hl7-foa-final-060102015 (2).pdf

U.S. Department of Health and Human Services Office of the National Coordinator for Health IT

Closing the Gap between Standards Development and Implementation

Program Guidance Funding Opportunity Announcement

Fiscal Year 2015

Application Due Date: July 24, 2015 Anticipated Award Date: August 21, 2015

OPPORTUNITY OVERVIEW

Executive Summary

I. Funding Opportunity Description:

A. Purpose

B. Background

C. Program Description

D. Project Approach and Structure

a. Improve Consistency of C-CDA Implementations Across Health IT Developers

b. Improve the Use and Consistency of Semantic Information in C-CDA

c. Additional Support for Developers Implementingthe C-CDA Specification

d. Publish the Latest Release of FHIR Standard

e. Comprehensive Planning to Ensure Support for Adoption of FHIR Standard

E. Deliverable Table

F. Proposal Criteria

G. General Funding Requirements

H. Project Evaluation and Measurement

I. Statutory Authority

II. Award Information

A. Performance Evaluation

B. Award Type

C. Substantial Involvement in Cooperative Agreements

III. Eligibility Information

A. Eligible Applicants

B. Sole Source Justification

C. Cost Sharing or Matching

IV. How to Apply Information

A. Address to Request Application Package

B. Content and Form Submission

Project Abstract

Budget Forms

Project Narrative

Budget Narrative

C. Submission Dates and Times

D. Application Screening Criteria

E. Application Responsiveness Criteria

F. Application Completeness Criteria

G. Grants.gov Registration

H. Applying Electronically through Grants.gov

I. Proof of the Applicant’s Status as a Non-Profit Entity

J. Intergovernmental Review of Applications

K.. Funding Restrictions

V. Application Review Information

A. Criteria

1. Discussion and Understanding of the Project – 25 points maximum

2. Technical Approach – 25 points maximum

3. Personnel Qualification and Past Performance – 30 points maximum

4. Management Plan – 15 points maximum

5. Budget Plan –5 points maximum

VI. Award Administration Information

A. Performance Evaluation

B. Public Materials Use

C. Intellectual Property/Copyrights

D. Notice of Award

VII. Other Terms

A. Administrative and National Policy Requirements

B. Post-Award Reporting Requirements

C. Audit Requirements

D. HHS Grants Policy Statement

E. Record Retention

F. Reporting

G. Financial Status and Cash Transaction Reports

H. Performance Reports

I. Non-Disclosure Requirements

J. Potential for Organizational and Personal Conflicts of Interest (COI)

K. Cooperative Agreement Terms and Conditions of Award

Cooperative Agreement Roles and Responsibilities

Standard Terms and Conditions - Awardee

Standard Terms and Conditions – ONC Grants

VIII. Agency Contacts

IX. Tips for Writing a Strong Application

X. Appendices

Appendix A. Instructions for completing the SF-424, Budget (SF 424A)

Appendix B. Budget Narrative/Justification, Page 1 – Sample Format with EXAMPLES

Appendix C. Budget Narrative/Justification –– Sample Template

Appendix D. Project Work Plan, Page 1 – Sample Template

OPPORTUNITY OVERVIEW

Funding Opportunity Announcement Title: Closing the Gap between Standards Development and

Implementation

Federal Funding Agency: Office of the National Coordinator for Health Information Technology (ONC), U.S. Department of Health and Human Services (HHS)

Announcement Type: Cooperative Agreement

Funding Opportunity Number: NAP-AX-15-003

Catalog of Federal Domestic Assistance (CFDA) Number: 93.826

Statutory Authority: Consolidated and Further Continuing Appropriations Act, 2015'', Pub. L. No. 113-235, Division G, Title II, and Title XXX, §§ 3001 (c)(2) and 3011 of the Public Health Service Act

Approximate Amount of Funding Available: $400,000

Anticipated number of Awards: One (1) award

Approximate Range of funding per award: N/A

Period of Performance: Five (5) years

Key Dates and Submission Information:

The application review and funding process for this cooperative agreement will take place according to the table below. The applicant will need to submit an application that will undergo an objective review. A successful application will result in the award of a five (5) year cooperative agreement.

FOA Release Date1 Section Reference Application Due Date

July 24, 2015 by 11:59pm EST

Section IV – Application and Submission Information

Anticipated Award Date

August 21, 2015 VI.A – Award Administration Information

Anticipated Project Start Date

September 1, 1 The announcements and start dates are approximate.

Executive Summary

This funding opportunity announcement (FOA) will provide funds in the form of a sole source, single award, through a cooperative agreement, between the Office of the National Coordinator for Health Information Technology (ONC) and Health Level 7 International (HL7). HL7 supports advancements in the technical standards necessary to achieve interoperability among health IT systems.

