MP-CPI-23-003 Full Announcement Revised 06-28-2023.pdf

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-23-003

Application Due Date:

08/01/2023 at 6:00 PM Eastern

Revised June 28, 2023 to correct period of performance on page 8 and to correct numbering of review criteria on page 34.

OVERVIEW

FEDERAL AGENCY NAME

The Office of the Assistant Secretary for Health, Office of Minority Health

FUNDING OPPORTUNITY TITLE

National Lupus Outreach and Clinical Trial Education Program

ACTION

Notice

ANNOUNCEMENT TYPE

Initial G (Grant)

FUNDING OPPORTUNITY NUMBER

MP-CPI-23-003

ASSISTANCE LISTING NUMBER AND PROGRAM:

93.137 , Community Programs to Improve Minority Health

DATES

Application Deadline: 08/01/2023 by 6:00 PM Eastern.

Technical Assistance Webinar: 06/27/2023 at 4:30 PM Eastern.

EXECUTIVE SUMMARY

The Office of Minority Health announces the availability of funds for Fiscal Year (FY) 2023 under the authority of 42 U.S.C. § 300u-6 (Section 1707 of the Public Health Service Act).

This notice solicits applications for projects to demonstrate the effectiveness of interventions for increasing racial and ethnic minority enrollment and retention in lupus-related clinical trials.

Projects will identify and sustain effective interventions that advance clinical trial diversity and ultimately result in reduced lupus-related health disparities experienced by racial and ethnic minority populations. Increasing minority participation in lupus clinical trials is important for addressing lupus-related racial and ethnic health disparities. Recipients will sustain increased enrollment of racial and ethnic minorities in lupus-related clinical trials through outreach and education interventions, and public-private and community partnerships. Recipients also will assess the impact of project findings by implementing a process and outcomes evaluation for dissemination to diverse stakeholders.

The Office of Minority Health (OMH) has supported past initiatives focused on lupus education for health professionals, improving diagnosis and treatment, and increasing clinical trial diversity. These past OMH efforts will inform this initiative, using the education and outreach approaches previously developed to increase participation in clinical trials. OMH encourages recipients to use previously OMH-funded lupus interventions to build sustainable methods for increasing enrollment in lupus-related clinical trials through outreach and educational interventions and public-private community partnerships.

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

B. Federal Award Information

1. Legal Authority

2. Award Information

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. 42

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. Existing OMH-funded Interventions

6. Clinical Trial Locator Resources

7. References Cited

A. Program Description The Office of Minority Health announces the availability of funds for Fiscal Year (FY) 2023 under the authority of 42 U.S.C. § 300u-6 (Section 1707 of the Public Health Service Act).

We have supported programs to address lupus disparities since 2009. The lupus program has helped to improve lupus awareness, diagnosis, and treatment through increased collaboration among lupus organizations dedicated to research, education, support, and advocacy; improved outreach and education efforts in the community; and engagement of healthcare providers, educators, and health professions schools. This initiative will target individuals, patients, communities, and practicing professionals in geographic areas and populations where lupus is more prevalent. Under this initiative, we will continue to support the development of public-private partnerships with organizations representing lupus patients, implementation of effective interventions, and engagement of the lupus community to increase participation in lupus clinical trials for minority populations at highest risk.

1. Background

Lupus is a chronic autoimmune disease that causes inflammation in different tissues of the body, which leads to numerous clinical symptoms, and poses disease management and treatment challenges for patients and health care providers.[1] Normal functioning immune systems produce antibodies that protect against infection or foreign agents. In autoimmune disorders, such as lupus, the immune system cannot differentiate between foreign microorganisms and healthy tissue, which triggers the creation of autoantibodies that attack the body’s healthy tissue, causing widespread inflammation as well as tissue and organ damage. The most common form of lupus is systemic lupus erythematosus (SLE), which affects different parts of the body including internal organs, joints, skin, brain, lungs, kidneys, and blood vessels.[2]

