oppMP-CPI-18-001-cfda93.137-cidMP-CPI-18-001-060257-instructions.pdf

DEPARTMENT OF HEALTH AND HUMAN SERVICES

AGENCY: Office of the Assistant Secretary for Health, Office of Minority Health

FUNDING OPPORTUNITY TITLE: The National Lupus Training, Outreach, and

Clinical Trial Education Program (Lupus Program)

ACTION: Notice

ANNOUNCEMENT TYPE: INITIAL COMPETITIVE GRANT

FUNDING OPPORTUNITY NUMBER: MP-CPI-18-001

CFDA NUMBER: 93.137

CFDA PROGRAM: Community Programs to Improve Minority Health Grant Program

DATES:

Technical Assistance:

A technical assistance webinar for potential applicants will be held on February 7, 2018, from

3:00pm – 4:00pm Eastern Time. In addition, a technical assistance webinar for potential applicants on “Evaluation –Review the Basics” will be held on February 8, 2018, from 3:00pm –

4:00pm Eastern Time. Information on how to access the webinar will be posted on the Office of

Minority Health’s website, www.minorityhealth.hhs.gov.

Please be sure to review the entire announcement promptly so you can have any questions answered well in advance of the application due date.

Applications: Your application is due March 30, 2018 by 6 p.m. Eastern Time. To receive consideration, you must submit your application electronically via Grants.gov no later than this http://www.minorityhealth.hhs.gov/ due date and time. If you do not submit your application by the specified deadline, we will return it to you unread. You must submit electronically via Grants.gov unless you obtain a written exemption from this requirement 2 business days in advance of the deadline from the

Director, HHS/Office of the Assistant Secretary for Health (OASH) Office of Grants

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

HHS/OASH OGM, and provide details as to why you are technologically unable to submit electronically through Grants.gov. Your request should be submitted at least 4 business days prior to the application deadline to ensure your request can be considered prior to 2 business days in advance of the deadline. If you request an exemption, include the following in your e-mail request: the HHS/OASH announcement number; your organization's DUNS number; your organization’s name, address and telephone number; the name and telephone number of your

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

System for Account Management (SAM) registration prior to the application due date will not be grounds for receiving an exemption to the electronic submission requirement. Failure to follow

Grants.gov instructions to ensure software compatibility will not be grounds for receiving an exemption to the electronic submission requirement.

The HHS/OASH OGM will only accept applications via alternate methods

(hardcopy paper via U.S. mail or other provider or PDF via email) from applicants obtaining prior written approval. If you receive an exemption, you must still submit your application by the deadline. Only applications submitted through the Grants.gov portal or alternate format (hardcopy paper via U.S. mail or other service or PDF via email) with an mailto:ogm.oash@hhs.gov approved written exemption will be accepted. See Section D.7 (“Other Submission

Requirements”) for information on application submission mechanisms.

Executive Order 12372 comment due date: The State Single Point of Contact (SPOC) has 60 days from the application due date to submit any comments. For more information on the

SPOC see section D.4 Intergovernmental Review.

To ensure adequate time to successfully submit your application, HHS/OASH recommends that you register as early as possible in Grants.gov since the registration process can take up to one month. For information on registering for Grants.gov, refer to http://www.grants.gov or contact the Grants.gov Contact Center 24 hours a day, 7 days a week

(excluding Federal holidays) at 1-800-518-4726 or support@grants.gov.

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

EXECUTIVE SUMMARY: The Office of Minority Health (OMH), located within the

Office of the Secretary of the United States Department of Health and Human Services

(HHS or Department), announces the anticipated availability of funds for Fiscal Year (FY)

2018 for grant awards for the National Lupus Training, Outreach, and Clinical Trial Education

Program (Lupus Program) under the authority of 42 U.S.C. § 300u-6 (Public Health Service Act

§ 1707). This notice solicits applications for the Lupus Program.

The Lupus Program seeks to reduce lupus-related health disparities among racial and ethnic minority populations disproportionately affected by this disease and also increase minority participation in clinical trials by: (1) developing public-private and community partnerships to http://www.grants.gov/ mailto:support@grants.gov promote recruitment and enrollment of minority populations affected by lupus into clinical trials

(Priority A); and (2) creating a research plan and develop/test effective clinical trial education models in lupus for minority populations (Priority B). Priority A is designed to improve the enrollment of minority populations in clinical trials through partnerships that work to create culturally and linguistically appropriate tools, resources and materials for minority populations affected by lupus, their caregivers and health care providers, and assess the impact of current minority clinical trial education and participation programs. Priority B requires that applicants design and implement a research plan that aims to create effective clinical trial education models in lupus for minority populations using an experimental or quasi-experimental framework.

