NOFO ID-IDP-23-001 Full Announcment.pdf

U.S. Department of Health and Human Services

Office of Infectious Disease and HIV/AIDS Policy

Notice of Funding Opportunity: Evaluation of linkage to care programs in support of hepatitis C elimination

Opportunity Number: ID-IDP-23-001

Application Due Date:

08/02/2023 at 6:00 PM Eastern

OVERVIEW

FEDERAL AGENCY NAME

The Office of the Assistant Secretary for Health, Office of Infectious Disease and HIV/AIDS Policy

FUNDING OPPORTUNITY TITLE

Evaluation of linkage to care programs in support of hepatitis C elimination

ACTION

Notice

ANNOUNCEMENT TYPE

Initial CA (Cooperative Agreement)

FUNDING OPPORTUNITY NUMBER

ID-IDP-23-001

ASSISTANCE LISTING NUMBER AND PROGRAM:

93.343 , Public Health Service Evaluation Funds

DATES

Application Deadline: 08/02/2023 by 6:00 PM Eastern.

Technical Assistance Webinar: 06/27/2023 at 2:30 PM Eastern.

EXECUTIVE SUMMARY

The Office of Infectious Disease and HIV/AIDS Policy announces the availability of funds for Fiscal Year (FY) 2023 under the authority of 42 U.S.C. § 238j (Section 241 of the Public Health Service Act); 42 U.S.C. 300u-1(a) and 300u-2(a) (Sections 1702 and 1703 of the Public Health Service Act) .

In accordance with this, the Office of Infectious Disease and HIV/AIDS Policy (OIDP) provides strategic leadership and management to reduce the burden of infectious disease. OIDP coordinates the Viral Hepatitis National Strategic Plan: A Roadmap to Elimination (VHNSP) across the U.S. Department of Health and Human Services (HHS) and works to promote best practices that improve health outcomes for people disproportionately impacted by hepatitis by reducing health disparities and social determinants of health. This initiative aligns with the HHS Strategic Plan FY2022-2026: 1) to protect individuals, families, and communities from infectious disease and non-communicable disease through equitable access to effective, innovative, readily available diagnostics, treatments, therapeutics, medical devices, and vaccines and 2) to expand equitable access to comprehensive, community-based, innovative, and culturally competent healthcare services while addressing social determinants of health.

The Office of the Assistant Secretary for Health (OASH) encourages all 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 their applications comply with all requirements and instructions.

Table of Contents

OVERVIEW

FEDERAL AGENCY NAME

FUNDING OPPORTUNITY TITLE

ACTION

ANNOUNCEMENT TYPE

FUNDING OPPORTUNITY NUMBER

ASSISTANCE LISTING NUMBER AND PROGRAM:

