sdo-foafinal6-30-15.pdf

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

Standards Development Organization Collaboration to Enhance Standards Alignment, Testing, and Measurement

Program Guidance Funding Opportunity Announcement

Fiscal Year 2015

Release/Posted Date: June 30, 2015

Application Due Date: August 30, 2015 Anticipated Award Date: September 15, 2015

Table of Contents

OPPORTUNITY OVERVIEW 5

Executive Summary 6

I. Funding Opportunity Description: 6

A. Purpose 6

B. Background 6

C. Program Description 7

D. Project Approach and Structure 7

E. Proposal Criteria 7

F. General Funding Requirements 8

G. Project Evaluation and Measurement 8

II. Award Information 9

A. Summary of Funding 9

B. Award Type 9

III. Eligibility Information 9

A. Eligible Applicants 9

B. Cost Sharing or Matching 10

IV. Application and Submission Information 10

A. Address to Request an Application Package 10

B. Content and Form of Application Submission 11

Project Abstract 11

Budget Forms 11

Project Narrative 11

Budget Narrative 12

C. Submission Dates and Times 12

D. Application Screening Criteria 12

E. Application Responsiveness Criteria 12

F. Application Completeness Criteria 13

G. Grants.gov Registration 13

H. Applying Electronically through Grants.gov 13

I. Intergovernmental Review of Applications 14

J. Funding Restrictions 14

V. Application Merit Review Information 14

A. Criteria 14

1. Discussion and Understanding of the Project – 40 points maximum 14

2. Technical Approach – 25 points maximum 14

3. Personnel Qualification and Past Performance – 15 points maximum 15

4. Management Plan – 15 points maximum 15

5. Budget Plan – 5 points maximum 15

VI. Award Administration Information 15

A. Performance Evaluation 15

B. Public Materials Use 15

C. Intellectual Property/Copyrights 16

D. Notice of Award 16

E. FY 2015 Appropriations Provision 16

VII. Terms and Conditions 17

A. Administrative and National Policy Requirements 17

B. Post-Award Reporting Requirements 17

C. Audit Requirements 17

D. HHS Grants Policy Statement (GPS) 17

E. Records Retention 17

F. Reporting 18

G. Financial Status and Cash Transaction Reports 18

H. Performance Reports 18

I. Non-Disclosure Requirements 18

J. Potential for Organizational and Personal Conflicts of Interest (COI) 19

K. Cooperative Agreement Terms and Conditions of Award 19

Cooperative Agreement Roles and Responsibilities 20

Standard Terms and Conditions - Awardees 21

VIII. Agency Contacts 22

IX. Appendices 23

Appendix A. Instructions for completing the SF-424 and SF 424A 23

Appendix B. Budget Narrative/Justification, Page 1 – Sample Format with EXAMPLES 31

Appendix C. Budget Narrative/Justification –– Sample Template 34

Appendix D. Project Work Plan, Page 1 – Sample Template 35

Appendix E. Project Work Plan, Page 2 – Sample Format 36

OPPORTUNITY OVERVIEW

Funding Opportunity Announcement Title: Standards Development Organization Collaboration to Enhance Standards Alignment, Testing, and Measurement

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-15-005

Catalog of Federal Domestic Assistance (CFDA) Number: 93.831

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: $100,000

Anticipated number of Awards: Up to Five (5) awards

Approximate Range of funding per award: $10,000 to $20,000

Project Period: Five (5) years

Budget Period of Performance: One (1) year1

Key Dates and Submission Information:

The application review and funding process for this cooperative agreement will take place according to the table below.

Milestone Date2 FOA Section Reference Letter of Intent Due Date July 15, 2015 Informational Session July 6, 2015 Application Due Date August 30, 2015, by

11:59pm EST Section IV –How to Apply Information

Anticipated Award Date September 15, 2015 VI.A – Award Administration Information

Anticipated Project Start Date September 30, 2015

1 Budget Periods will be issued in 12 month increments throughout the Project Period of Performance.

Continuation of awards will be conditioned on the availability of funds, evidence of satisfactory progress by the awardee (as documented in required reports), and the determination that continued funding is in the best interest of the Federal Government.