Applicants will be required to develop an action plan to disseminate the education models designed to increase minority populations’ participation. OMH expects the Lupus Program will accomplish the following goals:

Priority A: Increase the number of public-private and community partnerships with culturally and linguistically appropriate education and participation programs directed toward improving minority recruitment and enrollment in clinical trials related to lupus;

Priority B: Increase the number of innovative and effective provider education models that improve attitudes and practices of health care providers and paraprofessionals that will refer minority populations to clinical trials.

OMH expects to fund up to six grants to carry out Priority A or Priority B for a total of

$2,000,000 for both Priority A and Priority B, for a one year period of performance per year during a project period of two years. Each application should focus on only Priority A or on

Priority B. If you submit multiple applications under a priority area for the same project, we will consider the last application submitted prior to the deadline.

The assistance or benefits of the Lupus Program may not be denied to any person based on race, sex, color, or national origin.

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

A. PROGRAM DESCRIPTION:

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 which are designed to 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 system lupus erythematosus (SLE) which affects different parts of the body including internal organs, joints, skin, brain, lungs, kidneys, and blood vessels.2

Prevalence rates for children in the United States affected with SLE have been reported to range from 3.3 to 24.0 per 100,000.3 An estimated 10 to 20% of SLE diagnoses present during

1 Lim SS, Drenkard C. Epidemiology of lupus: an update. Current opinion in rheumatology. 2015;27(5):427-32.

2 McAlindon T. Update on the epidemiology of systemic lupus erythematosus: new spins on old ideas. Current opinion in rheumatology. 2000;12(2):104-12.

3 Hiraki LT, Benseler SM, Tyrrell PN, Hebert D, Harvey E, Silverman ED. Clinical and laboratory characteristics and long-term outcome of pediatric systemic lupus erythematosus: a longitudinal study. The Journal of Pediatrics.

2008;152(4):550-6.

childhood and adolescence, pediatric-onset cases are often associated with more severe symptoms that subsequently lead to rapid tissue or organ damage accrual than adult-onset SLE.4

Although science has made significant advances in the treatment and management of this disease, the cause of lupus is unknown and there is still no cure.

Lupus, in particular SLE, disproportionately affects minority populations, including

African Americans, Hispanics, Asians, and American Indians/Alaska Natives.5,6 Lupus is two to three times more common in African Americans .7 Other studies have demonstrated American

Indian and Alaska Natives have similar or higher rates of SLE to African Americans.8 The onset of lupus may occur at any age including in young children or the elderly; however, women of child bearing age (between 15 to 44 years old) are at the highest risk of onset.9 Women are more likely to be affected by lupus than men at an estimated ratio of 12 to 1.10 The racial and ethnic health disparity in lupus is closely related to the disparity seen in minority participation in clinical trials associated with autoimmune disorders.

4 Kamphuis S, Silverman ED. Prevalence and burden of pediatric-onset systemic lupus erythematosus. Nature reviews Rheumatology. 2010;6(9):538-46.

5 Dall'Era M, Cisternas MG, Snipes K, Herrinton LJ, Gordon C, Helmick CG. The Incidence and Prevalence of

Systemic Lupus Erythematosus in San Francisco County, California: The California Lupus Surveillance Project.

Arthritis & rheumatology (Hoboken, NJ). 2017;69(10):1996-2005.

6 Ferucci ED, Johnston JM, Gaddy JR, Sumner L, Posever JO, Choromanski TL, et al. Prevalence and incidence of systemic lupus erythematosus in a population-based registry of American Indian and Alaska Native people, 2007-

2009. Arthritis & rheumatology (Hoboken, NJ). 2014;66(9):2494-502.

7 Krishnan E, Hubert HB. Ethnicity and mortality from systemic lupus erythematosus in the US. Annals of the rheumatic diseases. 2006;65(11):1500-5.

8 Ferucci ED, Johnston JM, Gaddy JR, Sumner L, Posever JO, Choromanski TL, et al. Prevalence and incidence of systemic lupus erythematosus in a population-based registry of American Indian and Alaska Native people, 2007-

2009. Arthritis & rheumatology (Hoboken, NJ). 2014;66(9):2494-502.

9 National Institute of Arthritis and Musculoskeletal and Skin Diseases NIH. Systemic lupus erythematosus

Washington, DC: US Department of Health and Humans Services; Available from:

http://www.niams.nih.gov/Health_Info/Lupus/default.asp.