Although science continues to make significant advances in the treatment and management of this disease, the cause of lupus is unknown, and no cure exists. There is evidence of racial and ethnic disparities related to lupus, and differences by gender. African Americans are three to four times more likely to develop lupus than non-Hispanic whites.[3] A lupus study in California looked at four racial/ethnic groups: Blacks, whites, Asians/Pacific Islanders (APIs), and Hispanics. Findings indicated that Blacks, APIs, and Hispanics are at increased risk of developing severe symptoms and complications following SLE Diagnosis.[4] Other studies show that SLE rates among American Indians and Alaska Natives (AI/ANs) are similar or higher rates than rates among African Americans.[5] The onset of lupus may occur at any age, including among young children or the elderly; however, women of childbearing age (between 15 and 44 years old) are at the highest risk of onset.[6] Women are far more likely to have lupus than men at an estimated ratio of 12 to 1.[4] Women of color—African Americans, Hispanics/Latinos, AI/ANs, and APIs—are two to three times more likely to have lupus than white women.[7] Recent studies indicate that one in 537 young African American women have lupus.[7] Studies have demonstrated that minority women tend to develop lupus at a younger age, experience more serious complications, and have higher death rates from the disease.[7]

Clinical trials play a key role in identifying and developing new and better treatments for diseases, including lupus. Currently, there are approximately 400 sites seeking participation in lupus clinical trials in the U.S. and Canada.[8] Though many opportunities to participate in clinical trials exist, clinical trials for lupus have had limited success in recruiting minority participants.[9] This challenge is in line with the under-representation of racial and ethnic minority populations in clinical trials in general.[10] A recent study of national and international randomized controlled trials with lupus patients calculated that only 14 percent of those enrolled were Black, while Black people make up 43 percent of lupus cases. This same study noted that Black representation in randomized controlled trials in the US decreased between 2006 and 2011.[11] The Food and Drug Administration recommends that the participant pool in clinical trials reflect the demographics of the disease that the medical product is intended to treat.[12] Low minority participation in lupus clinical trials results in a lack of data on the effectiveness, safety, and side effects of treatment within populations with the highest incidence, prevalence, morbidity, and mortality.[13]

To increase participation in clinical trials, researchers have studied the barriers to participation in medical research. However, there are few evidence-supported interventions strategies or models to address the lack of minority participation in clinical trials. Studies exploring barriers to recruitment and enrollment have concluded the following factors contribute to the lack of clinical trial participation by minority populations: patient mistrust of the medical and research community, lack of access to health care, and lack of participant understanding clinical trials the benefits. Perceptions and biases of health care providers about minority participation and the lack of knowledge and awareness of clinical trials contributes to low minority participation. There are also logistical challenges that create barriers for participant referrals by providers.[10] Clinical trial sites are not in areas where minorities receive healthcare and clinic trial sponsors may not utilize voices in the community to recruit participants. Given these barriers, the adaption of interventions and models with strong evidence of engaging and increasing racial and ethnic populations in clinical trials have been found to be more viable and cost-effective options.

Adaption not only can preserve the effectiveness of an intervention but also enhance the results that are reached in clinical trials.

2. Expectations for Funded Projects

Funded projects should meet the following expectations:

a. Develop Public-Private and 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 racial and ethnic minority enrollment and retention in lupus clinical trials.

Recipients should implement a project that involves at least two collaborative partnerships with at least two different organizations. 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;

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) in their project implementation as appropriate.

b. Adaptation of Existing Interventions

We encourage recipients to adapt an existing OMH-funded intervention (Section I.5) to increase minority participation in clinical trials for the intended population of focus, while maintaining the fidelity of the original intervention. Fidelity refers to the degree to which an implementer adheres to the core components of the intervention. 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 racial and ethnic minority communities within cities and/or counties where lupus clinical trials are recruiting patients (for current trials, see Section I.6). Interventions may include:

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

Outreach and social media campaigns on lupus clinical trials aimed toward racial and ethnic minority individuals;

Capacity-building models designed to recruit, enroll and retain participants in clinical trials and patient-centered, culturally appropriate 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. Including diverse racial and ethnic populations in lupus clinical trials will ensure that treatment approaches and outcomes reflect the reality of the disease among various groups, thereby promoting health equity and facilitating a better understanding of the disease.

