U.S. Department of Health and Human Services

Office of Minority Health

Notice of Funding Opportunity

National Lupus Outreach and Clinical Trial Education Program

Opportunity Number

MP-CPI-26-001

Application Due Date

07/10/2026

Technical Assistance Webinar Date

06/24/2026

Table of Contents

SUMMARY

A. ELIGIBILITY INFORMATION

1. Eligible Applicants

a. Eligible Entities

b. PD/PI Eligibility

c. Other Considerations

2. Application Responsiveness Criteria

3. Cost Sharing or Matching

B. Agency Priorities

C. PROGRAM DESCRIPTION

1. Expectations for Recipients

a. Build and Sustain Trusted Community Partnerships

b. Adaptation of Evidence-Informed Practice

c. Demonstrate Increased Enrollment in Lupus Clinical Trials

d. Implement a Process and Outcomes Evaluation

e. Document and Disseminate Project Findings

2. Federal Involvement in the Project

3. Eligibility criteria for project participants

D. AWARD INFORMATION

E. APPLICATION CONTENTS AND FORMAT

1. Format of the Application

a. Project Narrative – Formatting

b. Appendices to the Project Narrative – Formatting

c. Budget Package - Formatting

2. Content

a. Project Narrative - Content

b. Appendices to the Project Narrative – Content

c. Budget Package - Content

F. SUBMISSION REQUIREMENTS AND DATES

1. Obtaining an Application Package

2. Required Registrations

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

b. Grants.gov Registration

3. Submission Instructions

a. Electronic Application Submission

b. Submission Dates and Times

c. NOFO Technical Assistance Webinar

4. Other Submission Requirements

a. Program-Specific Requirements

b. Follow-up Submission Requirements

G. APPLICATION REVIEW INFORMATION

Application Qualification

Merit Review

Programmatic Technical Review and Risk Assessment

1. Responsiveness Review

2. Merit Review Criteria

3. Merit Review and Selection Process

4. Review of Risk Posed by Applicant

H. AWARD NOTICES

I. AWARD REQUIREMENTS AND ADMINISTRATION

1. Administrative and National Policy Requirements

2. Program Specific Terms and Conditions

a. Paperwork Reduction Act Clearance Packages

3. Award Closeout

4. Lobbying Prohibitions

5. Non-Discrimination Requirements

6. Smoke- and Tobacco-free Workplace

7. Acknowledgement of Funding

8. HHS Rights to Materials and Data

9. Trafficking in Persons

10. Efficient Spending

11. Whistleblower Protection

12. Health Information Technology (IT) Interoperability

13. Certain telecommunications and video surveillance services or equipment

14. Human Subjects Protection

15. Research Integrity

16. Reporting

a. Performance Project Reports (PPR)

b. Financial Reports

c. Audits

d. FFATA and FSRS Reporting

f. Other Required Notifications

J. CONTACTS

Administrative and Budgetary Requirements

Program Requirements

Grants.gov Support

SAM.gov Registration Support

K. OTHER INFORMATION

1. Application Checklist

2. Acronyms

3. References

4. Object Class Descriptions and Required Justifications

5. Considerations in Recipient Plans for Oversight of Federal Funds

6. Financial Assistance General Certifications and Representations

BASIC INFORMATION

Opportunity Title

National Lupus Outreach and Clinical Trial Education Program

Program Office

The Office of the Assistant Secretary for Health, Office of Minority Health Application Submission and Format

Electronic application submitted via

Grants.gov ONLY. Opportunity Number

MP-CPI-26-001

Award Type

Grant

Application Deadline

07/10/2026

Announcement Type

Initial

Technical Assistance Webinar Date

06/24/2026

Assistance Listing

93.137, Community Programs to Improve Minority

Health

Technical Assistance Webinar

Details

See Section F.3.C for more details

Eligible Applicants (see Section A.1 for full details)

Executive Order 12372 does apply to this NOFO (see section E.3.D)

Estimated Total Funding Available

$3,000,000

Estimated Period of Performance

(months)

Estimated Number of Awards

Anticipated Award Date

09/30/2026

Anticipated Award Funding Range

$500,000

Anticipated Project Start Date

09/30/2026

QUESTIONS?

Additional contact information in Section G

SUMMARY

The Office of Minority Health (OMH) announces the anticipated availability of funds for

Fiscal Year (FY) 2026 grants under the authority of Section 1707 of the Public Health

Service Act (42 U.S.C. § 300u-6).

