LEAP in Health IT Frequently Asked Questions

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 publicly 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.

2023 Questions and Responses

QUESTIONS For Week Ending 06-09-2023

Q:
1. Can the Budget Narrative required as part of the Project Narrative simply refer to the standalone Budget Narrative?
2. If #1 is no, how does the information in the Project Narrative: Budget Narrative differ from the standalone Budget Narrative?
3. If #1 is no, should the budget information be identical in both locations?
A:
1. There are two parts of the NOFO that explain the requirement for a budget narrative. On page 22 of the NOFO, as part of the project narrative, we ask that the applicant provide a breakdown of how they plan to spend their allotted resources to complete their proposed activities. This should be no more than 3 pages of the project narrative. Additionally, as part of the appendices to the application, the applicant must submit a detailed budget narrative and supporting SF-424a form to breakdown the costs proposed to complete activities. Please see appendix D in the NOFO on page 54 for the template to be used. Please see page 23 for additional information regarding budget narratives.
2. The budget narrative, as part of the project narrative provides high level information regarding how the funds will be utilized. The budget narrative mentioned in the appendices is required as part of the budget submission, in addition to the SF-424a to support the costs broken out by cost category.
3. The budget information in the budget narrative as well as the budget narrative that accompanies the SF-424a should align.

QUESTIONS For Week Ending 06-02-2023

Q: From the NOFO, it looks like a 2–3-page budget narrative is required to be in the overall Project Narrative Attachment in addition to being included in the Budget Narrative Attachment form. Can you please confirm our understanding or clarify the budget narrative requirement?

A: There are two parts of the NOFO that explain the requirement for a budget narrative. On page 22 of the NOFO, as part of the project narrative, we ask that the applicant provide a breakdown of how they plan to spend their allotted resources to complete their proposed activities. This should be no more than 3 pages of the project narrative. Additionally, as part of the appendices to the application, the applicant must submit a detailed budget narrative and supporting SF-424a form to breakdown the costs proposed to complete activities. Please see appendix D in the NOFO on page 54 for the template to be used. Please see page 23 for additional information regarding budget narratives.

QUESTIONS For Week Ending 05-26-2023

Q: The NOFO indicates, on page 49, the SF-424A Budget Information will be completed for a two-year project and based on the Budget Narrative example in the NOFO (page 54), the Budget Narrative will also reflect the costs for the 2-year project only. However, applicants are encouraged to submit their application based on a five-year budget period. We have the following questions:
1. If an applicant is going to submit budget information for years 3, 4, and 5, must applicants list the budget line items for years 3, 4, and 5 in the SF-424A, and if so, where? If not in the SF-424A, where do applicants list the budget line items for years 3-5?
2. If an applicant is going to submit budget information for years 3, 4, and 5, must applicants describe the budget line items for years 3, 4, and 5 in the Budget Narrative
3. If an applicant is going to submit budget information for years 3, 4, and 5, is there a minimum or maximum amount applicants should budget for these years? If there are no minimum or maximum amounts at this time, do applicants just estimate their project costs for those years (without a minimum or maximum amount in mind)?
A:
1. Please submit a separate SF-424A for years 3 to 5. SF-424A for years 1 to 2 should not exceed $1,000,000 in federal funds.
2. Yes. Please follow the same suit for budget narratives as indicated above.
3. At this time, there is not a requirement for budget amounts for years 3 to 5. Applicants are encouraged to estimate budgets for years 3 to 5 as best as they can.
Q: I am contacting you because I would like to apply for an opportunity in regards to LEAP technology. I understand I have to apply at grantsolutions.gov, but when attempting to access the site to apply via Grants.gov -- it gives me an error message. Citing, I cannot apply this way. Question: Will I need to create a separate account with Grant Solutions in order to apply?

A: Applicants must Submit all material electronically through Grants.gov; this process is outlined in the NOFO on page 24. You can find the NOFO by going to this page, clicking on the opportunity number, followed by the related documents tab. The file name is listed as LEAP-FY2022-NOFO-FINAL.pdf.

QUESTIONS For Week Ending 05-19-2023

Q: Has the “Notice of Funding Opportunity” document been posted for 2023? On the grants.gov page, when clicking into Opportunity NAP-AX-22-001 and going to the “Related Documents” tab, the NOFO appears to be from 2022. I am looking for the detailed application criteria information that is referenced as being included in the NOFO. Can a link to this document be provided?

A: Yes, it has been posted. The document labeled LEAP FY2023 Special Emphasis Notice (SEN) was posted on April 10, 2023. You can find this document by going to this page and clicking on the opportunity number, followed by the Related Documents tab. As stated on page 10 of the SEN, “Unless otherwise indicated in this Notice, all requirements, instructions, and terms and conditions of the Leading Edge Acceleration Projects (LEAP) in Health Information Technology (IT) funding opportunity (NAP-AX-22-001 at https://www.grants.gov/web/grants/search-grants.html?keywords=nap-ax-22-001) will apply to applications submitted and awards made in response to this Notice.” For application submission instructions please reference Section E in the document titled “Notice of Funding Opportunity” posted on June 14, 2022.
Q: We are interested in submitting an application for Funding Opportunity # NAP-AX-22-001; Title: Leading Edge Acceleration Projects (LEAP) in Health Information Technology. The Notice of Funding Opportunity’s (attached) Key Dates section (page 15 of 59) lists 2022 dates (see below). Is there an updated version available for download that lists 2023 dates for the application due date, award date, etc.?

A: Please reference the LEAP FY2023 Special Emphasis Notice (SEN) that was posted on April 10, 2023 for application information and deadlines. You can find this document by going to this page and clicking on opportunity number, followed by the Related Documents tab. The file name is listed as LEAP FY2023 Special Emphasis Notice.pdf. Additionally, you can refer to slide 49 of the SEN informational session held on April 25, 2023

QUESTIONS For Week Ending 05-12-2023

Q: Is there a cost-sharing requirement?

A: There is no matching requirement under this funding opportunity.
Q: Should the Budget Narrative be submitted as an Appendix, or as the last section in the Project Narrative?

A: There are two parts of the NOFO that explain the requirement for a budget narrative. On page 22 of the NOFO, as part of the project narrative, we ask that the applicant provide a breakdown of how they plan to spend their allotted resources to complete their proposed activities. This should be no more than 3 pages of the project narrative. Additionally, as part of the appendices to the application, the applicant must submit a detailed budget narrative and supporting SF-424a form to breakdown the costs proposed to complete activities. Please see appendix D in the NOFO on page 54 for the template to be used. Please see page 23 for additional information regarding budget narratives.
Q: I was hoping you could clarify the deadline for us. The Grant Opportunity page lists the current closing date for applications as September 30th, 2027 and has an application deadline of June 12, 2023. Will there be additional applications considered with certain deadlines after the June 12th, 2023 date? Or is June 12th the final deadline?

A: The application deadline for this year’s Special Emphasis Notice (SEN) is June 12, 2023. Applications submitted after June 12, 2023 for this year’s SEN will not be considered. Please refer to the FY23 SEN that was posted on April 10, 2023 for application information and deadlines.
Q: I was unable to make the informational session held on 4/25 - would I be able to access the video and slides for the 2023 LEAP NOFO? I don’t believe it is posted on the website.

A: The slides and recording of the information session are available here: www.healthit.gov/topic/onc-funding-opportunities/leading-edge-acceleration-projects-leap-health-information.

QUESTIONS For Week Ending 05-05-2023

Q: We are looking for clarification regarding the timeline for completing the work. We understand that the grant will be awarded in the 2023 fiscal year. Is it safe to assume that the project has to be completed 12 months from the award date and not in the fiscal year 2023?

A: All awards made under this SEN are for a 2-year period of performance. Recipients will have two years from award date to complete their project in alignment with their project plan and associated budget.

QUESTIONS For Week Ending 04-28-2023

Q: I was unable to attend the information session and would like to know if the information session on April 25^th was recorded? If so, where can we find a copy?

A: Once they are ready, the slides and recording of the information session will be made available here under the section titled “informational session” under the 2023 SEN: https://www.healthit.gov/topic/onc-funding-opportunities/leading-edge-acceleration-projects-leap-health-information
Q: The guidelines state that proprietary technology cannot be used in the implementation of this grant. Does this mean that any product used in the assessment, monitoring and reporting of data quality must be non-proprietary?

A: Using and integrating with proprietary technologies is acceptable for piloting purposes. For details regarding requirements of using non-proprietary technology, please refer to the section titled “Health IT Coordination Requirements” on page 37 of the NOFO.
Q: At this time, is there a set date these awards will be announced?

A: The estimated award date for this funding opportunity is August 1, 2023. The application period closes June 12, 2023, at Noon (12:00pm) ET.
Q: What is the purpose of a letter of intent if they're not required - are there specific things that should be included to get any potential benefit?

A: A letter of intent is encouraged but not required. This letter of intent will assist ONC in planning for the application review process. For more details, please refer to section B. “Funding Opportunity Award Information” (page 16) of the NOFO.
Q: I want to clarify, only 2 applicants can be awarded the grants, one applicant per?

A: Correct, ONC may fund one applicant (one award) per area of interest.
Q: Is a fax number required as part of the project abstract?

A: No, a fax number is not required to be added in the project abstract.
Q: How can interested for-profit parties with technological solutions identify public and/or not-for-profit partner organizations to constitute a consortium to submit a joint application?