10 Dall'Era M, Cisternas MG, Snipes K, Herrinton LJ, Gordon C, Helmick CG. The Incidence and Prevalence of

Systemic Lupus Erythematosus in San Francisco County, California: The California Lupus Surveillance Project.

Arthritis & rheumatology (Hoboken, NJ). 2017;69(10):1996-2005.

http://www.niams.nih.gov/Health_Info/Lupus/default.asp

For the past twenty-five years, national efforts have been made by researchers and healthcare providers to increase minority participation in clinical trials. Recent evidence suggests that some progress has been made in enrolling minorities in different phases of clinical trial research, but there is still room for improvement. There is strong evidence that previous misconduct in human medical research is associated with the low participation of minorities in current clinical trials.11 To increase participation in clinical trials, researchers have studied the barriers to participation in medical research but few have developed intervention strategies or models to address the lack of minorities in all phases of clinical trials. Several studies exploring barriers to recruitment and enrollment have concluded the following themes contribute to the lack of participation in minority communities – patient mistrust of the medical and research community, lack of access to health care, the lack of participant understanding about clinical trials and the perceived direct or indirect benefits of medical research, and perceptions and biases of health providers about minority participation in clinical trials.12

Evidence from earlier studies indicated that patients from minority backgrounds, especially African Americans, have issues with trusting the medical community due to a history of exploitation of their community in medical research. A more recent study suggests that lack of access to transportation is a significant barrier for minority patients.13 Often the lack of access to affordable health care in minority populations contributes to the frequent use of emergency

11 Fisher JA, Kalbaugh CA. Challenging assumptions about minority participation in US clinical research. American

Journal of Public Health. 2011;101(12):2217-22.

12 Durant RW, Wenzel JA, Scarinci IC, Paterniti DA, Fouad MN, Hurd TC, et al. Perspectives on barriers and facilitators to minority recruitment for clinical trials among cancer center leaders, investigators, research staff, and referring clinicians: enhancing minority participation in clinical trials (EMPaCT). Cancer. 2014;120 Suppl 7:1097-

105.

13 Kurt A., Semler, L et al. Racial differences among factors associated with participation in clinical research trials.

Journal Racial & Ethnic Health Disparities (2017) 4: 827-836.

rooms or urgent care for medical treatment, this absence of continuity in care may contribute to the decreased likelihood of a patient being referred to a clinical trial.14,15

Patients with medical conditions may be unaware that they are eligible to enroll in clinical trials due to the lack of knowledge or awareness about trial participation. Many minority patients may also hold the belief that neither they nor their community will directly benefit from participating in a trial, and thus may decline enrollment.16 Others may find the presumed risks of participating in a trial not clearly outlined in recruitment or informed consent materials.

Information about clinical trials should also be made available for those with Limited English

Proficiency (LEP), who are often not recruited due to the expense and difficulty with translating trial information and consent forms into multiple languages. Improving the knowledge and understanding about clinical trials and the importance of diverse participant populations in medical research may increase the participation rates of minority populations in clinical trials.

Health care providers play a key role in communicating information about lupus to patients, and this also includes relaying information about enrolling into clinical trials. Research shows implicit bias against minority populations can prohibit physicians from presenting enrollment into clinical trials as an option. An example of this bias is a health provider not referring a patient to a trial due to the perception that minority participants are less likely to adhere to complicated instructions given in research studies. These biases are often influenced by

14 Fisher JA, Kalbaugh CA. Challenging assumptions about minority participation in US clinical research. American

15 Durant RW, Wenzel JA, Scarinci IC, Paterniti DA, Fouad MN, Hurd TC, et al. Perspectives on barriers and facilitators to minority recruitment for clinical trials among cancer center leaders, investigators, research staff, and referring clinicians: enhancing minority participation in clinical trials (EMPaCT). Cancer. 2014;120 Suppl 7:1097-

105.

