019 in regards to the LEAP in Health IT grant?
    A: The Webinar recording, which includes the slides, are now available on the LEAP in Health IT webpage .
  2. Q: I am woman, veteran-owned digital health startup interested in applying, but all these opportunities exclude Startups, which then excludes them from being commercially successful.Partnering with a University means they take the majority of funds for themselves. I have reached out to a few Consortiums in LA, but they are only interested in their own projects.This is an area of digital health we have been working on for the past 2 years and seeking funding to build out the platform. We recently won the [Redacted].Is there a way that a for-profit startup can apply independently? Can we create our own consortium with our clinical advisors? Appreciate any guidance you can give.
    A: Thank you for your inquiry regarding Area 2 of the Leading Edge Acceleration Project funding opportunity. Per the eligible applicants section on page 13 of the Notice of Funding Opportunity for this particular award, For Profit organizations are only eligible to apply as members of a consortia or as a sub-recipient. While we encourage all applications, ONC reviews and maps them back to the eligibility criteria as outlined in the funding opportunity. We will take your provided feedback and note it for future funding opportunities. Please continue to search grants.gov for additional funding opportunities both within and outside of ONC as there may be others that your for-profit business may qualify for. If you have additional questions, contact us at ONC-LEAP@hhs.gov.
  3. Q: Grant applications must respond to Area 1: Standardization and Implementation of Scalable HL7® FHIR® Consent Resource or Area 2: Design, Develop, and Demonstrate Enhanced Patient Engagement Technologies for Care and Research.Is it possible for [Redacted] to apply as a sub-recipient as a part of a consortia with two disparate Applicant Organizations? This would mean that [Redacted] could be a sub-recipient applicant for Organization 1 for Area 1 and a sub-recipient application for Organization 2 for Area 2.A: Yes, it is possible for your organization to be included as a sub recipient by two disparate applicants between the two interest areas.
Questions for Week Ending 04-05-2019 (Including questions from April 2nd’s Informational Session)
  1. Q: I’d like to inquire about the ONC Enhanced Patient Engagement Technology for Care and Research Funding opportunity through the LEAP in Health IT funding mechanism. Based on the article published by the Healthcare Innovation Group, I understand the deadline to apply is May 28, 2019. Could you please provide further details regarding funding requirements, guidelines, and application details? Thank you!
    A: All of the specific details relating to funding requirements, guidelines, and application details can be found in the LEAP in Health IT Notice of Funding Opportunity (NOFO) NAP-AX-18-003 and the Special Emphasis Notice (SEN). You may also review the slide deck and recording from the April 2nd Informational Session.
  2. Q: Do you have a link to yesterday’s session for those who were unable to attend?
    A: The Webinar PPT slides and recording are now available on the LEAP in Health IT webpage .

QUESTIONS FROM APRIL 2ND INFORMATIONAL SESSION

  1. Q: For Area 2, will the technology be considered public domain when the time period is over?
    A: Page 10 of the NOFO states the following in relation to technology public domain: publish or otherwise disseminate these project findings to maximize the accessibility of this knowledge to the entire health IT community.ONC prefers the technology leverages open source standards and specifications and provides clear plans for how it plans to widely disseminate the design, development, and testing of the technology.Additionally please reference the terms and conditions of the NOFO – Intangible Property and Copyrights which further discusses Government use of work that was federally funded.
  2. Q: Are there any limitations on the types of non-profits that would be eligible to apply?
    A:Please see Section B (page 13) of the LEAP in Health IT NOFO. Applicant eligibility can also be found on Slide 17 of the Webinar PPT slides.
  3. Q: When is the proposal due?
    A: May 28, 2019, 11:59 p.m. ET
  4. Q: For Area 2, can the grant be given for a demonstration of enhanced patient engagement technologies with diverse populations and not for Design & Development of the technology?