This notice solicits applications for projects to implement integrated, community-based models that increase participation of underrepresented populations in lupus clinical trials across the full participation pathway, including awareness, referral, screening, enrollment and retention.

OMH 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 their application complies with all requirements and instructions.

The Office of the Assistant Secretary for Health (OASH) Grants and Acquisitions Management

Division (GAM) will administer this award.

A. ELIGIBILITY INFORMATION

1. Eligible Applicants

You must meet all the eligibility requirements for us to review your application.

a. Eligible Entities

Any public or private 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 non-profit private entities are eligible to apply.

Public or non-profit community-based organizations (CBOs) are eligible to apply. Non-profit private institutions of higher education are eligible to apply.

Other 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

b. PD/PI Eligibility

There is no restriction on an individual’s eligibility to be Project Director (PD)/Principal

Investigator (PI). However, we will not make an award with a PD/PI who has an active government-wide exclusion, suspension, or debarment recorded in SAM.gov.

We expect that throughout the period of performance the PD/PI will be involved in, and have substantial knowledge about, all aspects of the project. Although your organization may recognize co-PD/PIs on team-managed projects, we recognize only a single PD/PI who will be responsible for the programmatic aspects of the project.

c. Other Considerations

Submitting Multiple Applications

You may submit more than one application, but each application must be for a distinctly different project.

If you submit multiple applications for the same project, we will accept only the last application submitted with a Grants.gov timestamp that is before the due date and time. We will disqualify all other versions of the application. See Section F.1.b for all disqualification factors.

Submitting an Application as a Group or Consortium

For any given project, we will only make an award to a single eligible entity. More than one entity may choose to work together on a project under this opportunity, but only one entity may submit the application. If awarded, that entity will be the award recipient and will be responsible for conducting the project.

The other entities may participate in the project, if awarded, and would be responsible to the recipient for their respective roles, typically as subrecipients.

Groups may form a consortium, partnership, or other legally recognized entity for the purpose of applying for this opportunity and carrying out any awarded project. The resulting entity must exist and be legally recognized when it applies and must have an active registration in SAM.gov. We will conduct a risk assessment on the applying entity (Section

F.4) prior to making any award.

Eligibility Documentation

We do not require you to submit documentation of your eligibility (e.g., proof of 501(c)(3) status as determined by the Internal Revenue Service or an authorizing tribal resolution) when you submit your application. It is important that your organization is correctly classified in your SAM registration (Section E.2.a).

During our review of your application, we might request additional documentation to support your eligibility. This request means only that your application is under review and not that you will receive an award.

More specific information on the type of documentation that we might request specific to this opportunity appears in Section E.4.b.

Application Disqualification

We will disqualify applications that fail to meet the eligibility, responsiveness, formatting, and submission requirements (Sections F.1.b) prior to conducting merit review. Disqualified applications will not undergo further review.

We will notify disqualified applicants at the end of the competition when we announce the award recipients.

2. 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.

3. Cost Sharing or Matching

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

B. Agency Priorities

The recipients of this award must implement any funds awarded under this NOFO to effectuate program goals and agency priorities in accordance with the Priorities of the Office of the

Assistant Secretary for Health (available online at: https://health.gov/priorities), and when authorized by law according to the OMH statute, regulations, legislative mandates, and additional program guidance. Funded activities must advance and support OASH’s mission to improve the health and well-being of Americans.

In addition, the recipient is required to administer any project that is awarded under this NOFO in accordance with the following objectives in the OMH statute that are authorized to advance them:

1. Implement a Quality Improvement and Quality Assurance (QI/QA) Plan with the goal to achieve optimal health outcomes https://health.gov/priorities

The recipients must demonstrate ongoing compliance with these priorities, in all programs that are authorized to advance them, through program design, implementation, reporting, and evaluation. Failure to meaningfully align funded activities with the applicable requirements may result in corrective action, additional reporting requirements, or other actions consistent with federal grant regulations found at 2 C.F.R. Part 200 and the terms and conditions of this award (including termination pursuant to 2 C.F.R. 200.340(a)(4) for no longer effectuating program goals or agency priorities).

C. PROGRAM DESCRIPTION

The Office of the Assistant Secretary for Health (OASH), Office of Minority Health

(OMH) announces the anticipated availability of funds for Fiscal Year (FY) 2026 grants under the authority of Section 1707 of the PHS Act (42 U.S.C. § 300u-6).

The primary focus of OASH is to lead Americans toward healthier lives by promoting health and well-being across the lifespan. Grants funded through this NOFO will:

• Reduce lupus-related adverse health outcomes by increasing participation of underrepresented populations in lupus clinical trials.