DATES

EXECUTIVE SUMMARY

A. Program Description

1. Background

2. Expectations for Funded Projects

3. Federal Agency Substantial Involvement

B. Federal Award Information

1. Legal Authority

2. Award Information

3. Federal Agency Substantial Involvement

C. ELIGIBILITY INFORMATION

1. Eligible Applicants

2. Cost Sharing or Matching

3. Other - Application Responsiveness Criteria

4. Application Disqualification Criteria

D. APPLICATION AND SUBMISSION INFORMATION

1. Address to Request Application Package

2. Content and Form of Application Submission

3. Application Content

4. Unique Entity Identifier and System for Award Management (SAM)

5. Submission Dates and Times

6. Intergovernmental Review

7. Funding Restrictions

8. Other Submission Requirements

E. APPLICATION REVIEW INFORMATION

1. Criteria

2. Review and Selection Process

3. Review of Risk Posed by Applicant

4. Final Award Decisions, Anticipated Announcement, and Federal Award Dates

F. FEDERAL AWARD ADMINISTRATION INFORMATION

1. Federal Award Notices

2. Administrative and National Policy Requirements

3. Program Specific Terms and Conditions

4. Closeout of Award

5. Lobbying Prohibitions

6. Non-Discrimination Requirements

7. Smoke- and Tobacco-free Workplace

8. Acknowledgement of Funding

9. HHS Rights to Materials and Data

10. Trafficking in Persons

11. Efficient Spending

12. Whistleblower Protection

13. Health Information Technology (IT) Interoperability

14. Prohibition on certain telecommunications and video surveillance services or equipment. 41

15. Human Subjects Protection

16. Research Integrity

17. Reporting

G. CONTACTS

1. Administrative and Budgetary Requirements

2. Program Requirements

3. Electronic Submission Requirements

H. OTHER INFORMATION

1. Awards under this Announcement

2. Application Elements

I. SUPPLEMENTARY MATERIALS

1. Acronyms

2. Considerations in Recipient Plans for Oversight of Federal Funds

3. Financial Assistance General Certifications and Representations

4. Disparity Impact Statements

5. References

A. Program Description The Office of Infectious Disease and HIV/AIDS Policy announces the availability of funds for Fiscal Year (FY) 2023 under the authority of 42 U.S.C. § 238j (Section 241 of the Public Health Service Act); 42 U.S.C. 300u-1(a) and 300u-2(a) (Sections 1702 and 1703 of the Public Health Service Act) .

In accordance with this, the Office of Infectious Disease and HIV/AIDS Policy (OIDP) provides strategic leadership and management to reduce the burden of infectious disease. OIDP coordinates the Viral Hepatitis National Strategic Plan: A Roadmap to Elimination (VHNSP) across the U.S. Department of Health and Human Services (HHS) and works to promote best practices that improve health outcomes for people disproportionately impacted by hepatitis by reducing health disparities and social determinants of health. This initiative aligns with the HHS Strategic Plan FY2022-2026: 1) to protect individuals, families, and communities from infectious disease and non-communicable disease through equitable access to effective, innovative, readily available diagnostics, treatments, therapeutics, medical devices, and vaccines and 2) to expand equitable access to comprehensive, community-based, innovative, and culturally competent healthcare services while addressing social determinants of health.

1. Background

Hepatitis C virus (HCV) infection is a major cause of disease and death in the United States. In the United States, it is estimated that up to 2.4 million people are living with chronic hepatitis C and the number of new HCV infections has more than doubled since 2013 (Center for Disease Control and Prevention, 2022; Hofmeister et al., 2019). HCV is one of the most common causes of liver cancer, which is the third leading cause of cancer death in the United States.

Although there is no vaccine to prevent HCV infection, there is an 8-to-12-week treatment that is over 95% effective at curing hepatitis C. Early diagnosis and treatment can reduce the risk of liver cancer, transmission, and the number of new infections. Despite having an effective treatment that can prevent infection, disease, and death, only one in three people received treatment for hepatitis C within a year of diagnosis (Thompson et al., 2022). The number of people treated for hepatitis C in the U.S declined from 164,247 in 2014 to 83,740 in 2020, far short of the HHS Viral Hepatitis National Strategic Plan goals to eliminate viral hepatitis by

2030 (CDC, 2022).

In the U.S, injection drug use by sharing needles or other equipment used to inject drugs, is the primary route of HCV transmission and people who inject drugs are most at risk for HCV infection (CDC, 2022). People who inject drugs are disproportionately incarcerated, leading to a higher prevalence of HCV in correctional settings compared with the general population (Akiyama et al., 2021). Justice-involved populations may not be able to receive hepatitis C treatment in jails or prisons due to short length of stays. Populations disproportionately impacted by hepatitis C can face barriers to accessing care and receiving hepatitis C treatment, including patient and system level-barriers, and stigma. Populations disproportionately impacted by hepatitis C also face barriers in addressing social determinants of health such as lack of income, stable housing, employment, education, and community infrastructure (HHS, 2022).

The VHNSP supports the need to integrate hepatitis C prevention, screening, diagnosis, and treatment in “high-impact” settings or settings where people disproportionately impacted by hepatitis C may touch the health care system. Examples of “high-impact” settings include correctional facilities, substance use treatment programs, syringe service programs, and other harm reduction programs. An integrated approach can reduce fragmented care and improve health outcomes for people with hepatitis C. Programs that provide linkage to care services, such as patient navigation, can be an effective strategy to improve patient outcomes when fully integrated care, provision of hepatitis C treatment in the “high-risk” setting, cannot be achieved.