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.
Q: Would multiple PIs be accepted?

A: No, each project must have one Principal Investigator (PI) who serves as the sole point of authority and accountability for the project.

QUESTIONS For Week Ending 04-21-2023

Q: There is a statement under area 2: “An applicant’s proposal shall not rely on proprietary technology.” Given that EHRs are proprietary technologies, can you further specify any requirements for IP developed or piloted through the selected projects?
A: The solution should be non-proprietary, however integrating with proprietary technologies is acceptable for piloting purposes. For details regarding requirements of using non-proprietary technology, please refer to the section titled “Health IT Coordination Requirements” on page 37 of the NOFO.

QUESTIONS For Week Ending 04-13-2023

Q: Are 501(c)6 organizations eligible to apply?
A: Yes. A 501c-6 is considered a non-profit organization and is therefore eligible to apply. Please refer to page 24 of the original Notice of Funding Opportunity (NOFO) for required documents that must be included in your application package as proof of non-profit status.

2022 FAQs

QUESTIONS For Week Ending 08-12-2022

Q: We are submitting an application to the above referenced FOA and I need clarification on the following.
1. Are biosketches required for all study staff or only key personnel?
2. Is Cost Match/Sharing mandatory?
3. Do we submit a 5-year or 2-year budget?
A:
1. There is no biosketch requirement included in this NOFO.
2. Please refer to page 47 of the NOFO, which provides details regarding the match requirement.
3. You may propose a two-year budget of up to $1,000,000.
Q: Could you confirm that the Project Activities on page 12 of 59 of the NOFO pertains to both Area of interest 1 and Area of Interest 2? Or do they just pertain to Area of Interest 2.
A: The Project Activities listed on page 12 of the NOFO pertains to both Area of Interest 1 and Area of Interest 2.

QUESTIONS For Week Ending 08-05-2022

Q: We are looking at the LEAP grant Area of Interest #2. It states that the program we develop would have to be implemented in two facilities. We have a hospital, clinic, and long term care facility. Would those be considered different facilities? We are one organization but they are in 3 different buildings in close proximity.

A: On page 11 of the NOFO, it sates “…solution should be implemented at two separate healthcare locations affiliated with the awardee,…and for two different use cases. The hospital, clinic, and long term care facility would be considered separate healthcare locations.
Q:
a. How do we find the:
   i. Applicant Control Number
   ii. Federal Entity Identifier
b. We don’t have a lobbying representative.
   i. Can we type in n/a?
c. Is there a match requirement?
d. Should we submit a 2 year or 5 year project budget?
e. Can the project budget be submitted in Excel and the narrative/justification in Word?

A.
a. Please refer to Appendix B, Instructions – SF-424, Application for Federal Assistance on page 44 of the NOFO for detailed instructions. Some of the items are required and some are optional at the discretion of the applicant or the federal agency. The required fields are identified with an asterisk (*) when you download the application package from grants.gov.
   i. For the Applicant Control Number, “Enter the entity identifier assigned by the Federal agency, if any, or the applicant's control number if applicable.”
   ii. For the Federal Entity Identifier, “Enter the number assigned to your organization by the federal agency, if any.” The entity identifier should have been assigned to your organization upon registration in SAM.gov
b. If you do not have lobbying activities, please enter N/A and submit the form with your application, as this is a required document.
c. Please refer to page 47 of the NOFO, which provides details regarding the match requirement.
d. You may propose a two-year budget of up to $1,000,000.
e. The project budget must be submitted using the SF-424a document in grants.gov. Further budget detail can be broken down in an excel document if necessary, however the SF-424a is the require form. The narrative must be submitted using the format in the appendix of the NOFO.

QUESTIONS For Week Ending 07-29-2022

Q: Is there somewhere I would be able to access the full application description/requirements? I created an account on grants.gov but work for a company that would be a sub-recipient, and it looks like I'm not able to access the application. I was hoping to get access to all the questions/required components so we can work on it.

A: Yes, on this page, if you click on the link under the opportunity number then select the “related documents” tab you will be able to access the full announcement zip file as well as the NOFO pdf document without a login.
Q: The NOFO for Leading Edge Acceleration Projects (LEAP) in Health Information Technology (NAP-AX-22-001) lists a “Budget Narrative” section in both the Project Narrative and as an Appendix. Could you please clarify the difference between these sections?

A: They are referring to the same component. The budget narrative, as part of the project narrative provides high level information regarding how the funds will be utilized. The budget narrative mentioned in the appendices is required as part of the budget submission, in addition to the SF-424a to support the costs broken out by cost category. Appendix D provides a template to complete the budget narrative that is populated with sample information. For more information, please refer to page 23 of the NOFO.

QUESTIONS For Week Ending 07-22-2022

Q: As I understand from the grant requirements, as a for profit organization, we are not eligible to prime on this opportunity. Therefore, I am asking you if you would speak with me on a phone call to discuss options, of being a sub to eligible organizations, that you are already associated with, that intend to prepare a proposal submission.

A:Please refer to the eligibility requirements on page 13 of the NOFO to see what organizations are eligible to apply for this award. If your organization is a for-profit organization, you may participate in projects as members of a consortia or as a sub-recipient only. Unfortunately, ONC is unable to match you with other applicants.

QUESTIONS For Week Ending 07-15-2022

Q: We were unable to submit letter of Intent for Leading Edge Acceleration Projects (LEAP) in Health IT by June 30^th. Does that preclude us from submitting application for the funding?

A: A letter of intent is encouraged but not required. For more details, please refer to section B. “Funding Opportunity Award Information” (page 16) of the NOFO.
Q: Can you point in the direction to LEAP informational session held on June 28th slide deck and Q&A?

A: The recording of the information session is available here: www.healthit.gov/topic/onc-funding-opportunities/leading-edge-acceleration-projects-leap-health-information

The Q&A from the information session can be found here: https://www.healthit.gov/topic/leap-health-it-frequently-asked-questions
Q: The notice of funding opportunity NAP-AX-22-001 under Area of Interest 1 Project Goals page 7 says “…awardee shall create and implement a comprehensive technology solution that supports 1) the collection and analysis of SDOH data in a EHR to identify population-level use cases for addressing health disparities, 2) closed loop referrals between an EHR and appropriate Community Based Organizations (CBOs) supporting human and social services…”.

a. By “supports the collection and analysis” in a EHR do you imply that proposed solutions should only be native extensions of EHRs that can perform these functions or that they could also be EHR-integrated Apps (SMART on FHIR or other) that can perform these functions?

b. Also, by “closed loop referrals between an EHR” and CBOs do you imply that proposed solutions should utilize 360X only or that they could also be EHR-integrated Apps (SMART on FHIR or other) that can perform this function?

c. The same line of question as above applies to the last sentence in Key Objective 1 which states “While creating the use case, the applicant must use standardized SDOH data collection within the EHR”. Do you imply that solutions that involve Apps running within (SMART on FHIR) or alongside the EHR would not be acceptable?

A: a.The comprehensive solution should allow for SDOH data to be collected/shared into the EHR and allow for analysis of SDOH data.

b. 360X is listed as an example standard but FHIR is acceptable.

c. The solutions must utilize nationally recognized standards such as those referenced throughout the NOFO for collecting and sharing information.

QUESTIONS For Week Ending 07-08-2022

Q: Can we please get access to the webinar recording?

A: Once they are ready, the slides and recording of the information session will be made available here: www.healthit.gov/topic/onc-funding-opportunities/leading-edge-acceleration-projects-leap-health-information

QUESTIONS For Week Ending 07-01-2022

Q: Can existing EMR technology be used for project proposal?

A: For details regarding requirements of using non-proprietary technology, please refer to section A. “Program Description/Purpose” (starting on page 5) and the “Health IT Coordination Requirements” section (page 37) of the NOFO.

Q: If our budget can be up to $1,000,000, should our five-year budget be up to $1,000,000 or can our two-year budget be up to $1,000,000?

A: You may propose a two-year budget of up to $1,000,000.
Q: Where can you get a copy of your slides?

A: The slides and recording of the information session will be made available here: www.healthit.gov/topic/onc-funding-opportunities/leading-edge-acceleration-projects-leap-health-information
Q: Are there copies of past award-winning grants available? Or past winning grant applications?

A: Past applications are not available to the public. However, you can learn more about the LEAP awardees and project portfolio here: www.healthit.gov/topic/leading-edge-acceleration-projects-leap-health-information-technology-health-it

QUESTIONS For Week Ending 06-24-2022

Q: The PDF for the current year has information for 2018. I am wondering if there is a current NOFO for this funding year for this opportunity? Thank you.

A: Please find the current NOFO funding opportunity here: www.grants.gov/web/grants/search-grants.html?keywords=nap-ax-22-001

2021 FAQs

QUESTIONS FOR 05-03-2021

Q: We are applying for a LEAP Grant. In filling out the SF-LLL (lobbying disclosure form), we do not have any contracted or paid Lobbyist. We are a nonprofit, are we required to put the name of a member of our staff (such as CEO) or can we just submit N/A? Thank you.

A: You may submit N/A.