• Support outreach, education, and partnerships that move beyond awareness building to measurable participation outcomes, including screening, enrollment, and retention in lupus clinical trials.

Background

Systemic lupus erythematosus (lupus) is a chronic autoimmune disease that causes inflammation across multiple organ systems, resulting in a wide range of clinical manifestations and ongoing challenges in disease management.¹,² In autoimmune conditions such as lupus, the immune system produces autoantibodies that target healthy tissue, leading to inflammation, tissue injury, and organ damage.² The most common form, systemic lupus erythematosus (SLE), can affect the skin, joints, kidneys, brain, lungs, blood vessels, and other organs.²

Although advances have improved disease management, the etiology of lupus remains incompletely understood, and no cure exists.¹,² Epidemiologic studies demonstrate variation in incidence, severity, and outcomes across populations. SLE occurs more frequently and with greater severity among Black, Hispanic/Latino, Asian, Pacific Islander, and American Indian, Alaska Native populations compared with non-Hispanic White populations.³-⁶ Population-based registry data further show that these groups are more likely to experience earlier disease onset, higher disease activity, and increased risk of complications.³–⁶ Women are disproportionately affected, particularly those of childbearing age.²,⁶

Clinical trials play a central role in the development of new lupus therapies. However, participation in lupus clinical trials does not consistently reflect the populations most affected by the disease. A recent systematic review of U.S. SLE clinical trials found underrepresentation of

Black, Asian, and Hispanic/Latino participants across most included studies.⁷ Earlier review literature similarly found that randomized SLE trials did not adequately reflect the racial and ethnic distribution of the lupus population.8 This limits the ability to fully evaluate treatment effects across populations with the highest burden of disease.⁷,8

Barriers to clinical trial participation occur at multiple stages, including awareness, referral, enrollment, and retention. Lupus-specific studies have identified concerns about side effects, uncertainty about trial processes, limited awareness, and logistical challenges as key factors influencing participation.⁹ In addition, broader clinical trial literature identifies factors across the patient journey that can affect recruitment and retention, including access barriers, trial burden, communication gaps, and site- or provider-level processes that influence whether patients move from outreach to enrollment.¹⁰,¹¹ These factors contribute to inefficiencies across the clinical trial pathway, particularly when research infrastructure is not well integrated with community-based care settings.¹⁰,¹¹

Current implementation and community-engagement literature further support the value of trusted messengers and community-based partnerships in improving trial participation. A recent review on community engagement strategies for underrepresented populations emphasizes the importance of identifying strong community partners and addressing both patient- and provider-level barriers to participation.¹²,¹³ A systematic review of strategies to improve enrollment of underrepresented populations found that successful approaches frequently used community-engaged methods and included health care providers as a key strategy.¹² Together, these findings support the use of trusted community channels and community-based partnerships to strengthen connections between outreach and enrollment.¹¹,¹²

Despite continued efforts to improve participation, gaps in enrollment persist. Evidence suggests that these gaps are associated with limited access to trial-ready sites, insufficient alignment between outreach and enrollment processes, and barriers that affect both patients and providers.⁶–

¹² Addressing these challenges requires coordinated approaches that strengthen community-based partnerships, improve pathway integration from awareness to enrollment, expand access to clinical trial infrastructure, and reduce operational barriers to participation.⁷–¹²

1. Expectations for Recipients

Funded projects should meet the following expectations:

a. Build and Sustain Trusted Community Partnerships

We expect recipients to utilize standard practices necessary for establishing and sustaining effective collaborative partnerships, including public-private and community partnerships. This includes developing a structure for regularly engaging community and partnering organizations in the design and review of outreach or education interventions to be tested through their project.

Recipients should leverage the strengths of each partner organization. Partners may also play a role in sustaining the project after the award ends, and in supporting and/or sustaining effective practices to increase underrepresented enrollment and retention in lupus clinical trials.

Recipients must have an established relationship with a lupus clinical trial site or have a plan to establish a relationship with a lupus clinical trial site by the end of the first quarter of the award period. In addition, recipients should implement a project that involves at least two collaborative partnerships with at least two different organizations. All partner organizations that will receive subawards of $10,000 or more must have an active SAM.gov registration at the time the application is submitted, or provide a written plan for obtaining registration within 30 days of award. For each anticipated subaward exceeding $10,000, the application must include a budget summary by object class, a description of the work to be performed, and the expected deliverables and timeline. Partners that are selected post-award must be documented in the first quarterly performance report with the same level of budget and scope detail. One of the organizations must be a:

• Local hospital, health care system, Federally Qualified Health Center (FQHC), or community health center;

• National, state, or local professional organization that represents primary care physicians, other health care providers, and/or Community Health Workers (CHWs);

• An organization with experience recruiting minority participants into clinical trials; or

• A Tribe or tribal organization.

