PKG00262596-instructions.pdf

DEPARTMENT OF

HEALTH AND HUMAN SERVICES

OFFICE OF THE

ASSISTANT SECRETARY FOR HEALTH

Office of Minority Health

Funding Opportunity: Sickle Cell Disease Clinical Data Collection Platform

Opportunity Number: MP-CPI-20-004

Application Due Date:

Tuesday, August 18, 2020 6:00 PM Eastern

OVERVIEW

FEDERAL AGENCY NAME

Office of the Assistant Secretary for Health and the Office of Minority Health

FUNDING OPPORTUNITY TITLE

Sickle Cell Disease Clinical Data Collection Platform

ACTION

Notice

ANNOUNCEMENT TYPE

Initial Competitive Grant

FUNDING OPPORTUNITY NUMBER

MP-CPI-20-004

CFDA NUMBER AND PROGRAM:

93.137 Community Program to Improve Minority Health

DATES

Application Deadline: Tuesday, August 18, 2020 by 6:00 PM Eastern.

Technical Assistance: webinar, Tuesday, July 22, 2020.

EXECUTIVE SUMMARY

The Office of the Assistant Secretary for Health and the Office of Minority Health (OMH) announce the availability of funds for a Fiscal Year (FY) 2020 grant award under the authority of

Section 1707 of the Public Health Service Act (42 U.S.C. § 300u-6).

Sickle cell disease (SCD) is the most common inherited blood disorder in the United States, estimated to affect approximately 100,000 Americans, most of whom are African American.1 This notice solicits applications for demonstration projects for the Sickle Cell Disease Clinical Data

Collection Platform initiative to determine whether a standardized clinical data collection platform, shared across medical centers and other healthcare facilities, can serve as a central repository for analyzing data from large patient cohorts, recruiting patients for clinical trials, assessing adherence to evidence-based clinical guidelines, and identifying new areas for research.

OMH expects the successful applicant to develop and implement an SCD clinical data collection platform and to create and manage a collaborative learning community of participating clinical care teams and patient/family members to pilot utilization of the shared data collection platform. The long-term vision and ultimate goal of this community is to improve patient care and outcomes, including improved quality of life, for individuals with SCD and their families and to reduce cost of care. The first step to meeting this goal is to demonstrate the feasibility and utilization of secure data collection platform for SCD.

Over time, OMH expects the SCD clinical data collection platform to be made widely available to additional institutions (e.g., emergency departments, community hospitals, and federally qualified health centers) in order to expand the number of SCD patients who benefit from this shared platform and collaborative learning community.

OMH anticipates the availability of approximately $1,000,000 annually to support one award for up to two years.

HHS/OASH encourages applicants to review all program requirements, eligibility information, application format and submission information, evaluation criteria, and other information in this funding announcement to ensure that its application complies with all requirements and instructions.

FUNDING OPPORTUNITY DETAILS

A. DATES

1) Application Deadline

Your application is due Tuesday, August 18, 2020 by 6 p.m. Eastern Time. To receive consideration, you must submit your application electronically via Grants.gov no later than this due date and time. If you do not submit your application by the specified deadline, we will return it to you unread. You must submit electronically via Grants.gov unless you obtain a written exemption from this requirement 2 business days in advance of the deadline from the Director, HHS/Office of the Assistant Secretary for Health (OASH) Grants and Acquisitions Management

(GAM) Division. To obtain an exemption, you must request one via email from the

HHS/OASH/GAM, and provide details as to why you are technologically unable to submit electronically through Grants.gov. Your request should be submitted at least 4 business days prior to the application deadline to ensure your request can be considered prior to 2 business days in advance of the deadline. If you request an exemption, include the following in your e-mail request:

the HHS/OASH announcement number; your organization's DUNS number; your organization’s name, address and telephone number; the name and telephone number of your Authorizing

Official; the Grants.gov Tracking Number (for example, GRANT####) assigned to your submission; and a copy of the "Rejected with Errors" notification from Grants.gov. Send the request with supporting documentation to ogm.oash@hhs.gov. Note: failure to have an active

System for Account Management (SAM) registration prior to the application due date will not be grounds for receiving an exemption to the electronic submission requirement. As a result of the public health emergency for COVID-19, the requirement for an active SAM registration at the mailto:ogm.oash@hhs.gov time of application submission has been relaxed (see Section F.4). However, if you do not have a

DUNS number at this time, you should contact the Grants.gov to establish a temporary DUNS number. Your application will not be accepted through Grants.gov without this number. Failure to follow Grants.gov instructions to ensure software compatibility will not be grounds for receiving an exemption to the electronic submission requirement.

The HHS/OASH GAM will only accept applications via alternate methods (hardcopy paper via U.S. mail or other provider or PDF via email) from applicants obtaining prior written approval.