U.S. Department of Health and Human Services (HHS) activities support efforts to increase access to health care, protect those in greatest need, expand educational opportunities, and modernize the nation’s infrastructure. Total funding available is $400,000. This collaboration with HL7 will begin with a focus on advancing the implementation consistency of the current versions of the Consolidated Clinical Document Architecture (C-CDA) (Releases 1.1 and 2.0) and supporting the implementation and governance of the Fast Healthcare Interoperability Resource (FHIR) standard and its accompanying resources and profiles. This cooperative agreement is one way ONC seeks to reach the milestones identified in ONC’s “Connecting Health and Care for the Nation: A Shared Nationwide Interoperability Roadmap Draft Version 1.0 (draft Roadmap) (available at http://www.healthit.gov/sites/default/files/nationwide-interoperability-roadmap-draft-version- 1.0.pdf).

I. Funding Opportunity Description:

A. Purpose

The purpose of this FOA is to establish a mechanism for ongoing cooperation between ONC and HL7. It aims to provide specific dedicated support to HL7 for work on HL7-led standards development as well as corresponding implementation guidance and testing concepts of mutual interest to ONC and HL7.

Additionally, given HL7’s broad standards portfolio and the many other purposes for which interoperability will be necessary and for which HL7-developed standards would need to be implemented, it is anticipated that this ongoing cooperative relationship could include specific work aimed at a range of different technical standards developed and maintained by HL7.

The initial tasks expected to be completed as part of this engagement include collaboration with HL7 to advance the implementation consistency and readiness of the current versions of the Consolidated Clinical Document Architecture (C-CDA) (Releases 1.1 and 2.0) and supporting the implementation and governance of the Fast Healthcare Interoperability Resource (FHIR) standard and its accompanying resources and profiles.

B. Background

The consistent implementation of standards within health IT systems is necessary to achieve interoperability among health care providers and across many different cases. Standardized ways to format and structure data, as well as represent its meaning in an unambiguous and computable way is critical to enable health care providers to send, receive, find, and use patient data when and where it is needed. Founded in 1987, HL7, an American National Standards Institute (ANSI), standards development organization (SDO), has developed and maintained a standards and implementation guidance for the exchange, integration, sharing, and retrieval of electronic health information in support of clinical practice.

When a computer system receives electronic health information from another system, it needs to be able to process the information without time-consuming human intervention. This can only occur if the sending system has used a consistent data format that is known to – and expected by – the receiving system. Given the http://www.healthit.gov/sites/default/files/nationwide-interoperability-roadmap-draft-version-1.0.pdf http://www.healthit.gov/sites/default/files/nationwide-interoperability-roadmap-draft-version-1.0.pdf vast number of systems that exchange electronic health information, expecting each to negotiate agreed-upon exchange formats with all other systems with which it interacts is impractical. To address this issue, stakeholders in the health IT ecosystem have organized themselves under the auspices of standards development organizations (SDOs) to develop standardized data formats pertaining to specific purposes. HL7 is one such SDO.

The primary responsibility of SDOs are development and maintenance of the data formats as technical standards and any accompanying implementation specifications/profiles that provide additional implementation instructions to developers based on the particular purpose for which the standard is intended to be used.

HL7 and the health IT industry have worked diligently to update the C-CDA specification to release an updated version (Release 2.0), and are on a trajectory to publish the next version of the newer FHIR standard in 2015. The C-CDA has been included in ONC’s health IT certification regulations since 2012, and is also referenced in ONC’s recently published 2015 Interoperability Standards Advisory. FHIR and its data-focused approach is anticipated to be an important contributor to achieving several of the milestones identified in ONC’s draft Roadmap, which was released for public comment in early 2015.

Despite the effort and commitment exhibited by HL7 volunteers, more work remains in order to refine these specific standards, close any gaps between the standards development and implementation, develop broad and more comprehensive testing infrastructures, and disseminate additional guidance back to the health IT developers and health care providers.

1. Consolidated Clinical Document Architecture (C-CDA)

The Consolidated Clinical Document Architecture (C-CDA) is an implementation guide that was created in 2012 to help simplify implementations and contains the commonly used HL7’s Clinical Document Architecture (CDA) templates. CDA is the base standard which provides a common architecture for the creation of an electronic clinical document. Though much of the industry has implemented C-CDA, there remains significant variability in its implementation. This variability impacts interoperability overall and limits a receiving system’s ability to fully process the information and properly integrate the information into a patient record. At the same time, health care providers have adopted, implemented, and are using health IT systems to send summary of care records formatted according to the C-CDA at a steadily increasing rate.

Implementation experience and feedback from the field indicates that more guidance on how to consistently implement the C-CDA specification is needed in order to support interoperability among health IT systems.