QUESTIONS FOR Week Ending 04-30-2021

Q: Below is a list of questions regarding the ONC LEAP SEN 2021 for your review and we kindly request a reply:

On Page 3 of the SEN, the below phrasing is used, indicating that non-proprietary approaches for managing referrals are to be used:

The current challenges in SDOH data use and interoperability warrant investment in piloting health IT standards and non-proprietary approaches for managing care referrals for social services and support, and secure communication tools for non-clinical, health-supporting services. Innovation is needed to ensure care referrals and the bi-directional exchange of electronic information across these organizations are not only possible but done in a manner that keeps patient health records up-to-date and represent longitudinal and person-centered health and care.

They later, in page 4 when speaking about goals that must be addressed to receive funding they use this phrasing:

The development and/or use of any non-proprietary tools necessary for the successful completion of a pilot project must be clearly defined.

Finally they use this line on page 5 when talking about to be considered for an award:

An applicant’s proposal shall not rely on a single vendor or proprietary technology.

Are an HIE’s IR and/or SDOH tools considered to be proprietary?

A: We are seeking projects that can demonstrate and advance interoperability between health IT systems or clinical and community resources systems. Reliance on a single vendor or use of a proprietary tool that is not openly accessible does not meet the objective of this SEN, which is to develop standards and solutions that are usable and scalable. For example, previous awardees work on existing standards and contributed to updates to implementation guides, which are non-proprietary and openly accessible.
Q: I was reviewing this opportunity and had a question about implementing EPIC Community Connect within our health system. I read in the announcement that An applicant’s proposal shall not rely on a single vendor or proprietary technology. Would EPIC be considered as an exclusion?

A: EPIC would not be considered as an exclusion. However, reliance on only EPIC products would not meet the objectives of this award. We are seeking projects that can demonstrate and advance interoperability between health IT systems or clinical and community resources systems.
Q: Good afternoon,

Is this grant still open for applications?

https://www.grantsolutions.gov/gs/preaward/previewPublicAnnouncement.do?id=62586

A: Yes. The application deadline is May 10, 2021

QUESTIONS FOR Week Ending 04-23-2021

Q: My organization, [Redacted], will be submitting an application for the referenced notice. In the process of deciding upon which SDOH domain to focus on, we simultaneously received a request from a local substance abuse coalition who is attempting very similar work. The coalition is a multi-disciplinary team consisting of public health officials, health care providers, law enforcement and others.

They currently are working under 2 federal grants, one of which provides for a Quick Response Team (QRT). While this work has positively impacted the response to overdoses they have learned they have data coming in from multiple sources and there is no feedback loop.

While helping them enhance service to overdose victims is worthy and has immense value in terms of scalability and replicability, we also suspect reduction of drug overdoses does not meet the requirements of this particular NOFO. Would that be accurate? If so, love your advice on how to request funding for this worthy cause…

A: Please refer to pages 2-5 of the SEN that describes the desired outcomes/deliverables for Area 1 of this year’s SEN. We welcome any eligible organization to submit an application that is designed to meet the intended outcomes. As an open and competitive award program, we are unable to provide any direct advise or pre-approve a potential applicant’s proposal.
Q: For Area 1 in the Special Emphasis Notice LEAP 2021: Is there a formal Evaluation Section required as part of the submission? There seems to be no specific mention of it in the instructions as the focus seems to be on demonstrating a functional system rather than measuring its impact on patient outcomes. Is that correct?

A: As stated on the slide 19 and during the Informational Session, and on page 8 of the SEN, “Unless otherwise indicated in this Notice, all requirements, instructions, and terms and conditions of the Leading Edge Acceleration Projects (LEAP) in Health Information Technology (IT) funding opportunity (see NAP-AX-18-003 at https://www.grants.gov/web/grants/view-opportunity.html?oppId=306704) will apply to applications submitted and awards made in response to this Notice.” This includes any evaluation requirements for applicant proposals.
Q:
1. The LEAP Notice of Funding Opportunity describes key project milestones, including establishing a technical expert panel (TEP). The FY2021 Special Emphasis Notice does not mention forming a TEP. Does ONC require formation of a TEP for these current SEN projects?
2. The grants.gov entry for NAP-AX-18-003 indicates that the Funding Instrument Type is “Cooperative Agreement/Grant”. Could you confirm whether the funding instrument used for this program will be a cooperative agreement or a grant? Furthermore, is it correct to assume that substantial ONC programmatic involvement with the awardees is anticipated during the performance of the activities?
3. The LEAP Notice of Funding Opportunity specifies that any material meant for public release must be compliant with Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d). Could you clarify the extent to which 508 Compliance applies to software developed under this agreement and the expectations for demonstrating such compliance?
4. Is the basis for determining an employee’s salary (relevant to the salary ceiling) recognized as annual or hourly?
A:
1. As stated in the slide 19 and during the Informational Session, and on page 8 of the SEN, “Unless otherwise indicated in this Notice, all requirements, instructions, and terms and conditions of the Leading Edge Acceleration Projects (LEAP) in Health Information Technology (IT) funding opportunity (see NAP-AX-18-003 a will apply to applications submitted and awards made in response to this Notice.”
2. This is a cooperative agreement. Please refer to pages 15-16 for a definition and activities that are part of a cooperative agreement.
3. Materials that are public-facing such as Final Reports must be 508-complaiant. You can find guidelines, resources, and testing tool on the GSA 508 website.
4. This determination would be at the discretion of the applying organization and how they determine that particular employee’s status (whether hourly or salary), based on their regular day to day operations and established policies and procedures

QUESTIONS FOR Week Ending 04-16-2021

Q: This proposal reads "Development of health IT tools to facilitate the standardized gathering and assessment of high-quality data needed for research, including development and testing of artificial intelligence (AI) applications".

Does this imply that a responsive application must include an AI application? If so, are there any standard ones that ONC wishes to be used?

A: ONC does not have a 'preferred' AI application to be utilized - we do ask for examples / use cases. ONC would further highlight that the goal of this areas of interest is to develop open, scalable health IT-based tools that make EHR data research and AI-ready - by systematically measuring completeness and quality; improving interoperability; and automating assessment of data, their features, and provenance. The applicant should then provide specific examples of the types of research and AI algorithms and/or applications that would benefit from these data. ONC does not stipulate which algorithm or applications should be utilized. Applicants are encouraged to seek those that are open source.

More specifically, to meet this goal, the recipient must:
1. Implement a phased approach for the enhancement and/or development of open, scalable, health IT-based tools to • Provide specific examples of the types of research and AI algorithms and/or applications that would benefit from these data.
2. Demonstrate their tools for preparing research- and AI-ready EHR data in partnership with at least two other institutions. It is desirable that institutions use differing health IT systems from different health IT developers. Partnerships should be formed to demonstrate generalizability and provide external validity of research findings. Involvement with FQHCs and small-sized health care providers is strongly encouraged to demonstrate tool scalability with providers typically unable to participate in research.
Develop and implement a comprehensive dissemination plan to scale and spread their awarded project’s findings and outputs to be used by other relevant stakeholders.
Q: We are considering submitting a proposal entitled “[Redacted]” to the program "Develop Tools for Making Electronic Health Records Data Research and Artificial Intelligence-Ready" NOTICE NUMBER: NAP-AX-18-003

We would like to discuss with you and check whether our proposal fits for the above program.

A: As per the instructions on Page 26 of the Notice of Funding Opportunity (NOFO), Restrictions on Oral Conversations, “Federal officials may not participate in oral communications initiated by any person or entity concerning a pending application for a competitive grant or other competitive form of federal financial assistance,” All questions will be answered in the form of a FAQ that is updated weekly and publicly available.

ONC is unable to discuss whether an organization’s proposal will appropriately fit with potential applicants.
Q: [Organization redacted] is interested in the above named opportunity and wanted to find out if we have missed any deadlines that would prohibit us from responding.

A: The applications deadline for this year’s Special Emphasis Notice (SEN) is May 10, 2021. There are no other deadlines prohibiting an organization who meets the eligible applicant criteria from applying.
Q: I am writing with a question regarding the [Organization redacted] participation in this LEAP grant submission. We have received several requests for partnership from entities and coalitions across the country. Before committing to all or just one entity I want to double-check whether the [Organization redacted] team can participate in more than one submission.

A: Yes, organizations are permitted to submit letters of commitment to participate in more than one organization’s submission proposal.
Q: My organization is planning to submit a proposal under NAP-AX-18-003 due 05/10/2021 and I need to verify the following details/parameters:
1. This proposal should be submitted System-to-System via Commons or should it be uploaded to grants.gov as a PDF separate from our electronic S2S method (which is the most commonly employed method in our submissions to NIH, NSF, and DoD)?
2. It is not clear to me what type of budget should be used here – should it be modular, detailed, or another budget format?
3. I am also not clear on what type of application this should be classified as (i.e. R01, P01, etc) and would greatly appreciate if this could be clarified).
4. Should we use our full IDC rate in this budget, since it is very limited in its total cost cap for a 2 (to possibly 5 overall) year project and the preponderance of effort will be off-campus?
5. Is the proposed budget submitted for this application should include 5 years or only the initial 2 years that the award would be made for should this be chosen for funding?
A:
1. Please refer to the How to Apply page on grants.gov, which also has an FAQ page to guide potential applicants. All applications must be submitted via grants.gov in order to be considered for award.
2. Budgets must be submitted on the SF-424A; please refer to slide 29 from the SEN Informational Session for a list of required documents. Your application should also include a brief budget narrative as part of your application package that provides a high-level overview of your proposed budget and how it supports your proposed project activities.
3. This is a cooperative agreement award
4. Yes
5. The budget should cover a 2-year period-of-performance but may also include an extended budget and project proposal for years 3-5. Please note however, that the LEAP award only commits to awarding projects for a 2-year period-of-performance and that the decision to extend and fund years 3-5 is subject to the availability of funds and alignment with ONC’s priorities.
Q: We're looking to apply to the attached grant (Leading Edge Acceleration Projects (LEAP) in Health Information Technology and Leading Edge Acceleration Project), but are a bit confused as to whether these applications apply to the same grant opportunity.