If you receive an exemption, you must still submit your application by the deadline. Only applications submitted through the Grants.gov portal or alternate format (hardcopy paper via U.S.

mail or other service or PDF via email) with an approved written exemption will be accepted. See

Section F.8 (“Other Submission Requirements”) for information on application submission mechanisms.

Executive Order 12372 comment due date: The State Single Point of Contact (SPOC) has

60 days from the application due date to submit any comments. For more information on the SPOC see section F.6 Intergovernmental Review.

To ensure adequate time to submit your application successfully, HHS/OASH recommends that you register as early as possible in Grants.gov since the registration process can take up to one month. You must register an authorizing official for your organization. HHS/OASH does not determine your organization’s authorizing official; your organization makes that designation. For information on registering for Grants.gov, refer to http://www.grants.gov or contact the Grants.gov

Contact Center 24 hours a day, 7 days a week (excluding Federal holidays) at 1-800-518-4726 or support@grants.gov.

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

Your organization is strongly encouraged to register multiple authorized organization representatives in Grants.gov to ensure someone is available to submit your application.

2) Technical Assistance

A technical assistance webinar for potential applicants will be held on Tuesday, July 22, 2020. Please check the Office of Minority Health website, www.minorityhealth.hhs.gov, for more detailed information.

We recommend you review the entire announcement promptly so you can have any questions answered well in advance of the application due date. We also recommend you subscribe to this announcement in Grants.gov so you receive any amendments, question and answer documents, or other updates.

B. PROGRAM DESCRIPTION:

The Office of the Assistant Secretary for Health and the Office of Minority Health (OMH) announce the availability of funds for a Fiscal Year (FY) 2020 grant award under the authority of

Section 1707 of the Public Health Service Act (42 U.S.C. § 300u-6).

OMH is dedicated to improving the health of racial and ethnic minority populations through the development of health policies and programs that will help eliminate health disparities.

Through its demonstration grants, OMH supports the identification of effective approaches for improving health outcomes with the ultimate goal of promoting dissemination and sustainability of these approaches. This particular grant aligns with the following priorities of the Assistant

Secretary for Health: Sickle Cell Disease; Health Transformation; Health Opportunity; Health

Innovation and the following HHS Strategic Goals: Strategic Goal 1: Reform, Strengthen, and

Modernize the Nation's Healthcare System; Strategic Goal 2: Protect the Health of Americans http://www.minorityhealth.hhs.gov/

Where They Live, Learn, Work, and Play; and Strategic Goal 4: Foster Sound, Sustained Advances in the Sciences.2 This initiative is intended to ultimately improve the lives of patients with SCD, most of whom are racial/ethnic minorities, by improving clinical care delivery and thus aligns directly with OMH’s mission.

The Sickle Cell Disease Clinical Data Collection Platform initiative is designed to determine whether a standardized clinical data collection platform, shared across medical centers and other healthcare facilities, can serve as a central repository for analyzing data from large patient cohorts, recruiting patients for clinical trials, assessing adherence to evidence-based clinical guidelines, and identifying new areas for research. OMH expects the successful applicant to plan, design and develop the data collection platform; develop a plan to align and integrate the platform with clinical care sites; define criteria for participating pilot sites; identify and recruit hub and satellite sites to pilot the shared platform; create and manage a collaborative learning community;

evaluate utilization of the data collection platform; and develop dissemination and sustainability plans. When fully developed, OMH expects that the platform will be made widely available to healthcare providers who treat patients with SCD and researchers.

1) Background

Sickle cell disease (SCD) is the most common inherited blood disorder in the United

States, estimated to affect approximately 100,000 Americans, most of whom are African

American.1 SCD is characterized by debilitating pain crises, frequent hospitalizations, and chronic end-organ damage.3 It occurs in about one of every 365 Black/African-American births and in about one of every 16,300 Hispanic-American births.3 SCD is particularly common among those of sub-Saharan African descent.3 Some individuals who descend from Saudi

Arabia, India, and Mediterranean countries such as Turkey, Greece, and Italy may also be affected.3 Clinical care for SCD patients is underutilized, with numerous studies documenting low adherence to recommended therapies that include hydroxyurea, prophylactic antibiotics, and transcranial Doppler screening to assess stroke risk.4 In general, people with SCD have less access to comprehensive team care than people with other genetic disorders such as hemophilia and cystic fibrosis.5 Comprehensive SCD care centers have been established throughout the

United States—mostly in large metropolitan areas, including at some Historically Black

Colleges and Universities (HBCUs)—but such centers are not accessible to all individuals living with SCD. A shared data platform, where providers can document their experiences as well as those of their patients, and learn from other providers, can promote common clinical improvement goals across centers

Pediatric learning collaboratives have been shown to improve child health outcomes for diseases such as cystic fibrosis and cardiovascular disease.6, 7 In 2002, the Quality in Pediatric