2 The dates are approximate.

Executive Summary

This funding opportunity announcement (FOA) will provide funds in the form of up to five (5) new cooperative agreements between the Office of the National Coordinator for Health Information Technology (ONC) and various standards development organizations (SDOs). These SDOs support advancements in the technical standards necessary to achieve interoperability among health information technology (IT) systems.

U.S. Department of Health and Human Services (HHS) activities support efforts to enhance the health and well-being of Americans by providing for effective health and human services and by fostering sound, sustained advances in the sciences underlying medicine, public health, and social services. Total funding available is $100,000. This collaboration with various SDOs will begin with a focused review of their available or potential standards testing infrastructure and their ability to measure the way in which the standards they publish are used in the field.

I. Funding Opportunity Description:

A. Purpose

The purpose of this FOA is to establish a mechanism for ongoing collaboration among ONC and various SDOs. It aims to provide support to these organizations for standards and interoperability work within these organization’s portfolios that is of mutual interest to ONC. This includes, but is not limited to, standards that involve clinical data exchange, such as those used for e-prescribing, public health reporting, “query,” research, lab ordering and lab results; standards for transporting clinical health information; and standards used to represent clinical concepts in vocabularies, terminologies, and code sets. Additionally, it is anticipated that these ongoing cooperative relationships include specific work aimed at the range of different technical standards developed and maintained by these SDOs, how those standards align with other SDO’s work, and how to measure the use of published standards.

The initial tasks expected to be completed as part of each cooperative agreement include a focused review of each awardee’s available or potential standards testing infrastructure and its ability to measure the adoption and use of its published standards in the field.

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. Various standards development organizations (SDOs) have developed and maintained 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 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 SDOs to develop standardized data formats pertaining to specific purposes.

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.

C. Program Description

These potential cooperative agreements involve a range of different technical standards developed and maintained by SDOs. Tasks associated with these cooperative agreements must include timing and technical alignment among different SDOs’ standards and how to measure the adoption and use of published standards.

SDOs awarded a cooperative agreement are expected to focus first on a review of their available or potential standards testing infrastructure and their ability to measure the way in which the standards they publish are used in the field. Activities completed through this cooperative agreement will be made available as public information or for public use at an agreed upon timeframe post-award.

D. Project Approach and Structure

ONC will fund up to five cooperative agreements totaling $100,000 in the first year, with additional funds provided in future years, subject to availability of funds. The awardees will focus on the alignment of standards among their different portfolios, the testing infrastructures that could be developed or advanced to support test-driven standards development and implementation consistency, and ways in which the adoption and use of published standards could be measured over time. ONC will provide more in depth clarity of the intent of the goals during their meetings in the implementation phase of this agreement. Furthermore, the awardees are expected to provide a report to ONC addressing the specific testing infrastructure and standards measurement questions identified below

• Do you have a testing infrastructure to analyze and assess health IT conformance to the standards your organization publishes?

o If yes what is it and how comprehensive is it? What types of testing are performed, and in what manner (e.g., as standards are being developed versus post-publication)?

o If you do not have a testing infrastructure, what would it take (e.g., resources/personnel or a contract mechanism) for your organization to create a testing infrastructure for the standards your organization publishes? Or explain what alternatives already exist that address the testing of the standards your organization publishes.

• Does your organization track any metrics related to the adoption (in products) or use (in deployments) in the field?

o If yes, please explain the types and nature of metrics your organization can capture related to the standards you published and what limitations you may have.

o If no, please explain how and whether your organization could reliably measure standards implementation and use.

E. Proposal Criteria

Applicants must address the following in their proposal:

• Their testing infrastructure, if present, and how robust and comprehensive it is;

• The types and manner in which tests are performed, if a testing infrastructure is present;

• If they do not have a testing infrastructure, what would be needed to create one, or alternatives present that address testing standards for their organization;

• If their organization tracks adoption or use related metrics;

• If adoption and use metrics are tracked, an explanation of the types and nature of the metrics, and any limitations; and

• If adoption and metrics are not tracked, an explanation of how and whether their organization can reliably measure standards implementation and use.

