The Standards Exploration Award (SEA) Cooperative Agreement Program

Please note that this is a competitive award and we are only able to answer general questions. We will make information equally and publically available in the form of a written FAQ which is updated on a weekly basis. ONC is not able to answer direct questions specific to individual organization’s proposals.

New Questions for 7/8/2016

Q: Regarding OMB form 4040-0013: Disclosure of Lobbying Activities. We are the applying organization. However, our Lobbying Registrant is not an individual but rather a sub-arm in the organization. Further, we do not intent to lobby as part of our response to the proposal. Can you advise on how we should best complete OMB 4040-0013?

A: Please disclose the information. You may also disclose that you do not intend to lobby as part of this project proposal.

New Questions for 7/7/2016

Q: Will all of the cooperative agreements proposals become public?  Or, will just those that are awarded become public?  Where will these be made available?

A: No proposals are made public

Q: Once our cooperative agreement proposal is submitted, will there be any interaction between ONC and the submitter between the submission date and the expected award date of 8/29?  Should we be expecting clarifying questions from ONC or other questions related to the proposal?

A: Please see pages 20-21 of the Funding Opportunity Announcement

New Questions for 7/6/2016

Q: In your solicitation for the High Impact Pilots (HIP) Program the deadline is listed as "The deadline for the submission of applications under this Funding Opportunity Announcement is 11:59 Eastern Standard Time on July 8, 2016." Could you clarify if this is AM or PM?

A: PM

Q: SF-424A instructions (on p. 37 of the FOA) for Section B Budget Categories requires that we use column 3 (federal costs), column 4 (non-federal costs) and column 5 (sum).  Due to the auto-populating of Section B column header information from the Section A row descriptions (column a of Section A), I must enter in Section A the federal and non-federal costs on separate lines (lines 3 and 4, in order to populate the column 3 and 4 headings in Section B).  Section A instructions do not specify particular rows for cost input, so is this method of entry in Section A compliant with the FOA instructions (in order to be compliant with Section B instructions)? If this method is not compliant, please let us know an alternative method to have the appropriate cost data appear in columns 3, 4 and 5 of Section B.

A: Please complete the federal column (column 3), non-federal column, as applicable (column 4), and total sum (column 5).

New Questions for 7/5/2016

Q: Is form SF-LLL required if our organization has not hired a lobbyist at any time?  If yes, how should we document on the form that we have not hired a lobbyist?

A: Please submit the form even if you have not hired a lobbyist.  You can enter N/A on the form to indicate that you have not hired lobbyists.

Q: You have answered a number times the questions about IP Rights in the FAQs. In the last answer you write "Award recipients may also pursue commercial application of intellectual property and require payments for the use of such property; however, the funding 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.” The last statement "and to authorize others to do so” is at odds to the statement that recipients can pursue commercial application of their award IP.  If you are able to provide the recipient’s IP at will to any third party, for example to a large IT conglomerate, then the award recipient has no protection for their IP. Is this interpretation at fault?

A: This is not at odds with the pursuit of IP. Per the HHS Grants Policy Statement, ONC reserves the right to have access to the information that is generated by way of the funds that are awarded to the respective organizations.  It is not the intent to compromise any information or system that generates/houses information.  For further information please reference the following: http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

New Questions for Week Ending 7/1/2016

**Please note: An amended version of the Funding Opportunity Announcement was released on June 28, 2016. The amendments are to pages 16-17 and related to the page limit recommendations for the Project Narrative composition, which is limited to no more than 25-pages. In the originally released FOA, the page limit recommendations for the Problem Statement, Project Scope, Collaborator Involvement (if applicable), Project Approach, Project Management, Project Plan, and Project Risks and Risk Mitigation Strategy did not add up to 25; this correct version does. The amended FOA also corrected the Appendix E template.**

Q: Does ONC have a policy regarding  indirect costs on subawards or contractual costs? 

A: This program must follow the federal regulations as outlined in 45 CFR 75.414.  Any regulation that is placed upon a prime recipient must be passed down to sub-recipients. 

Q: Per the FAQ shown below, please direct us to instructions on how to identify and document subawardees in the budget narrative? 

A: Sub-recipients must be accounted for in the “other” category in the budget narrative, and in the SF-424a. Each sub recipient must have their own budget break out in narrative form, as well as their own 424a.   

Q: Are there any requirements outside of the budget narrative and the Collaborator Involvement Section of the Project Narrative related to subawardees? Can funds be allocated across collaborators? 