Could you please explain the difference between the two attachments, and if we should be applying to one or the other? Lastly, we're under the impression that as a small business, we are eligible for this grant opportunity. Could you please confirm this?

Attachments: LEAP Notice of Funding Opportunity and LEAP Special Emphasis Notice 2020

A: ONC is accepting applications in response to the Special Emphasis Notice (SEN) for FY 2021.

As stated in the slide 19 and during the Informational Session, and on page 8 of the SEN, “Unless otherwise indicated in this Notice, all requirements, instructions, and terms and conditions of the Leading Edge Acceleration Projects (LEAP) in Health Information Technology (IT) funding opportunity (see NAP-AX-18-003 at https://www.grants.gov/web/grants/view-opportunity.html?oppId=306704) will apply to applications submitted and awards made in response to this Notice.”

Please refer to the eligibility requirements on page 13 of the NOFO, to see what organizations are eligible to apply for this award. If your organization is a for-profit organization, you are not eligible, however, a for-profit organization may participate as a sub-member in a consortium or project partner under a non-profit organization’s application.

QUESTIONS FOR Week Ending 04-09-2021

No questions submitted for week ending April 9, 2021

QUESTIONS FOR Week Ending 03-02-2021

No questions submitted for week ending April 2, 2021

QUESTIONS FOR Week Ending 03-26-2021

Q: We are a group of digital health companies that have developed an integrated set of care and health tools, resources and systems. On page 5 of your ONC Notice # NAP-AX—18-003, you indicated that “An applicant’s proposal shall not rely on single vendor or proprietary technology.” Some of our technologies are open source and some pieces of the AI technologies and systems are proprietary. Is it possible for us to discuss these issues with you to see if we are eligible to submit an application?

A: As per the instructions on Page 26 of the Notice of Funding Opportunity (NOFO), Restrictions on Oral Conversations, “Federal officials may not participate in oral communications initiated by any person or entity concerning a pending application for a competitive grant or other competitive form of federal financial assistance,” All questions will be answered in the form of a FAQ that is updated weekly and publicly available.

On Page 1-2 of the SEN, the stated objective for the LEAP in Health IT projects are to, “address well-documented and fast emerging challenges inhibiting the development, use, and/or advancement of well-designed, interoperable health IT, which is scalable across the health care industry.”

Reliance on a single vendor or proprietary technology does not ensure widespread scalability and ease of adoption and is the reason behind this requirement.
Q: On page 5 of the Special Emphasis Notice it state that “An applicant’s proposal shall not rely on a single vendor or proprietary technology”. Does this specifically disqualify applicant organizations (e.g., a health system, payor, or health information exchange, etc.) from using an I&R vendor platform (e.g., Aunt Bertha, NowPow, UniteUS, etc.) as part of its solution?

A: On Page 1-2 of the SEN, the stated objective for the LEAP in Health IT projects are to, “address well-documented and fast emerging challenges inhibiting the development, use, and/or advancement of well-designed, interoperable health IT, which is scalable across the health care industry.”

Reliance on a single vendor or proprietary technology does not ensure widespread scalability and ease of adoption and is the reason behind this requirement.
Q: On this page I see the Special Emphasis Notice, followed by a link for the full notice of funding opportunity. However, the full notice appears to be the 2018 announcement. Is there an updated version for 2021?

A: As per the guidance on Page 2 of the SEN and Slide 20 of the Informational Session PPT, “Aside from areas of interest, required expertise, and deadlines listed in the Special Emphasis Notice all other requirements, application instructions, and terms and conditions of NOFO NAP-AX-18-003 apply”
Q: Can collaborating institutions/ sub-award recipients can be located abroad?

A: HHS Policy allows for organizations outside of the US to operate as subcontractors/subrecipients however, these relationships require prior approval.
Q: Are co-PIs allowable under this award?

A: No, each project must have one Principal Investigator (PI) who serves as the sole point of authority and accountability for the project.
Q: We are looking for clarification on where to find the downloadable application for this funding opportunity, NAP-AX-18003, that is due by May 10, 2021.

https://www.grants.gov/web/grants/search-grants.html?keywords=NAPAX18003

However, when I click on the “PACKAGE” tab and then click on the “Preview” hyperlink, and the “Download Instructions” button, it opens up a 53 page PDf file that appears to be an older version of the application for two different “Areas of Interest”. Also, the cover page on the application contains, “Notice of Funding Opportunity Leading Edge Acceleration Projects (LEAP) in Health Information Technology

Application Due Date: [08/17/2018] Anticipated Award Date: [09/19/2018]”. Should we just use this as our outline?

We’d greatly appreciate if you can provide some guidance and/or direct us as to where a copy of the application for this most recent NOFO is available.

A: Please refer to the How to Apply page on grants.gov, which also has an FAQ page to guide potential applicants.

As stated in the slide 19 and during the Informational Session, and on page 8 of the SEN, “Unless otherwise indicated in this Notice, all requirements, instructions, and terms and conditions of the Leading Edge Acceleration Projects (LEAP) in Health Information Technology (IT) funding opportunity (see NAP-AX-18-003 at https://www.grants.gov/web/grants/view-opportunity.html?oppId=306704) will apply to applications submitted and awards made in response to this Notice.”
Q: A question about the requirements for the special emphasis notice for FY21

Page 7:

More specifically, to meet this goal, the recipient must:

• Implement a phased approach for the enhancement and/or development of open, scalable, health IT-based tools to boost high quality data for training, learning, modeling, and analysis in coordination with relevant stakeholders, including but not limited to federal health research funders, researchers (i.e., potential tool end-users), and health IT developers, to advance their use in at least two of the health research needs identified above.

Our question is what exactly is meant by “two of the health research needs identified above”.

1) I believe the reference is to the research needs listed in the final paragraph on Page 6:

The goal of this area of interest is to develop tools for making EHR data research- and AI-ready by systematically measuring completeness and quality; improving interoperability; and automating assessment of data, their features, and provenance.

2) Alternatively, the reference could be to the problems listed in the immediately preceding paragraph on Page 7:

Such tools should provide universal solutions to problems faced by researchers such as:

• Automating mapping of EHR data to common data models (e.g., Informatics for Integrating Biology & the Bedside [i2b2]’s data model, Patient-Centered Outcomes Research Network [PCORnet]’s common data model, Observational Medical Outcomes Partnership [OMOP], FDA’s Sentinel Initiative common data model)

• Enhancing semantic interoperability (i.e., fluent machine-to-machine communications) of multi-institution generated data

• Assessing and documenting data quality using standardized terms such as conformance, completeness, and plausibility

• Synthesizing metadata (e.g., patient demographic or provider characteristic metrics) in a standardized way to assess and mitigate downstream bias, including representation bias, measurement bias, aggregation bias, and historical bias

However the “such as” suggests that these are examples of meeting the requirement, but not the requirement itself.

A: The goal is what is stated on the SEN. The list below is an example of solutions the applicant could propose to address under this award.

General Questions from March 9, 2021 Informational Session

Q: My question is, provided the submission includes these partnerships, is a for-profit company able to submit a proposal for this award or must it come from another partner in the grant consortium who is not a for-profit company?

A: The slides from the March 9, 2021 Informational Session, along with video recording are available on our webpage.
Q: Can a 501c-6 association be an applicant?

A: Yes. A 501c-6 is considered a non-profit organization and is therefore eligible to apply. Please refer to page 24-25 of the original Notice of Funding Opportunity (NOFO) for required documents that must be included in your application package as proof of non-profit status.
Q: Is the Letter of Intent (LOI) to be sent only by the primary organization? Or all participating organizations?

A: A LOI should be sent from the primary applicant, though they may list their intended partners for the project.
Q: If I’m going to partner with a non-profit to be eligible for this grant who needs to send the Letter of Intent to Apply?

A: A LOI should be sent from the primary applicant, though they may list their intended partners for the project.
Q: Are biosketches requested but they do not count towards the page limit?

A: Biosketches are required for key personnel. They are attached as an appendix and do not count toward the page limit.
Q: Can one institution or PI apply for both areas separately?

A: Yes. Organizations can apply for both Areas of Interest. However, please note that you must submit two separate applications. Applications that include proposals for both Areas of Interest in a single application will not be considered.
Q: Any restrictions on the number of co-principal investigators?

A: Yes, each project must have one Principal Investigator (PI) who serves as the sole point of authority and accountability for the project.
Q: Can you confirm that applicants are not required to submit a letter of intent? If we do submit a letter of intent, will we get any review or additional information before the application deadline?

A: Letters of Intent are strongly encouraged, but not required. Please refer to slide 27 of the SEN Informational Session for additional information. We do not review or provide additional information on an applicant’s proposed project when a LOI is submitted.
Q: Can we partner with Health Systems for both of the areas of interest?

A: Yes. However, please note that you must submit two separate applications. Applications that include proposals for both Areas of Interest in a single application will not be considered, and your proposals in each Area of Interest must include the Health Systems roles and budget allocations are distinct between each application and interest area.
Q: Can a qualified applicant who has not done any business with ONC/ Federal Health IT, apply for both areas?