Subspecialty Care workgroup, chartered by the American Board of Pediatrics, developed a pediatric collaborative improvement network model, which built on successful examples of cooperative multi-site clinical efforts that used data for learning and improvement, such as the

Children’s Oncology Group and the Cystic Fibrosis Foundation. As of 2013, 9 of 14 pediatric subspecialties have implemented collaborative network improvement efforts.8 The Institute of

Medicine (now the National Academy of Medicine) endorsed a Learning Healthcare System “in which knowledge generation is so embedded into the core of the practice of medicine that it is a natural outgrowth and product of the healthcare delivery process and leads to continual improvement of care.”9 This concept is also supported by the Patient-Centered Outcomes

Research Institute (PCORI).8 Currently, no such networks exist for SCD, but these approaches could be tailored to meet the needs of SCD patients and their families. Of note, the focus of this initiative is on clinical data. The shared data collection platform supported by this grant would complement existing SCD data sources, such as the Centers for Disease Control and Prevention

(CDC) Sickle Cell Data Collection Program, which primarily collects administrative data from multiple sources.

Collaborative networks for other diseases have been shown to improve clinical outcomes, reduce cost of care, and increase patient-reported quality of life.8 Examples of such networks include the ImproveCareNow Collaborative Chronic Care Network for children and adolescents with Crohn’s Disease and ulcerative colitis and the National Pediatric Cardiology Quality

Improvement Collaborative.10,11 Development and implementation of a secure, standardized data collection platform could allow providers who treat SCD patients to better understand population and patient level factors associated with poor clinical outcomes, such as suboptimal use of hydroxyurea, inability to access specialty care, and uncontrolled pain, and provide additional support for clinical decision making.

2) Expectations

OMH expects the successful applicant to:

a. Design a secure SCD data collection platform, affording personally identifiable health information the protections of the Privacy Rule and Security

Rule of the Health Insurance Portability and Accountability Act of 1996

(HIPAA).

• Empanel a technical advisory group (TAG) with members knowledgeable of

SCD patient care, clinical data platform development, SCD clinical trials https://www.improvecarenow.org/ https://www.ncbiqic.org/ https://www.ncbiqic.org/ networks, CDC’s Sickle Cell Data Collection Program, private insurance and

Medicaid reimbursement policies, patient/family engagement in care, and data security and privacy. The TAG should include community members living with

SCD or family members with SCD. OMH will not be a member of the TAG, nor will it manage or control the TAG. Any advice of the TAG is expected to be given to the grantee.

• Develop a plan for the content and technical requirements of the platform, including how it can be utilized as a central repository for analyzing data from large patient cohorts, recruiting patients to clinical trials, assessing adherence to evidence-based clinical guidelines, and identifying new areas for research;

with input from the TAG and community.

• Identify priority outcomes based on input from SCD patients, their advocates and families, clinicians, and the TAG.

• Develop a strategic plan (short and long-term) for the data collection platform;

with input from the TAG.

• Develop a plan to coordinate, collaborate, and align priorities among participating institutions; with input from the TAG.

• Develop a data management plan for how the SCD data platform will be designed and implemented to ensure appropriate management of data, including data security and privacy protections, and HIPAA compliance to protect confidentiality.

b. Develop and implement the SCD data collection platform and collaborative learning community

• Configure a data collection and reporting system, including the capability to provide real-time feedback and built-in analytic tools.

• Define criteria (e.g., IT capacity, number of patients with SCD served, etc.) for participating pilot sites, including hub sites (e.g., academic health centers, including those that are or are in HBCUs, or health systems) and satellite sites

(e.g., community hospitals, federally qualified health centers).

• Identify and recruit hub sites and their satellite sites, based on defined selection criteria, to participate in the shared data collection platform and collaborative learning community.

• Execute a Memorandum of Agreement (MOA) with participating hub sites.

OMH expects the MOA to include partnerships with relevant State Health

Department(s) and/or State Medicaid Offices.

• Convene annual meetings with state partners to inform them of progress on the data platform and discuss potential areas for collaboration.

• Create and foster a collaborative learning community of participating institutions, SCD patients/family members, and other stakeholders.

• Develop a plan to communicate to patients and their families about patient protections regarding how their health information will be collected and used.

• Develop and continuously update a data collection plan based on quality improvement (QI) assessments and user feedback.

• Provide continuing education (CE) credits, Maintenance of Certification

(MOC), and other educational incentives, as applicable.

c. Evaluate the SCD data collection platform

• Identify and develop appropriate measures/indicators to monitor and document the utilization, data quality, and progress of the SCD data collection platform

• Assess feasibility of data collection and standardization, collaboration across institutions, and timeliness of incorporating user feedback

• Collect, analyze and evaluate data to demonstrate the utility of the platform as measured by the number of providers using the platform, users’ self-reported satisfaction with the system, as well as users’ perception of its utility for the improvement of patient care.