We strongly encourage recipients to engage community-based organizations (CBOs), health care providers and clinical trial sites in their project implementation as appropriate. Recipients should demonstrate an existing partnership or a clear plan to establish relationships with lupus clinical trial sites to support referral, screening, enrollment, and retention activities.

b. Adaptation of Evidence-Informed Practice

We encourage recipients to adopt an evidence-informed practice to increase minority participation in clinical trials for the intended population of focus. We also expect recipients to implement the adapted intervention and ensure the sustainability of the improved results.

Recipients should implement the adapted intervention(s) in underrepresented communities within cities and/or counties where lupus clinical trials are recruiting patients, and in medically underserved areas.

Interventions may include:

• Education models that improve attitudes and practices of health care providers and paraprofessionals to increase underrepresented enrollment and retention in lupus clinical trials;

• Outreach on lupus clinical trials aimed toward underrepresented individuals;

• Capacity-building models designed to recruit, enroll and retain participants in clinical trials and patient-centered, culturally appropriate lupus clinical trial education models.

c. Demonstrate Increased Enrollment in Lupus Clinical Trials

We expect recipients to demonstrate the extent to which the project has increased the number of participants recruited, screened, and enrolled into lupus clinical trials. Recipients must establish a baseline count of referrals, screenings, and enrollments at the start of the project period, verified by the partnering clinical trial site(s), and must report against that baseline at each quarterly reporting interval. Self-reported enrollment counts must be corroborated by documentation from the clinical trial site (e.g., site enrollment logs, IRB-approved participant tracking records).

d. Implement a Process and Outcomes Evaluation

We expect projects to implement a rigorous evaluation to assess the impact of project activities.

Recipients should implement a process and outcomes evaluation that assesses the extent to which the intervention increased underrepresented referrals, enrollment, and/or retention in lupus clinical trials. In addition to this measure, recipients should measure lupus clinical trial knowledge of healthcare providers/community health workers and measure attitudes, knowledge and beliefs gained using pre- and post-surveys. The evaluation should also assess the continued effectiveness of adapted interventions, fidelity, and any differential effects based on the adaptation approach.

The evaluation plan should clearly demonstrate that evaluation of the impact of the intervention will be able to detect a statistically significant difference in key project outcomes, if such an impact is present. The evaluation design should control for threats to validity, including effect size. We expect the impact analysis of the intervention to be conducted within the period of performance.

Recipients should:

• Use SMART objectives

• Collect baseline, interim, and post-intervention data

• Measure outcomes across the participation pathway to ensure federal resources are impacting the number of referrals, enrollment and retention in lupus clinical trials

e. Document and Disseminate Project Findings

We anticipate recipients will develop new knowledge about existing interventions that increase underrepresented populations’ participation in lupus clinical trials. Recipients should document project knowledge and findings, to include implementation process, lessons learned, successes and challenges. We expect recipients to communicate and disseminate project knowledge and findings, to include dissemination to federal, state, territorial and tribal public health agencies;

policymakers; community organizations; community members; and other stakeholders. All appropriate findings and products may be posted on an HHS/OMH sponsored website (Section

F.9). We expect that nationwide dissemination of products and knowledge will occur. When published, materials should be freely, immediately, and accessible to the public.

Recipients should:

• Publish findings

• Share best practices

• Ensure public accessibility

2. Federal Involvement in the Project

If you receive an award, we will encourage you to seek the advice and opinion of federal staff when problems arise. However, you would be responsible for making sound programmatic and administrative judgments. The responsibility for operating decisions will be yours and does not shift to HHS, OASH, or OMH.

Under a grant, the program office’s involvement may include routine monitoring and technical assistance such as monthly conference calls, occasional site visits, ongoing review of plans and progress, participation in relevant meetings, provision of training and technical assistance.

3. Eligibility criteria for project participants

You must not restrict participation in the project on the basis of race, color, national origin, religion, sex, disability, age, or another protected characteristic (See Section H.5).

D. AWARD INFORMATION

Budget period

We expect to fund awards in 12-month budget periods for a total period of performance up to 36 months (3 years). However, we may approve shorter periods of performance. Budget periods may vary from the estimated 12 months because of the timing of award issuance or other administrative factors.