F. General Funding Requirements

All applications must address the following requirements:

• If a testing infrastructure exists, applicants must show how their testing infrastructure (for the standards within their portfolio) can support the demonstration of interoperability between different health IT systems. This should include an analysis of the types of tests performed, and a synopsis of the manner the tests are performed (e.g., post-publication versus the developmental stage).

• If a testing infrastructure is not present, applicants must show an analysis of what is needed to initiate a testing platform to include, but not limited to personnel, funds, or a potential contractor or sub-awardee. If the applicant is aware of alternative testing platforms, provide an analysis of a recommendation on which would be the preferred method (creating a testing infrastructure or the alternatives).

• The applicant must provide an analysis of any metrics used to track adoption and use of standards within the applicant’s standards portfolio. If the applicant has tracked metrics, an explanation of the types of metrics used for these standards, and if any limitations were present. For those applicants that have not used metrics, an analysis on how and if their organization could feasibly measure standards implementation and use.

G. Project Evaluation and Measurement

This FOA provides applicants with flexibility to propose measurements that show improvement to the testing infrastructure. Additionally, the applicants are to propose measurements and a methodology for measuring adoption and use of standards. After award, ONC will work with all awardees to obtain a consistent methodology and measurements across all the awardees for reports to ONC.

The table below identifies specific milestones to support the execution of a cooperative agreement and the due dates by which the milestones will be met. Deliverables No. 1, No. 2, and No. 3 in the table below, have been already specified. Deliverables for subsequent years will be developed with the awardees depending on their initial responses to the questions in the Project Approach and Structure section.

No. Deliverable Due Date

1. Detailed Implementation Plan (includes specific list of activities and deliverables approved by ONC) Two weeks after award date and quarterly thereafter

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

3. Report addressing standards testing and measurement

6 months after award date

II. Award Information

A. Summary of Funding Type of Award Cooperative Agreement Approximate Total Funding $100,000 Number of Awards Up to five Anticipated Award Date September 15, 2015 Project Period Length 5 Years Estimated Start Date September 30, 2015

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 awardee (as documented in required reports), and the determination that continued funding is in the best interest of the Federal Government.

ONC reserves the right to make supplement awards under this announcement, consistent with Agency policy, if additional funding becomes available after the original awards are made, to continue to advance the objectives of this FOA.

B. Award Type

The funding instrument used for this program will be a cooperative agreement, an award type in which substantial ONC programmatic involvement with the awardees 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 awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and ONC as defined in the funding agreement.

ONC will work closely with the awardees to plan and implement processes in a collaborative fashion.

Specifically, ONC staff will be 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

Applicants must be a United States-based non-profit institution or organization, or state or local government agency. Applications must meet the requirements of Responsiveness and Completeness Criteria found under Section IV.C and D below.

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

U.S.-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.

B. Cost Sharing or Matching

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

IV. Application and Submission Information

A. Address to Request an Application Package

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

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

ACCEPTED THROUGH PAPER MAIL, COURIER, OR DELIVERY SERVICE.

AN 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.

Application 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- 15-005 or CFDA number (93.831).

• Organizations applying for federal grants need to be registered with the System for Award Management (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.

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

• 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 application 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.

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

B. Content and Form of Application Submission

Project Abstract

Applicants 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, applicants should prepare a clear, accurate, and 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 applicants 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

Applicants are required to fill out the following forms and submit these forms through grants.gov as part of the application package.

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 instructions regarding these forms can be found in Appendix A.

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 and address the requirements as listed in the sections I. G. General Funding Requirements and I.

H. Project Evaluation and Measurement, found above.

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

Budget Narrative

The applicants are required to outline proposed costs that support all project activities in the Budget Narrative/Justification. The applications 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.

C. Submission Dates and Times

The applicants will be required to submit an application that will undergo screening for completeness and responsiveness and, if successful, a merit review process. The applications must be submitted via grants.gov no later than 11:59 p.m. EST August 15, 2015. If the applications fails to meet the application due date, it will not be reviewed and will receive no further consideration.

