PKG00262979-instructions.pdf

U.S. Department of Health and Human Services

Office of the National Coordinator for Health Information Technology

Notice of Funding Opportunity (NOFO)

Public Health Emergency Response Related HL7® Standards, Solutions and Future Pandemics

Application Due Date: 09/11/2020 Anticipated Award Date: 09/30/2020

Table of Contents

Executive Summary

A. Program Description/Purpose Structure and Approach

Performance Goals/Program Milestones

B. Funding Opportunity Award Information Key Award Parameters

Key Dates Roles and Responsibilities Under a Cooperative Agreement Notice of Intent

C. Eligibility Information

D. Application and Submission Information Application Package

Application Submission Instructions Restrictions on Oral Conversations

E. Application Review Information Screening Review

Merit Review Pre-Award Risk Assessment

F. Federal Award Administration Information Award Decisions

Notice of Grant Award Terms and Conditions

G. Points of Contact

Appendix A – Tips for Writing a Strong Application Appendix B – Instructions – SF-424 Application for Federal Assistance Appendix C - Instructions – SF-424A, Budget Information for Non-Construction Programs Appendix D – Budget Narrative/Justification Template Appendix E – Letter of Commitment Template

Executive Summary

The coronavirus disease 2019 (COVID-19) pandemic has had a widespread impact around the world, and is reshaping ways of life, the economy, and health care delivery across our country. The virulence and transmissibility of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the strain of coronavirus that causes COVID-19, are striking. But crucially there remains a paucity of relevant clinical information to drive an adequate response. Even in an information technology (IT) dominated era, fundamental measurements to guide a standardized public health response remains unclear. Knowledge lags on incidence, prevalence, case-fatality rates, and clinical predictors of outcomes. While some of the knowledge gaps relate to the need for further laboratory testing, data that should be widely available in electronic health records (EHRs) have not yet been effectively shared across clinical sites, public health agencies, or with policy makers. Standards Development Organizations (SDOs), who develop standardized data formats and exchange methods to support common use cases and business transactions, are working with stakeholders to address knowledge gaps and identify opportunities arising from the pandemic. SDOs are primarily responsible for developing and maintaining the technical standards and accompanying implementation specifications/profiles that provide instructions to implementers.

Health Level 7 International (HL7®) is the exclusive SDO with the ability, authority, and intellectual property rights to develop and maintain many technical standards of significance to health information exchange and interoperability across health IT systems, such as public health and Fast Healthcare Interoperability Resources (FHIR®) specifications, and their accompanying Implementation Guides (IGs). HL7® standards are developed through a public, transparent, and collaborative process and made available for use in the public domain.

Leveraging current work done by the Office of the National Coordinator for Health Information Technology (ONC), such as the 21st Century Cures Act (Cures Act) Final Rule1, as well as the Center for Disease Control and Prevention (CDC)’s implementation guidance for the use of HL7® messaging standards for public health reporting2, and the HL7® BRIDG3 standard that the National Cancer Institute (NCI) and Food and Drug Administration (FDA) have helped develop, ONC has identified five key gap and opportunity areas that could be accelerated to support the advanced nationwide interoperability towards the diagnoses and treatment of patients of COVID-19 and future public health emergencies.

Through this Notice of Funding Opportunity (NOFO), a single source cooperative agreement will be awarded to HL7® to prioritize and expedite the accelerated development and deployment of five (5) gap and opportunity areas specifically identified by ONC that advances the diagnoses, treatment, and care of patients of COVID-19 and other public health emergencies. Specifically, these five areas are:

1) Expanding the clinical domains supported by HL7® Standards

2) Privacy, Security, and Consent

3) Application Programming Interface (API) for Population Level Services

4) Social Determinants of Health (SDOH) Standards

5) Advancing Public Health Standards

This NOFO is a new, sole source, 4-year cooperative agreement for a maximum award of $2,000,000. (Funding Opportunity Number COVID-C3-20-003; Catalog of Federal Domestic Assistance Number 93.826), as authorized

1 https://www.federalregister.gov/documents/2020/05/01/2020-07419/21st-century-cures-act-interoperability-information-blocking-and-the-onc-health-it-certification 2 https://www.cdc.gov/vaccines/programs/iis/technical-guidance/hl7.html 3 https://www.cdisc.org/standards/domain-information-module/bridg under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (Pub. L. No. 116-136, March 27, 2020) and Section 3011, Public Service Health Act (PHSA). The eligible applicant must submit an application by XXX. Subsequent years of funding for this cooperative agreement is contingent on meaningful progress and availability of funds.