A: This funding opportunity is open to anyone who meets the eligibility requirements as noted on slide 21 on the SEN Informational Session slide deck and page 13 of the original Notice of Funding Opportunity (NOFO) may apply regardless of having done any business with ONC or not.
Q: Who would own any potential IP that may come out of this grant? Does the applicant team/company surrender their developer rights and possible future commercialization plans to ONC and/or the Gov?

A: Please refer to the section on Intangible Property and Copyrights (45 CFR Part 75) on pages 35-36 of the Notice of Funding Opportunity (NOFO) that 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 to own an organization's licensure or IP.

Budget-Related Questions from March 9, 2021 Informational Session

Q: What are the budget restrictions on what % of the total budget can be allocated to sub-contracts?

A: ONC does not have a set limitation on the amount of funds that can allocated to sub-contracts. ONC is required to review in advance the potential effect of the transfer of substantial funds on the approved project. This is done through a review of the sub recipients’ budget. There should be an allocation in the prime awardees budget to manage the sub recipient.
Q: Is there any indirect cost that can be billed, separately from the grant? Please clarify this for the letter of intent also.

A: 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.
Please refer to slide 27 of the SEN Informational Session for Letter of Intent-related information.

Area of Interest 1 Questions from March 9, 2021 Informational Session

Q: Can proposed projects be for organizations that are already using a SDOH community referral management platform? Or does it have to be for the implementation/measurement of net new projects?

A: The intent of the LEAP in Health IT awards is to seek projects that will demonstrate the objectives as identified in the SEN. If your organization has already accomplished something similar and intends to build upon that platform to expand/further adoption, with the focus on the use and/or enhancement of health IT standards as per the SEN then it would fit the intent of this SEN.
Q: Regarding the two (2) jurisdictions, do they have to be two (2) different states? Or may it be, for example, two (2) different municipalities or two (2) different cities in the same state?

A: There is no specific requirement that they have to be two different states, though it can be. We would consider two different jurisdictions as being two un-associated organizations and/or disparate EHRs.
Q: How jurisdictions are defined? Would two health centers serving different cities within a county be considered as entities from two jurisdictions?

A: Yes, two health centers serving different cities within a county could be considered as entities from two jurisdictions.
Q: Can the solution involve the use of a vendor solution (such as a closed loop referral system) that would be used along with other clinical systems (so it would not be the sole system)? Or does the use of a vendor solution prohibit eligibility to apply/successfully be awarded?

A: Please refer to slide 13 of the SEN Informational Session slides under “Other Requirements”.
Q: Area 1: requirement is to "develop and/or use non-proprietary tools necessary to complete the project". Does this mean that there will be a requirement to make available "open source" software upon completion of the project? Or, alternatively, can the university work with the investigators for an IP plan to license the technology developed afterwards?

A: The intention of these projects is to 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. Scalability is an important part of furthering a new generation of health IT development and interoperability, with open source software such as FHIR-based APIs is a big part of. If an applicant does not intend to build off of an open source platform, they must explain how they intend to make their end products widely available to the public.
Please refer to the section on Intangible Property and Copyrights (45 CFR Part 75) on pages 35-36 of the Notice of Funding Opportunity (NOFO) that 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 to own an organization's licensure or IP.
Q: Can you please provide, in the chat, the summary of Area 1 that was described on an early slide?

A: We are not able to directly respond to questions during the Informational Session. The summary of Area 1 can be found on the slide deck posted on our LEAP SEN page on slides 10-13.
Q: If an Area 1 applicant is working with an EHR vendor and an SDOH vendor, is it possible for that solution/approach to work with the prototype/open-source rules? Epic or Cerner (for example) may not share their source code, and the existing SDOH vendor may not as well. But this project would be coordinating information between those systems and the applicant could share any specific prototypes/data/screening questions and coding information. Can that work or do all technology solutions need to be open-sourced and shared as part of this project?

A: The intention of these projects is to 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. Scalability is an important part of furthering a new generation of health IT development and interoperability, with open source software such as FHIR-based APIs is a big part of. If an applicant does not intent to build off of an open source platform, they must explain how they intend to make their end products widely available to the public.
Please refer to the section on Intangible Property and Copyrights (45 CFR Part 75) on pages 35-36 of the Notice of Funding Opportunity (NOFO) that 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 to own an organization's licensure or IP.

Area of Interest 2 Questions from March 9, 2021 Informational Session

Q: For Area 2, must the two partner institutions be US-based?

A: Yes
Q: You had mentioned that we need to show partnership with 2 other institutions. Will you be recommending potential partners, or we need to seek them out prior to application? How does the I/P and legal terms work out when in such a partnership.

A: Applicants should seek out potential partners and note guidance within the SEN if involving other institutions and partners (e.g., working with a federally qualified health center (FQHC) or community-based organizations (CBO))For Area 2, can for-profit companies submit the grant proposal provided the consortia meets the requirement of including approved organizations types (non-profit, fqhc, etc...)? Or are submissions only allowed from those organizations regardless of how the consortia is structured?.
Q: For Area 2, can for-profit companies submit the grant proposal provided the consortia meets the requirement of including approved organizations types (non-profit, fqhc, etc...)? Or are submissions only allowed from those organizations regardless of how the consortia is structured?

A: Any application submitted under this SEN, regardless of which Area of Interest, must meet the eligibility requirements as noted on slide 21 on the SEN Informational Session slide deck and page 13 of the original Notice of Funding Opportunity (NOFO).

QUESTIONS FOR WEEK ENDING 03-12-2021

Q: During yesterday's information session the presenter described certain eligibility requirements for for-profit companies to participate in the Area 2 funding opportunity. Specifically it was mentioned that for-profit companies may participate as a sub-member of a consortium. The funding notice (here) specifies partnership with 2 other institutions, with a preference for FQHC's and other small-sized healthcare provider groups.

My question is, provided the submission includes these partnerships, is a for-profit company able to submit a proposal for this award or must it come from another partner in the grant consortium who is not a for-profit company?

A: Per the eligibility requirements on page 13 of the NOFO, for-profit organizations are not eligible to apply for this award. However, a for-profit organization may participate as a sub-member in a consortium or project partner under a non-profit organization’s application.
Q: May we please have access to the slides that were presented?

Our non-profit mission is tightly aligned with the goals of Area 1: Referral Management to Address Social Determinants of Health Aligned with Clinical Care.

A: The slides from the March 9, 2021 Informational Session, along with a video recording will become available on our webpage shortly. Please continue to check this page for updates.
Q: Could you connect me to the recording of the Feb 9 webinar described below?

ONC Information Session - LEAP SEN 2021
Mar 9, 2021 02:00 PM in Eastern Time (US and Canada)

A: The recording of the March 9, 2021 Informational Session, along with slide deck will become available on our webpage shortly. Please continue to check this page for updates.

QUESTIONS FOR WEEK ENDING 03-05-2021

Q: Upon reviewing the NAP-AX-18-003 document, we would like to ask for clarification on the second to last paragraph of page 3. The paragraph reads, “The approach must be piloted in at least (2) jurisdictions to ensure the approach is scalable and replicable to one or more of the SDOH domains regardless of locality.” Should we assume that this is not a requirement to have done something in the past but rather something that will be accomplished in the future as a part of area 1 activities.

A: Correct. The intent of the LEAP in Health IT awards is to seek projects that will demonstrate the objectives as identified in the SEN. However, if your organization has already accomplished something similar and intends to build upon that further, that would fit the intent of this SEN.
Q: In reviewing the eligibility criteria for the LEAP Notice of Funding Opportunity, no reference was made (either as a qualification or a disqualification) to organizations that are incorporated as a 501c-6 Trade Association.

Our non-profit mission is tightly aligned with the goals of Area 1: Referral Management to Address Social Determinants of Health Aligned with Clinical Care.

Can you let me know if a 501c-6 is eligible to participate in the opportunity?

A: As 501c-6 is considered a non-profit and therefore eligible to apply.

2020 FAQs

QUESTIONS FOR 06-05-2020

Q: We have gone through the process of filing for a SAM account, and a grants.gov account– yet I have heard from SAM help desk that our account will NOT be approved for 7-10 business days which will negatively impact us as it relates to filing for this application electronically on Monday June 8 through grants.gov (as grants.gov has told us we must have a SAM account).

Can you tell us if there is a path to submit this manually/non-grants.gov or some escalation you can help us with to get a SAM account finalized? Our group has worked hard on developing an innovative approach to enabling a FHIR based CRN. It would be unfortunate if we could not submit our application.

A: All applications must be submitted via grants.gov. Unfortunately, any applications that are not submitted via grants.gov will not be considered for award.

QUESTIONS FOR 06-04-2020

Q: Can you tell me where the attachments go into Cayuse? What is the order of attachments? Do Biosketches go under Attachment 1?

A: All applications must be submitted via grants.gov. Please refer to slide 29 of the SEN PPT or page 25 of the NOFO for application submission instructions.

QUESTIONS FOR 06-03-2020

Q: I am gathering data to support a healthcare platform we are working on to improve patient treatment plans and outcomes. Does the ONC have available data about Healthcare IT spending that I may access for the providers and payers?

A: Unfortunately ONC does not have any readily available data specific to health IT spending for providers and payors.