A: There must be a primary applicant for a FOA application. Collaborators must be listed as subawardees. Applicants must include how they will allocate funds in alignment with their Projects, as well as how subawardees will be managed.  Further information can be referenced in 45 CFR 75.351 through 75.353

Q: The instructions for Section B Budget Categories does not align with the current pdf file in the grant package.  The columns listed on the pdf file (1,2,3,4) relate to specific grants and not the funding stream (federal vs. non-federal). Column 1's header has been auto-populated with the name of the Grant Program Function I entered in Section A.  Please advise if we should use column 1 as auto-filled or columns 3 and 4 as per the instructions (page 37). 

A: The current PDF file is for the narrative, which is a different document as the SF-424a.  Columns 3, 4, and 5 in section 6 of the SF-425 must be filled out, in addition to the budget narrative template.

Q: I am working with several different groups as a collaborative effort for the High Impact Pilot funding announcement.  I have several questions regarding the use of funds and the disbursement of funding. My understanding is that for profit can apply for the funding.  If so, can they simply act as a funding distributor to the other agencies within the proposal? Part of the proposal is ensuring that clinicians are involved; can part of the funding be used towards an incentive or paying for clinicians work?

A: For profits can apply yes, however profit cannot be made off of federal grants.  The prime recipient can act as a pass-through entity to other organizations, in the form of a sub-recipient relationship. Please refer to 45 CFR 75.352 regarding the requirements for pass through entities.  Incentives are typically not an allowable charge to a federal award. 

Q: Page 18 of the FOA states that the Budget Narrative cannot exceed 1 page.   Slide 21 of the webinar slides states there is no limit to the Budget Narrative.  These appear to conflict.  Is there a 1-page Budget Narrative as a component of the Project Narrative?  And is there a separate, unlimited page Budget Narrative deliverable?

A: The Budget Narrative/Justification is a high-level description of your proposed budget and how it aligns/supports your proposed Project, and must not exceed 1-page. This does not count as part of the 25-page limit Project Narrative. The more detailed budget breakdown has no page limit.

Q: We are planning to respond to this funding opportunity and would like to request an extension for a week from the due date. Can ONC accommodate this request please? Will ONC be granting any application deadline extensions?

A: No

Q: On page 9 on the FOA it states that "projects that are too modest are at risk of not being funded." Can you clarify what "too modest" means?

A: Proposing Project objectives/goals that are too easily obtainable with little effort simply for the purpose of being able to show success at the end of the Project period-of-performance. 

New Questions for Week Ending 6/24/2016

Q: One of the Priority Categories is Comprehensive Medication Management. There are many varying definitions of this process across the industry. Can you provide an ONC definition of Comprehensive Medication Management or a reference to the definition.

A: Please see page 5 of the Funding Opportunity Announcement. You may also refer to slide 13 of the Informational Session Webinar.

Q: What is the purpose of the second year? Are there any requirements for the second year?

A: This is a one-year (12-month) program. ONC maintains the ability to exercise flexibility for purposes of delays beyond an award recipient’s immediate control, and will be considered on a case-by-case basis. ONC intends to administer this as a one-year (12-month) program, as such, there are no requirements that applicants need to address for the second year.

Q: We are working with partners/collaborators on our efforts. Some of these partners/collaborators require a non-disclosure agreement (NDA). As a result, we cannot identify them specifically as collaborators or it will violate the NDA. Please describe the best way to handle this situation within the proposal and identification of collaborators.

A: Per page 16 of the Funding Opportunity Announcement (Collaborator Involvement – if applicable), applicants must describe the role and make-up of any strategic collaborators assisting in their proposed project. Additionally, Letters of Commitment from key collaborating organizations or agencies that have a significant coordination role in carrying out the Project (page 19 of the FOA) are requested as part of an applicant’s “Other documents”. As the funding agency, ONC has a fiduciary responsibility over these award dollars and therefore must have access to all relevant information. A non-disclosure agreement does not preclude one from sharing who they are partnering with.

Q: In the FAQs already published, there appears to be conflicting information in two responses below.  Can you clarify which is correct?  In addition, related to your response to the first question below, on Page 10, Subtask 1.4, the deliverable appears to be the Kick-off meeting (5 days after the approved project plan), rather than the actual deployment of the technology (5 days after the approval of the project plan).  Please clarify.

[Note: The question author refers to the questions and answers listed below]:

Q: Are there any assumptions about when the HIT needs to be deployed and used?  For example, while the grant period begins in September, can the HIT implementation begin in March, with the analysis occurring between March and September '17?