A. Program Description/Purpose

Background Information

The objective of this cooperative agreement is to close the gaps and leverage current opportunities in our current health IT environment that support the diagnoses, treatment, and care of patients of COVID-19 and other public health emergencies in the following areas:

Expanding the Clinical Domains Supported by HL7® Standards COVID-19 has provided a live example for the importance of real time, up-to-date clinical health data. The development of technical standards that enhance the ability to exchange these data would be valuable next steps for the United States Health Information Technology (U.S. health IT) platform. This work will be done through the development of new HL7® standards and components in new and emerging clinical domains, prioritizing those highlighted by the current pandemic.

Privacy, Security, and Consent Privacy and security protection in health information technology will become increasingly challenging due to need for the health information including patients’ laboratory testing results to be accessible to public health organization, state and federal agencies, and to employers in a secure and privacy enabled manner. Federal funding will accelerate the development of privacy and security standards, and will provide guidance and tools that can help organizations improve the privacy and security of health information overall.

API for Population Services Since the World Health Organization (WHO) declared COVID-19 a pandemic4 on March 11, 2020, the need for fundamental measurements to guide public health response has become more urgent. This led to an immediate need for a durable national surveillance system with relevant standards-based API technologies. Enhancing surveillance and management of COVID-19 patients will be crucial in the coming months and beyond. It will require a widely deployed standardized solution and approach. The Bulk Data Access API allows large amounts of medical records for multiple patients to be moved between systems during a single transaction which supports public health and medical research use cases where large amounts of data need to be obtained and analyzed.

Currently, most APIs only allow a single individual’s medical records to be moved one at time.

Developing, Advancing and Harmonizing Social Determinants of Health (SDOH) Standards COVID-19 has highlighted the gaps and inequalities in our society. The social needs of the most vulnerable populations have been magnified which makes the documentation and integration of social risk data in clinical care a priority. More providers are seeing the intersection of social determinants and health status daily. For example, someone may not be able to get tested if they have no access to safe transportation. Special populations, such as those with substance use disorders (SUD), are vulnerable to the effects of COVID-19, as they are more likely to experience homelessness, social isolation, and hopelessness, which is expected to increase during this pandemic. Currently, there are advancements in standards development in the SDOH domains of food, housing, 5 https://www.hl7.org/implement/standards/product_brief.cfm?product_id=7 https://www.hl7.org/implement/standards/product_brief.cfm?product_id=7 and transportation for the purposes of screening, diagnosis, goal-setting, and interventions. However, gaps remain in other domains of SDOH and the areas of referrals and interventions. The advancement and harmonization of SDOH-related data standards, through the use of FHIR® and APIs, can enhance SDOH data exchange to give providers access to data that can be used to support the needs of their patient and change expected reversal effects of vulnerable populations during a pandemic.

Advancing Public Health Standards COVID-19 has presented challenges for reporting situational awareness across local jurisdictions and the federal level as it relates to bed and ventilator count, reporting of laboratory results, vaccine administration, and other medical counter measures such as morbidity and mortality. Other public health related issues include low-level adoption of Public Health IGs, lack of pre-hospital data, use of reusable concepts, and issues related to accurate real-time reporting. The public health goals that are outlined in this cooperative agreement are structured to address these challenges.

In summary, the pandemic has exposed numerous gaps in our current health IT infrastructure needed to address a nationwide, public health crisis. The important work that lies ahead for this country must begin now as we implement the various goals outlined in this cooperative agreement.

Structure and Approach Key Goals, Activities, Deliverables, and Timeline

The goals and activities listed below outline HL7® standards development and implementation efforts to support the current COVID-19 pandemic, future pandemics, and other public health emergencies. Additional activities may be required to achieve the outlined goals. The recipient of the cooperative agreement is encouraged to work closely with programmatic support offices at ONC and other HHS components to accomplish these goals. The products of all standards development and implementation activities conducted under this cooperative agreement will be freely and publicly available on the HL7 website.

Objective 1: Expanding the Clinical Domains Supported by HL7® Standards

Goal: Support the development of HL7® standards and implementation specifications in new and emerging clinical domains.

HL7 standards, including FHIR®, Clinical Document Architecture (CDA®)5, V3 and V2 support a broad set of clinical domains at varied levels of maturity. Recipient should identify the clinical domains that are of most importance to the industry and facilitate the development of new standards and additional implementation guidance to support interoperability of the health information.

The recipient is encouraged to prioritize clinical domains that have been highlighted by the current pandemic.

While current FHIR® Resources, for example, capture clinical information at the patient level, new data elements could capture more detail. Additionally, new IGs could provide an out-of-the-box specialty packages for working

5 https://www.hl7.org/implement/standards/product_brief.cfm?product_id=7 https://www.hl7.org/implement/standards/product_brief.cfm?product_id=7 with this data. Disease-specific IGs could also incorporate bulk data capabilities that enhance disease modeling and predictive analytics, in addition to use beyond the current pandemic.

Objective 2: Privacy, Security, and Consent

Goal: Improve the privacy and security of health information.