QUESTIONS FOR WEEK ENDING 05-29-2020

Q: Are these registries required to be FHIR compatible already to be eligible for the grant? Or is it okay that they are not yet FHIR compatible and that the grant is designed to help and catalyze their registries (and other registries) nationwide to *become* FHIR compatible?

A: As stated on page 5 of the SEN, “Applicants must also be utilizing a FHIR-enabled product. If an applicant is not currently FHIR-enabled, they will be required to become upgrade their software to become FHIR-enabled within six (6) months of the project award date.”
Q: I am pleased to submit my forthcoming application for the Leading-Edge Acceleration (LEAP) in Health Information Technology funding opportunity…[redacted]… I appreciate your consideration very much.

A: We are unable to accept applications at the ONC-LEAP@hhs.gov email address. All applications must be submitted following the applications instructions as outlined in the NOFO via grants.gov. Applications that are submitted using any other vehicle other than grants.gov will not be considered.
Q: Our organization is in the process of negotiating a federally-negotiated indirect cost rate, but it will likely not come through in time for the June 8 deadline. We do anticipate having a federally-negotiated indirect cost rate before project start. Is there any potential for an organization to retroactively apply an indirect rate if awarded?

A: ONC cannot retroactively apply an indirect cost rate to an award. The rate can be applied utilizing the start date of the agreement. The applicant can include the indirect cost as part of their budget to be submitted with their application, however the indirect cost rate agreement would need to be submitted to the ONC grants office prior to any budget approvals.
Q: For the FAQ: There is a 20% minimum level of effort requirement for the PI/PD. Can a portion or all of this be provided as an in-kind contribution, or must the full 20% be direct charged in the budget? For example PI LOE is 20%. Expense to ONC is 10%, expense to prime applicant is 10%.

A: We have no preference on how the 20% is budgeted as long as the PI meets the 20% minimum LOE.

QUESTIONS FOR WEEK ENDING 05-15-2020

Q: Can you please provide additional information about eligibility for grant opportunity NAP-AX-18-003 (Leading Edge Acceleration Projects in Health Information Technology)? Specifically, is CDC considered an “eligible agency of the federal government”?

A: There are some federal agencies that are eligible to apply for other federal grants and cooperative agreements. If you are a federal agency and are not sure if you are eligible, please check with your budget office or general counsel.
Q: Enclosed is a project plan & timeline for your perusal. Does this document answer any potential concerns about the project’s eligibility for your program? We would hire a US business partner for the development of the application.

A: This is a competitive award and we are only able to answer general questions. ONC is unable to answer direct questions specific to an individual organization’s proposal or “pre-approve” whether a potential applicants proposal is appropriate or eligible. Please refer back to the notice of funding opportunity and special emphasis notice for applicant eligibility.
Q: I can only find the attached RFP on your site: https://www.healthit.gov/topic/onc-funding-opportunities/leading-edge-a…. Is this the current one we should use for our application for the June 8, 2020 deadline? If not, can you please send me the current RFP?

A: Please refer back to the notice of funding opportunity and special emphasis notice for the current announcement and application requirements.
Q:
1. As it relates to the project objectives #1 under Area one, Identify the clinical registry(ies) that will be used by the project. Do the clinical registry(ies) have to be active at the time of application submission?
2. Can our research under the LEAP Grant involve real patients and their associated data using a clinical research guidelines?
A:
1. Yes, it is the expectation that applicants will partner with an active clinical registry. If the applicant intends to partner with a clinical registry that is not current active, the applicant must include the timeline of when the clinical registry is expected to become active.
2. Yes, research conducted under this cooperative agreement may involve real patients and associated data, provided that their consent is obtained and included before any information is publicly released.
Q: Would it be possible to extend the deadline for our responses to the ONC LEAP SEN until later in June 2020? Many of our team members are currently busy supporting COVID-19 initiatives and research for the state of [redacted]. We would like to have some additional time to allow us to prepare a thoughtful and thorough response to your RFP.

A: At this time ONC is not entertaining the possibility of a deadline extension.
Q: For Area 3, our team’s attempts to engage partners to help demonstrate and pilot “real-world implementations” of a solution have been consistently and adversely impacted by COVID-19. Unfortunately, the same people in who are instrumental to demonstrating the ability to work with both health and human service data are very busy focusing on the pandemic. Would ONC consider moving this LEAP SEN, particularly Area 3, out to a different period?

A: Due to regulations and requirements around the use of federal funds within appropriate fiscal years and federal awards under the way this NOFO is drafted, we are unable to move the period of this SEN to a different period.

QUESTIONS FOR WEEK ENDING 05-08-2020

Q: We’re interested in applying for the above grant however we missed the letter of intent grace period since one of our contacts just forwarded this opportunity. I was wondering is it ok to submit the grant application?

Secondly, we are using latest technologies like AI and Blockchain to facilitate instant patient data security and interoperability which can also integrate with existing FHIR technologies. Does that fall under the scope of the grant?

A: As noted in the special emphasis notice (SEN) (please refer to page 10), and stated during the informational sessions (please refer to slide 28), “Applicants are strongly encouraged but not required, to submit a nonbinding email Letter of Intent (LOI) to apply.”

As a matter of fairness, ONC does not provide potential applicants on guidance or confirmation as to whether or not their proposal is applicable. We strongly encourage potential applicants to carefully review the SEN to determine whether their project idea fits within the scope of any of the 3 areas of interest.
Q: The 2018 NOFO instructions require the Proposed Approach to be linked to “Objectives”: “This section should be organized so that the relationship of each element of the plan to each of the areas objectives and associated activities are completely clear” (p. 19 of 53). Yet the 2020 Special Emphasis Notice does not have the same delineation of Objectives as did earlier notices. Is it safe to assume that “Goals” are to be interpreted as “Objectives” for the purpose of developing a Proposed Approach, e.g. there should be activities for each of the five goals listed in Area 3 (p. 8 of 10)? If not, would you clarify the Objectives to be referenced in the Proposed Approach?

A: Please refer to slides 11, 14, and 17 from the Informational Session slide deck for the Associated Objectives for each area of interests’ Goals. You may also refer to the following pages in the special emphasis notice:
- Area of Interest 1: Pages 4-5
- Area of Interest 2: Page 6
- Area of Interest 3: Pages 8-9

QUESTIONS FOR WEEK ENDING 05-01-2020

Q: Do we need to budget for any travel expenses required as part of the grant?

A: Yes. All anticipated travel under this cooperative agreement, must be included in your budget proposal.
Q: Hello – is it still possible to submit questions about LEAP? In particular – we wanted to know if the total funding ($500K) be available if we had a shorter time frame e.g. 1 year versus 2 years? Is there any prohibition to completing the work earlier?

A: All awards made under this SEN are for a 2-year period of performance. Recipients will have two years to execute and complete their project in alignment with their project plan and associated budget.

QUESTIONS FOR WEEK ENDING 04-24-2020

Q: I am working on a LEAP grant application and wondering if there is an updated full Notice of Funding Opportunity for 2020? The link that is listed on the Health IT.gov appears to describe the 2018 grant opportunity.

A: The Notice of Funding Opportunity (NOFO) on the LEAP in Health IT website is the current NOFO. The “updated” funding opportunity announcement for 2020 is the Special Emphasis Notice (SEN), which identifies the three (3) areas of interest that applicants may apply for this year. Outside of the specifics relating to the areas of interest, all other requirements, such as application instructions and evaluation criteria, as detailed in the original NOFO apply.
Q: I posed a question to the ONC LEAP as to whether a “special District government” was eligible to apply for funding through this program. Your response was that you were not familiar with this designation and needed more information in order to make a determination on eligibility.

Per the U.S. Census Bureau (2002). 2002 Census of Governments, Vol 1, Number 1, Government Organization, GC02(1)-1 (PDF). Washington, DC: U.S. Government Printing Office. pp. vii–viii. “Special districts (also known as special service districts, special district governments, limited purpose entities, or special-purpose districts[failed verification] in the United States) are independent, special-purpose governmental units that exist separately from local governments such as county, municipal, and township governments, with substantial administrative and fiscal independence. They are formed to perform a single function or a set of related functions.”

My organization, [redacted], is the only public teaching hospital in [redacted]. Our purpose is to provide health care to the public while we serve as a teaching hospital.

A: Provided that your entity is not a for-profit, based on the information provided, your organization would fall under the category of eligible applicants.
Q: I have a question regarding eligibility for the ONC LEAP program, as identified in the subject line. Are “special district government” organizations eligible to apply? I have reviewed the eligibility requirements available but special district governments are not specifically identified as eligible.

A: We are not familiar with “Special District Governments” and require more information as to what a “Special District Government” is, where this designation came from, etc. in order to provide an answer. Please contact us with ONC-LEAP@hhs.gov with more details regarding “Special District Governments” in order for us to be able to provide you with the appropriate guidance you are seeking.
Q: I tried to access the meeting on the 15th at 2pm with the link below but it didn't let me in the zoom call. I was thinking the recording would be made available similarly to what happened for 2018 and 2019. I'm reaching out to confirm if this will be the case as the deadline for the letter of intent is only in 3 business days.

A: The slides and recording from the Informational Session are available on the LEAP in Health IT webpage. We apologize for the delay in posting as we encountered technical difficulties in uploading the recording.
Q: I’m checking to see where/when I can find responses to the questions raised during the LEAP presentation. I haven’t been able to locate them on the ONC site.