Linkage to care connects HCV-positive individuals to appropriate HCV care. In “high-impact” settings, such as opioid treatment clinics, outpatient clinics for people who inject drugs, and correctional settings, patient navigation and peer support achieved timely linkage to hepatitis C care and improved hepatitis C outcomes (Litwin et al., 2022; Ward et al., 2019). Patient navigation has also been shown to support the facilitation of obtaining insurance and medication prior authorization for HCV-positive patients, which is a major administrative barrier (Ford et al., 2017).

To reach elimination, the VHNSP supports improved linkage to care between community-based organizations, correctional facilities, syringe service programs and other substance use disorder treatment programs with viral hepatitis treatment providers (HHS, 2020). There is a need to assess effectiveness of novel linkage to care strategies in populations disproportionately impacted by hepatitis C to identify barriers and facilitators and further support sustained investment in linkage to care strategies. The purpose of this OIDP project is to implement and rigorously evaluate novel hepatitis C linkage to care strategies.

2. Expectations for Funded Projects

OIDP intends to fund projects focused on implementing and evaluating the effectiveness of novel linkage to care services in settings with high prevalence of HCV including correctional facilities, substance use treatment programs, syringe service programs, other harm reduction programs, etc. The evaluation must address both process and outcome evaluations. Award recipient under this announcement should meet each of the below expectations in the execution of their funded project:

a. Develop partnerships to implement novel linkage to care services

Recipients should develop partnerships with at least two community and/or governmental organizations to implement novel interventions that improve hepatitis C navigation or linkage to care services for populations disproportionately impacted by hepatitis C in “high-impact” settings. Examples of “high-impact” settings include correctional facilities, substance use treatment programs, syringe service programs, and other harm reduction programs, etc.

We strongly encourage partnership with correctional facilities. We strongly encourage recipients to involve at least one partner that serves and/or is located in a rural setting. Rural refers to HRSA-designated rural areas, as defined by the Rural Health Grants Eligibility Analyzer (https://data.hrsa.gov/tools/rural-health).

Linkage to care includes ensuring that persons with a positive HCV antibody test receive an HCV RNA test, and those with current HCV infection (HCV RNA positive) are linked to a health care provider who is prepared to provide counseling services and comprehensive curative treatment. Patients linked to care are those who have attended a first medical appointment for evaluation or treatment. Visits for HCV RNA testing only are not considered linked to care.

We strongly encourage recipients to seek and include the meaningful involvement of communities, including state and/or local health departments, local governmental agencies and/or businesses, and community-based organizations in the development and implementation of the proposed research, and in the translation and dissemination of research results.

b. Conduct a process and outcomes evaluation

Recipients must develop and implement a process and outcomes evaluation to evaluate the effectiveness of hepatitis C linkage to care strategies. The process evaluation should describe facilitators and barriers to implementation, the extent to which the program was implemented as designed without redundancy, and whether the program was accessible and acceptable to the population served.

The outcome evaluation should examine the effectiveness of the linkage to care strategies on key health outcomes. Recipients should evaluate both short-term and long-term health outcomes and may include secondary outcomes as appropriate.

Short-term health outcomes may include: increased hepatitis C screening, increased awareness of infection status, increased timely linkage to appropriate hepatitis C medical care, etc.

Long-term health outcomes may include: increased treatment among those diagnosed with HCV infection, reduced transmission of HCV, reduced HCV-associated morbidity and mortality, etc.

Secondary outcomes of interest may include: increased linkage to appropriate medical care for other comorbidities, such as HIV, STI, mental health, and substance use disorder, increased support for housing, employment, and other support services, etc.

https://data.hrsa.gov/tools/rural-health

Recipients are also encouraged to conduct additional analyses, such as an economic evaluation, that will support the goals of the project.

Recipients should have access to and use appropriate data sources of sufficient quantity and quality to meet the project goals within three years. Where applicable, recipients should identify additional data sources to address any gaps identified in those originally proposed.

c. Disseminate promising practices

Research findings should be disseminated through publications, including articles in peer reviewed scientific journals, reports, as well as presentations at professional conferences, and in institutional and community-based venues. Recipients should identify promising practices that may be generalized to communities outside the study and can be translated into practice.

d. Disparity Impact Statement

Recipients are expected to develop a disparity impact statement (DIS) during the project period using local data to identify populations at highest risk for health disparities relative to this initiative. Additional information and links to resources are available in Section I.2.