Recipient should accelerate the development and deployment of standards, guidance, and tools that can help health care organizations protect the privacy and security of health information, including identity management, authentication, authorization and consent management. Activities that may improve privacy and security of health information include but are not limited to:

• Development and publication of standards and IGs related to privacy and security.

• Development of educational materials, guidance, and tooling to support privacy and consent management.

• Enabling patients to express their privacy preferences in a computable manner.

Objective 3: Application Programming Interface (API) for Population Level Services

Goal: Advance the use of HL7® FHIR Bulk Data Access Implementation Guide6 standard (“Bulk Access API”) and other relevant API standards to improve surveillance capacity for future pandemics and other public health emergencies.

The “Bulk Access API” standard provides organizations and providers accountable for managing health of populations with an efficient way to access large volumes of information on groups of individuals.

Recipient is encouraged to further explore the use of the “Bulk Access API” standard to new use cases including, but not limited to public health surveillance and develop further guidance to expand the use of the “Bulk Access API” standard.

Objective 4: Developing, Advancing and Harmonizing Social Determinants of Health (SDOH) Standards

Goal: Develop, advance and harmonize SDOH Standards through the use of FHIR and APIs to enhance SDOH data exchange to give providers access to data that can be used to support the needs of their patients. ONC is interested in applying the three-part approach from the Cures Act to implement the strategies indicated in the Draft Federal Health IT Strategic Plan. This approach should include the following:

• Exploring the current state of federal (e.g., Advancing Standards for Precision Medicine) and non-federal stakeholder activities (e.g., Gravity Project, ) and their future approaches.

• Identifying, recommending, and developing bidirectional mapping between non-health care data and relevant health IT standards for clinical care and nonclinical setting use (FHIR Resources, profiles).

6 https://build.fhir.org/ig/HL7/us-bulk-data/ https://www.healthit.gov/topic/advancing-standards-precision-medicine https://www.hl7.org/gravity/ https://build.fhir.org/ig/HL7/us-bulk-data/

Priority areas of interest include the following;

• Current standards in development related to food insecurity, transportation, and housing.

• Referral standards such as HL7®’s Bidirectional Services eReferrals (BsER).

• Standards that support the use of SDOH data for public/population health (e.g., Covid-19, opioid use) prediction, prevention, treatment, and planning.

Objective 5: Advancing Public Health Standards

Goal: Support the development of HL7® standards and implementation specifications to meet public health needs.

Recipient to support public health reporting requirements, including transmission to immunization registries, syndromic surveillance, electronic laboratory reporting, electronic case reporting, etc. Many of the standards need to be updated based on the experience of the recent pandemic, and also new standards need to be developed to support future needs.

Recipient is encouraged to evaluate the current HL7® standards used for public health related activities and facilitate the development of updated standards and new standards to support interoperability of the health information for public health.

Performance Goals/Program Milestones

To ensure the success of this cooperative agreement, the applicant will propose a performance metricf the projects through the progress on milestones and metrics. Applicants must provide baseline measurements and propose performance metrics to demonstrate successful support for the rapid development of the gap areas identified in this NOFO related to HL7® standards and solutions. For each milestone and metric, ONC, will work with the applicant to determine the appropriate targets and reporting requirements.

B. Funding Opportunity Award Information

Key Award Parameters

Title: Public Health Emergency Response Related HL7® Standards, Solutions and Future Pandemics

Federal Funding Agency: Department of Health and Human Services

Office of the National Coordinator for Health Information Technology

Announcement Type: Cooperative Agreement.

Application Type: New

Notice of Funding Opportunity Number: COVID-C3-20-003

Catalog of Federal Domestic Assistance (CFDA) Number: 93.826

Eligible Applicants: This is a non-competitive funding opportunity and is restricted to the organization designated below. Organizations not designated as such are not eligible to apply for this opportunity, and therefore should not submit an application. Applications submitted by organizations not designated below will not be considered.

Designated Organization: Health Level 7 International (HL7®)

1. Sole Source Justification

The primary responsibility of standards development organizations (SDOs) are the development and maintenance of health IT technical standards, as well as any accompanying implementation specifications that provide additional implementation instructions for developers. Health Level 7 International (HL7®) is the exclusive SDO with the ability, authority, and intellectual property rights to develop and maintain the v2, v3, CDA, and FHIR® standards. Additionally, HL7® solely governs the processes by which these standards and accompanying implementation guidance are issued and updated. Attempting to complete these or any future tasks specific to HL7® standards with another SDO or organization would require HL7® engagement to ballot and publish a final product. Thus, HL7®’s involvement is both fundamental and necessary to publish an HL7 standard or implementation guidance.

HL7® members include organizations that are actively engaged in implementing the v2, v3, CDA, and FHIR® standard in health IT systems, and hence can provide necessary feedback in timely manner through a well-established and American National Standards Institute (ANSI)-accredited process for consensus standards development. The goals and expected outcomes of this cooperative agreement can only be achieved accurately by HL7®.