A: Recipients must deploy their Technology Solution within 5 business days of ONC’s approval of their Project Plan. Please see page 10 of the FOA, Subtask 1.4.

Q: We have a current capability deployed as a component of our health IT infrastructure. As part of a HIP or SEA proposal, may funds be used to implement an API for an emerging standard identified in the ISA? Does this new API need to be deployed within 5 days of approval of the Project Plan by ONC or can it be deployed after that date as long as proposed measurement milestones are achieved?

A: It is the expectation that any awardee is ready to deploy their project shortly after the approval of their final project plan and kick-off meeting with any project partners to demonstrate results and evaluate progress with their selected Impact Dimension(s) within the 12-month period-of-performance as stated in the FOA.

A: The associated task for a recipient’s initial deployment of their Technology Solution is their kick-off meeting. It is expected that the Technology Solution will be deployed shortly after their kick-off meeting.

Q: The instructions for the project plan on page 17 of the FOA appear to include a requirement to provide narrative to respond to some of the instructions quoted below.  In addition to providing a project plan which lays out the tasks, start and end dates and timeframes necessary to achieve the requirements of the cooperative agreement, can you clarify the instructions as to whether this section should also include narrative to answer the questions quoted below?

[Note: Quote below is annotated to specify the components the question is seeking clarification on]:

“Applicants are required to submit a Project Plan to ONC… Applicants must include the use case for their Technology Solution in their application…In the Project Plan, applicants must provide their Priority Category, Impact Dimensions, and selected standard(s) from the 2016 ISA, if applicable. If there are no standards included in the 2016 ISA that addresses a need for interoperability within the applicant’s Project, applicants may propose, and must justify rationale if using alternative standards that can meet unaddressed, compelling needs of the evolving health care ecosystem in lieu of using standards from the 2016 ISA.   Project Plans must include baseline measurements and the applicant’s propose performance metrics for the Impact Dimensions they will be evaluating to demonstrate successful application of standards and technology.  Metrics may include how the applicant would set goals and track progress on improvement of adoption and use measures back to ONC.    Applicants must, in their Project Plan, assess their current state of infrastructure’s technical readiness and demonstrate their understanding of the specific technologies being contemplated and applied to advance interoperable health IT systems within their selected Priority Category. (3-4 pages)”

A: Please refer to pages 16-17 of the Funding Opportunity Announcement for the detailed requirements of the 25-page Project Narrative.

Q: In the FOA, it looks like the Project Plan is part of the overall page limit for the full project narrative. Does the Project Plan count toward the overall Project Narrative page limit or is it separate?

A: Yes. Pages 16-17 of the FOA are the required components of the 25-page Project Narrative.    

Q: Should the HIP/SEA Project [Grant] Abstract and Narrative (which includes Problem Statement, Project Scope, Collaborator Involvement (if applicable), Project Approach, Project Management, Project Plan, and Project Risks and Risk Mitigation Strategies) be single or double-spaced?  throughout, or whether the requirement is just that there is double-spacing between paragraphs which have single-spacing?             

A: Double-spaced

Q: It looks like the Project Plan is part of the overall page limit for the full project narrative. Does the Project Plan count toward the overall Project Narrative page limit or is it separate?

A: It is part of the Project Narrative page limit

Q: We would like to include our company’s corporate capabilities and experience in the application, as is suggested by the information in the Merit Review section; however, the FOA does not indicate which section of the Project Summary this information should go in.  Can you provide your expectations or some guidance on this?

A: Please refer to pages 16-17 of the Funding Opportunity Announcement

New Questions for Week Ending 6/17/2016

Q: Is a letter of intent/notice of intent a pre-requisite in order to apply for the HIP and/or SEA award?

A: No

Q: If my organization is submitting an application for the HIP and/or SEA FOA, can I still be an Objective Reviewer.

A: No. If your organization is either submitting an application for the HIP and/or SEA FOA, or if you have a current grant, cooperative agreement, or contract with ONC, you are not be eligible to be an Objective Reviewer for the FOAs.

Q: Your FAQs say that work created with awarded funds requires an irrevocable royalty-free license to the government.  But the text says any work licensed (aka already developed, but paid for with awarded funds) also requires an irrevocable royalty-free license to the government.  In our specific situation, our (existing) interoperability solution is sold on a monthly subscription basis.  Does this clause mean that if the awarded funds are used to pay for the monthly subscription fees that the government would automatically get an irrevocable royalty-free license to the code used to implement the solution and that we would have to give it to you if you asked for it?