2. Fast Healthcare Interoperability Resources (FHIR)

Over the long-term, FHIR is poised to fundamentally change aspects of interoperability in health care, allowing for more specific, tailored, data-centric ways of exchanging information. To achieve automated interoperability, individual data elements are exchanged (e.g. medication or allergies) rather than an entire C- CDA document. HL7’s FHIR is emerging and exploring ways to accommodate new methods of exchanging information. Work is currently underway in HL7 to complete the development of a second draft standard for trial use. This next version’s timely release is significant and necessary to continue to advance industry momentum surrounding its implementation and use. Additionally, it will also be necessary for the industry to plan additional infrastructure necessary to support the adoption of the FHIR standard, as well as thoughtful planning for the migration and transition from C-CDA to the FHIR standard for specific purposes.

C. Program Description

This potential cooperative agreement involves interoperability specifications and standards work specific to Standards Development Organizations (SDOs). In this instance, HL7 is uniquely positioned as the sole SDO that can work with ONC to develop and ballot additional implementation guidance for HL7 standards through its ANSI-accredited processes as well as serve as the authoritative source for implementation best practices and testing concepts associated with the standards it produces and maintains. HL7 will work with ONC and external stakeholders to provide the necessary steps to improve specific technical standards (such as C-CDA and FHIR) to achieve interoperability. Activities completed through this cooperative agreement will be made available for public use at an agreed upon timeframe post-award.

D. Project Approach and Structure

To close the gap between standards development and implementation, ONC will fund one award of $400,000 through a cooperative agreement. The awardee will close any gaps between the standards development and implementation, develop broad and more comprehensive testing infrastructures, and disseminate additional guidance back to the health IT developers and health care providers. While ONC provides an expected outcome for each goal, ONC will provide more in depth clarity of the intent of the goals during their meetings in the implementation phase of this agreement. Furthermore, HL7 is expected to provide a detailed list of how it plans to accomplish each of the tasks for each of the goals. The goals and activities listed below are explicitly for C-CDA and FHIR. It should also be noted these goals are based on ONC’s assessment of activities, and should be considered neither complete nor exhaustive.

a. Improve consistency of C-CDA Release 1.1 and Release 2.0 Implementations across health IT developers

It is expected that an outcome of this cooperative agreement is that health IT systems will implement the C-CDA Releases 1.1 and 2.0 those specified by ONC in its regulations.

List of Activities:

• Task 1: CDA Examples Task Force2 developed artifacts are used by HL7 to develop additional implementation guidance for single and consistent implementation of C-CDA Releases 1.1 and 2.0.

• Task 2: HL7 organizes connect-a-thon events, to identify real-world implementation inconsistencies with CCDA Releases 1.1 and 2.0. And, based on the results, develops detailed guidance for developers and implementers on any identified barriers to interoperability as well as any implementation guidance or tools necessary to migrate from Release 1.1 to 2.0.

b. Improve the use and consistency of semantic information in C-CDA

Another expected outcome of this cooperative agreement is to have e-health IT systems implement C- CDA with consistent semantic information and with greater semantic accuracy3.

2 http://wiki.hl7.org/index.php?title=CDA_Example_Task_Force 3 “Are Meaningful Use Stage 2 certified EHRs ready for interoperability? Findings from the SMART C-CDA Collaborative” by John D.

D’Amore et.al., http://jamia.oxfordjournals.org/content/21/6/1060 http://wiki.hl7.org/index.php?title=CDA_Example_Task_Force http://jamia.oxfordjournals.org/content/21/6/1060

List of Activities:

• Task 1: HL7 develops quantitative measures and testing infrastructure for evaluating syntactic and semantic accuracy in C-CDA Release 1.1 and 2.0 using previous work from Substitutable Medical Apps and Reusable Technology (SMART) Program5.

• Task 2: HL7 develops additional guidance for use of terminology and vocabulary standards for specific sections and entries in C-CDA Releases 1.1 and 2.0 from large coding systems used in C-CDA, including but not limited to Systemized Nomenclature of Medicine-Clinical Terms (SNOMED-CT), RxNorm and Logical Observation Identifiers Names and Codes (LOINC).

c. Additional Support for developers implementing the C-CDA Specification

ONC expects HL7 to be able to respond accurately and promptly to developer questions on implementing C-CDA Release 1.1 and 2.0 specifications.

List of Activities:

• Task 1: HL7 publishes updated C-CDA Companion Guide4 for Releases 1.1 and 2.0 based on additional guidance developed through this cooperative agreement and other activities.

• Task 2: HL7 supports “Help Desk” for answering questions from developers that are implementing C- CDA Releases 1.1 and 2.0.

• Task 3: HL7 publishes Frequently Asked Questions (FAQs) on implementing and using C-CDA Releases 1.1 and 2.0.

• Task 4: HL7 organizes webinars periodically with developer community.

. d. Publish the latest release of FHIR Standard5 as soon as possible

ONC will support HL7’s timely publication and release of the latest FHIR Draft Standard for Trial Use version 2 (DSTU2).

List of Activities:

• Task 1: HL7 monitors the FHIR DSTU2 ballot reconciliation activities and provides additional technical support as needed to HL7 working groups to complete the standard development process in timely manner.