Legislative Authority: Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (Pub. L. No.

116-136, March 27, 2020) and Section 3011, Public Service Health Act (PHSA)

Approximate Amount of Available Funding (inclusive of direct and indirect costs):

Anticipated Number of Awards: 1

Approximate Amount of Award: $2,000,000.00

Project Period: 09/30/3020 – 09/29/2024 Budget Period(s): 09/30/2020 - 09/29/2021

Funding of future non-competing continuation awards is conditioned on the availability of funds, satisfactory progress by the recipient, and an awarding office determination that continued funding of the award is in the best interests of the Government.

Continued funding will be contingent on the recipient continuing to meet all the milestones and the availability of funds. Additional funding is also contingent on other HHS Components mission critical needs. In accepting an ONC award, the recipient assumes legal, financial, administrative, and programmatic responsibility for administering the award in accordance with the terms and conditions of the award, as well as applicable laws, rules, regulations, and Executive Orders governing HHS assistance awards, all of which are incorporated into this award by reference. Failing to comply with these requirements may result in suspension or termination of the award and/or ONC's recovery of award funds.

Cost-Sharing Requirements: There are no matching or cost share requirements for this program.

Program Income:

There are four potential ways in which ONC may require that a recipient apply program income as specified in the Notice of Grant Award (NGA): 1) deduct it from total allowable project/program costs to determine the net allowable costs on which the Federal share of costs is based; 2) add it to funds otherwise available for the project, generally resulting in an increase to the total approved budget; 3) use it to meet a matching or cost sharing requirement; or 4) a combination of these alternatives.

Costs paid by program income generally are subject to the applicable cost principles and other Federal requirements and must be disbursed for project purposes before requesting additional payments of Federal funds. In the event program income remains at the end of the award, the additional income is considered part of the award funding and must be returned to ONC. If program income is generated, the recipient must use the additive method.

Intergovernmental Review: Applications for this Cooperative Agreement are not subject to review by states under Executive Order 12372, “Intergovernmental Review of Federal Programs” (45 CFR 100).

Please check box “C” on item 19 of the SF 424 (Application for Federal Assistance) as Review by State Executive Order 12372, does not apply to this Cooperative Agreement.

Key Dates

Milestone Date

NOFO Released

08/12/2020

Applications Due

09/11/2020

Anticipated Award Date

09/30/2020

Anticipated Project Start Date

09/30/2020

Roles and Responsibilities Under a Cooperative Agreement

The funding instrument used for this project will be the cooperative agreement, an assistance mechanism, in which substantial ONC programmatic involvement is anticipated during the project period. Under the cooperative agreement, the ONC purpose is to support and stimulate the recipient’s activities by involvement in, and otherwise working jointly with, each recipient in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this premise, the dominant role and prime responsibility resides with the recipient for the project as a whole.

To facilitate appropriate involvement, during the period of this cooperative agreement, ONC and the recipient will be in contact monthly and more frequently when appropriate.

Specific activities in which ONC may assume substantial involvement include, but are not limited to:

♦Releasing funds based on achievement of performance goals/project milestones.

♦Reviewing and approving substantive provisions of proposed subawards or subcontracts.

♦ Working with the recipient to set the priorities and implementation direction that will be detailed in the Implementation Plan and all other deliverables submitted to meet the goals of the project (identified in Deliverable Table).

♦Conduct, on an annual basis, reassessments of the state of public health needs, and in collaboration, update the Implementation Plan and any other related activities and priorities. The Implementation Plan and any other related activities and priorities may also be reassessed and adjusted at any time if deemed necessary by ONC and/or the recipient.

♦ Participating in the selection of key personnel, as deemed necessary.

♦ Releasing funds based on achievement of performance goals/project milestones.

♦ Agency review, assessment, and final approval of priorities and deliverables as identified by the recipient.

♦ Engaging with leadership of the recipient’s organization to ensure successful execution of the cooperative agreement.

♦Reviewing and accepting deliverables.

♦Providing tactical guidance and feedback during project execution.

♦Ending an activity if performance goals/project milestones are not met.

♦Meeting with recipient(s) monthly at a minimum, and more frequently as requested by the recipient(s) or ONC.

♦ Conduct regular meetings with HL7.

♦ Collaborate with HL7 to identify and prioritize the types and numbers of underlying technical infrastructure upgrades needed, as well as the timeline of which these upgrades must be completed by.

♦ Provide substantive input in the development of the Connect-a-thons and other in-person or virtual testing events.

♦ Conduct, on an annual basis, update the Project Implementation Plan and any other related activities and priorities. The Project Implementation Plan and any other related activities and priorities may also be reassessed and adjusted at any time if deemed necessary by ONC and/or

HL7.