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: The phrase “must have the technical infrastructure in place” can be interpreted in multiple ways. What exactly does that mean?  For example, does it mean the software solution must be ready to go live?

A: It is the expectation that any awardee is ready to deploy their project to demonstrate results and evaluate their progress with their selected Impact Dimension(s). This includes the use of standards as proposed in their application within the period-of-performance as stated in the FOA.

Q: We are planning to propose the development of a standards-based app to be integrated with our EHR and deployed at our organization. The app has not been developed yet. We anticipate that a good portion of our budget would go towards software development of this app. Also, the app would be ready to go live in clinical settings probably only in the second half of the project. Would this qualify for funding in the HIP program?

A: We are unable to answer questions specific to any potential applicant’s project proposal. It is the expectation that any awardee is ready to deploy their project shortly after the approval of their final project plan and kick-off meeting with any project partners to demonstrate results and evaluate progress with their selected Impact Dimension(s) within the 12-month period-of-performance as stated in the FOA.

Q: In the HIP/SEA FOAs it says, “For any work owned by a third-party that was licensed by the recipient under this award, the recipient will ensure that said license also reserves for the Government a perpetual, royalty-free, nonexclusive, and irrevocable right to reproduce, publish, or otherwise use the work for Federal purposes, and to authorize others to do so.” We are proposing to implement an interoperability solution using our own apps and the [redacted] which is run on proprietary software.   We will also be integrating into the solution third-party apps that connect to our system.  Neither our partners or ourselves are willing to effectively give away our software by signing such language.  Can you clarify and give us assurances we and our partners won’t be effectively giving away our proprietary IP by participating in this effort?

A: HHS reserves the right to have access to any solution(s) developed under this cooperative agreement. As the funding agency, we reserve 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. To clarify further, this would be pertaining to the information contained within these solutions, and not the platform itself.   

Q: Please clarify your response from an earlier draft of the posted FAQs:  "Award recipients are expected to have the technical readiness to immediately implement their project plan and start deploying their Technical Solution; the purpose of this program is not for recipients to build new technology products, but rather to execute and advance usage.”

Please clarify this statement.  The application of our standards-based Technical Solution will necessarily include service integration/stabilization work, data model and semantic normalization/transformations, and CDS rules/logic that need to be defined, implemented, and refined based on pilot feedback. Are these allowable activities or are funds only to be applied to the installation and evaluation of existing technologies/knowledge bases/data models?

A: We are unable to answer questions specific to any potential applicant’s project proposal. It is the expectation that any awardee is ready to deploy their project shortly after the approval of their final project plan and kick-off meeting with any project partners to demonstrate results and evaluate progress with their selected Impact Dimension(s) within the 12-month period-of-performance as stated in the FOA.

Q: As mentioned in the FOA and clarified in the FAQs, there is a one-page recommendation for the budget narrative high-level overview that is included in the Project Narrative, with a more detailed Budget Narrative to be included as a separate attachment. Can you further clarify if the more detailed Budget Narrative has a page limit and whether or not those pages are included in the maximum 25-page requirement for the Project Narrative?

A: The detailed budget narrative has no page limit and is not included in the 25-page requirement for the Project Narrative. Please see slide 21 from the Informational Session Webinar.

Q: Within the Priority Categories, you list subcategories.  Is it a requirement to select a subcategory? If so, can we add one if the given categories do not fit our project?

A: If your project proposal does not fit into any of the identified priority categories and/or subcategories, you may submit your project proposal under the “Self-Identified” category.

Q: We have a current capability deployed as a component of our health IT infrastructure. As part of a HIP or SEA proposal, may funds be used to implement an API for an emerging standard identified in the ISA? Does this new API need to be deployed within 5 days of approval of the Project Plan by ONC or can it be deployed after that date as long as proposed measurement milestones are achieved?

A: It is the expectation that any awardee is ready to deploy their project shortly not long after the approval of their final project plan and kick-off meeting with any project partners to demonstrate results and evaluate progress with their selected Impact Dimension(s) within the 12-month period-of-performance as stated in the FOA.

Q: On page 16 you mention including resumes under the collaborators (and state that they are not part of the 25 pages). On page 19 your mention under Other documents Key project personnel including CVs. There are 5 key personnel on my project and all are academicians. Is it acceptable to provide NIH-style 5 page maximum biosketches?