A: The FAQs are now posted. We apologize for the one day delay.
Q: Per the April 15 ONC LEAP SEN 2020 information session, ONC informed the audience questions would be posted to the FAQ site weekly, on Monday. I only see a May 2019 update as the last posting, are there questions that we can anticipate on the site? In addition the registration process failed us last week and our consortia was not able to view the slides, can those be posted?

A: The FAQs are now posted. We apologize for the one day delay.
Q: How might one be on the selection review or committee?

A: If you, or your organization does not intend to apply for a LEAP award, and are interested in serving as a Merit Reviewer, please email ONC-LEAP@hhs.gov. Note that all potential Merit Reviewers are required to complete a Conflict of Interest form.
Q: The LEAP 8/17/18 NOFO which is the application format, has a number of project activities that would be a challenge to fulfill with the limited funding available for Area 3: Integrating Health Care and Human Services. Since this is a Cooperative Agreement, what sort of resources can an applicant expect from CMS and ONC in support of this work? It is difficult to create a realistic budget proposal without information about what resources may be available from CMS/ONC.

Much of the work envisioned under Area 3 complements and extends on-going work funded through Advanced Planning Documents. Can resources funded through the HITECH, MMIS or other APDs be used to supplement the work funded through the LEAP Cooperative Agreement?

A: This is a cooperative agreement award that is issued through ONC. CMS has provided input, but is not directly involved in the LEAP program otherwise. As a cooperative agreement, the award recipient will work collaboratively with their assigned ONC project officer to ensure the timely objectives, milestones, and deliverables under this award are met. The ONC project officer may also request CMS input as deemed appropriate. However, in terms of financial resources, it is limited to no more than $500,000 for area of interest 3; no additional financial resources will be made available to the recipient from ONC or CMS. Resources, such as outputs or deliverables that resulted from HITECH, MMIS, or other APDs may be used, provided that it is not financial. Federal funds from other projects are not allowed to supplement other federally funded awards.

QUESTIONS FOR WEEK ENDING 04-17-2020

Q: I attended the virtual webinar regarding the grants in LEAP Health IT, which was wonderful and I greatly appreciated the information. I was actually looking for more information on the Community Health Peer Learning Program grant that I saw on the HealthIT.gov website under funding opportunities.

I know the webinar did not cover this specific grant and the literature on the website cites an application due date in April of 2015, so I was wondering if you all had any insight as to if this grant is open again or if we are able to apply currently?

A: The funding opportunity you are inquiring about is listed under Previous Funding Announcements and is no longer an active funding opportunity.
Q: What is, or proposed to be, the most accurate and updated source of APIs available for post- market surveillance notices such as product advisories and recalls?

A: Health Level 7 International (HL7®) is the owner and steward of the HL7 fast healthcare interoperability resources (FHIR®) standard; you can find the most current and accurate FHIR-based application programming interface (API) on their website. In regards to post-market surveillance notices such as product advisories and recalls, we refer you to the Food and Drug Administration (FDA), as the regulators of post-market products. Their Global Unique Device Identification Database (GUDID) page can be found here. We also suggest checking the FDA’s Sentinel Initiative page here.
Q: I have a few questions I’d like to submit:
1. Will the NIH Salary cap be used?
2. Is F&A negotiable or is the institution’s negotiated rate used?
3. Last year’s opportunity lists 33% of the budget for consultants, and 20% minimum commitment for PI’s. Is that true for this opportunity?
A:
1. ONC does not follow NIH guidelines for maximum salary cap, however all salary costs associated with projects must be comparable for that specific position and geographical location.
2. The institutions approved, negotiated rate is used. In the event an organization is applying F&A to an award, their current approved agreement must accompany the application.
3. Yes. As noted in the presentation and SEN, other than the identified areas of interest and associated objectives and required expertise, all other requirements, evaluation criteria, and terms and conditions of the original NOFO apply.
Q: My organization is exploring applying for the LEAP Health Information Technology grant and I have a couple of questions:
1. My organization is classified as a Special District Government. According to eligibility requirements in the guidance, units of local and state government are eligible to apply. However, I don’t see that this eligiibliyt [sic] includes special district governments. Can you please confirm our eligibility?
2. It appears that this opportunity has been available since 2018. Are funds still available for grant purposes?
A:
1. We are not familiar with “Special District Governments” and will need more information regarding this matter in order to provide an answer. Please contact us with ONC-LEAP@hhs.gov with more details.
2. The LEAP in Health IT notice of funding opportunity (NOFO) is open for 3-years, with funding available each fiscal year under a special emphasis notice (SEN). The full amount of allocated funds for each fiscal year has been awarded in FY 2018 (under the initial NOFO) and FY 2019 (under the 2019 SEN). New funds for FY 2020 are now being made via this year’s SEN. Only applications for the Areas of Interest as identified in this year’s SEN will be considered.
Q: “…Easily, I can complete your application however, I wish to request ‘special handling.’ The Federal Government has spent billions of dollars on interoperability. For a tiny fraction of this expenditure, we could connect the Healthcare Community… Because of the need and yes, the savings / cost containment, I / we want to begin immediately. …”

A: Unfortunately this is a competitive award and in the interest of fairness, ONC is unable to entertain “special handling” requests that bypass the competitive award process. Anyone interested in receiving an award under this special emphasis notice (SEN) must apply using the process and required elements as outlined in the notice of funding opportunity (NOFO) and SEN, and is subjective to an objective review evaluation and selection of award recipients will be made based on evaluation scores, with programmatic concurrence.
Q: “…I have an interest in EHR improvement, including a project I'm trying to test the waters of viability about. Don't want to take much of your time, but could you tell me if this is a project you'd be interested in? (Promise I'm not trying to bypass the normal application process, just an outsider to ONC and this venue for research funding, so thought the least time-wasting approach would be to inquire informally first!)…”

A: Unfortunately this is a competitive award and in the interest of fairness, ONC is not able to pre-vet or advise potential applicants on whether or not a proposal is appropriate or whether or not a potential applicant should submit or not submit an application.

QUESTIONS FROM APRIL 15^TH INFORMATIONAL SESSION WEBINAR

GENERAL QUESTIONS

Q: Are there handouts for this meeting?

Can we get a copy of this webinar recording?

A: The PPT slide deck, along with the recording of the Informational Session, are available at the LEAP in Health IT webpage.
Q: Is the $1m funding level for Areas 1 and 2 equal to $500,000 per year for 2 years for each?

A: Areas of Interest 1 and 2 recipients will receive a total of no more than $1M for the full 2-year period of performance each. The Area of Interest 3 recipient receive a total of no more than $500,000 for the full 2-year period of performance. The recipients have the full 2-year period of performance to complete their proposed projects and expend their total awarded funds.
Q: What are eligible federal agencies?

A: There are some federal agencies that are eligible to apply for other federal grants and cooperative agreements. If you are a federal agency and are not sure if you are eligible, we recommend you check with your budget office or general counsel.
Q: Please explain further how a for-profit organization may participate.

A: A for-profit organization may participate if they partner with an eligible applicant (i.e., non-profit organization, university, etc.) as a sub-recipient. The applicant must be eligible, but may list project partners who are for-profit organizations as their sub-recipient(s). The applicant is responsible for managing all deliverables, performance, and expenditures of their partners, should their project be selected. If the applicants intends to partner with a for-profit organization, they must include these expenses in their budget proposal.
Q: Is an organization designated as a “special district government” eligible to apply?

A: We are not familiar with “Special District Governments” and will need more information regarding this matter in order to provide an answer. Please contact us with ONC-LEAP@hhs.gov with more details.
Q: Can “sub-recipient” be defined please? Under eligibility.

A: A sub-recipient is someone that the recipient partners with in order to complete the project. Each application may only have one applicant (prime), but a prime may work with other interested parties or partners, known as sub-recipients.
Q: Will the recipient of the award own their IP from this project?

A: Per 45 CFR 75.322 (b) The non-Federal entity may copyright any work that is subject to copyright and was developed, or for which ownership was acquired, under a Federal award. The HHS awarding agency reserves a royalty-free, nonexclusive and irrevocable right to reproduce, publish, or otherwise use the work for Federal purposes, and to authorize others to do so.
Q: How might one be on the selection review or committee?

A: If you, or your organization does not intend to apply for a LEAP award, and are interested in serving as a Merit Reviewer, please email ONC-LEAP@hhs.gov. Note that all potential Merit Reviewers are required to complete a Conflict of Interest form.
Q: Can there be multiple PIs in this proposal?

A: No, each project must have one Principal Investigator (PI) who serves as the sole point of authority and accountability for the project.
Q: Does the LOI need to be a PDF on letterhead, or is email format sufficient?

A: There is no preference on how an organizations submits a LOI beyond that it be sent to ONC-LEAP@hhs.gov by April 27^th and includes the following information:
- Name of applicant organization
- Organization type
- City and State
- NOFO No. NAP-AX-18-003
- Title: LEAP Special Emphasis Notice (Applications to Address the Development and Testing for Data Sharing Functionalities to Support Clinical Care, Research, and Improved Health Care Outcomes)
- Area of Interest
LOIs are strongly encouraged, but not required and are non-binding.
Q: Are these 3 opportunities for non-profits only?

A: Please refer to Slide 22 of the Informational Session Webinar PPT or Section B (Page 13) of the NOFO for the full list of eligible applicants.
Q: Is the funding amount an annual amount or total over the two years? (e.g., for area 1 is it $1M total, or $1M per year?)