3. Federal Agency Substantial Involvement

Recipients will receive funding under a cooperative agreement. A cooperative agreement is a form of assistance that allows for substantial involvement by federal agency. Additional details of the substantial involvement for awards made under this NOFO are described in Section B.3.

B. Federal Award Information

1. Legal Authority

42 U.S.C. § 238j (Section 241 of the Public Health Service Act); 42 U.S.C. 300u-1(a) and 300u- 2(a) (Sections 1702 and 1703 of the Public Health Service Act)

2. Award Information

We intend to make funds available for competing CA (Cooperative Agreement) awards.

We will fund awards in annual increments and generally for a period of performance up to 3 year(s), although we may approve shorter periods of performance. Budget periods may also vary from the estimate indicated below due to timing of award issuance or other administrative factors.

Recipients will be required to submit a non-competing continuation application for each budget period after the first. 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 $440,000

Anticipated Number of Awards 1

Award Ceiling (Federal Funds including indirect costs) $440,000 per budget period

Award Floor (Federal Funds including indirect costs) $200,000 per budget period

Anticipated Start Date 09/15/2023

Estimated Period of Performance Not to exceed 3 year(s)

Anticipated Initial Budget Period Length 12 months

Type of Award Cooperative Agreement

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

3. Federal Agency Substantial Involvement

Awards made under this NOFO will be cooperative agreements. A cooperative agreement is a form of assistance that allows for substantial involvement by the program office. Substantial involvement is in addition to the usual monitoring and technical assistance provided under a grant (e.g., assistance from the assigned Federal project officer, monthly conference calls, occasional site visits, ongoing review of plans and progress, participation in relevant meetings, provision of training and technical assistance). Substantial programmatic involvement for cooperative agreements under this NOFO may include:

Providing prior approval for change of time that Key Personnel are dedicated to the project and for replacement of Key Personnel. Key Personnel are those personnel whose expertise and experience may be so integrated to the conduct of the project that prior approval is necessary.

Serving as a resource to provide programmatic support during the implementation of activities.

Identification of other organizations with whom the recipient may be asked to develop partnerships.

Assisting the recipient to monitor the progress of the project, which includes but is not limited to collecting, reporting, and analyzing data, and required reporting during the period of performance.

Participating in the preparation of publications and public presentations of the data obtained and dissemination of products produced under this cooperative agreement.

C. ELIGIBILITY INFORMATION

1. Eligible Applicants

Any public or private (profit or nonprofit) entity located in a State (which includes one of the 50 United States, District of Columbia, Commonwealth of Puerto Rico, U.S. Virgin Islands, Commonwealth of the Northern Mariana Islands, American Samoa, Guam, Republic of Palau, Federated States of Micronesia, and the Republic of the Marshall Islands) is eligible to apply for an award under this announcement.

Faith-based organizations and American Indian/Alaskan Native/Native American (AI/AN/NA) organizations that are public or private entities are eligible to apply.

Public or private community-based organizations (CBOs) are eligible to apply.

Examples of eligible Organizations include:

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 a 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 institutions of higher education

For profit organizations other than small businesses

Small businesses

2. Cost Sharing or Matching

You are not required to provide cost sharing or matching in your proposed budget. If you voluntarily include cost sharing in your application, you must include in your budget narrative a non-federal sources justification as described in Section D.3.b.1.t or your application will be disqualified (Section C.4.k). Voluntary cost sharing is not expected for research applications.

During the merit review of an application, cost sharing will only be considered in the overall review of the adequacy of the total proposed budget (Federal and non-Federal share) to support the project proposed.

Applications including cost sharing or matching, whether required or voluntary, that result in an award will include the cost sharing or matching commitment on the notice of award at the level proposed in the application. See Section D.3.b.1.s. Any change in the responsibility to provide cost sharing or matching at that level will require prior approval of the grants management officer.