A: Key personnel resumes/CVs fall under “other applicable documents” and is not subject to the 25-page limit.

Q: We have a current capability deployed as a component of our health IT infrastructure. As part of a HIP or SEA proposal, may funds be used to implement an API for an emerging standard identified in the ISA? Does this new API need to be deployed within 5 days of approval of the Project Plan by ONC or can it be deployed after that date as long as proposed measurement milestones are achieved? 

A: It is the expectation that any awardee is ready to deploy their project shortly not long after the approval of their final project plan and kick-off meeting with any project partners to demonstrate results and evaluate progress with their selected Impact Dimension(s) within the 12-month period-of-performance as stated in the FOA.

General Questions

Q: What is the difference between the two awards (HIP and SEA)? Can you succinctly explain the difference between the two (HIP and SEA) new FOAs? They share a lot of the same language and I am having trouble distinguishing their requirements. Are they the same, with the HIP having a larger scope of work?

A: Yes. The HIP and SEA programs use the same framework with the HIP program requiring a larger scope of work. The specific differences between the two programs are:

• HIP: 3-7 anticipated awards ranging from $100k-$500k and must select 3 Impact Dimensions
• SEA: 3-5 anticipated awards ranging from $50k-$100k and must select 1 Impact Dimension

Q: I would like to join the meeting on May 23rd. Where is the location?

A: Both the HIP and SEA Informational Sessions will be held virtually. You can register for the HIP session hereWeb Site Disclaimers and the SEA session hereWeb Site Disclaimers. (Please note the dates for the HIP and SEA FOA Informational Sessions have now past)

Q: So you won't be answering questions?

A: All questions relating to this FOA must be submitted in writing and will be answered in the form of a FAQ that will be publically available on the SEA webpage. The FAQ will be updated weekly, so please continue to check the webpage for new information.

Q: I found a lot of great information on HIP and SEA online but I could not find a link to the FOAs itself.  Could you point us to it? 

A: The FOA can be found at HIP: http://www.grants.gov/web/grants/view-opportunity.html?oppId=283657 SEA: http://www.grants.gov/web/grants/view-opportunity.html?oppId=283656

Q: Will the slides (from the Webinar) be posted or distributed?

A: Yes, both the slides and the Webinar recording will be made publically available and posted at the Standards Exploration Awards homepage - https://www.healthit.gov/techlab/pilots/standards-exploration-awards

Q: I was hoping to get more information about what the intentions are for this funding rather than how to submit the proposal.

A: The Program Objectives, Desired Impact, and Outcomes can be found on page 4 of the FOA

Q: Do the HIP and SEA funding follow this same process, e.g. through Grants.gov?

A: Yes

Q: Are you allowed to apply for both the HIP and SEA Programs?

A: Yes, applicants may apply for both the HIP and the SEA Cooperative Agreement Programs. Please note in the event an applicant chooses to apply for both Programs, they must select different Impact Dimensions for each applications.

Q: How do we submit a combined SEA and HIP response if we have the same proposal?

A: The HIP and SEA are two separate cooperative agreement programs and must be applied for separately. Combined applications for both programs are not permissible. Please note in the event an applicant chooses to apply for both Programs, they must select different Impact Dimensions for each applications.

Q: Who are the stakeholders?

A: Stakeholders are those could be impacted, both directly and indirectly, by these Projects. To name a few, they can include, but are not limited to, clinicians, nurses, hospitals, rural hospitals, consumers, pharmacists, and researchers.

Q: Have requests for proposals like this been done before? It seems like a multi-disciplinary effort that might include industry. If yes, is it possible to see an example of what has been submitted in the past or an example of what sort of institutions collaborated together to do such a project?

A: No, this is a new program

Q: Where is the (letter of intent) LOI for this project? Are there any templates for submitting a formal proposal? Where can we find the application process and forms, I looked on the website and was unable to locate the actual application.

A: There is no formal LOI or application template. Please refer to webinar slides 18 (letters of intent) and 20-25 (application process and application components), and pages 15-20 of the FOA.

Q: Do we need to select the Category and impact dimensions while emailing letter of intent?

A: No

Q: Are there any steps to apply following the information sessions and submitting letters of intent?

A: There are no additional steps required following the Informational Session and the submittal of the Letter(s) of Intent, beyond completing and submitting the FOA application should you choose to proceed. Please refer to webinar slides 20-25 (application process and application components), and pages 15-20 of the FOA.