♦ Engage with HL7 leadership as necessary to ensure successful execution of the cooperative agreement.

Informational Session An Informational Session will not be conducted.

Letter of Intent A letter of intent is not required for this award.

C. Eligibility Information

See Section B, Funding Opportunity Award Information, for eligibility, cost-sharing, and other key award information.

D. Application and Submission Information

Application Package The following documents comprise, as applicable, the application package. Additional information regarding each of these documents is further provided.

• Project Abstract

• Project Narrative

• 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

• Budget Narrative

• Letters of Commitment

• Proof of Non-Profit Status (if, applicable)

Appendix A, Tips for Writing a Strong Application, can be used as a resource.

The Project Narrative and Budget Narrative sections of the application must be double-spaced, on 8-1/2” X 11” plain white paper with 1” margins on all sides, and use either Cambria or Times New Roman font size of not less than 11 point. Smaller font sizes may be used to fill in the Standard Forms, exhibits, and figures, though all text in forms, exhibits, and figures must not be smaller than 8 point font.

Project Abstract Applicants shall include a one-page abstract that is no more than 500 words. This abstract is often distributed to the public and Congress and represents a high-level summary of the project. As a result, applicant should prepare a clear, accurate, concise abstract that can be understood without reference to other parts of the application and that provides a description of the proposed project, including: the project’s goal(s), objectives, overall approach, anticipated outcomes, products, and duration.

The applicant shall place the following information at the top of the Project Abstract (this information is not included in the 500 word maximum):

• Project Title

• Applicant Name

• Physical Address

• Contact Name

• Contact Phone Numbers (Voice, Fax)

• E-Mail Address

• Web Site Address, if applicable

Project Narrative The project narrative provides the most substantive information regarding the proposed project in a clear and concise manner. To that end, the project narrative should address the elements articulated in the Program Description/Purpose and Structure and Approach sections of this NOFO. The project narrative should also align with the Performance Goals/Program Milestones and Merit Review Evaluation criteria presented in this NOFO (e.g., organizational experience, past performance).

The Project Narrative must be double-spaced, formatted to 8 ½” x 11” (letter-size) pages, 1” or larger margins on all sides, and a font size of not less than 11 point. The maximum length allowed for the Project Narrative is 30 pages. A Project Narrative that exceeds the 30-page limit will not be accepted.

Resumes of Key Personnel, if requested, are not counted as part of the Project Narrative and are not included in the 30-page limit. The specific sections that must be included in the Project Narrative are detailed below.

Project Implementation Plan As a cooperative agreement between the recipient and ONC, administrative activities will be written out in the implementation plan completed by the recipient. Revisions may be conducted throughout the duration of the period-of-performance.

Form SF-424, Application for Federal Assistance Appendix B provides line-by-line instructions to complete the form. Please note that the SF-424 is used for a wide variety of Federal grant programs, and Federal agencies have the discretion to require some or all of the information on these forms. Accordingly, when completing the form, please use the instructions in Appendix B in lieu of the standard instructions attached to SF-424.

Form SF-424A, Budget Information for Non-Construction Programs Appendix C provides line-by-line instructions to complete the form. Please note that the SF-424A is used for a wide variety of Federal grant programs, and Federal agencies have the discretion to require some or all of the information on these forms. Accordingly, when completing the form, please use the instructions in Appendix C in lieu of the standard instructions attached to SF-424A. All direct and indirect costs must be allowable, allocable, reasonable and necessary.

Form SF-424B, Assurances for Non-Construction Programs This form contains laws and other assurances applicants must comply with under the discretionary funds programs administered by the Office of the National Coordinator for Health Information Technology.

Please note that a duly authorized representative of the applicant organization must certify that the organization is in compliance with these assurances.

Form SF-LLL, Disclosure of Lobbying Activities 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.

Budget Narrative The budget narrative describes how the proposed budget, as articulated in the SF-424A, aligns with the applicant’s project narrative. That is to ensure that costs are realistic (not artificially too low) and reasonable (not inflated) in view of programmatic requirements. Appendix D provides a template to complete the budget narrative populated with sample information.

When more than 33% of a project’s total budget falls under a contractual expense, a detailed budget narrative/justification must be provided for each sub-contractor or sub-recipient. Applicants requesting funding for multi-year grant programs are required to provide a combined multi-year budget narrative/justification, as well as a detailed budget narrative/justification for each year of potential grant funding. A separate budget narrative/justification is also required for each potential year of grant funding requested.

The full Budget Narrative/Justification should be included in the application immediately following the SF 424 forms. The Budget Narrative must be double-spaced, formatted to 8 ½” x 11” (letter-size) pages, 1” or larger margins on all sides, and a font size of not less than 11 point.