For multi-year projects, recipients must submit a non-competing continuation (NCC) application for each budget period after the first year. We will provide guidance generally 3 months prior to the end of the active budget period. Continuation funding is contingent upon the availability of funds, satisfactory progress of the project, appropriate stewardship of federal funds, and the best interests of the government. Funding for all approved budget periods after the first is generally the same as the initial award amount and may be subject to any offset with funds unused in a previous budget period.

E. APPLICATION CONTENTS AND FORMAT

1. Format of the Application

You must prepare your application using the forms and information described in this NOFO.

The official online application package on Grants.gov contains all necessary forms and guidance for preparing an application. This package includes but is not limited to:

• Full Text of the NOFO

• Standard forms (required) and their instructions o SF-424 Application for Federal Assistance o SF-424A Budget Information for Non-Construction Programs o SF-LLL Disclosure of Lobbying Activities o Project Abstract Summary

• Sample templates, if available.

In addition to the four standard forms in the application package, your application will consist of three sections of materials you prepare:

• Project Narrative

• Appendices to the Project Narrative

• Budget Package.

We strongly encourage you to read all instructions for the application format and content to avoid disqualification of your application. An application checklist is available in Section J.1.

a. Project Narrative – Formatting

Following the formatting instructions below will help ensure that your application is readable for review process. Acceptable electronic file formats are in Section E.3.a.

Names of Individuals

We encourage you to use individuals’ full names (first, middle, last) on the standard forms and any other documents such as résumés/curricula vitae/biographical sketches to distinguish them for verification in the SAM exclusion records. Delays in award processing may result if full names are not provided.

You should avoid submitting personally identifiable information such as personal contact information (e.g., home address and telephone number) on résumés/curricula vitae/biographical sketches. Do not submit Social Security Numbers.

If you receive an award, only one Project Director/Principal Investigator (PD/PI) will be named on the award documents. (Section A.1.b) Avoid using a placeholder or honorary PD/PI. If you have not hired an individual to be the PD/PI, you should name an interim PD/PI, and your application should clearly identify that person as such.

We typically expect the PD/PI to be named on the SF-424 in box 8.f. Avoid naming grant writers in box 8.f unless they have the expertise to respond to technical questions about the proposed project in a timely manner.

Identify other personnel who are essential or key to the execution of the proposed project clearly in your project narrative.

If you receive an award, a request for a change in PD/PI or key personnel under any circumstance requires prior approval of the grants management officer before becoming effective. We may disallow any costs incurred as a result of that change prior to our approval.

See Section H.1.c.

Page Formatting

If you submit documents that do not conform to the following instructions, GAM will disqualify your application during the review process (Section F.1.b).

Use an easily readable typeface, such as Times New Roman or Arial.

Use a 12-point font.

Use an 8.5” X 11” page size. Any other size page (e.g., A4, legal) will disqualify your application.

You must double-space the Project Narrative pages, or we will disqualify your application. You may single-space tables or use alternate fonts, but you must ensure the tables are easy to read.

Do not number pages or include a table of contents. Our grants management system will generate page numbers once your application is complete.

You must submit your application in the English language and in terms of U.S. dollars (2 CFR

200.111).

Page Limits

Your project narrative and appendices must adhere to these page limits.

The page limits do not include the budget package.

The page limits do not include the required forms (SF-424, SF-424A, SF-LLL, and the Project

Abstract Summary).

If your application exceeds the specified page limits when printed on 8.5” X 11” page, we will not review your application further.

We encourage you to print out your application before submitting it to ensure that it is within the page limits and is easy to read. Do not reduce pages to fit multiple pages on a single sheet to avoid exceeding the page limitation.

Do not hyperlink to documents or sites outside of your application to augment your application.

Reviewers will not be permitted to follow links to external content during their assessment of your application. The one exception to this is a link to your internal controls as part of your budget package.

Page Limit

Project Narrative 40 pages

Project Narrative plus Appendices 65 pages

Labeling Proprietary Information

Proprietary information includes patentable ideas, trade secrets, privileged or confidential commercial or financial information, the disclosure of which may harm the applicant. You should include proprietary information in your application only to the extent that it is essential to the reviewers’ understanding of the project. Proprietary information should not appear in your

Project Abstract Summary.

https://www.ecfr.gov/current/title-2/section-200.111

If your application contains proprietary information, you should clearly label the top of the first page of the project narrative. For example:

“Contains proprietary or confidential information that [Your Organization Name] requests are not released to persons outside the government, except for purposes of review and evaluation.”