Q: Are there any assumptions about when the HIT needs to be deployed and used?  For example, while the grant period begins in September, can the HIT implementation begin in March, with the analysis occurring between March and September '17?

A: Recipients must deploy their Technology Solution within 5 business days of ONC’s approval of their Project Plan. Please see page 10 of the FOA, Subtask 1.4.

Q: Could you clarify when the solution proposed in the HIP and SEA program needs to be deployed (i.e., installed and ready for clinicians to use)? Page 10 of the [FOA] indicates that Subtask 1.4 is for the “deployment of the technology solution”, but that the deliverable is a “kick off meeting with project collaborators.” On the other hand, the FAQ response to the question below implies that the solution needs to be deployed 5 days after ONC’s approval of the project plan. I guess the question is what does ONC mean by “deployment of technology solution”. If the goal of HIP is to fund new solutions, how could a solution be deployed within about a month of the project award date?

[Note: The question author refers to the question listed below]:

Q: Are there any assumptions about when the HIT needs to be deployed and used?  For example, while the grant period begins in September, can the HIT implementation begin in March, with the analysis occurring between March and September '17?

A: Recipients must deploy their Technology Solution within 5 business days of ONC’s approval of their Project Plan. Please see page 10 of the FOA, Subtask 1.4.

A: A successful applicant must have the technical infrastructure in place to deploy the Technical Solutions, as proposed in their application, to achieve the goals and objectives under this Program. The first deliverable relating to the “deployment of the Technology Solution” is to begin executing your project plan with your project collaborators within 5 business days of ONC’s approval of the final project plan. Award recipients are expected to have the technical readiness to immediately implement their project plan and start deploying their Technical Solution; the purpose of this program is not for recipients to build new technology products, but rather to execute and advance usage. 

Q: Can you submit the 12-month project as part of a greater project? Or should it stand alone?

A: The Project(s) need to address the requirements as outlined in the FOA.

Q: Does the application have to be an individual one or can it be a group application?

A: Group collaborations are allowed

Q: Can funds be allocated across collaborators?

A: There must be a primary applicant for a FOA application. Collaborators must be listed as subawardees. Applicants must include how they will allocate funds in alignment with their Projects, as well as how subawardees will be managed.

Q: Can we submit more than one application and/or participate in multiple applications?

A: An applicant can only submit one application per funding opportunity announcement

Q: Can more than one Priority Category be chosen?

A: Yes. Should you choose to select more than one Priority Category, your Project Proposal should address how the selection of multiple Priority Categories will support the overall objective of your Project.           

Q: Are you looking to fund the development costs of brand new projects, or will you fund the evaluation of an IT solution that has already been implemented but not fully evaluated?

A: These FOAs are intended to pilot new Projects. Proposals to evaluate work already done will not be considered.         

Q: What is the expectation of results, outcomes or deliverables expected by the end of the performance period for each?

A: ONC is seeking to advance the use of interoperable standards through health IT for the identified priority categories to make an impact (improve) the areas of practice efficiency, clinical quality, cost efficiency, privacy and security, safety, patient engagement, and interoperable exchange. Please see Pages 4 (Project Objects, Desired Impact and Outcomes) and 10 (Structure and Approach and Project Deliverables and Evaluation) of the FOA.

Q: Did I understand correctly that all applications within the Laboratory Data Exchange Category must include order transmission as well as result delivery?  If so, can a project that only involves result delivery be submitted under the other category?

A: No. The Laboratory Data Exchange category is described as “The demonstrated use of the Laboratory Results Initiative (LRI), Laboratory Orders Initiatives (LOI), and electronic Directory of Services (eDOS) standards. If a Project proposal only involves results delivery it may be submitted under another category. Please refer to page 5 of the FOA.

Q: What do you mean by “Full Loop Labs”?

A: Full Loop Labs is defined on page 5 of the FOA

Q: Does being a Health Center Controlled Network give you a higher chance of receiving the HIP or SEA award?

A: All applications will be reviewed on the merit and reasonableness of their proposals. Please see pages 22-23 of the FOA.

Q: Would the development of a standards based innovation repository for nursing clinical decision support be responsive to this call for applications?

A: This could be submitted under the “Self-Identified” Priority Category

Q: Does the 25 page limit include references?

A: Yes

Eligible Applicants

Q: Are EMR vendors allowed to apply for the High Impact Pilots and/or Standards Exploration Awards Program?