• Identify and document “lessons learned” from the development and implementation of the data collection platform.

d. Develop and implement a dissemination plan

• Develop and implement a plan to make the data collection platform widely available to healthcare providers who treat SCD patients.

e. Develop and implement a sustainability plan

• Develop and begin implementation of a plan to support the project after the project period.

C. AUTHORITY

Section 1707 of the Public Health Service Act (42 U.S.C. § 300u-6).

D. FEDERAL AWARD INFORMATION

The Office of Minority Health intends to make funds available for competing grant.

We will fund awards in annual increments (budget periods) and generally for a project period up to 2 years, although we may approve shorter project periods. Budget periods may also vary from the estimate indicated below due to timing of award issuance or other administrative factors. Funding for all approved budget periods beyond the first is generally level with the initial award amount and is contingent upon the availability of funds, satisfactory progress of the project, adequate stewardship of Federal funds, and the best interests of the Government.

Award Information

Estimated Federal Funds Available: $1,000,000

Anticipated Number of Awards: 1

Award Ceiling (Federal Funds including indirect costs): $1,000,000 per budget period

Award Floor (Federal Funds including indirect costs): $750,000 per budget period

Anticipated Start Date: September 30, 2020

Estimated Period of Performance: Not to exceed 2 years

Anticipated Initial Budget Period Length: 12 months

Type of Award: Grant

Type of Application Accepted: Electronic via Grants.gov ONLY unless an exemption is granted

E. ELIGIBILITY INFORMATION

1) Eligible Applicants.

• State Governments

• County Governments

• City or township governments

• Special district governments

• Independent school districts

• Public and State controlled institutions of higher education

• Native American tribal governments (Federally recognized)

• Public Housing authorities/Indian housing authorities

• Native American tribal organizations (other than federally recognized tribal governments)

• Nonprofits having 501(c)(3) status with the IRS, other than institutions of higher education

• Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education

• Private non-profit institutions of higher education

• U.S. Territories

2) Cost Sharing or Matching

You are not required to provide cost sharing or matching in your proposed budget.

3) Application Disqualification Criteria

If you successfully submit an application, we will screen it to ensure it meets the below requirements. If we determine your application fails to meet the criteria described below we will disqualify it, that is, we will not review it and will give it no further consideration.

(a) You must submit your application electronically via www.grants.gov

(unless an exemption was granted 2 business days prior to the deadline) by the date and time indicated in the DATES section (A.1) of this announcement.

(b) If you successfully submit multiple applications from the same organization for the same project, we will only review the last application received by the deadline.

(c) HHS/OASH/GAM deems your application eligible according to section

E.1 Eligible Applicants.

(d) You must complete the required forms in the application package: SF-424, SF-424A, SF-424B, SF-LLL, and Project Abstract Summary.

(e) Your Project Narrative section of the application must be double-spaced, on the equivalent of 8 ½” x 11” inch page size, with 1” margins on all sides (top, bottom, left and right) and font size not less than 12 points.

(f) Your Project Narrative must not exceed 40 pages. NOTE: The following items do not count toward the Project Narrative page limit: all required forms, including SF-424, SF-424A, SF-424B, SF-LLL, Project Abstract Summary, and

Budget Narrative (including budget tables).

(g) Your total application, including the Project Narrative plus Appendices, must not exceed 60 pages. NOTE: items listed in “(f)” immediately above do not count toward total page limit.

(h) Your Federal funds request including indirect costs must not exceed the maximum indicated in Award Ceiling.

(i) Your Federal funds request including indirect costs must not be below the minimum indicated in Award Floor.

F. APPLICATION AND SUBMISSION INFORMATION

1) Address to Request Application Package

You may obtain an application package electronically by accessing Grants.gov at http://www.grants.gov/. You can find it by searching on the CFDA number shown on page 2 of this funding opportunity announcement. If you have problems accessing the application or difficulty downloading, contact:

OASH Grants and Acquisitions Management

Phone: 240-453-8822

Email: OASH_Grants@hhs.gov

2) Content and Form of Application Submission

a. Application Format

Your application must be prepared using the forms and information provided in the online application package.

The Project Narrative, and total application including appendices, must adhere to the page limit indicated in Application Disqualification Criteria listed in Section E.3. The page limit does not include the Budget Narrative (including budget tables), required forms, assurances, and certifications as described in the Application Disqualification Criteria. Please do not number pages or include a table of contents. Our grants management system will generate page numbers once your application is complete. If your application exceeds the specified page limits for the Project

Narrative or Project Narrative plus Appendices when printed on 8.5” X 11” paper by

HHS/OASH/GAM, we will not review it. We recommend you print out your application before submitting electronically to ensure that it is within the page limits and is easy to read.

You must double-space the Project Narrative pages.