16 Corbie‐Smith G, Thomas SB, Williams MV, Moody‐Ayers S. Attitudes and beliefs of African Americans toward participation in medical research. Journal of General Internal Medicine. 1999;14(9):537-46.

racial stereotypes in society and can limit the referral for trial enrollment for populations that differ from the referring physician.17

A multilevel model solution derived from general systems theory posited by Hamel et al., suggests medical institutions can increase minority participation in clinical trials by enhancing community engagement through trusted partnerships with members (organizations) of the community for which it serves.15 Additionally, their model supports developing relationships with local health providers that work directly with minority populations. Anecdotal reports suggest that minority populations, in particular African Americans and Hispanics, are more likely to participate in phase I of a clinical trial although these same populations have much lower rates of participation in the subsequent clinical trial phases. 18

The underrepresentation of minority populations in all phases of clinical trials generates concern about the reduced generalizability of results derived from research findings in medical research, and further widens the gap of health disparities in disease management and treatment of lupus. In order to address the barriers related to the recruitment, enrollment, and retention of minority participants into all phases of clinical trials, researchers must focus on developing effective clinical trial education models that focus on the inclusion of a diverse population of participants in clinical trials.

Purpose

17 Hamel LM, Penner LA, Albrecht TL, Heath E, Gwede CK, Eggly S. Barriers to clinical trial enrollment in racial and ethnic minority patients with cancer. Cancer control: Journal of the Moffitt Cancer Center. 2016;23(4):327.

18 Fisher JA, Kalbaugh CA. Challenging assumptions about minority participation in US clinical research. American

The purpose of the National Lupus Training, Outreach, and Clinical Trial Education

Program (Lupus Program) is to eliminate health disparities among racial and ethnic minority populations and disadvantaged populations disproportionately affected by lupus, and improve the participation of minority populations in clinical trials. The Lupus Program aims to promote collaborative efforts between organizations and agencies that serve the lupus community, in order to expand the development of culturally and linguistically appropriate tools, resources and materials for persons living with lupus, their caregivers and health care providers.

Project Requirements

Each application must propose to conduct activities in one of two priority areas:

Priority A: Public-Private-Community Partnerships

Priority A focuses on developing public-private and community partnerships and evaluating minority clinical trial education and participation programs.

Priority A applications must propose projects with activities designed to:

foster public-private and community partnerships to address minority populations’ participation in clinical trials;

evaluate the effectiveness of current clinical trial education and participation programs; and engage the lupus community to expand the development of culturally and linguistically appropriate tools, resources, and materials geared towards adults and children affected by lupus, as well as, their caregivers and health care providers.

Each Priority A project must target a minimum of two or a maximum of three Medically

Underserved Areas and Populations (MUA/Ps), as defined in Appendix A to this

Announcement.

Priority B: Effective and Innovative Clinical Trial Education Models

Priority B focuses on designing a research plan and developing effective clinical trial education models in lupus for minority populations and education models for health care providers and health paraprofessionals.

Priority B applications must propose projects that will:

create a research plan for effective clinical trial education models focused on increasing the enrollment of minority populations into clinical trials at all phases;

examine the attitudes, beliefs, and practices (behavioral intentions) of primary care physicians (PCPs), other health care providers and paraprofessionals associated with the referral of minority populations to clinical trials;

develop and test innovative model education programs for PCPs, other health care providers and paraprofessionals serving minority populations;

implement PCP, other health care provider, and paraprofessional educational interventions using the selected model during the project period, and adapt the intervention(s) for clinical trial education to address lupus using a culturally and linguistically appropriate framework for minority populations;

design recruitment and participation initiatives for PCPs with the goal of increasing clinical trial participation and education among minority populations;

develop and submit an action plan for disseminating a successful education intervention; and prepare a manuscript for publication that reports the results of the educational intervention evaluation during the project period.

Each Priority B project must target a minimum of two or a maximum of three Medically

Underserved Areas and Populations (MUA/Ps).

Project Requirements for Both Priority A and Priority B

All applicants are required to use the National Standards for Culturally and Linguistically

Appropriate Services in Health and Health Care (National CLAS Standards)19 as a framework to develop Priority A and Priority B proposals.

OMH expects successful applicants to utilize standard practices necessary for effective collaborative partnerships. This includes developing a structure for involvement, regularly engaging community and partnering organizations in the design and review of strategies, tools, resources, and approaches needed to carry out the Lupus Program, and leveraging the strengths of each partner organization without duplication of effort.

In addition, OMH expects that successful applicants will have significant demonstrated expertise in:

Lupus epidemiology, diagnosis, treatment, and disparity related issues in both adults and children;

19 https://www.thinkculturalhealth.hhs.gov/clas/standards .

http://www.minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53 https://www.thinkculturalhealth.hhs.gov/clas/standards

Implementing and executing the most effective strategies for achieving desired outcomes resulting from provider and paraprofessional education;

Designing and testing provider, paraprofessional and caregiver education model(s);

Gaining access to representative samples of health care providers and paraprofessionals;

Implementing a provider, paraprofessional and caregiver education program;

Evaluating provider, paraprofessional and caregiver education programs across the full spectrum of health professions and para professions serving in primary care settings; and

Training providers and paraprofessionals in delivering culturally and linguistically appropriate care.