A: Yes

Q: What are the expected types of organization to apply? Specifically I want to review the requirements for applicants. Also, is this for EHR company, or startups of similar kind? For submitting a formal proposal, is it by invitation only after reviewing the letter of intent, or is it open to everyone who submits the LOI?

A: The FOA is open to anyone who meets the eligibility requirements and wishes to submit an application. Eligible applicants are: Private nonprofit institution/organizations, public nonprofit institution/organizations, and private or for profit organizations with proven knowledge of and familiarity addressing interoperability through implementation of health information technology. Please refer to page 11 of the FOA.

Funding, Allowable Expenses, and Budget Narratives

Q: On Page 12, “Release of Funds Approval – ONC Project Officers will be responsible for requesting authorization for the release of funds for their assigned Projects.” When and how often will these funds be available for the awardee to draw down? Is the awardee able to draw down funds monthly based on incurred costs?

A: Funds are anticipated to be released on a monthly basis for incurred costs.

Q: At what point in the 12-month process will award funds be made available to the successful grant recipient?

A: Funds will be made available to the recipient upon approval of their submitted budget by the ONC Office of Procurement and Grants (OPG). Recipients will be able to draw down funds for expenses incurred on a monthly basis.

Q: Is the awardee able to use funds to purchase licenses? Are licenses an eligible expense?

A: No.

Q: Can funding be used to purchase data infrastructure?  Is there a limit on amount to be used for data infrastructure?

A: No. Infrastructure is not an allowable cost under this cooperative agreement.

Q: Will you be discussing allowable expenses? Specifically could part of the grant funds be used to pay for interfaces?

A: No. Funds made available under this cooperative agreement cannot be used for any health IT infrastructure. Under the Merit Review section of the FOA, under Project Plan (page 17), applicants are instructed to include an assessment of “their current state of infrastructure’s technical readiness”. Award recipients must be able to execute and complete their Projects within the 12-month period-of-performance.

Q: Can you reiterate the budget narrative page requirements? Page 18 of the FOA indicates that it is limited to 1 page.

A: As part of the Project Narrative breakdown, an applicant is limited to a 1-page high level budget narrative.  The applicant however, is required to provide a detailed budget narrative to support the costs as outlined in their SF 424A – budget forms.  Appendix D in the FOA provides a template for the format of the budget narrative. 

Q: In the Pre-Award Risk Assessment process, will smaller entities without previous grant experiences be negatively impacted?

A: The purpose of the Pre-Award Risk Assessment is to ensure that the entities we may potentially award to are not in debt to the federal government from other federal awards, and not suspended or debarred, so that they are eligible to receive federal funding.  As the fiduciary agents, it is ONC’s duty to ensure that all applicants who may be eligible to receive funding are in good financial standing. 

Q: Could you clarify if software development (e.g., development of a SMART on FHIR app) can be funded under the HIP program? The FOA does not say anything about allowable expenses, but the answer to the following question in the FAQ did not clarify the allowable expenses.

[Note: The question author refers to the question listed below]:

Q: Will you be discussing allowable expenses? Specifically could part of the grant funds be used to pay for interfaces?

A: No. Funds made available under this cooperative agreement cannot be used for any health IT infrastructure. Under the Merit Review section of the FOA, under Project Plan (page 17), applicants are instructed to include an assessment of “their current state of infrastructure’s technical readiness”. Award recipients must be able to execute and complete their Projects within the 12-month period-of-performance.

A: Purchasing health IT infrastructure or products are not allowable costs under this cooperative agreement. Labor to support implementation of existing health IT infrastructure can be paid for through this cooperative agreement. The purpose of this program is to focus on addressing interoperability through implementation of Technology Solutions, support increased use of health information technology solutions, and incentivize use of standards from the Interoperability Standards Advisory (ISA) and newly emerging standards, which may include code development.

Technology Solution(s)

Q: On your webinar you used an example of Priority Categories Laboratory Data Exchange of returning the lab order to an EHR. Does an EHR have to be part of the answer?

A: An applicant must provide a Technology Solution that meets and addresses the requirements as set forth in the FOA. The purpose of the HIP and SEA FOAs is to award pilot projects that create a technology and standards-based solution including but not limited to new implementation specifications, mobile and software application, web-based services, application programming interfaces (API), testing and measurement tools, and security protocols. As found in the FOA, the applicant must provide a clear and specific description of the approach to the deployment and use of their Technology Solution through the use of standards to improve the sharing of health information among health care stakeholders, improve care delivery and demonstrate how health IT can positively impact patient experience and address challenges described in the Problem Statement.  