• Task 2: HL7 provides administrative support for the publication of the balloted FHIR DSTU2 standard during 2015.

4 “HL7 Implementation Guide: S&I Framework Transitions of Care Companion Guide to Consolidated-CDA for Meaningful Use Stage 2, Release 1 – US Realm”, http://www.hl7.org/implement/standards/product_brief.cfm?product_id=374 5 FHIR DSTU Release 2, http://hl7.org/implement/standards/FHIR-Develop/ http://www.hl7.org/implement/standards/product_brief.cfm?product_id=374 http://hl7.org/implement/standards/FHIR-Develop/

e. Comprehensive planning to ensure support for adoption of FHIR Standard

HL7 is expected to begin any necessary planning and infrastructure development for sustained adoption of FHIR standard.

List of Activities:

• Task 1: HL7 builds on its existing infrastructure to expand and organize the governance and tools needed to support development and the unambiguous maintenance of FHIR Profiles.

• Task 2: HL7 initiates the development of a testing platform to support testing of FHIR compliant systems.

E. Deliverable Table

The table below identifies specific milestones to support the execution of the cooperative agreement and the due date by which the milestones will be met. Deliverables No. 1, No. 2 and No. 3 in the table below, have been already specified. There is currently a placeholder in the deliverable table for deliverables associated with each goal described in “Project Goals” section. The specific deliverables for individual goals should be submitted by HL7 in their response to the cooperative agreement. ONC and HL7 will work together to set specific deliverables per the outlined goals identified in the Program Evaluation and Measurement Section.

No. Deliverable Due Date

1. Detailed Implementation Plan from HL7 (includes specific list of activities and deliverables approved by

ONC)

2 weeks after award date and monthly thereafter

2. Monthly progress meetings with ONC Monthly; additional meetings as requested by HL7 or ONC

3. Progress Report on each Goal Quarterly

F. Proposal Criteria

Applicant must address the following in their proposal:

• How the awardee will implement the C-CDA specification in a single and consistent manner;

• How semantic information will be improved to increase accuracy;

• How support for developers’ questions implementing C-CDA standards will be accomplished;

• The timeline between new standards development and release to the public; and

• How the awardee will plan for the adoption of the FHIR standard

G. General Funding Requirements

The application must address the following requirements:

• Improve the consistency of C-CDA implementations;

• Provide semantic information in a consistent manner;

• Have a support plan for developers;

• Publish updated standards releases within a timely manner; and

• Show a plan for adoption of the FHIR standard.

H. Project Evaluation and Measurement

This FOA provides applicants with flexibility to propose methods that continue to improve the consistency and readiness of the C-CDA specification and FHIR technical standard. ONC will measure the success of the awardee through project goals, including, but not limited to the following:

Project Goals:

1. Successfully improve the consistency of C-CDA implementations

a. The publication of a first suite of additional implementation guidance, best practices, and other such specific tools during 2015 and 2016 that provide for unambiguous methods for health IT developers to implement the C-CDA Release 1.1 and 2.0 specifications in a single and consistent manner.

2. Semantic information consistency

a. The publication of a first suite of additional implementation guidance, best practices, and other such specific tools during 2015 and 2016 that provide for unambiguous methods for health IT developers to implement the semantic requirements included in C-CDA Releases 1.1 and 2.0 with a high degree of accuracy and consistency.

3. Provide support for developers.

a. Have accurate and prompt responses to developer questions relating to implementation of C-

CDA Release 1.1 and 2.0 specifications.

4. The successful publication of a FHIR DSTU2 release during 2015.

5. Ensure adoption support of the FHIR Standard.

a. The formation and iteration of the governance and tools needed to support development and the unambiguous maintenance of FHIR Profiles.

ONC requires that at a minimum, 75% of the funds be allocated for achieving Goals 1 through 3, and 25% of the funds be allocated for Goals 4 and 5.

I. Statutory Authority

Consolidated and Further Continuing Appropriations Act, 2015'', Pub. L. No. 113-235, Division G, Title II, and Title XXX, §§ 3001(c)(2) and 3011 of the Public Health Service Act.

II. Award Information

Type of Award Cooperative Agreement Approximate Total Funding $400,000 Number of Awards One Anticipated Award Date August 21, 2015

Project Period Length 5 years Estimated Start Date TBD

Throughout the project period, ONC’s commitment to continuation of awards will be conditioned on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the Federal Government.

A. Performance Evaluation

The Awardee’s performance will be evaluated on a monthly basis by ONC to ensure that the project is meeting program objectives.

B. Award Type

The funding instrument used for this program will be the cooperative agreement, an award type in which substantial ONC programmatic involvement with the awardee is anticipated during the performance of the activities. Under the cooperative agreement, ONC’s purpose is to support and stimulate an awardee’s activities by involvement in and otherwise working jointly with the awardees in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardee for the project as a whole, although specific tasks and activities may be shared among the awardee and ONC as defined in this funding agreement.