Letters of Commitment (If Applicable) Include letters of commitment confirming the support to the project (should it be funded) made by key collaborating organizations and agencies. Any organization that is specifically named to have a significant coordination role in carrying out the project should be considered an essential collaborator such as interstate, intrastate, and regional partners. At a minimum, the letter must explain the demonstrated commitment to the project and how they will advance coordination and collaboration among critical stakeholders. See Appendix E for an example letter of commitment.

These letters should not be considered as part of the page limit. Signed letters of commitment should be scanned and included as attachments.

Indirect Cost Agreement(s) Applicants that have included indirect costs in their budgets must include a copy of the current indirect cost rate agreement approved by the Department of Health and Human Services or another federal agency. This is optional for applicants that have not included indirect costs in their budgets. Further, if any sub-contractors or sub-recipients are requesting indirect costs, copies of their indirect cost agreements must also be included with the application. Cost allocation plans are not accepted.

Application Submission Instructions

1) You must access the electronic application for this program via http://www.grants.gov. You can search the downloadable application page by the Notice of Funding Opportunity Number COVID-C3- 20-003 or CFDA number 93.826.

2) Applicants will be able to download a copy of the application packet and complete it off-line. In order to complete the application, an organization must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number. A DUNS number can be obtained via http://fedgov.dnb.com/webform and typically takes 1 to 2 business days. Please plan accordingly.

http://www.grants.gov/ http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform

3) Completed applications are uploaded into Grants.gov. APPLICATIONS WILL NOT BE

ACCEPTED THROUGH ANY OTHER WEBSITE, AND WILL NOT BE ACCEPTED THROUGH

PAPER MAIL, COURIER, OR DELIVERY SERVICE.

In order to upload applications into Grants.gov:

a) An applicant must be registered in the System for Award Management (SAM), at sam.gov, which requires having a DUNS number. The SAM registration process takes 7 to 10 business days so please plan accordingly. If you have already registered with SAM, but have not renewed your registration in the last 12 months, you will need to renew your registration.

b) Please note that entities registering in SAM must submit a notarized letter appointing their authorized Entity Administrator. This will not impact the registration approval process, but is required as part of your registration. For additional information, read SAM’s updated FAQs to learn more about changes to the notarized letter review process and other system improvements.

The following website depicts the SAM registration process:

http://www.grants.gov/web/grants/applicants/organization-registration.html

c) An applicant must be registered in Grants.gov which can take several days. To that end, applicants are strongly encouraged to register and test Grants.gov logins and passwords well in advance of the application deadline date. For assistance with www.grants.gov, please contact them at support@Grants.gov or 1-800-518-4726. Resources are available 24 hours a day/7 days a week.

A depiction of the Grants.gov application process can be found at http://www.grants.gov/web/grants/applicants/apply-for-grants.html

4) After electronically submitting your application, Grants.gov will generate an email tracking number and date of receipt verification confirming that the application was received, the date and time the application was received, and a tracking number. This notification does not ensure that your application could be opened and read -- only that the application was received.

The deadline for the submission of applications under this Notice of Funding Opportunity is 11:59 PM Eastern Standard Time on 09/11/2020. Applications that fail to meet the application deadline will not be reviewed and will receive no further consideration.

Restrictions on Oral Conversations

This funding announcement is subject to restrictions on oral conversations during the period of time commencing with the submission of a formal application by an individual or entity and ending with the award of the competitive funds. 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, whether or not the initiating party is a federally registered lobbyist.

This restriction applies unless:

• The communication is purely logistical.

http://www.grants.gov/ https://www.gsa.gov/about-us/organization/federal-acquisition-service/office-of-systems-management/integrated-award-environment-iae/sam-update http://www.grants.gov/web/grants/applicants/organization-registration.html

• The communication is made at a widely attended gathering.

• The communication is to or from a federal agency official and another federal Government employee.

• The communication is to or from a federal agency official and an elected chief executive of a state, local, or tribal government, or to or from a federal agency official and the Presiding Officer or Majority Leader in each chamber of a state legislature.

• The communication is initiated by the federal agency official.

E. Application Review Information

Screening Review If the applicant does not meet the following screening criteria, the application will be eliminated and will not be sent forward for merit review:

• The applicant meets the eligibility criteria.

• The application is received by the required deadline through http://www.grants.gov .

• The application contains all required components (e.g., Project Abstract, Project Narrative, SF-424).

• The application meets the formatting and length requirements. The Project Narrative must not exceed 30 pages. The Project Abstract and resumes do not count as part of the Project Narrative length limitation.

• Appendices and attachments are not used as a mechanism to exceed page limits of the Project Narrative.

