Frequently Asked Questions (FAQs)
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 05-24-2019
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.
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.
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.
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.
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
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.”
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.
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
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.
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.
- this is linking to the old PDF (from 2018)
FOA LEAPHealthIT (002).pdf Jul 09, 2018 02:22:28 PM EDT 551.1 KB
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.
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.
Q: Please note that the program documents as provided on Grants.gov feature multiple unusable links. https://protect2.fireeye.com/url?k=f29db323-aec8ba30-f29d821c-0cc47adb5…
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 firstname.lastname@example.org.
QUESTIONS FOR WEEK ENDING 05-03-2019
Q: Can you tell me what the earliest start date of the project period would be, if awarded? (https://protect2.fireeye.com/url?k=3510cae1-6944e3ca-3510fbde-0cc47a6d1…) 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.
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 Assistance
- Form SF-424A, Budget Information for Non-Construction Programs
- Form SF-424B, Assurances for Non-Construction Programs
- Form SF-LLL, Disclosure of Lobbying Activities
- Proof of Non-Profit Status (if applicable)
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
Q: We are for-profit applying for the LEAP Grant. We considering the two options to apply for this Grant.
- 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.
- 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.
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
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.
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 email@example.com or you can call 1-800-518-4726.
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.
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.
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
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.
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.
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)
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.
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
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.
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.
Q: When is the proposal due?
A: May 28, 2019, 11:59 p.m. ET
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.
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.
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.
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.
Q: When will the slide deck be available?
A: The Webinar slide deck and recording are now available.
Q: The meeting invitation indicated a 2-hour session. Will this meeting complete after the 5 minutes to enter Q&A?
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.
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.
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.
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.
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
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.
QUESTIONS FOR WEEK ENDING 03-14-2019
Q: Please send me all information you have on this topic. I would love to apply for this.
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 question 6 in FAQs for 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: https://rates.psc.gov/fms/dca/orgmenu1.html
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 question 3 under “Miscellaneous Questions,” under FAQs for Week Ending 7/13/2018
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 question 1 in “Questions About Funding” under FAQs for Week Ending 7/13/2018.
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 regulations 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?
A: 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.
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.
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: Letters of intent (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: A recording of the Informational Session will 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)
A.Questions About the Informational Session and Presentation Deck
Q: Is the [Informational Session] presentation deck available for download?
A: A recording of the Informational Session will 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 of the informational session.
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 .
B.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.
C.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.
D.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.
E.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.
F.Questions About Area of Interest 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 electronic health record (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 could not.
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.