C. Substantial Involvement in Cooperative Agreements

ONC will work closely with the awardee to plan and implement processes in a collaborative fashion. More particularly, ONC staff is substantially involved with the program activities, above and beyond routine grant monitoring. These activities include, but are not limited to: a) review and approval of the implementation plan and all other deliverables submitted to meet the goals of the project (identified in the Deliverable Table); b) providing tactical guidance and feedback during project execution; and c) engaging with leadership of the organization, as necessary, to ensure successful execution of the cooperative agreement.

III. Eligibility Information

A. 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).

B. Sole Source Justification

Health Level 7 International (HL7) is the exclusive standards development organization (SDO) with the ability, authority, and intellectual property rights to develop and maintain the C-CDA specification and FHIR standard among other produced by HL7. As a result, it is the Office of the National Coordinator for Health IT (ONC)’s belief that HL7 is the only organization that can successfully deliver the goals articulated in this cooperative agreement. Additionally, HL7 members include organizations that are actively engaged in implementing the C-CDA and FHIR standard in health IT systems, and hence can provide necessary feedback in timely manner through a well-established and ANSI-accredited process for consensus standards development. The goals and expected outcomes of this cooperative agreement can only be achieved accurately and in timely manner by HL7.

The primary responsibility of 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. HL7 is the single organization responsible for the development and maintenance of the C- CDA specification and FHIR standard, and solely governs the process by 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 be time consuming, inefficient, and would still ultimately require HL7 engagement to ballot and publish a final product. Thus, HL7’s involvement is both fundamental and always necessary to publish an HL7 standard or implementation guide. Furthermore, it is ONC’s intent to broadly coordinate with health IT industry stakeholders to improve and advance the technical standards and specifications required for interoperability. Working directly with HL7 will enable this coordination to be more effective and efficient, and will enable broad industry consensus to be more rapidly when done through HL7’s processes.

C. Cost Sharing or Matching

There is no cost sharing or match requirement for this award.

IV. How to Apply Information

A. Address to Request Application Package

Application materials will be available for download at http://www.grants.gov. ONC requires the applicant to submit application materials as a complete package. Such materials must be delivered through the electronic mail function at http://www.grants.gov.

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

ACCEPTED THROUGH PAPER MAIL, COURIER, OR DELIVERY SERVICE.

APPLICANT IS STRONGLY ENCOURAGED TO COMPLETE AND SUBMIT ITS APPLICATION AS

FAR IN ADVANCE OF THE SUBMISSION DEADLINE AS POSSIBLE. THE APPLICATION

INCLUDING ALL REQUIRED ATTACHMENTS AND INCLUDED FILES FOR POTENTIAL

CONSIDERATION IN THE REVIEW PROCESS MUST BE RECEIVED BY 11:59 PM EASTERN TIME

ON THE DATE SPECIFIED IN SECTION IV C, BELOW.

Applications Procedures:

• You must access the electronic application for this program via http://www.grants.gov. You must search the downloadable application page by the Funding Opportunity Number NAP-AX-15-003 or CFDA number (93.826).

• Applicant should have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number and register in the System for Award Management (SAM). Allow a minimum of five days to complete the SAM registration. It is critical to know that SAM registration requires an annual renewal.

http://www.grants.gov/ http://www.grants.gov/

• Submit all documents electronically, including all information included on the SF-424 and all necessary assurances and certifications.

• Ensure that the application complies with any page limitation requirements described in this Program Guidance.

• After electronically submitting your application, an automatic email notification will be sent to confirm the email was received. This notification does not provide assurance that your application was complete, only that the email was received.

• After ONC reviews submission, a return receipt will be emailed to the applicant contact indicating the files that were received and able to be successfully opened and read. Organizations applying for federal grants need to be registered with SAM. You can register with the SAM online in a process that will take about 30 minutes (http://www.sam.gov). 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 at http://www.sam.gov.

B. Content and Form Submission

Project Abstract

Applicant shall include a one-page abstract (no more than 500 words) of the application. This abstract is often distributed to provide information 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

• Address

• Contact Name

• Contact Phone Numbers (Voice, Fax)

• E-Mail Address

• Web Site Address, if applicable

Budget Forms

The applicant is required to fill out the following budget forms to include the costs associated with the proposed project activities. These forms will be submitted through grants.gov as part of the application package and will include the following:

Application for Federal Assistance (SF-424) Budget Information for Non-Construction Programs (SF-424A) Assurances for Non-Construction Programs (SF-424B) Disclosure of Lobbying Activities (SF-LLL)

Please note that these forms do not replace program-specific guidance provided in this funding opportunity announcement. Additional instruction regarding budget forms can be found in Appendix A.

http://www.sam.gov/ http://www.sam.gov/

Project Narrative

The Project Narrative is the part of the application that will offer the most substantive information about the proposed project, and it will be used as the primary basis to determine whether or not the project meets the minimum requirements for awards. The Project Narrative should provide a clear and concise description of your project.