FOA Released Letters of Intent Due

Applications Due Cooperative Agreements Awarded

Anticipated Start Date

June 30, 2015 July 15, 2015 August 30, 2015 September 15, September 30, D. Application Screening Criteria

If the application fails to meet the following screening criteria described below, it will receive no further consideration.

• The application must be submitted electronically via http://www.grants.gov by 11:59 p.m., EST, August 30, 2015.

• 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 point.

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

NOTE: Letters of Commitment and Résumés 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 receive no further consideration

• Meets the stated FOA requirements.

• 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.E, including all elements of the program narrative needed to forward it for merit review.

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

F. Application Completeness Criteria

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

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

• The applications meet 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 applicants are 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 applications 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 applicants 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 applicants can access the electronic application for this program on Grants.gov. Applicants must search the downloadable application page by the Funding Opportunity number NAP-AX-15-005 or CFDA number 93.831.

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

• To complete an application in Grants.gov, applicants must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number and be registered in the System for Award Management (SAM). Applicants 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 applicants 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 applicants 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, applicants 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 applications are submitted electronically, applicants will receive an automatic acknowledgement from Grants.gov that contains a Grants.gov tracking number.

http://www.grants.gov/ mailto:support@Grants.gov

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

• Applications must be submitted via http://www.grants.gov no later than 11:59p.m. EST on August 30, 2015.

I. Intergovernmental Review of Applications

The application for these cooperative agreements 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).

J. 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 Merit Review Information

A. Criteria

A panel that may include both expert peer reviewers and federal staff will review the applications to ensure that they meet 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 applicants upon request. The applications will be scored according to the following point system:

1. Discussion and Understanding of the Project – 40 points maximum

The applicants demonstrate knowledge and understanding of the testing and measurement issues associated with technical standards. The applicants provide a coherent response and proposed approach for addressing the standards testing and measurement questions.

2. Technical Approach – 25 points maximum

The applicants’ approach is succinct and logical in format and demonstrates methods consistent with the tasks to be accomplished. The applicants 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.

http://www.grants.gov/

3. Personnel Qualification and Past Performance – 15 points maximum

The applicants must demonstrate and provide evidence of technical experience necessary to assess the testing infrastructure and standards measurement questions in the FOA. All evidence of their past work must be provided in the personnel resumes in the appendix of the proposal.

4. Management Plan – 15 points maximum

The applicants must provide a project plan that includes a detailed implementation plan to carry out the creation of the report, monthly progress meetings, progress reports and a timeline for draft and final deliverables with specific dates identified.

5. Budget Plan – 5 points maximum

The applicants 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 applications will be reviewed for completeness and for responsiveness by ONC. An incomplete application and applications that is non-responsive to the eligibility criteria will not advance through the review process. The applicant will be notified that its application did not meet submission requirements.

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

VI. Award Administration Information

Type of Award: Cooperative Agreement

Total Amount of Funding Available: $100,000

Number of Awards: Up to 5

Project Period: 5 Years

A. Performance Evaluation

The awardees’ performance will be evaluated on a quarterly basis by ONC. The awardees will partner with ONC to establish quarterly reporting mechanisms to track and monitor progress towards goals (quantitative and qualitative data). The awardees must 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 project period.

C. Intellectual Property/Copyrights

The Government reserves all rights granted by, and awardees agree 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 awardees 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 awardees under this award, awardees 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 applicants’ Authorized Representative will receive the NGA electronically from ONC. The NGA is considered the official authorizing award document.

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

1. Legal names and addresses of performing organizations or institutions 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 numbers 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 awardees 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 awards and/or ONC’s recovery of award funds.

E. FY 2015 Appropriations Provision

Department of Health and Human Services (HHS) recipients must comply with all terms and conditions outlined in their grant award(s), including grant policy terms and conditions contained in applicable HHS Grants Policy Statements, and requirements imposed by program statutes and regulations, Executive Orders, and HHS grant administration regulations, as applicable; as well as any requirements or limitations in any applicable appropriations acts.