Awarded applications are subject to release under the Freedom of Information Act (FOIA) with redactions as the FOIA statute permits.

b. Appendices to the Project Narrative – Formatting

Your appendices should include any specific items outlined in Section D.2.b. 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/biographical sketches, organizational charts, tables, Memoranda of Agreement (MOAs) or Letters of Commitment (LOCs) may have formatting common to those documents, so long as the pages are easy to read. For example, resumes, MOAs and LOCs may be single-spaced.

You must upload all of your appendices as a single, consolidated file in the Attachments section of your Grants.gov application. You must use an acceptable file format (Section E.3.a). We strongly encourage you to convert your file(s) to PDF format before uploading and review them to ensure accurate conversion.

Your Project Narrative plus the Appendices may not exceed the total number of pages for the application (Section D.1.a).

c. Budget Package - Formatting

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 an 8.5” x 11” page. You must use an acceptable file format (Section E.3.a). We do not accept Excel or other similar spreadsheet formats.

The application page limit does not include the SF-424A or the budget narrative (including budget tables).

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

2. Content

a. Project Narrative - Content

The Project Narrative is the most important part of your application. We will use it as the primary basis to determine whether your project merits an award. The project narrative should provide a clear and concise description of your project. We recommend that your project narrative include the following components with the requested information. Labeling the sections accordingly will help the reviewers find information quickly.

• Significance of the Project;

• Goals, Objectives, and Outcomes;

• Project Plan;

• Organizational Capability;

• Evaluation Plan; and

• Dissemination Plan.

Further details:

Significance of the Project

Describe how you envision the project will benefit the field, targeted population, and society

(i.e., significance of the project). Using quantitative data, describe the significance of your project in meeting the need for increasing enrollment of clinical trial participants within your intended population(s) and geographic area(s) of focus to address the disproportionate impact of lupus on underrepresented populations. Refer to the population of focus data provided in your appendices as appropriate. Your description should identify the contributing factors to the disproportionate impact addressed by your project. Describe the specific barriers to your focus population's participation in clinical trials. Describe how the project will potentially affect the populations served, specific subgroups within those populations, and other identified interested stakeholders. Also describe the anticipated importance, supported by data, for public-private partnerships and community partnerships to support and sustain project activities.

Goals, Objectives, and Outcomes

Describe the overall project goals, annual short-term and long-term objectives, and outcomes.

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.

Provide a sufficient description of the magnitude of impact on intervention outcomes and performance measure objectives for the proposed activities. Your objectives should be

SMART (specific, measurable, attainable, relevant, time-bound). SMART objectives should include baseline data and quantifiable timeframes for achievement. Objectives should focus on overall goals of the project rather than project activities. Intervention objectives should describe the overall goals of the project rather than project activities. Goals must be ambitious and achievable in the project's timeframe. This section should clearly identify the measurable outcome(s) that will result from the project, and provide a specific, quantified estimate of the expected outcome(s).

Your objectives and outcomes should align with your vision of how the project will benefit the field, targeted population, and society (i.e., significance of the project).

Project Plan

In reference to your work plan in your appendices, provide a detailed summary of activities to be undertaken, and how those activities will assist in achieving the project goals and objectives including increasing underrepresented participation in lupus-related clinical trials.

Explain the rationale for the lupus intervention you selected and present a clear connection between any identified evidence gaps, needs, and the proposed project activities. Describe how the intervention will be tailored for the population(s) of focus while maintaining fidelity to its core components. Also describe specific practices you will use in your project to address the contributing factor(s) your proposal addresses. Identify any major barriers anticipated and how the project will be able to overcome those barriers.

Describe the approach and rationale for recruiting, enrolling, and retaining participants. Also describe how the approach will increase the number of participants recruited, screened, and enrolled into lupus clinical trials. Describe how your project will increase provider and/or underrepresented participation and address barriers to underrepresented participation in lupus clinical trials.

Describe the proposed approach for developing public-private and community partnerships and related activities, and the rationale behind the strategies that will be used to work with partners to achieve the project goals.

This section should describe how the proposed intervention is culturally and linguistically appropriate for the population of focus. Describe how you will apply the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care (National

CLAS Standards) (https://thinkculturalhealth.hhs.gov/clas/standards) to facilitate your project.

Describe the approach that you will use to monitor progress on the tasks and objectives.

Describe how you will use data collected over the course of your project to support quality improvement and ensure the project is implemented in a culturally appropriate manner over the full period of performance.

Organizational Capacity

Describe your organizational readiness to implement the intervention(s) or practice(s).