The Project Narrative must provide the reader with an understanding of how the applicant will:

• Improve consistency of C-CDA implementations across health IT developers;

• Improve the use and consistency of semantic information in C-CDA;

• Provide additional support to developers implementing the C-CDA specification;

• Publish the latest release of the FHIR standard as soon as it’s available; and

• Begin comprehensive planning of adoption of the FHIR standard.

The Project Narrative must be double-spaced, formatted to 8 ½” x 11” (letter-size) pages with 1” or larger margins on top, bottom, and both sides, and a font size of not less than 11 point. The maximum length allowed for the Project Narrative is 10 pages. A full application with a Project Narrative that exceeds 10 pages will not be accepted. Resumes of Key Personnel are not counted as part of the Project Narrative for purposes of the 10-page limit.

(Note: a concise resource offering tips for writing proposals for HHS grants and cooperative agreements can be accessed via the Web at:http://www.hrsa.gov/grants/apply/granttips.html)

Budget Narrative

The applicant is required to outline proposed costs that support all project activities in the Budget Narrative/Justification. The application must include the allowable activities that will take place during the funding period and outline the estimated costs that will be used specifically in support of the program. Costs are not allowed to be expended until the start date listed in the Notice of Grant Award. Whether direct or indirect, all costs must be allowable, allocable, reasonable and necessary under the applicable Uniform Guidance: http://www.ecfr.gov (2 CFR 200 Subpart E) and based on the programmatic requirements for administering the program. The budget period will be equivalent to the project period.

C. Submission Dates and Times

The applicant will be required to submit an application that will undergo screening for completeness and responsiveness and, if indicated, an objective review process. The application must be submitted via grants.gov no later than 11:59 p.m. EST July 24, 2015. If the application fails to meet the application due date, it will not be reviewed and will receive no further consideration. Grants.gov will automatically send the applicant a tracking number and date of receipt verification electronically once the application has been successfully received and validated. After the Office of Grants Management retrieves the application form from grants.gov, a return receipt will be emailed to the applicant contact. This will be in addition to the validation number provided by grants.gov.

http://www.hrsa.gov/grants/apply/granttips.html http://www.ecfr.gov/

FOA Released Letters of Intent Due

Applications Due Cooperative Agreements

Awarded

Anticipated Start Date

April 24, 2015 NA July 24, 2015 August 21, 2015 September 1, D. Application Screening Criteria

If the application fails to meet the following screening criteria described below, it will not be reviewed and will receive no further consideration.

In order for an application to be reviewed, it must meet the following screening requirements:

• The application must be submitted electronically via http://www.grants.gov by 11:59 p.m., Eastern Time, July 24, 2014.

• The Project Narrative section of the application must be double-spaced, on 8 ½” x 11” plain white paper with 1” margins on both sides, and a font size of not less than 11.

• The Project Narrative must not exceed 10 pages. Any pages over the limit will not be reviewed.

NOTE: Letters of Commitment and Resumés of Key Project Personnel are not counted as part of the Project Narrative for purposes of the 10-page limit.

E. Application Responsiveness Criteria

If the application does not meet the following responsiveness criteria, it will be administratively eliminated and will not be sent forward for merit review:

The application clearly addresses the project theme.

The applicant meets the eligibility criteria as required by Section III.A, Eligible Applicants.

The application is complete and includes the required components stated in Section I.B, including all elements of the program narrative needed to forward it for merit review.

F. Application Completeness Criteria

ONC will screen the application to identify those that do not meet criteria outlined below. The application screening criteria are:

• The application is received by the deadline required under Section IV.C, Submission Dates and Times.

• The application meets the formatting and length requirements found in Section IV.B, Content and

Form of Application Submission.

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

G. Grants.gov Registration

Registration with Grants.gov can take several days. The applicant is strongly encouraged to locate and test current logins and passwords for this system well in advance of the deadline date. For assistance with www.grants.gov, please contact them at support@Grants.gov or 1-800-518-4726 24 hours a day/7 days a week.

H. Applying Electronically through Grants.gov

All information needed to submit the application electronically through this site can be found at Grants.gov.

Additionally, there are a variety of requirements that are critical to know and comply with in order to meet the application deadline and submission requirements:

• The applicant will be able to download a copy of the application packet, complete it off-line, and then upload and submit the application via the website.

• The applicant can access the electronic application for this program on Grants.gov. Applicants must search the downloadable application page by the Funding Opportunity NAP-AX-15-003 or CFDA number 93.826.

• ONC strongly recommends that applicant not wait until the application due date to begin the application process through Grants.gov.

• To complete an application in Grants.gov, applicant must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number and be registered in the System for Award Management (SAM). Applicant should allow a minimum of five days to complete the SAM registration. It is critical to know that SAM registration requires an annual renewal. As a result, ONC strongly encourages applicant to ensure that their registrations are current or to renew their registration well in advance of the application deadline. For more information or to check or renew registration, go to http://www.sam.gov.