You should use an easily readable typeface, such as Times New Roman or Arial. You must use 12-point font. You may single-space tables or use alternate fonts but you must ensure the tables are easy to read.

b. Appendices Format

Your Appendices should include any specific documents outlined in Section D.2.iii., under the heading “Appendices” in the Application Content section of this funding opportunity announcement. Your documents should be easy to read. You should use the same formatting specified for the Project Narrative. However, documents such as résumés/CVs, organizational charts, tables, or letters of commitment may use formatting common to those documents, but the pages must be easy to read. All of your appendices must be uploaded as a single, consolidated file in the Attachments section of your Grants.gov application.

c. Project Abstract Summary Format

You must complete the Project Abstract Summary form provided in the application package. The abstract will be used to provide reviewers with an overview of the application and will form the basis for the application summary in grants management and program summary documents. If your project is funded, HHS may publish information from your form; therefore, do not include sensitive or proprietary information.

d. Budget Narrative Format

The Budget Narrative should use the formatting required of the Project Narrative for the explanatory text. Budget tables may be single-spaced but should be laid out in an easily-readable format and within the printable margins of the page.

3) Application Content

Successful applications will contain the following information:

a. Project Narrative Content

The Project Narrative is the most important part of the application, since it will be used as the primary basis to determine whether your project meets the minimum requirements for an award under this announcement. The Project Narrative should provide a clear and concise description of your project that includes sufficient detail of how your team will meet all of the expectations delineated earlier in this FOA. HHS/OASH recommends that your project narrative include the following components: 1) Problem Statement; 2) Goals, Objectives and Outcomes; 3) Project

Plan; 4) Evaluation Plan; 5) Dissemination Plan; 6) Sustainability Plan; and 7) Organizational

Capability.

1) Problem Statement:

You should describe in this section, in both quantitative and qualitative terms, the nature and scope of the specific and particular problem or issue, and the proposed intervention it is designed to address. You should detail how the project will potentially affect the populations served, specific subgroups within those populations, and other interested stakeholders as identified. We recommend that you focus your problem statement on the specific aspects of the history, existing literature, current status, and policy considerations bearing on the program area, and the roles of the national, state, and local agencies responsible for their operation, rather than providing a broad or sweeping historical overview that is not directly related to the proposed interventions and activities.

Specific to this initiative:

• Describe the purpose of the program, target population(s), proposed services and interventions, and anticipated outcomes.

• Describe the target population(s), to include demographics, number of targeted persons residing in the project area, and other statistics that demonstrate the need for improved clinical care delivery in SCD.

• Define the geographic areas you will serve and describe how the applicant organization is strategically located to facilitate improved clinical care for SCD.

• List anticipated challenges and opportunities for enhancing SCD clinical care.

• Describe how you determined the need for services, including any pertinent statistics to substantiate this rationale.

2) Goals, Objectives and Outcomes:

You should describe in this section your project’s proposed goal(s) and major objectives.

Unless your project involves multiple, complex interventions, we recommend you have only one overall goal. All objectives should be described in SMART (specific, measurable, accurate, realistic and timely) terms. SMART objectives should include baseline data and quantifiable timeframes for achievement. Objectives must focus on overall goals of the project rather than project activities. Goals must be ambitious and achievable in the project's timeframe/project period.

You should clearly identify the measurable outcome(s) that will result from your project.

Identify impact outcomes and performance measures for the proposed activities. Tie outcomes/impacts and measures to long-term goals and objectives. HHS/OASH will not fund any project that does not include measurable outcomes. In addition to discussion in the narrative, you should describe how you envision the project will benefit the field at large.

A “measurable outcome” is an observable end-result that describes how a particular intervention benefits program participants. It demonstrates the “impact” of the intervention. For example, a change in a client’s financial, health, and/or functional status; mental well-being;

knowledge; skill; attitude; awareness; or behavior. It can also describe a change in the degree to which participants exercise choice over the types of services they receive, or whether they are satisfied with the way a service is delivered. Additional examples include: a change in the responsiveness or cost-effectiveness of a service delivery system; a new model of support or care that can be replicated; new knowledge; a measurable increase in community awareness; or a measurable increase in persons receiving services. A measurable outcome is not a measurable output, such as: the number of clients served; the number of training sessions held; or the number of service units provided.

You should keep the focus of this section on describing what outcome(s) will be produced by the project. In many cases, it is very appropriate for a project to have only ONE outcome that it is trying to achieve through the intervention reflected in the project’s design.

3) Project Plan:

Provide a detailed summary of activities to be undertaken and how they will assist in achieving the project goals and objectives.

(a) Describe your plan for designing a secure SCD data collection platform, including:

• Describe how the technical advisory group (TAG) will be assembled, including identification and recruitment of potential members, development of TAG policies and protocols, and governance structures.

• Describe the methodology for how the content and technical requirements of the data collection platform will be developed and utilized.