Cost-Sharing or Matching may include any in-kind contributions necessary to the execution of the proposed project (45 C.F.R. § 75.306).

3. Other - Application Responsiveness Criteria

We will review your application to determine whether it meets the responsiveness criteria below.

If your application does not meet the responsiveness criteria, we will disqualify it from the competition; we will not review it beyond the initial screening. The responsiveness criteria are as follows

There are no Other - Application Responsiveness Criteria.

4. Application Disqualification Criteria

If you successfully submit an application, the OASH Grants and Acquisitions Management (GAM) Division will determine whether your application is eligible according to section C.1 Eligible Applicants. 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 https://grants.gov/ (unless an exemption was granted by the grants management officer 2 business days prior to the deadline) by the date and time indicated in Section D.5 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. You must complete the required forms in the application package: SF-424, SF-424A, SF-LLL, and Project Abstract Summary (Section D.2.a).

https://grants.gov/

d. Your application must be submitted in the English language and must be in terms of U.S. dollars (45 C.F.R. § 75.111(a)).

e. Your Project Narrative section of the application must be double-spaced, on the equivalent of 8 ½ ” x 11” page size, with 1” margins on all sides (top, bottom, left and right) and font size not less than 12 points (Section D.2.a).

f. Your Project Narrative must not exceed 30 pages. The following items do not count toward the Project Narrative page limit: all required forms, including SF-424, SF-424A, SF-LLL, Project Abstract Summary, and Budget Narrative (including budget tables)(Section D.2.a).

g. Your total application (i.e., the Project Narrative plus Appendices) must not exceed 60 pages. The following items do not count toward the Project Narrative page limit: all required forms, including SF-424, SF-424A, SF- LLL, Project Abstract Summary, and Budget Narrative (including budget tables)(Section D.2.a).

h. Your Federal funds request including indirect costs must not be above the maximum indicated in Award Ceiling (Section B.2).

i. Your Federal funds request including indirect costs must not be below the Minimum indicated in Award Floor, if any (Section B.2).

j. Your application must meet the Other - Application Responsiveness Criteria outlined above (Section C.3).

k. If your application includes cost sharing (voluntary or required, Section C.2), you must include in your budget narrative a non-federal sources justification.

D. APPLICATION AND SUBMISSION INFORMATION

1. Address to Request Application Package

You may obtain an application package electronically by accessing Grants.gov at https://www.grants.gov/. You can find it by searching on the Assistance Listing (formerly CFDA) number shown on page 1 of this funding opportunity announcement. If you have problems accessing the application or difficulty downloading, contact:

OASH Grants and Acquisitions Management Division

Phone: 240-453-8822

Email: OASH_Grants@hhs.gov https://www.grants.gov/ mailto: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. This includes but is not limited to:

SF-424 Application for Federal Assistance SF-424A Budget Information for Non-Construction Programs SF-LLL Disclosure of Lobbying Activities Project Abstract Summary

We encourage individuals to use their full name (first, middle, last) on the Standard Forms and other documents such as résumés/curricula vitae/biographical sketches to distinguish them for verification in the System for Award Management exclusion records. Delays may result in award processing if full names are not provided.

Only one Project Director/Principal Investigator (PD/PI) will be named on any resulting award.

You should clearly identify the individual in that role in your application. This individual should be the person who will be responsible for the programmatic aspects of the project if an award is made. A placeholder PD/PI is strongly discouraged because this may not present a clear picture for the review. Furthermore, once an award is issued a request for a change in PD/PI requires prior approval of the grants management officer (45 C.F.R. § 75.308(c)(1)(ii-iii)).

The Project Narrative, and total application including appendices, must adhere to the page limit indicated in Application Disqualification Criteria listed in Section C.4. The page limit does not include the Budget Narrative (including budget tables), required forms, assurances, and certifications as described in the Application Disqualification Criteria.

You must double-space the Project Narrative pages.

Your application must be submitted in the English language and must be in the terms of U.S.

dollars (45 C.F.R. § 75.111(a))

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.