• The applicant must submit all documents electronically, including all information included on the SF424 and all necessary assurances and certifications.

• Prior to application submission, if Microsoft Vista and Office 2007 are used, applicant should review the Grants.gov compatibility information and submission instructions provided at Grants.gov (click on “Vista and Microsoft Office 2007 Compatibility Information”).

• If the application fails to meet the application due date, it will not be reviewed and will receive no further consideration.

• After application is submitted electronically, applicant will receive an automatic acknowledgement from Grants.gov that contains a Grants.gov tracking number.

• After ONC reviews the submission, a return receipt will be emailed to the awardee contact indicating the files that were received and able to be successfully opened and read.

• Application must be submitted via http://www.grants.gov no later than 11:59p.m. EST on July 24, 2015.

Key Contact for Applications:

Inquiries should be addressed to:

Matthew Rahn U.S. Department of Health and Human Services Office of the National Coordinator for Health Information Technology Email: SDOFOA@hhs.gov

I. Proof of the Applicant’s Status as a Non-Profit Entity

If the applicant is a US-based non-profit entity it must provide documentation of its 501C status or IRS determination letter, IRS tax exemption certificate, or letter from state taxing body verifying tax-exempt status.

http://www.grants.gov/ http://www.sam.gov/ http://www.grants.gov/ mailto:SDOFOA@hhs.gov mailto://support@Grants.gov

J. Intergovernmental Review of Applications

The application for this cooperative agreement is 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).

K.. Funding Restrictions

Funds under this announcement cannot be used for the following purposes:

• To supplant or replace current public or private funding.

• To supplant on-going 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 building.

• To reimburse pre-award costs.

• Indirect costs should not exceed 8% of direct costs.

If you are requesting indirect costs in your budget, you must include a copy of your indirect cost rate agreement. If your indirect cost rate is a provisional rate, the agreement should be less than 12 months of age.

Guidance for completing your budget can be found in Appendix A.

V. Application Review Information

A. Criteria

A panel that may include both expert peer reviewers and Federal staff will review the application to ensure that it meets the responsiveness and screening criteria outlined in this section. The purpose of this review is to determine if the approach and strategy are aligned with grant requirements. The detailed results of this review will be shared with the applicant upon request. The application will be scored according to the following point system:

1. Discussion and Understanding of the Project – 25 points maximum

The applicant demonstrates knowledge and understanding of the implementation challenges of the technical standards specified in the cooperative agreement. The applicant provides guidance that specifies solutions to overcome these challenges and leads to consistent implementation and adoption of technical standards.

2. Technical Approach – 25 points maximum

The applicant’s approach is succinct and logical in format and demonstrates methods consistent with the tasks to be accomplished. The applicant must propose a clear and detailed actionable plan which includes specific list of activities and deliverables to achieve the goals specified in the cooperative agreement.

3. Personnel Qualification and Past Performance – 30 points maximum

The applicant must demonstrate and provide evidence of technical experience for identifying, assessing and determining improvements to be made to technical standards and specifications listed in the cooperative agreement. The technical experts to perform tasks on this Funding Opportunity Announcement (FOA) must have the expertise to be able to successfully complete the tasks. The applicant must demonstrate ability to successfully manage projects of similar size and ability to engage with health IT industry stakeholders. All evidence of their past work must be provided in the personnel resumes in the appendix of the applicant’s proposal.

4. Management Plan – 15 points maximum

The applicant must provide a project plan that includes a detailed implementation 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.

5. Budget Plan –5 points maximum

The applicant must provide a detailed breakdown on how they plan to spend the allotted resources to complete the tasks outlined in the cooperative agreement based on the guidance provided by ONC in the Purpose of the cooperative agreement.

MAXIMUM TECHNICAL SCORE = 100 POINTS

The application will be reviewed for completeness by the Office of Procurement and Grants, and for responsiveness by ONC. An incomplete application and application that is non-responsive to the eligibility criteria will not advance through the review process. The applicant will be notified that their application did not meet submission requirements.

• An objective review panel will evaluate your application according to the criteria listed in the Criteria section above.

Anticipated Announcement and Award Dates

Award Date: August 21, 2015.

VI. Award Administration Information

Type of Award: Cooperative Agreement

Total Amount of Funding Available $400,000 (Estimated)

Number of Awards 1

Project Period and Budget End Date 5 years

A. Performance Evaluation

The awardee’s performance will be evaluated on a monthly basis by ONC. The awardee will partner with ONC to establish monthly reporting mechanisms to track and monitor progress towards goals (quantitative and qualitative data). The awardee shall submit one Final Project Report related to the overall project performance. A specific Final Project Report format will be finalized by ONC following the award date.