For both priorities, the applicant must demonstrate that the proposed project involves a collaborative partnership with at least two partners (including the applicant), one of whom must be a:

Federally Qualified Health Center (FQHC), community health center, or local hospital;

State or local professional organization that represents PCPs or other health care providers, or paraprofessionals; or

Native American tribe or tribal organization or other tribal cultural organization.

Each applicant for funding under the Lupus Program must serve as the lead agency for the project, responsible for its implementation and management; and serve as the fiscal agent for the federal grant if awarded. The applicant organization must represent a collaborative partnership that includes a variety of networks. Collaborating network partners may include, but are not limited to, community health center, local healthcare center and hospital, community center and other healthcare provider, chronic disease management program, etc.

Applicants must also have the necessary partnerships already in place to conduct the proposed intervention(s). Moreover, successful applicants will have a history of forming, managing, and engaging community and partnering organizations in the conduct of health related initiatives.

Each application must address only Priority A or Priority B, and must state whether it seeks funding for Priority A or Priority B. If multiple applications for the same project are submitted under a priority area, only the last application submitted prior to the deadline will be considered.

These demonstration grants are not intended to fund ongoing program operations or replace existing or expiring funding, but rather to test modifications or new innovative programs that are grounded in and build upon successful evidence-based programs.

The assistance or benefits of the Lupus Program may not be denied to any person based on race, sex, color, or national origin.

OMH Expectations

OMH expects that, for the project’s targeted geographic areas, the lupus intervention will result in:

Priority A

Increased number of public-private and community partnerships that promote lupus-related clinical trial education and participation programs;

Increased use of culturally and linguistically appropriate tools, resources and materials to disseminate clinical trial information to patients and their families;

Increased number of individuals with knowledge about lupus and its symptoms and information about participating in clinical trials; and

Evaluation of the effectiveness of existing clinical trial education and participation programs.

Priority B

Identification of successful and effective evidence-based provider education intervention models to improve knowledge, attitudes, and practices of PCPs, other health care providers and paraprofessionals regarding minority participation in clinical trials;

Use of experimental design to evaluate culturally and linguistically appropriate lupus clinical trial education, recruitment, and participation intervention models that focus on minority populations; and

An action plan for disseminating the education models to increase minority populations’ participation in lupus clinical trials.

Performance Measures: Process and Outcome Measures

OMH requires that all funded projects document program progress through the use of process and outcome performance measures throughout the project’s period of performance. The process and outcome measures should be depicted in the proposed project’s logic model, and clearly align with the proposed project’s objectives, strategies and practices or activities, and long-term goals.

All projects must include process and outcome measures of implementation of the

National Standards for Culturally and Linguistically Appropriate Services in Health and

Health Care (National CLAS Standards). To measure the impact of implementation of the National CLAS Standards, OMH recommends use of the Consumers Assessment of

Health Providers and Systems (CAHPS) Cultural Competency Item Set and/or the

Experience of Care and Health Outcomes Survey.

OMH recommends the following process and outcome measures:

Priority A:

Priority A programs should:

(1) Foster public-private and community partnerships to address minority populations’ participation in clinical trials; evaluate the effectiveness of current clinical trial education and participation programs; and

(2) Engage the lupus community to expand the development of culturally and linguistically appropriate tools, resources, and materials geared towards adults and children affected by lupus, as well as, their caregivers and health care providers.

Recommended Process Measures for Priority A Programs:

a. Number of collaborative work plans dedicated to the development of clinical trials educational and participation programs.

b. Number of persons aware of lupus-related clinical trials in minority populations.

c. Number of PCPs, other health care providers, caregivers and paraprofessionals who use culturally and linguistically appropriate lupus materials to disseminate information about clinical trials to patients and families.

d. Number of collaborating partner organizations.

e. Number of programs/services that are responsive to the cultural and linguistic needs of the project’s target communities.

f. Number of clinical trial education and participation programs.