Q: If the PCP/their practice does not have an EHR system, but is working with a non-profit organization that is providing medical services to the underserved & they do not have an EHR would that be an example of what the respondents needs to answer in the Pilot?

A: An applicant must provide a Technology Solution that meets and addresses the requirements as set forth in the FOA. The purpose of the HIP and SEA FOAs is to award pilot projects that create a technology and standards-based solution including but not limited to new implementation specifications, mobile and software application, web-based services, application programming interfaces (API), testing and measurement tools, and security protocols. As found in the FOA, the applicant must provide a clear and specific description of the approach to the deployment and use of their Technology Solution through the use of standards to improve the sharing of health information among health care stakeholders, improve care delivery and demonstrate how health IT can positively impact patient experience and address challenges described in the Problem Statement.  

Q: Is it correct to assume that the FOA in general is looking for a Technology Solution that should include at least two or more separate EHR’s, other health organizations/Providers and the patient in a given geographic area to accomplish the interoperability after deployment of that technology? Is there a restriction on patient location or EHR?

A: An applicant must provide a Technology Solution that meets and addresses the requirements as set forth in the FOA. The purpose of the HIP and SEA FOAs is to award pilot projects that create a technology and standards-based solution including but not limited to new implementation specifications, mobile and software application, web-based services, application programming interfaces (API), testing and measurement tools, and security protocols. As found in the FOA, the applicant must provide a clear and specific description of the approach to the deployment and use of their Technology Solution through the use of standards to improve the sharing of health information among health care stakeholders, improve care delivery and demonstrate how health IT can positively impact patient experience and address challenges described in the Problem Statement.  

Q: On page 3, you say “… recipients must, in their Project Plan, assess their current state of infrastructure’s technical readiness …”  To which infrastructure does this apply?  If the use case is a healthcare provider organization (HPO) that will be using the solution for medication management, does the “infrastructure” refer to the technical readiness of the HPO? Or something else?

A: An applicant must provide a Technology Solution that meets and addresses the requirements as set forth in the FOA. The purpose of the HIP and SEA FOAs is to award pilot projects that create a technology and standards-based solution including but not limited to new implementation specifications, mobile and software application, web-based services, application programming interfaces (API), testing and measurement tools, and security protocols. As found in the FOA, the applicant must provide a clear and specific description of the approach to the deployment and use of their Technology Solution through the use of standards to improve the sharing of health information among health care stakeholders, improve care delivery and demonstrate how health IT can positively impact patient experience and address challenges described in the Problem Statement.  

Use of Standards and the Interoperability Standards Advisory (ISA)

Q: What justifications and additional information do you need about emerging standards that are not part of the ISA?

A: Applicants proposing to use an emerging alternative standard that is not currently identified in the 2016 Interoperability Standards Advisory (ISA) should provide a brief narrative explaining how the standard(s) they propose to use will address the interoperability needs of their proposed Project. 

Q: You say that the standards must come from the 2016 Interoperability Standards Advisory.  The standards related to the electronic exchange of healthcare information related to pharmacy services are created and promoted by the National Council for Prescription Drug Programs (NCPDP).  This organization is not referenced in the 2016 ISA.  Please provide guidance on how to handle this, if our Priority Category is Comprehensive Medication Management.

A: Please see the 2nd bullet of the webinar slide 9. You may also refer to Activity 3 on page 7 of the FOA.

Intangible Property

Q: Can you clarify the purpose/intention of the Intangible Property Section?

A: The purpose/intention of the Intangible Property Section is to provide interested applicants with guidance regarding the HHS Intellectual Property regulations as governed by 45 CFR 75.322.

Q: Can you explain ownership of intellectual property which is specified on pages 4 and 28?  It states that the Government reserves the rights to a perpetual, royalty fee, nonexclusive license to what is developed.  Does this mean that the code and processes developed are made public/must be open source? Please explain the requirement on page 29, section f:  “…recipient will ensure that said license also reserves for the Government a perpetual, royalty-free…”. Is our understanding correct in that the solution(s) developed in this FFO become property of HHIS or at least are available for HHS to reproduce?  

A: Correct, HHS reserves the right to have access to any solution(s) developed under this cooperative agreement. In general, award recipients own the rights in data produced under a Federal award, including the ability to asset copyright in any work that is subject to copyright protection and which was developed, or for which ownership was acquired under an award. Award recipients may also pursue commercial application of intellectual property and require payments for the use of such property; however, the funding 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.

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