For emphasis areas 1 and 2, is the $1 million amount for each year, or does the $1 million need to cover two years of activity?

A: The funding amount (up to $1M for Areas of Interest 1 and 2 and $500K for Area of Interest 3) is the total award amount for the entire 2-year period of performance.
Q: If we would like to submit multiple applications under multiple areas of interest, should we also email multiple LOIs, or can we indicate this all in one email?

A: You may indicate it all in one email.
Q: Will ONC facilitate collaboration between applicants who may have complementary proposals?

A: No. ONC does not facilitate collaboration between applicants who have complementary proposals.
Q: What requirements flow down to sub-contractors?

A: Please see 45 CFR 75.101 for sub-contractor flow down requirements. Please note that a sub-contractor is not the same as a sub recipient. In the event an applicant intends to have sub-recipients, all award requirements would flow down.
Q: If we are a private business (startup) how can we tell if we are eligible?

A: Please refer to Slide 22 of the Informational Session Webinar PPT or Section B (Page 13) of the NOFO for the full list of eligible applicants.
Q: Are applications limited to US applicants solely, or can they applicants be a consortium of US and Canadian entities (Organizations)?

A: Please refer to Slide 22 of the Informational Session Webinar PPT or Section B (Page 13) of the NOFO for the full list of eligible applicants.
Q: Can multiple organizations that bring complementary capabilities partner on one application?

A: Yes. Multiple organizations may partner together to apply for an award. However, there must be a single applicant (prime) and single Principal Investigator (PI) and Project Director (PD) identified that will serve as the overall project lead.
Q: If we submit an LOI will we receive a response confirming or denying our eligibility?

A: We do not confirm or deny a potential applicant’s eligibility based on a LOI.
Q: Are there specific Intellectual Property considerations? Albeit Open Source, who will hold IP rights?

A: The recipient may own IP from the project however, under 45 CFR 75.322 (b) The non-Federal entity may copyright any work that is subject to copyright and was developed, or for which ownership was acquired, under a Federal award. The HHS awarding agency reserves a royalty-free, nonexclusive and irrevocable right to reproduce, publish, or otherwise use the work for Federal purposes, and to authorize others to do so.
Q: Much of the guidance is focused on the first two 'research' projects - but don't seem fully applicable to #3. Is there different guidance for #3?

A: It is unclear as to how the guidance is not applicable to area of interest 3. Please clarify or provide more information so that we may better address your question.
Q: The scoring also seems focused on the first two projects but appears less relevant to #3. Do you have any supplemental guidance about criteria that will be used for #3?

A: It is unclear as to how the evaluation criteria is not applicable to area of interest 3. Please clarify or provide more information so that we may better address your question.
Q: Slide 38 - Dissemination Plan did not mention open-source software. Is the open source component of the Dissemination Plan mandatory, highly desired, nice to have, or not needed?

A: The intention of these projects is to 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. Scalability is an important part of furthering a new generation of health IT development and interoperability, with open source software such as FHIR-based APIs is a big part of. If an applicant does not intent to build off of an open source platform, they must explain how they intend to make their end products widely available to the public.
Q: Does ONC follow NIH guidelines for maximum salary support of the PI and other investigators?

A: ONC does not follow NIH guidelines for maximum salary cap, however all salary costs associated with projects must be comparable for that specific position and geographical location.
Q: For project that extend beyond the first two years, must the funding allocated cover all (up to 5) years?

A: Awards made under this SEN are for a 2-year period of performance. While applications may propose additional 3 years (up to 5 years total), they are not guaranteed to the additional 3 years as supplemental awards under this SEN is subject to availability of funds and meaningful progress of the recipient.
Q: Many RFAs have extended application submission dates due to COVID. Do you anticipate such an extension?

A: Not at this time.
Q: How are institutional indirects handled?

A: Indirect costs that are to be applied to an award must be based on an approved Indirect Cost Rate Agreement. In the event that an organization does not have one, they are able to apply a 10% de minimus rate per 45 CFR 75.414.
Q: Is there a requirement that the third project duration is two full years? Can we recommend a shorter time period e.g. 1 year?

A: All awards made under this SEN are for a 2-year period of performance.
Q: Can an application focus on a specific disease area or does it have to be generalized to all health care areas?

A: We do not require that an application focus solely on a specific disease area or generalized to all health care areas. It is open to the applicant to propose.
Q: Are past LEAP in Health IT awardees eligible to submit for this funding opportunity or are they part of a separate review process and funding stream?

A: Anyone who meets the eligibility requirements as indicated on Slide 22 of the Informational Session Webinar PPT or Section B (Page 13) of the NOFO for the full list of eligible applicants.
Q: If we perceive a need for infrastructure that is not covered under the topics listed, can we submit that?

A: No. Only applications that address the objectives as described in the Areas of Interest in the SEN will be considered for funding.
Q: Will the LOIs (or a list of entities that submitted LOIs) be made public prior to the application deadline?

A: No. ONC does not release the names of people who submit LOIs or applications.
Q: Will this project be in support of VHA?

A: We are unclear as to what this question is asking for. This SEN is posted by ONC, in support of our mission and objectives. While findings and outcomes of these projects may benefit the VHA, as a provider and payor of health care services, it is not specific for any one particular VHA initiative or service. Please provide additional clarification or information in order for us to address this question.
Q: Is there a possibility to combine this funding with other funding for COVID-19 initiatives?

A: Not at this time.
Q: Are applicants from private sector encouraged, or is it better to have a university research organization to work with?

A: Anyone meeting the eligibility requirements are encouraged to apply.
Q: Is there a limit to number of partnerships allowed to form for the application of any areas of interest?

A: There is no limit on the number of partnerships allowed to form for the application in any of the areas of interest.
Q: How many applicants were there in 2018 and 2019?

A: ONC is unable to disclose that information.
Q: If there is only one award per section, is there a means to coordinate with those submitting larger projects?

A: No.

QUESTIONS SPECIFIC TO AREA OF INTEREST 1

Q: In the slides re Goals, did you mean “increase normalization and standardization” as opposed to “reduce.” Aren’t we always promoting data exchange using shared standards?

A: The Goal is to reduce “effort” related to “data normalization and standardization” by using well-established standards for data exchange.
Q: Assuming that the correct IG is the Women’s Health Technology Coordinated Registry Network FHIR IG (v0.2.0: STU 1 Ballot 2) based on FHIR R4. However, the Implementation Guidance specifies use of FHIR versions either STU3 or DSTU2. Does the IG fully support FHIR R4?

A: The WHT CRN IG was developed based on the R4 and is currently being updated to support FHIR R4 after comments on Structured Data Capture (SDC) were received to address changes that were identified.
Q: For the Registry emphasis area, does the registry need to be multicenter?

A: While most disease registries are multi-center, we do not specify that they must be in order to propose them under this project. We leave the choice of registry (single center or multicenter) up to the applicant to propose.
Q: For the registry emphasis area, does the registry need to be an existing registry or can the work be accomplished within one or… more centers getting ready for a new registry in the planning stages, i.e., a federal NOT has been issued for a registry and centers are getting ready?

A: The selected registry(ies) must be functioning and collecting data when the response is received on this cooperative agreement.

QUESTIONS SPECIFIC TO AREA OF INTEREST 2

Q: Can an application for No 2 utilize a software platform that is currently available on a commercial basis outside of the US to support clinical, biopharma, and research goals leveraging clinical and genomic data across institutions?

A: One of the goals of LEAP is to create scalable solutions to advance or improve the use of health IT. Applicants are encouraged to focus on utilizing platforms that integrate and leverage open standards and can be made widely accessible / scalable.

QUESTIONS SPECIFIC TO AREA OF INTEREST 3

Q: For Area 3, is incorporating patient consent mandatory, highly desired, or nice to have?

A: Applicants must comply with applicable existing laws regarding data sharing. The intent of Area 3 is not to develop a technical consent solution. Please see page 8 of the LEAP SEN to review goals for Area 3.
Q: Per Area 3, can the project be proposed around a specific disease such as mental health?

A: The project proposal can focus on a specific population or health condition.
Q: In Area 3, are Social Determinants of Health encapsulated within your reference to Social Services? If so, would Gravity instead of FHIR qualify for Area 1 or Area 2?

A: Social determinants of health are one component of information gathered that can be counted as social services and vice versa. We are unclear as to how Gravity instead of FHIR would qualify for Area 1 or 2 since Gravity is a project within HL7, whereas FHIR a standard. Please provide clarification or more information so that we may better address your question.

2019 FAQs

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.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=306704

FOA LEAPHealthIT (002).pdf Jul 09, 2018 02:22:28 PM EDT 551.1 KB
- 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.
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 support@grants.gov.

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)
  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

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.
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 support@grants.gov 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 2^nd’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 2^nd 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 2^ND 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?

A: Yes
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.

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

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.

2018 FAQs

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?

A: All questions must be posted and answered publicly on the LEAP webpage. Please refer to page 26 of the NOFO.
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 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: 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?

A: No.
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?

A: Yes.
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 publicly 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?

A: There is no matching requirements under this funding opportunity, please see page 14 of the NOFO; we also recommend you review 45 CFR 75.306which provides the HHS regs for cost sharing/matching.
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?

A: No
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.

G.Miscellaneous Questions

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.