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 (Section C.4(f)-(g)) when printed on 8.5” X 11” paper as determined by OASH/GAM, the application will not be reviewed further. We recommend you print out your application before submitting electronically to ensure that it is within the page limits and is easy to read.

b. Appendices Format

Your appendices should include any specific documents outlined in Section D.3.c, under the heading “Appendices” in the Application Content section of this announcement. Your documents should be easy to read. You should use the same formatting specified for the Project Narrative.

However, documents such as résumés/curricula vitae, 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.

Furthermore, if your project is funded, HHS will publish the abstract from your form on TAGGS.hhs.gov and USASpending.gov. The abstract may also appear on the program office website or other government website. Therefore, do not include sensitive or proprietary information in your abstract.

Research awards may enter zero for “Estimated number of people to be served as a result of the award of this grant.”

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, because 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. HHS/OASH recommends that your project narrative include the following components:

1. Statement of Need Describe with data the nature and scope of the particular need you plan to address. You should include a description of the current gaps, barriers, and facilitators in hepatitis C linkage to care strategies in the population(s) or setting(s) that will be evaluated. Include a description of how your proposed project will build upon or expand prior research or otherwise contribute to the field.

Focus your statement of need on the specific aspects of the history and policy considerations bearing on hepatitis C linkage to care and existing literature with a focus on high quality evidence including randomized controlled trials, cohort studies, case control studies, and if necessary, case series from the primary literature. Avoid providing a broad or sweeping historical overview that is not directly related to the proposed intervention(s) and activities that will be implemented and evaluated.

2. Proposed Partnerships and Interventions Describe the hepatitis C navigation or linkage to care program(s), population(s), and/or setting(s) that you are proposing to partner with and the novel intervention(s) you plan to implement and evaluate. Describe the partner organization(s), how they were identified, and how they will be meaningfully engaged in the project. Examples of partner organizations include: community-based organizations, correctional facilities (jails or prisons), harm reduction programs, substance use disorder treatment programs, and local or state health departments. Provide data-driven rationale of how the “high-impact” setting(s) were selected.

Provide a clear and concise description of the linkage to care intervention(s), a description of specific activities, and how it addresses the need you identified in your statement of need. Explain the rationale for using a particular intervention(s) (e.g., has this approach been successful in other settings or does the research suggest this direction) and to present a clear connection between identified system gaps and needs and activities.

Clearly describe roles and responsibilities of each partnering entity. This includes demonstration of your access to planned data sources and study populations, and all partnerships necessary to complete the proposed project. The roles and responsibilities for each partner should be substantiated with a signed Data Sharing Agreement, Memorandum of Agreement, or Letter of Commitment, that describes the partner’s commitment of resources, time, and personnel to the proposed evaluation (Section D.3.c.2).

3. Evaluation Approach and Outcomes Describe your evaluation plan for both a process and an outcome analysis to assess the impact of the intervention(s). Include the methods you will use to evaluate whether the proposed intervention was implemented as planned and achieves its measurable outcome(s). The process evaluation should describe facilitators and barriers to implementation, the extent to which the program was implemented as designed, and whether the program was accessible and acceptable to the population of focus. The outcome evaluation should examine the effectiveness of the linkage to care programs on key health outcomes. An economic evaluation is also encouraged to provide cost-benefit of the intervention(s). You should clearly identify the measurable outcome(s) that will result from your project. You should describe how you will measure and report on the outcomes of the project. You should describe the quantitative and qualitative tools and techniques that you will employ to measure the outcome(s) and how you will identify and document the “lessons learned.”

We will not fund any project that does not include measurable outcomes. 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. 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.

In addition to discussion in the narrative, you should describe how you envision the project will benefit the field at large.

Describe your data management plan (DMP), including available data sources and feasibility of collecting appropriate process and outcome measures. The DMP should include a description of the protection of privacy, confidentiality, security, and intellectual property, or other rights.

4. Dissemination You should describe the method you will use to 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. This may include but is not limited to peer reviewed journals. We may publish (including on a website), all appropriate findings and products (See Section H.9).

You should propose other, innovative approaches to sharing results with audiences who might be interested in using the results of your project to inform practice, service delivery, program development, and/or policymaking, especially to those who would be interested in replicating the project.