Describe how your organization (or your division of a larger agency responsible for this project) is organized, the nature and scope of its work, and the capabilities it possesses.

Describe any current or previous relevant experience, including any significant experience relative to the inclusion of underrepresented populations in clinical trials. Describe any experience and expertise in the following area:

• Health education and outreach to of minority populations– including education on lupus disease awareness, health literacy, navigation of the healthcare system https://thinkculturalhealth.hhs.gov/clas/standards

• Clinical trial outreach to increase underrepresented population enrollment;

• Evaluation of outreach education and training programs related to recruitment, participation and retention in clinical trials; and

• Engagement with individuals and families of people living with lupus.

If relevant to your selected intervention, include experience working with CHWs and other patient advocates and their role in outreach, education, and training related to recruitment and participation in clinical trials.

Describe the organization’s history of forming, managing, and engaging community and partnering organizations in the conduct of health-related initiatives. Describe your existing public-private and community partnerships relevant to this project and identify partner roles and responsibilities in reference to any submitted memoranda of agreement (MOAs).

Describe your readiness for implementing the project and achieving measurable outcomes in the period of performance.

Describe areas of expertise for key personnel in reference to the curricula vitae, résumés, or biographical sketches you submit. At a minimum, key personnel include the Program

Director/Principal Investigator who will have day-to-day oversight of the project. You should identify the specific knowledge and expertise on issues related to clinical trials to support developing and implementing effective outreach or education interventions regarding lupus clinical trials. You should also identify the significant knowledge and expertise in lupus epidemiology, diagnosis, treatment, and health care access issues.

Key Personnel includes those individuals in roles who will oversee the technical, professional, managerial, and essential support functions and/or assume responsibility for assuring the validity and quality of your organization’s project. Key personnel do not include individuals who provide routine administrative support to the project as part of their broader support of the organization. You should describe the qualifications, competing time commitments, and related ongoing projects of all key personnel. Identify the individuals/organizations responsible for evaluation activities and their qualifications.

Describe the relationship between the evaluator and your organization and the degree of independence the evaluator will have. The evaluator must have structural independence from program implementation staff. Evaluators who report directly to the Project

Director/Principal Investigator or who are responsible for implementing program activities are not considered independent. Recipients are strongly encouraged to contract with a third-party evaluator. If an internal evaluator is proposed, the applicant must provide a detailed explanation of the safeguards that will ensure objectivity, including separation of duties and independent reporting lines.

Reference the organizational chart in your appendices. This chart should include the contractual and/or supportive organizations that will become part of the network. Describe any contractual and/or supportive staff/organization(s) that will have a secondary role(s) in implementing the project and achieving project goals should be included.

Evaluation Plan

Provide a process and outcomes evaluation plan for the project describing the evaluation approach you will use to determine whether the project reaches its population(s) of focus.

Your evaluation plan should demonstrate the impact of the project on the identified adverse health outcomes. Your evaluation design should clearly establish whether project activities result in the intended outcome(s). The evaluation design must demonstrate controls for threats to validity and the ability to show a statistically significant impact of your intervention on the key outcomes.

Identify the data you will collect and use to monitor and document key project outcome(s), detailing the validity and reliability of proposed measures/indicators. Describe the methods you will use to collect your data, including performance measurement data, and how you will overcome any potential obstacles to data collection.

Include your approach to collecting, at minimum, baseline, interim, and post-intervention process and outcome measures.

Specifically describe how you will:

• Evaluate all components of the project’s logic model, including how the inputs, processes, outputs, and outcomes will be measured and linked

• Track screening and enrollment outcomes, including eligibility determination and participation rates

• Monitor retention in clinical trials, where feasible, including follow-up mechanism

• Assess the extent to which the intervention(s) increased underrepresented participation across all stages of the clinical trial pathway (referral, screening, enrollment and retention)

• Identify barriers and challenges to participation in lupus clinical trials.

• Detail the role of your project partners in supporting data collection, tracking, and evaluation activities

Applicants must:

• Define measurable outcomes (not outputs)

• Demonstrate ability to detect impact

• Use quantitative and qualitative methods

Dissemination Plan

Describe the method you will use to disseminate the project's results and findings on time and in easily understandable formats to the population served, the general public, and other parties interested in using the project results. In addition to traditional forms of dissemination such as scholarly articles in peer review journals, we encourage you to propose innovative approaches to inform those who might be interested in using the results of your project.