VII. Terms and Conditions

These special terms and conditions of the awards 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.

These cooperative agreements are for a period of five years. By accepting an award, the awardees are 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 not 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 applicants of a successful application, adherence to which is a required condition of any award. In general, successful applicants under this guidance must comply with the reporting and review activities, outlined in this FOA.

C. Audit Requirements

The awardees 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.

D. HHS Grants Policy Statement (GPS)

ONC awards are subject to the requirements of the HHS GPS that are applicable to the grant/cooperative agreement based on awardee 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. Records Retention

The awardees 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 Federal Financial Report (FFR) is http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf 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 http://www.hhs.gov/grantsnet/adminis/gpd/ submitted. For awards where the FFR is submitted at the end of the competitive segment, the three-year retention period will be calculated from the date the FFR for the entire competitive segment is submitted. The awardees must retain the records pertinent to the entire competitive segment for three years from the date the FFR is submitted. See 2 CFR 200.333 for exceptions and qualifications to the three-year retention requirement (e.g., if any litigation, claim, financial management review, or audit is started before the expiration of the three-year period, the records must be retained until all litigation, claims, or audit findings involving the records have been resolved and final action taken). Those sections also specify the retention period for other types of grant-related records, including indirect cost proposals and property records. See 2 CFR 200.326 for records retention and access requirements for contracts under grants.

F. Reporting

All reporting requirements will be provided to applicants, adherence to which is a required condition of any award. In general, applicants must comply with the following reporting and review activities.

G. Financial Status and Cash Transaction Reports

Semi-annual expenditures must be submitted for each fiscal year during the project period (October 1 through September 30) using 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 Online Data Collection (OLDC) system. ONC will not accept reports sent directly to the ONC Grants mailbox.

The FFR Cash Transaction Report is submitted via the Payment Management System (PMS) every calendar quarter for the life of the grant. The report must be submitted within 30 days after the end of the quarter (January 31, April 30, July 31, and October 31). The awardees are still required to complete the FFR Cash Transaction Report via the PMS each calendar quarter.

H. Performance Reports

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

I. Non-Disclosure Requirements

Since these cooperative agreements may require the awardees to have access to information relating to any and all aspects of grants management operation that may be of a technical, legal, sensitive, and/or confidential nature and which may be of the sole property of the U.S. Government, each awardee must ensure that all its personnel (to include chief executives, directors, any consultants, sub-awardees, or any other personnel that are substantially involved in the performance of this cooperative agreement) who will be personally and substantially involved in the performance of this cooperative agreement:

• Execute and submit Non-Disclosure Agreements prior to the commencement of any work on the cooperative agreement; and

• Put in place appropriate procedures for the protection of such information, and must be liable to the Government for any misuse or unauthorized disclosure of such information by its personnel, as defined above.

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

The term “organizational conflict of interest” means that the applicants (to include its chief executives, directors, any consultants, sub-awardees, or any other personnel that are substantially involved in the performance of this cooperative agreement) has interests in which:

i. May diminish its capacity to give impartial, technically sound, objective assistance and advice in performing these tasks;

ii. May otherwise result in a biased work product under this cooperative agreement; or

iii. May result in an unfair competitive advantage to itself or others.

In accordance with Section 200.112, the applicants and non-federal entities must disclose in writing any potential conflicts of interest (COI) that they have with the HHS awarding agency and/or any other pass-through entities. The applicants must notify the HHS awarding agency and its respective grants management officer (GMO) when they believe a COI may exist. If after award the awardees discover a COI, with respect to these cooperative agreements, they must make an immediate and full disclosure in writing to the GMO.

The disclosure must include identification of the conflict, the manner in which it arose, and description of the action the awardees have taken or proposed to take to avoid, eliminate, or neutralize the conflict.