5. Organizational Capacity You should describe your organization’s capability to successfully implement and evaluate the proposed project. You should describe your organization’s readiness to begin implementation and evaluation of the intervention within the first 3-6 months of the project. You should describe how your organization (or the particular division of a larger organization which will have responsibility for this project) is organized, the nature and scope of its work, and the capabilities it possesses. Your description should cover capabilities of your organization not included elsewhere in the program narrative, such as any current or previous relevant experience and/or the record of the project team in preparing cogent and useful reports, publications, and other products. Refer to the organization chart in your Appendices showing the relationship of the project to your organization and your partners.

You should clearly delineate the roles and responsibilities of project staff and subrecipients and how they will contribute to achieving the project’s objectives and outcomes. Identify the key personnel for the project, describe their role on the project, and include their organization of affiliation. Key personnel should include at minimum the Project Director/ Principal Investigator (PD/PI) and Lead Evaluator for the project.

Identify any additional project personnel whose contributions are essential to the project.

Summarize the relevant skills, experience, and training for each key personnel position that demonstrates the person selected is well-suited to their role on the project.

You should specify who would have day-to-day responsibility for key tasks such as:

leadership of evaluation; monitoring the project’s on-going progress; preparation of reports; and communications with other partners and OIDP. You should clearly identify the individual who will serve as the PD/PI and that individual’s qualifications. We expect that, throughout the award period, the PD/PI will have involvement in, and substantial knowledge about, all aspects of the project.

Also include information about any contractual and/or supportive staff/organization(s) that will have a secondary role(s) in implementing the project and achieving project goals.

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.

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). You must state the method you are selecting for your indirect cost rate. See Indirect Costs (Section D.3.b.1.o)) for further information. If you are providing in-kind contributions of any type or value, including costs otherwise covered by your indirect cost rate, you must identify those costs, and you should, as appropriate, include the value of the in-kind contribution as proposed cost-sharing (voluntary or required ) (45 C.F.R. § 75.306).

Please be sure to carefully review Section D.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. For awards with an anticipated period of performance of one year or less, this will be the budget request for the entire project. Provide a budget justification, which includes explanatory text and line-item detail, for the entire 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 in an anticipated multi-year project, provide a summary narrative and line-item budget for each year beyond the first. For categories or items that differ significantly from the first budget year, provide a detailed justification explaining these changes.

Do not include costs beyond the first budget period 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 period.

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. If you are proposing to provide services to clients, you should describe how many clients you expect 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 (if applicable) must be detailed and justified in the budget narrative. "Federal resources" refers only to the HHS/OASH funds for which you are applying under this NOFO. "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.

Object Class Federal Funds Requested

Non-federal Resources

Total Budget

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

Subrecipient/contract and consultant detailed costs should all be included in those specific line items, not in the overall project object class line items. For example, subrecipient travel should be included in the Contractual line item not in Travel. Subrecipient/contract and consultant activities must be described in sufficient detail to describe accurately the project activities that each will conduct.

1. Object Class Descriptions and Required Justifications

a. Personnel Description

Costs of staff salaries and wages, excluding benefits.

b. Personnel Justification

Clearly identify the PD/PI, 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.7.2) 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.

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. Do not include travel costs for subrecipients or contractors under this object class.

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 under this object class.

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. (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 C.F.R. § 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.

Whenever you intend to transfer a substantive part of the project effort to another entity (including non-employee individuals), you must provide a detailed budget and budget narrative for each subrecipient/contractor, by title/name, 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 transferred, the estimated costs, and the process for selecting the subrecipient/contractor.

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 and must clearly identify that selection in your submitted budget.

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 acknowledgment that the organization is accepting a lower rate than allowed.

Per 45 C.F.R. § 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.”

The de minimis rate 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.

Indirect costs on Federal awards for training are limited to a fixed rate of eight percent of MTDC exclusive of tuition and related fees, direct expenditures for equipment, and subawards in excess of $25,000 (45 C.F.R. § 75.414 (c)(1)(i)).

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 C.F.R. § 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. Except as otherwise provided in Federal statutes, regulations, or the terms and conditions of the Federal award, program income does not include rebates, credits, discounts, and interest earned on any of them. See also 45 C.F.R.