Merit Review An independent review consisting of at least one individual, will evaluate this application to ensure that it meets the screening criteria identified above. This reviewer will be an expert in their field from an academic institution, non-profit organization, and/or local and Federal government agencies. The reviewer will review, evaluate, and score the application, in accordance with the criteria identified below:

Applications are scored by assigning a maximum of 100 points across five criteria:

1. Understanding of the Project (20 Points)

2. Technical Approach (30 Points)

3. Project Team and Staffing Qualifications (20 Points)

4. Implementation Plan and Project Management (20 Points)

5. Reasonableness of the Budget Narrative (10 Points)

1. Understanding of the Project – 20 points maximum

• How well does the applicant demonstrate their knowledge and understanding of the implementation challenges of the technical standards specified in the NOFO?

• How well does the applicant provide guidance that specifies solutions to overcome these challenges and leads to consistent implementation and adoption of technical standards?

• How well does the application understand the current challenges and addresses the purpose and objectives of this NOFO?

o To what extent is the proposed project parallel NOFO goals?

• To what extent does the applicant describe how the project and expected outcomes and results will inform the field and future health IT development, the use of FHIR®, public health, and emergency preparedness?

http://www.grants.gov/

2. Technical Approach – 30 points maximum

• The extent to which the proposed approach will address the challenges on a proposed timeline within the parameters of a self-contained five-year project period-of-performance.

• The extent to which the proposed approach specifies solutions to known gaps, in a reasonable, efficient, and timely manner.

• The extent to which the proposed approach plans to engage industry stakeholders.

• Extent to which the proposed approach are specifically stated, adequately developed, well-integrated, well-reasoned, and appropriate to the goals/objectives of the project.

• The extent to which the applicant’s approach is succinct and logical and demonstrates methods consistent with the tasks to be accomplished.

o Does the applicant propose a clear and actionable plan with a specific list of activities and deliverables to achieve the objectives proposed as specified in the NOFO?

3. Personnel Qualification and Past Performance – 20 points maximum

• Does the applicant demonstrate and provide evidence of technical experience for identifying, assessing, and determining improvements to be made to technical standards and specifications listed in the NOFO?

• To what extent does the applicant have the ability to engage with other health IT industry stakeholders?

• Are the PD/PI, collaborators, and other key project team members appropriately trained and well-suited to carry out this work?

o Is evidence of their past work supporting their suitability provided in their personnel resumes (as an appendix to the applicant’s proposal)?

• Do the PD/PI and project team bring complementary and integrated expertise to the project?

• Is there adequate PD/PI support allocated throughout the project period-of-performance?

• Does the application demonstrate the investigators’ aptitude to identify and address weaknesses encountered during the conduct of the project?

• Does the application demonstrate that the project team will have adequate administrative structure and processes in place to oversee the successful conduct of the proposed study?

• Did project team members describe and justify their proposed role and why their experience and qualifications make them well-suited for this role?

• Did team members for whom biographical sketches are not required, describe their proposed role and why their experience and qualifications make them well-suited for this role in the in the Budget Justification?

• Extent to which the proposed activities bring all the resources necessary to perform the proposed work and the identification of proposed strategies to complete activities within a five-year time frame?

4. Implementation Plan and Project Management – 20 points maximum

• The extent to which the applicant describes a draft implementation plan that includes a detailed plan to carry out each of the activities proposed in the response, monthly progress meetings, progress reports and a timeline for draft and final deliverables for each of the goals with specific dates identified.

• The extent to which the plan describes a project management approach for ensuring project success within and across collaborators.

5. Reasonableness of Budget Narrative –10 points maximum

• Is the use of consultants and/or subrecipients, if applicable, appropriate and adequate to advance the project in accordance with the timelines?

• Extent to which the budget is justified with respect to the adequacy and reasonableness of resources requested, and the amount of the budget allocated to administration is minimized while still allowing coherent management of an integrated project.

MAXIMUM TECHNICAL SCORE = 100 POINTS

Pre-Award Risk Assessment ONC is required to conduct a risk assessment to assess the risk posed by a potential recipient, prior to issuing an award. In doing so, ONC will take into account the applicant’s financial stability, quality of management systems, history of performance, reports and findings from audits, and the applicant’s ability to effectively implement statutory, regulatory, or other requirements imposed on non-Federal entities. To facilitate this assessment, ONC may review information available in systems, such as the Excluded Parties List System, review documentation, such as previous audits, and/or desk reviews or site visits conducted from previous awards. ONC may elect not to fund applicants with management or financial instability that directly relates to the organization’s ability to implement statutory, regulatory or other requirement s (45 CFR Part 75.205.)

F. Federal Award Administration Information

Award Decisions The final award decision will be made by the National Coordinator for Health Information Technology taking into consideration several factors such as the results of the merit review process, results of the pre-award risk assessment, compliance with programmatic and grants management requirements; the reasonableness of the estimated costs, available funding, program priorities; and the likelihood that the proposed project will result in the benefits expected. The applicant will receive a summary of the objective review panel’s assessment of the application’s strengths, weaknesses, and score.