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 racial and ethnic minority 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.

e. Document and Disseminate Project Findings

We anticipate recipients will develop new knowledge about existing interventions that increase minority 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 equitably accessible to the public.

f. Develop a Disparity Impact Statement

Recipients should 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.

B. Federal Award Information

1. Legal Authority

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

2. Award Information

We intend to make funds available for competing G (Grant) 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 $2,000,000

Anticipated Number of Awards 6

Award Ceiling (Federal Funds including indirect costs) $500,000 per budget period

Award Floor (Federal Funds including indirect costs) $300,000 per budget period

Anticipated Start Date 09/01/2023

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

Anticipated Initial Budget Period Length 12 months

Type of Award Grant

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

C. ELIGIBILITY INFORMATION

1. Eligible Applicants

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

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).

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 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).

g. Your total application (i.e., the Project Narrative plus Appendices) must not exceed 80 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.

https://grants.gov/

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

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)) https://www.grants.gov/ mailto:OASH_Grants@hhs.gov

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.

d. Budget Narrative Format

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

3. Application Content

Successful applications will contain the following information:

a. Project Narrative Content

The Project Narrative is the most important part of the application, since it will be used as the primary basis to determine whether your project meets the minimum requirements for an award under this announcement. The Project Narrative should provide a clear and concise description of your project. We recommend that your project narrative include the following components: 1) Significance of the Project; 2) Goals, Objectives, and Outcomes; 3) Project Plan; 4) Organizational Capability; 5) Evaluation Plan; and 6) Dissemination Plan.

1) 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 in of clinical trial participants within your intended population(s) and geographic area(s) of focus to address the disproportionate impact of lupus on racial and ethnic minority populations. Refer to the population of focus data provided in your appendices (Section D.3.c.3) 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.

2) 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 SMARTIE (specific, measurable, attainable, relevant, time-bound, inclusive, equitable).

SMARTIE objectives should include baseline data and quantifiable time-frames 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 time-frame. 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).

3) Project Plan

In reference to your work plan in your appendices (Section D.3.c.1), provide a detailed summary of activities to be undertaken, and how those activities will assist in achieving the project goals and objectives including increasing minority participation in lupus-related clinical trials. Explain the rationale for the lupus intervention you selected (previously OMH-funded interventions encouraged), 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 minority participation and address barriers to minority 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.

4) 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 responsibile 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 minority populations in clinical trials. Describe any experience and expertise in providing outreach to and education of minority populations; clinical trial outreach to increase enrollment; evaluation of outreach education and training program related to recruitment, participation and retention in clinical trials; and working 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)(Section D.3.c.#). 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 vitae, resumes, or biographical sketches you submit (Section D.3.c.#). At a minimum, key personnel includes the Program https://thinkculturalhealth.hhs.gov/clas/standards

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 disparity-related 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 does 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.

Reference the organizational chart in your appendices (Section D.3.c.#). 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.

5) 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 equity impact of the project on the identified health disparities. 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. Describe how you will evaluate all project components of the project’s logic model (Section D.3.c.2), including how the inputs, processes, outputs, and outcomes will be measured. Describe how you will assess the extent to which the intervention(s) increased racial and ethnic minority enrollment and retention in lupus clinical trials. Describe any involvement of your partners in the evaluation activities. .

6) 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 informing those who might be interested in using the results of your project. Dissemination efforts should focus on assisting those you may replicate 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. 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, 10% $30,000 $3,000 $3,000

Position Title and

Full Name

Percent Time

Annual Salary

Federally-funded Salary

Non-federal Salary

Total Project Salary

Susan R.

Smith

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.