Recommended Outcome Measures for Priority A Programs:

a. Significant increase in collaborative work plans dedicated to the development of clinical trials educational and participation programs.

b. Significant increase in target populations’ awareness of lupus-related clinical trials in minority populations.

c. Significant increase in the number of PCPs, other health care providers, caregivers and paraprofessionals who use culturally and linguistically appropriate lupus materials to disseminate information about clinical trials to patients and families.

d. Significant improvement in the effectiveness of collaborative efforts with partner organization(s).

e. Significant improvement in program services that meet the National CLAS

Standards and are responsive to the needs of the project’s target communities.

f. Significant increase in the number of minority populations’ participation in clinical trial education programs.

Priority B:

Priority B programs should:

(1) Create a research plan for effective clinical trial education models focused on increasing the enrollment of minority populations to clinical trials at all phases;

(2) Examine the attitudes, beliefs, and practices (behavioral intentions) of PCPs, other health care providers and paraprofessionals associated with the referral of minority populations to clinical trials;

(3) Develop and test innovative model education programs for PCPs, other health care providers and paraprofessionals serving minority populations;

(4) Implement PCPs, other health care providers, and paraprofessional educational interventions using the selected model during the project period, and adapt the intervention(s) for clinical trial education to address lupus using a culturally and linguistically appropriate framework for minority populations;

(5) Design recruitment and participation initiatives for PCPs with the goal of increasing clinical trial participation and education among minority populations;

(6) Develop and submit an action plan for disseminating a successful education intervention; and

(7) Prepare a manuscript for publication that reports the results of the educational intervention evaluation during project period.

Recommended Process Measures for Priority B Programs:

a. Number of resulting clinical trial education model(s) that result in the improvement of the use by PCPs, other health care professionals, caregivers and paraprofessionals of culturally and linguistically appropriate materials to communicate lupus-related clinical trial information in a health care setting.

b. Number of resulting clinical trial education model(s) that result in improvements in the knowledge, attitudes and intentions to educate, recruit or refer minority populations into clinical trials in a culturally and linguistically appropriate manner and that led to a meaningful impact on the willingness of minority patients to participate in clinical trials.

c. Number of programs/services that are responsive to the cultural and linguistic needs of the project’s target communities.

d. Number of minority populations participating in model clinical trial education programs.

Recommended Outcome Measures for Priority B Programs:

a. Significant increase in the number of PCPs, other health care professionals, caregivers and paraprofessionals’ use of culturally and linguistically appropriate materials to communicate lupus clinical trial information in a health care setting.

b. Significant increase in the number of clinical trial education models that result in the improvement of PCPs, other health care professionals, caregivers and paraprofessionals’ use of culturally and linguistically appropriate materials to communicate lupus-related clinical trial information in a health care setting.

c. Significant improvements in clinical trial education models that result in improvements in the knowledge, attitudes and intentions of providers, other health care professionals, and paraprofessionals to educate, recruit or refer minority populations into clinical trials in a culturally and linguistically appropriate manner and that led to a meaningful impact in the willingness of minority patients to participate in clinical trials.

d. Significant improvement in program services that meet the National CLAS

Standards and are responsive to the needs of the project’s target communities.

e. Significant increase in minority populations’ participation in lupus clinical trial.

AUTHORITY: 42 U.S.C. § 300u-6 (Public Health Service Act § 1707)

B. FEDERAL AWARD INFORMATION

OMH intends to make available approximately $2,000,000 for competing grants. The final funding amount will not be determined until enactment of the FY 2018 federal budget.

We will fund the Lupus Program awards in annual increments (budget periods) and generally for a project period of up to two years. Funding for all approved budget periods beyond the first year of the award 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: up to 6

Award Ceiling (Federal Funds including indirect costs): Priority A: $375,000 per budget period; Priority B: $500,000 per budget period

Award Floor (Federal Funds including indirect costs): Priority A: $325,000 per budget period; Priority B: $425,000 per budget period

Anticipated Start Date: 07/01/2018

Period of Performance: Not to exceed 2 years

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.

State governments

County governments

Special district governments

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 with 501 (c)(3) IRS status (other than institution of higher education)

Nonprofits without 501(c)(3) IRS status (other than institution of higher education)

Private Institutions of higher education

For-profit organizations (other than small business)

Small, minority, and women-owned businesses

2. Cost Sharing or Matching You are not required to provide cost sharing or matching in your proposed budget.

3. Other Eligibility Information

Application Responsiveness Criteria

We will review your application to determine whether it meets the following responsiveness criteria. If your application does not meet the responsiveness criteria, we will eliminate it from the competition and it will not be reviewed.