• Describe the process for how priority outcomes will be determined and vetted through the TAG and other stakeholders.

• Describe the process for how a strategic plan (short and long-term) will be developed for the data collection platform initiative.

• Describe the process for coordinating and aligning priorities across participating institutions, including processes for handling situations when there are competing priorities or non-alignment.

• Describe how the data management plan will be developed and implemented to ensure appropriate management of data, including data security and privacy, and that the SCD data platform will be designed and implemented with HIPAA compliance to protect confidentiality.

(b) Describe how the SCD data collection platform and associated collaborative learning community will be implemented, including:

• Describe the process and technical requirements for configuring a data collection and reporting system, including the capability to provide real-time feedback and built-in analytic tools.

• Describe the process for defining selection criteria for participating pilot sites, including hub sites and satellite sites.

• Describe the process for identifying and recruiting hub sites and their satellite sites, based on defined selection criteria and encouraging participation in the shared data collection platform and collaborative learning community.

• Describe the process for executing Memorandums of Agreement (MOA) with participating hub sites and state partners.

• Describe the process for creating and fostering a collaborative learning community of participating institutions, SCD patients/family members, and other stakeholders that include, but are not limited to, members from the TAG.

• Describe your approach for developing and implementing a plan to communicate to patients and their families about patient protections regarding how their health information will be collected and used.

• Describe the process for developing and updating the data collection plan based on quality improvement (QI) assessments and user feedback.

• Describe the process for providing continuing education (CE) credits, Maintenance of Certification (MOC), and other educational incentives, as applicable.

You should also describe the approach that will be used to monitor and track progress on the project’s tasks and objectives. Include a work plan describing how the project will be accomplished. Your work plan should reflect, and be consistent with, the Project Narrative and

Budget Narrative, and must cover all years of the project period. However, each year’s activities should be fully attainable in one budget year. You may propose multi-year activities, as well as activities that build upon each other, but each phase of the project must be discrete and attainable within a single budget year. Your work plan should include a statement of the project’s overall goal, anticipated outcome(s), key objectives, and the major tasks, action steps, or products that will be pursued or developed to achieve the goal and outcome(s). For each major task of each year, action step, or product, your work plan should identify the timeframes involved (including start-and end-dates), and the lead person responsible for completing the task.

4) Evaluation Plan:

Describe your evaluation design and how your evaluation design will demonstrate the utility of the platform as measured by the number of providers using the platform, users’ self-reported satisfaction with the system, as well as users’ perception of its utility for the improvement of patient care. Describe how you will assess the feasibility of data collection and standardization, collaboration across institutions, and timeliness of incorporating user feedback. Describe how you will assess clinical sites’ IT capacity. Describe how you will measure and report the outcomes.

Describe how you will identify and document lessons learned from the development and implementation of the data collection platform. Please also describe the relationship between your evaluator and your organization and the degree of independence the evaluator will have.

5) Dissemination Plan:

You should describe the method you will use to make the data collection platform widely available and disseminate the project’s results and findings in a timely manner and in easily understandable formats to the population served, the general public, and other parties who might be interested in using the results of the project. HHS/OASH may publish (including on a website), all appropriate findings and products. Therefore, you should propose other, innovative approaches to informing parties who might be interested in using the results of your project to inform practice, service delivery, program development, and/or policy-making, especially to those parties who would be interested in replicating the project. HHS/OASH expects that nationwide dissemination of products and knowledge will occur.

6) Sustainability Plan:

Applications should include a summary for a feasible, time-phased sustainability plan.

Feasible sustainability plans should address financial, staff and supervisory, and material resources that are needed to sustain the data collection platform and collaborative learning community after the project period ends.

7) Organizational Capability:

You should describe your organization’s capability to successfully implement the proposed project, including implementation readiness and ability to demonstrate outcomes within the project period. You should provide evidence of your agency’s (or the particular division of a larger agency which will have responsibility for this project) ability to effectively develop and implement a data collection platform. You should include areas of expertise, key personnel, credentials of proposed staff, technical experience, unique capabilities, history of performing and implementing similar projects, why you are positioned to respond to the project requirements, and why you are best suited to implement and complete the project. Describe your and any proposed partners’ connection to the communities to be served and participants to be engaged. Describe any prior experience/collaboration with public health partners, community-based organizations (CBOs), and other relevant agencies/institutions.

You should clearly delineate the roles and responsibilities of project staff and subrecipients, if any, and how they contribute to achieving the project’s objectives and outcomes. You should specify who has day-to-day responsibility for key tasks such as: leadership of project; monitoring the project’s on-going progress; preparation of reports; data collection and analysis; and communications with other partners and HHS/OASH. You should clearly identify the individual who will serve as the Principal Investigator/Project Director and that individual’s qualifications.