Dissemination efforts should focus on assisting those who may be interested in replicating your project. All relevant findings and products may be posted on an HHS/OMH- sponsored website as determined by HHS/OMH. See also Section F.9.

b. Appendices to the Project Narrative – Content

All items described in this section will count toward the total page limit of your application. You must submit them as a single electronic file uploaded to the Attachments section of your

Grants.gov application.

Samples and optional forms/templates for some of these items are located under the Related

Documents tab for this NOFO on Grants.gov.

Your application should include the following appendices:

Work Plan

Your Work Plan should reflect, and be consistent with, the Project Narrative and Budget

Narrative, and must cover all years of the period of performance. 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.

An optional Objective Work Plan (OWP) template is provided in the application materials on grants.gov (the 3 instruction pages will not count toward your page limit) or you may create your own work plan. Regardless of the option you choose, the work plan you submit must address all the content requested.

Logic Model

You should submit a detailed logic model that describes the inputs, objectives, activities, outputs, and short- and long-term outcomes of the intervention being tested through the proposed project. All program objectives, activities, and anticipated outcomes shall be reflected in the logic model and demonstrate that the proposed project reflects a coherent approach.

Project Population(s) of Focus

Submit a table outlining the population(s) of focus within the identified geographic area of focus using quantitative data.

Memoranda of Agreement (MOAs) and/or Letters of Commitment (LOCs)

If available at the time of submission, signed MOAs or signed LOCs may be submitted for each partner (or one signed MOA with all partners). MOAs and LOCs should include a description of the specific roles, responsibilities, resources, and contributions of partner(s) to the project.

Signed LOCs must detail the specific role and resources that will be provided, or activities that will be undertaken, in support of the applicant. The organization’s expertise, experience, and access to the targeted population(s) should also be described in the LOC. Fully-executed

MOAs may be required within the first 30 days following the start of the project period of any award made under this announcement.

MOAs and LOCs are not the same as letters of support. Letters of support are letters that are general in nature that speak to the writer’s belief in the capability of an applicant to accomplish a goal/task. Letters of support also may indicate an intent or interest to work together in the future, but they lack specificity. You should NOT provide letters of support.

Letters of support will not be considered during the review.

Organizational Chart

Include an organizational chart that reflects the management structure for the project and demonstrates where the project resides within the greater organization.

Curriculum Vitae/Résumés/Biosketches for Key Project Personnel

Submit with your application curriculum vitae, résumés, or biosketches of the Project

Director/Principal Investigator, Evaluator, and others identified as essential in the proposal.

Key Personnel includes those individuals in roles who will oversee the technical, professional, managerial, and essential support functions and/or assume responsibility for assuring the validity and quality of your organization’s project. Do not include curriculum vitae, résumés, or biosketches for individuals who provide routine administrative support to the project as part of their broader support of the organization. You should use full names

(first, middle, last) on these documents to distinguish them for verification in the System for

Award Management exclusion records. You should use the formatting common to those documents. (See https://grants.nih.gov/grants/forms/biosketch.htm for templates and sample biographical sketches.)

References Cited

Include your references cited in your project narrative. You may use any standard format that you choose as long as it will clearly lead the reader to your source of information or data.

c. Budget Package - Content

A complete budget package consists of the following required components:

• SF-424A “Budget Information Non-Construction Programs”

• Budget narrative with detailed justification by cost category/object class, and

• Plan for oversight of federal funds.

You should include supporting documentation for your budget (e.g., a copy of your approved indirect cost rate) as part of the budget package, not as part of your appendices to the project narrative. There is no page limit for the budget package contents. If you are recommended for an award, you may be asked to provide additional information about your budget package.

Throughout your budget package, “Federal resources” refers only to the funds you are requesting from the program office for this project. “Non-federal resources” are all other non-HHS/OASH federal and non-federal resources. Funds from federal grant programs typically are not eligible as https://grants.nih.gov/grants/forms/biosketch.htm cost share for other federal grants. It is your responsibility to confirm with other federal agencies whether funds you receive from them are eligible resources to apply to your proposed project.

Standard Form SF-424A

You must enter the project budget according to the directions provided with the standard form.

You must provide costs by object class category for the first 12 months (i.e., first budget period) of the proposed project using Section B, box 6 of SF-424A. If the estimated period of performance is 12 months or less, this will be your total budget request for the entire project.

"Federal resources" refers only to the funds for which you are applying under this NOFO. "Non-federal resources" are all other resources (federal and non-federal).

Do not include costs beyond the first budget period in the object class budget in box 6 of SF-

424A or box 18 of SF-424. The amounts entered in these sections should only reflect the first budget period.

If there is a discrepancy between your SF-424A and budget narrative and…