The applicant must submit with its application in the Appendices a Letter of

Commitment (LOC) between the applicant organization and each partner organization or agency identified at the time of application. Each LOC must clearly delineate the roles and responsibilities of each partner, summarize the activities to be carried out by each organization relative to the proposed project; identify the resources each partner organization will provide to the project and the source of resources, if federally supported; indicate the amount of grant funds, if any, the partner organizations will receive from the project (if awarded); and indicate the specific dates of the agreement and the terms for termination of the agreement. A representative from the applicant organization and each partner organization must sign the LOC. The agreement must be signed by individuals with the authority to represent the organizations (e.g., president, chief executive officer, executive director, agency authorizing official). Signatures may be by facsimile transmission or other electronic means, and the LOC may be executed in any number of counterparts, all of which together shall constitute one signed LOC.

The application must demonstrate that the National Standards for Culturally and

Linguistically Appropriate Services in Health and Health Care (National CLAS

Standards) serves as a framework for project interventions, resources, and materials.

Applicants for a Priority A project or a Priority B project must target two to three

MUA/Ps. A brief description of the proposed MUA/Ps must be included in the

Project Abstract Summary and Executive Summary.

Application Disqualification Criteria

If you successfully submit an application, we will screen it to assure a level playing field for all applicants. If we determine your application fails to meet the criteria described below we will disqualify it, that is, it will not be reviewed and will receive no further consideration.

a) You must submit your application electronically via www.grants.gov (unless an exemption was granted 2 business days prior to the deadline) by the date and time indicated in the

DATES section of this announcement.

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

c) HHS/OASH/OGM deems your application eligible according to section C.1 Eligible

Applicants.

d) Your Project Narrative section of the application must be double-spaced, on the equivalent of

8 ½ ” x 11” inch page size, with 1” margins on all sides (top, bottom, left and right) and font size not less than 12 points.

e) Your Project Narrative must not exceed 50 pages. NOTE: The following items do not count toward the 50 page limit: all required forms, including SF-424, SF-424A, SF-424B, SF-LLL, Project Abstract Summary, and Budget Narrative (including budget tables).

f) Your total application, including the Project Narrative plus Appendices, must not exceed 75 pages. NOTE: items listed in “e” immediately above and any information about previously federally funded lupus project(s) do not count toward the 75 page total maximum limit.

g) Your Federal funds request including indirect costs does not exceed the maximum indicated in Range of Awards.

h) Your application meets the Application Responsiveness Criteria outlined above.

D. APPLICATION AND SUBMISSION INFORMATION

1. Address to Request Application Package

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

Office of Grants Management

Phone: 240-453-8822

Email: ogm.oash@hhs.gov

2. Content and Form of Application Submission

i. Letter of Intent: We are not requesting a letter of intent.

ii. Application Format

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

The Project Narrative, and total application including appendices, must adhere to the page limit indicated in Application Disqualification Criteria listed in Section C.

You must double-space the Project Narrative pages.

You should use an easily readable typeface, such as Times New Roman or Arial. You must use 12-point font. You may single-space tables or use alternate fonts but you must ensure the tables are easy to read. The page limit does not include the Budget Narrative (including budget tables), required forms, assurances, and certifications as described in the Application

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

mailto:ogm.oash@hhs.gov

If your application exceeds the specified page limits for the Project Narrative or Project

Narrative plus Appendices when printed on 8.5” X 11” paper by HHS/OASH/OGM, we will not review it. We recommend you print out your application before submitting electronically to ensure that it is within the page limits and is easy to read.

Appendices

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

Project Abstract Summary

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

Budget Narrative

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.

iii. Application Content

Successful applications will contain the following information:

Project Narrative

The Project Narrative is the most important part of the application, since it will be used as the primary basis to determine whether or not your project meets the minimum requirements for an award under this announcement. The Project Narrative should provide a clear and concise description of your project. HHS/OASH recommends that your project narrative include the following components:

Executive Summary

Problem Statement

Organizational Capability

Goals and Objectives

Outcomes

Program Plan

Proposed Intervention

Special Target Populations and Organizations

Project Management

Evaluation

Dissemination

Executive Summary. This section should include a brief description of the proposed project, including: goal(s); objectives; MUA/Ps including the communities and populations to be served in which the project will be implemented; expected outcomes;

and products to be developed.