HHS/OASH expects that, throughout the award period, the Principal Investigator/Project Director will have involvement in, and substantial knowledge about, all aspects of the project. You should clearly identify the organization responsible for evaluation activities and that organization’s evaluation qualifications.

b. Budget Narrative Content

You must complete the required budget forms and submit a budget narrative with detailed justification as part of your application. You must enter the project budget on the Budget

Information Non-construction Programs standard form (SF 424A) according to the directions provided with this standard form. The budget narrative consists of a detailed line-item budget that includes calculations for all costs and activities by "object class categories" identified on the SF-

424A and justification of the costs. You must indicate the method you are selecting for your indirect cost rate. See Indirect Costs below for further information.

Project budget calculations must include estimation methods, quantities, unit costs, and other similar quantitative detail sufficient to verify the calculations. If matching or cost sharing is required, you must include a detailed listing of any funding sources identified in box 18 of the SF-

424 (Application for Federal Assistance).

Please be sure to carefully review section F.7 Funding Restrictions for specific information regarding allowable, unallowable, and restricted costs.

You must provide an object class category budget using Section B, box 6 of the SF 424A for the first year of the proposed project. Provide a budget justification, which includes explanatory text and line-item detail, for the first year of the proposed project. The budget narrative should describe how the categorical costs are derived. Discuss the necessity, reasonableness, and allocation of the proposed costs.

For subsequent budget years, provide a summary narrative and line item budget. For categories or items that differ significantly from the first budget year, provide a detailed justification explaining these changes. Note, do not include costs beyond the first budget year in the object class budget in box 6 of the SF- 424A or box 18 of the SF-424; the amounts entered in these sections should only reflect the first budget year.

Your budget narrative should justify the overall cost of the project as well as the proposed cost per activity, service delivered, and/or product. For example, the budget narrative should define the amount of work you have planned and expect to perform, what it will cost, and an explanation of how the result is cost effective. For example, if you are proposing to provide services to clients, you should describe how many clients are you expecting to serve, the unit cost of serving each client, and how this is cost effective.

Use the following guidelines for preparing the detailed object class budget required by box

6 of the SF-424A. The object class budget organizes your proposed costs into a set of defined categories outlined below. Both federal and non-federal resources (when required) must be detailed and justified in the budget narrative. "Federal resources" refers only to the HHS/OASH funds for which you are applying. "Non-federal resources" are all other non-HHS/OASH federal and non-federal resources. We recommend you present budget amounts and computations in a columnar format: first column, object class categories; second column, federal funds requested;

third column, non-federal resources; and last column, total budget.

Sample Budget Table

Object Class Federal Funds

Requested

Non-federal

Resources

Total Budget

Personnel $100,000 $25,000 $125,000

Note, subrecipient/contract and consultant detailed costs should all be included in those specific line items, not in the overall project object class line items, i.e., subrecipient travel should be included in the Contractual line item not in Travel.

1) Object Class Descriptions and Required Justifications

(a) Personnel Description

Costs of staff salaries and wages, excluding benefits.

(b) Personnel Justification

Clearly identify the project director or principal investigator, if known at the time of application. Provide a separate table for personnel costs detailing for each proposed staff person:

the title; full name (if known at time of application), time commitment to the project as a percentage or full-time equivalent: annual salary and/or annual wage rate; federally funded award salary; non-federal award salary, if applicable; and total salary. No salary rate may exceed the statutory limitation in effect at the time you submit your application (see D.6 Funding Restrictions, Salary Rate Limitation for details). Do not include the costs of consultants, personnel costs of delegate agencies, or of specific project(s) and/or businesses to be financed by the applicant.

Contractors and consultants should not be placed under this category.

Sample Personnel Table

Position Title and Full Name

Percent Time Annual Salary Federally-funded Salary

Non-federal Salary

Total Project Salary

Project Director, John K. Doe

50% $100,000 $50,000 $0 $50,000

Data Assistant, Susan R. Smith

10% $30,000 $3,000 $3,000

(c) Fringe Benefits Description

Costs of employee fringe benefits unless treated as part of an approved indirect cost rate.

(d) Fringe Benefits Justification:

Provide a breakdown of the amounts and percentages that comprise fringe benefit costs such as health insurance, Federal Insurance Contributions Act (FICA) taxes, retirement insurance, and taxes.

(e) Travel Description

Costs of travel by staff of the applicant organization only.

(f) Travel Justification

For each trip proposed for applicant organization staff only, show the date of the proposed travel, total number of traveler(s); travel destination; duration of trip; per diem; mileage allowances, if privately owned vehicles will be used; and other transportation costs and subsistence allowances. Do not include travel costs for subrecipients or contractors.