Notice of Grant Award The successful applicant will receive a letter of notification acknowledging that an award was funded, but does not provide authorization for the applicant to begin performance and expend funds associated with the award.

Following this notice, the successful applicant will receive a Notice of Grant Award (NGA). The NGA will include, at a minimum, the following:

• Legal name and address of the organization or institutions to whom ONC has issued an award.

• Award number assigned by ONC.

• Project period, specifying the amount of time ONC intends to support the project without requiring re-competition for funds.

• Total amount of financial assistance approved by ONC during the project period.

• Budget period, specifying the increments in which the project will be funded, subject to the availability of funds.

• Applicable award terms and conditions.

• Performance goals, indicators, milestones, or expected outcomes (such as outputs, or services performed or public impacts of any of these) with an expected timeline for accomplishment.

The successful applicants’ Authorized Representatives will receive the NGA electronically from ONC.

The Awardee accepts the award by drawing down funds. By accepting an ONC award, the awardee assumes legal, financial, administrative, and programmatic responsibility for administering the award in accordance with the terms and conditions of the award, as well as applicable laws, rules, regulations, and Executive Orders governing HHS assistance awards, all of which are to be incorporated into the award by reference. Failure to comply with these requirements may result in suspension or termination of the awards and/or ONC’s recovery of award funds.

Terms and Conditions

Incorporated by Reference The NGA is subject to, by reference, the terms and conditions incorporated in the following documents:

• 2 CFR, Part 200 - Uniform Administrative Requirements, Cost Principles, and Audit Requirements For Federal Awards https://www.ecfr.gov/cgi-bin/text-idx?tpl=/ecfrbrowse/Title02/2cfr200_main_02.tpl

• 45 CFR, Part 75—Uniform Administrative Requirements, Cost Principles, and Audit

Requirements For HHS Awards - http://www.ecfr.gov/cgi-bin/text-idx?SID=06a0b0411d1520fae5e2799030e64ebf&node=pt45.1.75&rgn=div5

• HHS Grants Policy Statement - https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

Specific terms and conditions, incorporated by reference above, are further delineated below due to their importance in terms of integrity, achieving programmatic objectives, and/or sound financial stewardship of federal funds.

Performance Reporting ONC Program Progress Reports (PPR) are due quarterly. The PPR will address, to the extent applicable:

• Degree to which performance goals were attained (actual performance versus targeted performance).

• Data source and validation method for performance measures.

• Opportunities to address performance deficiencies.

• Accomplishments.

• Next steps.

• Challenges/barriers.

• Recommendations to address challenges and barriers.

https://www.ecfr.gov/cgi-bin/text-idx?tpl=/ecfrbrowse/Title02/2cfr200_main_02.tpl http://www.ecfr.gov/cgi-bin/text-idx?SID=06a0b0411d1520fae5e2799030e64ebf&node=pt45.1.75&rgn=div5 http://www.ecfr.gov/cgi-bin/text-idx?SID=06a0b0411d1520fae5e2799030e64ebf&node=pt45.1.75&rgn=div5 http://www.ecfr.gov/cgi-bin/text-idx?SID=06a0b0411d1520fae5e2799030e64ebf&node=pt45.1.75&rgn=div5 https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

ONC will provide specific guidance regarding the content and format of the PPR before the reports are due.

Financial Reporting Expenditures must be reported, on a semi-annual basis, using the SF-425, Federal Financial Report (FFR). Reports are due to HHS no later than April 30 of each year the award is active for funds expended between October and March, and no later than October 31 for funds expended between April and September. The semi-annual FFR will be submitted using the Payment Management System (PMS).

ONC will not accept reports sent directly to the ONC Grants mailbox.

The FFR Cash Transaction Report, a subset of the SF-425, Federal Financial Report, is submitted via the PMS every calendar quarter for the life of the award. The report must be submitted within 30 days after the end of the quarter (January 31, April 30, July 31, and October 31).

Federal Funding and Accountability and Transparency Act of 2006 The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier sub-awards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of ONC grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all sub-awards over $25,000.

Federal Awardee Performance and Integrity Information System (FAPIIS) As of January 1, 2016, recipients of Federal grants and cooperative agreements are subject to new mandatory disclosure requirements. Recipients that have Federal contracts, grants, and cooperative agreement awards with a cumulative total value greater than $10,000,000 must disclose in FAPIIS, semiannually, any information about criminal, civil, and administrative proceedings for the most recent five-year period in connection with the award or performance of a grant, cooperative, agreement, or procurement contract from the Federal Government. All information posted in FAPIIS on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.

Funding Restrictions Funds cannot be used for the following purposes:

• To supplant or replace current public or private funding.

• To supplant ongoing or usual activities of any organization involved in the project.

• To purchase or improve land, or to purchase, construct, or make permanent improvements to any…