B. Public Materials Use

Section 508-compliant materials developed through this funding will be made publicly available at the end of the project period, if not released over the course of the program period.

C. Intellectual Property/Copyrights

The Government reserves all rights granted by, and recipient agrees to be bound by, Administrative Requirements, Cost Principles, and audit requirements as codified in 2 CFR 200 regarding rights in intangible property, 2 C.F.R §200.315, which is specifically incorporated therein. Generally, the recipient may copyright any work that is subject to copyright and was developed, or for which ownership was purchased under this award. The Government 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. For any work owned by a third-party that was licensed by the recipient under this award, recipient will assure that said license also reserves for the Government a royalty-free, non-exclusive, and irrevocable right to reproduce, publish, or otherwise use the work for Federal purposes, and authorize others to do so.

D. Notice of Award

The Notice of Grant Award (NGA) is signed by the ONC Grants Management Officer. The successful applicant’s Authorized Representative will receive the NGA electronically from ONC. The NGA is considered the official authorizing award document.

The NGA will include amount of funds awarded, the terms and conditions of the cooperative agreement, the effective date of the award, the budget period for which support will be given, the total project period timeframe, and the total approved budget.

The NGA will provide pertinent instructions and information including, at a minimum, the following:

1. Legal name and address of performing organization or institution to whom ONC has issued an award under the terms of this request for applications;

2. Title of project;

3. Name(s) of institution(s) or Project Directors (PDs) chosen to direct and control approved activities;

4. Identifying award number assigned by ONC;

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

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

7. Legal authorities under which the award is issued;

8. Appropriate Catalog of Federal Domestic Assistance (CFDA) number;

9. Applicable award terms and conditions;

10. Approved budget plan for categorizing allocable project funds to accomplish the stated purpose of the award; and

11. Other information or provisions deemed necessary by ONC to carry out its respective awarding activities or to accomplish the purpose of a particular award.

In 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. Failing to comply with these requirements may result in suspension or termination of the award and/or ONC’s recovery of award funds.

VII. Other Terms

These special terms and conditions of the award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS grant administration regulations in 2 CFR Part 200, Subparts B through D, and other HHS and ONC policy statements.

This cooperative agreement is for a period of five years. By accepting an award, the awardee is required to abide by 2CFR Part 200, Subparts B through D, and other HHS and ONC policy statements. Drawdown of funding for this cooperative agreement serves as official acceptance of this cooperative agreement. If you do no plan to accept the award, please send a letter of declination to the ONC Project Officer within 30 days of receipt of the Notice of Grant Award.

A. Administrative and National Policy Requirements

The award is subject to HHS Administrative Requirements, which can be found in 2 CFR 200, Subparts B through D and the Standard Terms and Conditions implemented through the HHS Grants Policy Statement (GPS) located at http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf.

B. Post-Award Reporting Requirements

All reporting requirements will be provided to the applicant of a successful application, adherence to which is a required condition of any award. In general, a successful applicant under this guidance must comply with the following reporting and review activities:

C. Audit Requirements

The awardee must comply with audit requirements of Office of Management and Budget (OMB) Uniform Guidance as codified in 2 CFR Part 200, Subpart F. Information on the scope, frequency, and other aspects of the audits can be found at http://www.ecfr.gov/cgi-bin/text-idx?SID=ed90f54836feb6a994f657188eb05e33&node=2:1.1.2.2.1&rgn=div5. The HHS Office of the Inspector General (OIG) maintains a toll-free number (1-800-HHS-TIPS [1-800-447-8477]) for receiving information concerning fraud, waste, or abuse under grants and cooperative agreements. Information also may be submitted by e-mail to hhstips@oig.hhs.gov or by mail to Office of the Inspector General, Department of Health and Human Services, Attn: HOTLINE, 330 Independence Ave., SW, Washington, DC 20201. Such reports are treated as sensitive material and submitters may decline to give their names if they choose to remain anonymous.

http://www.ecfr.gov/cgi-bin/text-idx?SID=ed90f54836feb6a994f657188eb05e33&node=2:1.1.2.2.1&rgn=div5 http://www.ecfr.gov/cgi-bin/text-idx?SID=ed90f54836feb6a994f657188eb05e33&node=2:1.1.2.2.1&rgn=div5 mailto:hhstips@oig.hhs.gov

D. HHS Grants Policy Statement

ONC awards are subject to the requirements of the HHS GPS that are applicable to the grant/cooperative agreement based on recipient type and purpose of award. This includes, as applicable, any requirements in Parts I and II of the HHS GPS that apply to the award, as well as any requirements of Part IV. The HHS GPS is available at http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf. The general terms and conditions in the HHS GPS will apply as indicated unless there are statutory, regulatory, or award-specific.

E. Record Retention

The awardee generally must retain financial and programmatic records, supporting documents, statistical records, and all other records that are required by the terms of a grant, or may reasonably be considered pertinent to a grant, for a period of three years from the date the final annual FFR is submitted.