(g) Equipment Description

Equipment means tangible personal property (including information technology systems) having a useful life of more than one year and a per-unit acquisition cost which equals or exceeds the lesser of the capitalization level established by the non-Federal entity for financial statement purposes, or $5,000. (Note: Acquisition cost means the cost of the asset including the cost to ready the asset for its intended use. Acquisition cost for equipment, for example, means the net invoice price of the equipment, including the cost of any modifications, attachments, accessories, or auxiliary apparatus necessary to make it usable for the purpose for which it is acquired. Acquisition costs for software includes those development costs capitalized in accordance with generally accepted accounting principles (GAAP). Ancillary charges, such as taxes, duty, protective in transit insurance, freight, and installation may be included in or excluded from the acquisition cost in accordance with the non- Federal entity’s regular accounting practices.) See 45 C.F.R. § 75.2 for additional information.

(h) Equipment Justification

For each type of equipment requested you must provide a description of the equipment; the cost per unit; the number of units; the total cost; and a plan for use of the equipment in the project;

as well as a plan for the use, and/or disposal of, the equipment after the project ends. An applicant organization that uses its own definition for equipment should provide a copy of its policy, or section of its policy, that includes the equipment definition; include this with your Budget

Narrative file. Reference the policy in this justification and include the policy copy in your Budget

Narrative file (not your appendices).

(i) Supplies Description

Costs of all tangible personal property other than those included under the Equipment category. This includes office and other consumable supplies with a per-unit cost of less than

$5,000.

(j) Supplies Justification

Specify general categories of supplies and their costs. Show computations and provide other information that supports the amount requested.

(k) Contractual Description

Costs of all contracts or subawards for services and goods except for those that belong under other categories such as equipment, supplies, construction, etc. Include third-party evaluation contracts, if applicable, and contracts or subawards with subrecipient organizations

(with budget detail), including delegate agencies and specific project(s) and/or businesses to be financed by the applicant. This line item is not for individual consultants.

(l) Contractual Justification

Demonstrate that all procurement transactions will be conducted in a manner to provide, to the maximum extent practical, open, and free competition. Recipients and subrecipients are required to use 45 CFR § 75.329 procedures and must justify any anticipated procurement action that is expected to be awarded without competition and exceeds the simplified acquisition threshold fixed by 41 U.S.C. § 134 and currently set at $250,000. Recipients may be required to make pre-award review and procurement documents, such as requests for proposals or invitations for bids, independent cost estimates, etc., available to HHS/OASH.

Note: Whenever you intend to delegate part of the project to another agency, you must provide a detailed budget and budget narrative for each subrecipient/contractor, by agency title, along with the same supporting information referred to in these instructions. If you plan to select the subrecipients/contractors post-award and a detailed budget is not available at the time of application, you must provide information on the nature of the work to be delegated, the estimated costs, and the process for selecting the delegate agency.

(m) Other Description

Enter the total of all other costs. Such costs, where applicable and appropriate, may include but are not limited to: consultants; insurance; professional services (including audit charges); space and equipment rent; printing and publication; training, such as tuition and stipends; participant support costs including incentives, staff development costs; and any other costs not addressed elsewhere in the budget.

(n) Other Justification

Provide computations, a narrative description, and a justification for each cost under this category.

(o) Indirect Costs Description

Total amount of indirect costs. This category has one of two methods that you may select.

You may only select one.

• Your organization currently has an indirect cost rate approved by the

Department of Health and Human Services (HHS) or another cognizant federal agency. You should enclose a copy of the current approved rate agreement in your Budget Narrative file. If you request a rate that is less than allowed, your authorized representative must submit a signed acknowledgement that the organization is accepting a lower rate than allowed.

• Per 45 CFR § 75.414(f) Indirect (F&A) costs, “any non-Federal entity [i.e., applicant] that has never received a negotiated indirect cost rate, … may elect to charge a de minimis rate of 10% of modified total direct costs (MTDC) which may be used indefinitely. As described in § 75.403, costs must be consistently charged as either indirect or direct costs, but may not be double charged or inconsistently charged as both. If chosen, this methodology once elected must be used consistently for all Federal awards until such time as a non-Federal entity chooses to negotiate for a rate, which the non-Federal entity may apply to do at any time.”

This method only applies if you have never received an approved negotiated indirect cost rate from HHS or another cognizant federal agency. If you are waiting for approval of an indirect cost rate, you may request the 10% de minimis rate. If you choose this method, costs included in the indirect cost pool must not be charged as direct costs to the award.

(p) Indirect Costs Justification

Provide the calculation for your indirect costs total, i.e., show each line item included in the base, the total of these lines, and the application of the indirect rate. If you have multiple approved rates, indicate which rate as described in your approved agreement is being applied and why that rate is being used. For example, if you have both on-campus and off-campus rates, identify which is being used and why.

(q) Program Income Description

Program income means gross income earned by your organization that is directly generated by this project if funded except as provided in 45 CFR § 75.307(f). Program income includes but is not limited to income from fees for services performed or the use or rental of real or personal property acquired under the award. Interest earned on advances of Federal funds is not program income.