    A: The Purpose of Area 2 is to make significant advancements and transform patient engagement technologies through innovative design and development. Applicants are expected to explore approaches for state-of the-art solutions. We refer you back to the goal of the LEAP in Health IT NOFO: to address emerging challenges and develop approaches that scale across the health care industry. The purpose is not to fund individual demonstration projects.
  5. Q: How many applications are you anticipating?
    A: We do not have an answer for that at this time. The Letter of Intent due date is April 11, 2019.
  6. Q: Just to be clear, the consortia must be led by one of the nonprofit groups listed on one of the beginning slides, and that nonprofit must perform a substantial amount of the work. Is there a required percentage, e.g., 51%?
    A: There is no percentage requirement that the nonprofit leading the consortia must adhere to. However, if an applicant intends to partner with an organization who will be doing work that equals to more than 33% of the projects total budget, it will require a separate budget.
  7. Q: You had mentioned that a consortia cannot apply to both areas in a single proposal – is it permissible to apply to each area with 2 different proposals?
    A: Applications addressing both areas of interest in a single application package will not be considered. However, an applicant may submit multiple applications in order to apply for each of the different areas of interest.
  8. Q: When will the slide deck be available?
    A: The Webinar slide deck and recording are now available.
  9. Q: The meeting invitation indicated a 2-hour session. Will this meeting complete after the 5 minutes to enter Q&A?
    A: Yes
  10. Q: Are there limitations on sustainability strategies that can be used to further expand this work?
    A: The applicant is not limited on their sustainability strategies that can be used to further expand this work. However, please keep in mind that this funding is only available for the 2 year period-of-performance and that years 3-5 are optional subject to the availability of funds and meaningful progress of the awardee. Any future budgets to build additional sustainability strategies outside the self-contained 2 year period-of-performance should not assume or be dependent on federal funding.
  11. Q: One of the challenges in developing new technologies is that it requires ongoing maintenance, support and advancements. Thus, if commercialization and monetization strategies are not possible, what possible solutions are appropriate under this NOFO to sustain such platform/ecosystem?
    A: Please email ONC-LEAP@hhs.gov; we need some additional clarification to your question in order to answer it appropriately.
  12. Q: For lobbying activities; should these be limited to a federal level or do local lobbying activities also suffice?
    A: The filing of a form is required for each payment or agreement to make payment to any lobbying entity for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with a covered Federal action. Refer to the implementing guidance published by the Office of Management and Budget for additional information.
  13. Q: For Area 1, if the challenges for the four use cases are addressed between the two-year self-contained period AND the optional 3-5 year period, will submitters automatically lose some of the 20 points available under the Approach and Activities bullet 1?
    A: Applicants must be able to propose projects that can be reasonably completed within the 2-year period-of-performance, but have the option to propose additional work that could be conducted in the optional 3-5 year period. Please note that the optional 3-5 year period is not guaranteed and is subject to the availability of funds and meaningful progress by the awardee.
  14. Q: If your organization has different portfolios and a distinct portfolio from that which is applying for the funding is involved in lobbying, does this affect the application?
    A: This information must be disclosed since it would still be associated with the applying organization. A review of the lobbying form must be conducted prior to making a determination of whether it would affect the application. Refer to the implementing guidance published by the Office of Management and Budget (OMB) for additional information.
Questions for Week Ending 03-29-2019
  1. Q: On March 6, 2019, we made a general inquiry about grant funds and received a reply, thank you.Today, we are interested in learning if grant opportunity notice number #NAP-AX-18-003 is applicable to our need. We’re working with a federally qualified health center (FQHC) in [REDACTED] to find funds for the purposes of upgrading/replacing their electronic health records system. The ballpark dollar amount that we hope to secure is [REDACTED]. Please advise.
    A: All questions must be posted and answered publicly on the LEAP webpage. We also encourage you to register for the Informational Session on this special emphasis notice for the LEAP program here.
Questions for Week Ending 03-14-2019
  1. Q: Please send me all information you have on this topic. I would love to apply for this.A: All questions must be posted and answered publicly on the LEAP webpage. You may also register for the Informational Session on this special emphasis notice for the LEAP program here.