In the event the awardees were aware of an organizational COI prior to award of the cooperative agreement and did not disclose the conflict to the GMO or becomes aware of an organizational COI after award of these cooperative agreements and does not disclose the COI within ten (10) days of becoming aware of such conflict, the Government may terminate the cooperative agreement and the awardees will not be entitled to reimbursement of any cost incurred in performing the cooperative agreement or payment of any fee thereunder.

The rights and remedies of the Government provided in this clause must not be exclusive and are in addition to any other rights and remedies of the Government provided by law or under this cooperative agreement.

K. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 2 CFR Part 200, Subpart B through D, and other HHS and ONC grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an “assistance” mechanism, in which substantial ONC programmatic involvement with each awardee is anticipated during the performance of the activities. Under the cooperative agreements, the ONC purpose is to support and stimulate the awardee’s activities by involvement in and otherwise working jointly with each awardee 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 awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and ONC as defined below.

To facilitate appropriate involvement, during the period of these cooperative agreements, ONC and the awardees will be in contact monthly and more frequently, when appropriate. Requests to modify or amend the cooperative agreements may be made by ONC or the awardees at any time. Modifications and/or amendments to the cooperative agreements must be effective upon the mutual agreement of both parties, except where ONC is authorized under the Terms and Conditions of award, 2 CFR Part 200, Subpart B through D, or other applicable regulation or statute to make unilateral amendments.

Cooperative Agreement Roles and Responsibilities

The Office of the National Coordinator for Health Information Technology (ONC) will have substantial involvement in program awards as outlined below:

• Technical Assistance – This includes, but is not limited to: feedback related to testing infrastructure components, the ability to test standards, and areas in which standards development or implementation specification development by the awardee would be of significant interest and priority.

• Project Officers – ONC will assign a specific Project Officer to these cooperative agreements awards to support and monitor the awardees throughout the project period.

• Release of Funds Approval – the ONC Project Officer will be responsible for requesting authorization of the release of funds this project.

• Monitoring – ONC Project Officers in conjunction with the Grants Division will monitor the progress of the awardees on a regular basis. This monitoring may be by phone, document review, on-site visit, other meetings, and by other appropriate means, such as reviewing program progress reports and Federal Financial Reports (SF-425). This monitoring will be to determine compliance with programmatic and financial requirements.

Standard Terms and Conditions - Awardees

The Awardees and assigned points of contact retain the primary responsibility and dominant role for planning, directing, and executing the proposed project as outlined in the terms and conditions of the cooperative agreement with substantial ONC involvement. Responsibilities include:

• Requirements – The awardees must comply with all current and future requirements of the project, including meaningful use requirements, certification criteria, and standards (including privacy and security) specified and approved by the Secretary of HHS.

• Reporting – Awardees are required to comply with all reporting requirements outlined in this Funding Opportunity Announcement and the terms and conditions of the cooperative agreement to ensure the timely release of funds.

The awardees and any sub-awardee must comply with the most recent version of the HHS Grants Policy Statement. In addition, awardees must comply with the Administrative Requirements, Cost Principles, and Audit Requirements as codified in 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards, Subparts B-F.

The awardees agree that all allocations and use of funds under this award will be in accordance with the Funding Opportunity Announcement specific to this program.

The awardees understands and agrees to comply with 31 U.S.C. 1352, “Limitation on use of the appropriated funds to influence certain Federal contracting and financial transactions,” and will not use any Federal funds, either directly or indirectly, in support of the enactment, repeal, modification, or adoption of any law, regulation, or policy at any level of government.

These awards are subject to the requirements of Section 106 (g) of the Trafficking Victims Protection Act of 2000, as amended (22 U.S.C. 7104). For the full text of the award term, go to http://www.hrsa.gov/grants/trafficking.htm. If you are unable to access this link, please contact Division of Grants at ONCGrants@hhs.gov.

Green Procurement: To mitigate the environmental impacts of acquisition of IT and other products/equipment, awardees are encouraged to:

(1) Participate in “Green procurement” based on the HHS Affirmative Procurement Plan (http://www.hhs.gov/asfr/ogapa/acquisition/10-2010_hhs_affirmative_procurement_plan.doc) and similar guidance from the Environmental Protection…