Problem Statement. This section should describe, in both quantitative and qualitative terms, the nature and scope of the specific and particular problem or issue, and the proposed intervention it is designed to address. It should detail how the project will potentially affect the populations served, specific subgroups within those populations, and other interested stakeholders as identified. The applicant must address the problem concerning lupus in each of the geographic areas selected.

Organizational Capability. Your application should include an organizational capability statement and vitae or biographical sketches for key project personnel. The organizational capability statement should describe how the applicant agency (or the particular division of a larger agency which will have responsibility for this project) is organized, the nature and scope of its work, and the capabilities it possesses. This description should cover capabilities of the applicant agency not included in the program narrative, such as any current or previous relevant experience and/or the record of the project team in preparing cogent and useful reports, publications, and other products. The applicant should document significant experience working on lupus, the necessary partnerships in place to conduct the intervention, and knowledge regarding the most effective strategies for working with these entities to achieve Lupus Program programmatic goals. Experience documentation should include a brief synopsis regarding any lupus project funding currently received or received within the past five years and briefly describe the innovative strategy. The applicant should also document significant knowledge and expertise in lupus epidemiology, diagnosis, treatment, and disparity related issues. For Priority B, the applicant should also document significant knowledge and expertise in issues related to clinical trials to support developing and implementing innovative education interventions and models regarding clinical trials. Include an organizational chart showing the relationship of the project to the current organization and include the organizational chart in the Appendices. This chart may also include the contractual and/or supportive organizations that will become part of the network.

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

Goals and Objectives. This section should consist of a description of the project’s goal(s) and major objectives. Objectives must follow the SMART approach (Specific, Measurable, Attainable/Achievable, Relevant, and Time bound.) Developing specific, measurable objectives requires time, orderly thinking, and a clear picture of the results expected from program activities. The more specific your objectives are, the easier it will be to demonstrate success. SMART objectives can serve as your performance measures because they provide the specific information needed to identify expected results.

Outcomes. This section of the project narrative must clearly identify the measurable outcome(s) that will result from your project. HHS/OASH will not fund any project that does not include measurable outcomes. In addition to discussion in the narrative, applicants must describe how they envision the project will benefit the field at large.

A “measurable outcome” is an observable end-result that describes how a particular intervention benefits program participants. It demonstrates the “impact” of the intervention. For example, a change in a client’s financial, health, and/or functional status; mental well-being; knowledge; skill; attitude; awareness; or behavior. It can also describe a change in the degree to which participants exercise choice over the types of services they receive, or whether they are satisfied with the way a service is delivered.

Additional examples include: a change in the responsiveness or cost-effectiveness of a service delivery system; a new model of support or care that can be replicated; new knowledge; a measurable increase in community awareness; or a measurable increase in persons receiving services. A measurable outcome is not a measurable output, such as:

the number of clients served; the number of training sessions held; or the number of service units provided.

You should keep the focus of this section on describing what outcome(s) will be produced by the project. You should use the Evaluation section noted below to describe how the outcome(s) will be measured and reported. Your application will be scored on the clarity and nature of your proposed outcomes, not on the number of outcomes cited.

In some cases, it is appropriate for a project to have only ONE outcome that it is trying to achieve through the intervention reflected in the project’s design.

Program Plan

Proposed Intervention/Plan. This section should provide a clear and concise description of the intervention/plan you are proposing to use to address the need identified in the program announcement and the problem described in the

“Problem Statement” above. Describe specific innovative strategies, practices, or interventions planned to achieve each objective that are expected have a positive impact. You are expected to explain the rationale for using a particular intervention/plan and to present a clear connection between identified system gaps and needs and your proposed activities. Describe the unique role and responsibilities of each partner in the collaborative partnership. Your proposal should detail the nature of the activities to be undertaken, how they address system gaps and identified issues, and how they will assist in achieving the overall project goals and objectives. Clarification as to why these specific activities were selected is appropriate (i.e. has this approach been successful in other settings? Does the research suggest this direction?). Also note any major barriers you anticipate encountering and how your project will be able to overcome those barriers. At minimum, you should:

o Describe the role and makeup of potential sub-recipients intended to be involved in completing specific tasks, and identify the level of effort each sub-recipient is anticipated to provide in completing programmatic activities.

o Provide specifics about the strategies, expected outcomes, and barriers for all anticipated years of the grant.

Special Target Populations and Organizations. This section should describe how you plan to involve community-based organizations, network partners, and stakeholders in a meaningful way in the planning and implementation of the proposed project. This section should also describe how your proposed intervention will target minority populations, including limited English speaking populations. This section should also identify the languages spoken by the target populations.